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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 6, 2025

CORBUS PHARMACEUTICALS HOLDINGS, INC.

(Exact name of Registrant as Specified in Its Charter)

Delaware

001-37348

46-4348039

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

500 River Ridge Drive

Norwood, Massachusetts

02062

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: (617) 963-0100

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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


Title of each class

Trading
Symbol(s)


Name of each exchange on which registered

Common Stock, par value $0.0001 per share

CRBP

The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

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. ☐

 

Item 2.02 Results of Operations and Financial Condition.

Corbus Pharmaceuticals Holdings, Inc. (the “Company”) issued a press release on May 6, 2025, disclosing financial information and operating metrics for its fiscal quarter ended March 31, 2025 and discussing its business outlook. A copy of the Company’s press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 7.01 Regulation FD Disclosure.

See “Item 2.02 Results of Operations and Financial Condition” above.

The information in this Current Report on Form 8-K under Items 2.02 and 7.01, including the information contained in Exhibit 99.1, is being furnished to the Securities and Exchange Commission, and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934, except as shall be expressly set forth by a specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) The following exhibit is furnished with this report:

Exhibit No.

Description

99.1

Press Release issued by Corbus Pharmaceuticals Holdings, Inc. dated May 6, 2025.

104

Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 

 

 

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

 

 

 

Exhibit 99.1

 

Corbus Pharmaceuticals Reports First Quarter 2025 Financial Results and Provides a Corporate Update

 

•
Dose optimization and RP2D determination on schedule for completion in Q4 2025 for the Nectin-4 ADC CRB-701 in HNSCC, cervical and mUC tumors
•
SAD/MAD study on schedule for completion in Q3 2025 for the anti-obesity CB1 inverse agonist CRB-913
•
Dose escalation study on schedule for completion in Q4 2025 for the anti-αvβ8 integrin mAB-CRB-601 in solid tumors

 

Norwood, MA, May 6, 2025 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), an oncology and obesity company with a diversified portfolio, today provided a corporate update and reported financial results for the quarter ended March 31, 2025.

 

“During the first quarter of 2025, we continued to advance our pipeline by presenting encouraging CRB-701 Phase 1 solid tumor data from U.S. and U.K. sites at ASCO GU and initiating the CRB-913 Phase 1 study in obesity,” said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. “We look forward to reporting clinical data from all three of our pipeline programs in the 2nd half of this year including: RP2D data from our Nectin-4 ADC (CRB-701), SAD/MAD data from our anti-obesity CB1 inverse agonist (CRB-913) and the first ever dose escalation data in solid tumors for the anti- αvβ8 mAb (CRB-601). The data will be very informative in determining the next steps in our oncology and obesity programs and will form the basis of discussions with regulatory authorities and other relevant parties.”

 

Key Corporate and Program Updates

CRB-701 for the treatment of solid tumors, is a next-generation antibody drug conjugate (ADC) targeting Nectin-4 that contains a site-specific, cleavable linker and a precise drug antibody ratio of 2 using monomethyl auristatin E (MMAE) as the payload.

•
Phase 1 dose escalation data was presented as a poster presentation at ASCO GU in February 2025. The Phase 1/2 study (NCT06265727) is being conducted by Corbus in the U.S. and Europe.

Study Highlights:

o
Safety, tolerability and PK comparable to SYS6002 Phase 1 Chinese data presented at ASCO 2024 by our partner CSPC.
o
Low levels of peripheral neuropathy and skin toxicity were observed in both studies.
o
Clinical responses were seen in urothelial (mUC) and cervical cancer participants in both studies.
o
First-time treatment in participants with head and neck squamous cell carcinoma (HNSCC) yielded multiple responses.

 

•
Dose optimization is on-going with dosing at 2.7 mg/kg and 3.6 mg/kg cohorts in HNSCC, cervical and mUC tumors. The Company expects to complete dose optimization and establish a recommended Phase 2 dose (RP2D) in the fourth quarter of 2025.

 

•
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CRB-701 for the treatment of relapsed or refractory metastatic cervical cancer.

 

CRB-913 is a second generation, highly peripherally restricted, oral small molecule CB1 receptor inverse agonist drug designed for the treatment of obesity. CB1 inverse agonism is a clinically validated mechanism to

induce weight loss. The Company dosed the first participant in the Phase 1 SAD/MAD study in March 2025, which is scheduled to be completed in Q3 2025. The Phase 1b dose-range finding study is expected to commence in the fourth quarter of 2025 and scheduled for completion in the second half of 2026.

 

•
The Company’s pre-clinical data demonstrates CRB-913 is markedly more peripherally restricted than either monlunabant or rimonabant. CRB-913 has a brain to plasma ratio fifty times lower than rimonabant and is fifteen times more peripherally restricted than monlunabant.

CRB-601 is a potent and selective anti-αvβ8 integrin monoclonal antibody (mAB) designed to block the activation of latent TGFβ in the tumor micro-environment to treat solid tumors.

•
The first participant was dosed in December 2024 in the dose escalation portion of a Phase 1 study which is being conducted in the U.S. and Europe and scheduled for completion in Q4 2025.

 

Financial Results for the Quarter Ended March 31, 2025

The Company reported a net loss of approximately $17.0 million, or a net loss per basic and diluted share of $1.39, for the three months ended March 31, 2025, compared to a net loss of $6.9 million, or a net loss per basic and diluted share of $0.83, for the three months ended March 31, 2024.

Operating expenses increased by $10.2 million to approximately $19.8 million for the three months ended March 31, 2025, compared to approximately $9.6 million for the three months ended March 31, 2024. The increase was primarily attributable to an increase in clinical development expenses.

As of March 31, 2025, the Company had $132.8 million of cash, cash equivalents, and investment on hand, which is expected to fund operations through Q2 2027 based on planned expenditures.

 

About Corbus

Corbus Pharmaceuticals Holdings, Inc. 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 includes CRB-701, a next-generation antibody drug conjugate that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload, CRB-601, an anti-integrin monoclonal antibody that blocks the activation of TGFβ expressed on cancer cells, and CRB-913, a highly peripherally restricted CB1 receptor inverse agonist for the treatment of obesity. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on X, LinkedIn and Facebook.

 

Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s trial results, product development, clinical and regulatory timelines, including timing for completion of trials and presentation of data, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions.

 

These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors on our operations, clinical

development plans and timelines, which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

 

All product names, logos, brands and company names are trademarks or registered trademarks of their respective owners. Their use does not imply affiliation or endorsement by these companies.

 

 

INVESTOR CONTACT:

Sean Moran

Chief Financial Officer

Corbus Pharmaceuticals

smoran@corbuspharma.com

 

Bruce Mackle
Managing Director
LifeSci Advisors, LLC
bmackle@lifesciadvisors.com

 

---tables to follow---

 

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

)

 

Corbus Pharmaceuticals Holdings, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except share and per share amounts)

 

 

 

 

March 31, 2025

(Unaudited)

 

 

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

 

 

 

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