Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

FORM 10-Q

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

xQUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended December 31, 2017
OR
¨TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2023

or

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: 000-54495

Commission File Number: 001-39683

REZOLUTE, INC

INC.

(Exact Name of Registrant as Specified in its Charter)

Delaware

27-3440894

Nevada

27-3440894

(State ofor other jurisdiction of incorporation or organization)

(I.R.S. Employer Identification No.)

275 Shoreline Drive, Suite 500, Redwood City, California

94065

1450 Infinite Drive, Louisville, Colorado80027

(Address of Principal Executive Offices)principal executive offices)

(Zip Code)

(303) 222-2128

(650) 206-4507

(Registrant’s Telephone Number,telephone number, including Area Code)area code)

AntriaBio, Inc.

Not Applicable

(Former name, former address and former fiscal year, if changed since last report)

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

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.001 per share

RZLT

Nasdaq Capital Market

Indicate by check mark whether the 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.xYes¨No

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post such files)files.).

xYes¨No

Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, orand an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one):

Large accelerated filer  ¨

Accelerated filer  ¨

Non-accelerated filer  ¨

Smaller reporting company x

(Do not check if a smaller reporting company)

Emerging Growth Company  ¨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 17(a)(2)(B) of the Securities Act.¨

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

¨YesxNo

Number ofThe registrant had 36,827,567 shares of issuer’sits $0.001 par value common stock outstanding as of February 14, 2018: 54,073,309May 8, 2023.

Table of Contents

Table of Contents

TABLE OF CONTENTS

Page

PART I - FINANCIAL INFORMATION

PART I – FINANCIAL INFORMATION

2

Item 1. Financial Statements

ITEM 1.  FINANCIAL STATEMENTS

2
Unaudited Condensed Consolidated Balance Sheets – DecemberMarch 31, 20172023 and June 30, 20172022

2

3

Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss – Three and six months ended DecemberNine Months Ended March 31, 20172023 and 20162022

3

4

Unaudited Condensed Consolidated Statements of Stockholders’Shareholders’ Equity – From June 30, 2017 to DecemberNine Months Ended March 31, 20172023 and 2022

4

5

Unaudited Condensed Consolidated Statements of Cash Flows – Six months ended DecemberNine Months Ended March 31, 20172023 and 20162022

5

6

Notes to Unaudited Condensed Consolidated Financial Statements

6

8

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

23

ITEM 2.  MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSItem 3. Quantitative and Qualitative Disclosures About Market Risk

15

32

ITEM 3.  QUALITATIVE AND QUANTITATIVE DISCUSSION ABOUT MARKET RISKItem 4. Controls and Procedures

17

32

ITEM 4.  CONTROLS AND PROCEDURES

18

PART II – OTHER INFORMATION

18

ITEMItem 1. LEGAL PROCEEDINGSLegal Proceedings

18

33

ITEMItem 1A. RISK FACTORSRisk Factors

18

33

ITEMItem 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDSUnregistered Sales of Equity Securities and Use of Proceeds

18

34

ITEMItem 3. DEFAULTS UPON SENIOR SECURITIESDefaults Upon Senior Securities

18

34

ITEMItem 4. MINE SAFETY DISCLOSUREMine Safety Disclosures

18

35

ITEMItem 5. OTHER INFORMATIONOther Information

19

35

ITEMItem 6. EXHIBITSExhibits

36

19Signatures

37

 i

i

Table of Contents

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q (“Report”) contains statements reflecting assumptions, expectations, projections, intentions or beliefs about future events that are intended as “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements included or incorporated by reference in this report,Report, other than statements of historical fact, that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. These statements appear in a number of places, including, but not limited to “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” These statements represent our reasonable judgment of the future based on various factors and using numerous assumptions and are subject to known and unknown risks, uncertainties and other factors that could cause our actual results and financial position to differ materially from those contemplated by the statements. You can identify these statements by the fact that they do not relate strictly to historical or current facts, and use words such as “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “may,” “should,” “plan,” “project” and other words of similar meaning. In particular, these include, but are not limited to, statements relating to the following:

our projected operating or financial results, including anticipated cash flows used in operations;

our expectations regarding capital expenditures, research and development expenseexpenses and other payments;

our expectation about the extent and duration of the COVID-19 pandemic (“COVID-19”) on our business;
our beliefs and assumptions relating to our liquidity position, including our ability to obtain additional financing;

our ability to obtain regulatory approvals and the speed of such approvals, for our pharmaceutical drugs and diagnostics; and

our future dependence on third party manufacturers or strategic partners to manufacture any of our pharmaceutical drugs and diagnostics that receive regulatory approval, and our ability to identify strategic partners and enter into license, co-development, collaboration or similar arrangements.

Any or all of our forward-looking statements may turn out to be wrong. They can be affected by inaccurate assumptions or by known orand unknown risks, uncertainties and other factors including, among others:but not limited to, the risks described in Part II, Item 1.A Risk Factors, as well as “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended June 30, 2022 (the “2022 Form 10-K”), filed with the Securities and Exchange Commission (“SEC”) on September 15, 2022.

the loss of key management personnel or sponsored research partners on whom we depend;

the progress and results of clinical trials for our product candidates;

our ability to navigate the regulatory approval process in the U.S. and other countries, and our success in obtaining required regulatory approvals for our product candidates;

commercial developments for products that compete with our product candidates;

the actual and perceived effectiveness of our product candidates, and how those product candidates compare to competitive products;

the strength of our intellectual property protection, and our success in avoiding infringing the intellectual property rights of others;

adverse developments in our research and development activities;

potential liability if our product candidates cause illness, injury or death, or adverse publicity from any such events;

our ability to operate our business efficiently, manage capital expenditures and costs (including general and administrative expenses) and obtain financing when required;

our expectations with respect to our acquisition activity.

In addition, there may be other factors that could cause our actual results to be materially different from the results referenced in the forward-looking statements, some of which are included elsewhere in this Quarterly Report, on Form 10-Q, including “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” Many of these factors will be important in determining our actual future results. Consequently, no forward-looking statement can be guaranteed. Our actual future results may vary materially from those expressed or implied in any forward-looking statements. All forward-looking statements contained in this Quarterly Report of Form 10-Q are qualified in their entirety by this cautionary statement. Forward-looking statements speak only as of the date they are made, and we disclaim any obligation to update any forward-looking statements to reflect events or circumstances after the date of this Quarterly Report, on Form 10-Q, except as otherwise required by applicable law.

 1

ii

PART I - FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS.

Rezolute, Inc.

Unaudited Condensed Consolidated Balance Sheets

(In thousands, except per share amounts)

  December 31, 2017  June 30, 2017 
  (Unaudited) 
Assets        
         
Current assets        
Cash $868,071  $4,486,538 
Other current assets  295,728  442,015 
Total current assets  1,163,799   4,928,553 
         
Non-current assets        
Fixed assets, net  4,797,823   5,325,401 
Intangible assets, net  40,676   44,322 
Deferred lease asset  74,831   86,293 
Deposits  244,341   244,341 
Total non-current assets  5,157,671   5,700,357 
         
Total Assets $6,321,470  $10,628,910 
         
Liabilities and Stockholders’ Equity        
         
Current liabilities:        
Accounts payable and accrued expenses $2,121,854  $1,652,677 
Convertible notes payable  10,000   10,000 
Deferred lease liability, current portion  116,234   105,295 
Interest payable  2,762   2,762 
Warrant derivative liability  90   588 
Total current liabilities  2,250,940   1,771,322 
         
Non-current liabilities:        
Deferred lease liability, less current portion  243,686   304,575 
Deposit liability  25,046   25,046 
Total non-current liabilities  268,732   329,621 
         
Total Liabilities  2,519,672   2,100,943 
         
Commitments and Contingencies  (Note 10)        
         
Stockholders’ equity:        
Preferred stock, $0.001 par value; 20,000,000 shares authorized; none issued and outstanding  -   - 
Common stock, $0.001 par value, 200,000,000 shares authorized; 54,073,309 and 49,228,640  shares issued and outstanding, December 31, 2017 and June 30, 2017  54,075   49,230 
Additional paid-in capital  80,472,885   72,800,699 
Accumulated deficit  (76,725,162)  (64,321,962)
Total stockholders’ equity  3,801,798   8,527,967 
         
Total Liabilities and Stockholders’ Equity $6,321,470  $10,628,910 

    

March 31, 

June 30, 

    

2023

    

2022

Assets

Current assets:

 

  

  

Cash and cash equivalents

$

33,743

$

150,410

Investments in marketable debt securities

69,319

Prepaid expenses and other

2,464

1,694

Total current assets

 

105,526

 

152,104

Long-term assets:

Investments in marketable debt securities

26,210

Right-of-use assets

 

2,172

 

152

Property and equipment, net

 

149

 

16

Deposits and other

148

148

Total assets

$

134,205

$

152,420

Liabilities and Shareholders' Equity

 

  

 

  

Current liabilities:

 

  

 

  

Accounts payable

$

2,947

$

1,132

Accrued liabilities:

 

 

Accrued clinical and other

1,121

979

Insurance premiums

243

Current portion of operating lease liabilities

319

108

Total current liabilities

 

4,387

 

2,462

Long term liabilities:

Operating lease liabilities, net of current portion

 

2,055

 

80

Embedded derivative liabilities

447

407

Total liabilities

 

6,889

 

2,949

Commitments and contingencies (Notes 5, 9 and 10)

 

  

 

  

Shareholders' equity:

 

  

 

  

Preferred stock, $0.001 par value; 400 shares authorized; no shares issued and outstanding

 

 

Common stock, $0.001 par value; 100,000 shares authorized; issued and outstanding 36,827 and 33,582 shares as of March 31, 2023 and June 30, 2022, respectively

 

37

 

34

Additional paid-in capital

 

375,668

 

358,635

Accumulated other comprehensive loss

(132)

Accumulated deficit

 

(248,257)

 

(209,198)

Total shareholders’ equity

 

127,316

 

149,471

Total liabilities and shareholders’ equity

$

134,205

$

152,420

SeeThe accompanying notes toare an integral part of these unaudited condensed consolidated financial statementsstatements.

 2

3

Rezolute, Inc.

Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except per share amounts)

  Three Months  Six Months 
  Ended December 31,  Ended December 31, 
  2017  2016  2017  2016 
  (Unaudited)  (Unaudited) 
Operating expenses                
Research and development                
Compensation and benefits $1,482,946  $1,909,518  $2,983,810  $3,213,358 
Consultants and outside costs  233,798   194,783   364,159   466,258 
Material manufacturing costs  227,602   567,430   653,691   1,079,137 
Clinical trial costs  581,988   -   1,561,754   - 
License costs  407,605   -   1,178,505   - 
Facilities and other costs  479,149   403,648   981,807   802,555 
   3,413,088   3,075,379   7,723,726   5,561,308 
                 
General and administrative                
Compensation and benefits  1,672,494   1,285,052   3,467,921   2,151,953 
Professional fees  213,399   139,865   436,993   286,016 
Investor relations  133,705   87,428   193,576   155,535 
General and administrative  318,272   301,520   645,872   558,115 
   2,337,870   1,813,865   4,744,362   3,151,619 
                 
Total operating expenses  5,750,958   4,889,244   12,468,088   8,712,927 
                 
Loss from operations  (5,750,958)  (4,889,244)  (12,468,088)  (8,712,927)
                 
Other income (expense)                
Interest income  524   -   861   - 
Rent income  31,838   -   63,676   - 
Interest expense  (147)  -   (147)  (1,595)
Derivative gains  156   1,313   498   10,725 
Total other income  32,371   1,313   64,888   9,130 
                 
Net loss $(5,718,587) $(4,887,931) $(12,403,200) $(8,703,797)
                 
Net loss per common share - basic and diluted $(0.11) $(0.12) $(0.23) $(0.23)
                 
Weighted average number of common shares outstanding - basic and diluted  53,762,358   40,788,241   53,327,558   38,091,406 

Three Months Ended

Nine Months Ended

March 31, 

March 31, 

    

2023

    

2022

2023

    

2022

Operating expenses:

 

  

 

  

  

 

  

Research and development

 

$

14,231

 

$

8,686

$

32,880

$

23,912

General and administrative

 

2,911

 

2,068

8,872

 

6,632

Total operating expenses

 

17,142

 

10,754

41,752

 

30,544

Operating loss

 

(17,142)

 

(10,754)

(41,752)

 

(30,544)

Non-operating income (expense):

 

  

 

  

  

 

  

Interest and other income, net

1,484

2,733

13

Loss from change in fair value of derivative liabilities

(14)

(12)

(40)

(8)

Employee retention credit

231

Interest expense

 

 

(442)

 

(1,329)

Total non-operating income (expense), net

 

1,470

 

(454)

2,693

 

(1,093)

Net loss

$

(15,672)

$

(11,208)

$

(39,059)

$

(31,637)

Other comprehensive loss:

Net unrealized loss on available-for-sale marketable debt securities

(132)

(132)

Comprehensive loss

$

(15,804)

$

(11,208)

$

(39,191)

$

(31,637)

Net loss per common share:

Basic and diluted

$

(0.30)

$

(0.65)

$

(0.76)

$

(2.30)

Weighted average number of common shares outstanding:

 

 

Basic and diluted

51,409

17,218

51,113

 

13,748

SeeThe accompanying notes toare an integral part of these unaudited condensed consolidated financial statementsstatements.

 3

4

Rezolute, Inc.

Unaudited Condensed Consolidated Statements of Stockholders’Shareholders’ Equity

From June 30, 2016 to DecemberNine Months Ended March 31, 2017 (Unaudited)2023 and 2022

(In thousands)

Accumulated

Additional

Other

Total

Common Stock

Paid-in

Comprehensive

Accumulated

Shareholders'

    

Shares

    

Amount

    

Capital

    

Loss

    

Deficit

    

Equity

Nine Months Ended March 31, 2023:

Balances, June 30, 2022

 

33,582

$

34

$

358,635

$

$

(209,198)

$

149,471

Gross proceeds from issuance of common stock for cash in 2022 Private Placement

3,245

3

12,327

12,330

Underwriting commissions and other equity offering costs

(759)

(759)

Share-based compensation

5,465

5,465

Net change in accumulated other comprehensive loss

(132)

(132)

Net loss

 

 

 

 

 

(39,059)

 

(39,059)

Balances, March 31, 2023

36,827

$

37

$

375,668

$

(132)

$

(248,257)

$

127,316

Nine Months Ended March 31, 2022:

Balances, June 30, 2021

8,352

$

8

$

194,229

$

$

(168,138)

$

26,099

Gross proceeds from issuance of equity securities for cash in Underwritten Public Offering:

Common stock

6,147

6

39,950

39,956

Pre-Funded warrants

10,783

10,783

Gross proceeds from issuance of common stock for cash:

In Registered Direct Offering

769

1

4,999

5,000

Under Equity Distribution Agreement

138

1

1,518

1,519

Under LPC Purchase Agreement

116

1,172

1,172

Underwriting discounts and other equity offering costs

(4,136)

(4,136)

Share-based compensation

2,701

2,701

Issuance of commitment shares

34

450

450

Net loss

(31,637)

(31,637)

Balances, March 31, 2022

 

15,556

$

16

$

251,666

$

$

(199,775)

$

51,907

        Additional     Total 
  Common Stock, $0.001 Par Value  Paid-in  Accumulated  Stockholders’ 
  Shares  Amount  Capital  Deficit  Equity 
                
Balance at June 30, 2017  49,228,640  $49,230  $72,800,699  $(64,321,962) $8,527,967 
                     
Stock-based compensation net of forfeitures of $317,674 (Unaudited)  -   -   2,701,728   -   2,701,728 
                     
Fair value of warrants issued for consulting services (Unaudited)  -   -   535,303   -   535,303 
                     
Issuance of common stock, net of issuance costs of $60,000 (Unaudited)  4,500,000   4,500   4,435,500   -   4,440,000 
                     
Commitment fee for issuance of common stock (Unaudited)  344,669   345   (345)  -   - 
                     
Net loss for the six months ended December 31, 2017 (Unaudited)  -   -   -   (12,403,200)  (12,403,200)
                     
Balance at December 31, 2017 (Unaudited)  54,073,309  $54,075  $80,472,885  $(76,725,162) $3,801,798 

SeeThe accompanying notes toare an integral part of these unaudited condensed consolidated financial statementsstatements.

 4

5

Rezolute, Inc.

Unaudited Condensed Consolidated Statements of Cash Flows

(Unaudited)(In thousands)

  Six Months 
  Ended December 30, 
  2017  2016 
       
CASH FLOWS FROM OPERATING ACTIVITIES:        
Net Loss $(12,403,200) $(8,703,797)
Amortization of intangible asset  3,646   3,646 
Depreciation expense  533,394   546,429 
Stock-based compensation expense  2,701,728   2,125,966 
Derivative gains  (498)  (10,725)
Warrant expense for consulting services  535,303   - 
Changes in operating assets and liabilities:        
Decrease in other assets  146,287   29,153 
Decrease in deferred lease asset  11,462   - 
Increase in accounts payable and accrued expenses  469,177   12,097 
Decrease in interest payable  -   (2,800)
Decrease in deferred lease liability  (49,950)  (58,924)
Net Cash Used In Operating Activities  (8,052,651)  (6,058,955)
         
CASH FLOWS FROM INVESTING ACTIVITIES:        
Purchase of fixed assets  (5,816)  (272,587)
Return of security deposit  -   187,500 
Net Cash Used In Investing Activities  (5,816)  (85,087)
         
CASH FLOWS FROM FINANCING ACTIVITIES:        
Payments on lease payable  -   (23,128)
Proceeds from issuance of equity financing  4,500,000   6,361,499 
Payment of placement agent compensation and issuance costs  (60,000)  (683,194)
Net Cash Provided by Financing Activities  4,440,000   5,655,177 
         
Net decrease in cash  (3,618,467)  (488,865)
         
Cash - Beginning of Period  4,486,538   4,062,013 
         
Cash - End of Period $868,071  $3,573,148 
         
SUPPLEMENTARY CASH FLOW INFORMATION:        
Cash Paid During the Period for:        
Taxes $-  $- 
Interest $-  $- 
         
Non-Cash Transactions:        
Fixed assets acquired through accounts payable and accrued expenses $-  $18,016 
Warrant value recorded as issuance costs $-  $516,550 
Conversion of note payable into common stock $-  $50,000 
Conversion of interest payable into common stock $-  $9,517 

    

Nine Months Ended

March 31, 

    

2023

    

2022

CASH FLOWS FROM OPERATING ACTIVITIES:

 

  

 

  

Net loss

$

(39,059)

$

(31,637)

Share-based compensation expense

5,465

2,701

Non-cash lease expense

233

221

Accretion of discounts and amortization of premiums on marketable debt securities, net

(708)

Loss from change in fair value of derivative liabilities

40

8

Depreciation and amortization expense

21

10

Accretion of debt discount and issuance costs

319

Changes in operating assets and liabilities:

 

  

 

  

Decrease (increase) in prepaid expenses and other assets

 

(770)

 

17

Increase in accounts payable

 

1,815

 

548

Increase (decrease) in accrued liabilities

(168)

307

Net Cash Used in Operating Activities

 

(33,131)

 

(27,506)

CASH FLOWS FROM INVESTING ACTIVITIES

 

Purchase of marketable debt securities

(94,954)

Purchase of property and equipment

(153)

 

Total Cash Used in Investing Activities

 

(95,107)

 

CASH FLOWS FROM FINANCING ACTIVITIES:

 

  

  

Gross proceeds from issuance of equity securities for cash:

2022 Private Placement

12,330

Proceeds from 2021 Underwritten Public Offering

50,738

Proceeds from 2021 Registered Direct Offering

5,000

Under Equity Distribution Agreement

1,519

Under LPC Purchase Agreement

1,171

Payment of commissions and other offering costs

 

(759)

(3,449)

Payment of debt discount and issuance costs

 

 

(104)

Net Cash Provided by Financing Activities

 

11,571

 

54,875

Net increase (decrease) in cash, cash equivalents and restricted cash

(116,667)

27,369

Cash, cash equivalents and restricted cash at beginning of period

 

150,410

 

41,047

Cash, cash equivalents and restricted cash at end of period

$

33,743

$

68,416

SeeThe accompanying notes toare an integral part of these unaudited condensed consolidated financial statementsstatements.

 5

6

Rezolute, Inc.

Unaudited Condensed Consolidated Statements of Cash Flows, Continued

(In thousands)

Nine Months Ended

March 31, 

2023

    

2022

CASH, CASH EQUIVALENTS AND RESTRICTED CASH:

Cash and cash equivalents, end of period

$

33,743

$

63,416

Restricted cash, end of period

5,000

Total cash, cash equivalents and restricted cash, end of period

$

33,743

$

68,416

SUPPLEMENTARY CASH FLOW INFORMATION:

 

  

 

  

Cash paid for interest

$

$

1,011

Cash paid for income taxes

Cash paid for amounts included in the measurement of operating lease liabilities

87

254

Operating lease liabilities incurred in exchange for right-of-use assets

2,204

NON-CASH INVESTING AND FINANCING ACTIVITIES:

 

  

 

  

Issuance of commitment shares for deferred offering costs subsequently charged to additional paid-in capital

$

$

450

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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Table of Contents

Rezolute, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements
December 31, 2017
(Unaudited)

NOTE 1 — NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Note 1 Nature of Operations

These financial statements represent the consolidated financial statements of Rezolute, Inc. (“Rezolute”(the “Company”), and its wholly owned operating subsidiary AntriaBio Delaware, Inc. (“Antria Delaware”). Rezolute and Antria Delaware are collectively referred to herein as the “Company”. The Company is a clinical stage biopharmaceutical Company.business developing transformative therapies for metabolic diseases related to chronic glucose imbalance. The Company’s primary clinical assets consist of (i) RZ358, which is a potential treatment for congenital hyperinsulinism, an ultra-rare pediatric genetic disorder characterized by excessive production of insulin by the pancreas, and (ii) RZ402, which is an oral plasma kallikrein inhibitor (“PKI”) being developed as a potential therapy for the chronic treatment of diabetic macular edema.

Note 2 Summary of Significant Accounting Policies

Basis of Presentation

The accompanying unaudited interim financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America and(“GAAP”), the rules and regulations of the United States Securities and Exchange CommissionSEC for interim financial information, and with the instructions to Form 10-Q and Article 8 of Regulation S-X.

The condensed consolidated balance sheet as of June 30, 2022, has been derived from the Company’s audited consolidated financial statements. The unaudited interim financial statements should be read in conjunction with the Company’s Annual Report on2022 Form 10-K, filed on September 22, 2017, which contains the Company’s audited financial statements and notes thereto, together with the Management’s Discussion and Analysis of Financial Condition and Results of Operations for the fiscal year ended June 30, 2017.

2022.

Certain information orand footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of AmericaGAAP have been condensed or omitted, pursuant to the rules and regulations of the Securities and Exchange CommissionSEC for interim financial reporting. Accordingly, they do not include all the information and footnotesfootnote disclosures necessary for a comprehensive presentation of financial position, results of operations, orand cash flows. It is management’s opinion, however, that all material adjustments (consisting of normal recurring adjustments) have been made whichthat are necessary for a fair financial statement presentation.presentation have been made. The interim results for the periodthree and nine months ended DecemberMarch 31, 20172023 are not necessarily indicative of the financial condition and results of operations that may be expected for any future interim period or for the full fiscal year.year ending June 30, 2023.

Consolidation

The Company has two wholly owned subsidiaries consisting of Rezolute (Bio) Ireland Limited, and Rezolute Bio UK, Ltd. The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.

Use of Estimates

The preparation of financial statements in conformity with U.S. generally accepted accounting principlesGAAP requires management to make judgments, estimates and assumptions that affect the reported amounts in the unaudited condensed consolidated financial statements and the accompanying notes. SuchThe Company bases its estimates and assumptions impact, among others,on current facts, historical experience, and various other factors that it believes are reasonable under the following: estimated useful livescircumstances, to determine the carrying values of assets and liabilities that are not readily apparent from other sources. The Company’s significant accounting estimates include, but are not necessarily limited to, determination if other than temporary impairment exists for marketable debt securities, the fair value of depreciable assets, thederivative liabilities, fair value of share-based payments, management’s assessment of going concern, and warrants, fair value of derivative instruments, estimates of the probability and potential magnitude of contingent liabilities and the valuation allowance for deferred tax assets due to continuing and expected future operating losses.clinical trial accrued liabilities. Actual results could differ from those estimates.

Risks and Uncertainties

The Company’s operations may be subject to significant riskrisks and uncertainties including financial, operational, regulatory and other risks associated with a clinical stage company,business, including the potential risk of business failure. Seefailure, and the future impact of COVID-19.

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Rezolute, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

Significant Accounting Policies

There have been no changes to the Company’s significant accounting policies from those described in Note 3 regarding going concern matters.1 to the financial statements in Item 8 of the 2022 Form 10-K other than the policy described below.

 6

Investments in Marketable Debt Securities

Fixed Assets

Under the investment policy approved by the Company’s Board of Directors, eligible investments in fixed income debt securities must be denominated and payable in U.S. dollars, including eligible corporate bonds, corporate commercial paper, U.S. government obligations, and money market funds. This investment policy only permits investments in the debt securities of issuers that meet stringent credit quality ratings on the date of the investment. The investment policy also places restrictions on the length of maturities and concentrations by type and issuer. The Company’s cash and investments are held or issued by financial institutions that management believes are of high credit quality. However, they are exposed to credit risk in the event of default by the third parties that hold or issue such assets. The Company classifies investments in marketable debt securities that mature in less than one year as short-term assets. For investments that mature in more than one year, the investments are classified as long-term assets unless management intends to liquidate the investments to fund current operations before the scheduled maturity dates.

Fixed assetsThe Company accounts for its investments in marketable debt securities as available-for-sale securities whereby they are carriedrecorded in the unaudited condensed consolidated balance sheet at cost less accumulated depreciation. Depreciationfair value. Interest income is computedrecognized in the unaudited condensed consolidated statement of operations, consisting of accrued interest earned based on the coupon rate of the security, plus the impact of accreting discounts and amortizing premiums to maturity using the straight-line method overwhich approximates the estimated useful lives.

Researchinterest method. Unrealized gains and Development Costs

Researchlosses due to subsequent changes in fair value of the investments are reported in shareholders’ equity as a component of accumulated other comprehensive income (loss). The Company reviews the components of its portfolio of available-for-sale debt securities, using both quantitative and development costsqualitative factors, to determine if declines in fair value below amortized cost have resulted from a credit-related loss or other factors. If declines in fair value are expensed as incurred and include salaries, benefits anddue to a deterioration of credit quality of the issuer, the Company recognizes (i) a loss in other staff-related costs; consultants and outside costs; material manufacturing costs, clinical trial costs; and facilities and other costs. These costs relate to research and development costs without an allocation of general and administrative expenses.

Fair Value of Financial Instruments

Faircomprehensive income (loss) if the reduction in fair value is defined as the exchange price that would be received for an assetconsidered temporary, or paid to transfer(ii) a liability (an exit price)loss in the principal or most advantageous marketconsolidated statement of operations if the reduction in fair value is considered other than temporary. For a decline in fair value that is solely due to changes in interest rates, impairment is not recognized if the Company has the ability and intent to hold the investment until maturity. The cost basis of any securities sold prior to maturity will be determined using the specific identification method. 

Recent Accounting Pronouncements

Recently Adopted Standard.  The following standard was adopted during the nine months ended March 31, 2023:

In August 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for the asset or liabilityConvertible Instruments and Contracts in an orderly transaction between market participants onEntity’s Own Equity). ASU 2020-06 reduces the measurement date. An entity is required to maximizenumber of accounting models for convertible debt instruments and convertible preferred stock, which results in fewer embedded conversion features being separately recognized from the use of observable inputs and minimizehost contract as compared with current GAAP. Additionally, ASU 2020-06 affects the use of unobservable inputs when measuring fair value. The standard describes three levels of inputsdiluted earnings per share calculation for instruments that may be usedsettled in cash or shares and for convertible instruments and requires enhanced disclosures about the terms of convertible instruments and contracts in an entity’s own equity. ASU 2020-06 allows entities to measure fair value are as follows:use a modified or full retrospective transition method. The Company adopted this standard using the full retrospective transition method effective July 1, 2022. The adoption did not have any impact on the Company’s consolidated financial statements.

·Level 1: Quoted prices for identical assets and liabilities in active markets;
·Level 2: Quoted prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets and liabilities in markets that are not active; and model-derived valuations in which all significant inputs and significant value drivers are observable in active markets; and
·Level 3: Valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable.

The carrying amounts of financial instruments including cash, accounts payable and accrued expenses, and convertible note payable approximated fair value as of December 31, 2017 and June 30, 2017 dueStandard Required to the relatively short maturity of the respective instruments.

The warrant derivative liability recorded as of December 31, 2017 and June 30, 2017 is recorded at an estimated fair value based on a Black-Scholes pricing model. The warrant derivative liability is a level 3 fair value measurement with the entire changebe Adopted in the balance recorded through earnings. See significant assumptions in Note 8.Future Periods. The following table sets forth a reconciliationaccounting standard is not yet effective; management has not completed its evaluation to determine the impact that adoption of changes inthis standard will have on the fair valueCompany’s consolidated financial statements.

9

Table of financial instruments classified as level 3 in the fair value hierarchy:Contents

Balance as of June 30, 2017 $(588)
Total unrealized gains (losses):    
Included in earnings  498 
Balance as of December 31, 2017 $(90)

Rezolute, Inc.

Recent Accounting PronouncementsNotes to Unaudited Condensed Consolidated Financial Statements

In JanuaryJune 2016, the FASB issued ASU 2016-01,2016-13, Financial Instruments – Overall- Credit Losses (Topic 326):Recognition and Measurement of Credit Losses on Financial Assets and Financial LiabilitiesInstruments., which addresses certain aspects of recognition, measurement, presentation, and disclosure ASU 2016-13 amends the guidance on the impairment of financial instruments. This update adds an impairment model (known as the current expected credit losses model) that is based on expected losses rather than incurred losses. Under the new guidance, an entity recognizes, as an allowance, its estimate of expected credit losses. In November 2019, ASU 2016-01 will be effective for us starting on July 1, 2018,2016-13 was amended by ASU 2019-10, Financial Instruments- Credit Losses (Topic 326), Derivatives and early adoption is not permitted. We are currently evaluating the impact that the standard will have on our consolidated financial statements.

In February 2016, the FASB issued ASU 2016-02,Hedging (Topic 815), and Leases (Topic 842). This update requires organizations to recognize lease assets and lease liabilities on whereby the balance sheet and also disclose key information about leasing arrangements. Thiseffective date for ASU 2016-13 for smaller reporting companies is effectivenow required for annual reporting periodsfiscal years beginning on or after December 15, 2018, and2022, including interim periods within those annual periods. Earlier application is permitted for all entities as of the beginning of an interim or annual period. We will be required to adopt ASU 2016-02 starting on July 1, 2019. We are currently evaluating the impact the adoption of this ASU will have on our consolidated financial statements.

 7

In March 2016, the FASB issued ASU 2016-09.Compensation – Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting.fiscal years. The update will affect all entities that issue share-based payment awards to their employees and is effective for annual periods beginning after December 15, 2016 for public entities. The areas for simplification in ASU 2016-09 involve several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. We adopted the ASU starting on July 1, 2017 and there is a minimal impact on our consolidated financial statements.

In May 2017, the FASB issued ASU 2017-9.Compensation – Stock Compensation (Topic 718): Scope of Modification Accounting.The update includes guidance on what changes to share-based payment awards would require modification accounting and is effective for annual periods after December 15, 2017. We expect to adopt the ASU 2017-9 on July 1, 2018. We doCompany does not expect the adoption of ASU 2016-13 will have a material impact on its consolidated financial statements.

Other accounting standards that have been issued or proposed by the new provisionsFASB or other standards-setting bodies that do not require adoption until a future date are not currently expected to have a material impact on ourthe Company’s financial condition or results of operations.statements upon adoption.

Note 3 Going Concern

NOTE 2 — LIQUIDITY

As reflected in the accompanying financial statements,a clinical stage business, the Company has not yet generated any revenues and had an accumulated deficit of $248.3 million as of March 31, 2023. For the nine months ended March 31, 2023, the Company incurred a net loss of $12,403,200$39.1 million and net cash used in operationsoperating activities amounted to $33.1 million. For the fiscal year ended June 30, 2022, the Company incurred a net loss of $8,052,651$41.1 million and net cash used in operating activities amounted to $39.6 million.  As of March 31, 2023, the Company’s capital resources consist of cash and cash equivalents of $33.7 million, short-term investments in marketable debt securities of $69.3 million and long-term investments in marketable debt securities of $26.2 million.

As of March 31, 2023, the Company has total liabilities of $6.9 million, including current liabilities of $4.4 million. As discussed in Note 5, the Company is subject to license agreements that provide for future contractual payments upon achievement of various milestone events. Pursuant to the sixActiveSite License Agreement (as defined below), a $3.0 million milestone payment was paid in February 2023 upon dosing of the first patient in a Phase 2 clinical trial for RZ402.  Pursuant to the XOMA License Agreement (as defined below), a $5.0 million milestone payment will be due upon dosing of the first patient in a Phase 3 clinical trial for RZ358.  First patient dosing milestone RZ358 Phase 3 clinical trial is expected to occur within the next 12 months.

Management believes the Company’s existing cash and cash equivalents and investments in marketable debt securities will be adequate to meet the Company’s contractual obligations and carry out ongoing clinical trials and other planned activities at least through May 2024.

On March 10, 2023, Silicon Valley Bank (“SVB”) was shut down, followed on March 11, 2023 by Signature Bank and on May 1, 2023 by First Republic Bank whereby the Federal Deposit Insurance Corporation was appointed as receiver for each of those banks. Starting in January 2023, SVB Asset Management (“SAM”), a nonbank affiliate of SVB and a member of SVB Financial Group, provided investment services relating to the Company’s investment in marketable debt securities held in a segregated custodial account held by a third-party custodian, U.S. Bank. At the time of the closing of SVB, the Company had approximately $20.5 million in cash and certain cash equivalents in an Overnight Money Market Mutual Fund (“MMF”), for which SAM was the investment advisor of until April 13, 2023, when the MMF was liquidated and transferred to a similar investment under the control of a new investment advisor. The Company’s investment portfolio did not and currently does not contain any securities of SVB, and the Company did not have any deposit accounts with SVB. The Company does not believe it was or will be impacted by the closure of SVB and will continue to monitor the banking industry situation as it evolves.

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Rezolute, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

NOTE 3 —INVESTMENTS IN MARKETABLE DEBT SECURITIES

Investments in marketable debt securities, including cash and cash equivalents, are as follows (in thousands):

Estimated Fair Value at

March 31, 

June 30, 

2023

    

2022

Cash and cash equivalents

$

33,743

$

150,410

Short-term investments in marketable debt securities

69,319

Long-term investments in marketable debt securities

26,210

Total cash, cash equivalents and investments in marketable debt securities

$

129,272

$

150,410

The Company only invests in liquid, high quality debt securities. Our investments in debt securities are subject to interest rate risk. To minimize the exposure due to an adverse shift in interest rates, the Company generally invests in securities with expected maturities of two years or less and maintains a weighted average maturity of one year or less. As of March 31, 2023 investments in marketable debt securities with a fair value of $69.3 million are scheduled to mature during the 12-month period ending March 31, 2024 and substantially all of the remaining investments, which have a fair value of $26.2 million, are scheduled to mature during the 12 month period ending March 31, 2025.

During the nine months ended DecemberMarch 31, 2017, working deficit2023 and 2022, we sold no available-for-sale securities.

Accrued interest receivable on all marketable debt securities amounted to $0.3 million which is included in other current assets in the accompanying condensed consolidated balance sheet as of $1,087,141March 31, 2023.  We did not have any accrued interest receivable as of June 30, 2022.

The following table summarizes the unrealized gains and stockholders’ equitylosses that result in differences between the amortized cost basis and fair value of $3,801,798the Company’s cash, cash equivalents and an accumulated deficitmarketable debt securities held as of $76,725,162 at DecemberMarch 31, 2017.2023 and June 30, 2022 (in thousands):

March 31, 2023

June 30,

Gross Unrealized

2022

Amortized Cost

    

Gains

    

Losses

    

Fair Value

Fair Value

Corporate commercial paper

$

38,416

$

2

$

(37)

$

38,381

$

Obligations of U.S. government agencies

24,379

23

(1)

24,401

U.S. Treasury obligations

5,941

1

5,942

Corporate notes and bonds

22,150

4

(122)

22,032

Asset-backed securities

4,775

(2)

4,773

Available-for-sale investments

$

95,661

$

30

$

(162)

$

95,529

$

Money market funds

20,497

Cash

13,246

150,410

Total cash, cash equivalents and investments in marketable debt securities

$

129,272

$

150,410

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Rezolute, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

NOTE 4 — OPERATING LEASES

In April 2022, the Company entered into a lease agreement for a new corporate headquarters in Redwood City, California.  The space consists of approximately 9,300 square feet and provides for total base rent payments of approximately $2.9 million through the expected expiration of the lease in November 2027. The landlord was required to make improvements to the facility before the Company could occupy the space. These improvements were completed in October 2022, triggering the commencement of the lease. The lease provided for a six-month rent abatement period beginning upon commencement of the lease term. In addition, the lease provided an allowance of approximately $0.1 million that may be utilized by the Company for the purchase of furniture and equipment. The average base rent payable in cash over the 60-month lease term is approximately $48,000 per month. Upon commencement of the lease, the Company recognized a right-of-use asset for approximately $2.3 million, and a related operating lease liability for approximately $2.2 million.

The carrying values of all of the Company’s right-of-use assets and operating lease liabilities are as follows (in thousands):

March 31, 

June 30, 

    

2023

    

2022

Right-of-use assets

$

2,172

$

152

Operating lease liabilities:

 

  

 

  

Current

$

319

$

108

Long-term

 

2,055

 

80

Total

$

2,374

$

188

For the three and nine months ended March 31, 2023 and 2022, operating lease expense is included under the following captions in the accompanying condensed consolidated statements of operations and comprehensive loss (in thousands):

Three Months Ended

Nine Months Ended

March 31, 

March 31, 

    

2023

    

2022

2023

    

2022

Research and development

$

139

$

66

$

331

$

216

General and administrative

 

34

 

32

 

105

 

75

Total

$

173

$

98

$

436

$

291

As of March 31, 2023, the weighted average remaining lease term under operating leases was 4.4 years, and the weighted average discount rate for operating lease liabilities was 6.8%. Future cash payments under all operating lease agreements as of March 31, 2023 are as follows (in thousands):

Fiscal year ending June 30, 

    

  

Remainder of fiscal year 2023

$

80

2024

689

2025

627

2026

646

2027

666

Thereafter

224

Total lease payments

2,932

Less imputed interest

 

(558)

Present value of operating lease liabilities

$

2,374

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Rezolute, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

NOTE 5 — LICENSE AGREEMENTS

XOMA License Agreement

In December 2017, the Company entered into a license agreement (the “XOMA License Agreement”) with XOMA Corporation (“XOMA”), through its wholly-owned subsidiary, XOMA (US) LLC, pursuant to which XOMA granted an exclusive global license to the Company to develop and commercialize XOMA 358 (formerly X358, now RZ358) for all indications. In January 2019, the XOMA License Agreement was amended with an updated payment schedule, as well as revising the amount the Company was required to expend on development of RZ358 and related licensed products, and revised provisions with respect to the Company’s diligence efforts in conducting clinical studies.

In January 2022, the Company was required to make a milestone payment under the XOMA License Agreement of $2.0 million that became due upon the dosing of the last patient in the Company’s Phase 2b Clinical Trial for RZ358.  Upon the achievement of certain clinical and regulatory events under the XOMA License Agreement, the Company will be required to make additional milestone payments to XOMA up to $35.0 million.  After the clinical and regulatory milestones, the Company will be required, upon the future commercialization of RZ358, to pay royalties to XOMA based on the net sales of the related products and additional milestone payments to XOMA up to $185.0 million related to annual net sales amounts. The next milestone payment of $5.0 million will be due upon dosing of the first patient in a Phase 3 clinical trial for RZ358.

ActiveSite License Agreement

On August 4, 2017, the Company entered into a Development and License Agreement (the “ActiveSite License Agreement”) with ActiveSite Pharmaceuticals, Inc. (“ActiveSite”) pursuant to which the Company acquired the rights to ActiveSite’s Plasma Kallikrein Inhibitor program (“PKI Portfolio”). The Company is initially using the PKI Portfolio to develop an oral PKI therapeutic for diabetic macular edema (RZ402) and may use the PKI Portfolio to develop other therapeutics for different indications. The ActiveSite License Agreement requires various milestone payments up to $46.5 million, if all milestones are achieved. The first milestone payment for $1.0 million was paid in December 2020 after clearance was received for an Initial Drug Application, or IND, filed with the U.S. Food and Drug Administration (“FDA”). The second milestone payment of $3.0 million was paid in February 2023 after dosing of the first patient in a Phase 2 clinical stagetrial for RZ402. The next milestone payment of $5.0 million will be due upon the first dosing of a patient in a Phase 3 clinical trial. The Company is also required to pay royalties equal to 2.0% of any sales of products that use the PKI Portfolio. There have been no events that would result in any royalty payments owed under the ActiveSite License Agreement to date.

NOTE 6 — EMBEDDED DERIVATIVE LIABILITY

On April 14, 2021, the Company entered into a $30.0 million Loan and has not yet generated any revenues. These factors raise substantial doubt aboutSecurity Agreement (the “Loan Agreement”) with SLR Investment Corp. and certain other lenders (the “Lenders”). The Lenders agreed to loan up to $30.0 million in three tranches consisting of (i) a $15.0 million term A loan that was funded on April 14, 2021, (ii) term B and term C loans for an aggregate of $15.0 million, which were subject to the Company’s ability to continueobtain prescribed amounts of financing and the achievement of certain clinical milestones. The Company did not achieve the initial clinical milestones by January 2022 and, accordingly, the term B and term C loans were no longer a source of liquidity. The term A loan had a maturity date of April 1, 2026 (the “Maturity Date”) but was repaid in full on June 30, 2022.

Concurrently with the execution of the Loan Agreement, the Company entered into an exit fee agreement (the “Exit Fee Agreement”) that provides for a fee of 4.00% of the funded principal balance of each term loan in the event certain transactions (defined as “Exit Events”) occur prior to April 13, 2031. Exit Events include, but are not limited to, sales of substantially all assets, certain mergers, change of control transactions, and issuances of common stock that result in new investors owning more than 35% of the Company’s

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Rezolute, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

shares. As of April 14, 2021, the Company allocated a portion of the proceeds from the term A loan to recognize a liability for the fair value of embedded derivatives. Fair value was determined primarily based on the Company’s strategic corporate development plans.  Management has performed a detailed evaluation of the different types of Exit Events that could occur and has determine fair value using a discounted rate equivalent to the effective rate for the term A loan of 12.6%. Fair value of embedded derivatives is reassessed at the end of each reporting period with changes in fair value recognized as a going concern.nonoperating gain or loss.  

The Company expects that its current cash resources as well as expected lack of operating cash flows will not be sufficient to sustain operations for a period greater than one year. The ability of the Company to continue its operations is dependent on Management’s plans, which include continuing to raise capital through equity or debt based financings. There can be no assurances that such capital will be available to us on acceptable terms, or at all.

NOTE 7 — SHAREHOLDERS’ EQUITY

Quarterly Changes in Shareholders’ Equity

The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. These financial statements do not include any adjustments relating to the recovery of the recorded assets or the classification of the liabilities that might be necessary should the Company be unable to continue as a going concern.

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Note 4 Fixed Assets

The following is a summary of fixed assets and accumulated depreciation:

  Useful       
  Life  December 31, 2017  June 30, 2017 
Furniture and fixtures  5 - 7 years  $118,450  $118,450 
Lab equipment  3 - 15 years   3,951,855   3,946,040 
Leasehold Improvements  5 - 7 years   3,247,038   3,247,038 
       7,317,343   7,311,528 
Less: accumulated depreciation and amortization      (2,519,520)  (1,986,127)
      $4,797,823  $5,325,401 

Depreciation expense was $266,781 and $278,074table presents changes in shareholders’ equity for the three months ended DecemberMarch 31, 20172023 and 2016, respectively2022:

Accumulated

Additional

Other

Total

Common Stock

Paid-in

Comprehensive

Accumulated

Shareholders'

    

Shares

    

Amount

    

Capital

    

Loss

    

Deficit

    

Equity

Three Months Ended March 31, 2023:

Balances, December 31, 2022

 

36,827

$

37

$

373,813

$

$

(232,585)

$

141,265

Share-based compensation

1,855

1,855

Net change in accumulated other comprehensive loss

(132)

(132)

Net loss

 

 

 

 

 

(15,672)

 

(15,672)

Balances, March 31, 2023

36,827

$

37

$

375,668

$

(132)

$

(248,257)

$

127,316

Three Months Ended March 31, 2022:

Balances, December 31, 2021

15,556

$

16

$

250,816

$

$

(188,567)

$

62,265

Share-based compensation

850

850

Net loss

(11,208)

(11,208)

Balances, March 31, 2022

 

15,556

$

16

$

251,666

$

$

(199,775)

$

51,907

July 2022 Financing

In May 2022, the Company entered into securities purchase agreements (“SPAs”) with Handok, Inc. (“Handok”) and was $533,394 and $546,429certain of its affiliates.  Handok is an affiliate of a member of the Company’s Board of Directors. In July 2022, the Company entered into amended SPAs for a private placement of common stock (the “2022 Private Placement”).   The 2022 Private Placement resulted in gross proceeds of $12.3 million in exchange for the six months ended December 31, 2017issuance of approximately 3.2 million shares of common stock. The Company incurred approximately $0.8 million for underwriting commissions and 2016, respectivelyother offering costs, resulting in net proceeds of $11.5 million.

Underwritten Public Offering

Note 5 Related Party Transactions

During the three and six months ended December 31, 2017,On October 12, 2021, the Company incurred investor relations expense of $33,322 and $33,322 and general and administrative expenses of $67,439 and $67,439, see Note 8 for discussion related to warrants issuedentered into an underwriting agreement (the “Underwriting Agreement”) with Oppenheimer & Co., Inc., as compensation for such services. During the three and six months ended December 31, 2016, the Company incurred investor relations expense of $31,050 and $67,275 and general and administrative expenses of $13,928 and $13,928 for services performed by related partiesrepresentative of the Companyunderwriters listed therein (the “Underwriters”) for the planned issuance and were includedsale of equity securities in an underwritten public offering (the “Underwritten Offering”). On October 15, 2021, closing occurred for the Underwritten Offering resulting in the statementissuance of operations. As of December 31, 2017, and June 30, 2017, there were none and $25,200, respectively, related party expenses recorded in accounts payable and accrued expense – related party.

Note 6 Convertible Notes Payable

As of December 31, 2017, and June 30, 2017, the convertible note outstanding balance was $10,000 and $10,000, respectively. As of December 31, 2017, the outstanding convertible note has matured and payment is due. The convertible note which has not been repaid or converted continues to accrue interest at a rate of 8%.

On January 30, 2018, the Company issued a secured convertible promissory note for $500,000 as well as a warrant to purchase 250,000(i) 6,030,847 shares of common stock at $6.50 per share for gross proceeds of $39.2 million, and (ii) 1,661,461 pre-funded warrants to a related party. The Note bears interest at 12% per annum and matures at the earlier of January 31, 2019 or when the Company raises $10 million in an equity financing. The note will be secured by a perfected security interest in the tangible assets of the Company.

Note 7 Shareholders’ Equity

During the year ended June 30, 2017, the Company closed private placement transactions in which the Company issued 5,783,184 units to accredited investors. Each investor was issued either Class A Units or Class B units of the Company. Each Class A Unit received one sharepurchase 1,661,461 shares of common stock at an issuance price of $6.49 per warrant (the “Pre-Funded Warrants”) for gross proceeds of $10.8 million. The aggregate gross proceeds from the Underwritten Offering amounted to $50.0 million, excluding the exercise of the Underwriters’ Option discussed below, and one-halfbefore deductions for underwriting discounts

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Rezolute, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

and commissions of 6.0% of the gross proceeds and other offering costs of approximately $0.3 million. After deducting total offering costs of $3.3 million, the net proceeds of the Underwritten Offering amounted to approximately $46.7 million.

In connection with the Underwritten Offering, the Company granted the Underwriters a 30-day option to purchase up to an additional 1,153,845 shares of its common share purchase warrant. If the investor had previously investedstock in the Company they were eligibleUnderwritten Offering at a public offering price of $6.50 per share, less underwriting discounts and commissions (the “Underwriters’ Option”). In November 2021, the Underwriters’ Option was partially exercised for a Class B Unit116,266 shares resulting in additional gross proceeds of approximately $0.8 million.

Pre-Funded Warrants

The Pre-Funded Warrants issued in the Underwritten Offering have an exercise price of $0.01 per share, which received one shareis subject to adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the common stock and one common share purchase warrant.stock. Each common share purchase warrantPre-Funded Warrant is exercisable at $1.65 per shareany time and from time to time after issuance with no stated expiration date. In the event of certain corporate transactions, the holders of the Pre-Funded Warrants will expire 60 months followingbe entitled to receive, upon exercise of the issuance. AsPre-Funded Warrants, the kind and amount of June 30, 2017,securities, cash or other property that the Companyholders would have received net proceedshad they exercised the Pre-Funded Warrants immediately prior to such transaction. The Pre-Funded Warrants do not entitle the holders thereof to any voting rights or any of approximately $5.2 million after the placement agent compensation and issuance costs paid of $683,194 and $516,550 of warrant expense recorded as issuance costs.

The Company also entered into a private placement transaction in which the Company issued common stock to accredited investors at an offering price of $1.00 per share. As of June 30, 2017, the Company received net proceeds of approximately $8.1 million after the placement agent compensation of $186,671 of warrant expense recorded as issuance costs, as there was no placement agent compensation.

During the six months ended December 31, 2017, the Company closed an additional private placement transaction in which the Company issued common stock to accredited investors at an offering price of $1.00 per share. The Company received net proceeds of $4.44 million after the placement agent compensation of $60,000.

 9

Lincoln Park Transaction – On December 22, 2017, we entered into the Lincoln Park Purchase Agreement pursuantother rights or privileges to which Lincoln Park has agreed to purchase from us up to an aggregate of $10.0 millionholders of the Company’s common stock (subject to certain limitations)are entitled.

The gross proceeds of $10.8 million received from time to time over the 36-month termissuance of the agreement. We alsoPre-Funded Warrants was recorded as a component of shareholders’ equity within additional paid-in capital. In accordance with the terms of the warrant agreement, holders of the outstanding warrants are not entitled to exercise any portion of the Pre-Funded Warrant if, upon exercise of such portion of the warrant, the holder’s aggregate ownership of the Company’s common stock or the combined voting power beneficially owned by such holder would exceed a designated percentage elected by the holder ranging from 4.99% to 19.99%, after giving effect to the exercise (the “Maximum Ownership Percentage”). Upon at least 61 days’ prior notice to the Company, any warrant holder may elect to increase or decrease the Maximum Ownership Percentage to any other percentage not to exceed 19.99%. As of March 31, 2023, no shares underlying the Pre-Funded Warrants have been exercised.

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Notes to Unaudited Condensed Consolidated Financial Statements

Registered Direct Offering

Concurrently with the Underwritten Offering, a major shareholder (the “Purchaser”) that is affiliated with a member of the Company’s Board of Directors entered into a registration rightssubscription agreement with Lincoln Parkfor a registered direct offering, pursuant to which the Company filed withagreed to sell to the Securities and Exchange Commission (the “SEC”) the registration statement to register for resale under the Securities ActPurchaser an aggregate of 1933, as amended, or the Securities Act, the shares of common stock that have been or may be issued to Lincoln Park under the Purchase Agreement.

As a result, on December 22, 2017, 344,669 newly issued769,231 shares of the Company’s common stock equalat a purchase price of $6.50 per share. The closing for the registered direct offering occurred on October 27, 2021, whereby the Company received gross proceeds of $5.0 million.

Equity Distribution Agreement

In December 2020, the Company and Oppenheimer & Co. Inc. (the “Agent”) entered into an Equity Distribution Agreement (the “EDA”) that provides for an “at the market offering” for the sale of up to three percent of the $10$50.0 million availability, were issued to Lincoln Park as consideration for Lincoln Park’s commitment to purchasein shares of the Company’s common stock (the “Placement Shares”) through the Agent. The Agent was acting as sales agent and was required to use commercially reasonable efforts to sell all of the Placement Shares requested to be sold by the Company, consistent with the Agent’s normal trading and sales practices, on mutually agreed terms between the Agent and the Company. The EDA was scheduled to terminate when all of the Placement Shares had been sold, or earlier upon the election of either the Company or the Agent. In May 2022, the Company provided the Agent with notice of termination of the EDA and no further shares will be issued under thethis agreement.

Under the terms and subject to the conditions of the Lincoln Park Purchase Agreement,EDA, the Company hasagreed to pay the right, but not the obligation,Agent a commission equal to sell to Lincoln Park, and Lincoln Park is obligated to purchase up to $10.0 million worth of shares3.0% of the Company’s common stock. Such futuregross 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 option, over the 36-month term of the agreement.

As contemplated by the Lincoln Park Purchase Agreement, and so long as the closing price of the Company’s common stock exceeds $0.40 per share, thenPlacement Shares plus certain expenses incurred by the Agent in connection with the offering. For the nine months ended March 31, 2022, the Company may direct Lincoln Park, at its sole discretion to purchase up to 65,000sold 138,388 shares of its common stock onpursuant to the EDA for net proceeds of approximately $1.5 million.

LPC Purchase Agreement

In August 2021, the Company entered into a purchase agreement (the “Purchase Agreement”) and a registration rights agreement (the “RRA”) with Lincoln Park Capital Fund, LLC (“LPC”), which provides that the Company may sell to LPC up to an aggregate of $20.0 million shares (the “Purchase Shares”) of its common stock. The Company concurrently filed a prospectus supplement with the SEC to register the shares issuable under the Purchase Agreement. The aggregate number of shares that the Company could sell to LPC under the Purchase Agreement was 1,669,620 shares of common stock, subject to certain exceptions set forth in the Purchase Agreement.

LPC’s initial purchase consisted of 95,708 Purchase Shares at a purchase price of approximately $10.45 per share for a total purchase price of $1.0 million. Concurrently, the Company issued 33,799 shares of common stock to LPC as an initial fee for its commitment to purchase shares of common stock under the Purchase Agreement. Subject to the terms of the Purchase Agreement, the Company had the right, in its sole discretion, to present LPC with a purchase notice (a “Regular Purchase Notice”), directing LPC to purchase up to 25,000 Purchase Shares (a “Regular Purchase”). LPC’s committed obligation under any business day,single Regular Purchase generally could not exceed $2.0 million. The Purchase Agreement provided that five business day has passed since the most recent purchase. Thefor a purchase price per share for such purchases will beeach Regular Purchase (the “Purchase Price”) equal to the lower of:lesser of (i) the lowest sale price of the common stock on the applicableNasdaq Capital Market (“NCM”) on the purchase date of such shares; and (ii) the arithmetic average of the three (3) lowest closing sale prices for the Company’s common stock traded on the NCM during the twelve (12)ten consecutive business days ending on the business day immediately preceding suchthe purchase date of such shares.

On September 17, 2021, the Company submitted a Regular Purchase Notice, resulting in the sale of 20,000 Purchase Shares to LPC for net proceeds of approximately $0.2 million. In May 2022, the Company provided LPC with notice of termination of the Purchase Agreement whereby no further shares are issuable under this agreement.

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Notes to Unaudited Condensed Consolidated Financial Statements

NOTE 8 — SHARE-BASED COMPENSATION AND WARRANTS

Stock Option Plans

Presented below is a summary of the number of shares authorized, outstanding, and available for future grants under each of the Company’s stock option plans as of March 31, 2023 (in each case,thousands):

    

Plan Termination

    

Number of Shares

Description

    

Date

    

Authorized

    

Outstanding

    

Available

2015 Plan

 

February 2020

 

17

 

17

 

2016 Plan

 

October 2021

 

140

 

140

 

2019 Plan

 

July 2029

 

200

 

200

 

2021 Plan

March 2031

10,700

8,422

2,278

Total

 

  

 

11,057

 

8,779

 

2,278

2022 Employee Stock Purchase Plan

On June 16, 2022, the Company’s shareholders approved the adoption of the 2022 Employee Stock Purchase Plan (the “2022 ESPP”). The 2022 ESPP provides an opportunity for employees to be appropriately adjusted for any reorganization, recapitalization, non-cash dividend,purchase the Company’s common stock split or other similar transactionthrough accumulated payroll deductions.

The 2022 ESPP has consecutive offering periods that occursbegin approximately every 6 months commencing on the first trading day on or after July 1 and terminating on the datelast trading day of the purchase agreement).offering period ending on December 31 and commencing on the first trading day on or after January 1 and terminating on the last trading day of the offering period ending on June 30. The maximum amount2022 ESPP reserves 0.5 million shares for purchases. The first offering period concluded on December 31, 2022, and no purchases were made under the 2022 ESPP. As of March 31, 2023, no shares subject to any single regular purchase increases ashave been purchased under the 2022 ESPP.

Stock Options Outstanding

The following table sets forth a summary of the activity under all of the Company’s share price increases, subjectstock option plans for the nine months ended March 31, 2023 (shares in thousands):

    

Shares

    

Price (1)

    

Term (2)

Outstanding, June 30, 2022

 

8,506

$

5.24

9.7

Grants to employees

668

1.98

Expired

(116)

40.73

Forfeited

(279)

3.78

Outstanding, March 31, 2023

 

8,779

 

4.57

 

9.1

Vested, March 31, 2023

 

966

 

11.65

 

7.73

(1)Represents the weighted average exercise price.
(2)Represents the weighted average remaining contractual term for the number of years until the stock options expire.

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Notes to a maximumUnaudited Condensed Consolidated Financial Statements

For the nine months ended March 31, 2023, the aggregate fair value of $500,000.

In addition to regular purchases, the Company may also direct Lincoln Park to purchase other amounts as accelerated purchases or as additional 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 its common stock. There are no trading volume requirements or restrictions under the purchase agreement nor any upper limits on the price per share that Lincoln Park must payoptions granted for shares of common stock.

The Lincoln Park 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. The Company has the right to terminate the purchase agreement at any time, at no cost or penalty. During any “event of default” under the purchase agreement, all of which are outside of Lincoln Park’s control, Lincoln Park does not have the right to terminate the purchase agreement; however, the Company may not initiate any regular or other purchase of shares by Lincoln Park, until such event of default is cured. In addition, in the event of bankruptcy proceedings by or against the Company, the purchase agreement will automatically terminate.

Actual sales ofapproximately 0.7 million shares of common stock amounted to Lincoln Park under the purchase agreement will depend on a variety of factors to be determined by the Company from time to time, including, among others, market conditions, the trading price of the common stock and determinations by the Company$1.0 million or approximately $1.51 per share as to the appropriate sources of funding for the Company and its operations. Lincoln Park has no right to require any sales by the Company, but is obligated to make purchases from the Company as it directs in accordance with the purchase agreement. Lincoln Park has covenanted not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of the Company’s shares.

 10

The Company has not declared or paid any dividends or returned any capital to common stockholders as of December 31, 2017.

Note 8 Stock-Based Compensation

Options –On March 26, 2014, the Company adopted the AntriaBio, Inc. 2014 Stock and Incentive Plan which allows the Company to issue up to 3,750,000 of common stock in the form of stock options, incentive options or common stock. The Company had granted 3,295,000 of these shares to current employees and directors of the Company as of June 30, 2017 and no additional grants as of December 31, 2017. The options have an exercise price from $1.29 to $3.44 per share. The options vest monthly over four years, with some options subject to a one year cliff before options begin to vest monthly.

On February 23, 2015, the Company adopted the AntriaBio, Inc. 2015 Non Qualified Stock Option Plan which allows the Company to issue up to 6,850,000 of common stock in the form of stock options. The Company had granted 4,487,000 of these shares to current employees and directors of the Company as of June 30, 2017 and no additional grants as of December 31, 2017. The options have an exercise price of from $1.00 to $2.06 per share. The options vest monthly over 4 years with some options subject to a one year cliff before options begin to vest monthly.

On October 31, 2016, the Board adopted the AntriaBio, Inc. 2016 Non Qualified Stock Option Plan which allows the Company to issue up to 35,000,000 shares of common stock in the form of stock options. The 2016 Non Qualified Stock Option Plan was amended on August 21, 2017 to reduce the number of shares to be issued to 15,000,000 shares of common stock in the form of stock options. The Board had issued options to purchase 28,995,000 of these shares to current employees and directors as of June 30, 2017, of which 4,360,000 were cancelled before their terms were established and 11,090,000 were additionally cancelled by the Board during the year ended June 30, 2017. The Company had 1,550,000 of the cancelled stock options that had begun vesting prior to the cancellation and with the cancellation the Company recorded $1,199,847 of unrecognized stock compensation expense. The Company had granted 255,000 of these shares to current employees and directors of the Company as of December 31, 2017. The options have an exercise price from $1.00 to $1.20 per share. The options expire no later than ten years from the date of the grant. The options vest on a monthly basis over 48 months, except for 75,000 of the options which do not begin to vest until specific events have occurred and then begin to vest over 48 months and 60,000 of the options that all vest at the end of the consulting contract. Some options are subject to a one year cliff and all options have an exercise price based on the fair value of the common stock on the date of grant.

The Company has computed the fair value of all options granted that have begun vesting using the Black-Scholes option pricing model. The options that require specific events before they begin to vest are not valued until the specific event has occurred. In order to calculate the fair value of the options, certain assumptions are made regarding components of the model, including the estimated fair value of the underlying common stock, risk-free interest rate, volatility, expected dividend yield and expected option life. Changes to the assumptions could cause significant adjustments to valuation. The Company estimated a volatility factor utilizing comparable published volatility of several peer companies. Due to the small number of option holders, the Company does not calculate a forfeiture rate but simply accounts for forfeitures as they occur. The Company estimates the expected term based on the average of the vesting term and the contractual term of the options. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of the grant for treasury securitiesdates. Fair value was computed using the Black-Scholes-Merton (“BSM”) option-pricing model and will result in the recognition of similar maturity.compensation cost ratably over the expected vesting period of the stock options.

The Company has computedFor the fair value of all options granted during the sixnine months ended DecemberMarch 31, 2017 using the following assumptions:

 11

Expected volatility84%
Risk free interest rate2.0 - 2.21
Expected term (years)7
Dividend yield0%

Stock option activity is as follows:

     Weighted  Weighted Average 
  Number of  Average  Remaining 
  Options  Exercise Price  Contractual Life 
Outstanding, June 30, 2017  21,290,751  $1.65   7.7 
Granted  255,000  $1.08     
Forfeited  (457,000) $1.65     
Outstanding, December 31, 2017  21,088,751  $1.65   7.7 
             
Exercisable at December 31, 2017  9,250,001  $2.09   6.4 

Stock-based compensation expense related to2023, the fair value of stock options was included inestimated on the statementrespective dates of operations as research and development –grant, with the following weighted-average assumptions:

Market price of common stock on grant date

$

1.98

Expected volatility

    

91

%

Risk free interest rate

 

3.7

%

Expected term (years)

 

6.0

Dividend yield

 

0

%

Share-based compensation and benefits expense of $281,814 and $444,801 and as general and administrative – compensation and benefits expense of $912,215 and $792,137 for the three and nine months ended DecemberMarch 31, 20172023 and 2016, respectively. Stock-based2022 is included under the following captions in the unaudited condensed consolidated statements of operations and comprehensive loss (in thousands):

Three Months Ended

Nine Months Ended

March 31, 

March 31, 

2023

    

2022

2023

    

2022

Research and development

$

849

$

327

$

2,449

$

1,014

General and administrative

 

1,006

 

523

 

3,016

 

1,687

Total

$

1,855

$

850

$

5,465

$

2,701

Unrecognized share-based compensation expense related to the fair value of stock options was included in the statement of operations as research and development – compensation and benefits expense of $580,769 and $749,770 and as general and administrative – compensation and benefits expense of $2,120,959 and $1,376,196 for the six months ended December 31, 2017 and 2016, respectively. The unrecognized stock-based compensation expense at December 31, 2017 is $8,637,760. The Company determined the fair valueapproximately $18.8 million as of the dateMarch 31, 2023. This amount is expected to be recognized over a weighted average period of grant using3.1 years.

Warrants

In connection with an underwritten offering in October 2021, the Black-Scholes option pricing method and expenses the fair value ratably over the vesting period.

Warrants – The Company issued 1,661,461 pre-funded warrants to agents in conjunction with the closing of various financings and issued warrants in private placements as follows:

     Weighted  Weighted Average 
  Number of  Average  Remaining 
  Warrants  Exercise Price  Contractual Life 
Outstanding, June 30, 2017  32,796,448  $1.71   3.7 
Warrants issued for consulting services  650,000  $1.03     
Warrants expired  (285,407) $2.43     
Outstanding, December 31, 2017  33,161,041  $1.69   3.2 

For the Six Months Ended December 31, 2017: The Company issued warrants(“PFWs”) to purchase 100,0001,661,461 shares of common stock at aan issuance price of $1.00$6.49 per warrant for gross proceeds of $10.8 million (the “2021 PFWs”). The 2021 PFWs may be exercised at any time by paying the exercise price of $0.01 per share, insubject to certain ownership restrictions.

In connection with a consulting agreement. Theregistered direct offering in May 2022, the Company also issued warrants1,973,684 Class A PFWs and 10,947,371 Class B PFWs to purchase 50,000an aggregate of 12,921,055 shares of common stock at aan issuance price of $1.00$3.799 per warrant (collectively, the “2022 PFWs”).  As of March 31, 2023, all of the 2022 PFWs may be exercised at any time by paying the exercise price of $0.001 per share, in connection with investor services. Thesubject to certain ownership restrictions.

In addition, the Company has issued warrants to purchase 500,000 shares of common stock at a price of $1.04 per share in connectionconjunction with a consulting agreement.

The warrants exercisablevarious debt and equity financings and for 16,667 shares of common stock at December 31, 2017 are accounted for under liability accounting. The fair value as of December 31, 2017 and June 30, 2017 were $90 and $588, respectively which is reflected as a liability with the fair value adjustment recorded as derivative gains or losses on the consolidated statements of operations.

 12

The warrants exercisable for the 250,000 shares of common stock are accounted for under the equity method of accounting and are fair valued monthly at the date that the warrants vest.services. As of June 30, 2017, warrants to purchase 15,624 shares of common stock had vested and $12,564 had been recorded into equity and investor relations expense. As of DecemberMarch 31, 2017, warrants to purchase an additional 31,248 shares of common stock had vested and $27,333 had been recorded into equity and investor relations expense.

The warrants exercisable for 100,000 shares were accounted for under equity treatment and were fair valued as of the date of issuance. The fair value2023, all of the warrants was valued at $66,643were vested.

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Notes to Unaudited Condensed Consolidated Financial Statements

For the nine months ended March 31, 2023, no warrants were granted or exercised. Excluding the 2021 PFWs and recordedthe 2022 PFWs discussed above, the following table sets forth a summary of all other warrants for the nine months ended March 31, 2023 (shares in thousands):

    

Shares

    

Price (1)

    

Term (2)

Outstanding, June 30, 2022

 

1,150

  

$

22.83

 

4.2

Warrants granted

 

 

 

  

Warrant expirations

 

(28)

  

 

20.36

 

  

Outstanding, March 31, 2023

 

1,122

  

 

22.90

 

3.5

(1)Represents the weighted average exercise price.
(2)Represents the weighted average remaining contractual term for the number of years until the warrants expire.

NOTE 9 — COMMITMENTS AND CONTINGENCIES

Licensing Commitments

Please refer to Note 5 for further discussion of commitments to make milestone payments and to pay royalties under license agreements with XOMA and ActiveSite.

Legal Matters

From time to time, the Company may be involved in litigation relating to claims arising out of operations in the normal course of business. As of March 31, 2023, there were no pending or threatened lawsuits that could reasonably be expected to have a material effect on the Company’s results of operations. At each reporting period, the Company evaluates known claims to determine whether a potential loss amount or a potential range of loss is probable and reasonably estimable under ASC 450, Contingencies. Legal fees are expensed as additional paid-in-capitalincurred.

NOTE 10 — RELATED PARTY TRANSACTIONS

Related Party Licensing Agreement

On September 15, 2020, the Company and as general and administrative expenses. The warrants exercisableHandok entered into an exclusive license agreement (the “Handok License”) for 50,000 shares were accounted for under equity treatment and were fair valued asthe territory of the dateRepublic of issuance.Korea. The fair valueHandok License relates to pharmaceutical products in final dosage form containing the pharmaceutical compounds developed or to be developed by the Company, including those related to RZ358 and RZ402. The Handok License is in effect for a period of 20 years after the first commercial sale of each product and requires (i) milestone payments to the Company of $0.5 million upon approval of a New Drug Application (“NDA”) for each product in the territory, and (ii) the Company will sell products ordered by Handok at a transfer price equal to 70% of the warrants was valued at $33,322 and recorded as additional paid-in-capital and as investor relations expense. The warrants exercisable for 500,000 shares were accounted for under equity treatment and were fair valued as of the date of issuance. The fair value of the warrants was valued at $407,605 and recorded as additional paid-in-capital and license costs.

These warrants were valued using the Black-Scholes option pricing model on the date of issuance. In order to calculate the fair value of the warrants, certain assumptions were made regarding components of the model, including the closingnet selling price of the underlying common stock, risk-free interest rate, volatility, expected dividend yield,products. To date, no milestone payments have been earned by the Company.

Investors in 2022 Private Placement

Handok and warrant term. Changescertain of its affiliates were the sole investors in the 2022 Private Placement and the Registered Direct Offering discussed in Note 7.

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Notes to the assumptions could cause significant adjustments to valuation. Rezolute estimated a volatility factor utilizing comparable published volatilities of several peer companies. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of the grant for treasury securities of similar maturity.Unaudited Condensed Consolidated Financial Statements

The Black-Scholes valuation methodology was used because that model embodies all of the relevant assumptions that address the features underlying these instruments. Significant assumptions for the warrant values calculated for the three months ended December 31, 2017 were as follows:

Expected volatility53% - 85
Risk free interest rate1.76% - 2.37
Warrant term (years) 1 - 10
Dividend yield0%

Note 9 Income Taxes

NOTE 11 — INCOME TAXES

Income tax expense during interim periods is based on applying an estimated annualannualized effective income tax rate applied to year-to-date income, plus any significant unusual or infrequently occurringthe respective quarterly periods, adjusted for discrete tax items which are recorded in the interim period.period in which they occur. The computation of the annualannualized estimated effective tax rate atfor each interim period requires certain estimates and significant judgment including, but not limited to, the expected operating incomeresults for the year, projections of the proportion of income earned and taxed in various jurisdictions, permanent and temporary differences, and the likelihood of recovering deferred tax assets generated in the current year. The accounting estimates used to compute the provision for income taxes may change as new events occur, more experience is obtained, additional information becomes known or as the tax environment changes. In connection with the New Tax Cuts and Jobs Act, all gross deferred tax assets and liabilities have been remeasured at the 21% Federal statutory rate. There was no change to the net deferred tax asset recorded as the valuation allowance was also adjusted offsetting these changes.

InFor the three and sixnine months ended DecemberMarch 31, 2017,2023 and 2022, the Company did not recordrecognize any income tax provisionbenefit due to expected future losses anda full valuation allowance on its deferred tax assets.

Note 10 Commitments and Contingencies

Lease Commitments –In May 2014, the Company entered into a lease of approximately 27,000 square feet of office, laboratory and clean room space to be leased for seventy-two months. The lease requires monthly payments of $28,939 adjusted annually by approximately 3% plus triple net expenses monthly of $34,381 adjusted annually. The Company also made a security deposit of $750,000 whichdid not have any material changes to its conclusions regarding valuation allowances for deferred income tax assets or uncertain tax positions for the three and nine months ended March 31, 2023 and 2022.

NOTE 12 — NET LOSS PER SHARE

Basic net loss per share is heldcomputed by dividing net loss by the landlord,weighted average number of which $375,000 has been returned tocommon shares, 2021 PFWs and 2022 PFWs outstanding during the Companyperiod, without consideration for other potentially dilutive securities. PFWs are included in the computation of basic and diluted net loss per share since the remaining balance will be returned gradually over the next several years.

 13

On March 17, 2017, the Company entered into a lease of approximately 20,000 square feet of office space to be leased for eighty-two months. The lease requires monthly payments of $28,425 adjusted annually plus triple net expenses monthly of $28,410 adjusted annually. The Company also made a security deposit of $56,851 which will be returned at the endexercise price is negligible and all of the lease.

On March 17, 2017,PFWs are fully vested and exercisable. Accordingly, the Company sub-leased their original approximately 10,000 square feetweighted average number of office space to another company. The subleaseshares outstanding is computed as follows for eighty-twothe three and nine months unless the Company is unable to extend our current lease then the sub-lease will expire onended March 31, 2020. The Company is to receive monthly payments of $12,523 adjusted annually plus triple2023 and 2022 (in thousands):

Three Months Ended

Nine Months Ended

March 31, 

March 31, 

    

2023

    

2022

2023

    

2022

Common Stock

36,827

15,557

36,531

12,735

2021 PFWs

1,661

1,661

1,661

1,013

2022 PFWs:

Class A PFWs

1,974

1,974

Class B PFWs

10,947

10,947

Total

51,409

17,218

51,113

13,748

For the three and nine ended March 31, 2023 and 2022, basic and diluted net expenses monthly of $12,828 adjusted annually. The Company also received a security deposit of $25,046 which will be returned atloss per share were the end of the lease.same since all other common stock equivalents were anti-dilutive.

As of DecemberMarch 31, 2017,2023 and 2022, the minimum rental commitment underfollowing outstanding potential common stock equivalents were excluded from the leases arecomputation of diluted net loss per share since the impact of inclusion was anti-dilutive (in thousands):

2023

2022

Stock options

8,779

1,590

Warrants

1,122

1,158

Total

9,901

2,748

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Notes to Unaudited Condensed Consolidated Financial Statements

NOTE 13 — FINANCIAL INSTRUMENTS AND SIGNIFICANT CONCENTRATIONS

Fair Value Measurements

Fair value is defined as follows:

  Operating Leases  Sub-lease Income  Total 
Year Ending June 30,            
2018  365,680   (76,866)  288,814 
2019  747,953   (157,187)  590,766 
2020  688,892   (148,551)  540,341 
2021  338,392   -   338,392 
2022  347,836   -   347,836 
Thereafter  569,364   -   569,364 
  $3,058,117  $(382,604) $2,675,513 

License Agreements: On August 4, 2017,the price that would be received upon sale of an asset or paid to transfer a liability in an orderly transaction between market participants on the measurement date. When determining fair value, the Company enteredconsiders the principal or most advantageous market in which it transacts and considers assumptions that market participants would use when pricing the asset or liability. The Company applies the following fair value hierarchy, which prioritizes the inputs used to measure fair value into three levels and bases the categorization within the hierarchy upon the lowest level of input that is available and significant to the fair value measurement:

Level 1—Quoted prices in active markets for identical assets or liabilities accessible to the reporting entity at the measurement date.

Level 2—Other than quoted prices included in Level 1 that are observable for the asset and liability, either directly or indirectly through market corroboration, for substantially the full term of the asset or liability.

Level 3—Unobservable inputs for the asset or liability used to measure fair value to the extent that observable inputs are not available, thereby allowing for situations in which there is little, if any market activity for the asset or liability at the measurement date.

The following table presents information about the Company’s financial assets measured at fair value on a Developmentrecurring basis and License Agreement (“License Agreement”) with ActiveSite Pharmaceuticals, Inc.  (“ActiveSite”) pursuant to whichindicates the fair value hierarchy classification of such fair values as of March 31, 2023 (in thousands):

Fair Value Measurement as of March 31, 2023

Total

Level 1

Level 2

Level 3

Cash and cash equivalents:

Money market funds

$

20,497

$

20,497

$

$

Marketable debt securities:

Corporate commercial paper

38,381

38,381

U.S. Government agencies

24,401

24,401

U.S. Government treasuries

5,942

5,942

Corporate notes and bonds

22,032

22,032

Asset-backed securities

4,773

4,773

Total

$

116,026

$

26,439

$

89,587

$

Marketable debt securities classified as Level 2 within the valuation hierarchy generally consist of U.S. government agency securities, corporate bonds, and commercial paper. The Company determines the fair value of marketable debt securities based upon valuations obtained from third-party pricing sources.  Except for the amounts shown in the table above, the Company acquireddid not have any other assets measured at fair value on a recurring basis as of March 31, 2023. As of June 30, 2022, the rights to ActiveSite’s Plasma Kallikrein Inhibitor program (“PKI Program”).  The Company desires to use the PKI Program to develop, file, manufacture, market and sell products for diabetic macular edema and other human therapeutic indications.  The Company wasdid not have any assets required to make an upfront paymentbe measured at fair value on a recurring basis.

21

Table of $750,000Contents

Rezolute, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

The Company’s embedded derivative liabilities are classified under Level 3 of the hierarchy and are required to be measured and recorded at fair value on a recurring basis. Fair value is determined based on management’s assessment of the probability and timing of occurrence for the Exit Events discussed in Note 6 using a discount rate equal to the effective interest rate for the term A loan. The following table sets forth changes in the fair value of embedded derivative liabilities for the nine months ended March 31, 2023 and 2022 (in thousands):

2023

 

2022

Fair value, beginning of period

$

407

$

387

Loss from change in fair value

40

8

Fair value, end of period

$

447

$

395

Except for embedded derivative liabilities, the Company did not have any other liabilities measured at fair value on a recurring basis as of March 31, 2023 and June 30, 2022.

Due to the relatively short maturity of the respective instruments, the fair value of cash, accounts payable, within five (5) daysand accrued liabilities approximated their carrying values as of March 31, 2023 and June 30, 2022.

The Company’s policy is to recognize asset or liability transfers among Level 1, Level 2 and Level 3 as of the actual date of the parties executedevents or change in circumstances that caused the License Agreement, which was expensed as researchtransfer. During the nine months ended March 31, 2023 and development costs.2022, the Company did not have any transfers of its assets or liabilities between levels of the fair value hierarchy.

Significant Concentrations

Financial instruments that subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents and investments in marketable debt securities. The Company is required to pay up to an additional aggregatemaintains its cash in demand accounts at a high-quality financial institution. As of $36.5 million in development and regulatory milestone payments if certain clinical study objectivesfor the nine months ended March 31, 2023 and regulatory filings, acceptances and approvals are achieved. In addition, we are required to pay up to2022, cash deposits have exceeded the amount of insurance provided on such deposits by the Federal Deposit Insurance Corporation.

As of March 31, 2023, the Company has an aggregate of $10.0$53.1 million invested in sales milestone payments if certain annual sales targets are achieved.

On December 6, 2017,the debt securities of issuers in the banking and financial services industries, and an aggregate of $24.4 million invested in the debt securities of a single agency of the U.S. government.  While the Company’s investment policy requires investments in highly rated securities, a wide variety of broad economic factors and issuer-specific factors could result in credit agency downgrades below the Company’s minimum credit rating requirements that could result in losses regardless of whether the Company entered into a License Agreement and Common Stock Purchase Agreement (collectively “Transaction Documents”) with XOMA LLC (“XOMA”) pursuantelects to whichsell the securities or hold them until maturity.

As of March 31, 2023, the Company acquired the exclusive rights to develop and commercialize XOMA 358 (now RZ358) for an orphan indication, Congenital Hyperinsulinism. The Company is responsible for all development, regulatory, manufacturing and commercialization activities associated with RZ358. Pursuant to the Transaction Documents, the Company is required to pay XOMA $6 million and to issue XOMA $12 millionhad cash equivalents consisting of the Company’s common stock based upon the Company’s financing activities in 2018. The Company would be required to issue additional shares and a put option to XOMA if certain financing activities did not occur in 2018, as more fully described in the license agreement. The Company also has a required development spend every year related to RZ358. The Company is also required to make certain clinical, regulatory and annual net sales milestone payments of up to $222$20.5 million in the aggregate.MMF discussed in Note 2 and an aggregate of $13.2 million in checking and savings accounts at another large financial institution. As of June 30, 2022 the Company had cash and cash equivalents of $150.4 million in checking and savings accounts with a single financial institution. The Company is also obligedhas never experienced any losses related to pay XOMA royalties ranging from the high single digits to the mid-teens based upon annual net salesits investments in cash and cash equivalents.

22

Table of RZ358. Finally, under the terms of the License Agreement, the Company is required to pay XOMA a low single digit royalty on sales of the Company’s other products.Contents

 14

Legal Matters – From time to time, the Company may be involved in litigation relating to claims arising out of operations in the normal course of business. As of December 31, 2017, there were no pending or threatened lawsuits that could reasonably be expected to have a material effect on the results of our operations. There are no proceedings in which any of our directors, officers or affiliates, or any registered or beneficial shareholders, is an adverse party or has a material interest adverse to our interest.

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

General

This discussionCertain figures, such as interest rates and analysis should be readother percentages included in conjunction withthis section have been rounded for ease of presentation. Percentage figures included in this section have not in all cases been calculated on the accompanyingbasis of such rounded figures but on the basis of such amounts prior to rounding. For this reason, percentage amounts in this section may vary slightly from those obtained by performing the same calculations using the figures in our unaudited condensed consolidated financial statements and related notes. This discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of many factors.

Summary

In June 2017, we filed an IND for AB101 with the FDA and in July 2017, we dosed our first patientor in the Phase 1 first-in-humanassociated text. Certain other amounts that appear in this section may similarly not sum due to rounding. As used in the discussion below, “we,” “our,” “us,” and the “Company” refers to Rezolute, Inc.

As a Company, we are focused on advancing our compounds through clinical study (the “Study”). The studystudies.  Our lead clinical asset, RZ358, is a first-in-human single ascending dose study to assesspotential antibody treatment for congenital hyperinsulinism, an ultra-rare pediatric genetic disorder characterized by excessive production of insulin by the safety and tolerability, pharmacokinetics and pharmacodynamics of AB101 in patients with Type 1 Diabetes Mellitus. The first part of the studypancreas. Our second clinical asset, RZ402, is a sequential cohort dose ranging of AB101selective and there is an optional second study part to compare one or more tested doses of AB101 to Lantus®. In addition to safety and pharmacokinetic assessments, the time-action pharmacology of AB101 (onset, peak, and end of action) is being evaluated using several measures of glycemic response, including the hyperinsulinemic euglycemic clamp technique, continuous glucose monitoring, and background insulin use. In Q4 of calendar year 2017, we completed the first of up to five potential cohorts of the Study and having conducted the interim safety and dose escalation review meeting from that cohort, we plan on proceeding to a higher dose in the second cohort as planned per protocol. However, we will not begin dosing patients in the second cohort until we have raised additional capital. Further, as our clinical study is ongoing and we have not dose escalated beyond the first cohort, we do not anticipate announcing any results with respect to the Study until next year.

On August 4, 2017, we licensed from ActiveSite Pharmaceuticals, Inc. (“ActiveSite”) their oralpotent plasma kallikrein inhibitor portfolio (“PKI PortfolioPKI”) targetingbeing developed as a potential oral therapy for the chronic treatment of diabetic macular edema (“DMEDME”).

RZ358

In May 2022, we announced positive topline results from the RZ358-606 Phase 2b study (“RIZE”) and other plasma kallikrein-medicated diseases suchthrough the first quarter of 2023, we finalized tables, figures and listings (“TFL”) for the study as hereditary angioedema. ActiveSite has generated proof-of-concept datawell as clinical study reports (“CSRs”). In addition, we have been actively engaged in discussions with both European regulatory authorities as well as the U.S. Food and Drug Administration (“FDA”) regarding plans for their orally-administered plasma kallikrein inhibitors in clinically-relevant animal models of macular edema,a Phase 3 study (together the European regulatory authorities and we are leveraging that datathe FDA may be hereinafter referred to complete IND-enabling toxicology studies and prepare for human clinical trials.

On December 6, 2017, we completedas the last phase of our corporate development strategy to create a focused metabolic disease company with multiple indications in which we in-licensed a fully human monoclonal antibody from XOMA LLC that is currently in Phase 2 clinical development targeting a treatment for an ultra-orphan pediatric indication, congenital hyperinsulinism (the “CHI Program“Regulatory Authorities”). We believeexpect to commence the Phase 3 study during the Summer of 2023, but there can be no guarantee that we will be able to commence the CHI Programstudy on this timeline. Based on our current enrollment estimates, we expect to have top line results available from this study in the first quarter of 2025.

RZ402

In December 2022, we initiated a Phase 2 multi-center, randomized, double-masked, placebo-controlled, parallel-arm study to evaluate the safety, efficacy, and pharmacokinetics of RZ402 administered as a monotherapy over a 12-week treatment period in participants with DME who are naïve to, or have received limited anti-VEGF injections. The study population will include DME patients with mild to moderate non-proliferative diabetic retinopathy. Eligible participants will be randomized equally, to one of three RZ402 active treatment arms at doses of 50, 200, and 400 mg, or a placebo control arm, and will receive study drug once daily for 12 weeks, before completing a four-week follow-up. The study is expected to enroll up to approximately 100 patients overall, across approximately 25 investigational sites in the United States. The principal endpoints of the trial include (i) changes in central subfield thickness of the macula, as measured by Spectral Domain Ocular Coherence Tomography, (ii) changes in visual acuity as measured by the early treatment diabetic retinopathy scale, (iii) the repeat dose pharmacokinetics of RZ402 in patients with DME, and (iv) the safety and tolerability of RZ402. We expect to complete enrollment in 2023 and to announce results from the study in the first quarter of 2024.

Recent Developments

Investment in Marketable Debt Securities

In January 2023, our Board of Directors determined that it was in the best interest of the Company and its shareholders to diversify its cash position and use a compelling opportunity givenportion of the Company’s cash to invest an aggregate of $115.0 million of cash held in demand deposit accounts in marketable debt securities and an overnight money market mutual fund with the objective of achieving higher returns on investment.  

Headquarters Lease

In April 2022, we entered into a lease agreement for a new corporate headquarters facility in Redwood City, California.  The space consists of approximately 9,300 square feet and provides for total base rent payments of approximately $2.9 million through the expected

23

expiration of the lease in November 2027. The lease provides for a six-month rent abatement period that there is no approved therapybegan upon commencement of the lease term which occurred in October 2022.

Financing Activities

In July 2022, we entered into amended securities purchase agreements with Handok, Inc. (“Handok”) and certain of its affiliates (the “2022 Private Placement”), resulting in gross proceeds of $12.3 million in exchange for this devastating childhood disease.the issuance of approximately 3.2 million shares of common stock.  We incurred approximately $0.8 million for underwriting commissions and other offering costs, resulting in net proceeds of $11.5 million.

Termination of Loan Agreement

We believe that the CHI ProgramOn April 14, 2021, we entered into a $30.0 million Loan and Security Agreement (the “Loan Agreement”) with Solar Investment Corp. (“SLR”) as collateral agent, and the PKI Portfolio complementparties executing the Loan Agreement as lenders, including SLR in its capacity as a lender. The scheduled maturity date of the Loan Agreement was on April 1, 2026. In April 2021, we borrowed $15.0 million under the Loan Agreement. On June 30, 2022, we paid off the outstanding loan amount of $15.0 million in full and terminated the Loan Agreement in accordance with its terms.

Please refer to our endogenous super long acting basal program, AB101, currentlydiscussion under the caption Liquidity and Capital Resources for further discussion of our recent financing activities.

Factors Impacting our Results of Operations

We have not generated any meaningful revenues since our inception in Phase 1 clinical development. We further believe thatMarch 2010. Over the combination of these assets creates a potential highly valuable biopharmaceutical enterprise with a compelling investment thesis attractive to institutional investors. While we believe that our prospects are bright, we are currently significantly capital constrained and have elected to conduct a secured, convertible note financing to bridge the Company (the “Debt Financing”) until the Equity Financing is complete. We are seeking to raise $3,000,000 or more in the Debt Financing andlast several years, we have conducted our first for aggregate gross proceeds of $500,000 in January of 2018.

We have met with a variety of the largeprivate placements and mid-size health care funds to unveil the Rezolute story as we seekpublic offerings to raise at least $25 million (the “Equity Financing”)additional capital, adopted a licensing model to pursue development of product candidates, conducted pre-clinical and to date, as the funds have begun doing diligenceclinical trials, and conducted other research and development activities on our programspipeline of product candidates.

Due to the time required to conduct clinical trials and prospects,obtain regulatory approval for our product candidates, we have experienced very favorable receptionanticipate it will be several years before we generate substantial revenues, if ever. We expect to incur operating losses for the foreseeable future; therefore, we expect to continue efforts to raise additional capital to maintain our strategy and expanded pipeline. Nonetheless,current operating plans over the next several years. We cannot assure you that we recognizewill secure such financing or that it will take timebe adequate for the long-term execution of our business strategy. Even if we obtain additional financing, it may be costly and may require us to completeagree to covenants or other provisions that will favor new investors over our existing shareholders.

Key Components of Consolidated Statements of Operations and Comprehensive Loss

Research and development expenses. Research and development (“R&D”) expenses consist primarily of compensation and benefits for our personnel engaged in R&D activities, clinical trial costs, licensing costs, and consulting and outside services. Our R&D compensation costs include an allocable portion of our cash and share-based compensation, employee benefits, and consulting costs related to personnel engaged in the Equity Financingdesign and development of product candidates and other scientific research projects. We also allocate a portion of our facilities and overhead costs based on the personnel and other resources devoted to R&D activities.

General and administrative expenses. General and administrative (“G&A”) expenses consist primarily of (i) an allocable portion of our cash and share-based compensation and employee benefits related to personnel engaged in our administrative, finance, accounting, and executive functions, and (ii) an allocable portion of our facilities and overhead costs related to such personnel. G&A expenses also include travel, legal, auditing, consulting, investor relations and other costs primarily related to our status as we do not anticipate closing such a transaction untilpublic company.

Interest and other income. Interest and other income consist primarily of interest income earned on investments and temporary cash investments.

Loss from change in fair value of derivative liabilities. We recognize liabilities for financial instruments that are required to be accounted for as derivatives, as well as embedded derivatives in our debt agreements. Derivative liabilities are adjusted to fair value at the end of Q1 calendar year 2018each reporting period until the contracts are settled, expire, or early Q2. Further, no assurance can be given that any suchotherwise meet the conditions for equity classification. Changes in fair value are reflected as a gain or loss in our unaudited condensed consolidated statements of operations and of comprehensive loss.

24

Employee retention credit. In response to the COVID-19 pandemic, the United States government has designed programs to assist businesses in dealing with the financial hardships caused by the pandemic. We recognize the right to receive governmental assistance payments in the period in which the related conditions on which they depend are substantially met.

Interest expense. The components of interest expense include the amount of interest payable in cash at the stated interest rate, and accretion of debt discounts and issuance costs (“DDIC”) using the effective interest method. DDIC arises from the issuance of debt instruments and other related contracts or agreements which possess certain terms and conditions resulting in additional financing will be completed or will be timely completed on favorable terms. Currently, we cannot sustain operations withoutcosts arising from origination, exit and final fees, and other incremental and direct costs incurred to consummate the Debt Financing and without the larger Equity Financing we cannot continue to advance all of our current programs.financing.

 15

SignificantCritical Accounting Policies and Significant Judgments and Estimates

Overview

OurThe discussion herein is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America.States. The preparation of thethese unaudited condensed consolidated financial statements requires managementus to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements, andas well as the reported amounts ofrevenue and expenses during the reporting period. On an on-going basis, management evaluates itsperiods. These items are monitored and analyzed for changes in facts and circumstances, and material changes in these estimates and judgments, including those related tocould occur in the estimated useful lives and impairment of depreciable assets, the fair value of share-based payments and warrants, fair value of derivative instruments,future. We base our estimates of the probability and potential magnitude of contingent liabilities and income tax valuation allowances. Management bases its estimates and judgments on historical experience and on various other factors that we believe are believed to be reasonable under the circumstance,circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Changes in estimates are reflected in reported results for the period in which they become known. Actual results may differ from these estimates under different assumptions or conditions. The methods, estimates,

With respect to our significant accounting policies that are described in Note 1 to our consolidated financial statements included in Item 8 of our 2022 Form 10-K, we believe that the following accounting policies involve a greater degree of judgment and judgments used by us in applyingcomplexity. Accordingly, these are the policies we believe are the most critical accounting policies have a significant impact onto aid in fully understanding and evaluating our consolidated financial condition and results of operations.

Accounting for Complex Financings

In order to account for complex financing transactions, we are required to make judgments, assumptions, and estimates to determine the results we reportappropriate amounts reported in our consolidated financial statements. These financing transactions typically involve entering into several distinct legal agreements, whereby we are required to identify and account for each freestanding financial instrument separately. The freestanding financial instruments may be classified as debt, temporary equity or permanent equity instruments depending on the results of our evaluation. In addition, we evaluate if any of the financial instruments contain embedded features that are required to be accounted for as derivatives at fair value. Each freestanding financial instrument is required to be recognized at fair value on the closing date of the financing. The fair value of warrants is generally determined using the Black-Scholes-Merton (“BSM”) valuation model and the fair value of common stock is based on the trading price of our shares on the closing date.

For financial instruments classified as debt, a discount is recognized if the stated principal balance exceeds the initial allocation of fair value as of the closing date. This discount is accreted to interest expense using the interest method that results in recognition of interest expense at a fixed rate through the expected maturity date.

Share-Based Compensation Expense

We measure the fair value of services received in exchange for all stock options granted based on the fair value of the award as of the grant date. We compute the fair value of stock options with time-based vesting using the BSM option-pricing model and recognize the cost of the equity awards over the period that services are provided to earn the award. For awards that contain a graded vesting schedule, and the only condition for vesting is a service condition, compensation cost is recognized on a straight-line basis over the requisite service period as if the award was, in substance, a single award. We recognize the impact of forfeitures in the period that the forfeiture occurs, rather than estimating the number of awards that are not expected to vest in accounting for share-based compensation. For stock options that are voluntarily surrendered by employees, all unrecognized compensation is immediately recognized in the period the options are cancelled.

25

Research and Development

R&D costs are expensed as incurred. Intangible assets related to in-licensing costs under license agreements with third parties are charged to expense unless we are able to determine that the licensing rights have an alternative future use in other R&D projects or otherwise.

Clinical Trial Accruals

Clinical trial costs are a component of R&D expenses. We accrue and recognize expenses for clinical trial activities performed by third parties based upon estimates of the percentage of work completed over the life of the individual study in accordance with agreements established with clinical research organizations and clinical trial sites. We determine the estimates through discussions with internal clinical personnel and external service providers as to the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services. Nonrefundable advance payments for goods and services that will be used or rendered in future R&D activities, are deferred and recognized as expense in the period that the related goods are delivered, or services are performed.

Results of Operations

Three months ended March 31, 2023 and 2022

For Three and Six Months Ended December 31, 2017 and 2016

Results of operationsRevenue. As a clinical stage company, we did not generate any revenue for the three months ended DecemberMarch 31, 2017 (the “2018 quarter”)2023 and 2022. We are at an early stage of development and do not currently have any commercial products. Our existing product candidates will require extensive additional clinical evaluation, regulatory review, significant marketing efforts and substantial investment before they generate any revenues. We do not expect to be able to generate revenue from any of our product candidates for several years.

Research and development expenses. R&D expenses for the three months ended DecemberMarch 31, 2016 (the “2017 quarter”) reflected losses2023 and 2022 were as follows (in thousands, except percentages):

    

Increase

 

    

2023

    

2022

    

Amount

    

Percent

 

Total R&D expenses

$

14,231

$

8,686

$

5,545

 

64

%

The increase in R&D expenses of $5.5 million for the three months ended March 31, 2023 was primarily attributable to an increase of RZ358 related program costs of approximately $5,751,000$2.8 million. The increased expense consisted of an increase in manufacturing and $4,888,000, respectively.

Resultspreclinical costs of operations$1.8 million, clinical trial expense of $0.4 million, and other RZ358 program costs of $0.6 million.  RZ358 costs increased due to Phase 3 clinical readiness activities.  Compensation and benefits for our R&D workforce increased by approximately $1.1 million. Cash-based compensation and benefits increased by approximately $0.6 million that was primarily attributable to an increase in the average number of R&D employees from 26 for the sixthree months ended DecemberMarch 31, 2017 (the “2018 period”) and2022 to 36 for the sixthree months ended DecemberMarch 31, 2016 (the “2017 period”) reflected losses of2023. Share-based compensation and benefits increased by approximately $12,468,000 and $8,704,000, respectively.

Revenues

We are a$0.5 million attributable to an increase in share-based compensation related to stock options granted in June 2022 where expense is recognized over the respective vesting periods.  RZ402 program costs increased by approximately $0.4 million, primarily due to Phase 2 clinical stage company and have not generated any revenues since inception.

Expenses

Research and developmenttrial costs include salaries, benefits and other staff-related costs; consultants and outside costs; material manufacturing costs; and facilities and other costs. Research and developmentwhich dosed its first patients in February 2023. Milestone related costs were approximately $3,413,000 inincreased by $1.0 million for the 2018 quarter compared to $3,075,000 in the 2017 quarter. Research and development costs were approximately $7,723,000 in the 2018 period compared to $5,561,000 in the 2017 period. The main increases arethree months ended March 31, 2023 due to the Company continuing$3.0 million milestone due to hire staff to manufacture clinical material during the 2018 period as well as the startActiveSite upon dosing of the first clinical trialpatient in a Phase 2 study.  Milestone costs for the quarter ended March 31, 2022 related to the payment of $2.0 million to XOMA upon last patient dosing in the 2018 period.Phase 2b study.

General and administrative costsexpenses. G&A expenses for the three months ended March 31, 2023 and 2022 were approximately $2,338,000as follows (in thousands, except percentages):

    

Increase

 

    

2023

    

2022

    

Amount

    

Percent

 

Total G&A expenses

$

2,911

$

2,068

$

843

 

41

%

26

The increase in G&A expenses of $0.8 million for the 2018 quarter comparedthree months ended March 31, 2023 was attributable to $1,813,000increases in (i) share-based compensation expense of $0.5 million due to stock options granted in June 2022 where expense is recognized over the 2017 quarter. Generalrespective vesting periods, and administrative costs were approximately $4,774,000 in the 2018 period compared to $3,151,000 in the 2017 period. The main increase is(ii) cash-based compensation expense of $0.2 million due to an increase in stock compensation expense during the 2018 period as options were granted in the 2016 Stock Option Plan that were not in the 2017 period.

Impactaverage number of the U.S. Tax Reform

On December 22, 2017, the U.S. President signed the Tax Cuts and Jobs Act (the “Act”) into law. Effective January 1, 2018, among other changes, the Act (a) reduces the U.S. federal corporate tax rate to 21 percent, provides for a deemed repatriation and taxation at reduced rates on historical earnings (a “transition tax”) of certain non-US subsidiaries owned by U.S. companies and establishes new mechanisms to tax such earnings going forward. The Act has wide ranging implications for the Company. However, the impact on the Company’s financial statementsemployees from 9 for the three months ended March 31, 2022 to 12 employees for the three months ended March 31, 2023.

Interest and six-month periodsOther Income. Interest and other income amounted to $1.5 million for the three months ended DecemberMarch 31, 2017 is immaterial,2023, compared to none for the three months ended March 31, 2022. This increase was primarily becausedue to our decision in January 2023 to invest an aggregate of approximately $115.0 million in marketable debt securities and an overnight money market mutual fund that bear interest at a weighted average effective rate of approximately 5.0%, whereas our temporary cash investments for the Company hasthree months ended March 31, 2022 provided for earnings that were less than 1.0%.  The large increase in funds available for investment was attributable to the completion of equity financings between May 2022 and July 2022.

Interest Expense. We did not incur any interest expense for the three months ended March 31, 2023, whereas we incurred $0.4 million of interest expense for the three months ended March 31, 2022. Interest expense for the three months ended March 31, 2022 was solely attributable to the Loan Agreement and consisted of (i) interest expense of $0.3 million based on the weighted average contractual rate of 9.0%, and (ii) accretion of discount of $0.1 million. The Loan Agreement was repaid on June 30, 2022.

Income Taxes. For the three months ended March 31, 2023 and 2022, we did not recognize any income tax benefit due to our net losses, and our determination that a full valuation allowance onwas required for all of our deferred tax assetsassets.

Nine months ended March 31, 2023 and 2022

Revenue. As a clinical stage company, we did not generate any revenue for the nine months ended March 31, 2023 and 2022. We are at an early stage of development and do not currently have any commercial products. Our existing product candidates will require extensive additional clinical evaluation, regulatory review, significant marketing efforts and substantial investment before they generate any revenues. We do not expect to be able to generate revenue from any of our product candidates for several years.

Research and development expenses. R&D expenses for the nine months ended March 31, 2023 and 2022 were as follows (in thousands, except percentages):

    

Increase

 

    

2023

    

2022

    

Amount

    

Percent

 

Total R&D expenses

$

32,880

$

23,912

$

8,968

 

38

%

The increase in R&D expenses of $9.0 million for the nine months ended March 31, 2023 was partially attributable to compensation and benefits for our R&D workforce that increased by approximately $3.7 million. Cash-based compensation and benefits increased by approximately $2.3 million which was primarily attributable to an increase in the U.S.average number of R&D employees from 24 for the nine months ended March 31, 2022 to 35 for the nine months ended March 31, 2023.  In addition, approximately $1.4 million of this increase was attributable to an increase in share-based compensation related to stock options granted in June 2022 where expense is recognized over the respective vesting periods. In addition to the increases in compensation and benefits, an increase of $1.5 million was due to higher spending for RZ358 Phase 3 readiness manufacturing costs and $1.0 million for RZ402 Phase 2 clinical trial costs.

Milestone related costs under licensing agreements increased by $1.0 million for the nine months ended March 31, 2023 as a result of the $3.0 million milestone payment due to ActiveSite upon dosing of the first patient in a Phase 2 study.  Milestone costs for the nine months ended March 31, 2022 related to the payment of $2.0 million to XOMA (as defined below) upon last patient dosing in the Phase 2b study.    

Other R&D related costs increased by approximately $1.8 million for the nine months ended March 31, 2023 due an increase of $0.9 million related to R&D facilities costs driven by increased travel, rent and other facilities costs.  Other pipeline development costs increased by $0.6 million.

27

General and administrative expenses. G&A expenses for the nine months ended March 31, 2023 and 2022 were as follows (in thousands, except percentages):

    

Increase

 

    

2023

    

2022

    

Amount

    

Percent

 

Total G&A expenses

$

8,872

$

6,632

$

2,240

 

34

%

The increase in G&A expenses of $2.2 million for the nine months ended March 31, 2023 was primarily attributable to increases in (i) share-based compensation expense of $1.3 million due to stock options granted in June 2022 where expense is recognized over the respective vesting periods and (ii) cash-based compensation expense of $0.9 million that was primarily attributable to an increase in the average number of G&A employees from 8 for the nine months ended March 31, 2022 to 12 for the nine months ended March 31, 2023.  

Interest and Other Income. Interest and other income amounted to $2.7 million for the nine months ended March 31, 2023, compared to $13,000 of interest income for the nine months ended March 31, 2022. The increase in interest income for the nine months ended March 31, 2023 was primarily due to our decision in January 2023 to invest an aggregate of approximately $115.0 million in marketable debt securities and overnight money market mutual fund that bear interest at a weighted average effective rate of approximately 5.0%, which resultswhereas our temporary cash investments for the nine months ended March 31, 2022 provided for earnings that were less than 1.0%. The large increase in there being no U.S.funds available for investment was attributable to the completion of equity financings between May 2022 and July 2022.

Employee Retention Credit. We did not generate any employee retention credit income for the nine months ended March 31, 2023, compared to $0.2 million for the nine months ended March 31, 2022. The income in the prior year was a result of CARES Act benefits. For the nine months ended March 31, 2023, governmental assistance was not available under the CARES Act.

Interest Expense. We did not incur any interest expense for the nine months ended March 31, 2023 due to the repayment of the Loan Agreement on June 30, 2022, whereas we incurred $1.3 million of interest expense for the nine months ended March 31, 2022. Interest expense for the nine months ended March 31, 2022 was solely attributable to the Loan Agreement and consisted of (i) interest expense of $1.0 million based on the weighted average contractual rate of 9.0%, and (ii) accretion of discount of $0.3 million.

Income Taxes. For the nine months ended March 31, 2023 and 2022, we did not recognize any income tax benefit due to our net losses, and our determination that a valuation allowance was required for all of our deferred tax assets or liabilities recorded on the balance sheet that need to be remeasured at the new 21% rate. The Company will continue to analyze the effects of the Act on its financial statements and operations. Any additional impacts from the enactment of the Act will be recorded as they are identified during the measurement period as provided for in Staff Accounting Bulletin 118.assets.

 16

Liquidity and Capital Resources

Short-term Liquidity Requirements

As of DecemberMarch 31, 2017,2023, we have approximately $0.8had cash and cash equivalents of $33.7 million, in cash on handshort-term marketable debt securities of $69.3 million and working capital deficitwas approximately $101.1 million. We have incurred cumulative net losses of approximately $1.1$248.3 million since our inception and as a clinical stage company we have not generated any meaningful revenue to date.

Our primary source of liquidity has historically been from the completion of private placements and public offerings of our equity securities, as well as proceeds from the issuance of debt securities. For the nine months ended March 31, 2023, as discussed above under the caption Recent Developments, we issued common stock in the 2022 Private Placement that resulted in net proceeds of $11.6 million. DuringFor the fiscal year ended June 30, 2017,2022, we closedreceived net proceeds from the issuance of equity securities of $165.2 million. The completion of these equity financings is the primary factor that resulted in our cash and cash equivalents balance of $33.7 million and marketable debt securities investment balance of $95.5 million as of March 31, 2023. For further information about the key terms and results of our debt and equity financing activities, please refer to the discussion below under the captions 2022 Registered Direct Offering, 2021 Underwritten Public Offering and 2021 Registered Direct Offering.

Our most significant contractual obligations consist of milestone payments pursuant to licensing agreements with XOMA Corporation (“XOMA”) and ActiveSite Pharmaceuticals, Inc. (“ActiveSite”) discussed below. Based on our expectations for the dates when certain

28

clinical and regulatory milestones will be achieved, we anticipate that $5.0 million will be payable to XOMA within the next twelve months.  

Based on our cash and cash equivalents balance of $33.7 million and short-term investment balance of $69.3 million as of March 31, 2023, we believe we have adequate capital resources to meet all of our contractual obligations and conduct all planned activities to advance our clinical trials through the fiscal quarter ending March 31, 2024.

Long-term Liquidity Requirements

Our most significant long-term contractual obligations consist of remaining clinical and regulatory milestone payments up to $35.0 million payable to XOMA and $32.5 million in remaining clinical and regulatory milestones payments to ActiveSite, for a total of $67.5 million. As discussed above, we expect that $5.0 million will be payable to XOMA within the next twelve months. Accordingly, the remainder of $62.5 million is considered a long-term liquidity requirement. Due to uncertainties in the timing associated with clinical trial activities and regulatory approvals, there is even greater uncertainty in forecasting the additional milestone payments to XOMA and ActiveSite during the fiscal year ending June 30, 2024 and thereafter.

Our long-term contractual obligations also include (i) operating lease payments up to approximately $0.7 million per year through calendar year 2027, and (ii) an equity transaction in whichexit fee of $0.6 million if we issued units consistingenter into certain transactions (defined as “Exit Events”) prior to April 13, 2031. Exit Events include, but are not limited to, sales of one sharesubstantially all assets, certain mergers, change of control transactions, and issuances of common stock that result in new investors owning more than 35% of our common stock. As discussed above under the caption Recent Developments, on June 30, 2022 we terminated the Loan Agreement with SLR. However, we remain contingently obligated to pay the $0.6 million exit fee.

The following discussion provides additional information about the ongoing requirements pursuant to our license agreements with XOMA and ActiveSite, along with additional information about our recent financing activities that impacted our liquidity and capital resources through March 31, 2023.

XOMA License Agreement

In December 2017, we entered into a warrantlicense agreement (the “XOMA License Agreement”) with XOMA through its wholly-owned subsidiary, XOMA (US) LLC, pursuant to which XOMA granted an exclusive global license to develop and commercialize XOMA 358 (formerly X358, now RZ358) for all indications. In January 2019, the XOMA License Agreement was amended with an updated payment schedule, as well as revised the amount we were required to expend on development of RZ358 and related licensed products, and revised provisions with respect to our diligence efforts in conducting clinical studies.

The XOMA License Agreement requires various clinical and regulatory milestone payments up to $37.0 million in aggregate. The first such milestone payment of $2.0 million was triggered upon dosing of the last patient in our Phase 2 clinical study in January 2022. The next milestone payment of $5.0 million will be due upon the dosing of the first patient in a Phase 3 study, which we believe will occur in the next twelve months. Additionally, upon the future commercialization of RZ358, we will be required to pay royalties to XOMA based on the net sales of the related products, and milestone payments up to an additional $185.0 million if future annual sales related to RZ358 exceed targets ranging from $100.0 million to $1.0 billion. Through March 31, 2023, no events have occurred that would result in the requirement to make additional milestone payments and no royalties have been incurred.

ActiveSite License Agreement

In August 2017, we entered into a Development and License Agreement with ActiveSite (“ActiveSite License Agreement”) pursuant to which we acquired the rights to ActiveSite’s plasma kallikrein inhibitor portfolio (the “PKI Program”). We are planning to use the PKI Program to develop, file, manufacture, market and sell products for diabetic macular edema and other therapeutic indications. The ActiveSite License Agreement requires various milestone payments ranging from $1.0 million to $10.0 million when milestone events occur, up to $46.5 million of aggregate milestone payments. The first milestone payment for $1.0 million paid in December 2020 after completion of the preclinical work and submission of an IND to the FDA for RZ402. The second milestone payment for $3.0 million became due upon dosing of the first patient in a Phase 2 study in February 2023.  We will also be required to pay royalties equal to 2.0% of any sales of products that use the PKI Program. Through March 31, 2023, no events have occurred that would result in the requirement to make additional milestone payments and no royalties have been incurred.

29

2022 Registered Direct Offering

On May 1, 2022, we entered into an underwriting agreement with Jefferies LLC, as representative of the underwriters listed therein, relating to the issuance and sale of equity securities in an underwritten registered direct offering (the “2022 RDO”). The 2022 RDO resulted in the issuance of (i) approximately 18.0 million shares of our common stock at a public offering price of $3.80 per share, (ii) Class A pre-funded warrants (the “Class A PFWs”) to purchase either one-half or one share of common stock. During the year ended June 30, 2017, we also closed on an equity transaction in which we issued straightup to 2.0 million shares of common stock. During the six months ended December 31, 2017, we had an additional close on an equity transaction in which we issued straightstock at a public offering price of $3.799 per Class A PFW, and (iii) Class B pre-funded warrants (the “Class B PFWs”) to purchase up to 10.9 million shares of common stock.The Company receivedstock at a public offering price of $3.799 per Class B PFW. On May 4, 2022, the 2022 RDO closed resulting in net proceeds of approximately $14$110.1 million. The gross amount of the 2022 RDO was $117.6 million, before deduction of an aggregate of $7.1 million for underwriting discounts and approximately $0.4 million for professional fees and other offering expenses payable by us. We believe the additional funding from the 2022 RDO along with the funding received in July 2022 from the 2022 Private Placement provides us with sufficient cash to fund a Phase 3 clinical program for RZ358, as well as a Phase 2 proof of concept study for RZ402.

2021 Underwritten Public Offering and Registered Direct Offering

In October 2021, we entered into an underwriting agreement with Oppenheimer & Co., Inc., as representative of the underwriters listed therein (the “2021 Underwriters”) for the planned issuance and sale of equity securities in an underwritten public offering (the “2021 Underwritten Offering”). On October 15, 2021, closing occurred for the 2021 Underwritten Offering resulting in the issuance of (i) 6,030,847 shares of common stock at $6.50 per share for gross proceeds of $39.2 million, and (ii) 1,661,461 pre-funded warrants to purchase 1,661,461 shares of common stock at an issuance price of $6.49 per warrant (the “2021 PFWs”) for gross proceeds of $10.8 million. We granted the Underwriters a 30-day option to purchase up to an additional 1,153,845 shares of its common stock in the 2021 Underwritten Offering at a public offering price of $6.50 per share, less underwriting discounts and commissions (the “Underwriters’ Option”). In November 2021, the Underwriters’ Option was partially exercised for 116,266 shares resulting in gross proceeds of approximately $0.8 million. The aggregate gross proceeds from the 2021 Underwritten Offering amounted to $50.7 million, excluding the Underwriters’ Option, and before deductions for underwriting commissions of 6.0% of the gross proceeds and other offering costs of approximately $0.3 million. After deducting total offering costs of $3.3 million, the net proceeds of the 2021 Underwritten Offering amounted to approximately $47.2 million.

Concurrently with the 2021 Underwritten Offering, Handok, an entity affiliated with a member of the Board of Directors, entered into a subscription agreement for a registered direct offering (the “2021 RDO”) pursuant to which we agreed to sell to the Handok an aggregate of 769,231 shares of our common stock at a purchase price of $6.50 per share. The closing for the 2021 RDO occurred on October 27, 2021, whereby we received gross proceeds of $5.0 million.

EDA and LPC Financings

In December 2020, we entered into an Equity Distribution Agreement (the “EDA”) with Oppenheimer & Co. Inc. as sales agent that provided for an “at the market offering” for the sale of up to $50.0 million in shares of our common stock (the “Placement Shares”). For the nine months ended March 31, 2022, we sold 138,388 Placement Shares for which aggregate net proceeds of approximately $1.5 million were received. In August 2021, we entered into a purchase agreement (the “LPC Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“LPC”), that provided for issuances up to an aggregate of $20.0 million of shares of our common stock (the “Purchase Shares”). For the three months ended March 31, 2022, LPC did not purchase any shares of our common stock. In May 2022, we terminated the EDA and the LPC Purchase Agreement whereby no further equity securities are issuable under these agreements.

Loan Agreement

In April 2021, we borrowed $15.0 million under the Loan Agreement discussed above under the caption Recent Developments. Outstanding borrowings under the Loan Agreement provided for interest at a floating rate equal to (a) 8.75% per annum plus (b) the greater of (i) the rate per annum published by the Intercontinental Exchange Benchmark Administration Ltd. for a term of one month and (ii) 0.12% per annum. On June 30, 2022, we paid off the outstanding loan amount of $15.0 million and terminated the Loan Agreement in accordance with its terms. In addition to the repayment of principal and accrued interest, we paid (i) a prepayment fee equal to 2.00% of the outstanding principal balance for a total of $300,000, and (ii) a final fee equal to 4.75% of the aggregate amount of the term loans funded for a total of $712,500. The terminated Loan Agreement was secured by substantially all of our assets. The security interests and liens granted in connection with the terminated Loan Agreement were released on June 30, 2022.

30

Cash Flows Summary

Presented below is a summary of our operating, investing, and financing cash flows for the nine months ended March 31, 2023 and 2022 (in thousands):

    

2023

    

2022

    

Change

Net cash provided by (used in):

  

  

  

Operating activities

$

(33,131)

$

(27,506)

$

(5,625)

Investing activities

 

(95,107)

 

 

(95,107)

Financing activities

 

11,571

 

54,875

 

(43,304)

Cash Used in Operating Activities

For the nine months ended March 31, 2023 and 2022, cash used in operating activities amounted to $33.1 million and $27.5 million, respectively. The key components in the calculation of our cash used in operating activities are as follows (in thousands):

    

2023

    

2022

    

Change

Net loss

$

(39,059)

$

(31,637)

$

(7,422)

Non-cash expenses

 

5,759

 

3,259

 

2,500

Non-cash gains, net

 

(708)

 

 

(708)

Changes in operating assets and liabilities, net

 

877

 

872

 

5

Total

$

(33,131)

$

(27,506)

$

(5,625)

For the nine months ended March 31, 2023, our net loss was $39.1 million compared to $31.6 million for the nine months ended March 31, 2022. For further discussion about changes in our operating results for the nine months ended March 31, 2023 and 2022, please refer to Results of Operations above.

For the nine months ended March 31, 2023 and 2022, our non-cash expenses of $5.8 million and $3.3 million, respectively, were primarily attributable to share-based compensation expense, non-cash lease expense, and accretion of debt discount and issuance costs. For the nine months ended March 31, 2023, net non-cash gains of $0.7 million were attributable to accretion of discounts, net of amortization of premiums, related to our investments in marketable debt securities. For the nine months ended March 31, 2023, net changes in operating assets and liabilities increased operating cash flow by $0.9 million, primarily driven by an increase of $1.7 million in accounts payable and other accrued liabilities primarily. This amount was partially offset by reduced cash flows resulting from an increase in prepaid expenses and other assets of $0.8 million. For the nine months ended March 31, 2022, net changes in operating assets and liabilities increased operating cash flow by $0.9 million, primarily driven by an increase in accounts payable and other accrued liabilities.

Cash Provided by Investing Activities

For the nine months ended March 31, 2023, our net cash utilized in investing activities amounted to $95.1 million, primarily related to the purchase of $95.0 million of marketable debt securities. Additionally, $0.1 million of cash utilized in investing activities related to the purchase of furniture and equipment primarily for use in our new office location in Redwood City, California.  We did not have any cash flows from investing activities for the nine months ended March 31, 2022.

Cash Provided by Financing Activities

Net cash provided by financing activities for the nine months ended March 31, 2023 amounted to $11.6 million. This amount consisted of proceeds of $12.3 million from the transactions above.

2022 Private Placement. The Company is currently conducting a convertible notetotal proceeds from the 2022 Private Placement of $12.3 million were partially offset by payments of $0.8 million for underwriting commissions and other costs related to this offering.

31

Net cash provided by financing activities for the nine months ended March 31, 2022 amounted to raise $3$54.9 million. This amount consisted of proceeds of (i) $50.7 million in which we have closed on $500,000from the Underwritten Offering, (ii) $5.0 million from the Registered Direct Offering, (iii) $1.5 million from the EDA, and (iv) $1.2 million from the Purchase Agreement. The total proceeds from equity financing activities of the note financing. The notes also come with warrants at the time the notes are issued. The Company will continue$58.4 million were partially offset by payments of $3.4 million for underwriting discounts and other costs related to close on the note financing while the Company works to complete an Equity Financing. There are no assurances that anyequity offerings, and $0.1 million of the above financings will be completed or will be completed timely and on favorable terms.

Going Concern

The continuation of our business is dependent upon obtaining further financing and achieving a break even or profitable level of operations in our business. Thepayments for debt issuance of additional equity securities by us could result in a significant dilution in the equity interests of our current or future stockholders. Obtaining commercial loans, assuming those loans would be available, will increase our liabilities and future cash commitments. There are no assurances that we will be able to obtain additional financing through either private placements, and/or bank financing or other loans necessary to support our working capital requirements. To the extent that funds generated from operations and any private placements, public offerings and/or bank financing are insufficient, we will have to raise additional working capital. No assurance can be given that additional financing will be available, or if available, will be on terms acceptable to us. These conditions raise substantial doubt about our ability to continue as a going concern.

costs.

Recent Accounting Pronouncements

SeePlease refer to Note 21 to theour unaudited condensed consolidated financial statements included in Part I, Item 1 of this Form 10-QReport regarding the impact of certainrecent accounting pronouncements on our consolidated financial statements.

pronouncements.

Off-Balance Sheet Arrangements

We had nodid not have any off-balance sheet transactions.transactions for the periods covered by this Report.

ITEM

Item 3. QUALITATIVE AND QUANTITATIVE DISCUSSION ABOUT MARKET RISK.

Quantitative and Qualitative Disclosures About Market Risk.

Not required for smaller reporting companies.applicable.

 17

ITEMItem 4. CONTROLS AND PROCEDURES.

Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

As of the end of the period covered by this Quarterly Report on Form 10-Q, we carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer (our principal executive officer) and our Chief Accounting Officer (our principal accountingfinancial officer), of the effectiveness of our disclosure controls and procedures as defined in Rule 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended (“Exchange Act”). Based on that evaluation andassessment under those criteria, our management has determined that our internal control over financial reporting was not effective due to a material weakness in the system of internal control. A material weakness is a deficiency, or combination of deficiencies, that creates a reasonable possibility that a material misstatement of the annual or interim financial statements will not be prevented or detected in a timely manner.

As previously reported on our Annual Report on Form 10-K for the year ended June 30, 2022 in connection with the our assessment of the effectiveness of its internal control over financial reporting at the end of its last fiscal year, the material weakness identified by management is primarily that due to our limited number of employees, we have not adequately segregated certain duties to prevent employees from overriding the internal control system. During the fiscal year ended June 30, 2022, we implemented a more robust accounting software that is expected to result in stronger controls. In October 2022, we hired additional personnel, which will enable us to better segregate many functions. While we believe these are important steps in our ongoing remediation efforts, we cannot provide assurance that these or other measures will eventually result in the elimination of the material weakness described below, our management concluded that we did not maintain effective disclosure controls and procedures as of December 31, 2017 in ensuring that information that we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC rules and forms and that it is accumulated and communicated to the issuer’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate, to allow timely decisions regarding required disclosure. Our management has identified control deficiencies regarding a lack of segregation of duties, a need for a stronger internal control environment, and minimal review of complex accounting issues. Our management believes that these deficiencies, which in the aggregate constitute a material weakness, are due to the small size of our staff, which makes it challenging to maintain adequate disclosure controls.

above.

Changes in internal controls over financial reporting

During the period covered by this Quarterly Report on Form 10-Q, there were no changes in our internal control over financial reporting (as defined in Rule 13(a)-15(f) or 15(d)-15(f)) that occurred during the period covered by this quarterly report that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

32

PART II – OTHER INFORMATION

ITEMItem 1. LEGAL PROCEEDINGS.

Legal Proceedings.

None

Item 1A. Risk Factors.

ITEMOur risk factors are set forth under “Item 1A. RISK FACTORS.Risk Factors” in our 2022 Form 10-K (referred to as our “Legacy Risk Factor Disclosures”). As of the date of this Report, there have been no material changes with respect to Legacy Risk Factor Disclosures except for the risk factors set forth below.

CertainWe could recognize losses on securities held in our securities portfolio, particularly if interest rates increase or economic and market conditions deteriorate.

As of March 31, 2023, the fair value of the investments in our marketable debt securities portfolio was approximately $95.5 million. Factors beyond our control can significantly influence the fair value of securities in our portfolio and can cause potential adverse changes to the fair value of these securities. For example, fixed-rate securities acquired by us are generally subject to decreases in market value when interest rates rise. Additional factors existinclude, but are not limited to, rating agency downgrades of the securities or our own analysis of the value of the security, defaults by the issuer with respect to the underlying securities, and continued instability in the credit markets. Any of the foregoing factors could cause other-than-temporary impairment in future periods and result in realized losses. The process for determining whether impairment is other-than-temporary usually requires difficult, subjective judgments about the future financial performance of the issuer and any collateral underlying the security in order to assess the probability of receiving all contractual principal and interest payments on the security.

As of March 31, 2023, we had $132,000 in net unrealized losses in our marketable securities available-for-sale portfolio, and unrealized losses in our securities portfolio may increase in the future due to the aforementioned economic factors. While our goal is to hold each security until maturity, that may not be possible in light of our policy to preserve capital and liquidity and because investment in securities with unrealized losses has a diminished utility as a source of liquidity prior to maturity. Selling securities with an unrealized loss would result in the realization of such losses, which could have an adverse effect on our financial condition and results of operations.

The collapse of certain banks and potentially other financial institutions may adversely impact us.

On March 10, 2023, Silicon Valley Bank (“SVB”) was shut down, followed on March 11, 2023 by Signature Bank and on May 1, 2023 by First Republic Bank whereby, the Federal Deposit Insurance Corporation was appointed as receiver for each of those banks. As a result, there have been reports of instability at other banks across the globe. Despite the steps taken to date by U.S. agencies to protect depositors, the follow-on effects of the events surrounding the failures of SVB, Signature Bank, and First Republic Bank and the pressure on other banks are unknown. Such effects could include failures of other financial institutions to which we face direct or more significant exposure, and the extent of the impacts relating to financial institution instability or failure is uncertain. Our investment portfolio did not and currently does not contain any securities of SVB, and we did not have any deposit accounts with SVB. We are monitoring the situation and intend to minimize any disruptions to our operations should they arise. However, there may be risks that we have not yet identified, and we cannot guarantee that we will be able to avoid negative consequences directly or indirectly from the foregoing events or other impacts on financial institutions.

Any delays in the commencement or completion, or termination or suspension, of our future clinical trials, if any, could result in increased costs to us, delay or limit our ability to generate revenue and adversely affect our commercial prospects.

Before obtaining approval from the Regulatory Authorities for our drug candidates, we must conduct extensive clinical studies to demonstrate safety and efficacy. Clinical testing is expensive, time consuming and uncertain as to outcome. Any delays in the commencement or completion of our ongoing, planned or future clinical trials could significantly increase our costs, slow down our development and approval process and jeopardize our ability to commence product sales and generate revenues. We do not know whether our planned trials will begin on time or at all, or be completed on schedule, if at all. The commencement and completion of clinical trials can be delayed for a number of reasons, including delays related to:

33

Regulatory Authorities disagreeing as to the design or implementation of our clinical trials or with our recommended dose for any of our pipeline programs;
obtaining Regulatory Authority authorization to commence a trial or reaching a consensus with such Regulatory Authorities on trial design;
obtaining approval from one or more independent institutional review board (“IRB”) or Ethics Committee (“EC”) at each clinical trial site before each trial may be initiated;
IRBs/ECs refusing to approve, suspending or terminating the trial at an investigational site, precluding enrollment of additional subjects, or withdrawing their approval of the trial;
changes to clinical trial protocol;
clinical sites deviating from trial protocol or dropping out of a trial;
failing to manufacture or obtain sufficient quantities of drug candidate, or, if applicable, combination therapies for use in clinical trials;
patients failing to enroll or remain in our trial at the rate we expect, or failing to return for post-treatment follow-up;
patients choosing an alternative treatment, or participating in competing clinical trials;
lack of adequate funding to continue the clinical trial;
patients experiencing severe or unexpected drug-related adverse effects;
occurrence of serious adverse events in trials of the same class of agents conducted by other companies;
selecting or being required to use clinical end points that require prolonged periods of clinical observation or analysis of the resulting data;
a facility manufacturing our drug candidates, or any of their components, including without limitation, our own facilities being ordered by Regulatory Authorities to temporarily or permanently shut down due to violations of current good manufacture practices, regulations or other applicable requirements, or infections or cross-contaminations in the manufacturing process;
lack of stability of our clinical trial material or any quality issues that arise with the clinical trial material;
any changes to our manufacturing process that may be necessary or desired;
our, or our third-party contractors, not performing data collection or analysis in a timely or accurate manner or improperly disclosing data prematurely or otherwise in violation of a clinical trial protocol; or
any third-party contractors becoming debarred or suspended or otherwise penalized by Regulatory Authorities or other government or regulatory bodies for violations of regulatory requirements, in which case we may need to find a substitute contractor, and we may not be able to use some or all of the data produced by such contractors in support of our marketing applications.

We could also encounter delays if a clinical trial is suspended or terminated by us, by the IRBs/ECs of the institutions in which such trials are being conducted, by a Data Safety Monitoring Board for such trial or by Regulatory Authorities. Such authorities may impose such a suspension or termination due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by Regulatory Authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using the product under investigation, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. In addition, changes in regulatory requirements and policies may occur, and we may need to amend clinical trial protocols to comply with these changes. Amendments may require us to resubmit our clinical trial protocols to IRBs/ECs for reexamination, which may affectimpact the Company’s business andcosts, timing or successful completion of a clinical trial.

Any delay in, or failure to receive or maintain, approval for any of our product candidates could cause actual results to differ materiallyprevent us from those expressed in any forward-looking statements. The Company has not experienced any material changes from those risk factors as previously disclosed in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on September 22, 2017 (the “Form 10-K”).ever generating meaningful revenues or achieving profitability.

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

Unregistered Sales of Equity Securities and Use of Proceeds.

None.

ITEMItem 3. DEFAULTS UPON SENIOR SECURITIES.

Defaults Upon Senior Securities.

None.

34

ITEMItem 4. MINE SAFETY DISCLOSURES.

Mine Safety Disclosures.

Not applicable.

 18

ITEMItem 5. OTHER INFORMATION.

Other Information.

None.

35

Item 6. Exhibits.

ITEM 6. EXHIBITS.

The following exhibits are incorporated by reference or filed as part of this Quarterly Report on Form 10-Q:

Exhibit Number

Description of Exhibits

10.1*

Amended and Restated Employment Agreement of Nevan Elam, dated January 8, 2023

10.1

10.2*

LicenseAmended and Restated Employment Agreement with XOMA*%of Brian Roberts, dated January 8, 2023

31.1*

10.2

Common Stock Purchase Agreement with XOMA*%
31.1Certification of Chief Executive and Principal Financial Officer as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*

32.1*

31.2

Certification of Chief Accounting Officer as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*
32.1Certification of Chief Executive and Principal Financial Officer as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002*

101.INS*

Inline XBRL Instance Document

32.2

101.SC*

Certification of Chief Accounting Officer as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002*

Inline XBRL Taxonomy Extension Schema

101.CA*

Inline XBRL Taxonomy Extension Calculation Linkbase

101

101.DEF*

The following materials from our Quarterly Report on Form 10-Q for the quarter ended December 31, 2017

Inline XBRL Taxonomy Extension Definition Linkbase

101.LA*

Inline XBRL Taxonomy Extension Label Linkbase

101.PRE*

Inline XBRL Taxonomy Extension Presentation Linkbase

104

Cover Page Interactive Data File, formatted in Inline XBRL (eXtensible Business Reporting Language): (i) Balance Sheet, (ii) Statement of Operations, (iii) Statements of Cash Flows, (iv) Statements of Stockholders Equity and (v) related notes to these financial statements*(included as Exhibit 101)

* Filed herewith.

*Filed herewith
%Certain portions of this exhibit have been redacted pursuant to a confidential treatment request filed with the Commission on February 14, 2018.

 19

36

SIGNATURES

In accordance with Section 12 of the Securities Exchange Act of 1934, the Registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

REZOLUTE, INC.

REZOLUTE, INC.

Date: February 14, 2018May 11, 2023

By:

/s/ Nevan Charles Elam

Nevan Charles Elam

Chief Executive Officer

(Principal Executive and Financial Officer)

Date:  February 14, 2018By:/s/ Morgan Fields
Morgan Fields
Chief Accounting Officer
(Principal Accounting Officer)

 20

37