UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

☒
☒			QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, ~~2019~~

2020

☐
☐			TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to .

Commission File Number: 000-21088

~~VICAL INCORPORATED~~

BRICKELL BIOTECH, INC.

(Exact name of registrant as specified in its charter)

~~Delaware~~

~~93-0948554~~

Delaware

93-0948554

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

~~10390 Pacific Center Court~~

~~San Diego, California~~

5777 Central Avenue,

~~92121~~

Boulder,

80301

(Address of principal executive offices)

(Zip Code)

~~(858) 646-1100~~

(720) 505-4755

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Securities Act:


Title of each class	Trading symbol(s)	Name of each exchange on which registered
Common ~~Stock,~~stock, $0.01 par value per share	~~VICL~~ BBI	The Nasdaq ~~Capital~~Stock Market LLC

Indicate by check mark whether the ~~registrant~~registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth ~~company~~.company. See the definitions of ‘‘large accelerated filer,’’ ‘‘accelerated filer,’’ ‘‘smaller reporting company,’’ and ‘‘emerging growth company’’ in Rule ~~12b–2~~12b-2 of the Exchange Act.


Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

~~Indicate the number~~

As of August 12, 2020, there were 27,787,081 shares ~~outstanding of each~~ of the ~~issuer’s classes of~~registrant’s common stock ~~as of the latest practicable date.~~

~~Total shares of common stock outstanding at June 30, 2019: 22,841,278~~

outstanding.

~~VICAL INCORPORATED~~

BRICKELL BIOTECH, INC.

FORM 10-Q

INDEX


PART I. FINANCIAL INFORMATION

	ITEM 1. Financial Statements (Unaudited)		4 3

		~~Balance Sheets (unaudited) as of June 30, 2019 and December 31, 2018~~			4

		~~Statements of Operations (unaudited) for the three and six months ended June 30, 2019 and 2018~~			5

		~~Statements of Comprehensive Loss (unaudited) for the three and six months ended June 30, 2019 and 2018~~			6

	~~Statements of Stockholders’ Equity (unaudited) for the three and six months ended June 30, 2019 and 2018~~	7

	~~Statements of Cash Flows (unaudited) for the six months ended June 30, 2019 and 2018~~	8

	~~Notes to Financial Statements (unaudited)~~	9

	ITEM 2. ~~Management's~~Management’s Discussion and Analysis of Financial Condition and Results of Operations		16 21

	ITEM 3. Quantitative and Qualitative Disclosures About Market Risk		19 30

	ITEM 4. Controls and Procedures		19 30

PART II. OTHER INFORMATION
		ITEM 1. Legal Proceedings			31
		ITEM 1A. Risk Factors			20 31
		ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds			56
		ITEM 3. Defaults Upon Senior Securities		56
		ITEM 4. Mine Safety Disclosures		56
		ITEM 5. Other Information			23 56

	ITEM 6. Exhibits		24 56

~~SIGNATURE~~		25

P~~ART~~

PART I. FINANCIAL INFORMATION

I~~TEM 1.~~

~~FINANCIAL STATEMENTS~~

~~VICAL INCORPORATED~~

ITEM 1. FINANCIAL STATEMENTS

BRICKELL BIOTECH, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Inin thousands, except ~~par value~~share and per share data)

~~(Unaudited)~~

June 30,

December 31,

2019

2018

ASSETS

Current assets:

Cash and cash equivalents

$
10,813

$
11,870

Marketable securities, available-for-sale

30,907

36,201

Receivables and other assets

979

1,128

Total current assets

42,699

49,199

Long-term investments

—

2,386

Property and equipment, net

2

100

Other assets

—

659

Total assets

$
42,701

$
52,344

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:

Accounts payable and accrued expenses

$
1,159

$
3,551

Deferred revenue

—

30

Total current liabilities

1,159

3,581

Stockholders' equity:

Preferred stock, $0.01 par value, 5,000 shares authorized, none issued and outstanding

—

—

Common stock, $0.01 par value, 50,000 shares authorized, 22,841 and 21,817 shares
issued and outstanding at June 30, 2019 and December 31, 2018, respectively

229

218

Additional paid-in capital

490,343

490,337

Accumulated deficit

(449,072
)

(442,064
)
Accumulated other comprehensive income

42

272

Total stockholders' equity

41,542

48,763

Total liabilities and stockholders' equity

$
42,701

$
52,344

(unaudited)




	June 30, 2020		December 31, 2019

Assets
Current assets:
Cash and cash equivalents	$	21,570	$	7,232
Marketable securities, available-for-sale	—		4,497
Prepaid expenses and other current assets	5,736		6,240
Total current assets	27,306		17,969
Property and equipment, net	10		16
Operating lease right-of-use asset	114		159

Total assets	$	27,430	$	18,144
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	566	$	2,245
Accrued liabilities	6,261		6,379
Lease liability, current portion	83		78
Deferred revenue	142		1,795


Note payable, current portion	194		—

Total current liabilities	7,246		10,497
Lease liability, net of current portion	31		73




Note payable, net of current portion	243		—
Total liabilities	7,520		10,570

Commitments and contingencies (Note 6)
Stockholders’ equity:
Common stock, $0.01 par value, 50,000,000 shares authorized at June 30, 2020 and December 31, 2019; 26,671,573 and 8,480,968 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively	267		85
Additional paid-in capital	113,845		92,497
Accumulated other comprehensive gain	—		(28)
Accumulated deficit	(94,202)		(84,980)
Total stockholders’ equity	19,910		7,574
Total liabilities and stockholders’ equity	$	27,430	$	18,144

See accompanying notes to ~~unaudited~~these condensed consolidated financial ~~statements~~

statements.

~~VICAL INCORPORATED~~

BRICKELL BIOTECH, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Inin thousands, except share and per share data)

~~(Unaudited)~~

Three Months Ended

Six Months Ended

June 30,

June 30,

2019

2018

2019

2018

Revenues:

Contract revenue

$
—

$
725

$
—

$
1,431

License and royalty revenue

—

10

—

20

Total revenues

—

735

—

1,451

Operating expenses:

Research and development

759

3,602

4,641

7,266

Manufacturing and production

—

—

—

1,436

General and administrative

2,242

2,261

3,618

4,378

Total operating expenses

3,001

5,863

8,259

13,080

Loss from operations

(3,001
)

(5,128
)

(8,259
)

(11,629
)
Other income:

Investment and other income, net

571

260

1,251

491

Net loss

$
(2,430
)

$
(4,868
)

$
(7,008
)

$
(11,138
)
Basic and diluted net loss per share

$
(0.11
)

$
(0.22
)

$
(0.31
)

$
(0.51
)
Weighted average shares used in computing basic and diluted net
loss per share

22,825

21,837

22,404

21,834

(unaudited)


	Three Months Ended June 30,						Six Months Ended June 30,
	2020		2019		2020		2019
Collaboration revenue	$	607	$	2,573	$	1,653	$	6,065

Operating expenses:
Research and development	2,712		4,229		5,376		10,248
General and administrative	3,021		1,323		5,502		3,389
Total operating expenses	5,733		5,552		10,878		13,637
Loss from operations	(5,126)		(2,979)		(9,225)		(7,572)
Investment and other income, net	7		4		3		10

Interest expense	—		(660)		—		(884)

Change in fair value of derivative liability	—		(11)		—		(11)
Change in fair value of warrant liability	—		(8)		—		223
Net loss	(5,119)		(3,654)		(9,222)		(8,234)

Reduction (accretion) of redeemable convertible preferred stock to redemption value	—		(163)		—		10,356
Net income (loss) attributable to common stockholders	$	(5,119)	$	(3,817)	$	(9,222)	$	2,122
Net income (loss) per common share attributable to common stockholders, basic	$	(0.43)	$	(6.48)	$	(0.87)	$	3.60
Net loss per common share attributable to common stockholders, diluted	$	(0.43)	$	(6.48)	$	(0.87)	$	(4.46)
Weighted-average shares used to compute net income (loss) per share attributable to common stockholders, basic	11,819,152		589,001		10,595,960		589,001
Weighted-average shares used to compute net loss per share attributable to common stockholders, diluted	11,819,152		589,001		10,595,960		1,845,467

See accompanying notes to ~~unaudited~~these condensed consolidated financial ~~statements~~

statements.

~~VICAL INCORPORATED~~

BRICKELL BIOTECH, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(Inunaudited, in thousands)

~~(Unaudited)~~

Three Months Ended

Six Months Ended

June 30,

June 30,

2019

2018

2019

2018

Net loss

$
(2,430
)

$
(4,868
)

$
(7,008
)

$
(11,138
)
Other comprehensive loss:

Unrealized gain (loss) on available-for-sale and long-term marketable securities:

Unrealized gain arising during holding period, net of tax benefit of $0 and $6 for three months ended June 30, 2019 and 2018, respectively, and $0 and $6 for six months ended June 30, 2019 and 2018, respectively

25

73

143

8

Less: Reclassification adjustment for gains included in net loss

—

—

(373
)

—

Other comprehensive gain (loss)

25

73

(230
)

8

Total comprehensive loss

$
(2,405
)

$
(4,795
)

$
(7,238
)

$
(11,130
)


	Three Months Ended June 30,						Six Months Ended June 30,
	2020		2019		2020		2019
Net loss	$	(5,119)	$	(3,654)	$	(9,222)	$	(8,234)
Other comprehensive income:
Unrealized gain on available-for-sale marketable securities arising during holding period, net of tax benefit of $0	—		—		28		—


Total comprehensive loss	$	(5,119)	$	(3,654)	$	(9,194)	$	(8,234)

See accompanying notes to ~~unaudited~~these condensed consolidated financial ~~statements~~

statements.

~~VICAL INCORPORATED~~

BRICKELL BIOTECH, INC.

CONDENSED CONSOLIDATED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY

(DEFICIT)

(~~In thousands)~~

~~(Unaudited)~~

in thousands, except share data)

Common Stock

Number of
Shares

Amount

Additional
Paid-in
Capital

Accumulated
Deficit

Accumulated Other
Comprehensive
Income/(Loss)

Total
Stockholders’
Equity

Balance at January 1, 2019

21,817

$
218

$
490,337

$
(442,064
)

$
272

$
48,763

Net loss

—

—

—

(4,578
)

—

(4,578
)
Other comprehensive loss

—

—

—

—

(255
)

(255
)
Issuance of common stock upon exercise of warrants

993

10

—

—

—

10

Issuance of common stock underlying restricted
   stock units net of shares withheld to settle
   withholding taxes

13

1

—

—

—

1

Non-cash compensation expense related to grant of equity based compensation

—

—

(19
)

—

—

(19
)
Balance at March 31, 2019

22,823

$
229

$
490,318

$
(446,642
)

$
17

$
43,922

Net loss

—

—

—

(2,430
)

—

(2,430
)
Other comprehensive gain

—

—

—

—

25

25

Issuance of common stock underlying restricted
   stock units net of shares withheld to settle
   withholding taxes

18

—

2

—

—

2

Non-cash compensation expense related to grant of equity based compensation

—

—

23

—

—

23

Balance at June 30, 2019

22,841

$
229

$
490,343

$
(449,072
)

$
42

$
41,542

(unaudited)

Common Stock

Number of
Shares

Amount

Additional
Paid-in
Capital

Accumulated
Deficit

Accumulated Other
Comprehensive
Income/(Loss)

Total
Stockholders’
Equity

Balance at January 1, 2018

21,802

$
218

$
489,975

$
(426,738
)

$
122

$
63,577

Net loss

—

—

—

(6,270
)

—

(6,270
)
Retained earnings adjustment upon adoption of ASU 2014-09

—

—

—

928

—

928

Other comprehensive loss

—

—

—

—

(65
)

(65
)
Issuance of common stock

—

—

—

—

—

—

Issuance of common stock underlying restricted
   stock units net of shares withheld to settle
   withholding taxes

13

—

1

—

—

1

Non-cash compensation expense related to grant
   of equity based compensation

—

—

47

—

—

47

Balance at March 31, 2018

21,815

$
218

$
490,023

$
(432,080
)

$
57

$
58,218

Net loss

—

—

—

(4,868
)

—

(4,868
)
Other comprehensive gain

—

—

—

—

73

73

Issuance of common stock

—

—

—

—

—

—

Issuance of common stock underlying restricted
   stock units net of shares withheld to settle
   withholding taxes

—

—

—

—

—

—

Non-cash compensation expense related to grant
   of equity based compensation

—

—

162

—

—

162

Balance at June 30, 2018

21,815

$
218

$
490,185

$
(436,948
)

$
130

$
53,585


	Series A, B, C & C-1 Redeemable Convertible Preferred Stock				Common Stock						Additional Paid-In-Capital		Accumulated Other Comprehensive Gain (Loss)		Accumulated Deficit	Total Stockholders’ Equity
	Shares	Carrying Value		Shares	Par Value
Balance, December 31, 2019	—	$	—	8,480,968	$	85	$	92,497	$	(28)	$	(84,980)	$	7,574
Issuance of common stock and common stock purchase warrants, net of issuance costs of $10	—	—		950,000	10		1,980		—		—		1,990
Issuance of common stock upon exercise of warrants	—	—		221,293	2		13		—		—		15
Issuance of common stock upon restricted stock unit settlement, net of shares withheld for taxes	—	—		19,643	—		(13)		—		—		(13)

Stock-based compensation	—	—		—	—		403		—		—		403
Unrealized gain on available-for-sale marketable securities	—	—		—	—		—		28		—		28
Net loss	—	—		—	—		—		—		(4,103)		(4,103)
Balance, March 31, 2020	—	—		9,671,904	97		94,880		—		(89,083)		5,894
Issuance of common stock upon exercise of warrants	—	—		2,202,863	22		(15)		—		—		7
Issuance of common stock upon restricted stock unit settlement, net of shares withheld for taxes	—	—		6,673	—		(4)		—		—		(4)
Common stock and warrants issued, net of issuance costs of $1,443	—	—		14,790,133	148		18,531		—		—		18,679
Stock-based compensation	—	—		—	—		453		—		—		453
Net loss	—	—		—	—		—		—		(5,119)		(5,119)
Balance, June 30, 2020	—	$	—	26,671,573	$	267	$	113,845	$	—	$	(94,202)	$	19,910


	Series A, B, C & C-1 Redeemable Convertible Preferred Stock				Common Stock						Additional Paid-In-Capital		Accumulated Other Comprehensive Gain (Loss)		Accumulated Deficit	Total Stockholders’ Deficit
	Shares	Carrying Value		Shares	Par Value
Balance, December 31, 2018	1,256,466	$	58,290	589,001	$	6	$	—	$	—	$	(71,624)	$	(71,618)
Reduction of redeemable convertible preferred stock to redemption value	—	(10,519)		—	—		—		—		10,519		10,519
Stock-based compensation	—	—		—	—		384		—		—		384
Net loss	—	—		—	—		—		—		(4,580)		(4,580)
Balance, March 31, 2019	1,256,466	47,771		589,001	6		384		—		(65,685)		(65,295)
Stock based compensation	—	—		—	—		299		—		—		299
Accretion of redeemable convertible preferred stock to redemption value	—	163		—	—		(163)		—		—		(163)
Net loss	—	—		—	—		—		—		(3,654)		(3,654)
Balance, June 30, 2019	1,256,466	$	47,934	589,001	$	6	$	520	$	—	$	(69,339)	$	(68,813)

See accompanying notes to ~~unaudited~~these condensed consolidated financial ~~statements~~

statements.

~~VICAL INCORPORATED~~

BRICKELL BIOTECH, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Inunaudited, in thousands)

~~(Unaudited)~~

Six Months Ended

June 30,

2019

2018

Cash flows from operating activities:

Net loss

$
(7,008
)

$
(11,138
)
Adjustments to reconcile net loss to net cash used in operating activities:

Depreciation and amortization

18

119

Accretion of discount on short-term investments

(227
)

(70
)
Write-off of abandoned patents

—

673

Gain on sale of property and equipment

(309
)

—

Net gain on sale of long-term investment

(373
)

—

Compensation related to stock options and awards

4

209

Changes in operating assets and liabilities:

Receivables and other assets

808

3,882

Accounts payable and accrued expenses

(2,487
)

(2,058
)
Employee termination benefits accrual

96

2

Deferred revenue

(30
)

(249
)
Net cash used in operating activities

(9,508
)

(8,630
)
Cash flows from investing activities:

Proceeds from the sale of long-term investment

2,469

—

Maturities of marketable securities

12,000

14,719

Purchases of marketable securities

(6,419
)

(20,843
)
Sale of property and equipment

388

—

Purchases of property and equipment

—

(16
)
Net cash provided by (used in) investing activities

8,438

(6,140
)
Cash flows from financing activities:

Net proceeds from issuance of common stock

13

1

Payment of withholding taxes for net settlement of restricted stock units

—

(1
)
Net cash provided by financing activities

13

-

Net decrease in cash, cash equivalents and restricted cash

(1,057
)

(14,770
)
Cash, cash equivalents and restricted cash at beginning of period

11,870

25,033

Cash, cash equivalents and restricted cash at end of period

$
10,813

$
10,263


	Six Months Ended June 30,
	2020		2019
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$	(9,222)	$	(8,234)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	6		21
Accretion of discount on marketable securities	25		—


Change in fair value of derivative liability	—		11
Change in fair value of warrant liability	—		(223)





Amortization of discounts and financing costs	—		551
Stock-based compensation	856		683
Changes in operating assets and liabilities:
Prepaid expenses and other current assets	512		(165)
Accounts payable	(1,679)		3,053
Accrued liabilities	(135)		865



Deferred revenue	(1,653)		(6,064)

Net cash used in operating activities	(11,290)		(9,502)

CASH FLOWS FROM INVESTING ACTIVITIES:

Maturities of marketable securities	4,500		—
Capital expenditures	—		(4)
Net cash provided by (used in) investing activities	4,500		(4)

CASH FLOWS FROM FINANCING ACTIVITIES:


Proceeds from the issuance of common stock and warrants, net of issuance costs	20,669		—
Proceeds from the issuance of note payable	437		—
Proceeds from the exercise of warrants	22		—
Proceeds from issuance of convertible promissory notes	—		5,127
Payments of principal of note payable	—		(1,609)


Net cash provided by financing activities	21,128		3,518

NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS	14,338		(5,988)
CASH AND CASH EQUIVALENTS—BEGINNING	7,232		8,067
CASH AND CASH EQUIVALENTS—ENDING	$	21,570	$	2,079

Supplement Disclosure of Cash Flow Information:
Interest paid	$	—	$	234
Supplement Disclosure of Non-Cash Investing and Financing Activities:


Reduction of redeemable convertible preferred stock to redemption value	$	—	$	(10,376)
Warrants to purchase common stock issued with convertible promissory notes	$	—	$	1,029
Derivative liability issued with convertible promissory notes	$	—	$	996
Deferred financing costs included in accrued liabilities	$	—	$	154

Accretion of redeemable convertible preferred stock issuance costs	$	—	$	20

See accompanying notes to ~~unaudited~~these condensed consolidated financial ~~statements~~

statements.

~~VICAL INCORPORATED~~

BRICKELL BIOTECH, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

~~June 30,~~

(unaudited)

NOTE 1. ORGANIZATION AND NATURE OF OPERATIONS

Brickell Biotech, Inc. (the “Company” or “Brickell”) is a clinical-stage pharmaceutical company focused on the development of innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases. The Company’s pipeline consists of potential novel therapeutics for hyperhidrosis and other prevalent dermatological conditions. The Company’s pivotal Phase 3-ready clinical-stage product candidate, sofpironium bromide, is a proprietary new molecular entity that belongs to a class of medications called anticholinergics. The Company intends to develop sofpironium bromide as a potential best-in-class, self-administered, once daily, topical therapy for the treatment of primary axillary hyperhidrosis. The Company’s operations to date have been limited to business planning, raising capital, developing its pipeline assets (in particular sofpironium bromide), identifying product candidates, and other research and development.

On August 31, 2019,

~~(Unaudited)~~

1.	~~BASIS OF PRESENTATION~~

the Company, then known as Vical Incorporated or(“Vical”), and Brickell Biotech, Inc., a then privately-held Delaware corporation that began activities in September 2009 (“Private Brickell”), completed a recapitalization in accordance with the terms of the Agreement and Plan of Merger and Reorganization, dated June 2, 2019, as further amended on August 20, 2019 and on August 30, 2019 (the “Merger Agreement”), by and among Vical, Victory Subsidiary, Inc., a wholly-owned subsidiary of Vical (“Merger Sub”), and Private Brickell. Pursuant to the Merger Agreement, Merger Sub merged with and into Private Brickell, with Private Brickell surviving as a wholly-owned subsidiary of Vical (the “Merger”). Additionally, on August 31, 2019, immediately after the completion of the Merger, the Company changed its name from “Vical Incorporated” to “Brickell Biotech, Inc.” and Private Brickell changed its name from “Brickell Biotech, Inc.” to “Brickell Subsidiary, Inc.”

The accompanying condensed consolidated financial statements and related notes reflect the historical results of Private Brickell prior to the Merger and of the combined company following the Merger, and do not include the historical results of Vical prior to the completion of the Merger. These financial statements and related notes should be read in conjunction with the audited financial statements for the year ended December 31, 2019, included in the Company’s Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2020.

Liquidity and Capital Resources

The accompanying condensed consolidated financial statements have been prepared assuming that the Company will continue as a ~~Delaware corporation, was incorporated~~going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in ~~April 1987~~the normal course of business. The condensed consolidated financial statements do not reflect any adjustments relating to the recoverability and reclassification of assets and liabilities that might be necessary if the Company is unable to continue as a going concern. The Company has incurred significant operating losses and has ~~devoted substantially all~~an accumulated deficit as a result of ~~its resources since that time~~ongoing efforts to ~~the research~~develop product candidates, including conducting preclinical and ~~development of biopharmaceutical products, including those based on its patented DNA delivery technologies~~clinical trials and providing general and administrative support for these operations. For the ~~prevention and treatment of serious or life-threatening diseases.~~

~~The unaudited financial statements at June 30, 2019, and for the three and~~ six months ended June 30, ~~2019~~2020, the Company had a net loss of $9.2 million and ~~2018,~~net cash used in operating activities of $11.3 million. As of June 30, 2020, the Company had cash and cash equivalents of $21.6 million and an accumulated deficit of $94.2 million.

The Company believes that its cash and cash equivalents as of June 30, 2020 and periodic sales of the Company’s common stock under the Purchase Agreement (see Note 7. “Capital Stock”), are sufficient to fund its operations for at least the next 12 months from the issuance of these condensed consolidated financial statements. However, in order to sell additional shares of common stock under the Purchase Agreement, Lincoln Park Capital Fund, LLC (“Lincoln Park”) will need to purchase shares of common stock from the Company, subject to the conditions under the Purchase Agreement. Further, the Company will be significantly limited in its ability to sell shares of its common stock under the Purchase Agreement, or to utilize its common stock in any other capital raising transaction, if the Company’s stockholders do not approve an increase in the number of authorized shares of common stock of the Company, as further described in Note 7. “Capital Stock” and in Note 9. “Subsequent Events.” The Company expects to continue to incur additional substantial losses in the foreseeable future as a result of the Company’s research and development activities. Additional funding will be required in the future to proceed with the Company’s current and proposed research activities, including completing both pivotal U.S. Phase 3 clinical trials of sofpironium bromide.

NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation

The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, Brickell Subsidiary, Inc., and are presented in U.S. dollars and have been prepared in accordance ~~with the rules and regulations of the Securities and Exchange Commission, or SEC, and~~ with accounting principles generally accepted in the United States of America (“US GAAP”) and applicable torules and regulations of the SEC for interim reporting. As permitted under those rules and regulations, certain footnotes or other financial ~~statements.~~information normally included in financial statements prepared in accordance with US GAAP have been condensed or omitted. These ~~unaudited~~condensed consolidated financial statements have been prepared on the same basis as the ~~audited~~annual financial statements ~~included in the Company’s Annual Report on Form 10-K~~ and, ~~include all adjustments, consisting of only normal recurring accruals, which~~ in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments, which are necessary ~~to present fairly~~for a fair presentation of the Company’s financial ~~position as of the interim date and~~information. The results of operations for the ~~interim periods presented. Interim results~~three and six months ended June 30, 2020 are not necessarily indicative of the results to be expected for athe full year ending December 31, 2020, for any other interim period, or for any other future ~~periods.~~period. The ~~preparation~~condensed consolidated balance sheet as of December 31, 2019 has been derived from audited financial statements at that date but does not include all of the information required by US GAAP for complete financial statements. All intercompany balances and transactions have been eliminated in consolidation. The Company operates in 1 operating segment and, accordingly, no segment disclosures have been presented herein. The Company’s management performed an evaluation of its activities through the date of filing of these financial statements and concluded that there are no subsequent events requiring disclosure, other than as disclosed.

Use of Estimates

The Company’s condensed consolidated financial statements are prepared in accordance with US GAAP, which requires ~~management~~it to make estimates and assumptions that affect the reported amounts of assets and liabilities and ~~disclosures~~disclosure of contingent assets and contingent liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. ~~Actual results could differ materially from those estimates. These unaudited financial statements should be read in conjunction with~~Although these estimates are based on the Company’s ~~audited~~knowledge of current events and actions it may take in the future, actual results may ultimately differ from these estimates and assumptions.

Risks and Uncertainties

The Company’s business is subject to significant risks common to early-stage companies in the pharmaceutical industry including, but not limited to, the ability to develop appropriate formulations, scale up and produce the compounds; dependence on collaborative parties; uncertainties associated with obtaining and enforcing patents and other intellectual property rights; clinical implementation and success; the lengthy and expensive regulatory approval process; compliance with regulatory and other legal requirements; competition from other products; uncertainty of broad adoption of its approved products, if any, by physicians and patients; significant competition; ability to manage third-party manufacturers, suppliers, contract research organizations, business partners and other alliance management; and obtaining additional financing to fund the Company’s efforts.

The product candidates developed by the Company require approvals from the U.S. Food and Drug Administration (“FDA”) and foreign regulatory agencies prior to commercial sales in the United States or foreign jurisdictions, respectively. There can be no assurance that the Company’s current and future product candidates will receive the necessary approvals. If the Company is denied approval or approval is delayed, it may have a material adverse impact on the Company’s business and its financial ~~statements~~condition.

The Company expects to incur substantial operating losses for the ~~year ended December 31, 2018, included~~next several years and will need to obtain additional financing in ~~its Annual Report~~order to complete clinical studies and launch and commercialize any product candidates for which it receives regulatory approval. There can be no assurance that such financing will be available or will be at terms acceptable to the Company.

Fair Value Measurements

Fair value is the price that the Company would receive to sell an asset or pay to transfer a liability in a timely transaction with an independent counterparty in the principal market or in the absence of a principal market, the most advantageous market for the asset or liability. A three-tier hierarchy is established to distinguish between (1) inputs that reflect the assumptions market participants would use in pricing an asset or liability developed based on ~~Form 10-K filed with~~market data obtained from sources independent of the ~~SEC.~~

~~Cash, Cash Equivalents~~reporting entity (observable inputs) and ~~Marketable Securities~~

~~Cash~~(2) inputs that reflect the reporting entity’s own assumptions about the

assumptions market participants would use in pricing an asset or liability developed based on the best information available in the circumstances (unobservable inputs), and establishes a classification of fair value measurements for disclosure purposes.

The hierarchy is summarized in the three broad levels listed below:

Level 1—quoted prices in active markets for identical assets and liabilities

Level 2—other significant observable inputs (including quoted prices for similar assets and liabilities, interest rates, credit risk, etc.)

Level 3—significant unobservable inputs (including the Company’s own assumptions in determining the fair value of assets and liabilities)

The following table sets forth the fair value of the Company’s financial assets measured at fair value on a recurring basis based on the three-tier fair value hierarchy (in thousands):


	Level 1 (1)
	June 30, 2020		December 31, 2019
Assets:
Money market funds	$	21,570	$	7,232
U.S. treasuries	—		4,497
Total	$	21,570	$	11,729

____________

(1) No assets as of each respective date were identified as Level 2 or 3 based on the three-tier fair value hierarchy. The Company had no financial liabilities measured at fair value on a recurring basis as of each respective date.

Fair Value of Financial Instruments

The following methods and assumptions were used by the Company in estimating the fair values of each class of financial instrument disclosed herein:

Money Market Funds—The carrying amounts reported as cash and cash equivalents ~~consist~~in the condensed consolidated balance sheets approximate their fair values due to their short-term nature and/or market rates of ~~cash~~interest (Level 1 of the fair value hierarchy).

U.S. Treasuries—The Company designated its investments in U.S. treasury securities as available-for-sale securities and ~~highly liquid~~accounted for them at their respective fair values. The securities ~~with original maturities at~~were classified as short-term or long-term based on the ~~date~~nature of ~~acquisition of ninety days or less~~the securities and their availability to meet current operating requirements. Securities that ~~can be liquidated without prior notice or penalty. Investments with an original maturity of more than ninety days~~were readily available for use in current operations are ~~considered~~classified as short-term available-for-sale marketable securities and ~~have been classified by management~~are reported as ~~available-for-sale. These investments are~~a component of current assets in the condensed consolidated balance sheets (Level 1 of the fair value hierarchy).

Securities classified as current assets, even though the stated maturity date may be one year or more beyond the current balance sheet date which reflects management’s intention to use the proceeds from sales of these securities to fund its operations, as necessary. Such investmentsavailable-for-sale are ~~carried~~measured at fair value, including accrued interest, with temporary unrealized gains and losses ~~included~~reported as a ~~separate~~ component of stockholders’ ~~equity. Realized gains and losses from the sale of~~equity until their disposition. The Company reviews available-for-sale securities at the end of each period to determine whether they remain available-for-sale based on its then current intent. The cost of securities sold is based on the specific identification method. The securities are subject to a periodic impairment review. An impairment charge would occur when a decline in the fair value of the investments below the cost basis is judged to be other-than-temporary.

Leases

The Company accounts for leases under the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 842, Leases (“ASC 842”). Under ASC 842, the Company determines if an arrangement is a lease at inception. Leases with a term greater than one year are recognized on the balance sheet as right-of-use assets, lease liabilities and, if applicable, long-term lease liabilities. The Company has elected the practical expedient not to recognize on the balance

sheet leases with terms of one year or less and not to separate lease components and non-lease components for long-term real estate leases. Lease liabilities and their corresponding right-of-use assets are recorded based on the ~~amounts, net~~present value of ~~tax, reclassified out~~lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable. As such, the Company estimates the incremental borrowing rate based on industry peers in determining the present value of ~~accumulated other comprehensive income (loss), if any, are determined~~lease payments. The Company’s facility operating lease has one single component. The lease component results in a right-of-use asset being recorded on the balance sheet, which is amortized as lease expense on a ~~specific identification basis.~~

straight-line basis in the Company’s condensed consolidated statements of operations.

Revenue Recognition

The Company recognizes revenue ~~when control~~upon the transfer of ~~its products and~~promised goods or services ~~is transferred~~ to ~~its~~ customers in an amount that reflects the consideration to which the Company expects to ~~receive from its customers~~be entitled in exchange for those ~~products and~~goods or services. ~~This process involves identifying~~To determine revenue recognition for contracts with customers, the ~~contract~~Company performs the following five steps: (i) identify the contract(s) with a ~~customer, determining~~customer; (ii) identify the performance obligations in the ~~contract, determining~~contract; (iii) determine the ~~contract price, allocating~~transaction price; (iv) allocate the ~~contract~~transaction price to the ~~distinct~~ performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies the performance obligations. At contract inception, the Company assesses the goods or services promised within each contract and ~~recognizing~~assesses whether each promised good or service is distinct and determines those that are performance obligations. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the ~~performance obligations have been satisfied. A~~ performance obligation is ~~considered~~satisfied.

To date, the Company’s drug candidates have not been approved for sale by the FDA or any other country’s regulatory authority, and the Company has not generated or recognized any revenue from the sale of products.

In March 2015, the Company entered into a license, development, and commercialization agreement (as amended, the “Kaken Agreement”) with Kaken Pharmaceutical Co., Ltd. (“Kaken”). Under the Kaken Agreement, the Company granted to Kaken an exclusive right to develop, manufacture, and commercialize the Company’s sofpironium bromide compound, a topical anticholinergic, in Japan and certain other Asian countries (the “Territory”). In exchange, Kaken paid the Company an upfront, non-refundable payment of $11.0 million (the “upfront fee”). In addition, the Company was entitled to receive aggregate payments of up to $10.0 million upon the achievement of specified development milestones, and $30.0 million upon the achievement of commercial milestones, as well as tiered royalties based on a percentage of net sales of licensed products in the Territory. The Kaken Agreement further provides that Kaken will be responsible for funding all development and commercial costs for the program in the Territory. Kaken is also required to enter into negotiations with the Company, to supply the Company, at cost, with clinical supplies to perform Phase 3 clinical trials in the United States.

The Company evaluates collaboration arrangements to determine whether units of account within the collaboration arrangement exhibit the characteristics of a vendor and customer relationship. The Company determined that the licenses transferred to Kaken in exchange for the upfront fee were representative of this type of a relationship. If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, upfront fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other performance obligations, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a ~~contract when it~~point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition on a prospective basis.

Under Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers (“Topic 606”), the Company evaluated the terms of the Kaken Agreement, and the transfer of intellectual property and manufacturing rights (the “license”) was identified as the only performance obligation as of the inception of the agreement. The Company concluded that the license for the intellectual property was distinct from its ongoing supply obligations. The Company further determined that the transaction price under the arrangement was comprised of the $11.0 million upfront payment, which was allocated to the license performance obligation. The future potential milestone amounts were not included in the transaction price, as they were all determined to be fully constrained. As part of its evaluation of the development and regulatory milestones constraint, the Company determined that the achievement of such milestones is contingent upon success in future clinical trials and regulatory approvals, each of which is uncertain at this time. The Company will re-evaluate the transaction price each quarter and as uncertain events are resolved or other changes in circumstances occur. Future potential milestone amounts would be recognized as revenue from collaboration arrangements, if unconstrained. The remainder of the

arrangement, which largely consisted of both parties incurring costs in their respective territories, provides for the reimbursement of the ongoing supply costs. These costs were representative of a collaboration arrangement outside of the scope of Topic 606 as they do not have the characteristics of a vendor and customer relationship. Reimbursable program costs are recognized proportionately with the delivery of drug substance and are accounted for as reductions to research and development expense and are excluded from the transaction price.

In May 2018, the Company entered into an amendment to the Kaken Agreement, pursuant to which the Company received an upfront non-refundable fee of $15.6 million (the “Kaken R&D Payment”), which was initially recorded as deferred revenue, to provide the Company with research and development funds for the sole purpose of conducting certain clinical trials and other such research and development activities required to support the submission of a new drug application for sofpironium bromide. These clinical trials have a benefit to Kaken and have the characteristics of a vendor and customer ~~either on its own or together with other resources that are readily available~~relationship. The Company has accounted for the Kaken R&D Payment under the provisions of Topic 606. This Kaken R&D Payment is being initially recognized using an input method over the average estimated performance period of 1.45 years in proportion to the ~~customer~~cost incurred. Upon receipt of the Kaken R&D Payment, on May 31, 2018, a milestone payment originally due upon the first commercial sale in Japan was removed from the Kaken Agreement and ~~is separately identified in the contract. The Company considers a performance obligation satisfied once it has transferred control of a good or service~~all future royalties to the ~~customer, meaning~~Company under the customer has the ability to use and obtain the benefit of the good or service. The Company recognizes revenue for satisfied performance obligations only when it determines there are no uncertainties regarding payment terms or transfer of control.

~~Research and Development Costs~~

Research and development costs are expensed as incurred. Research and development costs include salaries and personnel-related costs, supplies and materials, outside services, costs of conducting preclinical and clinical trials, facilities costs and amortization of intangible assets. The Company accounts for its clinical trial costs by estimating the total cost to treat a patient in each clinical trial, and accruing this total cost for the patient over the estimated treatment period, which corresponds with the period over which the services are performed, beginning when the patient enrolls in the clinical trial. This estimated cost includes payments to the site conducting the trial, and patient-related lab and other costs related to the conduct of the trial. Cost per patient varies based on the type of clinical trial, the site of the clinical trial, the method of administration of the treatment, and the number of treatments that a patient receives. Treatment periods vary depending on the clinical trial. The Company makes revisions to the clinical trial cost estimates in the current period, as clinical trials progress.

~~Manufacturing and Production Costs~~

Manufacturing and production costs include expenses related to manufacturing contracts and expenses for the production of plasmid DNA for use in the Company’s research and development efforts. Production expenses related to the Company’s research and development efforts are expensed as incurred.

~~Net Loss Per Share~~

~~Basic and diluted net loss per share has been computed using the weighted-average number of shares of common stock outstanding~~Kaken Agreement were reduced 150 basis points.

Consequently, during the period. The weighted average number of shares used to compute diluted loss per share excludes any assumed exercise of stock options and warrants and any assumed issuance of common stock under restricted stock units (RSUs) as the effect would be antidilutive. Common stock equivalents of 6.2 million and 7.2 million for the three months ended June 30, 2020 and 2019, ~~and 2018, respectively, were excluded from~~ the ~~calculation because~~Company recognized revenue of ~~their antidilutive effect. Common stock equivalents of 6.6~~$0.6 million and ~~7.2~~$2.6 million, ~~for~~respectively, related to the Kaken R&D Payment. During the six months ended June 30, 2020 and 2019, the Company recognized revenue of $1.7 million and ~~2018,~~$6.1 million, respectively, ~~were~~related to the Kaken R&D Payment. As of June 30, 2020 and December 31, 2019, the Company had a deferred revenue balance related to the Kaken R&D Payment of $0.1 million and $1.8 million, respectively, which is recorded in deferred revenue on the accompanying condensed consolidated balance sheets.

Milestones

At the inception of each arrangement that includes milestone payments (variable consideration), the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company or the Company’s collaboration partner’s control, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such milestones and any related constraint, and if necessary, adjusts the Company’s estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license, collaboration or other revenues and earnings in the period of adjustment.

To date, Kaken has paid the Company $10.0 million in milestone payments under the Kaken Agreement.

Royalties

For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue from any collaborative arrangement.

Net Income (Loss) per Common Share

Basic and diluted net income (loss) per common share is computed by dividing net income (loss) attributable to common stockholders by the weighted average number of common shares outstanding. When the effects are not anti-dilutive, diluted earnings per share is computed by dividing the Company’s net income (loss) attributable to common stockholders by the weighted average number of common shares outstanding and the impact of all dilutive potential common shares.

Diluted earnings per share gives effect to all dilutive potential common shares outstanding during the period, including stock options, restricted stock units, and warrants, using the treasury stock method, and redeemable convertible preferred stock and

convertible promissory notes, using the if-converted method. In computing diluted earnings per share, the average stock price for the period is used in determining the number of shares assumed to be issued from the exercise of stock options, the vesting of restricted stock units, or the exercise of warrants. Potentially dilutive common share equivalents are excluded from the diluted earnings per share computation in net loss periods because their effect would be anti-dilutive.

The following table sets forth the potential common shares excluded from the calculation of net income (loss) per common share, because of their ~~antidilutive effect.~~

~~Stock-Based Compensation~~

The Company records its compensation expense associated with stock options and other forms of equity compensation based on their fair value at the date of grant using the Black-Scholes-Merton option pricing model. Stock-based compensation includes amortization related to stock option awards based on the estimated grant date fair value. Stock-based compensation expense related to stock options is recognized ratably over the vesting period of the option. In addition, the Company records expense related to RSUs granted based on the fair value of those awards on the grant date. The fair value related to the RSUs is amortized to expense over the vesting term of those awards. Forfeitures of stock options and RSUs are recognized as they occur.

~~Stock-based compensation expense for a stock-based award with a performance condition is recognized when the achievement of such performance condition is determined to~~inclusion would be probable. If the outcome of such performance condition is not determined to be probable or is not met, no compensation expense is recognized and any previously recognized compensation expense is reversed.

anti-dilutive:


	Three and Six Months Ended June 30,
	2020	2019
Outstanding warrants	19,556,108	349,074
Outstanding options	1,578,231	625,428
Unvested restricted stock units	253,045	—
Redeemable convertible preferred stock (as converted into common stock)	—	1,256,466

Promissory notes (as converted into common stock)	—	168,832
Total	21,387,384	2,399,800

Recent Accounting Pronouncements

– Adopted

In ~~February 2016,~~August 2018, the FASB issued ASU ~~No. 2016-02, “Leases~~2018-13, Fair Value Measurement (Topic ~~842).” The new standard requires a lessee~~820): Disclosure Framework—Changes to ~~record on~~ the ~~balance sheet the assets~~Disclosure Requirements for Fair Value Measurement (“ASU 2018-13”), which amends certain disclosure requirements over Level 1, Level 2, and liabilities for the rights and obligations created by leases with lease terms of more than 12 months and requires both lessees and lessors to disclose certain key information about lease transactions. The standardLevel 3 fair value measurements. ASU 2018-13 is effective for fiscal years beginning after December 15, ~~2018, including~~2019 and interim periods within those fiscal years. The Company adopted ~~this standard~~ASU 2018-13 during the ~~first quarter~~three months ended March 31, 2020, however, the effect of ~~2019. The~~ adoption ~~of this guidance~~ did not have a material impact on its disclosures.

NOTE 3. ACCRUED LIABILITIES

Accrued liabilities consisted of the following (in thousands):




	June 30, 2020		December 31, 2019
Accrued contracted research and development services	$	4,443	$	4,532
Accrued license fee	1,000		—
Accrued professional fees	365		1,788
Accrued compensation	453		59


Total	$	6,261	$	6,379

NOTE 4. CONVERTIBLE PROMISSORY NOTES

In March 2019, the Company initiated a convertible promissory notes offering pursuant to which the Company issued unsecured convertible promissory notes (the “Prom Notes”), bearing interest at 12.00% with a maturity of one year. Through August 31, 2019, the Company had raised an aggregate principal amount of $7.4 million in Prom Notes, including $1.7 million from certain of the Company’s ~~financial statements~~management and board of directors. On August 31, 2019, immediately prior to the Merger, the Prom Notes and related ~~disclosures.~~

accrued interest converted into 1,069,740 shares of Private Brickell common stock at a conversion price of $7.54 per share (the “Conversion”).

2.	~~STOCK-BASED COMPENSATION~~

~~Total stock-based compensation~~

The Prom Notes also provided for the issuance of warrants at 50% coverage, to acquire 490,683 shares of common stock. The warrants are exercisable for a term of five years at an exercise price of $10.36. The Company evaluated the various financial instruments under ASC 480, “Distinguishing Liabilities from Equity,” and ASC 815, “Derivatives and Hedging” (“ASC 815”), and determined the warrants required fair value accounting. The fair value of the warrants was recorded as a warrant liability upon issuance. The fair value of the warrants on the dates of issuance of $1.5 million was determined with the assistance of a third-party valuation firm. The fair value of the warrants was recorded as a debt discount upon issuance and was amortized to interest expense ~~was allocated to research and development, manufacturing and production and general and administrative expense as follows (in thousands):~~

over the term of the Prom Notes based on the effective interest method.

Three Months Ended

Six Months Ended

June 30,

June 30,

2019

2018

2019

2018

Research and development

$
6

$
48

$
(44
)

$
76

Manufacturing and production

—

—

—

(68
)
General and administrative

17

114

48

201

Total stock-based compensation expense

$
23

$
162

$
4

$
209

~~There were no stock-based awards granted by~~

At inception of the Prom Notes offering, the Company ~~during~~analyzed the conversion feature of the agreement for derivative accounting consideration under ASC 815 and determined that the embedded conversion features should be classified as a derivative, which was required to be bifurcated and recorded as a derivative liability.

The embedded derivative for the Prom Notes was carried on the Company’s condensed consolidated balance sheets at fair value. The derivative liability was marked-to-market each measurement period and any change in fair value was recorded as a component of the statements of operations. The fair value of the derivative liabilities on the date of issuance of $1.4 million was determined with the assistance of a third-party valuation firm. The fair value of the conversion feature was recorded as a debt discount upon issuance and was amortized to interest expense over the term of the Prom Notes based on the effective interest method.

During the three and six months ended June 30, 2019, the Company recognized $0.5 million of interest expense, including $0.4 million of accretion of discounts using an effective interest rate of 12.00%. During the three and six months ended June 30, 2020, no interest expense was recognized.

NOTE 5. NOTES PAYABLE

Loan Agreement with Hercules Capital, Inc.

On February 18, 2016, the Company entered into a loan and security agreement (the “Loan Agreement”) with Hercules Capital, Inc. (the “Lender”) under which the Company borrowed $7.5 million upon the execution of the Loan Agreement on February 18, 2016. The interest rate applicable to each tranche was variable based upon the greater of either (i) 9.2% and (ii) the sum of (a) the Prime Rate as reported in The Wall Street Journal minus 3.5%, plus (b) 9.2%. Payments under the Loan Agreement were interest only until June 1, 2017, followed by equal monthly payments of principal and interest through the maturity date of September 1, 2019. ~~During~~The Company paid the Lender aggregate facility fees of $0.2 million in connection with the Loan Agreement.

In connection with the Loan Agreement, the Company issued warrants to the Lender, which are exercisable for 9,005 shares of common stock at a per share exercise price of $33.31 (the “Hercules Capital Warrants”). The Hercules Capital Warrants will terminate, if not earlier exercised, on February 18, 2026. The fair value of the Hercules Capital Warrants was recorded at inception as a redeemable convertible preferred stock warrant liability upon issuance.

On September 3, 2019, the Company repaid the remaining outstanding loan balance of $2.6 million and an associated accrued interest and aggregate end-of-term payment of $0.6 million, and the Loan Agreement was terminated. At the effective time of the Merger, the warrant liability was reclassified to equity in the condensed consolidated balance sheets. As of June 30, 2020, there were no remaining unaccreted debt discounts and issuance costs.

Paycheck Protection Program

On April 15, 2020, the Company executed an unsecured promissory note (referred to in the condensed consolidated financial statements as of and for the six months ended June 30, ~~2018,~~2020 as a “note payable”) to IberiaBank (the “PPP Loan”) pursuant to the U.S. Small Business Administration’s Paycheck Protection Program (the “PPP”) under Division A, Title I of the federal Coronavirus Aid, Relief, and Economic Security (“CARES”) Act. A PPP loan is for the purpose of helping businesses keep their workforce employed during the Coronavirus (COVID-19) crisis. The Company ~~granted stock-based awards~~is using the PPP Loan proceeds for covered payroll costs and certain other permitted costs in accordance with ~~a total estimated value~~the relevant terms and conditions of the CARES Act.

The PPP Loan is in the principal amount of $0.4 million, bears interest at a fixed rate of 1.00% per annum and matures on April 15, 2022. The PPP Loan requires equal monthly payments of principal and interest commencing on November 15, 2020. The PPP Loan may be prepaid by the Company at any time prior to maturity without penalty. Under the terms of the PPP Loan, the Company is evaluating whether it may apply for forgiveness of the amount due on the PPP Loan.

NOTE 6. COMMITMENTS AND CONTINGENCIES

Operating Leases

In August 2016, the Company entered into a five-year lease for office space in Boulder, Colorado that expires on October 31, 2021 (the “Boulder Lease”) subject to the Company’s option to renew the Boulder Lease for 2 additional terms of three years each. Pursuant to the Boulder Lease, the Company leased 3,038 square feet of space in a multi-suite building. Rent payments under the Boulder Lease included base rent of $4,430 per month during the first year of the Boulder Lease with an annual increase of 3.5%, and additional monthly fees to cover the Company’s share of certain facility expenses, including utilities, property taxes, insurance, and maintenance, which were ~~equal to 2.5%~~$2,160 per month during the first year of the ~~outstanding shares~~Boulder Lease.

The Company recognized a right-of-use asset and corresponding lease liability on January 1, 2019, by calculating the present value of ~~common stock~~lease payments, discounted at 12.0%, the ~~end~~Company’s estimated incremental borrowing rate, over the 2.8 years expected remaining term. As the Company’s lease does not provide an implicit rate, the Company estimated the incremental borrowing rate based on industry peers. Industry peers consist of several public companies in the biotechnology industry with comparable characteristics, including clinical trials progress and therapeutic indications. Amortization of the ~~period. At June 30, 2019, total unrecognized estimated compensation expense related~~operating lease right-of-use asset for the Boulder Lease amounted to ~~unvested stock-based awards granted prior to that date was $0.1 million, which is expected to be recognized over a weighted-average period of 1.3 years.~~

3.	~~MARKETABLE SECURITIES, AVAILABLE FOR SALE~~

~~The following is a summary of available-for-sale marketable securities (in thousands):~~

June 30, 2019

Amortized
Cost

Unrealized
Gain

Unrealized
Loss

Market
Value

U.S. treasuries

$
30,865

$
42

$
—

$
30,907

$
30,865

$
42

$
—

$
30,907

December 31, 2018

Amortized
Cost

Unrealized
Gain

Unrealized
Loss

Market
Value

U.S. treasuries

$
36,219

$
—

$
18

$
36,201

$
36,219

$
—

$
18

$
36,201

~~At June 30, 2019, none of these securities were scheduled to mature outside of one year. The Company did not realize any gains or losses on sales of available-for-sale securities~~$19 thousand and $37 thousand for the three and six months ended June 30, ~~2019.~~2020, respectively, which was included in operating expense. As of June 30, ~~2019, none~~2020, the remaining lease term was 1.3 years.

The terms of the ~~securities had been in~~Boulder Lease provide for rental payments on a ~~continuous material unrealized loss position longer than one year.~~

4.	~~OTHER BALANCE SHEET ACCOUNTS~~

~~Accounts payable and accrued expenses consisted of~~monthly basis on a graduated scale. Lease expense for the ~~following (in thousands):~~

June 30,

December 31,

2019

2018

Employee compensation

$
335

$
1,768

Post-termination benefit accrual

96

—

Clinical trial accruals

111

1,000

Accounts payable

544

412

Other accrued liabilities

73

371

Total accounts payable and accrued expenses

$
1,159

$
3,551

5.	~~LONG-TERM INVESTMENTS~~

~~During the six~~three months ended June 30, 2020 and 2019 ~~the Company sold its auction rate security classified as a long-term investment with a par value of $2.5 million. Included in investment~~was $18 thousand and ~~other income~~$32 thousand, respectively. Lease expense for the six months ended June 30, 2020 and 2019 was $41 thousand and $60 thousand, respectively.

The following is a ~~net gain~~summary of ~~$0.4 million~~the contractual obligations related to ~~the sale.~~

6.	~~FAIR VALUE MEASUREMENTS~~

The Company measures fair value as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. Fair value measurements are based on a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:

~~Level 1: Observable inputs such as quoted prices in active markets;~~

~~Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and~~

~~Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions.~~

~~Cash equivalents, marketable securities and long-term investments measured at fair value are classified in the table below in one of the three categories described above (in thousands):~~

Fair Value Measurements

June 30, 2019

Level 1

Level 2

Level 3

Total

Money market funds

$
10,178

$
—

$
—

$
10,178

U.S. treasuries

30,907

—

—

30,907

$
41,085

$
—

$
—

$
41,085

Fair Value Measurements

December 31, 2018

Level 1

Level 2

Level 3

Total

Money market funds

$
11,523

$
—

$
—

$
11,523

U.S. treasuries

36,201

—

—

36,201

Auction rate securities

—

—

2,386

2,386

$
47,724

$
—

$
2,386

$
50,110

~~The Company invests in U.S. treasury securities, certificates of deposit and money market funds, which are valued based on publicly available quoted market prices for identical securities~~operating lease commitments as of June 30, ~~2019.~~2020 and the effect such obligations are expected to have on the Company’s liquidity and cash flows in future periods (in thousands):


Less than 1 year	$	93
1-3 years	31
3-5 years	—
More than 5 years	—
Imputed interest	(10)
Total	$	114

Amended and Restated License Agreement with Bodor

In February 2020, the Company, together with Brickell Subsidiary and Bodor Laboratories, Inc. and Dr. Nicholas S. Bodor (collectively, “Bodor”) entered into an amended and restated license agreement (the “Amended and Restated License Agreement”). The Amended and Restated License Agreement supersedes the License Agreement, dated December 15, 2012, entered into between Brickell Subsidiary and Bodor, as amended by Amendment No. 1 to License Agreement, effective as of October 21, 2013, and Amendment No. 2 to License Agreement, effective as of March 31, 2015.

The Amended and Restated License Agreement retains with the Company ~~determines~~a worldwide, exclusive license to develop, manufacture, market, sell and sublicense products containing the ~~fair value~~proprietary compound sofpironium bromide based upon the patents referenced in the Amended and Restated License Agreement for a defined field of ~~corporate bonds~~use. In exchange for entering into the Amended and Restated License Agreement, settling the previously disclosed dispute, and resolving the associated litigation between the Company and Bodor, the Company made an upfront payment of $1.0 million in cash to Bodor following the execution of the Amended and Restated License Agreement and the settlement agreement by and among the Company, Brickell Subsidiary, Inc., and Bodor, dated February 17, 2020. Additionally, under the original License Agreement and the Amended and Restated License Agreement, the Company is required to pay Bodor (i) a royalty on sales of product outside Kaken’s territory, including a low single-digit royalty on sales of certain product not covered by the patent estate licensed from Bodor; (ii) a specified percentage of all royalties the Company receives from Kaken for sales of product within its territory; (iii) a percentage of non-royalty sublicensing income the Company receives from Kaken or other sublicensees; and (iv) up to an aggregate of $1.8 million (plus an additional $0.1 million for approvals of additional products) in cash

payments and $1.5 million of shares of the Company’s common stock upon the achievement of certain development, regulatory and other ~~government-sponsored enterprise related securities with~~milestones, including the ~~aid~~enrollment of valuations provided by third parties using proprietary valuation models and analytical tools. These valuation models and analytical tools use market pricing or similar instruments that are both objective and publicly available, including matrix pricing or reported trades, benchmark yields, broker/dealer quotes, issuer spreads, two-sided markets, benchmark securities, bids and/or offers. The Company validates the ~~valuations received from its primary pricing vendors for its Level 2 securities by examining~~first patient in the inputs used in that vendor’s pricing process and determines whether they are reasonable and observable. The Company also compares those valuations to recent reported trades for those securities. As of June 30, 2019 and December 31, 2018,U.S. Phase 3 trials. During the ~~Company had no investments in Level 2 securities. The Company did not transfer any investments between level categories during the six~~three months ended June 30, ~~2019.~~

~~Activity for assets measured at fair value using significant unobservable inputs (Level 3) is presented~~2020, based on the foregoing, the Company made a $0.5 million milestone payment to Bodor following the closing of the public offering in June 2020 and accrued an additional $1.0 million related to its plan to initiate its U.S. Phase 3 pivotal program in the ~~table below (in thousands):~~

fourth quarter of 2020. As a result, the Company recorded $1.5 million as research and development expense in the condensed consolidated statements of operations during the three months ended June 30, 2020.

Balance at December 31, 2018

$
2,386

Change in fair market value included in other comprehensive loss

83

Sale of Level 3 security

(2,469
)
Balance at June 30, 2019

$
—

Total gains or losses for the period included in net loss attributable to the change in
unrealized gains or losses relating to assets still held at the reporting date

$
—

NOTE 7. CAPITAL STOCK

Common Stock

Each share of the Company’s common stock is entitled to one vote, and the holders of the Company’s common stock are entitled to receive dividends when and as declared or paid by its board of directors. The Company has reserved authorized shares of common stock for future issuance at June 30, 2020 as follows:

7.	~~COMMITMENTS AND CONTINGENCIES~~
		June 30, 2020
Shares available for grant under the Omnibus Plan		—
Common stock warrants		20,669,533
Common stock options outstanding		1,578,231


Unvested restricted stock units		253,045




Total		22,500,809

While 694,162 shares of common stock remained available for grant under the ~~ordinary course~~2020 Omnibus Long-Term Incentive Plan (the “Omnibus Plan”) as of ~~business,~~June 30, 2020, the Company’s board of directors, in connection with the public offering in June 2020 described below, utilized shares that were previously reserved for issuance under the Omnibus Plan and not subject to outstanding awards, to instead be reserved for issuance under the warrants issued in the June 2020 offering. As a result, the number of shares reserved for issuance as of June 30, 2020 under the Omnibus Plan was zero.

As described in the Company’s definitive proxy statement filed with the SEC on July 15, 2020, the Company ~~may become~~plans to hold a ~~party~~special meeting of stockholders on August 31, 2020, at which stockholders will be requested to ~~additional lawsuits involving various matters. The Company is unaware of any such lawsuits presently pending against it which, individually or in the aggregate, are deemed to be material~~approve an amendment to the Company’s ~~financial condition or results~~restated certificate of ~~operations.~~

~~The Company prosecutes its intellectual property vigorously~~incorporation to ~~obtain~~increase the ~~broadest valid scope for its patents. Due~~number of authorized shares of common stock from 50,000,000 to ~~uncertainty of the ultimate outcome of these matters, the impact on future operating results or~~100,000,000. If stockholders approve that amendment, the Company’s ~~financial condition is not subject~~board of directors plans to ~~reasonable estimates.~~

utilize a portion of those additional authorized shares to again reserve for issuance the number of shares available for grant under the Omnibus Plan. At the special meeting, the Company’s stockholders will also be requested to approve an amendment to the Omnibus Plan to increase the number of shares available for issuance thereunder by 4,500,000 shares.

8.	~~ASTELLAS OUT-LICENSE AGREEMENTS~~

Public Offering of Common Stock and Warrants

In ~~July 2011,~~June 2020, the Company entered into ~~license agreements~~an underwriting agreement with ~~Astellas Pharma~~Oppenheimer & Co. Inc. (“Oppenheimer”), ~~or Astellas, related~~as representative of several underwriters, relating to the public offering, issuance and sale of 14,790,133 shares of its common stock, and, to certain investors, pre-funded warrants to purchase 2,709,867 shares of its common stock, and accompanying common stock warrants to purchase up to an aggregate of 17,500,000 shares of its common stock (the “Offering”). Each share of common stock and pre-funded warrant to purchase one share of common stock was sold together with a common warrant to purchase one share of common stock. The public offering price of each share of common stock and accompanying common warrant was $1.15 and $1.149 for each pre-funded warrant and accompanying common warrant, respectively. The pre-funded warrants were immediately exercisable at a price of $0.001 per share of common stock. The common warrants were immediately exercisable at a price of $1.25 per share of common stock and will expire five years from the date of issuance. The shares of common stock and pre-funded warrants, and the accompanying common warrants, were issued separately and were immediately separable upon issuance. The Offering resulted in approximately $18.7 million of net proceeds to the Company after deducting underwriting commissions and discounts and other offering expenses of $1.4 million and excluding the proceeds, if any, from the exercise of the warrants. The Company anticipates using the net proceeds from the Offering for research and development, including clinical trials, working capital, and general corporate purposes.

Certain officers of the Company participated in the Offering by purchasing an aggregate purchase price of $0.2 million of the Company's common stock and warrants.

At Market Issuance Sales Agreement

On April 14, 2020, the Company entered into an At Market Issuance Sales Agreement (the “ATM Agreement”) with Oppenheimer & Co. Inc. as the Company’s sales agent (the “Agent”). Pursuant to the terms of the ATM Agreement, the Company may sell from time to time through the Agent shares of the Company’s common stock having an aggregate offering price of up to $8.0 million (the “Shares”). Any Shares will be issued pursuant to the Company’s ~~CMV program. The license agreement was terminated in February 2018.~~shelf registration statement on Form S-3 (Registration No. 333-236353). Sales of the Shares, if any, will be made by means of ordinary brokers’ transactions on the Nasdaq Capital Market at market prices or as otherwise agreed by the Company and the Agent. Under the terms of the ~~agreements,~~ATM Agreement, the Company ~~was performing research and development services and manufacturing services which were being paid~~may also sell the Shares from time to time to the Agent as principal for ~~by Astellas. During the three and six months ended June 30, 2018, the Company recognized $0.7 million and $1.2 million, respectively, of revenue related to these contract services.~~

9.	~~FACILITY LEASE~~

~~The Company occupies approximately 17,000 square feet of research laboratory and office space~~its own account at a ~~single site in San Diego, California under a sublease with Genopis, Inc., or Genopis. In July 2018, the Company entered into an agreement with Genopis~~price to ~~sell the Company’s idle manufacturing assets for $1.7 million. As part of the agreement, Genopis~~be agreed to sublease 51,400 square feet of the Company’s facility through the remaining term of the Company’s lease, which expired on December 31, 2018. Genopis was also required to sign a long-term lease with the facility’s landlord beginning on January 1, 2019. Genopis agreed to sublease 17,000 square feet of the facility (consisting of lab and office space) to the Company at no cost for the one-year period ending on December 31, 2019. The fair value of rent of the lab and office space that the Company is occupying at no cost was $0.4 million as of June 30, 2019 and is recorded in receivables and other assets.

10.	~~STOCKHOLDERS’ EQUITY~~

As of the date of this filing, the Company has on file a shelf registration statement that allows it to raise up to an additional $40.0 million from the sale of common stock, preferred stock, debt securities and/or warrants, subject to limitations on the amount of securities that it may sell under the registration statement in any 12-month period. Specific terms of any offering under a shelf registration statement and the securities involved would be establishedupon at the time of sale.

~~In November 2017,~~ Any sale of the Shares to the Agent as principal would be pursuant to the terms of a separate placement notice between the Company and the Agent. As of June 30, 2020, the Company had not yet sold any Shares under the ATM Agreement.

Private Placement Offerings

On February 17, 2020, the Company and Lincoln Park entered into (i) a securities purchase agreement (the “Securities Purchase Agreement”); (ii) a purchase agreement (the “Purchase Agreement”); and (iii) a registration rights agreement (the “Registration Rights Agreement”). Pursuant to the Securities Purchase Agreement, Lincoln Park purchased, and the Company sold, ~~9,194,286 shares~~(i) an aggregate of ~~its common stock in a public offering at a price of $1.75 per share, including an overallotment of 2,142,857 shares issued at a price of $1.75 per share, and pre-funded warrants to purchase 7,234,285~~950,000 shares of common stock at(the “Common Shares”); (ii) a warrant to initially purchase ~~price~~an aggregate of ~~$1.74 per share. The pre-funded warrants have~~up to 606,420 shares of common stock at an exercise price of $0.01 per share (the “Series A Warrant”); and ~~may be exercised at any time. In March 2019, 993,211 warrants were exercised. As~~(iii) a warrant to initially purchase an aggregate of ~~June 30, 2019, warrants~~up to ~~purchase 6,241,074~~1,556,420 shares of common stock ~~were outstanding.~~

~~11.~~

~~RELATED PARTY TRANSACTION~~

~~On April 4, 2017,~~at an exercise price of $1.16 per share (the “Series B Warrant” and together with the ~~Company entered into a research collaboration agreement with AnGes. As of~~Series A Warrant, the ~~date of~~“Warrants”). The aggregate gross purchase price for the ~~transaction, AnGes held 18.6% of the outstanding stock of the Company. Pursuant to the collaboration agreement, AnGes agreed to make a non-refundable payment to the Company of $750,000~~Common Shares and the ~~Company agreed to conduct certain research activities related to a development program targeting chronic hepatitis B. An amendment to the agreement~~Warrants was executed in September 2018 that added an additional non-refundable payment from AnGes to the Company of $145,000. The HBV program was cancelled in 2019. As of June 30, 2019, the Company had recognized the full $895,000 as contract revenue.

$2.0 million.

~~12.~~

~~RESTRUCTURING COSTS~~

In February 2019, the Company made the decision to discontinue the Phase 2 clinical trial of VL-2397. As a result, the Company restructured its operations to conserve capital and recorded restructuring charges of $0.6 million and $2.1 million during the three and six months ended June 30, 2019, respectively.

In January 2018, the Company and Astellas announced that ASP0113 did not meet its primary endpoint in a Phase 3 clinical study in CMV end organ disease, after which Astellas informed the Company that it was terminating further development. As a result, the Company restructured its operations to conserve capital, which included a staff reduction of 40 employees and the write-off of certain intangible assets. The Company recorded charges for one-time employee termination benefits of $1.1 million and for intangible asset impairments of $0.3 million during the six months ended June 30, 2018. Overhead costs associated with the former manufacturing facility of $0.6 million and $1.0 million were recognized as general and administrative expense during the three and six months ended June 30, 2018, respectively.

~~The following table summarizes the restructuring charges (in thousands) recorded for the six months ended June 30, 2019 and 2018:~~

Employee

Termination

Asset

2019

Benefits

Impairments

Total

Research and development

$
2,018

$
—

$
2,018

General and administrative

70

—

70

$
2,088

$
—

$
2,088

Employee

Termination

Asset

2018

Benefits

Impairments

Total

Research and development

$
272

$
267

$
539

Manufacturing and production

735

—

735

General and administrative

117

—

117

$
1,124

$
267

$
1,391

~~The following table sets forth the accrual activity for employee termination benefits for the six months ended June 30, 2019 (in thousands).~~

Balance at December 31, 2018

$
—

Accruals

2,088

Payments

(1,992
)
Balance at June 30, 2019

$
96

~~13.~~

~~MERGER AGREEMENT~~

On June 2, 2019, the Company entered into an Agreement and Plan of Merger and Reorganization, or the Merger Agreement, with Brickell Biotech, Inc., a Delaware corporation and clinical-stage medical dermatology company, or Brickell Biotech, and Victory Subsidiary, Inc., a Delaware corporation and wholly owned subsidiary of the Company, or Merger Sub. UponUnder the terms and subject to ~~satisfaction~~the conditions of the ~~conditions described~~Purchase Agreement, the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase, up to $28.0 million in the ~~Merger~~aggregate of shares of common stock. Sales of common stock by the Company, if any, will be subject to certain limitations, and may occur from time to time, at the Company’s sole discretion, over the 36-month period commencing on the date the conditions set forth in the Purchase Agreement are satisfied (such date on which all of such conditions are satisfied, the “Commencement Date”).

Following the Commencement Date, under the Purchase Agreement, on any business day selected by the Company, the Company may direct Lincoln Park to purchase up to 100,000 shares of common stock on such business day (each, a “Regular Purchase”), provided, however, that (i) the Regular Purchase may be increased to up to 125,000 shares, provided that the closing sale price of the common stock is not below $3.00 on the purchase date; and (ii) the Regular Purchase may be increased to up to 150,000 shares, provided that the closing sale price of the common stock is not below $5.00 on the purchase date. In each case, Lincoln Park’s maximum commitment in any single Regular Purchase may not exceed $1,000,000. The purchase price per share for each such Regular Purchase will be based off of prevailing market prices of common stock immediately preceding the time of sale. In addition to Regular Purchases, the Company may direct Lincoln Park to purchase other amounts as accelerated purchases or as additional accelerated purchases if the closing sale price of the common stock exceeds certain threshold prices as set forth in the Purchase Agreement. In all instances, the Company may not sell shares of its common stock to Lincoln Park under the Purchase Agreement if it would result in Lincoln Park beneficially owning more than 9.99% of the outstanding shares of common stock. As of June 30, 2020, the Company has not made any sales of its common stock under the Purchase Agreement.

The Company agreed with Lincoln Park that it will not enter into any “variable rate” transactions with any third party, subject to certain exceptions, for a period defined in the Purchase Agreement. The Company has the right to terminate the Purchase Agreement at any time, at no cost or penalty.

The Securities Purchase Agreement, the Purchase Agreement, and the Registration Rights Agreement contain customary representations, warranties, agreements and conditions to completing future sale transactions, indemnification rights and obligations of the parties.

Preferred Stock

As of June 30, 2020, the Company had no shares of preferred stock outstanding and had not designated the rights, preferences, or privileges of any class or series of preferred stock. Under the Company’s restated certificate of incorporation, the Company’s board of directors has the authority to issue up to 5,000,000 shares of preferred stock with a par value of $0.01 per share, at its discretion, in one or more classes or series and to fix the powers, preferences and rights, and the qualifications, limitations, or restrictions thereof, including dividend rights, conversion rights, voting rights, terms of redemption, and liquidation preferences, without further vote or action by the Company’s stockholders.

NOTE 8. STOCK-BASED COMPENSATION

Equity Incentive Plans

2020 Omnibus Plan

On April 20, 2020, the Company’s stockholders approved the Omnibus Plan, which replaced, with respect to new award grants, the Company’s 2009 Equity Incentive Plan, as amended and restated (the “2009 Plan”), and the Vical Equity Incentive Plan (the “Vical Plan”) (collectively, the “Prior Plans”) that were previously in effect. The number of shares authorized for issuance under the Omnibus Plan includes 625,000 new shares and 54,389 shares that remained available for future grants pursuant to the Prior Plans, plus any shares that are forfeited pursuant to outstanding grants under the Prior Plans that would have again become available for grants pursuant to the terms of those plans. Following the approval of the ~~transaction~~Omnibus Plan on April 20, 2020, no additional grants will be made pursuant to the Prior Plans, but awards outstanding under those plans as of that date remain outstanding in accordance with their terms.

At June 30, 2020, 92,436 shares were subject to outstanding awards under the Omnibus Plan, and while 694,162 shares remained available for grant under the Omnibus Plan, those shares were no longer reserved for issuance, as described above in Note 7. “Capital Stock.”

2009 Equity Incentive Plan

The 2009 Plan was replaced by the ~~Company’s stockholders, Merger Sub will be merged with~~Omnibus Plan on April 20, 2020 and, ~~into Brickell Biotech, or the Merger, with Brickell Biotech surviving the Merger~~ as a ~~wholly owned subsidiary of~~result, at June 30, 2020, there were 0 remaining shares available for new grants under the ~~Company.~~

~~Concurrent~~2009 Plan. However, at June 30, 2020, 1,351,974 shares were subject to outstanding awards under the 2009 Plan, which awards remain outstanding in accordance with the execution of the Merger Agreement, Brickell entered into a Funding Agreement, or the Funding Agreement, with NovaQuest Co-Investment Fund X, L.P., or NovaQuest, pursuant to which NovaQuest committed to provide up to $25.0 million in near-term research and development funding to Brickell following the closing of the Merger, or the Concurrent Financing, with $5.6 million of the commitment expected to be paid promptly following the closing of the Merger and the remaining

~~portion of the commitment expected to be paid in quarterly payments equal to 67% of invoiced research and development expenses incurred during the subsequent four fiscal quarters.~~

their terms.

Vical Equity Incentive Plan

In connection with the ~~Concurrent Financing, immediately following~~Merger, the ~~closing~~ Company adopted the Vical Plan, which was replaced by the Omnibus Plan on April 20, 2020. As a result, at June 30, 2020, there were 0 remaining shares available for new grants under the Vical Plan. However, at June 30, 2020, 386,866 shares were subject to outstanding awards under the Vical Plan, which awards remain outstanding in accordance with their terms.

Stock-based Compensation Expense

Total stock-based compensation expense reported in the condensed consolidated statements of operations was allocated as follows (in thousands):


	Three Months Ended June 30,						Six Months Ended June 30,
	2020		2019		2020		2019
Research and development	$	68	$	78	$	172	$	156
General and administrative	385		221		684		527
Total stock-based compensation expense	$	453	$	299	$	856	$	683

NOTE 9. SUBSEQUENT EVENTS

Proposed Amendment of Certificate of Incorporation and Omnibus Plan

On July 14, 2020, the Company’s board of directors adopted, subject to stockholder approval, an amendment to Article IV, Section Aof the ~~Merger,~~Company’s restated certificate of incorporation (the “Charter Amendment”) to increase the ~~combined company will issue warrants to NovaQuest, or the NovaQuest Warrants, to purchase~~number of authorized shares of ~~Vical~~the Company’s common ~~stock. The~~stock by 50,000,000 shares, or from 50,000,000 shares to 100,000,000 shares. Further, on July 14, 2020, the Company’s board of directors approved the following amendments to the Omnibus Plan, subject to stockholder approval:

•an increase in the maximum number of shares ~~of Vical common stock underlying~~that may be delivered under the ~~NovaQuest Warrants will be based on 10% warrant coverage on~~Omnibus Plan by an additional 4,500,000 shares, from 679,389 shares to 5,179,389 shares (which amount is in addition to any shares granted previously under the ~~$25.0 million NovaQuest funding commitment and~~Prior Plans that are forfeited, expire or are canceled after the ~~final exchange ratio for the Merger, or the Exchange Ratio, and the exercise price~~effective date of the ~~NovaQuest Warrants will be determined based on a 10% premium~~Omnibus Plan without delivery of shares or which result in the forfeiture of the shares back to the ~~Brickell price per share~~Company to the extent that such shares would have been added back to the reserve under the terms of ~~common stock implied value~~the Prior Plans); and

•a corresponding increase in the ~~Merger, as adjusted for the Exchange Ratio.~~

~~Immediately following the Merger, the former Brickell securityholders and NovaQuest, collectively, are expected to own, subject to adjustment, approximately 60% of the aggregate~~maximum number of shares of Vical common stock, and the securityholders of Vical immediately prior to the Merger are expected to own, subject to adjustment, approximately 40% of the aggregate number of shares of Vical common stock (in each case on a fully diluted basis using the treasury stock method in instances other thanthat may be delivered with respect to incentive stock options granted under the ~~NovaQuest Warrants~~Omnibus Plan by an additional 4,500,000shares, from 679,389 shares to 5,179,389 shares;

(collectively, the “Plan Amendments”).

The Charter Amendment and ~~certain equity issuances by Brickell following~~ the ~~signing~~Plan Amendments are subject to stockholder approval. On July 27, 2020, the Company filed a definitive proxy statement with the SEC related to a special meeting of stockholders to be held on August 31, 2020, at which stockholders will be requested to approve the ~~Merger Agreement~~Charter Amendment and ~~prior to~~ the ~~completion of the Merger).~~

Plan Amendments.

I~~TEM 2.~~

~~MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS~~

FORWARD-LOOKING STATEMENTS

This ~~Quarterly Report~~quarterly report on Form 10-Q ~~or Report,~~(“Quarterly Report”), contains forward-looking statements ~~within the meaning of Section 27A~~that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of ~~1933, as amended, or the Securities Act, and Section 21E~~1995. All statements contained in this Quarterly Report other than statements of ~~the Securities Exchange Act of 1934, as amended, or the Exchange Act,~~historical fact, including statements regarding our ~~business, our~~strategy, future operations, future financial position, liquidity, future revenue, projected expenses, results of operations, expectations concerning the ~~research~~timing and ~~development~~our ability to commence and subsequently report data from planned non-clinical studies and clinical trials, prospects, plans and objectives of biopharmaceutical products, the funding of our research and development efforts, whether and when the proposed merger with Brickell Biotech, Inc., or the Merger, will be consummated, the potential benefits to be derived from the Merger, financing and development plans of Brickell or the combined company if the Merger is consummated, and other statements describing our goals, expectations, intentions or beliefs. These statements often containmanagement are forward-looking statements. The words ~~such as~~“believe,” “may,” “will,” ~~“expect,~~“estimate,” “continue,” “anticipate,” “intend,” “plan,” ~~“believe,~~“expect,” ~~“estimate”~~“predict,” “potential,” “opportunity,” “goals,” or ~~other words indicating future results, though not all~~“should,” and similar expressions are intended to identify forward-looking ~~statements necessarily contain these identifying words.~~statements. Such statements ~~reflect our~~are based on management’s current ~~views~~expectations and ~~assumptions and are subject to~~involve risks and ~~uncertainties, particularly those inherent in the process of developing~~uncertainties. Actual results and ~~commercializing biopharmaceutical products, and whether the conditions to the closing of the Merger will be satisfied. Actual results~~performance could differ materially from those projected ~~herein. Factors~~in the forward-looking statements as a result of many factors. Unless otherwise mentioned or unless the context requires otherwise, all references in this Quarterly Report to “Brickell,” “Brickell Subsidiary,” “Company,” “we,” “us,” and “our,” or similar references, refer to Brickell Biotech, Inc., and our consolidated subsidiaries.

We based these forward-looking statements largely on our current expectations and projections about future events and trends that ~~could cause or contribute~~we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. These forward-looking statements are subject to ~~such differences include, but are not limited to,~~a number of risks, uncertainties, and assumptions, including those ~~discussed~~described in Part I, Item 1A. “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, ~~2018 and our preliminary proxy statement filed with the SEC on July 2,~~ 2019, and ~~in our subsequent filings with the SEC, and those identified~~ in Part II, Item 1A1A. “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 and in this Quarterly Report, and under a similar heading in any other periodic or current report we may file with the U.S. Securities and Exchange Commission (the “SEC”), in the future. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge quickly and from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the future events and trends discussed in this Quarterly Report ~~under~~may not occur and actual results could differ materially and adversely from those anticipated or implied in the ~~caption “Risk Factors”. As a result, you~~forward-looking statements. We undertake no obligation to revise or publicly release the results of any revision to these forward-looking statements, except as required by law. Given these risks and uncertainties, readers are cautioned not to ~~rely~~place undue reliance on ~~these~~such forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement.

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Overview

We ~~disclaim any duty to update any forward-looking statement to reflect events or circumstances that occur after the date on which such statement is made.~~

~~Overview~~

~~Until recently, we were~~are a clinical-stage pharmaceutical company focused on ~~developing our novel antifungal VL-2397,~~the development of innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases. Our pipeline consists of potential novel therapeutics for hyperhidrosis and other prevalent dermatological conditions. Our executive management team and board of directors bring extensive experience in product development and global commercialization, having served in leadership roles at large global pharmaceutical companies and biotechs that have developed and/or launched successful products, including several that were first-in-class and/or achieved iconic status, such as Cialis^®, Taltz^®, Gemzar^®, Prozac^®, Cymbalta^® and Juvederm^®.

Our pivotal Phase 3-ready clinical-stage product candidate, sofpironium bromide, is a proprietary new molecular entity. It belongs to a class of medications called anticholinergics. Anticholinergics block the action of acetylcholine, a chemical that transmits signals within the nervous system that are responsible for a range of bodily functions, including activation of the sweat glands. Sofpironium bromide was retrometabolically designed. Retrometabolic drugs are designed to exert their action topically and are potentially rapidly metabolized once absorbed into the blood. This proposed mechanism of action may allow for highly effective doses to be used while limiting systemic side effects. We intend to develop sofpironium bromide as a potential best-in-class, self-administered, once daily, topical therapy for the treatment of primary axillary hyperhidrosis.

Hyperhidrosis is a life-altering condition of sweating beyond what is physiologically required to maintain normal thermal regulation. It is believed to be caused by an overactive cholinergic response of the sweat glands and affects an estimated 15.3 million, or 4.8%, of the U.S. population. According to a 2016 update on the prevalence and severity of hyperhidrosis in the United States by Doolittle et al., axillary (underarm) hyperhidrosis, which is the targeted first potential indication for

sofpironium bromide, is the most common occurrence of hyperhidrosis, affecting approximately 65% of patients in the United States or an estimated 10 million individuals.

We and our development partner in Asia, Kaken Pharmaceutical Co., Ltd., (“Kaken”), have conducted 19 clinical trials of sofpironium bromide gel that encompass over 1,300 subjects in the United States and Japan. These trials evaluated the potential safety, tolerability, pharmacokinetics (PK), and efficacy of sofpironium bromide gel in adult and pediatric primary axillary hyperhidrosis patients and healthy adult subjects. Under our License, Development and Commercialization Agreement with Kaken, dated March 31, 2015 (as amended, the “Kaken Agreement”), in exchange for paying us an upfront, nonrefundable payment, we granted Kaken the exclusive right to develop, manufacture and commercialize sofpironium bromide in Japan and certain other Asian countries. In March 2019, Kaken completed a Phase 3 trial in patients with ~~invasive aspergillosis. VL-2397~~primary axillary hyperhidrosis in Japan, achieving statistical significance (p<0.05) on all primary and secondary endpoints.

Based on the positive results in the clinical trials for sofpironium bromide globally to date, we intend to initiate two pivotal Phase 3 clinical trials in up to 350 subjects per trial with primary axillary hyperhidrosis in the United States. Assuming the results of the Phase 3 clinical trials are favorable, we plan thereafter to submit a new drug application (“NDA”) to the U.S. Food and Drug Administration (the “FDA”), for the treatment of primary axillary hyperhidrosis by sofpironium bromide.

Recent Developments

Study Announcements

•In July 2020, we completed the analysis of our 12-month Phase 3 open-label long-term safety study, in 300 subjects 9 years and older with primary axillary hyperhidrosis, sofpironium bromide gel, 5% and 15%. The study results confirmed that sofpironium bromide gel, at both concentrations, was ~~being evaluated in a multicenter, open label randomized Phase 2 clinical study, designed to compare~~safe and generally well tolerated, which was consistent with the efficacy and safety of VL-2397 to standard treatment for invasive aspergillosis in acute leukemia patients and recipients of allogeneic hematopoietic cell transplant (HCT). In February 2019, we decided to discontinue theearlier Phase 2 clinical trial results. No treatment-related serious adverse events were observed. We expect to release additional details at an upcoming scientific forum.

•In June 2020, we announced positive Phase 3 pivotal study results in Japan from Kaken. All primary and secondary efficacy endpoints of ~~VL-2397~~the study were achieved and sofpironium bromide was safe and generally well tolerated. The study evaluated a total of 281 Japanese patients randomized 1:1 to apply sofpironium bromide gel, 5% (SB) or vehicle gel (placebo) to the axillae (i.e., underarm) for 42 days. These study results were presented as part of the Late-Breaking Research Program during the American Academy of Dermatology (AAD) Virtual Meeting Experience.

•In January 2020, Kaken announced submission of an NDA in ~~order~~Japan requesting approval to ~~conserve our cash resources while~~manufacture and market sofpironium bromide gel, 5% for primary axillary hyperhidrosis based on the positive Phase 3 data.

Upcoming Milestones

•Plan to initiate the U.S. Phase 3 pivotal program for sofpironium bromide gel, 15% in the fourth quarter of 2020. The planned program will be comprised of two pivotal Phase 3 trials to evaluate approximately 350 subjects per trial with primary axillary hyperhidrosis in the U.S. The first Phase 3 study is expected to begin in the fourth quarter of 2020.

•Expect Kaken to receive regulatory decision for sofpironium bromide gel, 5% in Japan, as early as the fourth quarter of 2020. Under the agreement with Kaken, we ~~pursue our strategic alternative review process.~~

Onare entitled to receive commercial milestone payments, as well as tiered royalties based on a percentage of net sales of sofpironium bromide in Japan.

Public Offering of Common Stock and Warrants

In June ~~2, 2019,~~2020, we entered into an underwriting agreement with Oppenheimer & Co. Inc. (“Oppenheimer”), as representative of several underwriters, relating to the public offering, issuance and sale of 14,790,133 shares of our common stock, and, to certain investors, pre-funded warrants to purchase 2,709,867 shares of our common stock, and accompanying common warrants to purchase up to an aggregate of 17,500,000 shares of our common stock (the “Offering”). Each share of common stock and pre-funded warrant to purchase one share of our common stock was sold together with a common warrant to purchase one share of our common stock. The public offering price of each share of common stock and accompanying common warrant was $1.15 and $1.149 for each pre-funded warrant and accompanying common warrant, respectively. The

pre-funded warrants were immediately exercisable at a price of $0.001 per share of our common stock. The common warrants were immediately exercisable at a price of $1.25 per share of our common stock and will expire five years from the date of issuance. The shares of common stock and pre-funded warrants, and the accompanying common warrants, were issued separately and were immediately separable upon issuance. The Offering resulted in approximately $18.7 million of net proceeds after deducting underwriting commissions and discounts and other offering expenses of $1.4 million and excluding the proceeds, if any, from the exercise of the warrants. We anticipate using the proceeds from the Offering for research and development, including clinical trials, working capital, and general corporate purposes.

At Market Issuance Sales Agreement

In April 2020, we entered into an At Market Issuance Sales Agreement (the “ATM Agreement”) with Oppenheimer as our sales agent (the “Agent”). Pursuant to the terms of the ATM Agreement, we may sell from time to time through the Agent shares of our common stock having an aggregate offering price of up to $8.0 million (the “Shares”). Any Shares will be issued pursuant to our shelf registration statement on Form S-3 (Registration No. 333-236353). Sales of the Shares, if any, will be made by means of ordinary brokers’ transactions on the Nasdaq Capital Market at market prices or as otherwise agreed by us and the Agent. Under the terms of the ATM Agreement, we may also sell the Shares from time to time to the Agent as principal for its own account at a price to be agreed upon at the time of sale. Any sale of the Shares to the Agent as principal would be pursuant to the terms of a separate placement notice between us and the Agent.

Private Placement Offerings

In February 2020, we entered into (i) a securities purchase agreement (the “Securities Purchase Agreement”); (ii) a purchase agreement (the “Purchase Agreement”); and (iii) a registration rights agreement (the “Registration Rights Agreement”), with Lincoln Park Capital Fund, LLC, an Illinois limited liability company (“Lincoln Park”). Pursuant to the Securities Purchase Agreement, Lincoln Park purchased, and we sold, (i) an aggregate of 950,000 shares of common stock (the “Common Shares”), (ii) a warrant to initially purchase an aggregate of up to 606,420 shares of common stock at an exercise price of $0.01 per share (the “Series A Warrant”), and (iii) a warrant to initially purchase an aggregate of up to 1,556,420 shares of common stock at an exercise price of $1.16 per share (the “Series B Warrant”, and together with the Series A Warrant, the “Warrants”). The aggregate gross purchase price for the Common Shares and the Warrants was $2.0 million.

Under the terms and subject to the conditions of the Purchase Agreement, we have the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase, up to $28.0 million in the aggregate of shares of our common stock. Sales of common stock by us, if any, will be subject to certain limitations, and may occur from time to time, at our sole discretion, over the 36-month period commencing on the date the conditions set forth in the Purchase Agreement are satisfied (such date on which all of such conditions are satisfied, the “Commencement Date”).

Following the Commencement Date, under the Purchase Agreement, on any business day selected by us, we may direct Lincoln Park to purchase up to 100,000 shares of our common stock on such business day (each, a “Regular Purchase”), provided, however, that (i) the Regular Purchase may be increased to up to 125,000 shares, provided that the closing sale price of the common stock is not below $3.00 on the purchase date; and (ii) the Regular Purchase may be increased to up to 150,000 shares, provided that the closing sale price of the common stock is not below $5.00 on the purchase date. In each case, Lincoln Park’s maximum commitment in any single Regular Purchase may not exceed $1,000,000. The purchase price per share for each such Regular Purchase will be based off of prevailing market prices of common stock immediately preceding the time of sale. In addition to Regular Purchases, we may direct Lincoln Park to purchase other amounts as accelerated purchases or as additional accelerated purchases if the closing sale price of the common stock exceeds certain threshold prices as set forth in the Purchase Agreement. In all instances, we may not sell shares of our common stock to Lincoln Park under the Purchase Agreement if it would result in Lincoln Park beneficially owning more than 9.99% of the outstanding shares of our common stock. As of June 30, 2020, we have not made any sales of our common stock under the Purchase Agreement.

We agreed with Lincoln Park that we will not enter into any “variable rate” transactions with any third party, subject to certain exceptions, for a period defined in the Purchase Agreement. We have the right to terminate the Purchase Agreement at any time, at no cost or penalty.

Amended and Restated License Agreement with Bodor

In February 2020, we, together with Brickell Subsidiary and Bodor Laboratories, Inc. and Dr. Nicholas S. Bodor (collectively, “Bodor”) entered into an amended and restated license agreement (the “Amended and Restated License Agreement”). The Amended and Restated License Agreement supersedes the License Agreement, dated December 15, 2012, entered into between Brickell Subsidiary and Bodor, as amended by Amendment No. 1 to License Agreement, effective as of October 21, 2013, and Amendment No. 2 to License Agreement, effective as of March 31, 2015.

The Amended and Restated License Agreement retains with us a worldwide, exclusive license to develop, manufacture, market, sell and sublicense products containing the proprietary compound sofpironium bromide based upon the patents referenced in the Amended and Restated License Agreement for a defined field of use. In exchange for entering into the Amended and Restated License Agreement, settling the previously disclosed dispute, and resolving the associated litigation between us and Bodor, we made an upfront payment of $1.0 million in cash to Bodor following the execution of the Amended and Restated License Agreement and the settlement agreement by and among the Company, Brickell Subsidiary, Inc., and Bodor, dated February 17, 2020. Additionally, based on the License Agreement and the Amended and Restated License Agreement, we are required to pay Bodor (i) a royalty on sales of product outside Kaken’s territory, including a low single-digit royalty on sales of certain product not covered by the patent estate licensed from Bodor; (ii) a specified percentage of all royalties we receive from Kaken for sales of product within its territory; (iii) a percentage of non-royalty sublicensing income we receive from Kaken or other sublicensees; and (iv) up to an aggregate of $1.8 million (plus an additional $0.1 million for approvals of additional products) in cash payments and $1.5 million of shares of the our common stock upon the achievement of certain development, regulatory and other milestones, including the enrollment of the first patient in the U.S. Phase 3 trials. During the three months ended June 30, 2020, based on the foregoing, we made a $0.5 million milestone payment to Bodor following the closing of the public offering in June 2020 and accrued an additional $1.0 million related to our plan to initiate our U.S. Phase 3 pivotal program in the fourth quarter of 2020. As a result, we recorded an aggregate of $1.5 million as research and development expense in the condensed consolidated statements of operations during the three months ended June 30, 2020.

Corporate History

On August 31, 2019, the Delaware corporation formerly known as “Vical Incorporated” (“Vical”), completed a reverse merger transaction in accordance with the terms and conditions of the Agreement and Plan of Merger and Reorganization, ~~or the Merger Agreement, with~~dated June 2, 2019, as further amended on August 20, 2019 and August 30, 2019, by and among Vical, Brickell Biotech, Inc., a then privately-held Delaware corporation ~~and clinical-stage medical dermatology company, or Brickell Biotech,~~that began activities in September 2009 (“Private Brickell”) and Victory Subsidiary, Inc., a ~~Delaware corporation and wholly owned~~wholly-owned subsidiary of ~~the Company, or~~ Vical (“Merger ~~Sub. Upon the terms and subject~~Sub”), pursuant to ~~satisfaction of the conditions described in the Merger Agreement, including approval of the transaction by the Company’s stockholders,~~which Merger Sub ~~will be~~ merged with and into Private Brickell, ~~Biotech, or~~with Private Brickell surviving the merger as a wholly-owned subsidiary of Vical (the “Merger”). Additionally, on August 31, 2019, immediately after the completion of the Merger, ~~with Brickell~~the Company changed its name from “Vical Incorporated” to “Brickell Biotech, ~~surviving the Merger as a wholly owned subsidiary of the Company~~

~~Research, Development~~Inc.”

Financial Overview

Our operations to date have been limited to business planning, raising capital, developing our pipeline assets (in particular sofpironium bromide), identifying product candidates, and ~~Manufacturing Programs~~

other research and development. To date, we have ~~not~~financed operations primarily through funds received ~~revenues~~from license and collaboration agreements, cash and investments acquired in connection with the Merger, and funds received from the sale of ~~independently developed pharmaceutical~~convertible preferred stock, debt, convertible notes, common stock, and warrants. We do not have any products approved for sale and have ~~received minimal revenues~~not generated any product sales. Since inception and through June 30, 2020, we have raised or generated an aggregate of $146.7 million to fund our operations, of which $39.1 million was through license and collaboration agreements, $37.0 million was from cash and investments acquired in the Merger, $33.6 million was from the sale of ~~commercially marketed products by~~convertible preferred stock, $22.1 million was from the sale of common stock and warrants, $7.5 million was from the sale of debt, and $7.4 million was from the sale of convertible notes. As of June 30, 2020, we had cash and cash equivalents of $21.6 million. In addition, we had approximately $4.6 million in prepaid expenses related to the Phase 3 program of sofpironium bromide.

Since inception, we have incurred operating losses. We recorded a net loss of $5.1 million and $3.7 million for the three months ended June 30, 2020 and 2019, respectively, and $9.2 million and $8.2 million for the six months ended June 30, 2020 and 2019, respectively. As of June 30, 2020, we had an accumulated deficit of $94.2 million. We expect to continue incurring significant expenses and operating losses for at least the next several years as we:

• initiate and execute our ~~licensees.~~two pivotal Phase 3 clinical trials for sofpironium bromide in the United States;

• contract to manufacture product candidates;

• advance research and development-related activities to develop and expand our product pipeline;

• maintain, expand, and protect our intellectual property portfolio;

• hire additional staff, including clinical, scientific, and management personnel; and

• add operational and finance personnel to support product development efforts and to support operating as a public company.

We do not expect to generate significant revenue unless and until we successfully complete development of, obtain marketing approval for, and commercialize product candidates, either alone or in collaboration with third parties. We expect these activities may take several years and our success in these efforts is subject to significant uncertainty, especially in light of our need to raise substantial funding in order to complete our Phase 3 program. Accordingly, we expect we will need to raise substantial additional capital prior to the regulatory approval and commercialization of any of our product candidates. Until such time, if ever, that we generate substantial product revenues, we expect to finance our operations through public or private equity or debt financings, collaborations or licenses, or other available financing transactions. However, we may be unable to raise additional funds through these or other means when needed.

Key Components of Operations

Collaboration Revenue

Collaboration revenue generally consists of revenue recognized under our strategic collaboration agreements for the development and commercialization of our product candidates. Our strategic collaboration agreements generally outline overall development plans and include payments we receive at signing, payments for the achievement of certain milestones, and royalties. For these activities and payments, we utilize judgment to assess the nature of the performance obligations to determine whether the performance obligations are satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. We have ~~previously earned revenues by performing services~~not recognized any royalty revenue to date. Other than the revenue we may generate in connection with these agreements, we do not expect to generate any revenue from any product candidates that we develop unless and until we obtain regulatory approval and commercialize our products or enter into other collaborative agreements with third parties.

Research and Development Expenses

Research and development expenses principally consist of payments to third parties known as Clinical Research Organizations (“CROs”). These CROs help plan, organize, and conduct clinical and nonclinical studies under our direction. Personnel costs, including wages, benefits, and share-based compensation, related to our research and development staff in support of product development activities are also included, as well as costs incurred for supplies, preclinical studies and ~~manufacturing contracts, from grants,~~toxicology tests, consultants, and ~~from licensing access~~facility and related overhead costs.

Below is a summary of our research and development expenses related to sofpironium bromide by categories of costs for the periods presented. The other expenses category includes travel, lab and office supplies, clinical trial management software, license fees, and other miscellaneous expenses. We expect our research and development expenses to increase in future periods following the initiation of the Phase 3 program for sofpironium bromide.


	Three Months Ended June 30,						Six Months Ended June 30,
	2020		2019		2020		2019

	(in thousands)




Direct program expenses related to sofpironium bromide	$	1,964	$	3,392	$	3,731	$	8,419
Personnel and other expenses
Salaries, benefits, and stock-based compensation	712		795		1,475		1,655
Regulatory and compliance	4		31		58		140
Other expenses	32		11		112		34
Total research and development expenses	$	2,712	$	4,229	$	5,376	$	10,248

General and Administrative Expenses

General and administrative expenses consist primarily of personnel costs, including wages, benefits, and share-based compensation, related to our ~~proprietary technologies. Revenues by source were~~executive, sales, marketing, finance, and human resources personnel, as ~~follows (in millions):~~

well as professional fees, including legal, accounting, and sublicensing fees.

Three Months Ended

Six Months Ended

June 30,

June 30,

Source

2019

2018

2019

2018

Astellas supply and services contract

—

$
0.7

—

$
1.2

Other contracts, licenses and royalties

—

—

—

0.3

Total revenues

$
—

$
0.7

$
—

$
1.5

~~In February 2019,~~We expect our overall general and administrative expenses to continue to increase in the near term as we ~~made the decision to discontinue the Phase 2 clinical trial of VL-2397 and,~~incur expenses associated with operating as a ~~result,~~public company compared to prior periods, which may include increased insurance premiums, investor relations expenses, legal and accounting fees associated with the expansion of our business and corporate governance, financial reporting expenses, and expenses related to Sarbanes-Oxley and other regulatory compliance obligations.

Total Other Income (Expense)

Investment and Other Income, Net

Investment and other income, net consists primarily of realized gains and losses associated with marketable securities and interest earned on cash and cash equivalent and marketable securities balances. Our interest income will vary each reporting period depending on our average cash balances during the period and market interest rates. We expect interest income to fluctuate in the future with changes in average cash balances and market interest rates.

Interest Expense

Interest expense historically consisted primarily of interest and amortization related to the issuance of $5.1 million of convertible promissory note principal during the six months ended June 30, 2019 and principal borrowings of $7.5 million provided by the loan and security agreement entered into with Hercules Capital, Inc. on February 18, 2016 (the “Loan Agreement”). In August 2019, the convertible promissory notes were converted and the Loan Agreement was repaid, and therefore, there was no interest expense thereafter related to these agreements.

Change in Fair Value of Warrant Liability

In connection with the Loan Agreement, we ~~restructured our operations~~issued warrants to ~~conserve capital.~~Hercules Capital, Inc., which are exercisable for 9,005 shares of common stock at a per share exercise price of $33.31. In ~~January 2018,~~connection with the convertible promissory notes, we issued warrants which are exercisable for 490,683 shares of common stock at a per share exercise price of $10.36.

We accounted for the warrants as liabilities at their estimated fair value. The warrants were subject to remeasurement to fair value at each balance sheet date, and ~~Astellas announced~~any fair value adjustments were recognized as changes in fair value of warrant liability in the condensed consolidated statements of operations. The liability was adjusted for changes in fair value through August 2019, and at that ~~ASP0113 did not meet its primary endpoint~~time the final warrant liability fair value was reclassified to equity in ~~a Phase 3 clinical study in CMV end organ disease, after which Astellas informed us that it was terminating further development.~~

the condensed consolidated balance sheets and no longer remeasured to fair value each period.

Critical Accounting Policies and Estimates

~~The preparation and presentation of~~

We have prepared the condensed consolidated financial statements in accordance with accounting principles generally accepted in the United States of America (“US GAAP”). The preparation of these condensed consolidated financial statements requires ~~that management~~us to make ~~a number of~~estimates, assumptions, and ~~informed estimates~~judgments that affect the reported amounts of assets, liabilities, ~~revenues~~expenses, and ~~expenses in our~~related disclosures at the date of the condensed consolidated financial statements, and ~~accompanying notes. Management bases~~the reported amounts of revenue and expenses during the reporting period. On an ongoing basis, management evaluates its critical estimates, including those related to revenue recognition, accrued research and development expenses, convertible promissory notes, redeemable convertible preferred stock, warrants, and stock-based compensation. We base our estimates on

our historical ~~information~~experience and on assumptions ~~believed to be reasonable. Although these estimates~~that we believe are ~~based on management’s best knowledge of current events and circumstances that may impact us in the future, they are inherently uncertain and~~reasonable; however, actual results ~~may~~ differ materially from these ~~estimates.~~

Our critical accounting policies are those that affect our financial statements materially and involve a significant level of judgment by management. Our critical accounting policies regarding revenue recognition areestimates under different assumptions or conditions.

For the six months ended June 30, 2020, there have been no material changes in the following areas: license and royalty agreements, manufacturing contracts, contract services and grant revenues. Our critical accounting policies also include recognition of research and development expenses and the valuation of long-lived and intangible assets.

~~We describe our significant accounting policies in Note 1 of the Notes to Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2018. We discuss~~ our critical accounting policies and estimates as compared to those disclosed in ~~the section titled~~Part II, Item 7. “Management’s Discussion and Analysis of Financial Condition and Results

of Operations” in our Annual Report on Form 10-K for the year ended December 31, ~~2018.~~

2019, filed with the SEC on March 18, 2020.

Recent Accounting Pronouncements

For information on the recent accounting pronouncements which may impact our business, see Note 12 of the ~~Notes~~notes to ~~Financial Statements~~the condensed consolidated financial statements included elsewhere in this Quarterly Report.

Results of Operations

Comparison of the Three Months Ended June 30, 2020 and 2019 ~~Compared with Three Months Ended June 30, 2018~~

~~Total Revenues. Total revenues~~


	Three Months Ended June 30,
	2020		2019
	(in thousands)
Collaboration revenue	$	607	$	2,573


Research and development expenses	(2,712)		(4,229)
General and administrative expenses	(3,021)		(1,323)





Total other income (expense), net	7		(675)
Net loss	$	(5,119)	$	(3,654)

Collaboration Revenue

Collaboration revenue decreased ~~to $0~~by $2.0 million for the three months ended June 30, 2020 compared to the three months ended June 30, 2019. Revenue in both periods was driven by research and development activities related to the Kaken Agreement for which Kaken provided research and development funding. The decrease in revenue recognized was attributable to our Phase 3 long-term safety study of sofpironium bromide gel and other ancillary clinical studies that were ongoing in 2019 but were concluded or winding down by the end of the first quarter of 2020. Conducting these studies is the basis for revenue recognition of a $15.6 million research and development payment received from Kaken in the second quarter of 2018.

Research and Development

Research and development expense decreased by $1.5 million for the three months ended June 30, 2020 compared to the three months ended June 30, 2019, which was primarily due to reduced clinical and other related regulatory and administrative costs of the Phase 3 long-term safety study of sofpironium bromide gel and other ancillary clinical studies that were concluded or winding down by the end of the first quarter of 2020. During the three months ended June 30, 2020, research and development expense of $1.5 million was recorded for paid or accrued milestone payments to Bodor, the licensor of sofpironium bromide.

General and Administrative Expenses

General and administrative expenses increased by $1.7 million for the three months ended June 30, 2020 compared to the three months ended June 30, 2019. This increase was primarily due to higher costs of $0.9 million for professional-related fees attributable to capital-raising activities and additional expenses associated with operating as a public company, $0.6 million for stock and other compensation expense that was driven by increased headcount, and $0.3 million for directors’ and officers’ liability insurance fees due to becoming a public company.

Total Other Income (Expense), Net

Total other income, net increased by $0.7 million for the three months ended June 30, ~~2018. This decrease was primarily due~~2020, compared to ~~the termination of the ASP0113 program in January 2018.~~

~~Research and Development Expenses. Research and development expenses decreased $2.8 million, or 78.9%, to $0.8 million~~total other expense, net for the three months ended June 30, ~~2019, from $3.6 million for the three months ended June 30, 2018. This decrease was primarily due to the termination of the VL-2397 in February~~ 2019. ~~As of June 30, 2019 we did not have any active research and development programs.~~

~~Manufacturing and Production Expenses. In February 2018, we discontinued all manufacturing and production activities and, as a result, we did not incur any manufacturing and production expenses in either period.~~

~~General and Administrative Expenses~~. General and administrative expenses decreased $0.1 million, or 0.8%, to $2.2 million for the three months ended June 30, 2019, from $2.3 million for the three months ended June 30, 2018. This decreaseThe change was primarily due to a decrease of $0.7 million in ~~wages~~interest expense

related to the issuance of convertible promissory notes in 2019 and ~~benefits as~~principal borrowings provided by the Loan Agreement with a ~~result~~former lender.

Comparison of ~~lower headcount and lower facility costs.~~

~~Investment and Other Income, Net. Investment and other income, net, increased $0.3 million to $0.6 million for~~ the three months ended June 30, 2019, from $0.3 million for the three months ended June 30, 2018 primarily due to a $0.3 million gain realized on the sale of assets during the three months ended June 30. 2019.

Six Months Ended June 30, 2020 and 2019 ~~Compared with Six Months Ended June 30, 2018~~

~~Total Revenues. Total revenues~~


	Six Months Ended June 30,
	2020		2019
	(in thousands)
Collaboration revenue	$	1,653	$	6,065


Research and development expenses	(5,376)		(10,248)
General and administrative expenses	(5,502)		(3,389)





Total other income (expense), net	3		(662)
Net loss	$	(9,222)	$	(8,234)

Collaboration Revenue

Collaboration revenue decreased ~~to $0 for the six months ended June 30, 2019, from $1.5 million for the six months ended June 30, 2018. This decrease was primarily due to the termination of the ASP0113 program in January 2018.~~

~~Research and Development Expenses~~. Research and development expenses decreased $2.6 million, or 36.1%, to $4.6 million for the six months ended June 30, 2019, from $7.2 million for the six months ended June 30, 2018. This decrease was primarily due to the termination of the VL-2397 program in February 2019 and the termination of the ASP0113 program in January 2018. As of June 30, 2019 we did not have any active research and development programs.

~~Manufacturing and Production Expenses~~. Manufacturing and production expenses decreased to $0.0 for the six months ended June 30, 2019 from $1.4 million for the six months ended June 30, 2018. This decrease was due to the termination of the ASP0113 program in January 2018. The termination resulted in a decrease in manufacturing activity and a headcount reduction. In February 2018, we discontinued all manufacturing and production activities and, as a result, we do not expect to incur any future manufacturing or production expenses unless the Merger is consummated.

~~General and Administrative Expenses. General and administrative expenses decreased $0.8 million, or 17.4%, to $3.6 million for the six months ended June 30, 2019, from~~by $4.4 million for the six months ended June 30, ~~2018. This decrease~~2020 compared to the six months ended June 30, 2019. Revenue in both periods was ~~primarily due~~driven by research and development activities related to athe Kaken Agreement for which Kaken provided research and development funding. The decrease in ~~wages and benefits as a result~~revenue recognized was attributable to our Phase 3 long-term safety study of ~~lower headcount and lower facility costs.~~

~~Investment and Other Income, Net. Investment~~sofpironium bromide gel and other ~~income, net, increased $0.8~~ancillary clinical studies that were ongoing in 2019 but were concluded or winding down by the end of the first quarter of 2020. Conducting these studies is the basis for revenue recognition of a $15.6 million ~~to $1.3~~research and development payment received from Kaken in the second quarter of 2018.

Research and Development

Research and development expenses decreased by $4.9 million for the six months ended June 30, 2020 compared to the six months ended June 30, 2019, ~~from $0.5~~which was primarily due to a decrease in clinical and other related regulatory and administrative costs of the Phase 3 long-term safety study of sofpironium bromide gel and other ancillary clinical studies that were concluded or winding down by the end of the first quarter of 2020. During the six months ended June 30, 2020, research and development expense of $1.5 million was recorded for paid or accrued milestone payments to Bodor.

General and Administrative Expenses

General and administrative expenses increased by $2.1 million for the six months ended June 30, ~~2018 primarily due~~2020 compared to ~~the reversal of previously recognized losses on long-term investments sold in March 2019 and a $0.3 million gain realized on the sale of assets during~~ the six months ended June 30, 2019.

~~Liquidity and Capital Resources~~

Since our inception, we have financed our operations primarily through private placements and public offerings of equity securities, and revenues from our operations. Cash, cash equivalents, marketable securities and long-term investments totaled $41.7 million at June 30, 2019, compared with $50.5 million at December 31, 2018. The decrease in our cash, cash equivalents and marketable securities for the six months ended June 30, 2019, This increase was primarily ~~the result~~due to higher costs of ~~the use~~$0.8 million for professional-related fees attributable to capital-raising activities and additional expenses associated with operating as a public company, $0.8 million for stock and other compensation expense that was driven by increased headcount, and $0.6 million for directors’ and officers’ liability insurance fees due to becoming a public company, partially offset by lower costs of ~~cash to fund our operations.~~

~~Net cash used in operating activities was $9.5~~$0.1 million ~~and $8.6~~for other miscellaneous expenses.

Total Other Income (Expense), Net

Total other income, net increased by $0.7 million for the six months ended June 30, ~~2019 and 2018, respectively. The increase in~~2020 compared to total other expense, net ~~cash used in operating activities~~ for the six months ended June 30, ~~2019, compared with the prior year period,~~2019. The change was primarily ~~the result of~~due to a decrease of $0.9 million in ~~cash receipts from Astellas due~~interest expense related to the ~~termination~~issuance of ~~the ASP0113 program.~~

~~Net cash~~convertible promissory notes in 2019 and principal borrowings provided by ~~(used in) investing activities was $8.4~~the Loan Agreement with a former lender, partially offset by a $0.2 million ~~and $(6.1) million for~~gain resulting from fair value adjustments to warrant liabilities during the six months ended June 30, 2019 that did not recur in 2020.

Liquidity and ~~2018, respectively. The increase in net cash provided by investing activities~~Capital Resources

We have incurred significant operating losses and have an accumulated deficit as a result of ongoing efforts to develop our product candidates, including conducting preclinical and clinical trials and providing general and administrative support for these operations. For the six months ended June 30, 2020 and 2019, we had a net loss of $9.2 million and $8.2 million, respectively. As of June 30, 2020 and December 31, 2019, we had an accumulated deficit of $94.2 million and $85.0 million, respectively. As of June 30, 2020, we had cash and cash equivalents of $21.6 million. Since inception, we have financed

operations primarily through payments received under strategic license and collaboration agreements, cash and investments acquired in the Merger, and funds received from the sale of convertible preferred stock, common stock and warrants, debt, and convertible notes.

We believe that our cash and cash equivalents as of June 30, 2020 and periodic sales of our common stock under the Purchase Agreement, are sufficient to fund our operations for at least the next 12 months from the issuance of this Quarterly Report. However, in order to sell additional shares of common stock under the Purchase Agreement, Lincoln Park will need to purchase shares of common stock from us, subject to the conditions under the Purchase Agreement. Further, we will be significantly limited in our ability to sell shares of our common stock under the Purchase Agreement, or to utilize our common stock in any other capital raising transaction, if our stockholders do not approve an increase in the number of authorized shares of our common stock, as further described in this Quarterly Report. We expect to continue to incur additional substantial losses in the foreseeable future as a result of our research and development activities. Additional funding will be required in the future to proceed with our current and proposed research activities, including completing the pivotal U.S. Phase 3 clinical trials of sofpironium bromide.

Cash Flows

Since inception, we have primarily used our available cash to fund expenditures related to product discovery and development activities. The following table sets forth a summary of cash flows for the periods presented:



	Six Months Ended June 30,
	2020		2019

	(in thousands)
Net cash used in operating activities	$	(11,290)	$	(9,502)
Net cash provided by (used in) investing activities	4,500		(4)
Net cash provided by financing activities	21,128		3,518
Net change in cash and cash equivalents	$	14,338	$	(5,988)

Operating Activities

Net cash used in operating activities of $11.3 million during the six months ended June 30, 2020 increased compared ~~with~~to $9.5 million during the same period in the prior year primarily due to an increase in net loss of $1.0 million, a change in working capital of $0.6 million, and a decrease of other non-cash expenses of $0.2 million.

Investing Activities

Net cash provided by investing activities of $4.5 million during the six months ended June 30, 2020 increased compared to cash used in investing activities of $4 thousand during the same period in the prior year. The $4.5 million increase was primarily the result of ~~a decrease of $11.7 million in net purchases~~maturities of marketable securities ~~and an increase~~ in ~~proceeds received from~~ the ~~sale of long-term investments.~~

2020 period.

Financing Activities

Net cash provided by financing activities ~~was $13,000 and $0 for~~of $21.1 million during the six months ended June 30, ~~2019 and 2018, respectively.~~

~~A discussion of our exposure~~2020 increased compared to ~~interest rate risk is included~~$3.5 million during the same period in ~~Part I, Item 3 of this Report under~~ the ~~heading “Quantitative and Qualitative Disclosures About Market Risk.”~~

~~We currently have on file an effective shelf registration statement that allows us~~prior year. The increase was primarily related to ~~raise up to $40.0 million~~higher net proceeds received in the 2020 period from the ~~sale~~issuance of common stock ~~preferred stock, debt securities and/or~~and warrants ~~subject~~of $20.7 million and proceeds from the issuance of a note payable of $0.4 million, compared to ~~limitations on~~net proceeds received in the ~~amount~~2019 period from the issuance of ~~securities that~~convertible promissory notes of $5.1 million, partially offset by the repayment of principal associated with the Loan Agreement in the 2019 period of $1.6 million.

Off-Balance Sheet Arrangements

As of June 30, 2020 and December 31, 2019, we ~~may sell under the registration statement~~had not been involved in any ~~12-month period.~~

Despite our current shelf registration statement, additional financing through these or other means may not be available on favorable terms or at all. If additional financing is not available, we anticipate that our available cash and existing sources of funding will be adequate to satisfy our cash needs at least through December 31, 2020.

~~Contractual Obligations~~

Under the indemnification agreements with our officers and directors, we have agreed to indemnify those individuals for any expenses and liabilities in the event of a threatened, pending or actual investigation, lawsuit, or criminal or investigative proceeding.

~~We have an employment agreement that contains severance~~material off-balance sheet arrangements, with our chief executive officer, or CEO, and severance agreements with two of our other employees. Under the agreement with our CEO, we are obligated to pay severance if we terminate the CEO’s employment without “cause,” or if the CEO resigns for “good reason,” as defined in the ~~agreement,~~rules and regulations of the SEC.

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

We are a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and are not required to provide the information under this item.

ITEM 4. CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in the reports that we file under the Exchange Act is recorded, processed, summarized, and reported within the time periods set forth therein. The severance for the CEO consists of continued base salary payments at the then-current rate, including the payment of health insurance premiums for 18 months, plus a payment equal to one and one-half times the CEO’s cash bonusspecified in the ~~previous year.~~rules and forms of the SEC, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosures. In ~~addition,~~designing and evaluating the ~~CEO receives accelerated vesting on all his unvested stock awards as if he had remained employed by us for 18 months from~~disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the ~~date~~desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of termination. In the event that the termination occurs within 24 months of a “change in control,” as defined in the agreement, the severance for the CEO consists of a lump sum payment equal to 24 months of base salary at the then-current rate, the payment of health insurance premiums for 18 months, plus a payment equal to onepossible controls and one-half times the CEO’s cash bonus in the previous year. In addition, all outstanding unvested stock awards will vest immediately. Under the agreements with our other two executives, we are obligated to pay severance if we terminate the executive’s employment without “cause,” or if the executive resigns for “good reason,” as defined in the agreements, within the periods set forth therein. The severance for one of these executives consists of a lump-sum payment equal to 12 months of base salary at the then-current rate, including the payment of health insurance premiums for 12 months, plus a payment equal to the executive’s cash bonus in the previous year. In addition, the executive receives accelerated vesting on all his unvested stock awards as if he had remained employed by us for 12 months from the date of termination. In the event that the termination occurs within 12 months of a “change in control,” as defined in the agreements, the

severance consists of a lump sum payment equal to 18 months of base salary at the then-current rate, the payment of health insurance premiums for 12 months, plus a payment equal to the executive’s cash bonus in the previous year. In addition, all outstanding unvested stock awards will vest immediately. The severance for the remaining executive consists of a lump-sum payment equal to six months of base salary at the then-current rate, including the payment of health insurance premiums for six months, plus a bonus payment of $75,000. The maximum payments due under these agreements would have been $2.4 million if each such employee was terminated at June 30, 2019.

~~Off-Balance Sheet Arrangements~~

~~As of June 30, 2019, we did not have any off-balance sheet arrangements.~~

procedures.

I~~TEM 3.~~

~~QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK~~

We are subject to interest rate risk. Our investment portfolio is maintained in accordance with our investment policy which defines allowable investments, specifies credit quality standards and limits the credit exposure of any single issuer. Our investment portfolio consists of cash equivalents and marketable securities. The average maturity of our investments is approximately three months. Our investments are classified as available-for-sale securities.

To assess our interest rate risk, we performed a sensitivity analysis projecting an ending fair value of our cash equivalents and marketable securities using the following assumptions: a three-month average maturity and a 150-basis-point increase in interest rates. This pro forma fair value would have been $0.2 million lower than the reported fair value of our investments at June 30, 2019.

~~Our investment securities consist of government agency securities.~~

I~~TEM 4.~~

~~CONTROLS AND PROCEDURES~~

Conclusion Regarding the Effectiveness of Disclosure Controls and Procedures

Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, we conducted an evaluation of the design and operation of our disclosure controls and procedures, as such term is defined in Rule 13a-15(e) and 15d-15(e) promulgated under the Exchange Act as of the end of the period covered by this Quarterly Report. Based on this evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were effective and were operating at a reasonable assurance level as of June 30, ~~2019.~~

2020.

Changes in Internal Control over Financial Reporting

Management has determined that there were no significant changes in our internal control over financial reporting that occurred during the three months ended June 30, ~~2019,~~2020 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

P~~ART~~

PART II. OTHER INFORMATION

~~ITEM 1A.~~

~~RISK FACTORS~~

~~You should consider carefully~~

ITEM 1. LEGAL PROCEEDINGS

Although we do not believe the ~~following information about~~action is likely to be material, nor that the ~~risks described below, together~~claims will be determined to be meritorious, Dr. Patricia S. Walker, our former President and Chief Scientific Officer, commenced litigation against us, one of our officers, our Board Chairperson and others, alleging wrongful termination for unspecified damages, claiming discrimination based on age, gender, and association with a person with a disability. We are contesting, and will continue to contest, these claims vigorously.

From time to time, we may become involved in other legal proceedings arising in the ~~other information contained in this Quarterly Report and in our other public filings in evaluating~~ordinary course of our business. ~~The risk~~We are not presently a party to any other legal proceedings that, if determined adversely to us, would individually or taken together have a material adverse effect on the Company.

ITEM 1A. RISK FACTORS

Our business, financial condition, and operating results may be affected by a number of factors, ~~set forth below did~~whether currently known or unknown, including but not ~~appear as separate risk~~limited to those described below. Any one or more of such factors could directly or ~~contain changes~~indirectly cause our actual results of operations and financial condition to ~~the similarly titled risk~~vary materially from past or anticipated future results of operations and financial condition. Any of these factors, ~~included~~ in ~~“Item 1A. Risk Factors” set forth~~whole or in ~~the Vical 10-Q, as filed with the SEC on May 2, 2019. If any of the following risks actually occur,~~part, could materially and adversely affect our business, financial condition, results of operations, and stock price. The following information should be read in conjunction with Part I, Item 2, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and the condensed consolidated financial statements and related notes in Part I, Item 1, “Financial Statements” of this Quarterly Report.

Risk factors below that have been modified from the version of that risk factor as it appeared in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 (other than typographical or definitional modifications), or additional risk factors that did not appear in that Annual Report on Form 10-K, are noted with an “*” preceding such risk factor.

Our business depends on the successful financing, clinical development, regulatory approval, and commercialization of sofpironium bromide.

The successful development, regulatory approval, and commercialization of sofpironium bromide requires significant additional financing and depends on a number of factors, including but not limited to the following:

•timely and successful completion of Phase 3 clinical trials in the United States not yet initiated, which may be significantly costlier than we currently anticipate and/or produce results that do not achieve the endpoints of the trials or which are ultimately deemed not to be clinically meaningful;

•whether we are required by the FDA or similar foreign regulatory agencies to conduct additional clinical trials beyond those currently planned to support the approval and commercialization of sofpironium bromide;

•achieving and maintaining, and, where applicable, ensuring that our third-party contractors achieve and maintain, compliance with our and their contractual obligations and with all regulatory and legal requirements applicable to sofpironium bromide;

•ability of third parties with which we contract to manufacture consistently adequate clinical trial and commercial supplies of sofpironium bromide, to remain in good standing with regulatory agencies and to develop, validate and maintain or supervise commercially viable manufacturing processes that are compliant with FDA-regulated Current Good Manufacturing Practices, (“cGMPs”), and the product’s package insert;

•a continued acceptable safety profile during clinical development and following approval of sofpironium bromide;

•ability to obtain favorable labeling for sofpironium bromide through regulators that allows for successful commercialization, given the drug may be marketed only to the extent approved by these regulatory authorities (unlike with most other industries);

•ability to commercialize sofpironium bromide successfully in the United States and internationally, if approved for marketing, sale and distribution in such countries and territories, whether alone or in collaboration with Kaken or others;

•acceptance by physicians, insurers and payors, and patients of the quality, benefits, safety, and efficacy of sofpironium bromide, if approved, including relative to alternative and competing treatments and the next best standard of care;

•existence of a regulatory and legal environment conducive to the success of sofpironium bromide;

•ability to price sofpironium bromide to recover our development costs and generate a satisfactory profit margin; and

•our ability and our partners’ ability to establish and enforce intellectual property rights in and to sofpironium bromide, including but not limited to patents and licenses.

If we do not achieve one or more of these factors, many of which are beyond our reasonable control, in a timely manner or at all, and with adequate financing, we could experience significant delays or an inability to obtain regulatory approvals or commercialize sofpironium bromide. Even if regulatory approvals are obtained, we may never be able to successfully commercialize sofpironium bromide. Accordingly, we cannot assure you that we will be able to generate sufficient revenue through the sale of sofpironium bromide, or any current primary asset, to continue our business.

*We have never conducted a Phase 3 clinical trial ourselves and may be unable to successfully do so for sofpironium bromide.

The conduct of a Phase 3 clinical trial is a long, expensive, complicated, uncertain, and highly regulated process. Although our employees have conducted successful Phase 2 and Phase 3 clinical trials in the past across many therapeutic areas while employed at other companies, we as a company have not conducted a pivotal Phase 3 clinical trial, and as a result, we may require more time and incur greater costs than we anticipate. We commenced a Phase 3 long-term safety study for sofpironium bromide gel in the third quarter of 2018 and intend to initiate two pivotal Phase 3 clinical trials in subjects with primary axillary hyperhidrosis in the United States. While we currently plan to initiate the U.S. Phase 3 pivotal program for sofpironium bromide gel, 15% in the fourth quarter of 2020, we may not be able to commence that program in that timeframe or at all. Failure to commence or complete, or delays in, our planned clinical trials would prevent us from, or delay us in, obtaining regulatory approval of and commercializing sofpironium bromide and could prevent us from, or delay us in, receiving development- or regulatory-based milestone payments and commercializing sofpironium bromide gel for the treatment of primary axillary hyperhidrosis, which would adversely impact our financial performance, as well as put us in potential breach of material contracts for the licensing and development of sofpironium bromide, subjecting us to significant contract liabilities, including but not limited to loss of rights in and to sofpironium bromide.

Clinical drug development for sofpironium bromide is very expensive, time-consuming, and uncertain.

Clinical development for sofpironium bromide is very expensive, time-consuming, difficult to design and implement, and its outcome is inherently uncertain. Most product candidates that commence clinical trials are never approved by regulatory authorities for commercialization and of those that are approved many do not cover their costs of development or ever generate a profit. In addition, we, any partner with which we currently or may in the future ~~growth prospects~~collaborate, the FDA, a local or central institutional review board, or other regulatory authorities, including state and local agencies and counterpart agencies in foreign countries, may suspend, delay, extend, require modifications or add additional requirements to or terminate our clinical trials at any time.

In the case of sofpironium bromide, we are seeking to deliver sufficient concentrations of the active pharmaceutical ingredient (“API”), absorbed from the skin surface through the skin barrier to the targeted dermal tissue to achieve the intended therapeutic effect, in this case treatment of primary axillary hyperhidrosis. The topical route of administration may involve new dosage forms, which can be difficult to develop and manufacture and may raise novel regulatory issues and result in development or review delays or inability to get the investigational drug approved for use.

Use of patient-reported outcome assessments (“PROs”), and gravimetric assessments in sofpironium bromide clinical trials may delay or adversely impact the development of sofpironium bromide gel or clinical trial results or increase our development costs.

Due to the difficulty of objectively measuring the symptoms of hyperhidrosis in a clinical trial, which is the primary target of treatment for sofpironium bromide, PROs will have an important role in the development and regulatory approval of sofpironium bromide. PROs involve patients’ own subjective assessments of efficacy, and this subjectivity increases the uncertainty of determining and achieving clinical endpoints and obtaining regulatory approval. Such assessments can be influenced by factors outside of our reasonable control and can vary widely from day to day for a particular patient, and from patient to patient and site to site within a clinical trial, notwithstanding that regulators may or may not accept PROs as part of the drug approval process. Additionally, gravimetric assessments of sweat production, another key clinical endpoint, may vary significantly for a particular patient, and from patient to patient and site to site within a clinical trial or between separate clinical trials. The reduction, if any, in a patient’s gravimetric sweat production has the potential for significant variability and uncertain outcomes. This potential for variability and uncertain outcomes may adversely impact our ability to achieve statistical significance on our primary and secondary endpoints or may provide us with initial or subsequent results that are ultimately deemed not to be clinically meaningful or that do not result in regulatory approval.

Sofpironium bromide may cause undesirable side effects or have other unexpected properties that could delay or prevent its regulatory approval, limit the commercial profile of an approved label, or result in post-approval regulatory action.

Unforeseen side effects from sofpironium bromide could arise either during clinical development or, if approved, after it has been marketed. Undesirable side effects caused by sofpironium bromide could cause us, any partners with which we may collaborate, or regulatory authorities to interrupt, extend, modify, delay, or halt clinical trials, or even later commercialization, and could result in a more restrictive or narrower product label or the delay or denial of regulatory approval by the FDA or comparable foreign authorities, or a product recall and/or cancellation.

Results of clinical trials could reveal a high and unacceptable severity and prevalence of side effects. In such an event, trials could be suspended or terminated, and the FDA or comparable foreign regulatory authorities could order us to cease further development of or deny approval of sofpironium bromide for any or all targeted indications. The drug-related side effects could affect patient recruitment or the ability of enrolled patients to complete the trial or result in product liability claims. Any of these occurrences may expose us to liability or harm our business, financial condition, operating results, and prospects.

Additionally, if we or others identify undesirable side effects, or other previously unknown problems, caused by sofpironium bromide after obtaining U.S. or foreign regulatory approval, a number of potentially negative consequences could result, which could prevent us or our potential partners from achieving or maintaining market acceptance of sofpironium bromide and could substantially increase the costs (and extent) of commercializing sofpironium bromide, potentially even leading to withdrawal of the drug.

*Under our Clinical Supply Agreement with Kaken, we owe an outstanding sum for Active Pharmaceutical Ingredient (“API”) for further development of sofpironium bromide, and our inability to obtain such API from Kaken on a timely basis, or Kaken’s attempt to immediately collect the outstanding sum in full, could have a material adverse impact on our business.

On July 30, 2019, we entered into a Clinical Supply Agreement with Kaken (the “Clinical Supply Agreement”) under which we made various purchase orders for certain amounts of drug substance and product components for use in non-clinical and clinical studies, as well as for scale-up validation activities. As of June 30, 2020, we owed Kaken approximately $2.7 million. As a result of our non-payment, Kaken could assert a breach or default under the Clinical Supply Agreement and seek damages and/or termination of the Clinical Supply Agreement, among other available remedies. We have entered into a letter agreement with Kaken specifying the terms under which Kaken will ship to us, and we will pay for, a portion of the API, but that letter agreement does not include a waiver of Kaken’s rights in respect of our non-payment. If Kaken were to seek the immediate payment of all amounts owed under the Clinical Supply Agreement, and we are unable to secure additional resources, our liquidity and cash position would ~~likely~~be impaired, and our ability to meet our other financial obligations as they come due could be materially ~~and~~ adversely affected.

*Kaken substantially controls the development of sofpironium bromide in Japan and certain other Asian countries and may make decisions regarding product development, regulatory strategy and commercialization that may not be in our best interests. Kaken may be unable to obtain positive approval of the drug in Asian markets.

The Kaken Agreement granted Kaken an exclusive Japan license and certain rights to additional Asian countries to develop and commercialize sofpironium bromide. Under the terms of the Kaken Agreement, as amended, we received an up-front

payment, development milestones and research and development payments and are eligible to receive future milestones and a royalty on net sales.

Kaken has final decision-making authority for the overall regulatory, development and commercialization strategy for sofpironium bromide, market access activities, pricing and reimbursement activities, promotion, distribution, packaging, sales and safety and pharmacovigilance in Japan and certain other Asian countries. In exercising its final decision-making authority in such territories, Kaken may make decisions regarding product development or regulatory strategy based on its determination of how best to preserve and extend regulatory approvals in these ~~circumstances,~~territories for sofpironium bromide, which may delay or prevent achieving regulatory approval for sofpironium bromide in Kaken’s territories, as well as by us in the United States and the other territories where we maintain exclusive rights. Additionally, Kaken is responsible for conducting certain nonclinical and API (chemistry, manufacturing, and controls)-related activities that will be required for FDA approval in the United States, and as a result, we are reliant on Kaken to execute successfully, in a timely, compliant, and efficient manner, such activities on our behalf. To the extent Kaken experiences delays and/or difficulties in performing its development activities, this could prevent or cause substantial delays in our ability to seek approval for sofpironium bromide gel in the United States and other territories in which we maintain exclusive rights.

In early 2020, Kaken announced submission of a new drug application for approval in Japan of manufacturing and marketing of sofpironium bromide gel for primary axillary hyperhidrosis. We cannot provide any assurance that such new drug application will be approved or that any other regulatory approvals in Japan or other Asian countries will occur. We will not receive additional milestone or other payments from Kaken if Kaken is not successful in its development, regulatory and/or commercial activities.

If we or any partners with which we may collaborate to market and sell sofpironium bromide are unable to achieve and maintain insurance coverage and adequate levels of reimbursement for this compound following regulatory approval and usage by patients, our commercial success may be hindered severely.

If sofpironium bromide only becomes available by prescription, successful sales by us or by any partners with which we collaborate may depend on the availability of insurance coverage and adequate reimbursement from third-party payors as patients would then be forced to pay for the drug out-of-pocket if coverage and associated reimbursement is denied. Patients who are prescribed medicine for the treatment of their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their prescription drugs. The availability of coverage and adequate reimbursement from governmental healthcare programs, such as Medicare and Medicaid in the United States, and private third-party payors is often critical to new product acceptance regardless of how well the product works. Coverage decisions may depend on clinical and economic standards that disfavor new drug products when more established or lower-cost therapeutic alternatives are already available or subsequently become available, even if these alternatives are not as safe and effective, or may be affected by the budgets and demands on the various entities responsible for providing health insurance to patients who will use sofpironium bromide. If insurers and payors decide that hyperhidrosis itself is not a disease they are willing to extend coverage to, which could happen if they only think the treatment improves quality of life, then coverage and reimbursement for sofpironium bromide may be denied, or at least severely restricted. In this case, patients would be forced to pay for sofpironium bromide out-of-pocket for cash, which they may not be willing or able to do. Even if we obtain coverage for sofpironium bromide, the resulting reimbursement payment rates might not be adequate or may require co-payments that patients find unacceptably high. Patients may not use sofpironium bromide unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of sofpironium bromide.

In addition, the market for sofpironium bromide will depend significantly on access to third-party payors’ drug formularies or lists of medications for which third-party payors provide coverage and reimbursement. The industry competition to be included in such formularies often leads to downward pricing pressures on pharmaceutical companies and there may be time limitations on when a new drug may even be eligible for formulary inclusion. Also, third-party payors may refuse to include sofpironium bromide in their formularies or otherwise restrict patient access to sofpironium bromide when a less costly generic equivalent or other treatment alternative is available in the discretion of the formulary.

Third-party payors, whether foreign or domestic, or governmental or commercial, are developing increasingly sophisticated methods of controlling healthcare costs. In the United States, although private third-party payors tend to follow Medicare and Medicaid practices, no uniform or consistent policy of coverage and reimbursement for drug products exists among third-party payors. Therefore, coverage and reimbursement for drug products can differ significantly from payor to payor as well as state to state. Consequently, the coverage determination process is often uncertain and a time-consuming and costly process that must be played out across many jurisdictions and different entities and which will require us to provide scientific, clinical

and health economics support for the use of sofpironium bromide compared to current alternatives and do so to each payor separately, with no assurance that coverage and adequate reimbursement will be obtained and in what amount or time frame.

Further, we believe that future coverage and reimbursement likely will be subject to increased restrictions both in the United States and in international markets, potentially based on changes in law and/or payor practices. Third-party coverage and reimbursement for sofpironium bromide may not be available or adequate in either the United States or international markets, which could harm our business, financial condition, operating results, and prospects.

Even if sofpironium bromide obtains regulatory approval, it may fail to achieve the broad degree of physician and patient adoption and use necessary for commercial success.

The commercial success of sofpironium bromide, if approved, will depend significantly on the broad adoption and use of it by physicians and patients for approved indications, and may not be commercially successful even though the drug is shown to be safe and effective. The degree and rate of physician and patient adoption of sofpironium bromide, if approved, especially in the United States, will depend on a number of factors, including but not limited to:

•patient demand for approved products that treat hyperhidrosis;

•our ability to market and sell the drug, including through direct-to-consumer advertising and non-traditional sales strategies;

•the safety and effectiveness of sofpironium bromide, and ease of use, compared to other available hyperhidrosis therapies, whether approved or used by physicians off-label;

•the availability of coverage and adequate reimbursement from managed care plans and other healthcare payors for sofpironium bromide;

•the cost of treatment with sofpironium bromide in relation to alternative hyperhidrosis treatments and willingness to pay for sofpironium bromide, if approved, on the part of patients;

•overcoming physician or patient biases toward particular therapies for the treatment of hyperhidrosis and achieving acceptance by physicians, major operators of clinics and patients of sofpironium bromide as a safe, effective, and economical hyperhidrosis treatment;

•patients’ perception of hyperhidrosis as a disease and one for which medical treatment may be appropriate and a prescription therapy may be available;

•insurers’ and physicians’ willingness to see hyperhidrosis as a disease worth treating and for which reimbursement will be made available for treatment;

•proper administration of sofpironium bromide;

•patient satisfaction with the results and administration of sofpironium bromide and overall treatment experience;

•limitations or contraindications, warnings, precautions, or approved indications for use different than those sought by us that are contained in any final FDA-approved labeling for sofpironium bromide;

•any FDA requirement to undertake a risk evaluation and mitigation strategy, or results from any post-marketing surveillance studies that FDA may require as a condition of product approval;

•the effectiveness of our sales, marketing, pricing, reimbursement and access, government affairs, legal, medical, public relations, compliance, and distribution efforts;

•adverse publicity about sofpironium bromide or favorable publicity about competitive products;

•new government regulations and programs, including price controls and/or public or private institutional limits or prohibitions on ways to commercialize drugs, such as increased scrutiny on direct-to-consumer advertising of pharmaceuticals or restrictions on sales representatives to market pharmaceuticals; and

•potential product liability claims or other product-related litigation or litigation related to licensing and or other commercial matters associated with sofpironium bromide.

If sofpironium bromide is approved for use but fails to achieve the broad degree of physician and patient adoption necessary for commercial success, our operating results and financial condition will be adversely affected, which may delay, prevent, or limit our ability to generate revenue and continue our business.

Sofpironium bromide, if approved, will face significant competition and its failure to compete effectively may prevent it from achieving significant market penetration.

The pharmaceutical industry is characterized by rapidly advancing technologies, intense competition, less effective patent terms, and a strong emphasis on developing newer, fast-to-market proprietary therapeutics. Numerous companies are engaged in the development, patenting, manufacturing, and marketing of healthcare products competitive with those that we are developing, including sofpironium bromide. We face competition from a number of sources, such as pharmaceutical companies, generic drug companies, biotechnology companies and academic and research institutions, many of which have greater financial resources, marketing capabilities, sales forces, manufacturing capabilities, research and development capabilities, regulatory expertise, clinical trial expertise, intellectual property portfolios, more international reach, experience in obtaining patents and regulatory approvals for product candidates and other resources than us. Some of the companies that offer competing products also have a broad range of other product offerings, large direct sales forces, and long-term customer relationships with our target physicians, which could inhibit our market penetration efforts. In addition, sofpironium bromide, if approved, may compete with other dermatological products, including over-the-counter (“OTC”) treatments, for a share of some patients’, or payors’, discretionary budgets and for physicians’ attention within their clinical practices.

We anticipate that sofpironium bromide would compete with other therapies currently used for hyperhidrosis, including but not limited to:

•Self-Administered Treatments. Self-administered treatments, such as OTC and prescription topical antiperspirants, and Qbrexza^® (glycopyrronium) 2.4% topical cloth. Oral and compounded topical anticholinergics also may be used off-label.

•Non-Surgical Office-Based Procedures. Office-based procedures have been approved by the FDA for certain uses and which may be used, on-or off-label, to treat hyperhidrosis, including intradermal injections of BOTOX^®, marketed by Allergan plc., and MiraDry^®, a microwave-based treatment marketed by Miramar Labs, Inc.

•Surgical Treatments. Surgical treatments include techniques for the removal of sweat glands, such as excision, curettage, and liposuction. Surgical procedures, such as endoscopic thoracic sympathectomy, are also used to destroy nerves that transmit activating signals to sweat glands.

To compete successfully in this market, we will have to provide an attractive and cost-effective alternative to these existing and other new therapies. Such competition could lead to reduced market share for sofpironium bromide and contribute to downward pressure on the pricing of sofpironium bromide, which could harm our business, financial condition, operating results, and prospects.

Due to less stringent regulatory requirements in certain foreign countries, there are many more dermatological products and procedures available for use in those international markets than are approved for use in the United States. In certain international markets, there are also fewer limitations on the claims that our competitors can make about the effectiveness of their products and the manner in which they can market them. As a result, we expect to face more competition in these markets than in the United States.

We may in the future face generic competition for sofpironium bromide, which could expose us to litigation or adversely affect our business, financial condition, operating results, and prospects.

Upon expiration of patent protection (including applicable extensions) in the United States (and any other countries where patent coverage exists) for sofpironium bromide, we could lose a significant portion of then-existing sales of sofpironium bromide in a short period of time from generic competition, which would reduce existing sales and could expose us to litigation, adversely affecting our business, financial condition, operating results, and prospects.

We have in the past relied, and expect to continue to rely, on third-party Clinical Research Organizations (“CROs”), and other third parties to conduct and oversee our sofpironium bromide clinical trials. If these third parties do not meet our requirements or otherwise conduct the trials as required or are unable to staff our trials, we may not be able to satisfy our contractual obligations or obtain regulatory approval for, or commercialize, sofpironium bromide.

We have in the past relied, and expect to continue to rely, on third-party CROs to conduct and oversee our sofpironium bromide clinical trials and other aspects of product development. We also rely on various medical institutions, clinical investigators and contract laboratories to conduct our trials in accordance with our clinical protocols and all applicable regulatory requirements, including the FDA’s regulations and good clinical practice (“GCP”) requirements, which are an international standard meant to protect the rights and health of patients and to define the roles of clinical trial sponsors, administrators and monitors, and state regulations governing the handling, storage, security and recordkeeping for drug and biologic products. These CROs and other third parties play a significant role in the conduct of these trials and the subsequent collection and analysis of data from the clinical trials. We rely heavily on these parties for the execution of our clinical trials and preclinical studies, and control only certain aspects of their activities. We and our CROs and other third-party contractors are required to comply with GCP and good laboratory practice (“GLP”) requirements, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for sofpironium bromide. Regulatory authorities enforce these GCP and GLP requirements through periodic inspections of trial sponsors, principal investigators, and trial sites. If we or any of these third parties fail to comply with applicable GCP and GLP requirements, or reveal noncompliance from an audit or inspection, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or other regulatory authorities may require us to perform additional clinical trials before approving our or our partners’ marketing applications. We cannot assure that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical or preclinical trials comply with applicable GCP and GLP requirements. In addition, our clinical trials generally must be conducted with product produced under cGMP regulations. Our failure to comply with these regulations and policies may require us to extend or repeat clinical trials, which would delay the regulatory approval process.

If any of our CROs or clinical trial sites terminate their involvement in one of our clinical trials for any reason, we may not be able to enter into arrangements with alternative CROs or clinical trial sites, or do so on commercially reasonable terms, and in a satisfactory timeframe. If our relationship with clinical trial sites is terminated, we may experience the loss of follow-up information on patients enrolled in our ongoing clinical trials unless we are able to transfer the care of those patients to another qualified clinical trial site. In addition, principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and could receive cash or equity compensation in connection with such services. If these relationships and any related compensation result in perceived or actual conflicts of interest, the integrity of the data generated at the applicable clinical trial site may be questioned by the FDA.

We currently have limited marketing capabilities and no sales organization. If we are unable to establish sales and marketing capabilities on our own or through third parties, or are delayed in establishing these capabilities, we will be unable to successfully commercialize our product candidates, if approved, or generate product revenue.

We currently have limited marketing capabilities and no sales organization. To commercialize our product candidates, if approved, in the United States, Canada, the European Union, Latin America and other jurisdictions we seek to enter, we must build our marketing, sales, distribution, managerial and other non-technical capabilities or make arrangements with third parties to perform these services, and we may not be successful in doing so. Although our employees have experience in the marketing, sale and distribution of pharmaceutical products, and business development activities involving external alliances, from prior employment at other companies, we as a company have no prior experience in the commercial launch, marketing, sale and distribution of pharmaceutical products, and there are significant risks involved in building and managing a sales organization, including our ability to hire, retain and incentivize qualified individuals, generate sufficient sales leads, provide adequate training to sales and marketing personnel, and effectively manage a geographically dispersed sales and marketing team so they operate in an effective and compliant way. Any failure or delay in the development of our internal sales, marketing, distribution, and pricing/reimbursement/access capabilities would impact adversely the commercialization of these products.

To commercialize sofpironium bromide in certain parts of Asia, we intend to leverage the commercial infrastructure of our partner, Kaken, which will provide us with resources and expertise in certain areas that are greater than we could initially build ourselves. We may choose to collaborate with additional third parties in various countries that have direct sales forces and established distribution systems, either to augment our own sales force and distribution systems or in lieu of our own sales force and distribution systems. If we are unable to enter into such arrangements on acceptable terms or at all, we may not be able to successfully commercialize our product candidates, especially in other countries where we currently do not have a foreign legal presence. The inability to commercialize successfully our product candidates, either on our own or through collaborations with one or more third parties, would harm our business, financial condition, operating results, and prospects.

Risks Related to Our Financial Operations

*We will need to raise substantial additional financing in the future to fund our operations, which may not be available to us on favorable terms or at all.

The advancement of the Phase 3 clinical trials for sofpironium bromide will require substantial additional financing. Pending our obtaining additional funding, we have taken, and expect to continue to take, actions to reduce our cash spend, including delaying the start of the clinical trials and/or staff reductions. Nonetheless, we will require substantial additional funds to conduct the costly and time-consuming clinical trials necessary to pursue regulatory approval of each potential product candidate and to continue the development of sofpironium bromide in new indications or uses including completing our pivotal U.S. Phase 3 program for sofpironium bromide for treatment of primary axillary hyperhidrosis. Our future capital requirements will depend upon a number of factors, including but not limited to: the number and timing of future product candidates in the pipeline; progress with and results from preclinical testing and clinical trials; the ability to manufacture sufficient drug supplies to complete preclinical and clinical trials; the costs involved in preparing, filing, acquiring, prosecuting, maintaining and enforcing patent and other intellectual property claims; compliance with our material contracts including the licensing agreement for sofpironium bromide; the time and costs involved in obtaining regulatory approvals and favorable reimbursement or formulary acceptance for such product candidates; and overall stock market and global business conditions and trends.

Raising additional capital may be costly or difficult to obtain and could significantly dilute stockholders’ ownership interests or inhibit our ability to achieve our business objectives. If we raise additional funds through public or private equity offerings, the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Further, to the extent that we raise additional capital through the sale of common stock or securities convertible or exchangeable into common stock, our stockholders’ ownership interests in our company will be diluted. In addition, any debt financing may subject us to fixed payment obligations and covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends. If we raise additional capital through marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish certain valuable intellectual property or other rights to our product candidates, technologies, future revenue streams or research programs or grant licenses on terms that may not be favorable to us in one or more countries.

Our ability to raise the significant additional funds required to complete the Phase 3 clinical trials for sofpironium bromide is uncertain and is limited given our small market capitalization. Even if we were to obtain sufficient funding, there can be no assurance that it will be available on terms acceptable to us or our stockholders. Currently, we have a limited under of shares of common stock that are unreserved and available for future issuance, and therefore without additional authorized shares of common stock, we will be severely restricted in our ability to pursue the additional financing required to complete our U.S. Phase 3 clinical trials of sofpironium bromide and conduct the necessary research and development activities related to regulatory submissions for sofpironium bromide. We have scheduled a special meeting of stockholders for August 31, 2020, at which we will request that stockholders approve, among other matters, an increase in the number of authorized shares of common stock by 50,000,000. We cannot assure you that our stockholders will approve such increase. If the increase is not approved by our stockholders, our business development and financing alternatives may be limited by the lack of sufficient unissued and unreserved authorized shares of common stock, and stockholder value may be harmed, perhaps severely, by this limitation. In addition, our success depends in part on our continued ability to attract, retain and motivate highly qualified management and clinical and scientific personnel, and if the increase is not approved by our stockholders, the lack of sufficient unissued and unreserved authorized shares of common stock to provide future equity incentive opportunities that our Compensation Committee deems appropriate could adversely impact our ability to achieve these goals. In summary, if our stockholders do not approve the increase, we may not be able to access the capital markets, initiate or complete pivotal

clinical trials and other key development activities, complete corporate collaborations or partnerships, attract, retain and motivate employees and others required to make our business successful, and pursue other business opportunities integral to our growth and success, all of which could severely harm our company and our prospects.

*Our operating results and liquidity needs could be affected negatively by global market fluctuations and economic downturn.

Our operating results and liquidity could be affected negatively by global economic conditions generally, both in the United States and elsewhere around the world. The market for discretionary pharmaceutical products, medical devices and procedures may be particularly vulnerable to unfavorable economic conditions. Some patients may consider sofpironium bromide as discretionary, and if full reimbursement for the product is not available, demand for the product may be tied to the discretionary, out-of-pocket cash-spending levels of our targeted patient populations. Domestic and international equity and debt markets have experienced and may continue to experience heightened volatility and turmoil based on domestic and international economic conditions and concerns. In the event these economic conditions and concerns continue or worsen and the markets continue to remain volatile, or a bear market ensues in the U.S. stock market, including as a result of the recent coronavirus outbreak, our operating results and liquidity could be affected adversely by those factors in many ways, including weakening demand for sofpironium bromide, making it more difficult for us to raise funds if necessary, and our stock price may decline.

*Our stock price has been and may continue to be highly volatile, and our common stock may continue to be illiquid.

The market price of our common stock following the Merger has been subject to significant fluctuations. The closing price of our common stock fluctuated from $4.69 per share as of September 3, 2019, the first trading date following the closing of the Merger, to $1.00 per share as of June 30, 2020. Market prices for securities of biotechnology and other life sciences companies historically have been particularly volatile subject even to large daily price swings. Some of the factors that may cause the market price of our common stock ~~would likely decline.~~

~~Risks Related~~to continue to fluctuate include, but are not limited to:

•material developments in, or the conclusion of, any litigation to enforce or defend any intellectual property rights or defend against the intellectual property rights of others;

•the entry into, or termination of, or breach by us or our partners of material agreements, including key commercial partner or licensing agreements, including the Kaken Agreement;

•our ability to obtain timely regulatory approvals for sofpironium bromide or future product candidates, and delays or failures to obtain such approvals;

•failure of sofpironium bromide, if approved, to achieve commercial success;

•issues in manufacturing or the supply chain for sofpironium bromide or future product candidates;

•the results of current and any future clinical trials of sofpironium bromide;

•failure of other product candidates, if approved, to achieve commercial success;

•announcements of any dilutive equity financings;

•announcements by commercial partners or competitors of new commercial products, clinical progress or the lack thereof, significant contracts, commercial relationships, or capital commitments;

•the introduction of technological innovations or new therapies or formulations that compete with sofpironium bromide;

•lack of commercial success of competitive products or products treating the same or similar indications;

•failure to elicit meaningful stock analyst coverage and downgrades of our stock by analysts; and

•the loss of key employees and/or inability to recruit the necessary talent for new positions or to replace exiting employees.

Moreover, the stock markets in general have experienced substantial volatility in our industry that has often been unrelated to the operating performance of individual companies or a certain industry segment, such as the reaction of global markets to the coronavirus outbreak. These broad market fluctuations may also adversely affect the trading price of our common stock.

In the past, following periods of volatility in the market price of a company’s securities, shareholders have often instituted class action securities litigation against those companies. Such litigation, if instituted, could result in substantial costs and diversion of management attention and resources, which could significantly harm our profitability and reputation. Such securities litigation often has ensued after a reverse merger or other merger and acquisition activity of the type we completed in 2019. Such litigation, if brought, could expose us to liability or impact negatively our business, financial condition, operating results, and prospects.

*Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations.

Our operations to date have been limited primarily to researching and developing sofpironium bromide and undertaking preclinical studies and clinical trials of sofpironium bromide. We (and our partners) have not yet obtained regulatory approvals for sofpironium bromide in any country. Consequently, any predictions you or we make about our future success or viability may not be as accurate as they could be if we had a longer operating history or approved products on the market. Our revenue and profitability will depend on development funding, including obtaining the additional funds needed to complete the Phase 3 clinical trials for sofpironium bromide, the achievement of sales milestones and royalties under an agreement with Kaken, as well as any potential future collaboration and license agreements and sales of sofpironium bromide or future products, if approved, and our ability to maintain the related license. These up-front and milestone payments may vary significantly from period to period, and country to country, and any such variance could cause a significant fluctuation in our operating results from one period to the next. In addition, we measure compensation cost for stock-based awards made to employees at the grant date of the award, based on the fair value of the award, and recognize the cost as an expense over the employee’s requisite service period. As the variables that we use as a basis for valuing these awards change over time, including our underlying stock price and stock price volatility, the magnitude of the expense that we must recognize may vary significantly. Furthermore, our operating results may fluctuate due to a variety of other factors, many of which are outside of our control and may be difficult to predict.

We incur costs and demands upon management as a result of complying with the laws and regulations affecting public companies.

We incur significant legal, accounting, and other expenses that Private Brickell did not incur as a private company prior to the Merger

and operating as a public company, including costs associated with public company reporting and other SEC requirements. We also incur costs associated with newly applicable corporate governance requirements, including requirements under the Sarbanes-Oxley Act, as well as new rules implemented by the SEC and The Nasdaq Stock Market LLC. These rules and regulations are expected to increase our legal and financial compliance costs and to make some activities more time-consuming and costly. Our executive officers, directors, and other personnel will need to devote substantial time to gaining expertise regarding operations as a public company and compliance with applicable laws and regulations. These rules and regulations may also make it expensive for us to operate our business.

We are a “smaller reporting company” and the reduced disclosure and governance requirements applicable to smaller reporting companies may make our common stock less attractive to some investors.

We qualify as a “smaller reporting company” under Rule 12b-2 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). As a smaller reporting company, we are entitled to rely on certain exemptions and reduced disclosure requirements, such as simplified executive compensation disclosures and reduced financial statement disclosure requirements, in our SEC filings. These exemptions and decreased disclosures in our SEC filings due to our status as a smaller reporting company may make it harder for investors to analyze our results of operations and financial prospects. We cannot predict if investors will find our common stock less attractive because we rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our common stock price may be more volatile. We will remain a “smaller reporting company” under Item 10(f)(1) of SEC

Regulation S-K as long as we maintain a public float as defined by that regulation of less than $250 million; or we have less than $100 million in annual revenues and (i) either no public float, or (ii) a public float of less than $700 million.

Provisions of Delaware law and our restated certificate of incorporation and amended and restated bylaws may discourage another company from acquiring us and may prevent attempts by our stockholders to replace or remove our current management.

Provisions of Delaware law and our restated certificate of incorporation and amended and restated bylaws may discourage, delay, or prevent a merger or acquisition that our stockholders may consider favorable, including transactions in which you might otherwise receive a premium for your shares. In addition, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace or remove our board of directors. These provisions include, but are not limited to:

•authorizing the issuance of “blank check” preferred stock without any need for action by stockholders;

•providing for a classified board of directors with staggered terms;

•requiring supermajority stockholder voting to effect certain amendments to our current certificate of incorporation and bylaws;

•eliminating the ability of stockholders to call special meetings of stockholders; and

•establishing advance notice requirements for nominations for election to our board of directors or for proposing matters that can be acted on by stockholders at stockholder meetings.

Although we believe these provisions collectively provide for an opportunity to receive higher bids by requiring potential acquirers to negotiate with our board of directors, they would apply even if an offer may be considered beneficial by some stockholders. In addition, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it difficult for stockholders to replace members of our board of directors, which is responsible for appointing the members of our management.

*If the ~~Merger~~holders of our company’s stock options and warrants exercise their rights to purchase our common stock, the ownership of our stockholders will be diluted.

As of June 30, 2020, we had outstanding warrants to purchase (i) one share of our common stock at an exercise price of $0.07 per share; (ii) 490,683 shares of our common stock at an exercise price of $10.36 per share; (iii) 9,005 shares of our common stock at an exercise price of $33.31 per share; (iv) 1,556,420 shares of our common stock at an exercise price of $1.16 per share; (v) 17,500,000 shares of our common stock at an exercise price of $1.25 per share; and (vi) 1,113,424 shares of our common stock at an exercise price of $0.001 per share. As of June 30, 2020, we also had 1,578,231 options issued and outstanding to purchase our common stock at a weighted average exercise price of $13.03 per share and 253,045 shares of common stock underlying unvested restricted stock units outstanding. If the holders of our outstanding stock options and warrants exercise their rights to acquire our common stock and service conditions related to restricted stock units are met, the percentage ownership of our stockholders existing prior to the exercise of such rights will be diluted.

*We may not be able to access the full amounts available under the Purchase Agreement with ~~Brickell is not consummated, Vical’s business~~Lincoln Park, which could ~~suffer materially and Vical’s~~prevent us from accessing the capital we need to continue our operations, which could have an adverse effect on our business.

On February 17, 2020, we entered into the Purchase Agreement with Lincoln Park pursuant to which Lincoln Park agreed to purchase from us up to an aggregate of $28.0 million of our common stock ~~price could decline.~~

~~The consummation of~~(subject to certain limitations) from time to time over the ~~Merger with Brickell is~~36-month period commencing on the date the conditions set forth in the Purchase Agreement are satisfied. All funds available under the Purchase Agreement are subject to the satisfaction of ~~a number of closing~~certain conditions specified in the Purchase Agreement, including ~~the receipt of Vical stockholder approvals, Vical’s successful application for initial listing with~~that our common stock remains listed on Nasdaq, the ~~occurrence~~effectiveness of a registration statement relating to the resale of the ~~special meeting of Vical’s stockholders,~~shares to be sold to Lincoln Park under the ~~satisfaction of the Vical net cash condition and other closing conditions. Vical and Brickell are targeting a closing of the Merger in the third quarter of 2019.~~

~~If the Merger is not consummated, Vical may be subject to a number of material risks, and its business and stock price could be adversely affected, as follows:~~

~~Vical has incurred and expects to continue to incur significant expenses related to the Merger with Brickell, even if the Merger is not consummated.~~

~~The Merger Agreement contains covenants restricting Vical’s solicitation of competing acquisition proposals and the conduct of Vical’s business between the date of signing the Merger~~Purchase Agreement and that no event of default has occurred under the ~~closing~~Purchase Agreement. Additionally, depending upon the prevailing market price of the Merger. As a result, significant business decisions and transactions before the closing of the Merger require the consent of Brickell. Accordingly, Vical may be unable to pursue business opportunities that would otherwise be in its best interest as a standalone company.

Vical has invested significant time and resources in the transaction process and if the Merger Agreement is terminated. Vical will have limited prospects, given the fact that Vical has discontinued all activities relating to development of its clinical programs, including its ASP0113 program collaboration with Astellas, its HSV-2 vaccine program and its VL-2397 Phase 2 clinical trial.

~~Vical could be obligated to pay Brickell a $1.0 million termination fee in connection with the termination of the Merger Agreement, depending on the reason for the termination.~~

~~In addition, if the Merger Agreement is terminated and Vical’s board of directors determines to seek another business combination, it~~our common stock, we may not be able to ~~find~~sell shares to Lincoln Park if such a ~~third party willing~~sale would result in us issuing to ~~provide equivalent or~~Lincoln Park more ~~attractive consideration~~ than 9.99% of our shares outstanding prior to entering into the ~~consideration~~Purchase Agreement. Further, we will be significantly limited in our ability to ~~be provided by each party~~sell

shares of common stock under the Purchase Agreement if our stockholders do not approve an increase in the ~~Merger. Due~~number of authorized shares of our common stock, as further described under “We will need to raise substantial additional financing in the ~~lengthy nature~~future to fund our operations, which may not be available to us on favorable terms or at all.” In the event that we are unable to satisfy the conditions specified, the purchase commitment made by Lincoln Park will be unavailable to us and Lincoln Park will not be required to purchase any shares of our common stock. If obtaining funding from Lincoln Park were to prove unavailable, we will need to secure other sources of funding in order to satisfy our working capital needs. Additionally, even if we are able to sell all shares under the ~~strategic process,~~Purchase Agreement, we will still need additional capital to fully implement our business, operating and development plans.

We do not anticipate paying any dividends in the ~~further passage~~foreseeable future.

Our current expectation is that we will retain our future earnings to fund the development and growth of ~~time~~our business. As a result, capital appreciation, if any, of our shares will ~~diminish cash available. In such circumstances, Vical’s board~~be your sole source of gain, if any, for the foreseeable future.

If we fail to attract and retain management and other key personnel and directors, may elect to, among other things, divest all or a portion of Vical’s business, or take the steps necessary to liquidate all of Vical’s business and assets, and in either such case, the consideration that Vical receiveswe may be ~~less attractive than~~unable to continue to successfully develop or commercialize our product candidates or otherwise implement our business plan.

Our ability to compete in the ~~consideration~~highly competitive pharmaceuticals industry depends on our ability to ~~be received by Vical pursuant to the Merger Agreement.~~

~~Some of Vical’s officers~~attract and ~~directors have conflicts of interest that may influence them to support or approve the Merger.~~

~~Officers~~retain highly qualified managerial, scientific, medical, legal, sales and marketing and other personnel, and directors of ~~Vical participate~~our board of directors. We are highly dependent on our management, scientific personnel, and our directors. The loss of the services of any of these individuals could impede, delay or prevent the successful development of our product pipeline, completion of our planned clinical trials, commercialization of our product candidates or in-licensing or acquisition of new assets and could impact negatively our ability to implement successfully our business plan and in ~~arrangements~~a way that ~~provide them~~complies with ~~interests~~all applicable laws. If we lose the services of any of these individuals, we might not be able to find suitable replacements on a timely basis or at all, and our business could be harmed as a result. We might not be able to attract or retain qualified management and other key personnel or directors in the Merger that are different from Vical’s stockholders, including, among others, to the extent applicable, their continued service as a director of the combined company, severance benefits and continued indemnification. These interests, among others, may influence the officers and directors of Vical to support or approve the Merger

Vical’s severance agreements with Vical’s executive officers and certain other employees require Vical to pay severance benefits to any of those persons who are terminated under specified circumstances, including in connection with a change of control of Vical, which could harm Vical’s financial condition or results.

Vical’s executive officers and certain other employees are parties to severance agreements that contain change of control and severance provisions providing for severance and other benefits and acceleration of vesting of stock options in the event of a termination of employment under specified circumstances. Based on the terms of their respective severance agreements, Vical’s executive officers will be entitled to receive an aggregate of approximately $2.3 million in severance benefitsfuture due to the terminations of their employment upon a change of control in connection with the consummation of the Merger. The payment of these severance benefits could harm Vical’s financial condition and results and reduce the cash available to the combined company following the Merger.

~~The Merger may be completed even though material adverse changes may result from the announcement of the Merger, industry-wide changes~~intense competition for qualified individuals among biotechnology, pharmaceutical and other ~~causes.~~

In general, either party can refuse to complete the Merger if there is a material adverse change affecting the other party following June 2, 2019, the date of the Merger Agreement. However, some types of changes do not permit either party to refuse to complete the Merger, even if such changes would have a material adverse effect on Vical or Brickell, to the extent they resulted from the following (unless, in some cases, they have a disproportionate effect on Vical or Brickell, as the case may be):

businesses.

~~changes in the general business or economic conditions affecting the industry in which Vical and Brickell, and their respective affiliates, operate;~~

•~~acts of war, armed hostilities or terrorism;~~

•~~changes in financial, banking or securities markets;~~

•~~any~~ ~~change in, or any compliance with or action taken for the purpose of complying with, any law or GAAP;~~

•~~the taking of any action required to be taken by the Merger Agreement;~~

•~~with respect to Vical, any change in the stock price or trading volume of Vical’s common stock;~~

•~~with respect to Vical, any failure to meet analysts’ financial or industry expectations or projections; and~~

•~~with respect to Vical, the announcement of the Merger Agreement or the pendency of the Merger.~~

~~If adverse changes occur but Vical and Brickell must still complete the Merger, the combined company’s stock price may suffer.~~

~~The market price of the combined company’s common stock may decline as a result of the Merger.~~

~~The market price of the combined company’s common stock may decline as a result of the Merger for a number of reasons, including if:~~

~~the combined company does not achieve the perceived benefits of the Merger as rapidly or to the extent anticipated by financial or industry analysts;~~

~~the effect of the Merger on the combined company’s business and prospects is not consistent with the expectations of financial or industry analysts; or~~

~~investors react negatively to the effect on the combined company’s business and prospects from the Merger.~~

~~Vical’s stockholders may not realize a benefit from the Merger commensurate with the ownership dilution they will experience in connection with the Merger.~~

If the combined company is unable to realize the strategic and financial benefits currently anticipated from the Merger, Vical’s stockholders will have experienced substantial dilution of their ownership interest without receiving any commensurate benefit. Significant management attention and resources will be required to integrate the two companies. Delays in this process could adversely affect the combined company’s business, financial results, financial condition and stock price following the Merger. Even if

the combined company is able to integrate the business operations successfully, there can be no assurance that this integration will result in the realization of the full benefits of synergies, innovation and operational efficiencies that may be possible from this integration and that these benefits will be achieved within a reasonable period of time.

The combined company will incur significant transaction costs as a result of the Merger, including investment banking, legal and accounting fees. In addition, the combined company will incur significant consolidation and integration expenses which cannot be accurately estimated at this time. Actual transaction costs may substantially exceed estimates and may have an adverse effect on the combined company’s financial condition and operating results.

~~During the pendency of the Merger, Vical and Brickell will be subject to contractual limitations set forth in the Merger Agreement that restrict the parties’~~*Our ability to ~~enter into business combination transactions with another party.~~

Covenants in the Merger Agreement impede the ability of Vical or Brickell to make acquisitions or complete other transactions that are not in the ordinary course of business pending completion of the Merger. As a result, if the Merger is not completed, the parties may be at a disadvantage to their competitors. In addition, while the Merger Agreement is in effect and subject to limited exceptions, each party is prohibited from soliciting, initiating, encouraging or taking actions designed to facilitate any inquiries or the making of any proposal or offer that could lead to the entering into certain extraordinary transactions with any third party, such as a sale of assets, an acquisition of Vical’s common stock, a tender offer for Vical’s common stock, a Merger or other business combination outside the ordinary course of business. Any such transactions could be favorable to such party’s stockholders.

Because the lack of a public market for Brickell’s common stock makes it difficult to evaluate the fairness of the Merger, Brickell’s stockholders may receive consideration in the Merger that is greater than or less than the fair market value of Brickell’s common stock.

The outstanding share capital of Brickell is privately held and is not traded in any public market. The lack of a public market makes it difficult to determine the fair market value of Brickell. It is possible that the value of Vical’s common stock to be issued in connection with the Merger will be greater than the fair market value of Brickell.

Because the Merger will result in an ownership change under Section 382 of the Internal Revenue Code (the “Code”) for Vical, Vical’s pre-Merger net operating loss carryforwards and certain other tax attributes will be subject to limitations. Theuse our net operating loss carryforwards and other tax ~~attributes of Brickell and of the combined company~~assets to offset future taxable income may ~~also~~ be subject to ~~limitations as a result~~certain limitations.

As of ~~ownership changes.~~

IfDecember 31, 2019, we had approximately $403.9 million of federal and $350.6 million of state operating loss (“NOL”) carryforwards available to offset future taxable income, which expire in varying amounts beginning in 2020 for federal and state purposes if unused. Utilization of these NOLs depends on many factors, including our future income, which cannot be assured. Under the U.S. Tax Cuts and Jobs Acts (“Tax Act”), U.S. federal NOLs incurred in 2018 and later years may be carried forward indefinitely, but our ability to utilize such U.S. federal NOLs to offset taxable income is limited to 80% of the current-year taxable income. It is uncertain if and to what extent various U.S. states will conform to the Tax Act. In addition, under Sections 382 and 383 of the Internal Revenue Code of 1986 and corresponding provisions of U.S. state law, if a corporation undergoes an “ownership change” (which is generally defined as a greater than 50 percentage points change (by value) in its equity ownership over a rolling three-year period), the corporation’s ability to use its pre-change NOL carryforwards and other pre-change tax attributes to offset its post-change income or taxes may be limited. We have not determined whether we have experienced Section 382 ownership changes in the past and if a portion of our NOLs is therefore subject to an annual limitation under Section 382. Therefore, we cannot provide any assurance that a change in ownership within the meaning of ~~Section 382~~the Internal Revenue Code of 1986 and corresponding provisions of U.S. state law has occurred in the ~~Code,~~past, and there is a risk that changes in ownership could have occurred. We may experience ownership changes as a result of subsequent changes in our stock ownership, as a result of offerings of our stock or subsequent shifts in our stock ownership, some of which may be outside of our control. In that case, the ~~corporation’s~~ability to use net operating loss carryforwards ~~and certain other tax attributes arising before the~~to offset future taxable income will be limited following any such ownership change, ~~are subject to limitations on use after~~and could be eliminated. If eliminated, the ~~ownership change. In general, an ownership change occurs if there is~~related asset would be removed from the deferred tax asset schedule with a ~~cumulative change~~corresponding reduction in the ~~corporation’s equity ownership~~valuation allowance on our financial statements.

*We may be adversely affected by ~~certain stockholders~~natural disasters and other catastrophic events and by man-made problems such as war or terrorism or labor disruptions that ~~exceeds fifty percentage points over~~could disrupt our business operations, and our business continuity and disaster recovery plans may not adequately protect us from a ~~rolling three-year period. Similar rules may apply under state tax laws. The Merger will result~~serious disaster.

Our corporate office is located in ~~an ownership change for Vical~~Boulder, Colorado, near a major flood and ~~accordingly, Vical’s net operating loss carryforwards and certain~~blizzard zone. If a disaster, power outage, computer hacking, or other ~~tax attributes will be subject to limitations (or disallowance) on their use after the Merger. Brickell’s net operating loss carryforwards may also be subject to limitation~~event occurred that prevented us from using all or a significant portion of our office, that damaged

critical infrastructure (such as ~~a result of prior shifts in equity ownership and/~~enterprise financial systems, IT systems, manufacturing resource planning or the Merger. Additional ownership changes in the future could result in additional limitations on Vical’s, Brickell’s and the combined company’s net operating loss carryforwards. Consequently, even if the combined company achieves profitability,enterprise quality systems), or that otherwise disrupted operations, it may ~~not~~ be ~~able~~difficult or, in certain cases, impossible for us to ~~utilize~~continue our business for a ~~material portion~~substantial period of ~~Vical’s, Brickell’s~~time. Our contract manufacturers’ and suppliers’ facilities are located in multiple locations where other natural disasters or ~~the combined company’s net operating loss carryforwards~~similar events, such as tornadoes, earthquakes, storms, fires, explosions or large-scale accidents or power outages, or IT threats, could severely disrupt our operations, could expose us to liability and ~~other tax attributes, which~~ could have a material adverse effect on ~~cash flow~~our business, financial condition, operating results, and prospects. In addition, acts of terrorism and other geo-political unrest or labor unrest, or natural disasters, or global developments like the coronavirus outbreak, could cause disruptions in our business or the businesses of our partners, manufacturers, or the economy as a whole. All of the aforementioned risks may be further increased if we do not implement a disaster recovery plan or our partners’ or manufacturers’ disaster recovery plans prove to be inadequate. To the extent that any of the above should result in delays in the regulatory approval, manufacture, distribution, or commercialization of sofpironium bromide, this could expose us to liability, and our business, financial condition, operating results, and prospects would suffer.

Our business and operations would suffer in the event of system failures, cyber-attacks, or a deficiency in our cyber-security.

Despite the implementation of security measures, our internal computer systems and those of our current and future CROs and other contractors and consultants, and even the regulators who we rely on to advance our business, are vulnerable to damage from computer viruses, unauthorized access, computer hacking or breaches, natural disasters, epidemics and pandemics, terrorism, war, labor unrest, and telecommunication and electrical failures. The risk of a security breach or disruption, particularly through cyber-attacks or cyber-intrusion, including by computer hackers, foreign governments, and cyber-terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased. While we have not experienced any such material system failure, accident, or security breach to date, if such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our development programs and our business operations. In addition, since we sponsor clinical trials, any breach that compromises patient data and identities causing a breach of privacy could generate significant reputational damage and legal liabilities and costs to recover and repair, including affecting trust in us to recruit for future clinical trials. For example, the loss of clinical trial data from completed or future clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications or inappropriate disclosure of confidential or proprietary information, we could incur liability and the further development and commercialization of our products and product candidates could be delayed.

Risks Related to Our Business

We currently have no products approved for sale, and we may never obtain regulatory approval to commercialize any of our product candidates.

The research, testing, manufacturing, safety surveillance, efficacy, quality assurance and control, recordkeeping, labeling, packaging, storage, approval, sale, marketing, distribution, import, export and reporting of safety and other post-market information related to our investigational drug products are subject to extensive regulation by the FDA and other regulatory authorities in the United States and in foreign countries, and such regulations differ from country to country and frequently are revised.

Even after we or our partners achieve regulatory approval for a product candidate, if any, we or our partners will be subject to continued regulatory review and compliance obligations, including on how the product is commercialized. For example, with respect to our product candidates for the U.S., the FDA may impose significant restrictions on the approved indicated use(s) for which the product may be marketed or on the conditions of approval. A product candidate’s approval may contain requirements for potentially costly post-approval studies and surveillance, including Phase 4 clinical trials, to monitor the safety and efficacy of the product or include in the approved label restrictions on the product and how it may be used or sold. We also will be subject to ongoing FDA obligations and continued regulatory review with respect to, among other things, the manufacturing, processing, labeling, packaging, distribution, pharmacovigilance and adverse event reporting, storage, advertising, promotion, and recordkeeping for our product candidates. These requirements include submissions of safety and other post-marketing information and reports, registration, continued compliance with cGMP requirements and with the FDA’s GCP requirements and GLP requirements, which are regulations and guidelines enforced by the FDA for all of our product candidates in clinical and preclinical development, and for any clinical trials that we conduct post-approval, as well as continued compliance with the FDA’s laws governing commercialization of the approved product, including but not

limited to the FDA’s Office of Prescription Drug Promotion regulation of promotional activities and direct-to-consumer advertising, fraud and abuse, antikickback, product sampling, debarment, scientific speaker engagements and activities, formulary interactions as well as interactions with healthcare practitioners, including various conflict-of-interest reporting requirements for any healthcare practitioners we may use as consultants, and laws relating to the pricing of drug products, including federal “best price” regulations that if not met can prohibit the company from participating in federal reimbursement programs like Medicare or Medicaid. To the extent that a product candidate is approved for sale in other countries, we may be subject to similar or more onerous (e.g., prohibition on direct-to-consumer advertising and price controls that do not exist in the United States) restrictions and requirements imposed by laws and government regulators, and even private institutions, in those countries.

In addition, manufacturers of drug and biologic products and their facilities are subject to continual review and periodic inspections by the FDA and other regulatory authorities for compliance with cGMP regulations. If we or a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the manufacturing, processing, distribution or storage facility where, or processes by which, the product is made, a regulatory agency may impose restrictions on that product or us, including requesting that we initiate a product recall, or requiring notice to physicians or the public, withdrawal of the product from the market, or suspension of manufacturing.

If we, our partners, our product candidates, or the manufacturing facilities for our product candidates fail to comply with applicable regulatory requirements, a regulatory agency may:

•impose restrictions on the sale, marketing, advertising, or manufacturing of the product, or amend, suspend, or withdraw product approvals, or revoke necessary licenses;

•mandate modifications to or prohibit promotional and other product-specific materials or require us to provide corrective information to healthcare practitioners and other customers and/or patients, or in our advertising and promotion;

•require us or our partners to enter into a consent decree, which can include imposition of various fines, reimbursements for inspection costs, required due dates for specific actions, penalties for noncompliance and, in extreme cases, require an independent compliance monitor to oversee our activities;

•issue warning letters, bring enforcement actions, initiate surprise inspections, issue show cause notices or untitled letters describing alleged violations, which may be publicly available;

•commence criminal investigations and prosecutions;

•debar certain healthcare professionals;

•exclude us from participating in or being eligible for government reimbursement and formulary inclusion;

•initiate audits, inspections, accounting and civil investigations or litigation;

•impose injunctions, suspensions or revocations of necessary approvals or other licenses;

•impose other civil or criminal penalties;

•suspend or cancel any ongoing clinical trials;

•place restrictions on the kind of promotional activities that can be done;

•delay or refuse to approve pending applications or supplements to approved applications filed by us or our potential partners;

•refuse to permit drugs or precursor chemicals to be imported or exported to or from the United States;

•suspend or impose restrictions on operations, including costly new manufacturing requirements;

•change or restrict our product labeling; or

•seize or detain products or require us or our partners to initiate a product recall.

The regulations, policies, or guidance of the FDA and other applicable government agencies may change quickly, and new or additional statutes or government laws or regulations may be enacted, including at federal, state, and local levels, or case law may issue, which can differ by geography and could prevent or delay regulatory approval of our product candidates or further restrict or regulate post-approval activities, including commercial efforts. We cannot predict the likelihood, nature or extent of adverse government regulations that may arise from future legislation or administrative action, or judicial outcomes based on litigation, either in the United States or abroad. If we are not able to achieve and maintain regulatory or other legal compliance, we may not be permitted to commercialize our product candidates, which would adversely affect our ability to generate revenue and achieve or maintain profitability.

*Major public health issues, and specifically the pandemic caused by the spread of COVID-19, could have an adverse impact on our financial condition and results of ~~operations.~~

operations and other aspects of our business.

The ~~Exchange Ratio is not adjustable based on the market price of Vical common stock so the Merger consideration at the closing~~outbreak of the ~~Merger~~novel Coronavirus (COVID-19) has evolved into a global pandemic. The extent to which the coronavirus impacts our business and operating results will depend on future developments that are highly uncertain and cannot be accurately predicted, including new information that may emerge concerning the coronavirus and the actions to contain the coronavirus or treat its impact, among others.

The effects of the coronavirus pandemic could delay or interrupt our business operations. For instance, our clinical trials may be affected by the pandemic. Site initiation, participant recruitment and enrollment, participant dosing, and distribution of clinical trial materials, study monitoring and data analysis may be paused or delayed due to changes in hospital or university policies, federal, state or local regulations, prioritization of hospital resources toward pandemic efforts, or other reasons related to the pandemic. Some participants and clinical investigators may not be able to comply with clinical trial protocols. For example, quarantines or other travel limitations (whether voluntary or required) may impede participant movement, affect sponsor access to study sites, or interrupt healthcare services, and we may be unable to conduct our clinical trials. Further, if our operations are adversely impacted, we risk a delay, default and/or nonperformance under existing agreements which may increase our costs. These cost increases may not be fully recoverable or adequately covered by insurance. Infections and deaths related to the pandemic may disrupt the United States’ and other countries’ healthcare and healthcare regulatory systems. Such disruptions could divert healthcare resources away from, or materially delay FDA or other regulatory review and/or approval with respect to, our clinical trials. It is unknown how long these disruptions could continue, were they to occur. Any elongation or de-prioritization of our clinical trials or delay in regulatory review resulting from such disruptions could materially affect the development and study of our product candidates.

We currently rely on third parties, such as contract laboratories, contract research organizations, medical institutions, and clinical investigators to conduct these studies and clinical trials. If these third parties themselves are adversely impacted by restrictions resulting from the coronavirus outbreak, we will likely experience delays and/or realize additional costs. As a result, our efforts to obtain regulatory approvals for, and to commercialize, our therapeutic candidates may be delayed or disrupted.

The spread of the coronavirus, which has caused a broad impact globally, including restrictions on travel and quarantine policies put into place by businesses and governments, may have a ~~greater or lesser value than at~~material economic effect on our business. While the ~~time~~potential economic impact brought by and the ~~Merger Agreement was signed.~~

~~At the effective time~~duration of the ~~Merger, outstanding shares~~pandemic may be difficult to assess or predict, it has already caused, and is likely to result in further, significant disruption of ~~Brickell~~global financial markets, which may reduce our ability to access capital ~~stock will be converted into shares~~either at all or on favorable terms. In addition, a recession, depression, or other sustained adverse market event resulting from the spread of ~~Vical~~the coronavirus could materially and adversely affect our business and the value of our common stock. ~~Applying~~

The ultimate impact of the ~~Exchange Ratio, the former Brickell securityholders~~current pandemic, or any other health epidemic, is highly uncertain and ~~NovaQuest, collectively, are expected to own,~~ subject to ~~adjustment, approximately 60%~~change. We do not yet know the full extent of potential delays or impacts on our business, our clinical trials, our research programs, healthcare systems or the global economy as a whole. However, these effects could have a material adverse effect on our business, financial condition and results of operations and cash flows.

We have sponsored or supported and may in the future sponsor or support clinical trials for our product candidates outside the United States, and the FDA and applicable foreign regulatory authorities may not accept data from such trials.

We have sponsored or supported and may in the future choose to sponsor or support one or more of our clinical trials outside of the ~~aggregate number~~United States. Although the FDA or applicable foreign regulatory authorities may accept data from clinical trials conducted outside the United States or the applicable jurisdiction, acceptance of ~~shares~~such study data by the FDA or applicable foreign regulatory authorities may be subject to certain conditions or exclusion. Where data from foreign clinical trials are intended to serve as the basis for marketing approval in the United States, the FDA will not approve the application on the basis of ~~Vical common stock,~~foreign data alone unless such data are applicable to the U.S. population and U.S. medical practice; the studies were performed by clinical investigators of recognized competence; and the ~~securityholders of Vical as of immediately prior~~data are considered valid without the need for an on-site inspection by the FDA or, if the FDA considers such an inspection to be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means. Many foreign regulatory bodies have similar requirements. In addition, such foreign studies would be subject to the ~~Merger are expected to own, subject to adjustment, approximately 40%~~applicable local laws of the ~~aggregate number of shares of Vical common stock (in each case on a fully diluted basis using~~foreign jurisdictions where the ~~treasury stock method in instances other than with respect to~~studies are conducted. There can be no assurance the ~~NovaQuest Warrants and certain equity issuances by Brickell following the signing~~FDA or applicable foreign regulatory authorities will accept data from trials conducted outside of the ~~Merger Agreement and prior to~~United States or the ~~completion of~~applicable home country. If the Merger). The exchange ratio formula is based on a $60.0 million valuation of Brickell and a $40.0 million valuation of Vical and is subject to adjustment based on the Vical net cash and Brickell net working capital balances prior to the completion of the Merger.

~~Any changes~~FDA or applicable foreign regulatory authority does not accept such data, it would likely result in the ~~market price~~need for additional clinical trials, which would be costly and time-consuming and delay aspects of ~~Vical common stock before the completion~~our business plan.

We may face product liability exposure, and if successful claims are brought against us, we may incur substantial liability if our insurance coverage for those claims is inadequate.

We face an inherent risk of ~~the Merger will not affect the number~~product liability or similar causes of ~~shares Brickell stockholders will be entitled to receive pursuant to the Merger Agreement. Therefore, if before the completion of the~~

Merger the market price of Vical common stock declines from the market price on the date of the Merger Agreement, then Brickell securityholders could receive Merger consideration with substantially lower value. Similarly, if before the completion of the Merger the market price of Vical common stock increases from the market price on the date of the Merger Agreement, then Brickell securityholders could receive Merger consideration with substantially more value for their shares of Brickell capital stock than the parties had negotiated for in the establishment of the Exchange Ratio. The Merger Agreement does not include a price-based termination right. Because the Exchange Ratio does not adjustaction as a result of ~~changes~~the clinical testing (and use) of our product candidates and will face an even greater risk if we commercialize any products. This risk exists even if a product is approved for commercial sale by the FDA and is manufactured in facilities licensed and regulated by the FDA or an applicable foreign regulatory authority and notwithstanding that we comply with applicable laws on promotional activity. Our products and product candidates are designed to affect important bodily functions and processes. Any side effects, manufacturing defects, misuse or abuse associated with our product candidates could result in actual or perceived injury to a patient that may or may not be reversible or potentially even cause death. We cannot offer any assurance that we will not face product liability or other similar suits in the ~~value~~future or that we will be successful in defending them, nor can we assure that our insurance coverage will be sufficient to cover our liability under any such cases.

In addition, a liability claim may be brought against us even if our product candidates merely appear to have caused an injury. Product liability claims may be brought against us by consumers, healthcare providers, pharmaceutical companies or others selling or otherwise coming into contact with our product candidates, among others, and under some circumstances even government agencies. If we cannot successfully defend against product liability or similar claims, we will incur substantial liabilities, reputational harm and possibly injunctions and punitive actions. In addition, regardless of ~~Vical common stock,~~merit or eventual outcome, product liability claims may result in:

•withdrawal or delay of recruitment or decreased enrollment rates of clinical trial participants;

•termination or increased government regulation of clinical trial sites or entire trial programs;

•the inability to commercialize, or restrictions on commercializing, our product candidates;

•decreased demand for ~~each one percentage point that~~our product candidates;

•impairment of our business reputation;

•product recall or withdrawal from the market ~~value~~or labeling, marketing, or promotional restrictions;

•substantial costs of ~~Vical common stock rises~~any related litigation or ~~declines, there is a corresponding one percentage point rise~~similar disputes;

•distraction of management’s attention and other resources from our primary business;

•significant delay in product launch;

•debarment of our clinical trial investigators or ~~decline, respectively, in the value of the total Merger consideration issued~~other related healthcare practitioners working with our company;

•substantial monetary awards to ~~Brickell securityholders.~~

~~The opinion received by Vical’s board of directors from MTS Securities has not been, and is not expected to be, updated to reflect changes in circumstances~~patients or other claimants against us that may not be covered by insurance;

•withdrawal of reimbursement or formulary inclusion; or

•loss of revenue.

We have ~~occurred since the date of the opinion.~~

~~Vical retained MTS Securities as a financial advisor~~obtained product liability insurance coverage for our clinical trials. Large judgments have been awarded in ~~connection with the Merger. On June 2, 2019, MTS Securities, an affiliate of MTS, delivered its opinion to the board of directors of Vical~~class action or individual lawsuits based on drugs that as of June 2, 2019, and subject to the various assumptions made, procedures followed, matters considered and qualifications and limitations set forth in such written opinion, the Exchange Ratio is fair, from a financial point of view, to the holders of Vical common stock. The opinion addresses solely the fairness, from a financial point of view and as of the date of such opinion, of the Exchange Ratio to the holders of Vical common stock and does not address any other terms in the Merger Agreement, or any other agreement contemplated by the Merger Agreement or relating to the Merger or any other aspect or implication of the Merger, including, without limitation, the form or structure of the Merger or the fairness of the Merger or the Exchange Ratio to any other securityholders or creditors or any other constituency of Vical. MTS Securities did not consider any potential legislative or regulatory changes currently being considered by the SEC, or any other governmental or regulatory bodies, or any changes in accounting methods or generally accepted accounting principles that may be adopted by the SEC or the Financial Accounting Standards Board. It should be understood that, although subsequent developments may affect the conclusion reached in the opinion, MTS Securities does not have any obligation to update, revise or reaffirm such opinion and has not done so.

Vical and Brickell may become involved in securities litigation or stockholder derivative litigation in connection with the Merger, and this could divert the attention of Vical and Brickell management and harm the combined company’s business, andhad unanticipated side effects. Our insurance coverage may not be sufficient to cover all of our product liability-related expenses or losses and may not cover us for any expenses or losses we may suffer. Moreover, insurance coverage is becoming increasingly expensive, restrictive, and narrow, and, in the future, we may not be able to maintain adequate insurance coverage at a reasonable cost, or through self-insurance, in sufficient amounts or upon adequate terms to protect us against losses due to product liability or other similar legal actions. We will need to increase our product liability coverage if any of our product candidates receive regulatory approval, which will be costly, and we may be unable to obtain this increased product liability insurance on commercially reasonable terms or at all and for all geographies in which we wish to launch. A successful product liability claim or series of claims brought against us could, if judgments exceed our insurance coverage, decrease our cash, expose us to liability and harm our business, financial condition, operating results, and prospects.

Our employees, independent contractors, principal investigators, other clinical trial staff, consultants, vendors, CROs and any partners with which we may collaborate may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

We are exposed to the risk that our employees, officers, directors, independent contractors, principal investigators, other clinical trial staff, consultants, advisors, vendors, CROs and any partners with which we may collaborate may engage in fraudulent or other illegal or unethical activity. Misconduct by these persons could include intentional, reckless, gross or negligent misconduct or unauthorized activity that violates: laws or regulations, including those laws requiring the reporting of true, complete and accurate information to the FDA or foreign regulatory authorities; product sampling; manufacturing standards; federal, state and foreign healthcare fraud and abuse laws and data privacy; anticorruption laws, anti-kickback and Medicare/Medicaid rules, debarment laws, promotional laws, securities laws, and/or laws that require the true, complete and accurate reporting of financial information or data, books and records. If any such or similar actions are instituted against us and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative and punitive penalties, damages, monetary fines, possible exclusion from participation in Medicare, Medicaid, and other federal or state healthcare programs, debarments, contractual damages, reputational harm, diminished profits and future earnings, injunctions, and curtailment or cessation of our operations, any of which could expose us to liability and adversely affect our business, financial condition, operating results, and prospects.

We may be subject to risks related to pre-approval promotion or off-label use, or unauthorized direct-to-consumer advertising of our product candidates.

In the United States, the FDA strictly regulates the advertising and promotion of drug products, and drug products may only be marketed or promoted for their FDA-approved uses, consistent with the product’s approved labeling and to appropriate patient populations. Advertising and promotion of any product candidate that obtains approval in the United States will be heavily scrutinized by the FDA, the Department of Justice, the Office of Inspector General of the Department of Health and Human Services, state attorneys general, members of Congress, the public, and others. Violations, including promotion of our products for unapproved or off-label uses, or inappropriate direct-to-consumer advertising, are subject to enforcement letters, inquiries and investigations, and civil, criminal, and/or administrative sanctions by the FDA and other government agencies or tribunals and lawsuits by competitors, healthcare practitioners, consumers, investors, or other plaintiffs. Additionally, advertising and promotion of any product candidate that obtains approval outside of the United States will be heavily scrutinized by relevant foreign regulatory authorities.

Even if we obtain regulatory approval for our product candidates, the FDA or comparable foreign regulatory authorities may require labeling changes or impose significant restrictions on a product’s indicated uses or marketing, or impose ongoing requirements for potentially costly post-approval studies or post-market surveillance.

In the United States, engaging in impermissible promotion of our product candidates for off-label uses, or engaging in pre-approval promotion of an unapproved drug candidate, also can subject us to false claims litigation under federal and state

statutes, which can lead to civil, criminal and/or administrative penalties and fines and agreements, such as a corporate integrity agreement, that materially restrict the manner in which we promote or distribute our product candidates. If we do not lawfully promote our products once they have received regulatory approval, we may become subject to such litigation and, if we are not successful in defending against such actions, those actions could expose us to liability and could have a material adverse effect on our business, financial condition, operating results, and prospects and even result in having an independent compliance monitor assigned to audit our ongoing operations at our cost for a lengthy period of time.

Other than sofpironium bromide, our other product candidates are at the early stages of clinical and regulatory development.

We are evaluating the next clinical development steps for various early-stage clinical product candidates (prior to Phase 3). The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming, costly, and inherently unpredictable, especially for early-stage product candidates. The time required to obtain approval for early stage product candidates from the FDA and comparable foreign authorities is unpredictable but typically takes many years, involves significant expenditures, and depends upon numerous factors, including the substantial discretion of the regulatory authorities. In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions. Our early stage product candidates will require substantial additional preclinical and clinical development before we will be able to submit an application to the FDA, if at all. Accordingly, we cannot provide assurance that we will be able to seek or obtain regulatory approval for any of our early stage product candidates.

We may choose not to continue developing or commercializing any of our early-stage product candidates at any time during development or after approval, which would reduce or eliminate our potential return on investment for those product candidates.

At any time, we may decide to discontinue the development of any of our early-stage product candidates for a variety of reasons, including the appearance of new technologies that make our product obsolete, competition from a competing product including entry of generics, supply chain considerations, intellectual property right impacts, ability to price or changes in or failure to comply with applicable regulatory requirements, or constraints on obtaining additional financing and capital. If we terminate a program in which we have invested significant resources, we will not receive any return on our investment, and we will have missed the opportunity to have allocated those resources to potentially more productive uses.

Healthcare reform measures could hinder or prevent the commercial success of our product candidates.

The current presidential administration and certain members of the majority of the U.S. Congress have sought to repeal all or part of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (or collectively, the “Affordable Care Act”) and implement a replacement program. For example, the so-called “individual mandate” was repealed as part of tax reform legislation adopted in December 2017, such that the shared responsibility payment for individuals who fail to maintain minimum essential coverage under section 5000A of the Internal Revenue Code was eliminated beginning in 2019. In addition, litigation may prevent some or all of the Affordable Care Act legislation from taking effect. For example, on December 14, 2018, the U.S. District Court for the Northern District of Texas held that the individual mandate is a critical and inseverable feature of the Affordable Care Act, and therefore, because it was repealed as part of the tax reform legislation, the remaining provisions of the Affordable Care Act are invalid as well. The impact of this ruling is stayed as it was appealed to the Fifth Circuit Court of Appeals. While the ruling will have no immediate effect, it is unclear how this decision, and subsequent appeals, if any, will impact the law. In 2020 and beyond, we may face additional uncertainties as a result of likely federal and administrative efforts to repeal, substantially modify or invalidate some or all of the provisions of the Affordable Care Act. There is no assurance that the Affordable Care Act, as amended in the future, will not adversely affect our business and financial results.

Additionally, in October 2018, the U.S. President proposed to lower Medicare Part B drug prices, in addition to contemplating other measures to lower or prescribe certain mandatory prescription drug prices or drug substitution policies. While these proposals have not yet been enacted, we expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in reduced demand for our product candidates if approved or additional pricing pressures.

There are also calls to severely curtail or ban all direct-to-consumer advertising of pharmaceuticals, or restrict activities by pharmaceutical sales representatives to have access to prescribers, which would limit our ability to market our product candidates. With regard to marketing directly to consumers and patients, the United States is in a minority of jurisdictions that even allow this kind of advertising and its removal could limit the potential reach of a marketing campaign.

We also may be subject to stricter healthcare laws, regulation and enforcement, and our failure to comply with those laws could expose us to liability or adversely affect our business, financial condition, operating results, and prospects.

Certain federal and state healthcare laws and regulations pertaining to fraud and abuse and patients’ rights and privacy are and will be applicable to our business. We are subject to regulation by both the federal government and the states in which we or our partners conduct business. The healthcare laws and regulations that may affect our ability to operate include: the Federal Food, Drug and Cosmetic Act (FDCA), as amended; Title 21 of the Code of Federal Regulations Part 202 (21 CFR Part 202); the 21^st Century Cures Act, the federal Anti-Kickback Statute; federal civil and criminal false claims laws and civil monetary penalty laws; the federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act; the Prescription Drug Marketing Act (for sampling of drug product among other things); the federal Best Price Act and Medicaid drug rebate program; the federal physician sunshine reporting requirements under the Affordable Care Act and state disclosure laws; the Foreign Corrupt Practices Act as it applies to activities both inside and outside of the United States; the new federal Right-to-Try legislation; and state law equivalents of many of the above federal laws.

Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our business activities could be subject to challenge under one or more of such laws. In addition, recent healthcare reform legislation has strengthened these laws. For example, the Affordable Care Act, among other things, amended the intent requirement of the federal Anti-Kickback Statute and certain criminal healthcare fraud statutes. A person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it. In addition, the Affordable Care Act provides that the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act.

Achieving and sustaining compliance with these laws may prove costly. In addition, any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business and result in reputational damage. If our operations are found to be in violation of any of the laws described above or any other governmental laws or regulations that apply to us, we may be subject to penalties, including administrative, civil and criminal penalties, damages, including punitive damages, fines, disgorgement, the exclusion from participation in federal and state healthcare programs, individual imprisonment or corporate criminal liability, or the curtailment or restructuring of our operations, and injunctions, any of which could expose us to liability and could adversely affect our business, financial condition, operating results, and prospects.

Subject to obtaining available financing, we intend to in-license and acquire product candidates and may engage in other strategic transactions, which could impact our liquidity, increase our expenses, and present significant distractions to our management.

One of our strategies is to in-license and acquire product candidates and we may engage in other strategic transactions. Additional potential transactions that we may consider include a variety of different business arrangements, including mergers and acquisitions, spin-offs, strategic partnerships, joint ventures, co-marketing, co-promotion, distributorships, development and co-development, restructurings, divestitures, business combinations and investments on a global basis. Any such transaction(s) may require us to incur non-recurring or other charges, may increase our near- and long-term expenditures, grow and expand rapidly putting pressure on current resources and capabilities, and may pose significant integration challenges or disrupt our management or business, which could adversely affect our operations and financial results. Accordingly, there can be no assurance that we will undertake or successfully complete any transactions of the nature described above, and any transaction that we do complete could expose us to liability, delays, and implementation obstacles that could harm our business, financial condition, operating results, and prospects. We have no current commitment or obligation to enter into any transaction described above other than ones to which we are already committed.

Our failure to in-license, acquire, develop, and market successfully additional product candidates or approved products would impair our ability to grow our business.

We intend to in-license, acquire, develop, and market additional products and product candidates. Because our internal research and development capabilities are limited, we may be dependent on pharmaceutical or other companies, investment groups or funds, academic or government scientists and other researchers to sell or license products or technology to us. The success of this strategy depends partly on our ability to identify and select promising pharmaceutical product candidates and products, negotiate licensing or acquisition agreements with their current owners, and finance these arrangements.

The process of proposing, negotiating, and implementing a license or acquisition of a product candidate or approved product is lengthy and complex. Other companies, including some with substantially greater financial, marketing, sales, legal and other resources, may compete with us for the license or acquisition of product candidates and approved products. We have limited resources to identify and execute the acquisition or in-licensing of third-party products, businesses and technologies and integrate them into our current infrastructure. Moreover, we may devote resources to potential acquisitions or licensing opportunities that are never completed, or we may fail to realize the anticipated benefits of such efforts. We may not be able to acquire the rights to additional product candidates on terms that we find acceptable or at all.

Further, any product candidate that we acquire may require additional development efforts prior to commercial sale, including preclinical or clinical testing and approval by the FDA and applicable foreign regulatory authorities for the targeted use(s), or present with significant integration issues. All product candidates are prone to significant risks of failure typical of pharmaceutical product development, including the possibility that a product candidate will not be shown to be sufficiently safe and effective for approval by regulatory authorities. In addition, we cannot provide assurance that any approved products that we acquire will be manufactured or sold profitably, obtain reimbursement, be subject to patents and other intellectual property rights that provide any form of market or regulatory exclusivity, sustain historical levels of performance that made the acquisition initially attractive, or achieve/maintain market acceptance.

Risks Related to Our Dependence on Third Parties

We expect to rely on our collaboration with third-party out-license partners for the successful development and commercialization of our product candidates.

We expect to rely upon the efforts of third-party out-license partners for the successful development and commercialization of our current and future product candidates. The clinical and commercial success of our product candidates may depend upon maintaining successful relationships with third-party out-license partners which are subject to a number of significant risks, including the following:

•our partners’ ability to execute their responsibilities in a timely, cost-efficient, and compliant manner;

•reduced control over supply, delivery, and manufacturing schedules;

•price increases and product reliability;

•manufacturing deviations from internal or regulatory specifications;

•quality or integrity incidents;

•the failure of partners to perform their obligations for technical, market, legal or other reasons;

•misappropriation of our current or future product candidates; and

•other risks in potentially meeting our current and future product commercialization schedule or satisfying the requirements of our end-users.

We cannot assure you that we will be able to establish or maintain third-party out-license partner relationships to successfully develop and commercialize our product candidates.

*We rely completely on third-party contractors to supply, manufacture and distribute clinical drug supplies for our product candidates, including certain sole-source suppliers and manufacturers; we intend to rely on third parties for commercial supply, manufacturing and distribution if any of our product candidates receive regulatory approval; and we

expect to rely on third parties for supply, manufacturing and distribution of preclinical, clinical and commercial supplies of any future product candidates.

We do not currently have, nor do we plan to acquire, the infrastructure or internal capability to supply, store, manufacture or distribute preclinical, clinical, or commercial quantities of drug substances or products. Additionally, we have not entered into a long-term commercial supply agreement to provide us with such drug substances or products. As a result, our ability to develop our product candidates is dependent, and our ability to supply our products commercially will depend, in part, on our ability to obtain the APIs and other substances and materials used in our product candidates successfully from third parties and to have finished products manufactured by third parties in accordance with regulatory requirements and in sufficient quantities for preclinical and clinical testing and commercialization. If we fail to develop and maintain supply and other technical relationships with these third parties, or global conditions like the coronavirus outbreak significantly and adversely impact such third parties, we may be unable to continue to develop or commercialize our products and product candidates.

We do not have direct control over whether our contract suppliers and manufacturers will maintain current pricing terms, be willing to continue supplying us with APIs and finished products or maintain adequate capacity and capabilities to serve our needs, including quality control, quality assurance and qualified personnel. We are dependent on our contract suppliers and manufacturers for day-to-day compliance with applicable laws and cGMPs for production of both APIs and finished products. If the safety or quality of any product or product candidate or component is compromised due to a failure to adhere to applicable laws or for other reasons, we may not be able to commercialize or obtain regulatory approval for the affected product or product candidate successfully, and we may be held liable for injuries sustained as a result.

In order to conduct larger or late-stage clinical trials for our product candidates and supply sufficient commercial quantities of the resulting drug product and its components, if that product candidate is approved for sale, our contract manufacturers and suppliers will need to produce our drug substances and product candidates in larger quantities, more cost-effectively and, in certain cases, at higher yields than they currently achieve. If our third-party contractors are unable to scale up the manufacture of any of our product candidates successfully in sufficient quality and quantity and at commercially reasonable prices, or are shut down or put on clinical hold by government regulators, and we are unable to find one or more replacement suppliers or manufacturers capable of production at a substantially equivalent cost in substantially equivalent volumes and quality, and we are unable to transfer the processes successfully on a timely basis, the development of that product candidate and regulatory approval or commercial launch for any resulting products may be delayed, or there may be a shortage in supply, either of which could significantly harm our business, financial condition, operating results, and prospects.

We expect to continue to depend on third-party contract suppliers and manufacturers for the foreseeable future. Our supply and manufacturing agreements, if any, do not guarantee that a contract supplier or manufacturer will provide services adequate for our needs. Additionally, any damage to or destruction of our third-party manufacturers’ or suppliers’ facilities or equipment, even by force majeure, may significantly impair our ability to have our products and product candidates manufactured on a timely basis. Our reliance on contract manufacturers and suppliers further exposes us to the possibility that they, or third parties with access to their facilities, will have access to and may misappropriate our trade secrets or other proprietary information. In addition, the manufacturing facilities of certain of our suppliers may be located outside of the United States. This may give rise to difficulties in importing our products or product candidates or their components into the United States or other countries.

Manufacturing and supply of the APIs and other substances and materials used in our product candidates and finished drug products is a complex and technically challenging undertaking, and there is potential for failure at many points in the manufacturing, testing, quality control and assurance and distribution supply chain, as well as the potential for latent defects after products have been manufactured and distributed.

Manufacturing and supply of APIs, other substances and materials and finished drug products is technically challenging. Changes beyond our direct control can impact the quality, volume, price and successful delivery of our products and product candidates and can impede, delay, limit or prevent the successful development and commercialization of our products and product candidates. Mistakes and mishandling, and/or disruptions in the supply chain, are not uncommon despite reasonable best efforts and can affect successful production and supply. Some of these risks include but are not limited to:

•failure of our manufacturers to follow cGMP or other legal requirements or mishandling of or adulterating product while in production or in preparation for transit;

•inability of our contract suppliers and manufacturers to efficiently and cost-effectively increase and maintain high yields and batch quality, consistency, and stability;

•difficulty in establishing optimal drug delivery substances and techniques, production and storage methods and packaging and shipment processes;

•challenges in designing effective drug delivery substances and techniques especially in light of competitor options;

•transportation and import/export risk, particularly given the global nature of our supply chain;

•delays in analytical results or failure of analytical techniques that we depend on for quality control/assurance and release of a product;

•natural disasters, strikes and labor disputes, epidemics or pandemics, war and terrorism, financial distress, lack of raw material supply, issues with facilities and equipment or other forms of disruption to business operations of our contract manufacturers and suppliers; and

•latent defects that may become apparent after a product has been released and even sold and used and that may result in recall and destruction of the product.

Any of these factors could result in delays or higher costs in connection with our clinical trials, regulatory submissions, required approvals or commercialization of our products, which could expose us to liability or harm our business, financial condition, operating results, and prospects.

Risks Related to Our Intellectual Property

We may not be able to obtain, maintain or enforce global patent rights or other intellectual property rights that cover sofpironium bromide and related technologies that are of sufficient breadth.

Our success with respect to sofpironium bromide will depend, in part, on our ability to protect patent and other intellectual property protections in both the United States and other countries, to preserve our trade secrets and to prevent third parties from infringing on our proprietary rights. Our ability to prevent unauthorized or infringing use of sofpironium bromide by third parties depends in substantial part on our ability to leverage valid and enforceable patents and other intellectual property rights around the world.

The patent application process, also known as patent prosecution, is expensive and time-consuming, and we and our current or future licensors and licensees may not be able to prepare, file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner in all the countries that may be desirable. It is also possible that we or our current licensors and licensees, or any future licensors or licensees, will fail to identify patentable aspects of inventions made in the course of development and commercialization activities before it is too late to obtain patent protection by others on them. Therefore, these and any of our patents and applications may not be prosecuted and enforced in a manner consistent with the best interests of our business. Moreover, our competitors independently may develop equivalent knowledge, methods and know-how or discover workarounds to our patents that would not constitute infringement. Our partners or licensees may inappropriately take or use our intellectual property and/or confidential information to infringe our patents or otherwise violate their contractual obligations as to us related to protection of our intellectual property. Any of these outcomes could impair our ability to enforce the exclusivity of our patents effectively, which may have an adverse impact on our business, financial condition, operating results, and prospects.

Due to constantly shifting global legal standards relating to patentability, validity, enforceability and claim scope of patents covering pharmaceutical inventions, our ability to protect patents in any jurisdiction is uncertain and involves complex legal and factual questions especially across countries. Accordingly, rights under any applicable patents that apply to us may not cover our product candidates or may not provide us with sufficient protection for our product candidates to afford a sustainable commercial advantage against competitive products or processes, including those from branded, generic, and OTC pharmaceutical companies. In addition, we cannot guarantee that any patents or other intellectual property rights will issue from any pending or future patent or other similar applications related to us. Even if patents or other intellectual property rights have issued or will issue, we cannot guarantee that the claims of these patents and other rights are or will be held valid or enforceable by the courts or other legal authorities, through injunction or otherwise, or will provide us with any

significant protection against competitive products or otherwise be commercially valuable to us in every country of commercial significance that we may target, or that a legislative or executive branch of government may alter the rights and enforceability thereof at any time.

Competitors in the field of dermatologic therapeutics have created a substantial amount of prior art, including scientific publications, abstracts, posters, presentations, patents and patent applications and other public disclosures including on the Internet and various social media. Our ability to protect valid and enforceable patents and other intellectual property rights depends on whether the differences between our proprietary technology and the prior art allow our technology to be patentable over the prior art. We do not have outstanding issued patents covering all of the recent developments in our technology and are unsure of the patent protection that we will be successful in securing, if any. Even if the patents do issue successfully, third parties may design around or challenge the validity, enforceability or scope of such issued patents or any other issued patents or intellectual property that apply to us, which may result in such patents and/or other intellectual property being narrowed, invalidated, or held unenforceable. If the breadth or strength of protection provided by the patents and other intellectual property we hold or pursue with respect to our product candidates is challenged, regardless of our future success, it could dissuade companies from collaborating with us to develop, or threaten our ability to commercialize or finance, our product candidates.

The laws of some foreign jurisdictions do not provide intellectual property rights to the same extent or duration as in the United States, and many companies have encountered significant difficulties in acquiring, maintaining, protecting, defending, and especially enforcing such rights in foreign jurisdictions. If we encounter such difficulties in protecting, or are otherwise precluded from effectively protecting, our intellectual property in foreign jurisdictions, our business prospects could be substantially harmed, especially internationally.

Patents have a limited lifespan. In the United States, the natural expiration of a patent is generally 20 years after it is filed, with patent term extensions granted in certain instances to compensate for part of the period in which the drug was under development and could not be commercialized while under the patent. Without patent protection for sofpironium bromide, we may be open to competition from generic versions of sofpironium bromide. The issued U.S. patents relating to sofpironium bromide run through 2031, including expected extensions just described. Other patent rights we are seeking in the United States would provide expected coverage through 2040, but only in the event of a grant of such rights.

Proprietary trade secrets and unpatented know-how and confidential information are also very important to our business. Although we have taken steps to protect our trade secrets, unpatented know-how and confidential information by entering into confidentiality and nondisclosure agreements with third parties and intellectual property protection agreements with officers, directors, employees, and certain consultants and advisors, there can be no assurance that binding agreements will not be breached or enforced by courts or other legal authorities, that we would have adequate remedies for any breach, including injunctive and other equitable relief, or that our trade secrets, unpatented know-how and confidential information will not otherwise become known, be inadvertently disclosed by us or our agents and representatives, or be independently discovered by our competitors. If trade secrets are independently discovered, we would not be able to prevent their use, and if we and our agents or representatives inadvertently disclose trade secrets, unpatented know-how, and/or confidential information, we may not be allowed to retrieve the inadvertently disclosed trade secret, unpatented know-how, and/or confidential information and maintain the exclusivity we previously enjoyed.

We may not be able to protect our intellectual property rights throughout the world.

Filing, prosecuting, and defending patents on our product candidates does not guarantee exclusivity. The requirements for patentability differ in certain countries, particularly developing countries, and can change over time in the same country. In addition, the laws of some other countries do not protect intellectual property rights to the same extent as laws in the United States, especially when it comes to granting use and other kinds of patents and what kind of enforcement rights will be allowed, especially injunctive relief in a civil infringement proceeding. Consequently, we may not be able to prevent third parties from practicing our inventions in countries outside the United States and even in launching an identical version of our product notwithstanding us having a valid patent or other intellectual property rights in that country. Competitors may use our technologies in jurisdictions where we or our licensors have not obtained patent or other protections to develop their own products, or produce copy products, and, further, may export otherwise infringing products to territories where we have patent and other protections but enforcement against infringing activities is inadequate or where we have no patents or other

intellectual property rights. These products may compete with our products, and our patents or other intellectual property rights may not be effective or sufficient to prevent them from commercialization or other uses.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly in developing countries, do not favor the enforcement of patents and other intellectual property protection, particularly those relating to pharmaceuticals, and the judicial and government systems are often corrupt, apathetic or ineffective, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our intellectual property rights generally. Proceedings to enforce our intellectual property rights in foreign jurisdictions could result in substantial costs and ~~damages.~~

~~Securities litigation~~divert our efforts and attention from other aspects of our business, could put our global patents and other rights at risk of being invalidated or ~~stockholder derivative litigation frequently follows~~interpreted narrowly and our global patent applications at risk of not issuing, and could provoke third parties to assert claims against us. We may not prevail in any lawsuit that we initiate or infringement action brought against us, and the ~~announcement~~damages or other remedies awarded, if any, may not be commercially meaningful when we are the plaintiff. When we are the defendant, we may be required to post large bonds to stay in the market while we defend ourselves from an infringement action.

In addition, certain countries in Europe and certain developing countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties, especially if the patent owner does not enforce or use its patents over a protracted period of ~~certain~~time. In some cases, the courts will force compulsory licenses on the patent holder even when finding the patentholder’s patents are valid if the court believes it is in the best interests of the country to have widespread access to an essential product covered by the patent. Further, there is no guarantee that any country will not adopt or impose compulsory licensing in the future. In these situations, the royalty the court requires to be paid by the licenseholder receiving the compulsory license may not be calculated at fair market value and can be inconsequential, thereby disaffecting the patentholder’s business. In these countries, we may have limited remedies if our patents are infringed or if we are compelled to grant a license to our patents to a third party, which could also materially diminish the value of those patents. This would limit our potential revenue opportunities. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant ~~business transactions, such as~~commercial advantage from the ~~sale~~intellectual property that we own or license, especially in comparison to what we enjoy from enforcing our intellectual property rights in the United States. Finally, our ability to protect and enforce our intellectual property rights may be adversely affected by unforeseen changes in both U.S. and foreign intellectual property laws, or changes to the policies in various government agencies in these countries, including but not limited to the patent office issuing patents and the health agency issuing pharmaceutical product approvals. For example, in Brazil, pharmaceutical patents require prior initial approval of the Brazilian health agency (ANVISA). Finally, many countries have large backlogs in patent prosecution, and in some countries in Latin America it can take years, even decades, just to get a pharmaceutical patent application reviewed notwithstanding the merits of the application.

Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by governmental patent and similar agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

Periodic maintenance and annuity fees on any issued patent are due to be paid to the U.S. Patent and Trademark Office (“USPTO”) and foreign patent agencies in several stages over the lifetime of a ~~business division or announcement~~patent. The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. While an inadvertent lapse can, in many cases, be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction just for failure to know about and/or timely pay such fee. Non-compliance events that could result in abandonment or lapse of a patent or patent application include failure to respond to official actions within prescribed time limits, non-payment of fees in prescribed time periods, and failure to properly legalize and submit formal documents in the format and style the country requires. If we or our licensors fail to maintain the patents and patent applications covering our product candidates for any reason, our competitors might be able to otherwise enter the market, which would have an adverse effect on our business, ~~combination transaction. Vical~~financial condition, operating results, and ~~Brickell~~prospects.

In addition, countries continue to increase the fees that are charged to acquire, maintain, and enforce patents and other intellectual property rights, which may become ~~involved~~prohibitive to initiate or continue paying in certain circumstances.

If we fail to comply with our obligations under our intellectual property license agreements, we could lose license rights that are important to our business. Additionally, these agreements may be subject to disagreement over contract

interpretation, which could narrow the scope of our rights to the relevant intellectual property or technology, or increase our financial or other obligations to our licensors.

We have entered into in-license arrangements with respect to certain of our product candidates. These license agreements impose various diligence, milestone, royalty, insurance, reporting and other obligations on us. If we fail to comply with these obligations, the respective licensors may have the right to terminate or modify the license, or trigger other more disadvantageous contract clauses, in which event we may not be able to finance, develop or market the affected product candidate. The loss of such rights could expose us to liability and could materially adversely affect our business, financial condition, operating results, and prospects.

Our commercial success depends on our ability to develop, manufacture, market and sell our product candidates and use our proprietary technologies without infringing the proprietary rights of third parties and do this in one or more countries. We cannot assure that marketing and selling such product candidates and using such technologies will not infringe existing or future patents or other intellectual property rights. Numerous U.S.- and foreign-issued patents and pending patent applications owned by third parties exist in the fields relating to our product candidates. As the biotechnology and pharmaceutical industries expand and more patents and other intellectual property rights are issued, the risk increases that others may assert that our product candidates, technologies, or methods of delivery or use(s) infringe their patent or other intellectual property rights. Moreover, it is not always clear to industry participants, including us, which patents and other intellectual property rights cover various drugs, biologics, drug delivery systems and formulations, manufacturing processes, or their methods of use, and which of these patents may be valid and enforceable. Thus, because of the large number of patents issued and patent applications filed in our fields across many countries, there may be a risk that third parties may allege they have patent or other rights encompassing our product candidates, technologies, or methods.

In addition, there may be issued patents of third parties that are infringed or are alleged to be infringed by our product candidates or proprietary technologies notwithstanding the patents we may possess. Because some patent applications in the United States and other countries may be maintained in confidence until the patents are issued, because patent applications in the United States and many foreign jurisdictions are typically not published until eighteen (18) months or some other time after filing, and because publications in the scientific literature or other public disclosures often lag behind actual discoveries, we cannot be certain that others have not filed patent applications for technology covered by our patents or our pending applications. Our competitors may have filed, and may in the future file, patent applications covering our product candidates or technology similar to our technology. Any such patent application may have priority over our patent applications or patents, which could further require us to obtain rights to issued patents covering such technologies, which may mean paying significant licensing fees or royalties, or the like. If another party has filed a U.S. patent application on inventions similar to ours, we or the licensor, may have to participate in the United States in an interference proceeding to determine priority of invention.

We may be exposed to, or threatened with, future litigation by third parties having patent or other intellectual property rights alleging that our product candidates or proprietary technologies infringe such third parties’ intellectual property rights, including litigation resulting from filing in the United States under Paragraph IV of the Hatch-Waxman Act or other countries’ laws similar to the Hatch-Waxman Act. These lawsuits could claim that there are existing patent rights for such drug, and this type of litigation ~~in connection with the Merger,~~can be costly and ~~the combined company may become involved in this type of litigation in the future. Litigation often is expensive and diverts management’s attention and resources, which~~ could adversely affect our operating results and divert the attention of managerial and technical personnel, even if we do not infringe such patents or the patents asserted against us are ultimately established as invalid. There is a risk that a court or other legal authority would decide that we are infringing the third party’s patents and would order us to stop the activities covered by the patents. In addition, there is a risk that a court or other legal authority will order us to pay the other party significant damages for having violated the other party’s patents or intellectual property rights.

Because we rely on certain third-party licensors, licensees, and partners and will continue to do so in the future, around the world, if one of our licensors, licensees, or partners is sued for infringing a third party’s intellectual property rights, this could expose us to liability and our business, financial condition, operating results, and prospects could suffer in the same manner as if we were sued directly. In addition to facing litigation risks, we have agreed to indemnify certain third-party licensors, licensees, and partners against claims of ~~Vical, Brickell~~infringement caused by our proprietary technologies, and we have entered or may enter into cost-sharing agreements with some of our licensors, licensees, and partners that could require us to pay some of the ~~combined company,~~costs of patent or other intellectual property rights litigation brought against those third parties whether or not the alleged infringement is caused by our proprietary technologies. In certain instances, these cost-sharing agreements could also require us to assume greater responsibility for infringement damages than would be assumed just on the basis of our technology.

The occurrence of any of the foregoing could expose us to liability or adversely affect our business, financial condition, operating results, and ~~insurance coverage~~prospects at any time.

We may be subject to claims that our employees, officers, directors, advisors, consultants, or independent contractors have wrongfully used or disclosed to us alleged trade secrets or other confidential and proprietary information of their former employers or their former or current partners or customers.

As is common in the biotechnology and pharmaceutical industries, certain of our employees, officers, and directors were formerly employed by other biotechnology or pharmaceutical companies, including our competitors or potential competitors. Moreover, we engage the services of advisors, consultants, and independent contractors to assist us in the development of our products and product candidates, many of whom were previously employed at, or may have previously been or are currently providing consulting services to, other biotechnology or pharmaceutical companies, including our competitors or potential competitors. We may be subject to claims that these employees, officers, directors, advisors, consultants, and independent contractors or we have inadvertently or otherwise used or disclosed trade secrets or other proprietary confidential information of their former employers or their former or current customers. Although we have no knowledge of any such claims being alleged to date, if such claims were to arise, litigation may be necessary to defend against any such claims. Even if we are successful in defending against any such claims, any litigation like this could be protracted, expensive, a distraction to our management team, and/or Board, not ~~be sufficient to cover all related costs~~viewed favorably by investors and ~~damages.~~

other third parties, and may potentially result in an unfavorable outcome.

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

None.

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

Not applicable.

ITEM 4. MINE SAFETY DISCLOSURES

Not applicable.

ITEM 5. OTHER INFORMATION

None.

ITEM 6. EXHIBITS

~~ITEM 5.~~

~~OTHER INFORMATION~~

We will hold our 2019 Annual Meeting of Stockholders, or the 2019 Annual Meeting, more than 30 days after the one-year anniversary of the 2018 Annual Meeting of Stockholders, which was held on May 23, 2018. Any proposal submitted by a stockholder intended to be presented for consideration at the 2019 Annual Meeting must be delivered to or mailed and received, according to our Amended and Restated Bylaws, by our corporate secretary at our principal executive offices, not less than 50 days nor more than 75 days prior to the meeting; provided, however, that in the event that less than 65 days’ notice or prior public disclosure of the date of the meeting is given or made to stockholders, notice by the stockholder to be timely must be so received not later than the close of business on the 15th day following the day on which such notice of the date of the 2019 Annual Meeting was mailed or such public disclosure was made. Any proposal submitted outside this timeframe will not be considered timely and such business will be excluded from consideration at the 2019 Annual Meeting. The notice to be delivered to our corporate secretary must be in writing and must comply with the provisions of our Amended and Restated Bylaws. For stockholders who wish to submit a proposal for consideration of inclusion in the 2019 proxy statement and presentation at the 2019 Annual Meeting pursuant to Rule 14a-8 under the Exchange Act, such proposal must be received by our corporate secretary at our principal executive offices no later than a reasonable time before we begin to print and mail the proxy materials for the 2019 Annual Meeting, and otherwise must comply with the Securities and Exchange Commission requirements in Proxy Rule 14a-8.

~~ITEM 6.~~

~~EXHIBITS~~

Exhibit

Number

Description of ~~Document~~

Exhibit

Filed Herewith

3.1

Restated Certificate of Incorporation, as currently in effect (incorporated by reference to Exhibit 3.2 to the Company’s Current Report on Form 8-K filed with the SEC on September 3, 2019).

~~2.1(1)~~

3.2

Amended and Restated Bylaws, as currently in effect (incorporated by reference to Exhibit 3.2 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on May 14, 2020).

4.1

Form of Warrant to Purchase Common Stock (incorporated by reference to Exhibit 4.2 to the Company’s amended Registration Statement on Form S-1/A filed with the SEC on June 17, 2020).

4.2

Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.3 to the Company’s amended Registration Statement on Form S-1/A filed with the SEC on June 8, 2020).

4.3

Form of Warrant Agency Agreement ~~and Plan of Merger and Reorganization,~~(incorporated by reference to Exhibit 4.4 to the Company’s amended Registration Statement on Form S-1/A filed with the SEC on June 17, 2020).

10.1

At Market Issuance Sales Agreement, dated ~~June 2, 2019,~~April 14, 2020, by and ~~among the Company,~~between Brickell Biotech, Inc. and ~~Victory Subsidiary,~~Oppenheimer & Co. Inc.

(incorporated by reference to Exhibit 1.1 to the Company’s Current Report on Form 8-K filed with the SEC on April 14, 2020).

~~3.1(2)~~

10.2

~~Restated Certificate of Incorporation. (P)~~

~~3.2(3)~~

~~Amended and Restated Bylaws.~~

~~3.3(4)~~

~~Certificate of Amendment to Restated Certificate of Incorporation.~~

~~3.4(5)~~

~~Certificate of Amendment to Restated Certificate of Incorporation.~~

~~3.5(6)~~

~~Certificate of Amendment to Restated Certificate of Incorporation.~~

~~3.6(7)~~

~~Certificate of Amendment to Restated Certificate of Incorporation.~~

~~4.1(2)~~

~~Specimen Common Stock Certificate. (P)~~

~~10.1(8)~~

Form of ~~Support~~Indemnification Agreement ~~dated June 2, 2019,~~ by and between the Company and ~~each of the parties named in each agreement therein.~~

its directors and executive officers.

~~10.2(9)~~

10.3

Form of ~~Lock-Up~~Restricted Stock Unit Award Agreement under the Brickell Biotech, Inc. 2020 Omnibus Long-Term Incentive Plan.

10.4

Form of Non-Qualified Stock Option Award Agreement under the Brickell Biotech, Inc. 2020 Omnibus Long-Term Incentive Plan.

10.5†

Amendment to License, Development and Commercialization Agreement, dated February 24, 2016, by and between Brickell Biotech, Inc. and Kaken Pharmaceutical Co., Ltd. (incorporated by reference to Exhibit 10.2 to the Company’s amended Registration Statement on Form S-1/A filed with the SEC on June ~~2, 2019, by each of the parties named in each agreement therein.~~

8, 2020).

~~10.3~~

10.6†

~~Separation~~Clinical Supply Agreement, dated ~~May 21,~~as of July 30, 2019, by and between Brickell Biotech, Inc. and Kaken Pharmaceutical Co., Ltd., and First Amendment to Clinical Supply Agreement, dated as of October 18, 2019 (incorporated by reference to Exhibit 10.4 to the ~~Company and Larry R. Smith, Ph.D.~~

Company’s amended Registration Statement on Form S-1/A filed with the SEC on June 8, 2020).

~~31.1~~

10.7†

Letter Agreement for Supply of API, dated as of April 26, 2020, by and between Brickell Biotech, Inc. and Kaken Pharmaceutical Co., Ltd. (incorporated by reference to Exhibit 10.5 to the Company’s amended Registration Statement on Form S-1/A filed with the SEC on June 8, 2020).

10.8

Consulting Agreement, dated as of December 18, 2017, by and between Brickell Biotech, Inc. and Michael Carruthers; Amendment No. 1 to Consulting Agreement, dated as of March 1, 2019, by and between Brickell Biotech, Inc. and Michael Carruthers; and Amendment No. 2 to Consulting Agreement, dated as of December 23, 2019, by and between Brickell Biotech, Inc. and Michael Carruthers (incorporated by reference to Exhibit 10.14 to the Company’s amended Registration Statement on Form S-1/A filed with the SEC on June 8, 2020).

31.1

Certification of ~~Vijay B. Samant, Chief~~Principal Executive Officer pursuant to ~~Rules~~Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act of 1934, as ~~amended, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.~~

amended.

31.2

Certification of ~~Anthony A. Ramos, Chief~~Principal Financial Officer pursuant to ~~Rules~~Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act of 1934, as ~~amended, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.~~

amended.

~~32.1~~

32.1*

Certification of ~~Vijay B. Samant, Chief~~Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. ~~Section~~ 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

~~32.2~~

101.INS

~~Certification of Anthony A. Ramos, Chief Financial Officer,~~Inline XBRL Instance Document

101.SCH

Inline XBRL Taxonomy Extension Schema Document

101.CAL

Inline XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF

Inline XBRL Taxonomy Extension Definition Linkbase Document

101.LAB

Inline XBRL Taxonomy Extension Label Linkbase Document

101.PRE

Inline XBRL Taxonomy Extension Presentation Linkbase Document

104

Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

__________________


†		Certain confidential information contained in this agreement has been omitted because it (i) is not material and (ii) would be competitively harmful if publicly disclosed.

×		Filed herewith.
*		This certification is being furnished pursuant to 18 U.S.C. Section 1350 ~~as adopted pursuant to~~and is not being filed for purposes of Section ~~906~~18 of the ~~Sarbanes-Oxley~~Securities Exchange Act of ~~2002.~~ 1934, as amended, and is not to be incorporated by reference into any filing of the Registrant, whether made before or after the date hereof.
~~101.INS~~			~~XBRL Instance Document.~~
~~101.SCH~~	~~XBRL Taxonomy Extension Schema Document.~~
~~101.CAL~~	~~XBRL Taxonomy Extension Calculation Linkbase Document.~~
~~101.DEF~~	~~XBRL Taxonomy Extension Definition Linkbase.~~
~~101.LAB~~	~~XBRL Taxonomy Extension Label Linkbase Document.~~
~~101.PRE~~	~~XBRL Taxonomy Extension Presentation Linkbase Document.~~

~~(P)~~

~~Paper exhibit~~

~~(1)~~

~~Incorporated by reference to exhibit 2.1 filed with the Company’s Current Report on Form 8-K filed on June 3, 2019.~~

~~(2)~~

~~Incorporated by reference to the exhibit of the same number filed with the Company’s Registration Statement on Form S-3 (No. 333-95812) filed on August 15, 1995.~~

~~(3)~~

~~Incorporated by reference to the exhibit of the same number filed with the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2010 (No. 000-21088) filed on August 6, 2010.~~

~~(4)~~

~~Incorporated by reference to exhibit 3.1 to the Company’s Current Report on Form 8-K filed on June 1, 2017.~~

SIGNATURES

~~(5)~~

~~Incorporated by reference to exhibit 3.1 to the Company’s Current Report on Form 8-K filed on May 25, 2016.~~

~~(6)~~

~~Incorporated by reference to exhibit 3.3 filed with the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2010 (No. 000-21088) filed on August 6, 2010.~~

~~(7)~~

~~Incorporated by reference to exhibit 4.2 filed with the Company’s Registration Statement on Form S-8 (No. 333-135266) filed on June 23, 2006.~~

~~(8)~~

~~Incorporated by reference to exhibit 10.1 filed with the Company’s Current Report on Form 8-K filed on June 3, 2019.~~

~~(9)~~

~~Incorporated by reference to exhibit 10.2 filed with the Company’s Current Report on Form 8-K filed on June 3, 2019.~~

~~SIGNATURE~~

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Quarterly Report to be signed on its behalf by the undersigned thereunto duly authorized.

~~Vical Incorporated~~

Brickell Biotech, Inc.

~~Date: July 12, 2019~~

~~By:~~

~~/s/ ANTHONY A. RAMOS~~

Date: August 12, 2020

By:

~~Anthony A. Ramos~~

/s/ Robert. B. Brown

~~Vice President,~~ Robert B. Brown

Chief Executive Officer

(Principal Executive Officer)

By:

/s/ R. Michael Carruthers

R. Michael Carruthers

Chief Financial Officer ~~(on behalf of the registrant and as the registrant’s~~

(Principal Financial ~~and~~Officer; Principal Accounting Officer)

	June 30,			December 31,
	2019			2018
ASSETS
Current assets:
Cash and cash equivalents	$	10,813		$	11,870
Marketable securities, available-for-sale		30,907			36,201
Receivables and other assets		979			1,128
Total current assets		42,699			49,199
Long-term investments		—			2,386
Property and equipment, net		2			100
Other assets		—			659
Total assets	$	42,701		$	52,344
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable and accrued expenses	$	1,159		$	3,551
Deferred revenue		—			30
Total current liabilities		1,159			3,581
Stockholders' equity:
Preferred stock, $0.01 par value, 5,000 shares authorized, none issued and outstanding		—			—
Common stock, $0.01 par value, 50,000 shares authorized, 22,841 and 21,817 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively		229			218
Additional paid-in capital		490,343			490,337
Accumulated deficit		(449,072	)		(442,064	)
Accumulated other comprehensive income		42			272
Total stockholders' equity		41,542			48,763
Total liabilities and stockholders' equity	$	42,701		$	52,344

	Three Months Ended						Six Months Ended
	June 30,						June 30,
	2019			2018			2019			2018
Revenues:
Contract revenue	$	—		$	725		$	—		$	1,431
License and royalty revenue		—			10			—			20
Total revenues		—			735			—			1,451
Operating expenses:
Research and development		759			3,602			4,641			7,266
Manufacturing and production		—			—			—			1,436
General and administrative		2,242			2,261			3,618			4,378
Total operating expenses		3,001			5,863			8,259			13,080
Loss from operations		(3,001	)		(5,128	)		(8,259	)		(11,629	)
Other income:
Investment and other income, net		571			260			1,251			491
Net loss	$	(2,430	)	$	(4,868	)	$	(7,008	)	$	(11,138	)
Basic and diluted net loss per share	$	(0.11	)	$	(0.22	)	$	(0.31	)	$	(0.51	)
Weighted average shares used in computing basic and diluted net loss per share		22,825			21,837			22,404			21,834

	Common Stock
	Number of Shares		Amount		Additional Paid-in Capital			Accumulated Deficit			Accumulated Other Comprehensive Income/(Loss)			Total Stockholders’ Equity
Balance at January 1, 2019		21,817	$	218	$	490,337		$	(442,064	)	$	272		$	48,763
Net loss		—		—		—			(4,578	)		—			(4,578	)
Other comprehensive loss		—		—		—			—			(255	)		(255	)
Issuance of common stock upon exercise of warrants		993		10		—			—			—			10
Issuance of common stock underlying restricted stock units net of shares withheld to settle withholding taxes		13		1		—			—			—			1
Non-cash compensation expense related to grant of equity based compensation		—		—		(19	)		—			—			(19	)
Balance at March 31, 2019		22,823	$	229	$	490,318		$	(446,642	)	$	17		$	43,922
Net loss		—		—		—			(2,430	)		—			(2,430	)
Other comprehensive gain		—		—		—			—			25			25
Issuance of common stock underlying restricted stock units net of shares withheld to settle withholding taxes		18		—		2			—			—			2
Non-cash compensation expense related to grant of equity based compensation		—		—		23			—			—			23
Balance at June 30, 2019		22,841	$	229	$	490,343		$	(449,072	)	$	42		$	41,542

	Fair Value Measurements
June 30, 2019	Level 1		Level 2		Level 3		Total
Money market funds	$	10,178	$	—	$	—	$	10,178
U.S. treasuries		30,907		—		—		30,907
	$	41,085	$	—	$	—	$	41,085

	Fair Value Measurements
December 31, 2018	Level 1		Level 2		Level 3		Total
Money market funds	$	11,523	$	—	$	—	$	11,523
U.S. treasuries		36,201		—		—		36,201
Auction rate securities		—		—		2,386		2,386
	$	47,724	$	—	$	2,386	$	50,110

Balance at December 31, 2018	$	2,386
Change in fair market value included in other comprehensive loss		83
Sale of Level 3 security		(2,469	)
Balance at June 30, 2019	$	—
Total gains or losses for the period included in net loss attributable to the change in unrealized gains or losses relating to assets still held at the reporting date	$	—

	Employee
	Termination		Asset
2019	Benefits		Impairments		Total
Research and development	$	2,018	$	—	$	2,018
General and administrative		70		—		70
	$	2,088	$	—	$	2,088

	Employee
	Termination		Asset
2018	Benefits		Impairments		Total
Research and development	$	272	$	267	$	539
Manufacturing and production		735		—		735
General and administrative		117		—		117
	$	1,124	$	267	$	1,391


Balance at December 31, 2018	$	—
Accruals		2,088
Payments		(1,992	)
Balance at June 30, 2019	$	96