SYS-6002

Dose optimization and RP2D determination on schedule for completion in Q4 2025 for the Nectin-4 ADC CRB-701 in HNSCC, cervical and mUC tumorsSAD/MAD study on schedule for completion in Q3 2025 for the anti-obesity CB1 inverse agonist CRB-913Dose escalation study on schedule for completion in Q4 2025 for the anti-αvβ8 integrin mAB-CRB-601 in solid tumors NORWOOD, Mass., May 06, 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: Safety, tolerability and PK comparable to SYS6002 Phase 1 Chinese data presented at ASCO 2024 by our partner CSPC.Low levels of peripheral neuropathy and skin toxicity were observed in both studies.Clinical responses were seen in urothelial (mUC) and cervical cancer participants in both studies.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 CorbusCorbus 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 MoranChief Financial OfficerCorbus Pharmaceuticalssmoran@corbuspharma.com Bruce MackleManaging DirectorLifeSci Advisors, LLCbmackle@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 MonthsEnded 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