No treatment-related neuropsychiatric events seen to date in SAD portion of Phase 1

MAD study on track for completion in Q3 2025

NORWOOD, Mass., June 30, 2025 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings Inc. (NASDAQ:CRBP), a clinical-stage company focused on oncology and obesity, today announced the initiation of the multiple ascending dose (MAD) portion of its Phase 1 trial for CRB-913, a highly peripherally restricted CB1 inverse agonist for the treatment of obesity. This follows safety and pharmacokinetics (PK) data analysis of the single ascending dose (SAD) study launched in March. The MAD portion of this clinical study is scheduled for completion in the third quarter of this year.

The MAD portion of the Phase 1 trial is designed to test a once-daily dosing of CRB-913 for 7 days. Similarly to the SAD study, the MAD study is undertaken with healthy volunteers and focuses on safety, tolerability and PK of increasing doses of CRB-913. The study is being conducted in the United States.

"The data collected to date shows a satisfactory translation from pre-clinical models to the clinical settings," said Yuval Cohen, PhD, CEO of Corbus. "An absence of treatment-related neuropsychiatric events was noted even at markedly higher doses than our modelling suggests would be required to achieve efficacy in clinical practice. We look forward to generating further clinical evidence in the multiple ascending dose cohorts before initiating a Phase 1b dose-range finding study in obese individuals later this year."

The SAD/MAD portion of the Phase 1 trial is scheduled to be completed in Q3 of 2025, and the Company expects to commence a Phase 1b dose-range finding study in Q4 of 2025. The dose-range finding study is scheduled for completion in the second half of 2026.

About CRB-913

CRB-913 is an oral small molecule inverse agonist of the G-protein Coupled Receptor (GPCR) cannabinoid type-1 (CB1). This is a recognized mechanism of action for weight loss, but the previous class of such experimental drugs was abandoned due to potential neuropsychiatric adverse event risks. CRB-913 is a member of a new class of peripherally restricted CB1 inverse agonists designed to have reduced brain penetration. Pre-clinical models have shown CRB-913 to be 15-fold less brain penetrant than monlunabant (another experimental CB1 inverse agonist) and to have 50 times lower brain:plasma ratio than rimonabant (an extensively studied first generation CB1 inverse agonist).

About Corbus

Corbus Pharmaceuticals Holdings, Inc. is a clinical-stage company focused on 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 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 statements 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.

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INVESTOR CONTACT:

Sean Moran

Chief Financial Officer

Corbus Pharmaceuticals

smoran@corbuspharma.com

Dan Ferry

Managing Director

LifeSci Advisors, LLC

daniel@lifesciadvisors.com

Corbus Pharmaceuticals Initiates Multiple Ascending Dose Portion of Phase 1 Study of Highly Peripherally Restricted CB1 Inverse Agonist CRB-913 for the Treatment of Obesity