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Corbus (NASDAQ: CRBP) details Q1 loss, FDA alignment and obesity trial

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(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Corbus Pharmaceuticals reported first-quarter 2026 results and highlighted progress in its oncology and obesity pipelines. The company posted a net loss of about $23.0 million, or $1.23 per share, on operating expenses of $24.3 million, primarily from higher clinical development spending. Cash, cash equivalents and investments totaled $138.2 million as of March 31, 2026, which Corbus expects will fund operations into 2028.

Corbus reached broad alignment with the FDA on the registration path for CRB-701 in second-line head and neck squamous cell carcinoma and cervical cancer and plans to start a registrational study in second-line HNSCC this summer, with updated monotherapy data to be presented at ASCO 2026. The company also completed enrollment and first visits in its CANYON-1 Phase 1b obesity trial of CRB-913, a peripherally restricted oral CB1 inverse agonist, and expects 16-week data from 240 patients in summer 2026.

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Insights

Corbus advances two late-stage-ready programs with cash runway into 2028.

Corbus Pharmaceuticals is transitioning from early development toward potential registrational activity in oncology while advancing its obesity program. Alignment with the FDA on the registration path for CRB-701 in HNSCC and cervical cancer reduces regulatory uncertainty around upcoming pivotal trial designs.

The company plans to initiate a registrational second-line HNSCC study this summer and present updated CRB-701 data at ASCO 2026, followed by combination data with Keytruda in early Q1 2027. In obesity, the CANYON-1 Phase 1b trial of CRB-913 has completed enrollment for its 16-week, 240-patient design, with topline data expected in summer 2026.

Financially, Corbus reported a quarterly net loss of about $23.0 million and operating expenses of $24.3 million, reflecting increased clinical spending. With $138.2 million in cash, cash equivalents and investments as of March 31, 2026, management indicates funding into 2028, providing a window to read out key oncology and obesity data.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 7.01 Regulation FD Disclosure Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Net loss $22.97M Quarter ended March 31, 2026
Net loss per share $1.23 per share Basic and diluted, Q1 2026
Operating expenses $24.30M Quarter ended March 31, 2026
Operating expenses prior-year quarter $19.78M Quarter ended March 31, 2025
Cash, cash equivalents and investments $138.2M As of March 31, 2026
Shares outstanding 17,738,870 shares Common stock issued and outstanding as of March 31, 2026
Weighted average shares 18,706,622 shares Basic and diluted, quarter ended March 31, 2026
Interest and investment income, net $1.40M Quarter ended March 31, 2026
Fast Track designations regulatory
"The U.S. Food and Drug Administration (FDA) has granted Fast Track designations to CRB-701 for the treatment of both cancer types."
A fast track designation is a regulatory status granted to a drug or therapy intended to treat a serious condition with unmet medical need, which gives the developer access to expedited interactions and review procedures with regulators. For investors, it’s like an express lane: it can shorten development and review timelines and reduce regulatory uncertainty, potentially speeding a product to market—but it does not guarantee approval or commercial success.
registrational study regulatory
"we’re on track to start a registrational study for CRB-701 in second-line HNSCC this summer."
A registrational study is a late-stage clinical trial designed to give the government regulators the evidence they need to decide whether a drug, therapy, or medical device can be approved for sale. Think of it as the final exam or road test for a medical product: its results largely determine whether the product can reach the market, which directly affects potential revenue, company valuation, and investor risk.
Phase 1/2 study financial
"Report monotherapy data from the Phase 1/2 study of CRB-701 in both HNSCC and cervical cancers"
A phase 1/2 study is an early-stage clinical trial that first tests a new drug or treatment for how safe it is and what dose people can tolerate (phase 1), then expands to see whether it shows initial signs of working in patients (phase 2). Think of it as a combined test-drive and small pilot launch: it helps companies gather crucial safety and early effectiveness data faster than separate trials, so investors use the results to gauge whether a treatment is worth further development or funding, while remembering that outcomes at this stage are still preliminary and risky.
Phase 1b clinical trial financial
"CANYON-1 Phase 1b clinical trial of CRB-913 for the treatment of obesity."
A phase 1b clinical trial is an early-stage human study that follows initial safety tests and checks how a new drug or treatment works at different doses in the target patient group. It matters to investors because it is one of the first steps showing whether a therapy is tolerable and shows any sign of benefit in real patients — like a small proof-of-concept test that can significantly raise or lower a drug’s commercial prospects.
CB1 inverse agonist medical
"CRB-913 is a highly peripherally restricted oral CB1 inverse agonist for the treatment of obesity."
A CB1 inverse agonist is a drug that binds to the brain and nervous system’s CB1 cannabinoid receptor and pushes its activity below its normal resting level, producing effects opposite to those of cannabis-like stimulation. For investors, these drugs matter because altering appetite, mood, pain or addiction pathways can create significant market opportunities or regulatory risks—think of it as turning a dimmer switch lower than the factory setting to achieve a different therapeutic outcome.
head and neck squamous cell carcinoma medical
"registration path for CRB-701 for 2L treatment in head and neck squamous cell carcinoma (HNSCC) and cervical cancer"
A type of cancer that starts in the thin, flat cells that line the mouth, throat, voice box and upper airway; imagine the lining like roof shingles that, when damaged, can grow into a harmful lump. It matters to investors because its diagnosis, treatment options and regulatory approvals drive demand for drugs, tests and therapies—affecting clinical trial outcomes, market size, company valuations and the financial risk/reward of healthcare investments.
Net loss $22.97M
Net loss per share (basic and diluted) $1.23
Operating expenses $24.30M
Cash, cash equivalents and investments $138.2M
false000159509700015950972026-05-122026-05-12

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 12, 2026

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 12, 2026, disclosing financial information and operating metrics for its fiscal quarter ended March 31, 2026 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 12, 2026.

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 12, 2026

By:

/s/ Yuval Cohen

Name: Yuval Cohen
Title: Chief Executive Officer

 

 

 


Exhibit 99.1

 

Corbus Pharmaceuticals Reports Q1 2026 Financial Results and Provides a Corporate Update

Reached broad alignment with the FDA on the registration path for CRB-701 for 2L treatment in head and neck squamous cell carcinoma (HNSCC) and cervical cancer with CRB-701
Announced presentation of updated CRB-701 data in HNSCC and cervical cancer at ASCO 2026
Completed enrollment in 16-week study CANYON-1 study (n=240) of CRB-913 for the treatment of obesity with topline data on track to report this summer

Norwood, MA, May 12, 2026 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a clinical-stage company focused on developing promising new therapies in oncology and obesity, today provided a corporate update and reported financial results for the 2026 first quarter ended March 31, 2026.

"We’ve continued to build strong momentum with CRB-701 and CRB-913, setting the stage for rapidly approaching inflection points for both the oncology and obesity programs,” said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus.

“Having reached broad alignment with the FDA, we’re on track to start a registrational study for CRB-701 in second-line HNSCC this summer. We’ll report updated data at ASCO 2026 that will provide clear insight into CRB-701's differentiated profile in 2L HNSCC and its upcoming registrational study. We’ll also present updated data in 2L cervical cancer, a patient population with few treatment options. Turning to obesity, we have reached last patient/first visit in our CANYON-1 Phase 1b study and are on schedule to report 16-week, 240-patient data for CRB-913 this summer. CRB-913 represents a unique oral obesity drug with a non-GLP-1 and non-incretin mechanism of action and has the potential for weight loss and long-term weight management. We’re excited about CRB-913's promise to deliver an orthogonal drug class into the obesity treatment landscape.”

Key Corporate and Program Updates

 

CRB-701 is a next-generation, highly stable Nectin-4 targeting antibody drug conjugate (ADC) being developed to treat HNSCC and cervical cancer. The U.S. Food and Drug Administration (FDA) has granted Fast Track designations to CRB-701 for the treatment of both cancer types. CRB-701 is licensed from CSPC Megalith Biopharmaceutical Co. Ltd. China.

 

Announced broad alignment with the FDA on the registration path for CRB-701 in HNSCC and cervical cancers and continued interactions with the FDA to finalize the protocols and statistical analysis plans for the registrational studies.
Anticipated catalysts for CRB-701 in 2026:
o
Report monotherapy data from the Phase 1/2 study of CRB-701 in both HNSCC and cervical cancers at the upcoming 2026 American Society of Clinical Oncology (ASCO) annual meeting. Link here (https://ir.corbuspharma.com/news-events/press-releases/detail/465/corbus-pharmaceuticals-announces-abstracts-accepted-for-presentation-at-asco-2026-featuring-updated-clinical-data-for-crb-701) for press release with more details.
o
Initiate a registrational study for CRB-701 in second-line HNSCC this summer.

 

 

o
Report CRB-701 + Keytruda® combination data in first-line HNSCC patients in early Q1 2027 to support potential further registration-enabling trials.

 

CRB-913 is a highly peripherally restricted oral CB1 inverse agonist for the treatment of obesity.

 

Completed enrollment of last patient and completion of the first clinical visit in the Company’s CANYON-1 Phase 1b clinical trial of CRB-913 for the treatment of obesity. The CANYON-1 study follows patients over a 12-week treatment period followed by a 4-week safety follow-up and is on track to be completed in the summer of 2026.
Anticipated catalyst for CRB-913 in 2026:
o
Report topline CANYON-1 Phase 1b dose-ranging 16-week study (n=240) in summer 2026.

 

Financial Results for the Quarter Ended March 31, 2026

The Company reported a net loss of approximately $23.0 million, or a net loss per basic and diluted share of $1.23, for the three months ended March 31, 2026, compared to 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.

Operating expenses increased by $4.5 million to approximately $24.3 million for the three months ended March 31, 2026, compared to approximately $19.8 million for the three months ended March 31, 2025. The increase was primarily attributable to an increase in clinical development expenses.

The Company had $138.2 million of cash, cash equivalents, and investments on hand as of March 31, 2026, which is expected to fund operations into 2028 based on current operating plans and planned expenditures.

About Corbus

Corbus Pharmaceuticals Holdings, Inc. is a clinical-stage company focused on developing promising new therapies in oncology and obesity 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 for the treatment of Nectin-4-expressing tumors and CRB-913, an orally delivered highly peripherally restricted CB1 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 of 1995, 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, anticipated regulatory interactions and outcomes, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities, sufficiency of cash runway 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 including those described in our Annual Report on Form 10-K for the year ended December 31, 2025. 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, except as required by law.

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 CONTACTS:

Sean Moran

Chief Financial Officer

Corbus Pharmaceuticals

smoran@corbuspharma.com

Dan Ferry
Managing Director
LifeSci Advisors, LLC
daniel@lifesciadvisors.com

 

MEDIA CONTACT:

Liz Melone

Founder & Principal

Melone Communications, LLC

liz@melonecomm.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,

 

 

 

2026

 

 

2025

 

Operating expenses:

 

 

 

 

 

 

Research and development

 

$

19,819

 

 

$

15,642

 

General and administrative

 

 

4,485

 

 

 

4,133

 

Total operating expenses

 

 

24,304

 

 

 

19,775

 

Operating loss

 

 

(24,304

)

 

 

(19,775

)

Other income (expense), net:

 

 

 

 

 

 

Interest and investment income, net

 

 

1,402

 

 

 

1,681

 

Other (expense) income, net

 

 

(67

)

 

 

1,116

 

Total other income, net

 

 

1,335

 

 

 

2,797

 

Net loss

 

$

(22,969

)

 

$

(16,978

)

Net loss per share, basic and diluted

 

$

(1.23

)

 

$

(1.39

)

Weighted average number of common shares outstanding, basic and diluted

 

 

18,706,622

 

 

 

12,202,092

 

 

 

 

 

 

 

Comprehensive loss:

 

 

 

 

 

 

Net loss

 

$

(22,969

)

 

$

(16,978

)

Other comprehensive loss:

 

 

 

 

 

 

Change in unrealized loss on marketable debt securities

 

 

(108

)

 

 

(58

)

Total other comprehensive loss

 

 

(108

)

 

 

(58

)

Total comprehensive loss

 

$

(23,077

)

 

$

(17,036

)

 

 

 


 

 

Corbus Pharmaceuticals Holdings, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except share and per share amounts)

 

 

 

 

March 31, 2026
(Unaudited)

 

 

December 31, 2025

 

 

 

 

 

 

 

 

ASSETS

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

25,661

 

 

$

28,492

 

Investments

 

 

112,558

 

 

 

134,777

 

Restricted cash

 

 

385

 

 

 

670

 

Prepaid expenses and other current assets

 

 

4,962

 

 

 

3,015

 

Total current assets

 

 

143,566

 

 

 

166,954

 

Property and equipment, net

 

 

116

 

 

 

159

 

Operating lease right-of-use assets

 

 

798

 

 

 

1,082

 

Total assets

 

$

144,480

 

 

$

168,195

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

435

 

 

$

2,215

 

Accrued expenses

 

 

16,498

 

 

 

16,844

 

Operating lease liabilities

 

 

1,205

 

 

 

1,633

 

Total current liabilities

 

 

18,138

 

 

 

20,692

 

Total liabilities

 

 

18,138

 

 

 

20,692

 

Stockholders’ equity:

 

 

 

 

 

 

Preferred stock, $0.0001 par value; 10,000,000 shares authorized, no shares issued and outstanding at March 31, 2026 and December 31, 2025

 

 

 

 

 

 

Common stock, $0.0001 par value; 300,000,000 shares authorized,
17,738,870 and 17,611,511 shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively

 

 

2

 

 

 

2

 

Additional paid-in capital

 

 

704,900

 

 

 

702,984

 

Accumulated deficit

 

 

(578,399

)

 

 

(555,430

)

Accumulated other comprehensive loss

 

 

(161

)

 

 

(53

)

Total stockholders’ equity

 

 

126,342

 

 

 

147,503

 

Total liabilities and stockholders’ equity

 

$

144,480

 

 

$

168,195

 

 


FAQ

What were Corbus Pharmaceuticals (CRBP) Q1 2026 financial results?

Corbus reported a Q1 2026 net loss of about $23.0 million, or $1.23 per share. Operating expenses were $24.3 million, up from $19.8 million a year earlier, mainly due to higher clinical development spending across its pipeline.

How much cash does Corbus Pharmaceuticals (CRBP) have and how long is its runway?

Corbus had $138.2 million in cash, cash equivalents, and investments as of March 31, 2026. Based on current operating plans and planned expenditures, the company expects this balance to fund operations into 2028, covering several upcoming clinical milestones.

What is the status of Corbus Pharmaceuticals’ CRB-701 oncology program?

CRB-701 has Fast Track designations for head and neck squamous cell carcinoma and cervical cancer. Corbus reached broad FDA alignment on its registration path and plans to start a registrational second-line HNSCC study this summer, with updated monotherapy data to be presented at ASCO 2026.

What are the next milestones for Corbus Pharmaceuticals’ obesity drug CRB-913?

CRB-913’s CANYON-1 Phase 1b obesity trial has completed enrollment and first visits for its 16-week, 240-patient design. Corbus expects to report topline dose-ranging data in summer 2026, following a 12-week treatment period and 4-week safety follow-up.

What clinical data will Corbus Pharmaceuticals (CRBP) present at ASCO 2026?

At ASCO 2026, Corbus plans to present updated monotherapy data for CRB-701 in head and neck squamous cell carcinoma and cervical cancer. These data are expected to clarify CRB-701’s profile and support its planned registrational development strategy.

How did Corbus Pharmaceuticals’ operating expenses change year over year?

Operating expenses rose to about $24.3 million for the quarter ended March 31, 2026, from approximately $19.8 million in the prior-year period. Management attributes this $4.5 million increase primarily to higher clinical development expenses across its lead programs.

Filing Exhibits & Attachments

2 documents