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s

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

FORM 10-Q

 

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

 

For the quarterly period ended March 31, 2025

 

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

 

Corbus Pharmaceuticals Holdings, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

46-4348039

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification Number)

 

500 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 ☒ No ☐

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

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. 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

Non-accelerated filer

Smaller reporting company

Emerging growth company

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

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

As of May 2, 2025, 12,236,767 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 March 31, 2025

 

TABLE OF CONTENTS

 

 

Page

PART I

 

FINANCIAL INFORMATION

 

Item 1. Condensed Consolidated Financial Statements (unaudited)

3

Condensed Consolidated Balance Sheets as of March 31, 2025 and December 31, 2024

3

Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three Months Ended March 31, 2025 and 2024

4

Condensed Consolidated Statement of Stockholders’ Equity for the Three Months Ended March 31, 2025 and 2024

5

Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2025 and 2024

6

Notes to Condensed Consolidated Financial Statements

7

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

18

Item 3. Quantitative and Qualitative Disclosures about Market Risk

23

Item 4. Controls and Procedures

23

 

PART II

 

OTHER INFORMATION

 

Item 1. Legal Proceedings

24

Item 1A. Risk Factors

24

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

24

Item 3. Defaults Upon Senior Securities

24

Item 4. Mine Safety Disclosures

24

Item 5. Other Information

24

Item 6. Exhibits

25

Signatures

26

 

-2-


PART I — FINANCIAL INFORMATION

 

Item 1. Financial Statements.

 

Corbus Pharmaceuticals Holdings, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except share and per share amounts)

(Unaudited)

 

 

 

March 31, 2025

 

 

December 31, 2024

 

 

 

 

 

 

 

 

ASSETS

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

18,900

 

 

$

17,198

 

Investments

 

 

113,887

 

 

 

131,864

 

Restricted cash

 

 

285

 

 

 

285

 

Prepaid expenses and other current assets

 

 

4,288

 

 

 

3,629

 

Total current assets

 

 

137,360

 

 

 

152,976

 

Restricted cash

 

 

385

 

 

 

385

 

Property and equipment, net

 

 

304

 

 

 

385

 

Operating lease right-of-use assets

 

 

1,882

 

 

 

2,133

 

Total assets

 

$

139,931

 

 

$

155,879

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

4,068

 

 

$

4,786

 

Accrued expenses

 

 

5,902

 

 

 

5,426

 

Operating lease liabilities, current

 

 

1,650

 

 

 

1,606

 

Total current liabilities

 

 

11,620

 

 

 

11,818

 

Operating lease liabilities, noncurrent

 

 

1,205

 

 

 

1,633

 

Total liabilities

 

 

12,825

 

 

 

13,451

 

Stockholders’ equity

 

 

 

 

 

 

Preferred stock, $0.0001 par value; 10,000,000 shares authorized, no shares
 issued and outstanding at March 31, 2025 and December 31, 2024.

 

 

 

 

 

 

Common stock, $0.0001 par value; 300,000,000 shares authorized,
12,232,853 and 12,179,482 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively

 

 

1

 

 

 

1

 

Additional paid-in capital

 

 

620,999

 

 

 

619,285

 

Accumulated deficit

 

 

(493,871

)

 

 

(476,893

)

Accumulated other comprehensive (loss) gain

 

 

(23

)

 

 

35

 

Total stockholders’ equity

 

 

127,106

 

 

 

142,428

 

Total liabilities and stockholders’ equity

 

$

139,931

 

 

$

155,879

 

 

See notes to the unaudited condensed consolidated financial statements.

-3-


Corbus Pharmaceuticals Holdings, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share amounts)

(Unaudited)

 

 

 

For the Three Months
Ended March 31,

 

 

 

2025

 

 

2024

 

Operating expenses:

 

 

 

 

 

 

Research and development

 

$

15,642

 

 

$

5,762

 

General and administrative

 

 

4,133

 

 

 

3,861

 

Total operating expenses

 

 

19,775

 

 

 

9,623

 

Operating loss

 

 

(19,775

)

 

 

(9,623

)

Other income (expense), net:

 

 

 

 

 

 

Interest and investment income, net

 

 

1,681

 

 

 

1,028

 

Interest expense

 

 

 

 

 

(839

)

Other income, net

 

 

1,116

 

 

 

2,535

 

Total other income, net

 

 

2,797

 

 

 

2,724

 

Net loss

 

$

(16,978

)

 

$

(6,899

)

Net loss per share, basic and diluted

 

$

(1.39

)

 

$

(0.83

)

Weighted average number of common shares outstanding, basic and diluted

 

 

12,202,092

 

 

 

8,310,508

 

 

 

 

 

 

 

Comprehensive loss:

 

 

 

 

 

 

Net loss

 

$

(16,978

)

 

$

(6,899

)

Other comprehensive loss:

 

 

 

 

 

 

Change in unrealized loss on marketable debt securities

 

 

(58

)

 

 

(328

)

Total other comprehensive loss

 

 

(58

)

 

 

(328

)

Total comprehensive loss

 

$

(17,036

)

 

$

(7,227

)

 

See notes to the unaudited condensed consolidated financial statements.

 

-4-


Corbus Pharmaceuticals Holdings, Inc.

Condensed Consolidated Statements of Stockholders’ Equity

(in thousands, except share amounts)

(Unaudited)

 

 

 

For the Three Months Ended March 31, 2025

 

 

 

Common Stock

 

 

Additional
Paid-in

 

 

Accumulated

 

 

Accumulated
Other
Comprehensive

 

 

Total
Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Loss

 

 

Equity

 

Balance at December 31, 2024

 

 

12,179,482

 

 

$

1

 

 

$

619,285

 

 

$

(476,893

)

 

$

35

 

 

$

142,428

 

Issuance of common stock upon vesting of restricted stock

 

 

53,371

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

1,714

 

 

 

 

 

 

 

 

 

1,714

 

Change in unrealized gain (loss) on marketable debt securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(58

)

 

 

(58

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

(16,978

)

 

 

 

 

 

(16,978

)

Balance at March 31, 2025

 

 

12,232,853

 

 

$

1

 

 

$

620,999

 

 

$

(493,871

)

 

$

(23

)

 

$

127,106

 

 

 

 

 

For the Three Months Ended March 31, 2024

 

 

 

Common Stock

 

 

Additional
Paid-in

 

 

Accumulated

 

 

Accumulated
Other
Comprehensive

 

 

Total
Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Loss

 

 

Equity

 

Balance at December 31, 2023

 

 

4,423,683

 

 

$

 

 

$

429,780

 

 

$

(436,684

)

 

$

(1

)

 

$

(6,905

)

Issuance of common stock, net of issuance costs

 

 

5,913,138

 

 

 

1

 

 

 

108,763

 

 

 

 

 

 

 

 

 

108,764

 

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

 

 

142,857

 

 

 

 

 

 

1,125

 

 

 

 

 

 

 

 

 

1,125

 

Issuance of common stock upon exercise of stock options

 

 

24,231

 

 

 

 

 

 

226

 

 

 

 

 

 

 

 

 

226

 

Issuance of common stock upon vesting of restricted stock

 

 

3,328

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

982

 

 

 

 

 

 

 

 

 

982

 

Change in unrealized gain (loss) on marketable debt securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(328

)

 

 

(328

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

(6,899

)

 

 

 

 

 

(6,899

)

Balance at March 31, 2024

 

 

10,507,237

 

 

$

1

 

 

$

540,876

 

 

$

(443,583

)

 

$

(329

)

 

$

96,965

 

 

See notes to the unaudited condensed consolidated financial statements.

 

 

-5-


Corbus Pharmaceuticals Holdings, Inc.

Condensed Consolidated Statements of Cash Flows

(in thousands)

(Unaudited)

 

 

 

Three Months Ended
March 31,

 

 

 

2025

 

 

2024

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(16,978

)

 

$

(6,899

)

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

 

 

 

 

 

 

Stock-based compensation expense

 

 

1,714

 

 

 

982

 

Depreciation expense

 

 

81

 

 

 

152

 

Net amortization of premiums and discounts on investments

 

 

(204

)

 

 

(909

)

Amortization of debt discount

 

 

 

 

 

188

 

Other

 

 

(34

)

 

 

5

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

(Increase) decrease in prepaid expenses and other current assets

 

 

(659

)

 

 

1,229

 

Decrease in other assets

 

 

 

 

 

213

 

Decrease in operating lease right-of-use asset

 

 

251

 

 

 

222

 

Decrease in other long-term liabilities

 

 

 

 

 

(44

)

Decrease in accounts payable

 

 

(684

)

 

 

(1,131

)

Increase (decrease) in accrued expenses

 

 

476

 

 

 

(1,632

)

Decrease in operating lease liabilities

 

 

(384

)

 

 

(343

)

Net cash used in operating activities

 

 

(16,421

)

 

 

(7,967

)

Cash flows from investing activities:

 

 

 

 

 

 

Purchases of investments

 

 

(37,605

)

 

 

(105,898

)

Proceeds from sales and maturities of investments

 

 

55,728

 

 

 

7,662

 

Net cash provided by (used in) investing activities

 

 

18,123

 

 

 

(98,236

)

Cash flows from financing activities:

 

 

 

 

 

 

Proceeds from issuance of common stock, net

 

 

 

 

 

108,899

 

Repayment of notes payable

 

 

 

 

 

(111

)

Repayment of long-term borrowings

 

 

 

 

 

(2,206

)

Net cash provided by financing activities

 

 

 

 

 

106,582

 

Net increase in cash, cash equivalents, and restricted cash

 

 

1,702

 

 

 

379

 

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

 

 

17,868

 

 

 

14,394

 

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

 

$

19,570

 

 

$

14,773

 

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

 

 

 

 

 

 

Cash paid during the period for interest

 

$

 

 

$

547

 

Common stock issuance costs not yet paid

 

$

75

 

 

$

171

 

Issuance of common stock for conversion of convertible debt

 

$

 

 

$

1,125

 

 

See notes to the unaudited condensed consolidated financial statements.

-6-


Corbus Pharmaceuticals Holdings, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

March 31, 2025

 

1. NATURE OF BUSINESS AND BASIS OF PRESENTATION

 

Nature of Business

 

Corbus Pharmaceuticals Holdings, Inc. (the "Company" or "Corbus") is an oncology and obesity company with a diversified portfolio and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways. Corbus’ pipeline is comprised of two experimental drugs targeting solid tumors: CRB-701, a next-generation antibody drug conjugate ("ADC") that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload of monomethyl auristatin E ("MMAE") and CRB-601, an anti-integrin monoclonal antibody that blocks the activation of TGFβ expressed on cancer cells. The pipeline also includes CRB-913, a highly peripherally restricted cannabinoid type-1 ("CB1") receptor inverse agonist for the treatment of obesity. 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.

 

Basis of Presentation

 

The accompanying unaudited financial statements have been prepared in accordance with generally accepted accounting principles in the United States ("U.S. GAAP") for interim financial reporting. 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 March 31, 2025 and the results of its operations and changes in stockholders’ equity for the three months ended March 31, 2025 and 2024 and its cash flows for the three months ended March 31, 2025 and 2024. Certain amounts in the prior year's financial statements have been reclassified to conform with the current year presentation. These reclassifications did not impact previously reported net loss or cash flows. The December 31, 2024 condensed consolidated balance sheet was derived from audited financial statements. The Company prepared the condensed consolidated financial statements following the requirements of the U.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 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, 2024, filed on March 11, 2025 (the "2024 Annual Report"). The results of operations for such interim periods are not necessarily indicative of the operating results for the full fiscal year.

 

Basis of 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.

 

The significant accounting policies used in preparation of these condensed consolidated financial statements in this Form 10-Q are consistent with those discussed in Note 3, "Significant Accounting Policies," in our 2024 Annual Report.

 

Recently Adopted Accounting Pronouncements

 

In November 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures, which requires entities to disclose disaggregated information about their effective tax rate reconciliations as well as expanded information on income taxes by jurisdiction. The standard is effective for fiscal years beginning after December 15, 2024 on a prospective basis. The Company discloses its income tax rate reconciliation in its annual consolidated financial statements only and does not expect the adoption to have a material impact on its consolidated financial statements.

 

-7-


Government Tax Credits

 

The Company is eligible to receive government assistance in the form of refundable research and development tax credits and the employee retention tax credit ("ERTC"). The Company may qualify for refundable research and development tax credits from foreign authorities in the form of cash that are earned on certain research and development expenses incurred primarily outside of the United States ("U.S.") by its foreign subsidiaries in the United Kingdom ("U.K.") and Australia. Under the Coronavirus Aid, Relief, and Economic Security Act of 2020, or CARES Act, the Company was eligible to claim the ERTC, which is a refundable tax credit against certain employment taxes. The Company records these tax credits as other income, net when the Company has reasonable assurance any conditions attached to the assistance have been met and the assistance will be received. The Company recognized $1.1 million and $2.5 million in government tax credits to other income, net for the three months ended March 31, 2025 and 2024, respectively. All amounts have been received, except for $1.1 million that is included in prepaid expenses and other current assets within the condensed consolidated balance sheet as of March 31, 2025. No future conditions impact the recognition of these tax credits.

 

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 March 31, 2025, had an accumulated deficit of approximately $493.9 million. The Company anticipates operating losses to continue for the foreseeable future due to, among other things, costs related to research funding, development of its product candidates and its pre-clinical and clinical programs, strategic alliances, and the development of its administrative organization. The Company expects that its cash, cash equivalents, and investments of approximately $132.8 million at March 31, 2025 will be sufficient to meet its operating and capital requirements at least twelve months from the issuance of this Quarterly Report on Form 10-Q.

 

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, delay, scale back or eliminate some or all of the Company’s planned clinical or pre-clinical trials.

 

3. CASH, CASH EQUIVALENTS, AND RESTRICTED CASH

 

The Company considers only those investments which are highly liquid, readily convertible to cash, and that mature within 90 days from the date of purchase to be cash equivalents. At March 31, 2025 and December 31, 2024, cash equivalents were comprised of money market funds and corporate debt securities with maturities less than 90 days from the date of purchase.

 

Restricted cash as of March 31, 2025 included security for a stand-by letter of credit issued in favor of a landlord for $0.7 million of which $0.3 million was classified in current assets and $0.4 million was classified in noncurrent assets as of March 31, 2025.

 

Cash, cash equivalents, and restricted cash consist of the following (in thousands):

 

 

 

March 31, 2025

 

 

December 31, 2024

 

Cash

 

$

2,355

 

 

$

5,047

 

Cash equivalents

 

 

16,545

 

 

 

12,151

 

Cash and cash equivalents

 

 

18,900

 

 

 

17,198

 

 

 

 

 

 

 

Restricted cash, current

 

 

285

 

 

 

285

 

Restricted cash, noncurrent

 

 

385

 

 

 

385

 

Restricted cash

 

 

670

 

 

 

670

 

Total cash, cash equivalents, and restricted cash shown in the statement of cash
   flows

 

$

19,570

 

 

$

17,868

 

 

As of March 31, 2025, the Company’s cash and cash equivalents held in the U.S. was approximately $16.7 million and approximately $2.2 million of cash was held in its subsidiaries in the U.K. and Australia. As of December 31, 2024, all of the Company’s cash was held in the U.S., except for approximately $4.9 million of cash which was held in its subsidiaries in the U.K. and Australia.

 

-8-


4. INVESTMENTS

 

The following table summarizes the Company’s investments as of March 31, 2025 (in thousands):

 

 

 

Amortized Cost

 

 

Gross
Unrealized
Gain

 

 

Gross
Unrealized
Losses

 

 

Fair Value

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Debt Securities:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. Treasury securities

 

$

7,528

 

 

$

13

 

 

$

-

 

 

$

7,541

 

U.S. government agency securities

 

 

17,669

 

 

 

12

 

 

 

(1

)

 

 

17,680

 

Commercial paper

 

 

4,404

 

 

 

-

 

 

 

-

 

 

 

4,404

 

Corporate debt securities

 

 

84,308

 

 

 

23

 

 

 

(69

)

 

 

84,262

 

Total

 

$

113,909

 

 

$

48

 

 

$

(70

)

 

$

113,887

 

 

The following table summarizes the amortized cost and fair value of the Company’s available-for-sale marketable debt securities by contractual maturity as of March 31, 2025 (in thousands):

 

 

 

Amortized Cost

 

 

Fair Value

 

 

 

 

 

 

 

 

Maturing in one year or less

 

$

103,660

 

 

$

103,656

 

Maturing after one year but less than three years

 

 

10,249

 

 

 

10,231

 

 

$

113,909

 

 

$

113,887

 

 

The following table summarizes the Company’s investments as of December 31, 2024 (in thousands):

 

 

 

Amortized Cost

 

 

Gross
Unrealized
Gain

 

 

Gross
Unrealized
Losses

 

 

Fair Value

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Debt Securities:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. Treasury securities

 

$

9,452

 

 

$

15

 

 

$

-

 

 

$

9,467

 

U.S. government agency securities

 

 

22,075

 

 

 

18

 

 

 

-

 

 

 

22,093

 

Corporate debt securities

 

 

100,302

 

 

 

56

 

 

 

(54

)

 

 

100,304

 

Total

 

$

131,829

 

 

$

89

 

 

$

(54

)

 

$

131,864

 

 

The following table summarizes the amortized cost and fair value of the Company’s available-for-sale marketable debt securities by contractual maturity as of December 31, 2024 (in thousands):

 

 

 

Amortized Cost

 

 

Fair Value

 

 

 

 

 

 

 

 

Maturing in one year or less

 

$

126,870

 

 

$

126,930

 

Maturing after one year but less than three years

 

 

4,959

 

 

 

4,934

 

 

$

131,829

 

 

$

131,864

 

 

 

5. FAIR VALUE OF FINANCIAL ASSETS AND LIABILITIES

 

The following table presents 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 March 31, 2025 (in thousands):

 

-9-


 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

15,394

 

 

$

 

 

$

 

 

$

15,394

 

Corporate debt securities

 

 

 

 

 

1,151

 

 

 

 

 

 

1,151

 

Investments:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. Treasury securities

 

 

 

 

 

7,541

 

 

 

 

 

 

7,541

 

U.S. government agency securities

 

 

 

 

 

17,680

 

 

 

 

 

 

17,680

 

Commercial paper

 

 

 

 

 

4,404

 

 

 

 

 

 

4,404

 

Corporate debt securities

 

 

 

 

 

84,262

 

 

 

 

 

 

84,262

 

 

$

15,394

 

 

$

115,038

 

 

$

 

 

$

130,432

 

 

The following table presents 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, 2024 (in thousands):

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Cash Equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

12,151

 

 

$

 

 

$

 

 

$

12,151

 

Investments:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. Treasury securities

 

 

 

 

 

9,467

 

 

 

 

 

 

9,467

 

U.S. government agency securities

 

 

 

 

 

22,093

 

 

 

 

 

 

22,093

 

Corporate debt securities

 

 

 

 

 

100,304

 

 

 

 

 

 

100,304

 

 

$

12,151

 

 

$

131,864

 

 

$

 

 

$

144,015

 

 

 

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 License 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 $0.3 million upfront cash payment and is obligated to pay potential milestone payments to Jenrin totaling up to $18.4 million for each compound it elects to develop based upon the achievement of specified development and regulatory milestones. In addition, the Company 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 achieved the first milestone in the amount of $0.4 million associated with the progression into a clinical trial for CRB-913 during the three months ended March 31, 2025. This amount is included in accounts payable within the condensed consolidated balance sheet as of March 31, 2025.

 

The Company entered into a license agreement (the "UCSF License Agreement") with the 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.

 

In consideration for the license and other rights granted to the Company under the UCSF License Agreement, the Company paid The Regents a license issue fee of $1.5 million. In consideration for the additional antibody patents granted to the Company, the Company paid The Regents a license issue fee of $0.8 million, paid in two equal installments of $0.4 million.

 

The Company further amended the UCSF License Agreement with The Regents effective August 14, 2023 to incorporate certain new technology rights and amend the payment schedule for the development milestone for the filing of patent rights and the development milestone for the filing of an Investigational New Drug ("IND").

-10-


 

In addition to the license issuance fees, the Company is obligated to pay an annual license maintenance fee, as well as up to $150.8 million in remaining potential milestone payments, excluding indication milestones for antibodies used for diagnostic products and services that will be an additional $50.0 thousand for each new indication, for the achievement of certain development, regulatory, and sales milestones. In addition, the Company is also obligated to pay royalties in the lower, 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 the Company from sublicensees or in connection with the sale of the licensed program. During the three months ended March 31, 2025, the Company paid $1.6 million under the UCSF License Agreement for previously achieved milestone payments. This amount was included within accounts payable within the condensed consolidated balance sheet as of December 31, 2024.

 

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 ADC 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 U.K., and Australia.

 

In consideration for the license granted to the Company under the CSPC License Agreement, the Company paid CSPC an upfront payment of $7.5 million ($5.0 million paid at signing during the first quarter of 2023 followed by $2.5 million paid during the third quarter of 2024). The Company is obligated to pay potential milestone payments to CSPC totaling up to $130.0 million based upon the achievement of specified development and regulatory milestones and $555.0 million in potential commercial milestone payments. In addition, we are obligated to pay royalties in the 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 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 payments 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 in the period that the relevant milestones are achieved as either research and development expense or as an intangible asset as applicable. Research and development expenses associated with upfront payments and clinical milestones was $0.4 million for the three months ended March 31, 2025 related to the CRB-913 milestone payment in accordance with the Jenrin License Agreement. For the three months ended March 31, 2024, no research and development expense associated with upfront payments or clinical milestones were incurred under any of the above agreements.

 

7. PROPERTY AND EQUIPMENT

 

Property and equipment consisted of the following (in thousands):

 

 

 

March 31,
2025

 

 

December 31,
2024

 

Computer hardware and software

 

$

13

 

 

$

13

 

Office furniture and equipment

 

 

1,114

 

 

 

1,114

 

Leasehold improvements

 

 

3,331

 

 

 

3,331

 

Property and equipment, gross

 

 

4,458

 

 

 

4,458

 

Less: accumulated depreciation

 

 

(4,154

)

 

 

(4,073

)

Property and equipment, net

 

$

304

 

 

$

385

 

 

Depreciation expense was $0.1 million and $0.2 million for the three months ended March 31, 2025 and 2024, respectively.

 

The Company notes no impairment charges were taken in the three months ended March 31, 2025 and 2024.

 

-11-


8. COMMITMENTS AND CONTINGENCIES

 

Operating Lease Commitment

 

Pursuant to the terms of the Company’s non-cancelable lease agreements in effect at March 31, 2025, the following table summarizes the Company’s maturities of operating lease liabilities as of March 31, 2025 (in thousands):

 

2025

 

$

1,352

 

2026

 

 

1,688

 

Total lease payments

 

 

3,040

 

 

 

 

Less: imputed interest

 

 

(185

)

Total

 

$

2,855

 

 

Sublease 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 was scheduled to end on October 31, 2026, however, it was terminated on June 24, 2024. The Company recorded no sublease income for the three months ended March 31, 2025 and sublease expense of $0.2 million for the three months ended March 31, 2024.

 

9. NOTES PAYABLE

 

Loan and Security Agreement with K2 HealthVentures LLC

 

On 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 unrelated third party (the "Loan and Security Agreement") and received $20.0 million upon signing. On August 1, 2024, the loan matured and the Company made a final payment in the amount of $11.8 million, which represented $10.1 million principal outstanding on the maturity date, $1.6 million final payment and accrued interest. The $1.6 million final payment was amortized over the life of the loan through interest expense within the condensed consolidated statements of operations and comprehensive loss. Interest payments were made monthly and accrued 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%.

 

The Company entered into an Amendment to the Loan and Security Agreement (the "Amended Loan and Security Agreement") on October 25, 2022. Pursuant to the Amended Loan and Security Agreement, K2HV could elect to convert up to $5.0 million of the outstanding loan balance into shares of the Company’s common stock at conversion prices as follows: $0.9 million of the loan at $4.50 per share, $1.1 million at $7.875 per share, and $3.0 million at $282.00 per share. On June 1, 2023, K2HV converted $0.9 million of the outstanding loan balance into 194,444 shares of the Company's stock at a conversion price of $4.50 per share. On March 6, 2024, K2HV converted $1.1 million of the outstanding loan balance into 142,857 shares of the Company's stock at a conversion price of $7.875 per share.


 

 

In connection with the Loan and Security Agreement, on July 28, 2020, the Company issued K2HV a warrant to purchase up to 2,873 common shares (the "K2 Warrant") at an exercise price of $208.80. The K2 Warrant may be exercised either for cash or on a cashless "net exercise" basis and expires on July 28, 2030.

 

The total debt discount related to the Amended Loan and Security Agreement of approximately $3.0 million was charged to interest expense using the effective interest method over the term of the debt. Interest expense for the three months ended March 31, 2025 and 2024 was approximately $0 and $0.8 million, respectively.

 

-12-


10. ACCRUED EXPENSES

 

Accrued expenses consisted of the following (in thousands):

 

 

 

March 31,
2025

 

 

December 31,
2024

 

 

 

 

 

 

 

 

Accrued pre-clinical and clinical costs

 

$

4,096

 

 

$

2,424

 

Accrued product development costs

 

 

390

 

 

 

280

 

Accrued compensation

 

 

999

 

 

 

2,276

 

Accrued administrative costs

 

 

417

 

 

 

446

 

Total

 

$

5,902

 

 

$

5,426

 

 

11. 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 shares outstanding during the period. For years in which there is a net loss, options, warrants and RSUs are anti-dilutive and therefore excluded from diluted loss per share calculations. The following table sets forth the computation of basic and diluted earnings per share for the three months ended March 31, 2025 and 2024 (in thousands except share and per share amounts):

 

 

 

Three Months Ended
March 31,

 

 

 

2025

 

 

2024

 

Net loss

 

$

(16,978

)

 

$

(6,899

)

Weighted average number of common shares-basic and diluted

 

 

12,202,092

 

 

 

8,310,508

 

Net loss per share of common stock-basic and diluted

 

$

(1.39

)

 

$

(0.83

)

 

The following common stock equivalents have been excluded from the calculation of diluted net loss per share for the periods presented because including them would have been anti-dilutive:

 

 

 

March 31,

 

 

 

2025

 

 

2024

 

Stock options

 

 

1,319,028

 

 

 

820,804

 

Unvested restricted stock units

 

 

473,792

 

 

 

212,493

 

Warrants

 

 

2,873

 

 

 

50,207

 

 

12. STOCKHOLDERS' EQUITY

 

Preferred Stock

 

The Company has authorized 10,000,000 shares of preferred stock, $0.0001 par value per share, of which 0 shares were issued and outstanding as of March 31, 2025 and December 31, 2024, respectively.

 

Common Stock

 

The Company has authorized 300,000,000 shares of common stock, $0.0001 par value per share, of which 12,232,853 and 12,179,482 shares were issued and outstanding as of March 31, 2025 and December 31, 2024, respectively.

 

Public Offering

 

On January 31, 2024, the Company entered into an underwriting agreement with Jefferies LLC ("Jefferies"), as representative of the several underwriters, relating to an underwritten public offering of 4,325,000 shares of the Company’s common stock, par value $0.0001, at a price to the public of $19.00 per share. The underwriters were also granted a 30-day option to purchase up to an additional 648,750 shares of common stock at the public offering price. On January 31, 2024, Jefferies gave notice to the Company of the underwriters’ election to exercise the option to purchase additional shares, in full. On February 2, 2024, the Company completed the public offering raising gross proceeds of approximately $94.5 million and net proceeds of $88.6 million after deducting underwriting discounts and commissions and other offering expenses payable by the Company.

 

-13-


Open Market Sale Agreement

 

On May 31, 2023, the Company entered into Amendment No. 1 to the Open Market Sale Agreement originally dated August 6, 2020 (as amended, the "Open Market Sale Agreement") with Jefferies, as sales agent. Under the Open Market Sale Agreement, the Company may issue and sell, from time to time through Jefferies, shares of its common stock having an aggregate offering price of up to $150.0 million (the "2024 Open Market Offering").

 

Under the Open Market Sale Agreement, Jefferies may sell the 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 may sell common stock in amounts and at times to be determined by the Company subject to the terms and conditions of the Open Market Sale Agreement, but the Company has no obligation to sell any of the common stock in the 2024 Open Market Offering.

 

The Company has agreed to 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.

 

During the three months ended March 31, 2024, the Company sold 939,388 shares of its common stock for net proceeds of approximately $20.2 million the Open Market Sale Agreement. The Company did not make any sales under the Open Market Sale Agreement during the three months ended March 31, 2025. As of March 31, 2025, approximately $76.4 million was available for issuance and sale under the 2024 Open Market Offering.

 

Other Common Stock Transactions

 

During the three months ended March 31, 2025 and 2024, the Company issued 0 and 24,231 shares of common stock upon the exercise of stock options to purchase common stock and the Company received proceeds of $0 and $0.2 million from those exercises, respectively.

 

During the three months ended March 31, 2025 and 2024, the Company issued 53,371 and 3,328 common shares from the vesting of shares from restricted stock, respectively, of which 625 and 0, respectively, were issued under the 2024 Plan and the remaining were issued under the 2014 Plan.

 

During the three months ended March 31, 2024, the Company issued 142,857 shares of common stock in a conversion pursuant to the K2HV Amended Loan and Security Agreement. No such amounts were issued during the three months ended March 31, 2025.

 

No warrants were exercised during the three months ended March 31, 2025 and 2024.

 

13. STOCK-BASED COMPENSATION AWARDS

 

On May 16, 2024, the Company's stockholders approved the 2024 Equity Compensation Plan (the "2024 Plan") authorizing the issuance of up to 2,000,000 shares, succeeding the 2014 Equity Incentive Plan (the "2014 Plan"), under which no further grants may be made pursuant to the terms of the 2014 Plan. Pursuant to the 2024 Plan, the Board may grant nonqualified stock options, incentive stock options, stock appreciation rights, restricted stock, restricted stock units ("RSUs"), performance shares, performance units, incentive bonus awards, other cash-based awards and other stock-based awards to employees, officers, non-employee directors, and other individual service providers.

 

Under the terms of the 2024 Plan and 2014 Plan, the Company granted stock options and RSUs to employees, officers, non-employee directors, consultants and advisors. Stock options have a ten-year term and an exercise price equal to the fair market value of a share of our common stock on the grant date. Stock options generally vest over four years with 25% vesting on the one-year anniversary of the grant date and the remainder vesting in equal monthly installments thereafter, except for grants to non-employee directors that vest annually. RSUs generally vest over a period of one to four years in annual installments beginning on the first anniversary of the grant date.

 

As of March 31, 2025, an aggregate of 829,334 shares of common stock were reserved for issuance upon the exercise or vesting of outstanding awards under the 2014 Plan. No additional grants can be made under the 2014 Plan.

 

As of March 31, 2025, an aggregate of 963,486 shares of common stock were reserved for issuance upon the exercise or vesting of outstanding awards and up to 1,033,106 shares of common stock may be issued pursuant to awards granted under the 2024 Plan.

 

Stock-based Compensation Expense

-14-


 

In connection with all stock-based compensation awards, total non-cash, stock-based compensation expense recognized in the condensed consolidated statements of operations and comprehensive loss was as follows (in thousands):

 

 

 

Three Months Ended March 31,

 

 

 

2025

 

 

2024

 

 

 

 

 

 

 

 

Research and development expenses

 

$

438

 

 

$

136

 

General and administrative expenses

 

 

1,276

 

 

 

846

 

Total stock-based compensation

 

$

1,714

 

 

$

982

 

 

The total stock-based compensation expense recognized by award type was as follows (in thousands):

 

 

 

Three Months Ended March 31,

 

 

 

2025

 

 

2024

 

 

 

 

 

 

 

 

Stock options

 

$

994

 

 

$

830

 

Restricted stock units

 

 

720

 

 

 

152

 

Total stock-based compensation

 

$

1,714

 

 

$

982

 

 

Stock Options

 

The fair value of each stock option award is estimated on the date of grant using the Black-Scholes stock option pricing model that uses the assumptions noted in the following table, except for the expected term for non-employees as noted in the following paragraph. The expected term of employee and non-employee director stock options granted under the 2014 Plan and 2024 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. The expected term is applied to the stock option grant group as a whole, as the Company does not expect substantially different exercise or post-vesting termination behavior among our employee population. For non-employee stock options, excluding directors, the Company has elected to utilize the contractual term as the expected term. The risk-free rate is based on the yield of a U.S. Treasury security with a term consistent with that used to value the stock option. The Company accounts for forfeitures as they occur.

 

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

 

 

 

Three Months Ended March 31,

 

 

 

2025

 

 

2024

 

Risk-free interest rate

 

 

4.43

%

 

 

4.22

%

Expected dividend yield

 

 

0

%

 

0%

 

Expected term in years

 

 

6.25

 

 

6.25

 

Expected volatility

 

 

130.41

%

 

 

123.75

%

 

A summary of stock option activity for the three months ended March 31, 2025 is presented below:

 

Stock Options

 

Shares

 

 

Weighted
 Average
Exercise
 Price

 

 

Weighted Average
 Remaining Contractual Term in Years

 

 

Aggregate
Intrinsic
Value (in thousands)

 

Outstanding at December 31, 2024

 

 

723,153

 

 

$

62.95

 

 

6.95

 

 

$

881

 

Granted

 

 

597,375

 

 

 

9.74

 

 

 

 

 

 

 

Exercised

 

 

 

 

 

 

 

 

 

 

 

 

Forfeited or canceled

 

 

 

 

 

 

 

 

 

 

 

 

Expired

 

 

(1,500

)

 

 

37.80

 

 

 

 

 

 

 

Outstanding at March 31, 2025

 

 

1,319,028

 

 

$

38.88

 

 

 

8.13

 

 

$

113

 

Exercisable at March 31, 2025

 

 

451,340

 

 

$

87.26

 

 

 

5.60

 

 

$

53

 

 

-15-


 

The weighted average grant-date fair value of stock options granted during the three months ended March 31, 2025 and 2024 was $8.87 and $21.25 per share, respectively. The aggregate intrinsic value of stock options exercised during the three months ended March 31, 2025 and 2024 was $0 and $0.7 million, respectively. As of March 31, 2025, there was $9.5 million of total unrecognized compensation expense related to unvested stock-based option compensation arrangements, which are expected to be recognized over a weighted average period of 1.74 years.

 

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. The Company accounts for forfeitures as they occur.

 

A summary of RSU activity for the three months ended March 31, 2025 is presented below:

 

RSU's

 

Number of Shares Underlying RSUs

 

 

Weighted
 Average
Grant Date Fair Value

 

Unvested at December 31, 2024

 

 

259,488

 

 

$

26.42

 

Granted

 

 

267,675

 

 

$

9.68

 

Forfeited

 

 

 

 

$

 

Vested

 

 

(53,371

)

 

$

22.92

 

Unvested at March 31, 2025

 

 

473,792

 

 

$

17.35

 

 

As of March 31, 2025, there was $7.0 million of unrecognized compensation expense related to unvested RSUs, which are expected to be recognized over a weighted average period of 2.05 years.

 

14. WARRANTS

 

No warrants were exercised during the three months ended March 31, 2025 and 2024.

 

At March 31, 2025, there were warrants outstanding to purchase 2,873 shares of common stock with a weighted average exercise price of $208.80 and a weighted average remaining life of 5.33 years.

 

On January 26, 2018, the Company entered into an Investment Agreement with the Cystic Fibrosis Foundation ("CFF") that included issuance of a warrant to purchase an 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 expired unexercised on January 26, 2025.

 

On July 28, 2020, the Company entered into the Loan and Security Agreement with K2HV and in connection with the funding of $20.0 million, the Company issued a warrant exercisable for 2,873 shares of the Company’s common stock (the "K2 Warrant") at an exercise price of $208.80 per share. The K2 Warrant is immediately exercisable for 2,873 shares and expires on July 28, 2030.

 

-16-


15. SEGMENT INFORMATION

 

The Company views its operations and manages its business in one reportable segment, which is developing and commercializing therapeutics for cancer and obesity.

The Company's Chief Executive Officer is the Chief Operating Decision Maker ("CODM"). The CODM makes decisions based on net income (loss). Significant expenses within net income (loss) include research and development and general and administrative expenses, which are each separately presented on the Company's condensed consolidated statements of operations and comprehensive loss. Other segment items within net income (loss) include interest and investment income, net, interest expense and other income, net.

The measure of segment assets is reported on the condensed consolidated balance sheets as total consolidated assets. All material long-lived assets are located in the United States. Long-lived assets consist of property and equipment, net, and operating lease right-of-use assets.

 

-17-


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 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;
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 anticipated in our forward-looking statements. Please see "Risk Factors" for additional risks which could adversely impact our business and financial performance.

 

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.

 

-18-


Overview

 

Corbus Pharmaceuticals Holdings, Inc. (the "Company," "Corbus," "we," "us," or "our") is an oncology and obesity company with a diversified portfolio and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways. Our pipeline is comprised of two experimental drugs targeting solid tumors: CRB-701, a next-generation antibody drug conjugate ("ADC") that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload of monomethyl auristatin E ("MMAE"); and CRB-601, an anti-integrin monoclonal antibody that blocks the activation of TGFβ expressed on cancer cells. The pipeline also includes CRB-913, a highly peripherally restricted cannabinoid type-1 ("CB1") receptor inverse agonist for the treatment of obesity.

 

Our oncology pipeline:

CRB-701 is a next-generation ADC that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload of MMAE. In February 2023, we obtained a license from CSPC Megalith Biopharmaceutical Co. Ltd. ("CSPC"), a subsidiary of CSPC Pharmaceutical Group Limited, to develop and commercialize the drug in the United States ("U.S."), Canada, the European Union (including the European Free Trade Area), the United Kingdom ("U.K.") and Australia. CRB-701 is currently being investigated by CSPC in a Phase 1 dose expansion clinical trial in participants with advanced solid tumors in China (the "China study"). We commenced a corresponding Phase 1 dose escalation study in the U.S. and the U.K. (the "Western study") in April 2024 and completed enrollment of the dose escalation phase in October 2024. The dose optimization portion in the Western study is currently ongoing and we are in the process of adding additional clinical sites in Europe. Both studies are enrolling participants with advanced solid tumors associated with Nectin-4 expression.
CRB-601 is a potent and selective anti-αvβ8 monoclonal antibody that blocks the activation of latent TGFβ found on cancer cells. In pre-clinical models, CRB-601 demonstrates enhanced anti-tumor activity when combined with an anti-PD-1 checkpoint inhibitor compared to each single agent on its own. Pre-clinical data suggests that blockade of latent TGFβ production by CRB-601 can lead to changes in immune cell infiltration in the tumor microenvironment, thus potentially enhancing the benefit of PD-1 blockade. CRB-601 is being developed as a potential treatment for participants with solid tumors in combination with existing therapies, including checkpoint inhibitors. The first participant in a Phase 1 dose escalation study was dosed in December 2024 under an open IND and regulatory approval for the study was received in the U.K. in January 2025.

Our obesity pipeline:

CRB-913 is a second-generation highly peripherally restricted CB1 receptor inverse agonist designed to treat obesity. We dosed the first participant in the single ascending/multiple ascending ("SAD/MAD") dose portion of a Phase 1 study in the first quarter of 2025. CB1 inverse agonism is a highly clinically validated mechanism to induce weight loss, however, neuropsychiatric adverse events have been reported in prior clinical studies with both rimonabant and monlunabant. CRB-913 has been specifically formulated to shift the drug exposure from the brain to the periphery to improve safety and tolerability. The drug has a brain to plasma ratio fifty times lower than rimonabant and fifteen times more peripherally restricted than monlunabant.

 

Financial Operations Overview

We are an oncology and obesity company and have not generated any revenues from the sale 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 one of our product candidates, which we expect will take a number of years and is subject to significant uncertainty. We have never been profitable and at March 31, 2025, we had an accumulated deficit of approximately $493.9 million. Our net losses for the three months ended March 31, 2025 and 2024, were approximately $17.0 million and $6.9 million, respectively.

 

We expect to continue to incur significant expenses for the foreseeable future. We expect our expenses to increase in connection with our ongoing activities, particularly as we continue the research and development of our product candidates. We will continue to incur significant operating losses as we move into the clinical phase and, accordingly, we will need additional financing to support our continuing operations. We will seek to fund our operations through public or private equity, 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.

-19-


We expect to continue to incur operating losses for at least the next several years 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 and purchase drugs for clinical studies.

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.

 

There have been no changes to the critical accounting estimates we identified in Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations in our 2024 Annual Report.

 

Results of Operations

Comparison of Three Months Ended March 31, 2025 and 2024

Operating Expense. The following table summarizes our operating expenses for the three months ended March 31, 2025 and 2024 (in thousands):

 

 

 

Three Months Ended March 31,

 

 

 

 

 

 

 

 

 

2025

 

 

2024

 

 

$ Change

 

 

% Change

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expense

 

$

15,642

 

 

$

5,762

 

 

$

9,880

 

 

 

171

%

General and administrative expense

 

 

4,133

 

 

 

3,861

 

 

 

272

 

 

 

7

%

Total operating expenses

 

$

19,775

 

 

$

9,623

 

 

$

10,152

 

 

 

105

%

 

Research and Development. The following table summarizes our research and development expenses for the three months ended March 31, 2025 and 2024 (in thousands):

 

 

 

Three Months Ended March 31,

 

 

 

 

 

 

 

 

 

2025

 

 

2024

 

 

$ Change

 

 

% Change

 

Program Specific Costs:

 

 

 

 

 

 

 

 

 

 

 

 

CRB-601

 

$

3,237

 

 

$

1,334

 

 

$

1,903

 

 

 

143

%

CRB-701

 

 

7,133

 

 

 

2,461

 

 

 

4,672

 

 

 

190

%

CRB-913

 

 

2,753

 

 

 

578

 

 

 

2,175

 

 

 

376

%

Other drug development

 

 

120

 

 

 

 

 

 

120

 

 

 

 

Total program specific costs

 

 

13,243

 

 

 

4,373

 

 

 

8,870

 

 

 

203

%

Unallocated internal costs:

 

 

 

 

 

 

 

 

 

 

 

 

Personnel related

 

 

1,982

 

 

 

900

 

 

 

1,082

 

 

 

120

%

Other unallocated

 

 

417

 

 

 

489

 

 

 

(72

)

 

 

-15

%

Total research and development expenses

 

$

15,642

 

 

$

5,762

 

 

$

9,880

 

 

 

171

%

 

Research and development expenses for the three months ended March 31, 2025 totaled approximately $15.6 million, an increase of $9.9 million from approximately $5.8 million recorded for the three months ended March 31, 2024.

 

-20-


Total program-specific costs increased by $8.9 million for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024. Costs related to CRB-601 increased by $1.9 million as a result of higher clinical costs as the first participant in a Phase 1 dose escalation study was dosed in December 2024 and dose escalation is on-going. Costs related to CRB-701 increased by $4.7 million as a result of higher clinical and drug supply related costs as the Phase 1 clinical trial enrollment began in April 2024 and is on-going. CRB-913 costs increased by $2.2 million due to the manufacturing of drug supply and commencement of the SAD/MAD dose portion of the Phase 1 clinical study during the first quarter of 2025.

 

Personnel related costs increased by $1.1 million for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024. The increase is primarily due to an increase in headcount.

 

We have a subsidiary in each of the U.K. and Australia. During the three months ended March 31, 2025 and 2024, approximately 38% and 30% of research and development expenses, respectively, were recorded in these entities.

 

General and Administrative. General and administrative expense for the three months ended March 31, 2025 totaled approximately $4.1 million, an increase of $0.3 million from approximately $3.9 million recorded for the three months ended March 31, 2024. The increase in first quarter 2025 as compared to first quarter 2024 was primarily attributable to an increase in stock-based compensation costs.

 

Other Income, Net. The following table summarizes our total other income, net for the three months ended March 31, 2025 and 2024 (in thousands):

 

 

 

Three Months Ended March 31,

 

 

 

 

 

 

 

 

 

2025

 

 

2024

 

 

$ Change

 

 

% Change

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest and investments income, net

 

$

1,681

 

 

$

1,028

 

 

$

653

 

 

 

64

%

Interest expense

 

 

 

 

 

(839

)

 

 

839

 

 

 

-100

%

Other income, net

 

 

1,116

 

 

 

2,535

 

 

 

(1,419

)

 

 

-56

%

Total other income, net

 

$

2,797

 

 

$

2,724

 

 

$

73

 

 

 

3

%

 

Total other income, net was comparable for the three months ended March 31, 2025 and 2024. Other income, net includes $1.1 million in employee retention tax credits for the three months ended March 31, 2025 and refundable research and development credits from a foreign tax authority of $2.5 million for the three months ended March 31, 2024.

 

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. At March 31, 2025, our accumulated deficit since inception was approximately $493.9 million.

 

At March 31, 2025, we had total current assets of approximately $137.4 million and current liabilities of approximately $11.6 million, resulting in working capital of approximately $125.7 million. Of our total cash, cash equivalents, investments, and restricted cash of $133.5 million at March 31, 2025, approximately $131.3 million was held within the U.S.

 

Cash Flows

The following table summarizes our cash flows for the three months ended March 31, 2025 and 2024 (in thousands):

 

 

 

Three Months Ended March 31,

 

 

 

2025

 

 

2024

 

 

 

 

 

 

 

 

Net cash used in operating activities

 

$

(16,421

)

 

$

(7,967

)

Net cash provided by (used in) investing activities

 

 

18,123

 

 

 

(98,236

)

Net cash provided by financing activities

 

 

 

 

 

106,582

 

Net increase in cash, cash equivalents, and restricted cash

 

$

1,702

 

 

$

379

 

 

Net cash used in operating activities for the three months ended March 31, 2025 was approximately $16.4 million, which includes a net loss of approximately $17.0 million, adjusted for non-cash expenses of approximately $1.6 million primarily related to stock-based compensation expense, and approximately $1.0 million of cash used by net working capital items principally due to a decrease in accounts payable and increases in accrued expenses and prepaid expenses and other current assets.

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Cash provided by investing activities for the three months ended March 31, 2025 totaled approximately $18.1 million, which was principally related to proceeds from sales and maturities of marketable securities.

 

No cash was provided by financing activities for the three months ended March 31, 2025.

 

Future Funding Requirements

 

Based on our current planned operations and our cash, cash equivalents, and investments of approximately $132.8 million at March 31, 2025, we expect to have sufficient funds to meet our operating and capital requirements to support our operations through the second quarter of 2027.

 

We will need to raise significant additional capital to continue to fund the clinical trials for CRB-701, CRB-601 and CRB-913. 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, 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.

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 clinical trials.

 

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, other than future royalty payments under license agreements discussed as follows:

 

License Agreement with Jenrin

Pursuant to the terms of the license agreement (the "Jenrin License Agreement") with Jenrin Discovery, LLC ("Jenrin"), 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. A $0.4 million milestone payment was achieved in the first quarter of 2025 and paid in April 2025. 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 License Agreement, subject to specified reductions.

The Jenrin License 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 License Agreement may be terminated earlier in specified situations, including termination for uncured material breach of the Jenrin License 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 UCSF

 

Pursuant to the terms of the license agreement (the "UCSF License Agreement") with the Regents of the University of California, we are obligated to pay up to $150.8 million in remaining potential milestone payments 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 $50.0 thousand for each new indication. In addition, we are obligated to pay 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 License 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 License Agreement may be terminated earlier in specified situations, including termination for material breach, termination by us with advance notice, and termination upon a party's bankruptcy.

 

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License Agreement with CSPC

 

Pursuant to the terms of the CSPC License Agreement with CSPC, we are obligated to pay potential milestone payments to CSPC totaling up to $130.0 million based upon the achievement of specified development and regulatory milestones and $555.0 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.

 

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.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

Not Applicable.

Item 4. Controls and Procedures.

 

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.

 

Based on that evaluation, our Chief Executive Officer and our Chief Financial Officer concluded that our disclosure controls and procedures as of the end of the period covered by this report were effective in ensuring that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that the information required to be disclosed by us in such reports is accumulated and communicated to our management, including our Chief Executive Officer and our Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.

Changes in Internal Control over Financial Reporting

There were no changes 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.

-23-


PART II — OTHER INFORMATION

 

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.

There have been no material changes in or additions to the risk factors included in our 2024 Annual Report.

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

None.

Item 3. Defaults Upon Senior Securities.

None.

Item 4. Mine Safety Disclosures.

Not applicable.

Item 5. Other Information.

 

Director and Officer Trading Arrangements

On March 14, 2025, Yuval Cohen, Ph.D., the Company's Chief Executive Officer and a member of the board of directors adopted a Rule 10b5-1 plan providing for the sale of up to 205,253 shares of the Company’s common stock. Pursuant to this plan, Dr. Cohen may sell shares of common stock beginning on October 24, 2025, subject to the terms of the agreement, and the plan terminates on March 15, 2026. The trading arrangement is intended to satisfy the affirmative defense of Rule 10b5-1(c).

Also on March 14, 2025, Sean Moran, the Company’s Chief Financial Officer, adopted a Rule 10b5-1 plan providing for the sale of up to 94,179 shares of common stock. Pursuant to this plan, Mr. Moran may sell shares beginning on October 24, 2025, subject to the terms of the agreement, and the plan terminates on March 15, 2026. The trading arrangement is intended to satisfy the affirmative defense of Rule 10b5-1(c).

No other directors or officers adopted, modified or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement (as defined in Item 408(c) of Regulation S-K) during the first quarter of 2025.

-24-


Item 6. Exhibits.

 

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

 

EXHIBIT INDEX

 

Exhibit

No.

Description

3.1

 

Amended and Restated Certificate of Incorporation of the Company, as amended (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).

 

 

 

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

 

Service Agreement between Corbus International Limited and Ian Hodgson, effective as of March 15, 2025 (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K, filed with the SEC on March 18, 2025). †

 

 

 

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.*

104

The cover page from the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025 is formatted in iXBRL*

 

*

Filed herewith.

**

Furnished, not filed.

Indicates a management contract or compensation plan, contract or arrangement.

 

 

 

 

 

 

 

-25-


SIGNATURES

Pursuant to the requirements 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: May 6, 2025

By:

/s/ Yuval Cohen

Name:

Yuval Cohen

Title:

Chief Executive Officer

(Principal Executive Officer)

Date: May 6, 2025

By:

/s/ Sean Moran

Name:

Sean Moran

Title:

Chief Financial Officer

(Principal Financial Officer and Chief Accounting Officer)

 

-26-