s

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 10-Q

[X]

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

For the quarterly period Septemberended June 30, 20172023

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:

001-37348

001-37348

Corbus Pharmaceuticals Holdings, Inc.

(Exact name of registrant as specified in its charter)

Delaware46-4348039

Delaware

46-4348039

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification Number)

100500 River Ridge Drive

Norwood, MA

02062

(Address of principal executive offices)

(Zip code)

(617)963-0100

(Registrant’s telephone number, including area code)

(Former Name, Former Address and Former Fiscal Year if Changed Since Last Report): N/A

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

Title of Each Class

Trading Symbol

Name of Each Exchange on Which Registered

Common Stock, par value $0.0001 per share

CRBP

The 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. Yes [X] 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). Yes [X] No [  ]

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

Large accelerated filer

[  ]

Accelerated filer

[X]

Non-accelerated filer

[  ]

 (Do not check if a smaller reporting company)

Smaller reporting company

[  ]

Emerging growth company

[X]

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

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

As of November 3, 2017, 54,873,010August 4, 2023, 4,423,683 shares of the registrant’s common stock, $0.0001 par value, were issued and outstanding.


CORBUS PHARMACEUTICALS HOLDINGS, INC.

Quarterly Report on Form 10-Q for the Quarter Ended SeptemberJune 30, 20172023

TABLE OF CONTENTS

  Page
 PART I 
   
 FINANCIAL INFORMATION 
   
1.Condensed Consolidated Financial Statements 
 Condensed Consolidated Balance Sheets as of September 30, 2017 (unaudited) and December 31, 20163
 Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2017 and 2016 (unaudited)4
 Condensed Consolidated Statement of Stockholders’ Equity for the Nine Months Ended September 30, 20175
 Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2017 and 2016 (unaudited)6
 Notes to Unaudited Condensed Consolidated Financial Statements7
2.Management’s Discussion and Analysis of Financial Condition and Results of Operations19
3.Quantitative and Qualitative Disclosures about Market Risk26
4.Controls and Procedures26
   
 PART II 
   
 OTHER INFORMATION 
   
1.Legal Proceedings26
1A.Risk Factors26
2.Unregistered Sales of Equity Securities and Use of Proceeds27
3.Defaults Upon Senior Securities27
4.Mine Safety Disclosures27
5.Other Information27
6.Exhibits27

2

Page

PART I

FINANCIAL INFORMATION

1. Condensed Consolidated Financial Statements (unaudited)

3

Condensed Consolidated Balance Sheets as of June 30, 2023 and December 31, 2022

3

Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Six Months Ended June 30, 2023 and 2022

4

Condensed Consolidated Statement of Stockholders’ Equity for the Three and Six Months Ended June 30, 2023 and 2022

5

Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2023 and 2022

7

Notes to Condensed Consolidated Financial Statements

8

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

26

3. Quantitative and Qualitative Disclosures about Market Risk

32

4. Controls and Procedures

32

PART II

OTHER INFORMATION

1. Legal Proceedings

34

1A. Risk Factors

34

2. Unregistered Sales of Equity Securities and Use of Proceeds

35

3. Defaults Upon Senior Securities

35

4. Mine Safety Disclosures

35

5. Other Information

35

6. Exhibits

36

-2-


PART I — FINANCIAL INFORMATION

Item 1. Financial Statements.

Corbus Pharmaceuticals Holdings, Inc.

Condensed Consolidated Balance Sheets (Unaudited)

 September 30, 2017 December 31, 2016 

 

June 30, 2023

 

 

December 31, 2022

 

 (Unaudited)   

 

 

 

 

 

 

ASSETS     

 

 

 

 

 

 

Current assets:     

 

 

 

 

 

 

Cash and cash equivalents $36,597,469  $14,992,257 

 

$

8,349,346

 

 

$

17,002,715

 

Investments

 

 

28,216,560

 

 

 

42,194,296

 

Restricted cash 200,000 150,000 

 

 

192,475

 

 

 

192,475

 

Grants receivable 500,000 1,000,000 
Stock subscriptions receivable  330,413 
Prepaid expenses and other current assets  719,868  930,261 

 

 

1,515,616

 

 

 

791,616

 

Total current assets 38,017,337 17,402,931 

 

 

38,273,997

 

 

 

60,181,102

 

Restricted cash  50,000 

 

 

477,425

 

 

 

477,425

 

Property and equipment, net 337,297 435,251 

 

 

1,273,602

 

 

 

1,613,815

 

Operating lease right of use assets

 

 

3,486,416

 

 

 

3,884,252

 

Other assets  65,026   

 

 

211,943

 

 

 

155,346

 

Total assets $38,419,660 $17,888,182 

 

$

43,723,383

 

 

$

66,311,940

 

LIABILITIES AND STOCKHOLDERS’ EQUITY     

 

 

 

 

 

 

Current liabilities:     

 

 

 

 

 

 

Notes payable $ $271,757 

 

$

51,157

 

 

$

353,323

 

Accounts payable 3,776,516 3,419,921 

 

 

1,505,734

 

 

 

2,173,963

 

Accrued expenses 2,558,602 3,256,455 

 

 

6,418,803

 

 

 

5,999,252

 

Deferred revenue  1,940,195 
Deferred rent, current    10,263 

Derivative liability

 

 

36,868

 

 

 

36,868

 

Operating lease liabilities, current

 

 

1,357,240

 

 

 

1,280,863

 

Current portion of long-term debt

 

 

7,016,096

 

 

 

2,795,669

 

Total current liabilities 6,335,118 8,898,591 

 

 

16,385,898

 

 

 

12,639,938

 

Deferred rent, noncurrent 102,561 65,724 
Other liabilities  1,482  4,632 

Long-term debt, net of debt discount

 

 

11,319,365

 

 

 

15,984,426

 

License agreement payable, noncurrent

 

 

2,500,000

 

 

 

 

Other long-term liabilities

 

 

22,205

 

 

 

22,205

 

Operating lease liabilities, noncurrent

 

 

3,975,329

 

 

 

4,675,354

 

Total liabilities 6,439,161 8,968,947 

 

 

34,202,797

 

 

 

33,321,923

 

Commitments and Contingencies     
Stockholders’ equity     

 

 

 

 

 

 

Preferred stock, $0.0001 par value; 10,000,000 shares authorized, no shares issued and outstanding at September 30, 2017 and December 31, 2016   
Common stock, $0.0001 par value; 150,000,000 shares authorized, 50,223,010 and 44,681,745 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively 5,022 4,468 

Preferred stock, $0.0001 par value; 10,000,000 shares authorized, no shares
issued and outstanding at June 30, 2023 and December 31, 2022. See Note 11

 

 

 

 

 

 

Common stock, $0.0001 par value; 300,000,000 shares authorized,
4,422,741 and 4,171,297 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively

 

 

442

 

 

 

417

 

Additional paid-in capital 86,979,888 42,191,256 

 

 

428,153,252

 

 

 

425,196,359

 

Accumulated deficit  (55,004,411)  (33,276,489)

 

 

(418,609,320

)

 

 

(392,080,667

)

Accumulated other comprehensive loss

 

 

(23,788

)

 

 

(126,092

)

Total stockholders’ equity  31,980,499  8,919,235 

 

 

9,520,586

 

 

 

32,990,017

 

Total liabilities and stockholders’ equity $38,419,660 $17,888,182 

 

$

43,723,383

 

 

$

66,311,940

 

See notes to the unaudited condensed consolidated financial statements.

-3-

3

Corbus Pharmaceuticals Holdings, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

 For the Three Months Ended For the Nine Months Ended 
 September 30, September 30, 

 

For the Three Months
Ended June 30,

 

 

For the Six Months
Ended June 30,

 

 2017 2016 2017 2016 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Collaboration revenue $796,312 $742,558  $2,440,195 $1,535,754 
Operating expenses:         

 

 

 

 

 

 

 

 

 

 

 

 

Research and development 5,622,511 4,315,632 17,752,283 10,056,568 

 

$

4,248,705

 

 

$

2,499,642

 

 

$

17,637,048

 

 

$

5,785,878

 

General and administrative  2,130,587  1,760,696  6,388,802  3,891,810 

 

 

3,940,286

 

 

 

4,840,368

 

 

 

7,848,968

 

 

 

10,071,291

 

Litigation settlement

 

 

 

 

 

5,000,000

 

 

 

 

 

 

5,000,000

 

Total operating expenses  7,753,098  6,076,328  24,141,085  13,948,378 

 

 

8,188,991

 

 

 

12,340,010

 

 

 

25,486,016

 

 

 

20,857,169

 

Operating loss (6,956,786) (5,333,770) (21,700,890) (12,412,624)

 

 

(8,188,991

)

 

 

(12,340,010

)

 

 

(25,486,016

)

 

 

(20,857,169

)

Other income (expense), net:         
Interest income, net 43,402 1,731 50,039 420 
Foreign currency exchange loss  (52,212)  (14,729)  (77,071)  (16,196)

Other expense, net:

 

 

 

 

 

 

 

 

 

 

 

 

Other income (expense), net

 

 

182,657

 

 

 

(208,683

)

 

 

412,164

 

 

 

(402,034

)

Interest expense, net

 

 

(775,586

)

 

 

(490,339

)

 

 

(1,453,608

)

 

 

(949,248

)

Foreign currency exchange loss, net

 

 

(1,921

)

 

 

(209,856

)

 

 

(1,193

)

 

 

(477,679

)

Other expense, net  (8,810)  (12,998)  (27,032)  (15,776)

 

 

(594,850

)

 

 

(908,878

)

 

 

(1,042,637

)

 

 

(1,828,961

)

Net loss $(6,965,596) $(5,346,768) $(21,727,922) $(12,428,400)

 

$

(8,783,841

)

 

$

(13,248,888

)

 

$

(26,528,653

)

 

$

(22,686,130

)

Net loss per share, basic and diluted $(0.14) $(0.12) $(0.44) $(0.31)

 

$

(2.05

)

 

$

(3.18

)

 

$

(6.27

)

 

$

(5.44

)

Weighted average number of common shares outstanding, basic and diluted  50,221,597  43,783,504  48,946,335  40,059,364 

 

 

4,277,701

 

 

 

4,170,464

 

 

 

4,229,894

 

 

 

4,170,255

 

 

 

 

 

 

 

 

 

 

 

 

 

Comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(8,783,841

)

 

$

(13,248,888

)

 

$

(26,528,653

)

 

$

(22,686,130

)

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

Change in unrealized gain (loss) on marketable debt securities

 

 

44,681

 

 

 

50,373

 

 

 

102,304

 

 

 

(56,875

)

Total other comprehensive income (loss)

 

 

44,681

 

 

 

50,373

 

 

 

102,304

 

 

 

(56,875

)

Total comprehensive loss

 

$

(8,739,160

)

 

$

(13,198,515

)

 

$

(26,426,349

)

 

$

(22,743,005

)

See notes to the unaudited condensed consolidated financial statements.

4

-4-


Corbus Pharmaceuticals Holdings, Inc.

Condensed Consolidated Statement of Stockholders’ Equity

(Unaudited)

     Additional     Total 
  Common Stock  Paid-in  Accumulated  Stockholders’ 
  Shares  Amount  Capital  Deficit  Equity 
Balance at December 31, 2016 (audited)  44,681,745  $4,468  $42,191,256  $(33,276,489) $8,919,235 
Issuance of common stock, net of issuance costs of $492,674  5,301,448   530   40,446,092      40,446,622 
Stock based compensation expense        4,233,511      4,233,511 
Issuance of common stock upon exercise of stock options  239,817   24   109,029      109,053 
Net loss           (21,727,922)  (21,727,922)
Balance at September 30, 2017  50,223,010  $5,022  $86,979,888  $(55,004,411) $31,980,499 

5

Corbus Pharmaceuticals Holdings, Inc.

Condensed Consolidated Statements of Cash FlowsStockholders’ Equity

(Unaudited)

  Nine Months Ended 
  September 30, 
  2017  2016 
Cash flows from operating activities:        
Net loss $

(21,727,922

) $(12,428,400)
Adjustments to reconcile net loss to net cash used in operating activities:        
Share-based compensation expense  4,233,511   1,522,345 
Depreciation and amortization  191,093   57,695 
Unrealized loss on foreign exchange  39,492    
Deferred rent  26,574    
Changes in operating assets and liabilities:        
Decrease in grants receivable  500,000    
Decrease in prepaid expenses  210,393   60,717 
Increase in other assets  (65,026)   
Increase in accounts payable  517,677   1,448,004 
(Decrease) increase in accrued expenses  

(668,286

)  1,772,585 
Decrease in deferred revenue  (1,940,195)  (535,753)
Increase in other long-term liabilities     10,205 
Net cash used in operating activities  (18,682,689)  (8,092,602)
Cash flows from investing activities:        
Purchases of property and equipment  (127,246)  (257,014)
Net cash used in investing activities  (127,246)  (257,014)
Cash flows from financing activities:        
Principal payments on notes payable  (271,757)  (162,019)
Proceeds from issuance of common stock  41,378,762   15,235,283 
Issuance costs paid for common stock financings  (689,023)   
Principal payments on capital lease obligation  (2,835)  (2,575)
Net cash provided by financing activities  40,415,147   15,070,689 
Net increase in cash, cash equivalents, and restricted cash  21,605,212   6,721,073 
Cash, cash equivalents, and restricted cash at beginning of the period  15,192,257   12,374,650 
Cash, cash equivalents, and restricted cash at end of the period $36,797,469  $19,095,723 
Supplemental disclosure of cash flow information and non-cash transactions:        
Cash paid during the period for interest $10,691  $3,815 
Cash paid during the period for income taxes $  $1,877 
Asset acquired under capital lease obligation $  $11,638 
Purchases of property and equipment included in accounts payable $  $13,999 

 

 

For the Three Months Ended June 30, 2023

 

 

 

Common Stock

 

 

Additional
Paid-in

 

 

Accumulated

 

 

Accumulated
Other
Comprehensive

 

 

Total
Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Loss

 

 

Equity

 

Balance at March 31, 2023

 

 

4,215,133

 

 

$

422

 

 

$

426,352,478

 

 

$

(409,825,479

)

 

$

(68,469

)

 

$

16,458,952

 

Issuance of common stock, net of issuance costs of $4,404

 

 

13,164

 

 

 

1

 

 

 

102,418

 

 

 

 

 

 

 

 

 

102,419

 

Issuance of common stock upon conversion of K2 Loan and Security Agreement

 

 

194,444

 

 

 

19

 

 

 

874,981

 

 

 

 

 

 

 

 

 

875,000

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

823,375

 

 

 

 

 

 

 

 

 

823,375

 

Change in unrealized gain (loss) on marketable debt securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

44,681

 

 

 

44,681

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(8,783,841

)

 

 

 

 

 

(8,783,841

)

Balance at June 30, 2023

 

 

4,422,741

 

 

$

442

 

 

$

428,153,252

 

 

$

(418,609,320

)

 

$

(23,788

)

 

$

9,520,586

 

 

 

For the Three Months Ended June 30, 2022

 

 

 

Common Stock

 

 

Additional
Paid-in

 

 

Accumulated

 

 

Accumulated
Other
Comprehensive

 

 

Total
Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Loss

 

 

Equity

 

Balance at March 31, 2022

 

 

4,170,464

 

 

$

417

 

 

$

420,495,566

 

 

$

(359,171,006

)

 

$

(169,693

)

 

$

61,155,284

 

Issuance of common stock, net of issuance costs of $0

 

 

417

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

1,513,089

 

 

 

 

 

 

 

 

 

1,513,089

 

Change in unrealized gain (loss) on marketable debt securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

50,373

 

 

 

50,373

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(13,248,888

)

 

 

 

 

 

(13,248,888

)

Balance at June 30, 2022

 

 

4,170,881

 

 

$

417

 

 

$

422,008,655

 

 

$

(372,419,894

)

 

$

(119,320

)

 

$

49,469,858

 

See notes to the unaudited condensed consolidated financial statements.

6

-5-


 

 

For the Six Months Ended June 30, 2023

 

 

 

Common Stock

 

 

Additional
Paid-in

 

 

Accumulated

 

 

Accumulated
Other
Comprehensive

 

 

Total
Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Loss

 

 

Equity

 

Balance at December 31, 2022

 

 

4,171,297

 

 

$

417

 

 

$

425,196,359

 

 

$

(392,080,667

)

 

$

(126,092

)

 

$

32,990,017

 

Issuance of common stock, net of issuance costs of $4,404

 

 

13,164

 

 

 

1

 

 

 

102,418

 

 

 

 

 

 

 

 

 

102,419

 

Issuance of common stock upon conversion of K2 Loan and Security Agreement

 

 

194,444

 

 

 

19

 

 

 

874,981

 

 

 

 

 

 

 

 

 

875,000

 

Issuance of common stock upon exercise of stock options

 

 

43,836

 

 

 

5

 

 

 

129,740

 

 

 

 

 

 

 

 

 

129,745

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

1,849,754

 

 

 

 

 

 

 

 

 

1,849,754

 

Change in unrealized gain (loss) on marketable debt securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

102,304

 

 

 

102,304

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(26,528,653

)

 

 

 

 

 

(26,528,653

)

Balance at June 30, 2023

 

 

4,422,741

 

 

$

442

 

 

$

428,153,252

 

 

$

(418,609,320

)

 

$

(23,788

)

 

$

9,520,586

 

 

 

For the Six Months Ended June 30, 2022

 

 

 

Common Stock

 

 

Additional
Paid-in

 

 

Accumulated

 

 

Accumulated
Other
Comprehensive

 

 

Total
 Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Loss

 

 

Equity

 

Balance at December 31, 2021

 

 

4,169,631

 

 

$

416

 

 

$

418,903,820

 

 

$

(349,733,764

)

 

$

(62,445

)

 

$

69,108,027

 

Issuance of common stock, net of issuance costs of $0

 

 

1,250

 

 

 

1

 

 

 

 

 

 

 

 

 

 

 

 

1

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

3,104,835

 

 

 

 

 

 

 

 

 

3,104,835

 

Change in unrealized gain (loss) on marketable debt securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(56,875

)

 

 

(56,875

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

(22,686,130

)

 

 

 

 

 

(22,686,130

)

Balance at June 30, 2022

 

 

4,170,881

 

 

$

417

 

 

$

422,008,655

 

 

$

(372,419,894

)

 

$

(119,320

)

 

$

49,469,858

 

See notes to the unaudited condensed consolidated financial statements.

-6-


Corbus Pharmaceuticals Holdings, Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

 

 

Six Months Ended
June 30,

 

 

 

2023

 

 

2022

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(26,528,653

)

 

$

(22,686,130

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

Stock-based compensation expense

 

 

1,849,754

 

 

 

3,104,835

 

Depreciation and amortization

 

 

340,213

 

 

 

387,803

 

Net amortization on (discount) premium of investments

 

 

(278,677

)

 

 

661,398

 

(Gain) loss on foreign exchange

 

 

(4,388

)

 

 

631,213

 

Amortization of debt discount

 

 

430,367

 

 

 

357,464

 

Realized loss on investments

 

 

1,528

 

 

 

118,671

 

Loss on sale of property and equipment

 

 

 

 

 

21,235

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

(Increase) decrease in prepaid expenses and other current assets

 

 

(698,679

)

 

 

622,737

 

Increase in other assets

 

 

(56,598

)

 

 

(57,780

)

Decrease in operating lease right of use asset

 

 

397,836

 

 

 

351,033

 

Increase in other long-term liabilities

 

 

2,500,000

 

 

 

 

Decrease in accounts payable

 

 

(663,843

)

 

 

(426,868

)

Increase (decrease) in accrued expenses

 

 

419,551

 

 

 

(5,376,890

)

Decrease in operating lease liabilities

 

 

(623,648

)

 

 

(553,125

)

Net cash used in operating activities

 

 

(22,915,237

)

 

 

(22,844,404

)

Cash flows from investing activities:

 

 

 

 

 

 

Purchases of investments

 

 

(23,930,480

)

 

 

(66,366,447

)

Proceeds from sales and maturities of investments

 

 

38,287,670

 

 

 

90,637,466

 

Purchases of property and equipment

 

 

 

 

 

(13,449

)

Proceeds from sale of property and equipment

 

 

 

 

 

8,100

 

Net cash provided by investing activities

 

 

14,357,190

 

 

 

24,265,670

 

Cash flows from financing activities:

 

 

 

 

 

 

Repayment of short-term borrowings

 

 

(302,166

)

 

 

(657,233

)

Proceeds from issuance of common stock

 

 

236,568

 

 

 

 

Issuance costs paid for common stock financings

 

 

(29,724

)

 

 

 

Net cash used in financing activities

 

 

(95,322

)

 

 

(657,233

)

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

 

 

(8,653,369

)

 

 

764,033

 

Cash, cash equivalents, and restricted cash at beginning of the period

 

 

17,672,615

 

 

 

25,676,532

 

Cash, cash equivalents, and restricted cash at end of the period

 

$

9,019,246

 

 

$

26,440,565

 

Supplemental disclosure of cash flow information and non-cash transactions:

 

 

 

 

 

 

Cash paid during the period for interest

 

$

1,321,575

 

 

$

887,428

 

Stock subscription receivable

 

$

40,928

 

 

$

 

Issuance of common stock for conversion of convertible debt

 

$

875,000

 

 

$

 

Write off of fully depreciated property and equipment

 

$

178,492

 

 

$

 

See notes to the unaudited condensed consolidated financial statements.

-7-


Corbus Pharmaceuticals Holdings, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

Nine Months Ended SeptemberJune 30, 20172023

1.NATURE OF OPERATIONS

1.NATURE OF OPERATIONS

Business

Corbus Pharmaceuticals Holdings, Inc. (the “Company” or “Corbus”) is a clinical stage pharmaceuticalprecision oncology company focusedcommitted to helping people defeat serious illness by bringing innovative scientific approaches to well understood biological pathways. Corbus' internally developing pipeline includes CRB-701, a next generation antibody drug conjugate ("ADC") that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload, and CRB-601, an anti-integrin monoclonal antibody that blocks the developmentactivation of TGFβ expressed on cancer cells. The Company has also developed CRB-913, an endocannabinoid small molecule drug, for the treatment of obesity and commercialization of novel therapeuticsis seeking partners to treat rare, chronic, and serious inflammatory and fibrotic diseases.fund further development. Since its inception, the Company has devoted substantially all of its efforts to business planning, research and development, recruiting management and technical staff, acquiring operating assets and raising capital. The Company’s business is subject to significant risks and uncertainties and the Company will be dependent on raising substantial additional capital before it becomes profitable, and it may never achieve profitability.

The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All significant intercompany transactions and accounts have been eliminated in consolidation. In the opinion of management of the Company, the accompanying unaudited condensed consolidated interim financial statements reflect all adjustments (which include only normal recurring adjustments) necessary to present fairly, in all material respects, the condensed consolidated financial position of the Company as of SeptemberJune 30, 2017,2023 and the results of its operations and changes in stockholders’ equity for the three months and ninesix months ended SeptemberJune 30, 20172023 and 20162022 and its cash flows for the ninesix months ended SeptemberJune 30, 20172023 and 2016.2022. The December 31, 20162022 condensed consolidated balance sheet was derived from audited financial statements. The Company prepared the condensed consolidated financial statements following the requirements of the SECU.S. Securities and Exchange Commission (the “SEC”) for interim reporting. Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP") have been condensed or omitted. It is suggested that these condensed consolidated financial statements be read in conjunction with the financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016,2022, filed on March 8, 2017.7, 2023 (the “2022 Annual Report”). The results of operations for such interim periods are not necessarily indicative of the operating results for the full fiscal year.

2.LIQUIDITY AND GOING CONCERN

2.LIQUIDITY

The accompanying condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the normal course of business. The Company has incurred recurring losses since inception and as of June 30, 2023, had an accumulated deficit of approximately $418,609,000. The Company anticipates operating losses and negative cash flows from operations to continue for the foreseeable future due to, among other things, costs related to research funding, development of its product candidates and its preclinicalpre-clinical and clinical programs, strategic alliances and the development of its administrative organization. The Company has incurred recurring losses since inception and as of September 30, 2017, had an accumulated deficit of $55,004,411. On October 26, 2017, the Company consummated an underwritten public offering of shares of its common stock pursuant to which the Company sold an aggregate of 4,650,000 shares of its common stock to institutional investors at a purchase price of $7.00 per share with net proceeds to the Company totaling approximately $30,397,000 (“October 2017 Offering”) (See Notes 9 and 13). The Company expects the cash, on handcash equivalents, and investments of $36,597,469$36,566,000 at SeptemberJune 30, 2017 together with the proceeds from the October 2017 Offering and the remaining milestone payment of $500,000 from the Cystic Fibrosis Foundation Therapeutics, Inc. (“CFFT”), which the Company received in the fourth quarter of 2017 (See Note 8), to2023 will not be sufficient to meet its operating and capital requirements at least 12twelve months from the filingissuance of this Quarterly Report on Form 10-Q.

Should the Company be unable to raise sufficient additional capital, the Company may be required to undertake cost-cutting measures including delaying or discontinuing certain clinical activities. The Company will need to raise significant additional capital to continue to fund the clinical trials for anabasum.CRB-701 and CRB-601. The Company may seek to sell common or preferred equity or convertible debt securities, enter into a credit facility or another form of third-party funding, or seek other debt financing. In addition, the Company may seek to raise cash through collaborative agreements or from government grants. The sale of equity and convertible debt securities may result in dilution to the Company’s stockholders and certain of those securities may have rights senior to those of the Company’s common shares. If the Company raises additional funds through the issuance of preferred stock, convertible debt securities or other debt financing, these securities or other debt could contain covenants that would restrict the Company’s operations. Any other third-party funding arrangement could require the Company to relinquish valuable rights.

7

The source, timing and availability of any future financing will depend principally upon market conditions, and, more specifically, on the progress of the Company’s clinical development programs. Funding may not be available when needed, at all, or on terms acceptable to the Company. Lack of necessary funds may require the Company to, among other things, to delay, scale back or eliminate some or all of the Company’s planned pre-clinical or clinical trials. These factors, among others, cause management to conclude there is a substantial doubt about the Company’s ability to continue as a going concern. There have been no adjustments made to these consolidated financial statements as a result of these uncertainties.

-8-

3.SIGNIFICANT ACCOUNTING POLICIES

On May 31, 2023, the Company entered into Amendment No. 1 to the Open Market Sale Agreement originally dated August 6, 2020(the “May 2023 Sale Agreement”) with Jefferies LLC (“Jefferies”), as sales agent, pursuant to which the Company may issue and sell, from time to time, through Jefferies, shares of its common stock, and pursuant to which Jefferies may sell its common stock by any method permitted by law deemed to be an “at the market offering” as defined by Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended. The Company will pay Jefferies a commission of 3.0% of the aggregate gross proceeds from each sale of common stock and have agreed to provide Jefferies with customary indemnification and contribution rights. The Company has also agreed to reimburse Jefferies for certain specified expenses. As of June 13, 2023, the Company was authorized to offer and sell up to $16,800,000 of its common stock pursuant to the May 2023 Sale Agreement. During the three months ended June 30, 2023, the Company sold 13,164 shares of its common stock for which the Company received gross proceeds of approximately $107,000, less issuance costs incurred of approximately $4,400 (see Note 12).

3.SIGNIFICANT ACCOUNTING POLICIES

A summary of the significant accounting policies followed by the Company in the preparation of the condensed consolidated financial statements is as follows:

Basis of Presentation

The accompanying financial statements have been prepared in accordance with U.S. GAAP.

Reverse Stock Split

On February 14, 2023, the Company completed a 1-for-30 reverse stock split of its outstanding common stock (the “Reverse Stock Split”). The Reverse Stock Split did not change the number of authorized shares of common stock or par value. All references in these condensed consolidated financial statements to shares, share prices, exercise prices, and other per share information in all periods have been adjusted, on a retroactive basis, to reflect the Reverse Stock Split (see Note 12).

Consolidation

The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All significant intercompany transactions and accounts have been eliminated in consolidation.

Use of Estimates

The process of preparing financial statements in conformity with accounting principles generally accepted in the United States of AmericaU.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, andthe disclosure of assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates and changes in estimates may occur. The most significant estimates are related to the expected performance period under the Company’s development award agreement with CFFT (See Note 8), stock basedstock-based compensation andexpense, the accrual of research, product development and clinical obligations.obligations, and the valuation of warrants (see Note 9 and Note 14) and the derivative liability associated with the K2 Loan and Security Agreement (see Note 15).

 

Prior to the registration of its common stock-9-


Cash, Cash Equivalents, and the subsequent public listing of the common stock, the Company had granted stock options at exercise prices not less than the fair value of its common stock as determined by the board of directors, with input from management. The Company’s board of directors determined the estimated fair value of the common stock based on a number of objective and subjective factors, including external market conditions affecting the biotechnology industry sector and the historic prices at which the Company sold shares of preferred stock.

Reclassifications

The Company hasreclassified certain prior period amounts to conform to the current period financial statement presentation, specifically in the presentation of the cash flow statement for the comparable prior period as a result of the Company’s early adoption in the fourth quarter of 2016 of ASU No. 2016-18,Restricted Cash (a consensus of the FASB Emerging Issues Task Force) (“ASU 2016-18”). ASU 2016-18 requires companies to show the changes in the total of cash, cash equivalents, restricted cash and restricted cash equivalents in the statement of cash flows and as a result, transfers between cash and cash equivalents and restricted cash and restricted cash equivalents will no longer be presented in the statement of cash flows. ASU 2016-18 is being applied using a retrospective transition method to each period presented. The impact on prior periods was not material to the Company’s financial statements.

Cash and Cash Equivalents

The Company considers only those investments which are highly liquid, readily convertible to cash, and that mature within three months90 days from date of purchase to be cash equivalents. Marketable investments are those with maturities in excess of three months. At SeptemberJune 30, 20172023 and December 31, 2016,2022, cash equivalents were comprised of money market funds. The Company had no marketable investments at September 30, 2017funds, commercial paper, and December 31, 2016.other debt securities with maturities less than three months from the date of purchase.

Restricted cash as of SeptemberJune 30, 2017 and December 31, 20162023 included a $150,000 collateral accountsecurity for the Company’s corporate credit cards and is classified in current assets. Additionally, as of September 30, 2017 and December 31, 2016 restricted cash included a stand-by letter of credit issued in favor of a landlord for $50,000$669,900 of which $192,475 was classified in current assets as of September 30, 2017 and $477,425 was classified in noncurrent assets as of December 31, 2016 (See Note 5).June 30, 2023.

8

Cash, and cash equivalents, and restricted cash consist of the following:

 September 30, 2017 December 31, 2016 

 

June 30, 2023

 

 

December 31, 2022

 

Cash $219,141  $1,127,530 

 

$

1,728,888

 

 

$

3,805,156

 

Money market fund  36,378,328   13,864,727 

Cash equivalents

 

 

6,620,458

 

 

 

13,197,559

 

Cash and cash equivalents  36,597,469   14,992,257 

 

$

8,349,346

 

 

$

17,002,715

 

        

 

 

 

 

 

 

Restricted cash, current  200,000   150,000 

 

 

192,475

 

 

 

192,475

 

Restricted cash, noncurrent     50,000 

 

 

477,425

 

 

 

477,425

 

Restricted cash  200,000   200,000 

 

$

669,900

 

 

$

669,900

 

Total cash, cash equivalents, and restricted cash shown in the statement of cash flows $36,797,469  $15,192,257 

 

$

9,019,246

 

 

$

17,672,615

 

Financial Instruments

The carrying amounts reported inAs of June 30, 2023, all of the consolidated balance sheet forCompany’s cash and cash equivalents receivables, accounts payablewas held in the United States ("U.S."), except for approximately $1,109,000 of cash which was held in its subsidiaries in the United Kingdom and accrued expenses approximateAustralia. As of December 31, 2022, all of the Company’s cash was held in the U.S., except for approximately $2,805,000 of cash which was held in its subsidiaries in the United Kingdom and Australia.

Investments

Investments consist of debt securities with maturities greater than 90 days at their acquisition date. The Company has classified its investments with maturities beyond one year as current, based on their highly liquid nature and because such investments represent the investment of cash that is available for current operations.

The Company classifies all of its marketable debt securities as available-for-sale securities. The Company’s marketable debt securities are measured and reported at fair value basedusing quoted prices in active markets for similar securities. Unrealized gains and losses on available-for-sale debt securities that are not related to credit losses are reported as accumulated other comprehensive gain or loss, which is a separate component of stockholders’ equity. The cost of debt securities sold is determined on a specific identification basis, and realized gains and losses are included in other income (expense), net in the short-term naturecondensed consolidated statements of operations and comprehensive loss.

The Company evaluates its marketable debt securities with unrealized losses for impairment. When assessing marketable debt securities for potential impairment, the Company considers available evidence, including the extent to which fair value is less than cost, whether an allowance for credit loss is required, and adverse factors that could affect the value of the securities. An impairment has occurred if the Company does not expect to recover the entire amortized cost basis of the marketable debt security. If the Company does not intend to sell the impaired debt security and it is not more likely than not required to sell the debt security before the recovery of its amortized cost basis, the amount of the impairment related to credit losses is recognized in an allowance for credit losses with an offsetting entry to Other income (expense), net. The remaining portion of the impairment related to other factors is recognized in Other comprehensive loss. Realized gains and losses for debt securities are included in Other income (expense), net. No such adjustments were necessary during the periods presented.

Concentrations of Credit Risk

The Company has no significant off-balance-sheet concentration of credit risk such as foreign exchange contracts, option contracts or other hedging arrangements. The Company may, from time to time, have cash in its U.S. banks in excess of Federal Deposit Insurance Corporation insurance limits and in its foreign banks in excess of their local insurance limits. However, the Company believes the risk of loss is minimal as these instruments. banks are large financial institutions.

-10-


Financial Instruments

The carrying values of the notes payable and debt approximate their fair value due to theirthe fact that they are at market terms.

Fair Value Measurements

The valuation of the Company’s debt and embedded derivatives are determined primarily by an income approach that considers the present value of net cash flows of the debt with and without prepayment and default features. These embedded debt features, which are determined to be classified as derivative liabilities are marked-to-market each reporting period, with a corresponding non-cash gain or loss charged to the current period. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, there exists a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:

Level 1 – Unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access as of the measurement date.

Level 2 – Inputs other than quoted prices included within Level 1 that are directly observable for the asset or liability or indirectly observable through corroboration with observable market data.

Level 3 – Unobservable inputs for the asset or liability only used when there is little, if any, market activity for the asset or liability at the measurement date.

The Company’s investments, debt, and its derivative liabilities are carried at fair value determined according to the fair value hierarchy described above. The carrying values of the Company’s prepaid expenses and other current assets and accrued expenses approximate their fair values due to the short-term nature of these assets and liabilities.

To determine the fair value of our embedded derivatives, management evaluates assumptions regarding the probability of certain future events. Other factors used to determine fair value include the discount rate, risk-free interest rate and derivative term. The fair value recorded for the derivative liability varies from period to period. This variability may result in the actual derivative liability for a period either above or below the estimates recorded on our condensed consolidated financial statements, resulting in fluctuations in other income (expense) because of the corresponding non-cash gain or loss recorded.

Property and Equipment

The estimated life for the Company’s property and equipment is as follows: three years for computer hardware and software and three to five years for office furniture and equipment. The Company’s leasehold improvements and assets under capital lease are amortized over the shorter of their useful lives or the respective leases. See Note 47 for details of property and equipment and Note 58 for operating and capital lease commitments.

Leases

Research

The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets and Development Expensesoperating lease liabilities current and Collaborative Research Agreementsnoncurrent in the Company’s condensed consolidated balance sheets.

Costs incurredROU assets represent the Company’s right to use an underlying asset for researchthe lease term and development are expensed as incurred.

For amounts received under the development awardlease liabilities represent its obligation to make lease payments arising from the CFFT (See Note 8),lease. ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As the Company’s leases do not provide an implicit rate, the Company uses an incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. This is the rate the Company would have to pay if borrowing on a collateralized basis over a similar term to each lease. The ROU asset also includes any lease payments made and excludes lease incentives. Lease expense for lease payments is recognized those amounts when the triggering event to receive those payments occurred, with those amounts being amortized on a straight-line basis over the expected durationlease term.

The Company has subleased a portion of its leased facility under an agreement considered to be an operating lease according to U.S. GAAP. The Company has not been legally released from its primary obligations under the original lease and therefore it continues to account for the original lease as it did before commencement of the remaining performance periodsublease. The Company will record both fixed and variable payments received from the sublessee in its statement of the development program under the award, which concluded in the third quarter of 2017.operations on a straight-line basis as an offset to rent expense.

-11-


Accruals for Research and Development Expenses and Clinical Trials

As part of the process of preparing its financial statements, the Company is required to estimate its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants, and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment terms that do not match the periods over which materials or services are provided under such contracts. The Company’s objective is to reflect the appropriate expenses in its financial statements by matching those expenses with the period in which services are performed and efforts are expended. The Company accounts for these expenses according to the timing of various aspects of the expenses. The Company determines accrual estimates by taking into account discussiondiscussions with applicable internal personnel and outside service providers as to the progress of clinical trials, or the services completed. During the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations (“CROs”) and other third-party vendors. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in it reporting amounts that are too high or too low for any particular period. For the three and ninesix months ended SeptemberJune 30, 20172023 and 2016,2022, there were no material adjustments to the Company’s prior period estimates of accrued expenses for clinical trials.

9

Revenue Recognition

Concentrations

We recognize revenue in accordance with Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers (“ASC 606”), which applies to all contracts with customers, except for contracts that are within the scope of Credit Risk

The Company has no significant off-balance-sheet concentration of credit riskother standards, such as foreignleases, insurance, collaboration arrangements, and financial instruments. Under ASC 606, we recognize revenue when our customer obtains control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange contracts, option contractsfor those goods or other hedging arrangements. The Company may from timeservices. To determine revenue recognition for arrangements that we determine are within the scope of ASC 606, we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to timethe performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy a performance obligation. At contract inception, once the contract is determined to be within the scope of ASC 606, we assess the goods or services promised within each contract and determine those that are performance obligations and assess whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.

Research and Development Expenses

Costs incurred for research and development are expensed as incurred.

Nonrefundable advance payments for goods or services that have cashthe characteristics that will be used or rendered for future research and development activities pursuant to executory contractual arrangements with third party research organizations are deferred and recognized as an expense as the related goods are delivered or the related services are performed.

Asset Acquisitions

We account for asset acquisitions under the accounting standards for business combinations and research and development, as applicable. In-process research and development acquired in banks in excessan asset acquisition is expensed immediately unless there is an alternative future use. Subsequent payments made for the achievement of Federal Deposit Insurance Corporation insurance limits. However, the Company believes the risk of loss is minimal as these banksmilestones are large financial institutions.evaluated to determine whether they have an alternative future use or should be expensed.

Segment Information

Operating segments are identified as components of an enterprise forabout which separate discrete financial information is usedavailable for evaluation by the chief operating decision maker, or decision makingdecision-making group, in making decisions regarding resource allocation and assessing performance. To date, the Company has viewed its operations and manages its business as principally one operating segment, which is developing and commercializing therapeutics to treat rare life-threating, inflammatory fibrotic diseases.for cancer. As of SeptemberJune 30, 2017 and December 31, 2016,2023, all of the Company’s assets were located in the U.S., except for approximately $1,109,000 of cash and cash equivalents and $933,000 of prepaid expenses and other assets which were held outside of the U.S., principally in its subsidiary in the United States.Kingdom. As of December 31, 2022, all of the Company’s assets were located in the U.S., except for approximately $2,805,000 of cash and cash equivalents and $136,000 of prepaid expenses and other assets which were held outside of the U.S., principally in its subsidiary in the United Kingdom.

-12-


Income Taxes

For federal and state income taxes, deferred tax assets and liabilities are recognized based upon temporary differences between the financial statement and the tax basis of assets and liabilities. Deferred income taxes are based upon prescribed rates and enacted laws applicable to periods in which differences are expected to reverse. A valuation allowance is recorded to reduce a net deferred tax assetbenefit when it is not more likely than not that the tax benefit from the deferred tax assets will not be realized. Accordingly, given the cumulative losses since inception, the Company has provided a valuation allowance equal to 100%100% of the deferred tax assetassets in order to eliminate the deferred tax assets amounts.

Tax positions taken or expected to be taken in the course of preparing the Company’s tax returns are required to be evaluated to determine whether the tax positions are “more-likely-than-not” of being sustained by the applicable tax authority. Tax positions not deemed to meet a more-likely-than-not threshold, as well as accrued interest and penalties, if any, would be recorded as a tax expense in the current year. There were no uncertain tax positions that require accrual or disclosure to the financial statements as of SeptemberJune 30, 20172023 or December 31, 2016.2022.

Impairment of Long-lived Assets

The Company continually monitors events and changes in circumstances that could indicate that carrying amounts of long-lived assets may not be recoverable. An impairment loss is recognized when expected undiscounted cash flows of an asset are less than an asset’s carrying value. Accordingly, when indicators of impairment are present, the Company evaluates the carrying value of such assets in relation to the operating performance and future undiscounted cash flows of the underlying assets. An impairment loss equal to the excess of the fair value of the asset over its carrying amount is recorded when it is determined that the carrying value of the asset may not be recoverable. NoThe Company notes no impairment charges were recorded duringtaken in the three and ninesix months ended SeptemberJune 30, 20172023 and 2016.2022.

Stock-based Payments

Share-based Payments

The Company recognizes compensation costs resulting from the issuance of stock-based awards, including stock options and restricted stock units (“RSUs”), to employees, non-employees and directors as an expense in the statementstatements of operations and comprehensive loss over the service period based on a measurement of fair value for each stock-based award. The fair value of each stock option grant is estimated as of the date of grant using the Black-Scholes option-pricing model. The fair value of restricted stock units is the quoted closing market price per share on the grant date. Forfeitures are estimated on the grant date based on historical experience and management’s expectations of future forfeitures. To the extent actual forfeitures differ from the estimates, the difference is recorded as a cumulative adjustment in the period in which the estimates are revised. The fair value of each grant is amortized as compensation cost on a straight-line basis over the requisite service period of the awards, which is generally the vesting period. Stock options granted to non-employee consultants

Foreign Currency

Transaction gains and losses arising from currency exchange rate fluctuations on transactions denominated in a currency other than the U.S. Dollar functional currency are revaluedrecorded in Other income (expense), net in the Company’s statements of operations and comprehensive loss. Such transaction gains and losses may be realized or unrealized depending upon whether the transaction settled during the period or remains outstanding at the endbalance sheet date. The functional currency of each reporting period until vested and the changes in their fair value are recorded as adjustments to expense overCompany's foreign subsidiaries is the related vesting period.

10

U.S. Dollar.

Net Loss Per Common Share

Basic and diluted net loss per share of the Company’s common stock has been computed by dividing net loss by the weighted average number of common shares outstanding during the period. For yearsperiods in which there is a net loss, options warrants and convertible securitieswarrants are anti-dilutive and therefore are excluded from diluted loss per share calculations. The following table sets forth the computation of basic and diluted earnings per share for the three and ninesix months ended SeptemberJune 30, 20172023 and 2016:2022:

 

  Three Months Ended September 30  Nine Months Ended September 30 
  2017  2016  2017  2016 
Basic and diluted net loss per share of common stock:                
Net loss $(6,965,596) $(5,346,768) $(21,727,922) $(12,428,400)
Weighted average shares of common stock outstanding  50,221,597   43,783,504   48,946,335   40,059,364 
Net loss per share of common stock-basic and diluted $(0.14) $(0.12) $(0.44) $(0.31)

 

 

Three Months Ended
June 30,

 

 

Six Months Ended
June 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Net loss

 

$

(8,783,841

)

 

$

(13,248,888

)

 

$

(26,528,653

)

 

$

(22,686,130

)

Weighted average number of common shares-basic

 

 

4,277,701

 

 

 

4,170,464

 

 

 

4,229,894

 

 

 

4,170,255

 

Net loss per share of common stock-basic

 

$

(2.05

)

 

$

(3.18

)

 

$

(6.27

)

 

$

(5.44

)

The following potentially dilutive securities for the three-13-


Warrants and nine months ended September 30, 2017stock options that have not been exercised and 2016unvested restricted stock units (see Notes 13 and 14) have been excluded from the computationdiluted calculation as all periods presented have a net loss and the impact of dilutive weighted average shares outstandingthese securities would be anti-dilutive.

Recently Adopted Accounting Pronouncements

In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), which requires the measurement and recognition of expected credit losses for financial assets held at amortized cost. ASU 2016-13 replaces the existing incurred loss impairment model with an expected loss model. It also eliminates the concept of other-than-temporary impairment and requires credit losses related to available-for-sale debt securities to be recorded through an allowance for credit losses rather than as a reduction in the amortized cost basis of the securities. These changes may result in earlier recognition of credit losses. In November 2018, the FASB issued ASU No. 2018-19, Codification Improvements to Topic 326, Financial Instruments—Credit Losses, which narrowed the scope and changed the effective date for non-public entities for ASU 2016-13. The FASB subsequently issued supplemental guidance within ASU No. 2019-05, Financial Instruments—Credit Losses (Topic 326): Targeted Transition Relief (“ASU 2019-05”). ASU 2019-05 provides an option to irrevocably elect the fair value option for certain financial assets previously measured at amortized cost basis. The Company's adoption of ASU 2016-13 as of January 1, 2023 had no impact on the Company's financial statements as there are no assets held at amortized cost on the balance sheet, and there are no credit losses associated with our available-for-sale debt securities.

In August 2020, the FASB issued 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 Convertible Instruments and Contracts in an Entity’s Own Equity which is intended to simplify various aspects of U.S. GAAP for certain financial instruments with characteristics of liabilities and equity. The Company's early adoption of ASU 2020-06 as of January 1, 2023 had no impact on the Company's financial statements and disclosures.

Recently Issued Accounting Pronouncements

The Company considers the applicability and impact of all ASUs. Management determined that recently issued ASUs are not expected to have a material impact on its condensed consolidated financial statements.

4. INVESTMENTS

The following table summarizes the Company’s investments as of June 30, 2023:

 

 

Amortized Cost

 

 

Gross
Unrealized
Gain

 

 

Gross
Unrealized
Losses

 

 

Fair Value

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Debt Securities:

 

 

 

 

 

 

 

 

 

 

 

 

Commercial paper

 

$

12,913,815

 

 

$

 

 

$

(968

)

 

$

12,912,847

 

Corporate debt securities

 

 

15,326,533

 

 

 

9

 

 

 

(22,829

)

 

 

15,303,713

 

Total

 

$

28,240,348

 

 

$

9

 

 

$

(23,797

)

 

$

28,216,560

 

The following table summarizes the amortized cost and fair value of the Company’s available-for-sale marketable securities by contractual maturity as of June 30, 2023:

 

 

Amortized Cost

 

 

Fair Value

 

 

 

 

 

 

 

 

Maturing in one year or less

 

$

28,240,348

 

 

$

28,216,560

 

Maturing after one year but less than three years

 

 

 

 

 

 

 

$

28,240,348

 

 

$

28,216,560

 

The following table summarizes the Company’s investments as of December 31, 2022:

-14-


 

 

Amortized Cost

 

 

Gross
Unrealized
Gain

 

 

Gross
Unrealized
Losses

 

 

Fair Value

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Debt Securities:

 

 

 

 

 

 

 

 

 

 

 

 

Commercial paper

 

$

12,173,980

 

 

$

 

 

$

 

 

$

12,173,980

 

Corporate debt securities

 

 

30,146,060

 

 

 

 

 

 

(125,744

)

 

 

30,020,316

 

Total

 

$

42,320,040

 

 

$

 

 

$

(125,744

)

 

$

42,194,296

 

The following table summarizes the amortized cost and fair value of the Company’s available-for-sale marketable securities by contractual maturity as of December 31, 2022:

 

 

Amortized Cost

 

 

Fair Value

 

 

 

 

 

 

 

 

Maturing in one year or less

 

$

42,320,040

 

 

$

42,194,296

 

Maturing after one year but less than three years

 

 

 

 

 

 

 

$

42,320,040

 

 

$

42,194,296

 

5. FAIR VALUE OF FINANCIAL ASSETS AND LIABILITIES

The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values as of June 30, 2023:

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Cash Equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

6,620,458

 

 

$

 

 

$

 

 

$

6,620,458

 

Investments:

 

 

 

 

 

 

 

 

 

 

 

 

Commercial paper

 

 

 

 

 

12,912,847

 

 

 

 

 

 

12,912,847

 

Corporate debt securities

 

 

 

 

 

15,303,713

 

 

 

 

 

 

15,303,713

 

 

$

6,620,458

 

 

$

28,216,560

 

 

$

 

 

$

34,837,018

 

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

Derivative liabilities

 

$

 

 

$

 

 

$

36,868

 

 

$

36,868

 

The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values as of December 31, 2022:

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Cash Equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

Money Market funds

 

$

8,470,790

 

 

$

 

 

$

 

 

$

8,470,790

 

Commercial paper

 

 

 

 

 

1,494,538

 

 

 

 

 

 

1,494,538

 

Corporate debt securities

 

 

 

 

 

3,232,231

 

 

 

 

 

 

3,232,231

 

Investments:

 

 

 

 

 

 

 

 

 

 

 

 

Commercial paper

 

 

 

 

 

12,173,980

 

 

 

 

 

 

12,173,980

 

Corporate debt securities

 

 

 

 

 

30,020,316

 

 

 

 

 

 

30,020,316

 

 

$

8,470,790

 

 

$

46,921,065

 

 

$

 

 

$

55,391,855

 

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

Derivative liabilities

 

$

 

 

$

 

 

$

36,868

 

 

$

36,868

 

-15-


6.LICENSE AGREEMENTS

The Company entered into a license agreement (the “Jenrin License Agreement”) with Jenrin Discovery, LLC ("Jenrin"), a privately-held Delaware limited liability company, effective September 20, 2018. Pursuant to the Jenrin License Agreement, Jenrin granted the Company exclusive worldwide rights to develop and commercialize the Licensed Products (as defined in the Jenrin Agreement) which includes the Jenrin library of over 600 compounds and multiple issued and pending patent filings. The compounds are designed to treat inflammatory and fibrotic diseases by targeting the endocannabinoid system.

In consideration of the license and other rights granted by Jenrin, the Company paid Jenrin a $250,000 upfront cash payment and is obligated to pay potential milestone payments to Jenrin totaling up to $18,400,000 for each compound it elects to develop based upon the achievement of specified development and regulatory milestones. In addition, Corbus is obligated to pay Jenrin royalties in the mid, single digits based on net sales of any Licensed Products, subject to specified reductions.

The Company entered into a license agreement (the “Milky Way License Agreement”) with Milky Way BioPharma, LLC (“Milky Way”), a subsidiary of Panorama Research Inc., effective May 25, 2021. Pursuant to the Milky Way License Agreement, the Company received an exclusive license, under certain patent rights and know-how owned or controlled by Milky Way, to develop, commercialize, and otherwise exploit products containing antibodies against integrin αvβ6 and/or integrin αvβ8 (“Licensed Products”), one of which the Company is referring to as CRB-602. Under the terms of the Milky Way License Agreement, the Company will have sole responsibility for research, development, and commercialization of any Licensed Products, and Company has agreed to use commercially reasonable efforts to perform these activities. The Milky Way Agreement may be terminated earlier in specified situations, including termination for material breach or termination by Corbus with advance notice.

In consideration for the computation of dilutive net loss per share as the inclusion would be anti-dilutive

  

Three and Nine Months Ended

September 30,
 
  2017  2016 
Warrants  1,288,500   1,789,250 
Stock options  7,724,779   5,932,679 
Total  9,013,279   7,721,929 

On October 26, 2017,license and other rights granted to the Company consummatedunder the Milky Way License Agreement, the Company paid Milky Way an underwritten public offeringupfront payment of $500,000 and issued to Milky Way 147,875 shares of its common stock pursuantstock. The Company is obligated to whichpay up to $53,000,000 in potential milestone payments for the achievement of certain development, regulatory, and sales milestones. At the Company’s election, the Company sold an aggregatemay satisfy a portion of 4,650,000certain milestone payments by issuing shares of its common stockstock. In addition, the Company is obligated to institutional investors atpay royalties in the low, single digits on sales of Licensed Products during the life of the applicable licensed patents on a purchase pricecountry-by-country and product-by-product basis, which is subject to a minimum annual royalty obligation, as well as a percentage share of $7.00 per sharecertain payments received by Company from sublicensees.

The Company entered into a license agreement (the “UCSF License Agreement”) with net proceedsthe Regents of the University of California (“The Regents”) effective May 26, 2021. Pursuant to the UCSF License Agreement, the Company received an exclusive license to certain patents relating to humanized antibodies against integrin αvβ8, one of which the Company is referring to as CRB-601, along with non-exclusive licenses to certain related know-how and materials. The Company amended the UCSF License Agreement with The Regents effective November 17, 2022 adding additional antibody patents to the agreement.

-16-


In consideration for the license and other rights granted to the Company totaling approximately $30,397,000 (“October 2017 Offering”) (See Notes 9under the UCSF License Agreement, the Company paid The Regents a license issue fee of $1,500,000. In consideration for the additional antibody patents granted to the Company, the Company will pay The Regents a license issue fee of $750,000, payable in two equal installments of $375,000 (first payment paid during the first quarter 2023 and 13)the second payment due on the first anniversary of the Amendment Effective Date).

Recent Accounting Pronouncements

Revenue Recognition

In May 2014,addition to the FASB issued guidance codifiedlicense issuance fees, the Company is obligated to pay an annual license maintenance fee, as well as up to $153,150,000 inAccounting Standards Codification (ASC) 606, Revenue Recognition — Revenue from Contracts with Customers (“ASC 606”) which amends potential milestone payments, excluding indication milestones for antibodies used for diagnostic products and services that will be an additional $50,000 for each new indication, for the guidance in formerASC 605, Revenue Recognition,achievement of certain development, regulatory, and sales milestones. In addition, the Company is effective for public companies for annual and interim periods beginning after December 15, 2017. Specifically, the new standard differs from the current accounting standard in many respects, such asalso obligated to pay royalties in the accountinglower, single digits on sales of products falling within the scope of the licensed patents, which is subject to a minimum annual royalty obligation, and a percentage share of certain payments received by Company from sublicensees or in connection with the sale of the licensed program.

The Company entered into a license agreement (the “CSPC License Agreement”) with CSPC Megalith Biopharmaceutical Co., Ltd ("CSPC"), a subsidiary of CSPC Pharmaceutical Group Limited, effective February 12, 2023. Pursuant to the CSPC License Agreement, the Company received an exclusive license to develop and commercialize a novel clinical stage antibody drug conjugate targeting Nectin-4, which the Company is referring to as CRB-701, in the U.S., Canada, the European Union (including the European Free Trade Area), the United Kingdom, and Australia.

In consideration for variable consideration received, includingthe license granted to the Company under the CSPC License Agreement, the Company will pay CSPC an upfront payment of $7,500,000 ($5,000,000 paid at signing during the first quarter 2023 followed by a $2,500,000 payment due after eighteen months). The Company is obligated to pay potential milestone payments or contingentto CSPC totaling up to $130,000,000 based upon the achievement of specified development and regulatory milestones and $555,000,000 in potential commercial milestone payments. UnderIn addition, we are obligated to pay royalties in the Company’s current accounting policy,low double digits based on net sales of any Licensed Products, as defined in the CSPC License Agreement.

The Company determined that substantially all of the fair value of the Jenrin License Agreement and CSPC License Agreement was attributable to a single in-process research and development asset which did not constitute a business. The Company determined that substantially all of the fair value of the Milky Way License Agreement and the UCSF License Agreement was attributable to separate groups of in-process research and development assets which did not constitute a business. The Company concluded that it did not have any alternative future use for the acquired in-process research and development assets. Thus, the Company recorded the various upfront payment to research and development expenses in the quarter the license deals became effective. The Company will account for the development, regulatory, and sales milestone payments are initially recognized as revenue only in the period that the payment-triggering event occurredrelevant milestones are achieved as either research and development expense or was achieved (See Note 8). ASC 606, however, may require to recognize such payments beforeas an intangible asset as applicable. In the payment-triggering event is completely achieved based on the Company’s estimate of the amount of consideration to which it will be entitled in exchange for transferring the services, subject to management’s assessment of whether it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The Company plans to adopt ASC 606 in the first quarter of 2018 using the modified retrospective method according to which the cumulative effect of initially applying ASC 606 is recognized at the date of initial application. Sincesix months ended June 30, 2023, the Company has concluded its performance obligationsrecorded the $7,500,000 upfront license payment to CSPC as research and has completed recognizing revenuedevelopment expense, which includes $2,500,000 in other long-term liabilities. In addition, the Company recorded a $1,200,000 development milestone as research and development expense, which includes $1,100,000 as accrued pre-clinical and clinical costs under the collaboration agreement with CFFT inUCSF License Agreement for the filing of patent rights. For the three months ended SeptemberJune 30, 2017 (See Note 8) and since the Company has not yet commercialized its product, the Company does not expect to2023, no other milestone payments have a cumulative effect at the date of adoption or for the adoption of ASC 606 to have a material effect on its financial statements. If and when the Company will sign new collaboration or revenue generating agreements, the Company will assess the accounting for those new agreementsbeen made under ASC 606.

11

Accounting for Leases

In February 2016, the FASB issued ASU No.2016-02,Leases (Topic 842)(“ASU 2016-02”).Under ASU 2016-02, a lessee will be required to recognize assets and liabilities for leases with lease terms of more than 12 months. Consistent with current GAAP, the recognition, measurement, and presentation of expenses and cash flows arising from a lease by a lessee primarily will depend on its classification as a finance or operating lease. However, unlike current GAAP, which requires only capital leases to be recognized on the balance sheet, ASU 2016-02 will require both types of leases to be recognized on the balance sheet. ASU 2016-02 will take effect for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018, with early application permitted. Management has not yet determined if it will adopt ASU 2016-02 earlier than the required adoption date. The adoption of ASU 2016-02 will have an impact on the Company’s financial position as the Company has operating lease commitments for office space as of September 30, 2017 with future non-cancelable lease payments amounting to $5,543,755 (see Note 5) for which ASU 2016-02 would apply.

Employee Share-Based Payment Accounting

On March 30, 2016, the FASB issued ASU No. 2016-09,Compensation—Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting(“ASU 2016-09”).ASU 2016-09 simplifies several aspectsany of the accounting for employee share-based payment transactions including the accounting for income taxes, forfeitures, and statutory tax withholding requirements, as well as classification in the statement of cash flows. ASU 2016-09 took effect for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2016. In the first quarter of 2017, when the Company adopted ASU 2016-09 it did not elect to account for forfeitures as they occur but rather to continue to estimate forfeitures at grant date. As a result the adoption of ASU 2016-09 did not have an impact on the Company’s consolidated financial statements.other above agreements.

7.PROPERTY AND EQUIPMENT

4.PROPERTY AND EQUIPMENT

Property and equipment consisted of the following:

 September 30, 2017  December 31, 2016 
      

 

June 30,
2023

 

 

December 31,
2022

 

Computer hardware and software $121,905  $96,131 

 

$

83,711

 

 

$

262,203

 

Office furniture and equipment  284,558   259,138 

 

 

1,113,980

 

 

 

1,113,980

 

Leasehold improvements  191,244   188,219 

 

 

3,330,855

 

 

 

3,330,855

 

Construction in progress  38,920    
Property and equipment, gross  636,627   543,488 

 

 

4,528,546

 

 

 

4,707,038

 

Less: accumulated depreciation  (299,330)  (108,237)

 

 

(3,254,944

)

 

 

(3,093,223

)

Property and equipment, net $337,297  $435,251 

 

$

1,273,602

 

 

$

1,613,815

 

Depreciation expense was $126,641$158,343 and $20,464$192,084 for the three months ended SeptemberJune 30, 20172023 and 2016,2022, respectively and $191,093$340,213 and $57,695$387,803 for the ninesix months ended SeptemberJune 30, 20172023 and 2016,2022, respectively.

On December 30, 2015, the Company entered into a lease agreement for a copier machine. The cost of the machine was approximately $12,000 and is included in office furniture and equipment category in the table above. The lease payments commenced when the machine was placed in service in January 2016. The machine is being amortized over the life of the lease, which is for a three-year term and includes a bargain purchase option at the end of the term. See Note 5 for details of this capital lease commitment.

12

5.COMMITMENTS AND CONTINGENCIES

-17-


8.COMMITMENTS AND CONTINGENCIES

Operating Lease Commitment

In September 2016, the Company amended its commercial lease for office space to expand into an additional 4,088 square feet of office space within the existing building for an aggregate total of 10,414 square feet of leased office space (“September 2016 Amendment”). The Company began occupying this space in early November 2016 and the final lease payment was to be due in January 2021. The September 2016 Amendment required an increase in the standby letter of credit to $50,000 (See Note 4). The September 2016 Amendment will be terminated upon the commencement date of the August 2017 Lease Agreement discussed below.

On August 21, 2017, the Company entered into a lease agreement (“August 2017 Lease Agreement”) with the existing landlord, pursuant to which the Company agreed to lease 32,733 square feet of office space (“Leased Premises”) in a building different than under the September 2016 Amendment. The initial term of the August 2017 Lease Agreement is for a period of seven years and is expected to begin upon the earlier of the date of completion of the Company’s work to be performed to prepare the Leased Premises for its initial occupancy or February 18, 2018. The base rent for the Leased Premises ranges from approximately $470,000 for the first year to $908,341 for the seventh year. Additionally, the August 2017 Lease Agreement required a standby irrevocable letter of credit of $400,000, which may be reduced, if the Company is not in default under the August 2017 Lease Agreement, to $300,000 and $200,000 on the third and fourth anniversary of the commencement date, respectively, The Company entered into an unsecured letter of credit for $400,000 in connection with the August 2017 Lease Agreement for which it incurred interest expense of $8,669 in the three and nine months ended September 30, 2017.

The Company records the total rent payable during the lease term on a straight-line basis over the term of the lease and records the difference between the rents paid and the straight-line rent as deferred rent, which is classified in deferred rent, current and deferred rent, noncurrent in the Company’s balance sheet as of September 30, 2017 and December 31, 2016.

Pursuant to the terms of the Company’s non-cancelable lease agreements in effect at SeptemberJune 30, 2017,2023, the future minimum rent commitments arefollowing table summarizes the Company’s maturities of operating lease liabilities as follows:of June 30, 2023:

2017 (remainder of year) $81,576 
2018  432,889 
2019  623,958 
2020  784,243 
2021  830,600 
2022  855,150 
Thereafter  1,935,339 
Total $5,543,755 

2023

 

$

853,956

 

2024

 

 

1,747,447

 

2025

 

 

1,794,889

 

2026

 

 

1,688,145

 

Total lease payments

 

$

6,084,437

 

 

 

 

Less: imputed interest

 

 

(751,868

)

Total

 

$

5,332,569

 

Total rent expenseSublease Commitment

Effective August 26, 2021, the Company entered into a sublease agreement with a third party to sublease 12,112 square feet of the 30,023 square feet currently being leased under one of its two existing lease agreements. The sublease commenced on October 1, 2021 and ends October 31, 2026. The Company notes sublease income of $59,133 and $55,133 for the three months ended SeptemberJune 30, 20172023 and 2016 was $92,6712022, respectively and $37,666, respectively. Total rent expense$114,266 and $110,266 for the ninesix months ended SeptemberJune 30, 20172023 and 20162022, respectively was $209,687recognized and $111,878, respectively.offset against rent expense.

Undiscounted sublease cash inflows have been summarized in the following table:

2023

 

$

134,241

 

2024

 

 

279,585

 

2025

 

 

291,697

 

2026

 

 

252,333

 

Total sublease payments

 

$

957,856

 

9.NOTES PAYABLE

Capital Lease Commitment

D&O Financing

The lease payments under the capital lease agreement for the copier machine commenced when the machine was placed in service in January 2016. The lease is for a three-year term and includes a bargain purchase option at the end of the term. In the accompanying balance sheet as of September 30, 2017, the current portion of this capital lease obligation is classified in accrued expenses and the long-term portion of the capital lease obligation is classified in other long-term liabilities. Pursuant to the terms of this capital lease agreement, the future minimum capital lease commitments are as follows as of September 30, 2017:

13

2017 (remainder of year) $1,136 
2018  4,543 
2019  379 
Total future minimum lease payments  6,058 
Less: interest  (430)
Future capital lease obligations  5,628 
Less: current portion  (4,146)
Long-term portion $1,482 

6.NOTES PAYABLE

In November 2015,2021, the Company entered into a loan agreement with a financing company for $207,750$984,375 to finance one of the Company’s insurance policies. The terms of the loan stipulatedstipulate equal monthly payments of principal and interest payments of $23,397$111,041 over a nine-month period.period. Interest accrues on this loan was accrued at an annual rate of 3.25%3.64%. This loan was fully repaid in July 2016.2022.

In October 2016,November 2022, the Company entered into a loan agreement with a financing company for $348,750$452,250 to finance one of the Company’s insurance policies. The terms of the loan stipulatedstipulate equal monthly payments of principal and interest payments of $39,114$51,387 over a nine-month period.period. Interest accruedaccrues on this loan at an annual rate of 2.25%5.4%. This loan was fully repaid in July 2017. Prepaid expenses as of SeptemberJune 30, 20172023 and December 31, 20162022, included $30,000approximately $167,500 and $378,750,$418,750, respectively, related to thisthe underlying insurance policy.policy being financed.

For three months ended September 30, 2017

-18-


Loan and 2016, interest expense for notes payable totaled $73 and $63, respectively. For nine months ended September 30, 2017 and 2016, interest expense for notes payable totaled $2,042 and $1,760, respectively.Security Agreement with K2 HealthVentures LLC

Notes payable consisted of the following:

  September 30, 2017  December 31, 2016 
       
Notes payable $  $271,757 
Less: current portion     (271,757)
Long term portion $  $ 

7.ACCRUED EXPENSES

Accrued expenses consisted of the following:

  September 30, 2017  December 31, 2016 
       
Accrued clinical operations and trials costs $1,395,736  $1,647,490 
Accrued product development costs  885,063   713,426 
Accrued compensation  131,905   778,250 
Accrued other  145,898   117,289 
Total $2,558,602  $3,256,455 

14

8.DEVELOPMENT AWARD AND DEFERRED REVENUE

On April 20, 2015,July 28, 2020, the Company, with its subsidiary, Corbus Pharmaceuticals, Inc., as borrower, entered into a secured Loan and Security Agreement with K2 HealthVentures LLC (“K2HV”), an award agreement with the CFFT, a non-profit drug discoveryunrelated third party (the “Loan and development affiliate of the Cystic Fibrosis Foundation, pursuant to which it received a development award (the “Award”Security Agreement”) for up to $5 million in funding. The funding from the Award supported a first-in-patient Phase 2 clinical trial of the Company’s oral anti-inflammatory drug anabasum in adults with cystic fibrosis (“CF”). The Company has billed and received $5.0 million in payments since the inception of the Award as outlined below. $20,000,000 upon signing. The payments received under the award were recorded as deferred revenue when the triggering event to receive those amounts has occurredloan matures on August 1, 2024 and were amortized on a straight-line basis over the expected duration of the remaining performance period under the Award which concluded in the third quarter of 2017.

Upon the execution of the Award agreement, the Company received a payment of $1,250,000 in May 2015. In November 2015, the Company received a second payment of $1,250,000 upon the achievement of a milestone for dosing the first patient. In August 2016, the Company received a third payment from the CFFT in the amount of $1,000,000 for achieving a milestone in July 2016 related to dosing the median clinical trial patient. In January 2017, the Company received a fourth payment from the CFFT in the amount of $1,000,000 for achieving a milestone in December 2016 related to completing the final visit for the final patient, which was billed by the Company to CFFT in December 2016 and was classified in grants receivable as of December 31, 2016. The Company achieved the final milestone in September 2017 related to the issuance to CFFT of the final integrated statistical report related to the Phase 2 CF clinical trial. At that time the Company had completed all its performance obligations under the contract and therefore the performance period had concluded. The final milestone amount of $500,000 was billed by the Company to CFFT in September 2017 and was classified in grants receivable as of September 30, 2017. The Company received the $500,000 milestone payment under the Award from CFFT in November 2017.

Pursuant to the terms of the Award agreement, the Company is obligated to make royaltyinterest only payments for the first 24 months and then interest and equal principal payments for the next 24 months commencing on September 1, 2022. The Company entered into an Amendment to CFFT contingentthe Loan and Security Agreement (the "Amended Loan and Security Agreement") on October 25, 2022. The Amended Loan and Security Agreement defers the commencement of principal repayments by a one-year period from September 1, 2022 to September 1, 2023 and if the Company raises at least $30 million in net proceeds through capital raising transactions, the commencement of principal repayments will be deferred by an additional six months to March 1, 2024. Interest accrues at a variable annual rate equal to the greater of (i) 8.5% and (ii) the rate of interest noted in The Wall Street Journal, Money Rates section, as the “Prime Rate” plus 5.25%, in each case, subject to a step-down of 25 basis points upon commercializationthe funding of anabasumthe second tranche. The interest rate used at June 30, 2023 was 13.5%.

In accordance with ASC Topic No. 470-50, “Debt – Modifications and Extinguishments” (Topic No. 470), the amendment noted above was determined to be a modification, thus no gain or loss was recorded.

Pursuant to the Loan and Security Agreement, K2HV may elect to convert up to $5,000,000 of the outstanding loan balance into shares of the Company’s common stock at a conversion price of $282.00 per share. The Amended Loan and Security Agreement adjusts the conversion price of $2,000,000 of the maximum $5,000,000 convertible amount by adjusting the conversion price of $875,000 of the loan from $282.00 per share to $4.50 per share, and $1,125,000 of the loan from $282.00 per share to $7.875 per share. The remaining $3,000,000 will continue to have a conversion price of $282.00 per share. The decrease in the Fieldconversion price resulted in an increase in the fair value of Usethe conversion option of $573,000, which was recorded as an increase to the debt discount and additional paid in capital as of December 31, 2022. On June 1, 2023, K2HV converted $875,000 of the outstanding loan balance into 194,444 shares of the Company's stock at a conversion price of $4.50 per share. As of June 30, 2023, $4,125,000 of the outstanding loan balance remains available to convert into shares of the Company's common stock.


In connection with the Loan and Security Agreement, on July 28, 2020, the Company issued K2HV a warrant to purchase up to 2,874 common shares (the “K2 Warrant”) at an exercise price of $208.80 (the “Warrant Price”). The K2 Warrant may be exercised either for cash or on a cashless “net exercise” basis and expires on July 28, 2030. The total proceeds attributed to the K2 Warrant was approximately $472,000 based on the relative fair value of the K2 Warrant as compared to the sum of the fair values of the K2 Warrant, prepayment feature, default feature, and debt. Total proceeds attributed to the prepayment and default features was approximately $546,000. The Company also incurred approximately $1,244,000 of debt issuance costs from the Loan and Security Agreement. In connection with entering into the Amended Loan and Security Agreement, the Company incurred an additional $119,000 of debt issuance costs. The proceeds attributed to the K2 Warrant, the prepayment and default features, and the debt issuance costs are all included in the debt discount. The Company is required to make a final payment in excess of the stated principal equal to $1,590,000. See Note 14 for more detail on assumptions used in the valuation of the K2 warrant and see Note 15 for more information on the assumptions used in valuation of the default and prepayment features.

The total principal amount of the loan under the Amended Loan and Security Agreement outstanding at June 30, 2023, including the $1,590,000 final payment discussed above, is $20,715,000.

Upon the occurrence of an Event of Default (as defined in the Award agreement)Loan and Security Agreement), and during the continuance of an Event of Default, the applicable rate of interest, described above, will be increased by 5.00% per annum. The secured term loan maturity date is August 1, 2024, and the Loan and Security Agreement includes both financial and non-financial covenants. The Company was in compliance with these covenants as follows: (i)of June 30, 2023. The obligations under the Loan and Security Agreement are secured on a royalty payment equal to five timessenior basis by a lien on substantially all of the amountassets of the Company receivesand its subsidiaries. The subsidiaries of the Company are guarantors of the obligations of the Company under the Award agreement, upLoan and Security Agreement.

The total debt discount related to $25 million, payable in three equal annual installments following the first commercial saleAmended Loan and Security Agreement of anabasum,approximately $2,954,000 is being charged to interest expense using the firsteffective interest method over the term of the debt. At June 30, 2023 and December 31, 2022, the fair value of our outstanding debt, which is due within 90 days following the first commercial sale of anabasum, (ii) a royalty payment to CFFT equal to the amount the Company receives under the Award agreement, up to $5 million, dueconsidered level 3 in the first calendar year in whichfair value hierarchy, approximates carrying value. Interest expense for the aggregate cumulativethree and six months ended June 30, 2023 was approximately $970,000 and $1,907,000, respectively. Interest expense for the three and six months ended June 30, 2022 was $698,000 and $1,382,000, respectively.

-19-


The net sales of anabasum in the Field of Use exceed $500 million, and (iii) royalty payment(s) to CFFT of up to approximately $15 million if the Company transfers, sells or licenses anabasum in the Field of Use other than for certain clinical or development purposes, or if the Company enters into a change of control transaction, with such payment(s) to be credited against the royalty payments due upon commercialization. The Field of Use is defined in the Award as the treatment in humans of CF, asbestosis, bronchiectasis, byssinosis, chronic bronchitis/COPD hypersensitivity pneumonitis, pneumoconiosis, primary ciliary dyskinesis, sarcoidosis and silicosis. Either CFFT or the Company may terminate the agreement for cause, which includes the Company’s material failure to achieve certain commercialization and development milestones. The Company’s payment obligations, if any, would survive the terminationcarrying amounts of the Award agreement. For the three months ended September 30, 2017 and 2016, the Company recognized revenue in respect of this collaboration of $796,312 and $742,558, respectively. For the nine months ended September 30, 2017 and 2016, the Company recorded revenue of $2,440,195 and $1,535,754, respectively. Deferred revenueliability components consists of the following:

  September 30, 2017  December 31, 2016 
       
Deferred revenue $  $1,940,195 
Less: current portion     (1,940,195)
Long-term portion $  $ 

 

 

June 30, 2023

 

 

December 31, 2022

 

 

 

 

 

 

 

 

Principal

 

$

19,125,000

 

 

$

20,000,000

 

Less: debt discount

 

 

(2,954,390

)

 

 

(2,954,390

)

Accretion of debt discount

 

 

2,164,851

 

 

 

1,734,485

 

Net carrying amount

 

$

18,335,461

 

 

$

18,780,095

 

    Less: current portion of long term debt

 

$

(7,016,096

)

 

 

(2,795,669

)

Total long-term debt, net of discount

 

$

11,319,365

 

 

$

15,984,426

 

The following table summarizes the future principal payments due under long-term debt:

9.COMMON STOCK

Fiscal Years Ending December 31st,

 

Principal Payments and final payment on Loan Agreement

 

 

 

 

 

2023

 

$

2,827,686

 

2024

 

 

17,887,314

 

Total

 

$

20,715,000

 

10.ACCRUED EXPENSES

Accrued expenses consisted of the following:

 

 

June 30,
2023

 

 

December 31,
2022

 

 

 

 

 

 

 

 

Accrued pre-clinical and clinical costs

 

$

2,694,611

 

 

$

2,137,317

 

Accrued product development costs

 

 

758,699

 

 

 

247,500

 

Accrued compensation

 

 

1,570,376

 

 

 

2,224,951

 

Accrued administrative costs

 

 

282,846

 

 

 

473,376

 

Accrued interest

 

 

1,112,271

 

 

 

916,108

 

Total

 

$

6,418,803

 

 

$

5,999,252

 

11.PREFERRED STOCK

The Company has authorized 150,000,00010,000,000 shares of commonpreferred stock, $0.0001$0.0001 par value per share, of which 50,223,010 shares and 44,681,7450 shares were issued and outstanding as of SeptemberJune 30, 20172023 and December 31, 2016,2022, respectively.

On October 12, 2022, the Board of Directors (the “Board”), declared a dividend of 0.008 of a share of Series A Preferred Stock (“Series A Preferred Stock”), for each outstanding share of Common Stock to stockholders of record at 5:00pm Eastern Time on October 22, 2022. The Certificate of Designation of Series A Preferred Stock was filed with the Delaware Secretary of State and became effective on October 12, 2022. The dividend was based on the number of outstanding shares of common stock prior to the Reverse Stock Split. This resulted in 1,002,247.048 shares of preferred stock being issued. The outstanding shares of Series A Preferred Stock were entitled to vote together with the outstanding shares of common stock as a single class exclusively with respect to any proposal to adopt an amendment to the Company’s Amended and Restated Certificate of Incorporation, as amended (the “Certificate of Incorporation”), to reclassify the outstanding shares of Common Stock into a smaller number of shares of Common Stock at a ratio specified in or determined in accordance with the terms of such amendment, as well as any proposal to adjourn any meeting of stockholders called for the purpose of voting on the Reverse Stock Split Proposal (the “Adjournment Proposal”).

-20-


The Company held a special meeting of stockholders on December 20, 2022 (the “Special Meeting”) for the purpose of voting on the Reverse Stock Split and the Adjournment Proposal. All shares of Series A Preferred Stock that were not present in person or by proxy at the Special Meeting, which totaled 500,894.04 shares, were automatically redeemed by the Company immediately prior to the opening of the polls at Special Meeting (the “Initial Redemption”). All shares that were not redeemed pursuant to the Initial Redemption would be redeemed if ordered by the Board or automatically upon the effectiveness of the amendment to the Certificate of Incorporation implementing the Reverse Stock Split (the "Subsequent Redemption" and together with the Initial Redemption, the "Redemption"). Each share of Series A Preferred Stock is entitled to receive $0.001 in cash for each 10 whole shares of Series A Preferred Stock immediately prior to the Redemption.

At the Special Meeting, both the Reverse Stock Split and Adjournment Proposal were approved.

Upon issuance of the Series A Preferred Stock, the Company was not solely in control of the Redemption of the shares of Series A Preferred Stock since the holders had the option of deciding whether to attend or return a proxy card for the Special Meeting, which determined whether a given holder’s shares of Series A Preferred Stock were redeemed in the Initial Redemption. Since the Redemption of the Series A Preferred Stock was not solely in the control of the Company, the shares of Series A Preferred Stock are classified within mezzanine equity. The shares of Series A Preferred Stock were initially recorded at redemption value, which approximated fair value.

After the Special Meeting upon approval of the Reverse Stock Split, the remaining 501,353.008 shares outstanding of Series A Preferred Stock would be considered mandatorily redeemable and reclassified to a current liability. As of December 31, 2022, the fair value of the Series A Preferred Stock were included in accrued expenses. As of June 30, 2023 and December 31, 2022, there were 0 shares of Series A Preferred Stock issued and outstanding within the condensed consolidated balance sheet, as such shares were considered a redemption payable. The Series A Preferred Stock were redeemed on February 14, 2023, upon the effectiveness of the amendment to the Certificate of Incorporation implementing the Reverse Stock Split pursuant to the terms of the Certificate of Designation of the Series A Preferred Stock.

12.COMMON STOCK

On February 28, 2017,14, 2023, the Company completed a 1-for-30 reverse stock split of its outstanding common stock. The Reverse Stock Split did not change the number of authorized shares of common stock or par value. All references in these condensed consolidated financial statements to shares, share prices, exercise prices, and other per share information in all periods have been adjusted, on a retroactive basis, to reflect the Reverse Stock Split.

The Company has authorized 300,000,000 shares of common stock, $0.0001 par value per share, of which 4,422,741 and 4,171,297 shares were issued and outstanding as of June 30, 2023 and December 31, 2022, respectively.

On May 31, 2023, the Company entered into a securities purchase agreement providing for the issuance and sale byMay 2023 Sale Agreement with Jefferies pursuant to which Jefferies is serving as the Company’s sales agent to sell shares of the Company’s common stock through an “at the market offering.” As of June 13, 2023, the Company was authorized to offer and sell up to $16,800,000of 3,887,815its common stock pursuant to the May 2023 Sale Agreement. During the three months ended June 30, 2023, the Company sold 13,164 shares of its common stock in a registered direct offering to institutional and accredited investors at a purchase price of $7.00 per share withfor which the Company received gross proceeds to theof approximately $107,000. The Company totaling $27,214,705 lessincurred total issuance costs of approximately $36,291.

15

In November 2016, the Company entered into a sales agreement with Cantor Fitzgerald (“Cantor”) under which the Company directed Cantor$192,000. These costs will be deferred to prepaid expenses and other current assets and will offset proceeds as its placement agent to sell common stock under an “At the Market Offering” (“Sales Agreement”). Salesis issued. As of common stock under the Sales Agreement were made pursuantJune 30, 2023, approximately $4,400 has been recorded to an effective registration statement for an aggregate offering of upadditional paid-in capital to $35 million, under which the Company sold an aggregate of approximately $15.4 million of common stock through September 30, 2017. Under the Sales Agreement, the Company was obligated to pay Cantor a 3% commission on grossoffset proceeds.

During the three and six months ended March 31, 2017, the Company sold 1,413,633 shares of its common stock under the Sales Agreement at an average selling price of approximately $9.71 per share for gross proceeds of $13,724,591 and net proceeds of $13,268,208. The Company did not sell any shares of its common stock under the Sales Agreement in the second or third quarter of 2017 and terminated the Sales Agreement in connection with the October 2017 Offering.

During the three months ended SeptemberJune 30, 2017,2023, the Company issued 2,5000 and 43,836 shares of common stock upon the exercise of stock options to purchase common stock and the Company received proceeds of $8,250approximately $0 and $129,740 from these exercises. those exercises, respectively.

During the ninethree and six months ended SeptemberJune 30, 2017,2022, the Company issued 239,817no shares of common stock upon the exercise of stock options to purchase common stock and the Company received proceeds of $109,053 from these exercises.no proceeds.

On October 26, 2017,During the three and six months ended June 30, 2023, the Company consummated an underwritten public offering of shares of its common stock pursuant to which the Company sold an aggregate of 4,650,000 shares of its common stock to institutional investors at a purchase price of $7.00 per share with gross proceeds to the Company totaling $32,550,000, less estimated issuance costs of approximately $2,153,000. TheCompany also granted the underwriters a 30-day option to purchase up to an additional 697,500issued no shares of common shares from the vesting of shares from restricted stock onunder the same terms as2014 Plan.

During the underwriters are purchasingthree and six months ended June 30, 2022, the base numberCompany issued 417 and 1,250 common shares from the vesting of shares.shares from restricted stock under the 2014 Plan.

10.STOCK OPTIONS

No warrants were exercised during the three and six months ended June 30, 2023 and 2022.

-21-


13. STOCK BASED AWARDS

In April 2014, the Company adopted the Corbus Pharmaceuticals Holdings, Inc. 2014 Equity Incentive Plan (the “2014 Plan”). Pursuant to the 2014 Plan, the Company’s Board of Directors may grant incentive and nonqualified stock options and restricted stock to employees, officers, directors, consultants and advisors. On January 1, 2016, pursuant to an annual evergreen provision contained in the 2014 Plan, the number of shares reserved for future grants was increased by 1,250,000 shares, respectively. As of December 31, 2016, there was a total of 9,916,017 shares reserved for issuance under the 2014 Plan and there were 2,840,133 shares available for future grants. Options issued under the 2014 Plan are exercisable for up to 10 years from the date of issuance.

Pursuant to the terms of an annual evergreen provision in the 2014 Plan, the number of shares of common stock available for issuance under the 2014 Plan shall automatically increase on January 1 of each year by at least seven percent (7%(7%) of the total number of shares of common stock outstanding on December 31st31st of the preceding calendar year, or, pursuant to the terms of the 2014 Plan, in any year, the Board of Directors may determine that such increase will provide for a lesser number of shares.

In accordance with the terms of the 2014 Plan, and pursuant to the annual evergreen provision contained in the 2014 Plan, effective as of January 1, 2017,2022, the number of shares of common stock available for issuance under the 2014 Plan increased by 3,127,722292,205 shares, which was seven percent (7%(7%) of the outstanding shares of common stock on December 31, 2016.2021. As of January 1, 2017, the 2014 Plan had2022, there was a total reserve of 13,043,7391,144,567 shares and there were 5,967,855558,671 shares available for future grants. As of SeptemberJune 30, 2017,2022, there were 4,613,438425,217 shares available for future grants.

In accordance with the terms of the 2014 Plan, and pursuant to the annual evergreen provision contained in the 2014 Plan, effective as of January 1, 2023, the number of shares of common stock available for issuance under the 2014 Plan increased by 291,991 shares, which was seven percent (7%) of the outstanding shares of common stock on December 31, 2022. As of January 1, 2023, there was a total reserve of 1,436,558 shares and 741,870 shares available for future grants. As of June 30, 2023, there were 555,704 shares available for future grants.

Share-based Compensation Expense

For stock options issued and outstanding for the three months ended September 30, 2017 and 2016, the Company recorded non-cash,In connection with all stock-based payment awards, total stock-based compensation expense, of $1,351,284 ($1,213,552 for employees and $137,732 for non-employees) and $828,097 ($813,200 for employees and $14,897 for non-employees), respectively, net of estimated forfeitures. For stock options issuedforfeitures, recognized in the condensed consolidated statements of operations and outstanding for the nine months ended September 30, 2017 and 2016, the Company recorded non-cash,comprehensive loss was as follows:

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

$

96,096

 

 

$

147,626

 

 

$

190,018

 

 

$

323,844

 

General and administrative expenses

 

 

727,279

 

 

 

1,365,463

 

 

 

1,659,736

 

 

 

2,780,991

 

Total stock-based compensation

 

$

823,375

 

 

$

1,513,089

 

 

$

1,849,754

 

 

$

3,104,835

 

The total stock-based compensation expense of $4,233,511 ($3,302,437 for employees and $931,073 for non-employees) and $1,522,345 ($1,377,811 for employees and $144,534 for non-employees) respectively, net of estimated forfeitures.recognized by award type was as follows:

16

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock options

 

$

819,168

 

 

$

1,513,089

 

 

$

1,842,909

 

 

$

3,104,835

 

Restricted stock units

 

 

4,207

 

 

 

 

 

 

6,845

 

 

 

 

Total stock-based compensation

 

$

823,375

 

 

$

1,513,089

 

 

$

1,849,754

 

 

$

3,104,835

 

Stock Options

The fair value of each option award for employees is estimated on the date of grant and for non-employees is estimated at the end of each reporting period using the Black-Scholes option pricing model that uses the assumptions noted in the following table. DueThe Company uses historical data, as well as subsequent events occurring prior to the issuance of the financial statements, to estimate option exercises and employee terminations in order to estimate its limited operating history and limited number of sales of its common stock, the Company estimated its volatility in consideration of a number of factors, including the volatility of comparable public companies and, commencing in 2015, the Company also included the volatility of its own common stock.forfeiture rate. The expected term of options granted under the 2014 Plan, all of which qualify as “plain vanilla” per SEC Staff Accounting Bulletin 107, is determined based on the simplified method due to the Company’s limited operating history, and is 6.25 years based on the average between the vesting period and the contractual life of the option. For non-employee options, the expected term is the contractual term. The risk-free rate is based on the yield of a U.S. Treasury security with a term consistent with the option.

The Company uses historical data to estimate forfeitures, which are estimated at 5%.-22-


The weighted average of assumptions used principally in determining the fair value of options granted to employees and non-employees were as follows:

 

Nine Months Ended

September 30,

 
 2017 2016 

 

Six Months Ended June 30,

 

Risk free interest rate  2.13%  1.65%

 

2023

 

 

2022

 

Risk-free interest rate

 

 

3.81

%

 

 

1.81

%

Expected dividend yield 0% 0%

 

 

0

%

 

 

0

%

Expected term in years 6.57 6.74 

 

6.25

 

 

 

6.25

 

Expected volatility 85.8% 93.1%

 

 

101.33

%

 

 

97.76

%

Estimated forfeiture rate

 

 

15.56

%

 

 

12.37

%

A summary of option activity for the ninesix months ended SeptemberJune 30, 20172023 and is presented below:

Options Shares  Weighted
Average
Exercise
Price
  

Weighted
Average
Remaining

Contractual
Term in
Years

  Aggregate
Intrinsic
Value
 
Outstanding at December 31, 2016  6,610,179  $2.54         
Granted  1,423,000   8.42         
Exercised  (239,817)  0.42         
Forfeited  (68,583)  6.62         
Outstanding at September 30, 2017  7,724,779  $3.66   7.93  $29,985,612 
Vested at September 30, 2017  4,055,877  $1.61   7.16  $22,466,228 

Options

 

Shares

 

 

Weighted
 Average
Exercise
 Price

 

 

Weighted Average
 Remaining Contractual
Term in Years

 

 

Aggregate
Intrinsic
Value

 

Outstanding at December 31, 2022

 

 

617,996

 

 

$

88.99

 

 

 

 

 

 

 

Granted

 

 

285,733

 

 

 

5.14

 

 

 

 

 

 

 

Exercised

 

 

(43,836

)

 

 

0.85

 

 

 

 

 

 

 

Forfeited or canceled

 

 

(120,909

)

 

 

67.78

 

 

 

 

 

 

 

Outstanding at June 30, 2023

 

 

738,984

 

 

$

64.97

 

 

 

7.24

 

 

$

20,769,766

 

Vested at June 30, 2023

 

 

388,412

 

 

$

106.91

 

 

 

5.57

 

 

$

5,252,474

 

Vested and expected to vest at June 30, 2023

 

 

671,776

 

 

$

70.47

 

 

 

7.03

 

 

$

17,407,765

 

The weighted average grant-dategrant date fair value of options granted during the ninesix months ended SeptemberJune 30, 20172023 and 20162022 was $6.22$4.20 and $2.85$10.80 per share, respectively. The aggregate intrinsic value of options exercised during the ninesix months ended SeptemberJune 30, 20172023 and September 30, 20162022 was approximately $1,935,624$92,689 and $610,608,$0, respectively. As of SeptemberJune 30, 2017,2023, there was approximately $12,809,402$4,300,982 of total unrecognized compensation expense, related to non-vested share-based option compensation arrangements. The unrecognized compensation expense is estimated to be recognized over a period of 3.051.79 years as of SeptemberJune 30, 2017.2023.

Restricted Stock Units

A RSU represents the right to receive one share of our common stock upon vesting of the RSU. The fair value of each RSU is based on the closing price of our common stock on the date of grant. We grant RSUs with service conditions that vest in four equal annual installments provided that the employee remains employed with us on the vesting date.

 

17

A summary of RSU activity for the six months ended June 30, 2023 and is presented below:

RSU's

 

Number of Shares Underlying RSUs

 

 

Weighted
 Average
Grant Date Fair Value

 

Unvested at December 31, 2022

 

 

 

 

$

 

Granted

 

 

25,659

 

 

 

4.63

 

Forfeited

 

 

(4,317

)

 

 

4.26

 

Vested

 

 

 

 

 

 

Unvested at June 30, 2023

 

 

21,342

 

 

$

4.71

 

As of June 30, 2023, there was $75,498 of unrecognized compensation costs related to unvested RSUs, which are expected to be recognized over a weighted average period of 3.65 years.

11.WARRANTS

-23-


14. WARRANTS

No warrants were exercised during the three and six months ended June 30, 2023 and 2022.

At SeptemberJune 30, 2017,2023, there were warrants outstanding to purchase 1,288,50050,207 shares of common stock with a weighted average exercise price of $1.00$283.81 and a weighted average remaining life of 1.662.11 years. No warrants were exercised during

On January 26, 2018, the nine months ended September 30, 2017. DuringCompany entered into an Investment Agreement with the nine months ended September 30, 2016, warrantsCystic Fibrosis Foundation ("CFF") that included issuance of a warrant to purchase 178,750an aggregate of 33,334 shares of the Company’s common stock (the “CFF Warrant”) at an exercise price of $396.00 per share. The CFF Warrant is currently exercisable for 33,334 shares of the Company’s common stock and expires on January 26, 2025. Any shares of the Company’s common stock issued upon exercise of the CFF Warrant will be unregistered and subject to a one-year lock-up. The CFF Warrant is classified as equity as it meets all the conditions under U.S. GAAP for equity classification. In accordance with U.S. GAAP, the Company has calculated the fair value of the warrant for initial measurement and will reassess whether equity classification for the warrant is appropriate upon any changes to the warrants or capital structure, at each balance sheet date. The weighted average assumptions used in determining the $6,215,225 fair value of the CFF Warrant were exercised onas follows:

Risk-free interest rate

2.60

%

Expected dividend yield

0

%

Expected term in years

7.00

Expected volatility

83.5

%

On July 28, 2020, the Company entered into the Loan and Security Agreement with K2HV pursuant to which K2HV may provide the Company with term loans in an aggregate principal amount of up to $50,000,000. On July 28, 2020, in connection with the funding of the first $20,000,000 tranche, the Company issued a cashless basis resulting inwarrant exercisable for 2,873 shares of the issuanceCompany’s common stock (the “K2 Warrant”) at an exercise price of 161,591$208.80 per share. The K2 Warrant is immediately exercisable for 2,873 shares and warrants to purchase 1,250expires on July 28, 2030. Any shares of the Company’s common stock issued upon exercise of the K2 Warrant are permitted to be settled in unregistered shares. The K2 Warrant is classified as equity as it meets all the conditions under U.S. GAAP for equity classification. In accordance with U.S. GAAP, the Company has calculated the fair value of the warrant for initial measurement and will reassess whether equity classification for the warrant is appropriate upon any changes to the warrants or capital structure, at each balance sheet date. The weighted average assumptions used in determining the $472,409 fair value of the K2 Warrant were exercised on a for cash basis. There were no warrants issued or cancelled during the nine months ended September 30, 2017 and 2016.as follows:

 

12.RELATED PARTY TRANSACTIONS

Risk-free interest rate

0.60

%

Expected dividend yield

0

%

Expected term in years

10.00

Expected volatility

80.0

%

On September 20, 2016,October 16, 2020, the Company entered into a consultingprofessional services agreement (the “2016 Consulting Agreement”) with Orchestra Medical Ventures, LLC (“Orchestra”), of which a member of our Board of Directors, David Hochman, is Managing Partner. Under this agreement, Orchestra rendered a variety of consulting and advisory services relating principally to identifying and evaluating strategic relationships, licensing opportunities, and business strategies. The term of the 2016 Consulting Agreement commenced on September 20, 2016 and expired on March 20, 2017.an investor relations service provider. Pursuant to the terms of the 2016 Consulting Agreement, the Company paid to Orchestra cash compensation in an aggregate amount of $100,000. In connection with this agreement, the Company granted an equity incentive award to Mr. Hochman consistingissued warrants exercisable for a total of options to purchase 50,00014,000 shares (“Option Shares”) of the Company’s common stock (the “Option Award”“Warrants”) pursuant to the Company’s 2014 Equity Compensation Plan, of which fifty percent (50%) vested on the three (3) month anniversary of the date of grant of the Option Award and the remainder of the Option Shares vested on the six (6) month anniversary of the date of grant of the Option Award. The Option Shares were granted withat an exercise price of $7.14$32.10 per share. The Company recorded stock-based compensation expense of approximately $222,000 during the year ended December 31, 2016 and $171,000 during the first quarter of 2017 in respectWarrants will be fully vested on October 19, 2021. Any shares of the Option Award. No stock-based compensation expense was recorded afterCompany’s common stock issued upon exercise of the first quarterWarrants are permitted to be settled in unregistered shares. The Warrants are classified as equity as they meet all the conditions under U.S. GAAP for equity classification. In accordance with U.S. GAAP, the Company has calculated the fair value of 2017 relatedthe warrants for initial measurement and will reassess whether classification for the warrant is appropriate upon any changes to the Option Shareswarrants or capital structure, at each balance sheet date. The weighted average assumptions used in determining the $334,740 fair value of the Warrants were as they were fully vested in March 2017.

13.SUBSEQUENT EVENTS

On October 26, 2017, the Company consummated an underwritten public offering of shares of its common stock pursuant to which the Company sold an aggregate of 4,650,000 shares of its common stock to institutional investors at a purchase price of $7.00 per share with gross proceeds to the Company totaling $32,550,000, less estimated issuance costs of approximately $2,153,000. TheCompany also granted the underwriters a 30-day option to purchase up to an additional 697,500 shares of common stock on the same terms as the underwriters purchased the base number of shares.follows:

 

18

Risk-free interest rate

0.90

%

Expected dividend yield

0

%

Expected term in years

5.00

Expected volatility

100.6

%

-24-


15. DERIVATIVE LIABILITY

On July 28, 2020, the Company, with its subsidiary, Corbus Pharmaceuticals, Inc., as borrower, entered into the Loan and Security Agreement with K2HV and received $20,000,000 upon signing. The Company has determined that a prepayment feature and default feature needed to be separately valued and marked to market each reporting period after assessing the agreement under ASC 815.

The value of these features is determined each reporting period by taking the present value of net cash flows with and without the prepayment features. The significant assumption used to determine the fair value of the debt without any features is the discount rate which has been estimated by using published market rates of triple CCC-rated public companies. All other inputs are taken from the Loan and Security Agreement. The additional significant assumptions used when valuing the prepayment feature is the probability of a change of control event. The Company has determined the probability from December 31, 2022 to June 30, 2023 has stayed consistent. The additional significant assumption used when valuing the default feature is the probability of defaulting on the repayment of loan. The Company has determined the probability from December 31, 2022 to June 30, 2023 has remained consistent. The value of these features was determined to be approximately $36,868 at December 31, 2022 and June 30, 2023, which resulted in no expense recognized in the first six months of 2023. The Company considers the fair value of the derivative liability to be Level 3 under the three-tier fair value hierarchy.

A roll forward of the fair value of the derivative liabilities for the six months ended June 30, 2023 is presented below.

 

 

June 30, 2023

 

Beginning balance, December 31, 2022

 

$

36,868

 

Change in fair value of derivative liabilities

 

 

 

Ending balance, June 30, 2023

 

$

36,868

 

-25-


Item 2.

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

The following discussion and analysis of our financial condition and results of operations should be read together with our financial statements and the related notes and the other financial information included elsewhere in this Quarterly Report. This discussion contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those discussed below and elsewhere in this Quarterly Report, particularly those under “Risk Factors.”

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This report on Form 10-Q contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 under Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include statements with respect to our beliefs, plans, objectives, goals, expectations, anticipations, assumptions, estimates, intentions and future performance, and involve known and unknown risks, uncertainties and other factors, which may be beyond our control, and which may cause our actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. All statements other than statements of historical fact are statements that could be forward-looking statements. You can identify these forward-looking statements through our use of words such as “may,” “can,” “anticipate,” “assume,” “should,” “indicate,” “would,” “believe,” “contemplate,” “expect,” “seek,” “estimate,” “continue,” “plan,” “point to,” “project,” “predict,” “could,” “intend,” “target,” “potential” and other similar words and expressions of the future.

There are a number of important factors that could cause the actual results to differ materially from those expressed in any forward-looking statement made by us. These factors include, but are not limited to:

our lack of operating history and history of operating losses;

our current and future capital requirements and our ability to satisfy our capital needs;

our ability to complete required clinical trials of our product and obtain approval from the FDA or other regulatory agents in different jurisdictions;

our ability to internally develop new product candidates, intellectual property, and other product candidates we may acquire and/or license;

our ability to maintain or protect the validity of our patents and other intellectual property;

our ability to retain key executive members;

our ability to internally develop new inventions and intellectual property;

interpretations of current laws and the passages of future laws;

acceptance of our business model by investors;

the accuracy of our estimates regarding expenses and capital requirements; and

our ability to adequately support growth.

The foregoing does not represent an exhaustive list of matters that may be covered by the forward-looking statements contained herein or risk factors that we are faced with that may cause our actual results to differ from those anticipateanticipated in our forward-looking statements. Please see “Risk Factors” for additional risks which could adversely impact our business and financial performance.

19

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this report or the date of the document incorporated by reference into this report. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise. We have expressed our expectations, beliefs and projections in good faith and we believe they have a reasonable basis. However, we cannot assure you that our expectations, beliefs or projections will result or be achieved or accomplished.

Overview

-26-


We are a clinical stage pharmaceutical company, focused on the development and commercialization of novel therapeutics to treat rare, chronic and serious inflammatory and fibrotic diseases with clear unmet medical needs. Our product anabasumOverview

Corbus Pharmaceuticals Holdings, Inc. is a novel synthetic oral endocannabinoid-mimetic drugprecision oncology company committed to helping people defeat serious illness by bringing innovative scientific approaches to well understood biological pathways. Corbus’ internally developing pipeline includes CRB-701, a next generation ADC that is intendedtargets the expression of Nectin-4 on cancer cells to resolve chronic inflammationrelease a cytotoxic payload and halt fibrotic processes without causing immunosuppression. AnabasumCRB-601, an anti-integrin monoclonal antibody that blocks the activation of TGFβ expressed on cancer cells. The Company has generated positive clinical data in three consecutive Phase 2 studies in diffuse cutaneous systemic sclerosis, cystic fibrosis and dermatomyositis. Anabasum is also being evaluated in open-label extension studies in systemic sclerosis and skin-predominant dermatomyositis.

Anabasum is a synthetic, rationally-designed oraldeveloped CRB-913, an endocannabinoid small molecule drug, that selectively binds to the cannabinoid receptor type 2, or CB2, found on activated immune cells, fibroblasts and muscle cells. Anabasum stimulates the production of Specialized Pro-Resolving Lipid Mediators (SPMs) that act to resolve inflammation and halt fibrosis by activating endogenous pathways. These endogenous resolution pathways are normally activated in healthy individuals during the course of normal immune responses but are dysfunctional in patients with chronic inflammatory and fibrotic diseases. Through its activation of the CB2 receptor, anabasum is designed to drive innate immune responses from the activation phase through completion of the resolution phase. The CB2 receptor plays an endogenous role in modulating and resolving inflammation by, in effect, turning heightened inflammation “off” and restoring homeostasis.

We are currently developing anabasum to treat four life-threatening diseases: systemic sclerosis; cystic fibrosis; diffuse cutaneous, skin-predominant dermatomyositis; and systemic lupus erythematosus, or SLE. The United States Food and Drug Administration, or the FDA, has granted anabasum Orphan Designation as well as Fast Track Status for both cystic fibrosis and systemic sclerosis. The European Medicines Authority, or the EMA, has granted anabasum Orphan Designation for both cystic fibrosis and systemic sclerosis.

In November 2016, we reported positive clinical data in a Phase 2 anabasum study for the treatment of systemic sclerosis. Following an end-of-Phase 2 meeting withobesity and is seeking partners to fund further development.

Corbus' precision oncology internally developing pipeline:

CRB-701 is a next generation ADC that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload. In February 2023, the Company obtained a license from CSPC to develop and commercialize the drug in the U.S., Canada, the European Union (including the European Free Trade Area), the United Kingdom, and Australia. The Investigational New Drug (IND) application for CRB-701 has been cleared by the U.S. FDA we submitted a protocol toand the FDA on March 31, 2017 fordrug is currently being investigated by CSPC in a Phase 3 study1 dose escalation clinical trial in systemic sclerosis. We also received protocol assistancepatients with advanced solid tumors in China. Corbus is planning to bridge data from this Phase 1 trial to support a U.S. clinical trial starting in the EMAfirst quarter of 2024.
CRB-601 is a potent and selective anti-αvβ8 monoclonal antibody that blocks the activation of TGFβ expressed on cancer cells in the Phase 3 study design. We expecttumor microenvironment. In pre-clinical models, CRB-601 demonstrates enhanced anti-tumor activity when combined with anti-PD-1 checkpoint inhibitor therapy compared to commenceeither single agent alone. Pre-clinical data suggests that blockade of latent TGFβ production by CRB-601 can lead to changes in immune cell infiltration in the Phase 3 studytumor microenvironment, potentially enhancing the benefit of PD-1 blockade. CRB-601 is being developed as a potential treatment for patients with solid tumors in systemic sclerosiscombination with existing therapies, including checkpoint inhibitors. The Company expects to submit an IND in the fourth quarter of 2017.

In December 2016, we completed a2023 and anticipates the Phase 2 study in cystic fibrosis and at the end of March 2017 we reported positive top-line data from this study. We are1 clinical trial to be initiated in the processfirst half of developing2024.

Corbus' endocannabinoid pipeline:

CRB-913 is a second-generation cannabinoid receptor type 1 (CB1) inverse agonist designed to treat obesity and related metabolic diseases. In the protocol design fordiet-induced obesity mice model (DIO), CRB-913 demonstrates a Phase 2b clinical trialreduction in weight and have received guidance on the design of the clinical protocol for the study from the Cystic Fibrosis Therapeutic Development Network. We also plan to obtain guidance from the FDAfood consumption, improvement in insulin resistance and the EMA on the clinical protocol design. We are currently planning forleptinemia, and finalizing the design of the Phase 2b study in cystic fibrosis and expect to commence this studyreduced fat deposits in the fourth quarter of 2017. We also expect to commence a Phase 2 study in SLE during the fourth quarter of 2017.

On October 19, 2017, we reported positive clinical data in a Phase 2 anabasum study for the treatment of skin-predominant dermatomyositis. We plan to meet with the FDA to discuss the next stepsliver. The CRB-913 program is in the clinical development program in dermatomyositis.

Since our inception,pre-clinical stage, and we have devoted substantially all of our effortsare seeking partnerships to business planning, research and development, recruiting management and technical staff, acquiring operating assets and raising capital. Our research and development activities have included conducting pre-clinical studies, developing manufacturing methods and the manufacturing of our drug anabasum for clinical trials and conducting clinical studies in patients. Three of the four clinical programs for anabasum are being supported, or have been supported, by non-dilutive awards and grants. The National Institutes of Health, or NIH, is funding the majority of the clinical development costs for the dermatomyositis and SLE Phase 2 clinical trials, and the Phase 2 clinical trial in cystic fibrosis has been supported by a $5 million award from the Cystic Fibrosis Foundation Therapeutics, Inc., or CFFT, a non-profit drug discovery and development affiliate of the Cystic Fibrosis Foundation.

20
fund further development.

Financial Operations Overview

We are a research and developmentprecision oncology company and have not generated any revenues from the sale of products. We have never been profitable and from inception through Septemberat June 30, 2017, our losses from operations have been2023, we had an accumulated deficit of approximately $55.0 million.$418,609,000. Our net losses for the three months ended SeptemberJune 30, 20172023 and 20162022, were approximately $6,966,000$8,784,000 and $5,347,000, respectively and for the nine$13,249,000, respectively. For six months ended SeptemberJune 30, 20172023 and 20162022, our net losses were approximately $21,728,000$26,529,000 and $12,428,000,$22,686,000, respectively.

We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. We expect our total expenses in 2023 to stay consistent as compared to 2022, however, research and development expenses will increase as assets in our pipeline move into the clinical phase and other operating expenses to increase significantly in connection with our ongoing activitiesdecrease as we expect legal and settlement costs from 2022 will not recur. We will continue to develop, seek regulatory approval ofincur significant operating losses and commercialize anabasum. Accordingly,accordingly we will need additional financing to support our continuing operations. We will seek to fund our operations through public or private equity or debt financings or other sources, which may include government grants and collaborations with third parties. Adequate additional financing may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategy. We will need to generate significant revenues to achieve profitability, and we may never do so.

We expect to continue to incur significant expenses and increasing operating losses for at least the next several years. We expect our expenses will increase substantially in the remainder of 2017 and in the futureyears in connection with our ongoing activities, as we:

conduct pre-clinical and clinical trials for our product candidates;
continue our research and development efforts; and
manufacture drugs for clinical studies.

conduct clinical trials for anabasum in scleroderma, cystic fibrosis, systemic lupus erythematosus and other indications;
continue our research and development efforts;
manufacture clinical study materials and develop commercial scale manufacturing capabilities;
seek regulatory approval for our product candidates;
add personnel to support development of our product candidates; and
operate as a public company

Critical Accounting Policies-27-


Recent Developments

Open Market Sale Agreement

On May 31, 2023, the Company entered into the May 2023 Sale Agreement with Jefferies, as sales agent, pursuant to which the Company may issue and Estimates

Our condensed consolidated financial statementssell, from time to time, through Jefferies, shares of its common stock, and pursuant to which Jefferies may sell its common stock by any method permitted by law deemed to be an “at the market offering” as defined by Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended. The Company will pay Jefferies a commission of 3.0% of the aggregate gross proceeds from each sale of common stock and have been prepared in accordanceagreed to provide Jefferies with accounting principles generally accepted incustomary indemnification and contribution rights. The Company has also agreed to reimburse Jefferies for certain specified expenses. As of June 13, 2023, the United StatesCompany was authorized to offer and sell up to $16,800,000 of America.its common stock pursuant to the May 2023 Sale Agreement. During the three months ended June 30, 2023, the Company sold 13,164 shares of its common stock for which the Company received gross proceeds of approximately $107,000. The preparationCompany has incurred total issuance costs of these financial statements requires managementapproximately $192,000. These costs will be deferred to make estimatesprepaid expenses and assumptions that affect the reported amounts ofother current assets and liabilities and the disclosurewill offset proceeds as common stock is issued. As of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period.

On an ongoing basis, we evaluate our estimates and judgments for all assets and liabilities, including those related to stock-based compensation expense. We base our estimates and judgments on historical experience, current economic and industry conditions and on various other factors that are believed to be reasonable under the circumstances. This forms the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

21

We believe that full considerationJune 30, 2023, approximately $4,400 has been givenrecorded to all relevant circumstances that we may be subjectadditional paid-in capital to and the consolidated financial statements accurately reflect our best estimate of the results of operations, financial position and cash flows for the periods presented.offset proceeds.

Results of Operations

Comparison of Three Months Ended SeptemberJune 30, 20172023 and 20162022

Collaboration Revenue

To date, we have not generated any revenues from the sales of products. We do not expect to generate revenue from product sales unless and until we successfully complete development and obtain regulatory approval for the marketing of anabasum, which we expect will take a number of years and is subject to significant uncertainty.

We recognized $796,312 and $742,558 of collaboration revenue in the three months ended September 30, 2017 and 2016, respectively, related to an award agreement we entered into in the second quarter of fiscal 2015 with the Cystic Fibrosis Foundation Therapeutics, Inc. (“CFFT”), a non-profit drug discovery and development affiliate of the Cystic Fibrosis Foundation, pursuant to which we received a development award (the “Award”) for up to $5 million in funding. The funding from the Award supported the Phase 2 clinical trial of anabasum in adults with cystic fibrosis. We have billed and received a total of $5.0 million in payments since the inception of the Award as outlined below. The payments received under the Award were recorded as deferred revenue when the triggering event to receive those amounts occurred and were amortized on a straight-line basis over the expected duration of the remaining performance period under the Award.

Upon the execution of the Award agreement, we received a payment of $1,250,000 in May 2015. In November 2015, we received a second payment of $1,250,000 upon the achievement of a milestone for dosing the first patient. In August 2016, we received a third payment from the CFFT in the amount of $1,000,000 for achieving a milestone in July 2016 related to dosing the median clinical trial patient. In January 2017, we received a fourth payment from the CFFT in the amount of $1,000,000 for achieving a milestone in December 2016 related to completing the final visit for the final patient. We achieved the final milestone in September 2017 related to the issuance to CFFT of the final integrated statistical report related to the Phase 2 CF clinical trial. At that time we had completed all of our performance obligations under the contract and therefore the performance period had concluded. The final milestone amount of $500,000 was billed by us to CFFT in September 2017 and was classified in grants receivable as of September 30, 2017. We received the $500,000 milestone payment under the Award from CFFT in November 2017.

Research and Development Expenses

Research and development expenses are incurred for the development of anabasum and consist primarily of payroll and payments to contract research and development companies. To date, these costs are related to generating pre-clinical data and the cost of manufacturing anabasum for clinical trials and conducting clinical trials. These costs are expected to increase significantly in the future as anabasum is evaluated in additional later stage clinical trials.

Development. Research and development expenses for the three months ended SeptemberJune 30, 20172023 totaled approximately $5,623,000,$4,249,000, an increase of approximately $1,307,000 over$1,749,000 from the $4,316,000$2,500,000 recorded for the three months ended SeptemberJune 30, 2016.2022. The increase in fiscal quarter 2023 as compared to 2022 was primarily attributable to increases of $473,000$1,240,000 in compensation costs, $420,000 inpre-clinical and clinical trial costs and $414,000$527,000 in stock-based compensation expense.consulting costs associated with advancing the Company's pipeline to prepare for IND filings and clinical trials.

GeneralDuring 2018, the Company formed a subsidiary in each of the United Kingdom and Administrative Expenses

GeneralAustralia and administrative expenses consist primarilyapproximately 46% and 21% of payroll, rent and professional services such as accounting and legal services. We anticipate that our general and administrative expenses will increase significantly during the remainder of 2017 and in the future as we increase our headcount to support our continued research and development expenses recorded for the three months ended June 30, 2023 and the potential commercialization of our product candidates. We also anticipate increased expenses related to audit, legal, regulatory,2022, respectively was recorded in these entities.

General and tax-related services associated with maintaining compliance with NASDAQ exchange listing and SEC requirements, director and officer insurance, and investor relations costs associated with being a public company.

22

Administrative.General and administrative expense for the three months ended SeptemberJune 30, 20172023 totaled approximately $2,131,000, an increase$3,940,000, a decrease of approximately $370,000 over$900,000 from the $1,761,000$4,840,000 recorded for the three months ended SeptemberJune 30, 2016.2022. The increasedecrease in fiscal 2023 as compared to fiscal 2022 was primarily attributable to increases of approximately $109,000decreases in stock-based compensation costs of $638,000 as stock options are being granted at lower current fair values as compared to earlier grants that are now fully vested, legal costs of $245,000 related to litigation with Venn Therapeutics, LLC and $232,000 in reduced premiums associated with insurance policies offset by an increase in severance expense $106,000of $416,000 associated with a reduction in recruiting cost and other individually immaterial items resulting inheadcount.

Litigation Settlement. There was no litigation settlement for the three months ended June 30, 2023. Litigation settlement expense for the three months ended June 30, 2022 totaled $5,000,000 as a net aggregate increaseresult of $155,000.the settlement with Venn Therapeutics, LLC.

Other Expense, Net

Net.Other expense, net for the three months ended SeptemberJune 30, 2017 totaled2023 was approximately $9,000, a decrease$595,000 as compared to other expense of approximately $4,000 from the $13,000$909,000 recorded for the three months ended SeptemberJune 30, 2016 and2022. The decrease of $314,000 in 2023 as compared to 2022 was primarily attributable to an increaseinvestment income in net interest income of approximately $42,000 partially offset by an increase2023 as compared to investment losses in realized and unrealized foreign currency exchange transaction losses of $37,000 in the three months ended September 30, 2017 compared with the three months ended September 30, 2016.2022.

-28-


Comparison of NineSix Months Ended SeptemberJune 30, 20172023 and 20162022

Collaboration Revenue

We have recorded $2,440,195 and $1,535,754 of collaboration revenue in the nine months ended September 30, 2017 and 2016, respectively, related to the agreement with the CFFT.

Research and Development Expenses

Development. Research and development expenses for the ninesix months ended SeptemberJune 30, 20172023 totaled approximately $17,752,000,$17,637,000, an increase of approximately $7,696,000 over$11,851,000 from the approximately $10,057,000$5,786,000 recorded for the ninesix months ended SeptemberJune 30, 2016.2022. The increase in fiscal 2023 as compared to fiscal 2022 was primarily attributable to increases in licensing costs of approximately $4,958,000$7,500,000 associated with the CSPC License Agreement, $1,200,000 associated with the achievement of a development milestone under the UCSF License Agreement, as well as $2,081,000 in pre-clinical and clinical trial costs, $1,544,000$665,000 in manufacturing costs, and $660,000 in consulting costs associated with advancing the Company's pipeline to prepare for IND filings and clinical trials. This increase is offset by decreases in compensation costs of $1,021,000 as a result of reduced headcount.

During 2018, the Company formed a subsidiary in each of the United Kingdom and $1,194,000Australia and approximately 20% and 28% of research and development expenses recorded for the six months ended June 30, 2023 and 2022, respectively was recorded in stock-based compensation expense.these entities.

General and Administrative Expenses

Administrative.General and administrative expense for the ninesix months ended SeptemberJune 30, 20172023 totaled approximately $6,389,000, an increase$7,849,000, a decrease of approximately $2,497,000 over$2,222,000 from the approximately $3,892,000$10,071,000 recorded for the ninesix months ended SeptemberJune 30, 2017.2022. The increasedecrease in fiscal 2023 as compared to fiscal 2022 was primarily attributable to increases of approximately $1,517,000decreases in stock-based compensation expense, $277,000costs of $1,121,000 as stock options are being granted at lower current fair values as compared to earlier grants that are now fully vested, legal costs of $856,000 related to the litigation with Venn Therapeutics, LLC, $447,000 in investor relations costs, $152,000 in recruiting costs, $141,000 inreduced premiums associated with insurance costs, $100,000policies, and $301,000 in consulting expenses cost and other individually immaterial items resultingtemporary employees offset by an increase in severance expense of $433,000 associated with a net aggregate increasereduction in headcount.

Litigation Settlement. There was no litigation settlement for the six months ended June 30, 2023. Litigation settlement expense for the six months ended June 30, 2022 totaled $5,000,000 as a result of $310,000.the settlement with Venn Therapeutics, LLC.

Other Expense, Net

Net.Other expense, net for the ninesix months ended SeptemberJune 30, 2017 totaled2023 was approximately $27,000, an increase of$1,043,000 as compared to approximately $11,000 over the $16,000 of other expense netof $1,829,000 recorded for the ninesix months ended SeptemberJune 30, 2016.2022. The increasedecrease of $786,000 in 2023 as compared to 2022 was primarily attributable to an increaseinvestment income in realized and unrealized foreign currency exchange transaction2023 as compared to investment losses of approximately $61,000 partially offset by an increase in interest income, net of approximately $50,000 in the nine months ended September 30, 2017 compared with the nine months ended September 30, 2016.2022.

Liquidity and Capital Resources

Since inception, we have experienced negative cash flows from operations. We have financed our operations primarily through sales of equity-related securities. In addition, the majority of the costs of the dermatomyositis and systemic lupus erythematosus clinical trials are being funded by NIH grants, and our cystic fibrosis clinical trial has been partially funded by a $5 million award from the CFFT. At SeptemberJune 30, 2017,2023, our accumulated deficit since inception was approximately $55,004,000.$418,609,000.

23

At SeptemberJune 30, 2017,2023, we had total current assets of approximately $38,017,000$38,274,000 and total current liabilities of approximately $6,335,000,$16,386,000, resulting in working capital of approximately $31,682,000. At September$21,888,000. Of our total cash, cash equivalents, investments, and restricted cash of $37,236,000 at June 30, 2017, we had total assets of2023, approximately $38,420,000 and total liabilities of approximately $6,439,000 resulting in a stockholders’ equity of approximately $31,980,000.$36,127,000 was held within the U.S.

Net cash used in operating activities for the ninesix months ended SeptemberJune 30, 20172023 was approximately $18,683,000,$22,915,000, which includes a net loss of approximately $21,728,000, offset by$26,529,000, adjusted for non-cash expenses of approximately $4,491,000$2,339,000 largely related to stock-based compensation expense, and approximately $1,275,000 of cash provided by net working capital items principally relateddue to an increase in stock-based compensation expense and increasedother long-term liabilities.

Cash provided by approximately $1,445,000 of cash used for net working capital items.

Cash used in investing activities for the ninesix months ended SeptemberJune 30, 20172023 totaled approximately $127,000 for the purchase$14,357,000, which was principally related to sales and purchases of property and equipment.marketable securities.

Cash provided byused in financing activities for the ninesix months ended SeptemberJune 30, 20172023 totaled approximately $40,415,000. On February 28, 2017, we entered into a securities purchase agreement providing for$95,000, which was related to the repayment of short-term borrowings offset by proceeds from the issuance and sale of 3,887,815 shares of our common stock in a registered direct offering to institutional and accredited investors at a purchase price of $7.00 per share with net proceeds to us totaling $27,177,102. In November 2016, we entered into a sales agreement with Cantor Fitzgerald under which we directed Cantor Fitzgerald as our placement agent to sell common stock under an “At the Market Offering” (“Sales Agreement”). Sales of common stock under the Sales Agreement were made pursuant to an effective registration statement for an aggregate offering of up to $35 million. During the nine months ended September 30, 2017, we received net proceeds of $13,403,584 from sales of our common stock pursuant to the Sales Agreement, net of 3% commission paid to Cantor Fitzgerald. All sales of common stock under the Sales Agreement occurred in the first quarter of 2017 and we did not sell any shares of our common stock under the Sales Agreement during the second or third quarter of 2017. The Sales Agreement was terminated in connection with the October 2017 Offering discussed below.stock.

On October 26, 2017, we consummated an underwritten public offering of shares of our common stock pursuant to which we sold an aggregate of 4,650,000 shares of our common stock to institutional investors at a purchase price of $7.00 per share with net proceeds to us totaling approximately $30,397,000 (“October 2017 Offering”).We also granted the underwriters a 30-day option to purchase up to an additional 697,500 shares of common stock on the same terms as the underwriters were purchasing the base number of shares. We expect to use the net proceeds from theOctober 2017 Offeringto fund our continued development of anabasum and for general corporate purposes, which may include funding preclinical studies and clinical trials, manufacturing anabasum for clinical trials and commercial launch, and acquisitions or investments in businesses, products or technologies that are complementary, and to increase our working capital and fund capital expenditures.

During the nine months ended September 30, 2017, we issued 239,817 shares of common stock upon the exercise of stock options to purchase common stock and we received proceeds of $109,053 from these exercises. Cash provided by financing activities for the nine months ended September 30, 2017 included principal payments on notes payable of approximately $272,000 in connection with our loan agreement with a financing company. The terms of the loan that we entered into in October 2016 stipulated equal monthly payments of principal and interest payments of $39,114 over a nine-month period. Interest accrued on this loan at an annual rate of 2.25%. This loan was fully repaid in July 2017.

We expect our cash, on handcash equivalents, and investments of $36,597,469approximately $36,566,000 at SeptemberJune 30, 2017 together with the proceeds from the October 2017 Offering and the remaining milestone payment of $500,000 from the Cystic Fibrosis Foundation Therapeutics, Inc. (“CFFT”), which we received in November 2017, to2023 will be sufficient to meet our operating and capital requirements intofund operations through the fourthsecond quarter of 20192024, based on current planned expenditures.

24

We will need to raise significant additional capital to continue to fund operations and the clinical trials for anabasum.CRB-701 and CRB-601. We may seek to sell common stock, including sales under our Sales Agreement,or preferred stockequity or convertible debt securities, enter into a credit facility or another form of third-party funding or seek other debt financing. In addition, we may seek to raise cash through collaborative agreements or from government grants. The sale of equity and convertible debt securities may result in dilution to our stockholders and certain of those securities may have rights senior to those of our common shares. If we raise additional funds through the issuance of preferred stock, convertible debt securities or other debt financing, these securities or other debt could contain covenants that would restrict our operations. Any other third-party funding arrangement could require us to relinquish valuable rights.

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The source, timing and availability of any future financing will depend principally upon market conditions, and, more specifically, on the progress of our clinical development programs. Funding may not be available when needed, at all, or on terms acceptable to us. Lack of necessary funds may require us, among other things, to delay, scale back or eliminate expenses including some or all of our planned pre-clinical or clinical trials. These factors, among others, cause management to conclude there is a substantial doubt about the Company’s ability to continue as a going concern.

Contractual Obligations and Commitments

The following table presents information about our known contractual obligations as of September 30, 2017. It does not reflect contractual obligations that may have arisen or may arise after that date. Except for historical facts, the information in this section is forward-looking information.

  Payments due by period 
Contractual Obligations Total  Remainder of
Fiscal 2017
  Fiscal
2018-2019
  Fiscal
2020-2021
  After
Fiscal 2021
 
Operating lease obligations (1) $5,543,755  $81,576  $1,056,847  $1,614,843  $2,790,489 
Capital lease obligations (2)  6,058   1,136   4,922       
Total $5,549,813  $82,712  $1,061,769  $1,614,843  $2,790,489 

(1)In September 2016, our commercial lease for office space was amended for our expansion into an additional 4,088 square feet of office space within the existing building for an aggregate total of 10,414 square feet of leased office space (“September 2016 Amendment”). We began occupying this space in November 2016 and the lease for this office space was to terminate in January 2021. On August 21, 2017, we entered into a lease agreement (“August 2017 Lease Agreement”) with the existing landlord, pursuant to which we agreed to lease 32,733 square feet of office space (“Leased Premises”) in a building different than under the September 2016 Amendment. The initial term of the August 2017 Lease Agreement is for a period of seven years and is expected to begin upon the earlier of the date of our completion of the work to be performed to prepare the Leased Premises for our initial occupancy or February 18, 2018. The base rent for the Leased Premises ranges from approximately $470,000 for the first year to $908,341 for the seventh year. Additionally, the August 2017 Lease Agreement required us to provide a standby irrevocable letter of credit of $400,000, which may be reduced, if we are not in default under the August 2017 Lease Agreement, to $300,000 and $200,000 on the third and fourth anniversary of the commencement date, respectively, We entered into an unsecured letter of credit for $400,000 in connection with the August 2017 Lease Agreement. The September 2016 Amendment will be terminated upon the commencement date of the August 2017 Lease Agreement.
(2)On December 30, 2015, we entered into a lease agreement for a copier machine. The machine was placed in service in January 2016. The lease is for a three-year term and includes a bargain purchase option at the end of the term.

We may enter into contracts in the normal course of business with clinical research organizations for clinical trials and clinical supply manufacturing and with vendors for pre-clinical research studies, research supplies and other services and products for operating purposes. These contracts generally provide for termination on notice, and therefore, we believe that our non-cancelable obligations under these agreements are not material. As of September 30, 2017, other than the items in the table above, we had no material contractual obligations or commitments that will affect our future liquidity.

25

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors.investors, other than future royalty payments under license agreements discussed as follows:

License Agreement with Jenrin

Pursuant to the terms of the Jenrin Agreement, we are obligated to pay potential milestone payments to Jenrin totaling up to $18.4 million for each compound we elect to develop based upon the achievement of specified development and regulatory milestones. In addition, we are obligated to pay Jenrin royalties in the mid, single digits based on net sales of any Licensed Products, as defined in the Jenrin Agreement, subject to specified reductions.

The Jenrin Agreement terminates on a country-by-country basis and product-by-product basis upon the expiration of the royalty term for such product in such country. Each royalty term begins on the date of the first commercial sale of the licensed product in the applicable country and ends on the later of seven years from such first commercial sale or the expiration of the last to expire of the applicable patents in that country. The Jenrin Agreement may be terminated earlier in specified situations, including termination for uncured material breach of the Jenrin Agreement by either party, termination by Jenrin in specified circumstances, termination by Corbus with advance notice and termination upon a party’s insolvency or bankruptcy.

License Agreement with Milky Way

Pursuant to the terms of the Milky Way Agreement, we are obligated to pay potential milestone payments to Milky Way totaling up to $53.0 million based upon the achievement of specified development and regulatory milestones. In addition, we are obligated to pay Milky Way royalties in the lower, single digits based on net sales of any Licensed Products, as defined in the Milky Way Agreement.

The Milky Way Agreement will remain in effect on a Licensed Product-by-License Product and country-by-country basis, until the expiration of the Royalty Term of the Licensed Product in the country. The "Royalty Term" means the period beginning from the First Commercial Sale of the Licensed Product in the country until the expiration of the last-to-expire Valid Claim in any Licensor Patent in the country that Covers the composition of matter of the Licensed product, the manufacture of the Licensed Product in the country, or a method of use of the Licensed Product for an indication for which Regulatory Approval has been obtained in the country. The Milky Way Agreement may be terminated earlier in specified situations, including termination for material breach or termination by Corbus with advance notice.

License Agreement with UCSF

Pursuant to the terms of the UCSF Agreement, we are obligated to pay potential milestone payments to UCSF totaling up to $153.15 million based upon the achievement of specified development and regulatory milestones, excluding indication milestones for antibodies used for diagnostic products and services that will be an additional $50,000 for each new indication. In addition, we are obligated to pay UCSF royalties in the lower, single digits based on net sales of any Licensed Products, as defined in the UCSF License Agreement, and any diagnostic products and services.

The UCSF Agreement will remain in effect until the expiration or abandonment of the last of the Patent Rights licensed. The Royalty Term is the duration of Patent Rights in that country covering the applicable Licensed Product or Licensed Services Sold in the country. The UCSF Agreement may be terminated earlier in specified situations, including termination for material breach, termination by Corbus with advance notice and termination upon a party's bankruptcy.

License Agreement with CSPC

Pursuant to the terms of the CSPC License Agreement, we are obligated to pay potential milestone payments to CSPC totaling up to $130 million based upon the achievement of specified development and regulatory milestones and $555 million in potential commercial milestone payments. In addition, we are obligated to pay CSPC royalties in the low, double digits based on net sales of any Licensed Products, as defined in the CSPC License Agreement.

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The CSPC License Agreement will remain in effect on a Licensed Product and on a country-by-country basis, until the expiration of the Royalty Term of the Licensed Product in the country. The Royalty Term is the period beginning from the First Commercial Sale of the Licensed Product in the country until the later of the expiration of the last-to-expire Valid Claim in any Licensor Patent in the country that Covers the Licensed product, 10 years after the date of the First Commercial Sale in the country, or expiration of the Regulatory Exclusivity for the Licensed Product in the country. The CSPC License Agreement may be terminated earlier in specified situations, including termination for material breach, termination by Corbus with advance notice and termination upon a party's bankruptcy.

Critical Accounting Policies and Estimates

Our condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the U.S. The preparation of these financial statements requires management to make estimates, assumptions, and judgments that affect the reported amounts of assets, liabilities, revenue, costs of expenses and related disclosures in the condensed consolidated financial statements. On an ongoing basis, we evaluate our estimates and judgments. We base our estimates and judgments on historical experience, current economic and industry conditions and on various other factors that are believed to be reasonable under the circumstances. This forms the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We believe our critical accounting policies that involve the most judgment and complexity are those relating to:

stock-based compensation;

accrued research and development expenses; and

right-of-use assets and lease liabilities.

Stock-Based Compensation

Stock options are granted with an exercise price at no less than fair market value at the date of the grant. The stock options normally expire ten years from the date of grant. Stock option awards vest upon terms determined by our Board.

We recognize compensation costs resulting from the issuance of stock-based awards to employees, members of our Board and consultants. The fair value of each option grant was estimated as of the date of grant using the Black-Scholes option-pricing model. The fair value is amortized as compensation cost on a straight-line basis over the requisite service period of the awards, which is generally the vesting period. We estimate volatility by analyzing the volatility of the trading price of our common stock. We use historical data, as well as subsequent events occurring prior to the issuance of the condensed consolidated financial statements, to estimate option exercise and employee forfeitures within the valuation model. The expected term of options granted to employees under our stock plans is based on the average of the contractual term (generally 10 years) and the vesting period (generally 48 months). The expected term of options granted under the 2014 Plan, all of which qualify as “plain vanilla” per SEC Staff Accounting Bulletin 107, is based on the average of the 6.25 years. For non-employee options, the expected term is the contractual term. The risk-free rate is based on the yield of a U.S. Treasury security with a term consistent with the option. We estimate the forfeiture rate at the time of grant and revise it, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Forfeitures were estimated based on management’s expectation through industry knowledge and historical data. We have never paid dividends on our common stock and do not anticipate paying dividends on our common stock in the foreseeable future. Accordingly, we have assumed no dividend yield for purposes of estimating the fair value of our share-based compensation.

Accrued Research and Development Expenses

As part of the process of preparing financial statements, we are required to estimate and accrue expenses, the largest of which are research and development expenses. This process involves: communicating with our applicable personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual cost; estimating and accruing expenses in our financial statements as of each balance sheet date based on facts and circumstances known to us at the time; and periodically confirming the accuracy of our estimates with selected service providers and making adjustments, if necessary.

Examples of estimated research and development expenses that we accrue include:

fees paid to CROs and research institutions in connection with pre-clinical studies;
fees paid to contract manufacturers in connection with the production of drugs for studies and clinical trials;
fees paid to CRO and research institutions in connection with conducting of clinical studies; and
professional service fees for consulting and related services.

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We base our expense accruals related to pre-clinical and clinical studies on our estimates of the services performed pursuant to contracts with multiple research institutions and clinical research organizations that conduct and manage pre-clinical and clinical studies on our behalf. The financial terms of these agreements vary from contract to contract and may result in uneven payment flows. Payments under some of these contracts depend on factors, such as the successful enrollment of patients and the completion of clinical study milestones. Our service providers invoice us monthly in arrears for services performed. In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If we do not identify costs that we have begun to incur or if we underestimate or overestimate the level of services performed or the costs of these services, our actual expenses could differ from our estimates.

To date, we have not experienced significant changes in our estimates of accrued research and development expenses following each applicable reporting period. However, due to the nature of estimates, we cannot assure you that we will not make changes to our estimates in the future as we become aware of additional information regarding the status or conduct of our clinical studies and other research activities.

Leases

We lease our office space. We determine if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets and operating lease liabilities current and noncurrent in our condensed consolidated balance sheets.

ROU assets represent our right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As our leases do not provide an implicit rate, we use an incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. This is the rate we would have to pay if borrowing on a collateralized basis over a similar term to each lease. The ROU asset also includes any lease payments made and excludes lease incentives. Lease expense for lease payments is recognized on a straight-line basis over the lease term.

The Company has subleased a portion of its leased facility under an agreement considered to be an operating lease according to U.S. GAAP. The Company has not been legally released from its primary obligations under the original lease and therefore it continues to account for the original lease as it did before commencement of the sublease. The Company will record both fixed and variable payments received from the sublessee in its statement of operations on a straight-line basis as an offset to rent expense.

Item 3.Quantitative and Qualitative Disclosures About Market Risk.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

Our exposure to market risk is limited to our cash and cash equivalents, all of which have maturities of three months or less. The primary objectives of our investment activities are to preserve principal, provide liquidity and maximize income without significantly increasing risk. Our primary exposure to market risk is interest income sensitivity, which is affected by changes in the general level of U.S. interest rates. However, because of the short-term nature of the instruments in our portfolio, a sudden change in market interest rates would not be expected to have a material impact on our financial condition and/or results of operation. We do not have any foreign currency or other derivative financial instruments.Not Applicable.

Item 4.

Controls and Procedures.

Disclosure Controls and ProceduresProcedures.

Inherent Limitations on Effectiveness of Controls

Our management, including our principal executive officer and principal financial officer, does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent or detect all errors and all fraud. A control system, no matter how well-designed and operated, can provide only reasonable, not absolute, assurance that the control system's objectives will be met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud will be detected.

Evaluation of Our Disclosure Controls and Procedures

We maintain disclosure controls and procedures that are designed to provide reasonable assurance that material information required to be disclosed in our periodic reports filed under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms and to provide reasonable assurance that such information is accumulated and communicated to our management, our principal executive officer and our principal financial officer, to allow timely decisions regarding required disclosure. Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) of the Exchange Act, as amended) as of the end of the period covered by this report.

In May 2023 in connection with the preparation the Company’s interim financial statements for the period ended March 31, 2023, the Company determined that our disclosure controls and procedures were not effective due to a material weakness. The material weakness related to our failure to maintain an effective control environment over the internal control activities to ensure the processing of and reporting of accruals associated with upfront payments and issue fees in licensing agreements were complete, accurate and timely.

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Based on thatupon, and as of the date of, this evaluation, our Chief Executive Officer and our Chief Financial Officer concluded that our disclosure controls and procedures as of June 30, 2023 were not effective.

Remediation Plan for Material Weakness

Management is actively engaged in implementing and assessing remediation efforts to address the endmaterial weakness. The monitoring and review controls over the preparation of the period covered by this report were effectivefinancial statements have been enhanced, including designing, documenting and implementing additional reconciliations, analysis and review procedures over accruals associated with upfront payments and issue fees in ensuringlicensing agreements. We can provide no assurance that information required toour remediation efforts described herein will be disclosed by us in reportssuccessful and that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specifiedwill not have material weaknesses in the SEC’s rules and forms andfuture.

Notwithstanding the material weakness in our internal control over financial reporting, we have concluded that the information required to be disclosed by uscondensed consolidated financial statements included in such reports is accumulatedthis Form 10-Q fairly present, in all material respects, our financial position, results of operations, changes in stockholders’ equity and communicated to our management, including our Chief Executive Officer and our Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.cash flows for the periods presented in conformity with U.S. GAAP.

Evaluation of Changes in Internal Control over Financial Reporting

There was no change in our internal control over financial reporting (as defined in Rule 13a-15(f) of the Exchange Act) that occurred during the period to which this report relates that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risks that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. From time to time, we make changes to our internal control over financial reporting that are intended to enhance its effectiveness and which do not have a material effect on our overall internal control over financial reporting.

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PART II — OTHER INFORMATION

Item 1.Legal Proceedings.

None.

We are not currently subject to any material legal proceedings. However, we may from time to time become a party to various legal proceedings arising in the ordinary course of our business.

Item 1A.Risk Factors.

Item 1A. Risk Factors.

ThereExcept as set forth below, there have been no material changes in or additions to the risk factors from what was reportedincluded in our 2016 Annual Report on Form 10-K.10-K for the year ended December 31, 2022.

Risks Related to Our Business, Financial Position and Need for Capital

26

Our recurring losses from operations have raised substantial doubt regarding our ability to continue as a going concern.

We have incurred recurring losses since inception and as of June 30, 2023, had an accumulated deficit of approximately $418,609,000. We anticipate operating losses to continue for the foreseeable future due to, among other things, costs related to research funding, development of our product candidates and pre-clinical and clinical programs, strategic alliances and the development of our administrative organization. We expect the cash, cash equivalents, and investments of approximately $36,566,000 at June 30, 2023 will not be sufficient to meet our operating and capital requirements at least twelve months from the issuance of this Quarterly Report on Form 10-Q. The consolidated financial statements do not include any adjustments that might be necessary should we be unable to continue as a going concern.

Our ability to continue as a going concern is dependent on our ability to raise additional equity or debt capital. Should we be unable to raise sufficient additional capital, we may be required to undertake cost-cutting measures including delaying or discontinuing certain clinical activities. We will need to raise significant additional capital to continue to fund the clinical trials for CRB-701 and CRB-601. We may seek to sell common or preferred equity or convertible debt securities, enter into a credit facility or another form of third-party funding, or seek other debt financing. In addition, the Company may seek to raise cash through collaborative agreements or from government grants. The sale of equity and convertible debt securities may result in dilution to our stockholders and certain of those securities may have rights senior to those of our common stock. If we raise additional funds through the issuance of preferred stock, convertible debt securities or other debt financing, these securities or other debt could contain covenants that would restrict our operations. Any other third-party funding arrangement could require us to relinquish valuable rights.

The source, timing and availability of any future financing will depend principally upon market conditions, and, more specifically, on the progress of our clinical development programs. Funding may not be available when needed, at all, or on terms acceptable to us. Lack of necessary funds may require us, among other things, to delay, scale back or eliminate some or all of our planned clinical trials. These factors among others create a substantial doubt about our ability to continue as a going concern.

We have identified a material weakness in our internal control over financial reporting and may identify additional material weaknesses in the future or otherwise fail to maintain an effective system of internal control. A failure of our control systems to prevent error or fraud may materially harm our company.

We are required, pursuant to Section 404 of the Sarbanes-Oxley Act, to furnish a report by our management on, among other things, the effectiveness of our internal control over financial reporting. This assessment will need to include disclosure of any material weaknesses identified by our management in our internal control over financial reporting. A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of annual or interim financial statements will not be prevented or detected on a timely basis.

Effective internal control over financial reporting is necessary for us to provide reliable and timely financial reports and, together with adequate disclosure controls and procedures, are designed to reasonably detect and prevent fraud. Any failure to implement required new or improved controls, or difficulties encountered in their implementation could cause us to fail to meet our reporting obligations. Undetected material weaknesses in our internal control over financial reporting could lead to financial statement restatements and require us to incur the expense of remediation. In May 2023 in connection with the preparation the Company’s interim financial statements for the period ended March 31, 2023, the Company determined that our disclosure controls and procedures were not effective due to a material weakness. The material weakness related to our failure to maintain an effective control environment over the internal control activities to ensure the processing of and reporting of accruals associated with upfront payments and issue fees in licensing agreements were complete, accurate and timely. Based upon, and as of the date of, this evaluation, our Chief Executive Officer and our Chief Financial Officer concluded that our disclosure controls and procedures as of June 30, 2023 were not effective.

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We do not expect that our disclosure controls or internal control over financial reporting will prevent or detect all error or all fraud. We may in the future discover other weaknesses in our system of internal control over financial reporting that could result in a material misstatement of our financial statements. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud will be detected. If we identify additional material weaknesses in our internal controls, investors could lose confidence in the reliability of our financial statements, the market price of our stock could decline and we could be subject to sanctions or investigations by The Nasdaq Stock Market, the SEC or other regulatory authorities. Failure of our control systems to detect or prevent error or fraud could materially adversely impact us.

Item 2.Unregistered Sales of Equity Securities and Use of Proceeds.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

None.

On June 1, 2023, we issued K2HV 194,444 shares of our common stock upon the conversion of $875,000 of the loan balance under the Amended Loan and Security Agreement at a conversion price of $4.50. Such issuance was exempt from registration under Section 4(a)(2) of the Securities Act of 1933, as amended.

Item 3.Defaults Upon Senior Securities.

Item 3. Defaults Upon Senior Securities.

None.

Item 4.Mine Safety Disclosures.

Item 4. Mine Safety Disclosures.

Not applicable.

Item 5.Other Information.

Item 5. Other Information.

None.

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Item 6. Exhibits.

The exhibits listed below are filed or furnished as part of this Quarterly Report on Form 10-Q.

EXHIBIT INDEX

Item 6.Exhibits

Exhibit

No.

Description

Exhibit

No.

Description

10.1

3.1

Lease Agreement, dated August 21, 2017, byAmended and between Corbus Pharmaceuticals, Inc. and River Ridge Limited PartnershipRestated Certificate of Incorporation of the Company, as amended (incorporated by reference to Exhibit the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on March 7, 2023).

3.2

Amended and Restated Bylaws of the Company (incorporated by reference to the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on March 7, 2023).

10.1 of

Separation and General Release Agreement between the Company and Craig Millian, dated April 24, 2023 (incorporated by reference to the Company’s Current Report on Form 8-K filed with the SEC on August 22, 2017)April 24, 2023).

10.2

Guarantee,Amendment No. 1 to Open Market Sale Agreement, dated August 21, 2017,May 31, 2023, by Corbus Pharmaceuticals Holdings, Inc.and between the Registrant and Jefferies LLC (incorporated by reference to Exhibit 10.2 of the Company’s Current ReportRegistration Statement on Form 8-KS-3 filed with the SEC on August 22, 2017)June 1, 2023).

31.1

Certification of Chief Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a).*

31.2

Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a).*

32.1

Certification of Chief Executive Officer pursuant to Rule 13a-14(b) or Rule 15d-14(b).**

32.2

Certification of Chief Financial Officer pursuant to Rule 13a-14(b) or Rule 15d-14(b).**

101.INS

Inline XBRL Instance Document.* - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document

101.SCH

Inline XBRL Taxonomy Extension Schema Document.*

101.CAL

Inline XBRL Taxonomy Extension Calculation Linkbase Document.*

101.DEF

Inline XBRL Taxonomy Extension Definition Linkbase Document.*

101.LAB

Inline XBRL Taxonomy Extension Label Linkbase Document.*

101.PRE

Inline XBRL Taxonomy Extension Presentation Linkbase Document.*

*Filed herewith.

**Furnished, not filed.

27

EXHIBIT INDEX

Exhibit

No.104

Description
10.1Lease Agreement, dated August 21, 2017, by and between Corbus Pharmaceuticals, Inc. and River Ridge Limited Partnership (incorporated by reference to Exhibit 10.1 of

The cover page from the Company’s CurrentQuarterly Report on Form 8-K filed with10-Q for the SEC on August 22, 2017).quarterly period ended June 30, 2023 is formatted in iXBRL*

*

Filed herewith.

10.2

**

Guarantee, dated August 21, 2017, by Corbus Pharmaceuticals Holdings, Inc. (incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K filed with the SEC on August 22, 2017).
31.1Certification of Chief Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a).*
31.2Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a).*
32.1Certification of Chief Executive Officer pursuant to Rule 13a-14(b) or Rule 15d-14(b).**
32.2Certification of Chief Financial Officer pursuant to Rule 13a-14(b) or Rule 15d-14(b).**
101.INSXBRL Instance Document.*
101.SCHXBRL Taxonomy Extension Schema Document.*
101.CALXBRL Taxonomy Extension Calculation Linkbase Document.*
101.DEFXBRL Taxonomy Extension Definition Linkbase Document.*
101.LABXBRL Taxonomy Extension Label Linkbase Document.*
101.PREXBRL Taxonomy Extension Presentation Linkbase Document.*

*Filed herewith.
**

Furnished, not filed.

28

SIGNATURES

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SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

Corbus Pharmaceuticals Holdings, Inc.

Date: NovemberAugust 8, 20172023

By:

/s/ Yuval Cohen

Name:

Yuval Cohen

Title:

Chief Executive Officer

(Principal Executive Officer)

Date: NovemberAugust 8, 20172023

By:

/s/ Sean Moran

Name:

Sean Moran

Title:

Chief Financial Officer

(Principal Financial Officer and Chief Accounting Officer)

29

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