CRBP

EX-99.1

2 crbp-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

Corbus Pharmaceuticals Reports Q2 2026 Financial Results and Provides a Corporate Update

• Obtained FDA clearance to proceed with registrational study (TEMPO-1) of CRB-701 in 2L oropharyngeal cancer and expect to initiate enrollment in September 2026

• Concluded last patient last visit in CANYON-1 Phase 1b study (n=240) of CRB-913 in obesity and on track to report data in September 2026

• Appointed new Chief Medical Officer, Chief Business Officer, and Board Member to strengthen senior leadership and guide the Company through registrational studies and commercialization readiness

Norwood, MA, August 6, 2026 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a clinical-stage company focused on developing new therapies in oncology and obesity, today provided a corporate update and reported financial results for the 2026 second quarter ended June 30, 2026.

"We’ve continued to build momentum as we prepare for two potentially impactful clinical development milestones in September: commencing enrollment of TEMPO-1, our Phase 3 study of CRB-701 in oropharyngeal cancer, and the data readout of CANYON-1, our Phase 1b study of CRB-913 in obesity. Both programs represent opportunities to address areas of significant unmet medical need,” said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. “CRB-701 has the potential to bring a much-needed therapeutic option for the growing oropharyngeal cancer patient population, for whom approved and other investigational therapies have shown little promise. CRB-913 is a unique daily oral obesity drug candidate with a mechanism of action entirely orthogonal to the GLP-1 class and with the potential for both weight loss and long-term weight management. We look forward to a productive second half of 2026 as we work to improve patient outcomes and generate meaningful value for shareholders.”

Key Corporate and Program Updates

CRB-701 is a next-generation, highly stable Nectin-4 targeting antibody drug conjugate (ADC) being developed to treat oropharyngeal squamous cell carcinoma (OPSCC), a type of head and neck squamous cell carcinoma (HNSCC), as well as 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.

• Obtained FDA clearance to proceed with TEMPO-1 registrational study (n=250) of CRB-701 in 2L OPSCC, representing the first registrational trial specifically designed to evaluate a targeted treatment in this patient population.

• Expect to commence enrollment in the TEMPO-1 study in September 2026.

• Reported 2L+ monotherapy data from the Phase 1/2 study of CRB-701 in HNSCC and cervical cancers at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. Link here for press release with more details (https://ir.corbuspharma.com/news-events/press-

releases/detail/471/corbus-pharmaceuticals-reports-updated-crb-701-phase-12-clinical-data-demonstrating-robust-activity-in-2l-oropharyngeal-and-cervical-cancers).

• Anticipate reporting CRB-701 + Keytruda® combination data in first-line (1L) settings in OPSCC patients in Q1 2027 to support potential further registration-enabling trials in the front line.

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

• Concluded last patient last visit in the CANYON-1 Phase 1b clinical trial of CRB-913 for the treatment of obesity. The CANYON-1 study followed 240 patients over a 12-week treatment period followed by a 4-week safety follow-up.

• On track to report topline data from CANYON-1 Phase 1b study in September 2026.

Corporate Appointments

Corbus strengthened its leadership team and Board of Directors with several key appointments in the second quarter of 2026.

• Leonardo Viana Nicacio, M.D. as Chief Medical Officer. Dr. Nicacio previously served as Chief Medical Officer at Protara Therapeutics and Senior Vice President, Head of Clinical Development and Global Medical Affairs at Stemline Therapeutics. He also held roles of increasing responsibility at Seagen (acquired by Pfizer), most recently as Vice President of Clinical Development, overseeing programs across a range of cancers, including bladder, breast, gynecologic, lung, colorectal, and head and neck cancers, and most notably the development of a therapeutic for metastatic cervical cancer, TIVDAK®.

• Nishant Saxena as Chief Business Officer. Mr. Saxena most recently served as Chief Financial Officer at Jeune Aesthetics, Inc., a wholly owned subsidiary of Krystal Biotech, Inc. Previously, he served as a Managing Director in Evercore’s healthcare group, where he advised on transactions totaling over $500 billion in aggregate value. Earlier in his career, Mr. Saxena held positions of increasing responsibility in private equity, venture capit

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8-K

false000159509700015950972026-03-092026-03-09

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): March 9, 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 March 9, 2026, disclosing financial information and operating metrics for its fiscal year ended December 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 Company also updated its presentation used by management to describe its business. A copy of the presentation is furnished as Exhibit 99.2 and is incorporated herein by reference.

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 and 99.2, 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 March 9, 2026.

99.2

Investor Presentation

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:

March 9, 2026

By:

/s/ Yuval Cohen

Name: Yuval Cohen Title: Chief Executive Officer