Washington, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Commission File Number: 001-37348 Corbus Pharmaceuticals Holdings, Inc. (Exact name of registrant as specified in its charter) or Delaware 46-4348039 (State or other jurisdiction of incorporation or organization) ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT ...

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," ...

Group 1 - Corbus Pharmaceuticals (CRBP) closed at $6.03, with a 0.5% gain over the past four weeks, and has a mean price target of $52.11, indicating a potential upside of 764.2% [1] - The mean estimate consists of nine short-term price targets with a standard deviation of $12.31, where the lowest estimate is $35 (480.4% increase) and the highest is $73 (1110.6% increase) [2] - Analysts show strong agreement on CRBP's ability to report better earnings than previously predicted, which supports the potential for stock upside [4][11] Group 2 - The Zacks Consensus Estimate for CRBP's current year earnings has increased by 0.1% over the last 30 days, with one estimate moving higher and no negative revisions [12] - CRBP holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates, indicating strong potential for near-term upside [13] - While consensus price targets may not be reliable for predicting exact gains, they can provide a directional guide for price movement [10][13]

Core Insights - Corbus Pharmaceuticals has initiated the dosing of the first subject in the Phase 1 trial of CRB-913, a drug aimed at treating obesity, under an open IND in the United States [1][4] - CRB-913 is a second-generation cannabinoid type-1 (CB1) receptor inverse agonist, designed to induce weight loss with a focus on minimizing neuropsychiatric risks associated with earlier drugs in this class [2][9] - Pre-clinical data indicates that CRB-913 is significantly more peripherally restricted compared to both monlunabant and rimonabant, with a brain-to-plasma ratio fifty times lower than rimonabant [3][9] Company Overview - Corbus Pharmaceuticals is focused on oncology and obesity, with a diversified portfolio that includes CRB-701, an antibody drug conjugate, and CRB-601, an anti-integrin monoclonal antibody [6] - The company aims to address unmet medical needs in weight loss through innovative mechanisms, including potential uses of CRB-913 as monotherapy or in combination with other therapies [5][9] Clinical Development Timeline - The SAD/MAD portion of the Phase 1 trial is expected to be completed in Q3 2025, followed by a Phase 1b dose-range finding study set to commence in Q4 2025 and conclude in the second half of 2026 [4][9]

Core Viewpoint - Corbus Pharmaceuticals (CRBP) is experiencing significant selling pressure, with a 22.7% decline over the past four weeks, but is now positioned for a potential trend reversal as it enters oversold territory, supported by analysts predicting better-than-expected earnings [1]. Group 1: Technical Indicators - The Relative Strength Index (RSI) is a key technical indicator used to identify oversold stocks, with a reading below 30 typically indicating oversold conditions [2]. - CRBP's current RSI reading is 26.65, suggesting that the heavy selling pressure may be exhausting, indicating a potential trend reversal [5]. Group 2: Fundamental Analysis - There is strong consensus among sell-side analysts that CRBP's earnings estimates for the current year have increased by 12.9% over the last 30 days, which often correlates with price appreciation [6]. - CRBP holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, further indicating a potential turnaround [7].

Corbus Pharmaceuticals (CRBP) has been on a downward spiral lately with significant selling pressure. After declining 22.9% over the past four weeks, the stock looks well positioned for a trend reversal as it is now in oversold territory and there is strong agreement among Wall Street analysts that the company will report better earnings than they predicted earlier.Guide to Identifying Oversold StocksWe use Relative Strength Index (RSI), one of the most commonly used technical indicators, for spotting wheth ...

Core Viewpoint - Corbus Pharmaceuticals (CRBP) has received a Zacks Rank upgrade to 2 (Buy), indicating a positive outlook based on rising earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system is based on changes in earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - Institutional investors often rely on earnings estimates to determine a stock's fair value, leading to buying or selling actions that affect stock prices [4]. Recent Performance and Outlook - Corbus Pharmaceuticals is projected to earn -$6.14 per share for the fiscal year ending December 2025, reflecting a year-over-year decline of 66.9% [8]. - Over the past three months, the Zacks Consensus Estimate for Corbus Pharmaceuticals has increased by 2.4%, indicating a positive trend in earnings estimates [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with only the top 20% receiving a 'Strong Buy' or 'Buy' rating [9][10]. - The upgrade to Zacks Rank 2 places Corbus Pharmaceuticals in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].

Clinical Trials and Efficacy - CRB-701 demonstrated an overall response rate (ORR) of 44% and a disease control rate (DCR) of 78% in metastatic urothelial cancer (mUC) during the Phase 1 dose escalation clinical trial[20]. - The Western study enrolled 38 participants, with 26 evaluable for efficacy, showing an ORR of 27% and a DCR of 77%[24]. - CRB-701 is currently in a Phase 1 dose expansion clinical trial in China and a corresponding Phase 1 dose optimization clinical trial in the U.S. and U.K.[122]. - CRB-601 is in a Phase 1 clinical trial in the U.S., with expansion planned into the U.K. in 2025[122]. - The dose optimization phase of the Western study is ongoing, with participants being randomized into 2.7 mg/kg and 3.6 mg/kg cohorts for various tumor types[32]. Safety and Side Effects - CRB-701 has a favorable safety profile, with only 4% of patients experiencing peripheral neuropathy and 16% experiencing skin rash disorders across both studies[29]. - CRB-913 has a brain to plasma ratio fifty times lower than rimonabant, enhancing its safety profile[38]. - Undesirable side effects from product candidates could delay or prevent regulatory approval, leading to increased product liability exposure and potential harm to the company's financial condition[143]. - Regulatory authorities may impose restrictions on marketing, require product recalls, or withdraw product approvals due to identified side effects, significantly increasing commercialization costs[144]. Financial Performance and Projections - As of December 31, 2024, the company reported a net loss of approximately $40.2 million, compared to a net loss of $44.6 million for the year ended December 31, 2023[114]. - The accumulated deficit as of December 31, 2024, was approximately $476.9 million[114]. - The company has never generated any product revenues and expects to incur substantial losses for the foreseeable future[111]. - The company expects to incur significant expenses to complete its pre-clinical and clinical programs for its drug candidates[114]. - Research and development expenses were approximately $32.2 million for 2024 and $31.2 million for 2023, reflecting ongoing investment in clinical and pre-clinical programs[44]. Regulatory and Approval Processes - The clinical development process includes three phases: Phase 1 focuses on safety with small groups, Phase 2 assesses efficacy in affected patients, and Phase 3 gathers extensive data on effectiveness and safety with several hundred to several thousand subjects[64]. - The FDA requires a clinical plan submission before trials, and can suspend or terminate studies if safety concerns arise[65]. - The approval process may be delayed or denied if the company cannot satisfy the FDA's Chemistry, Manufacturing, and Control Requirements[135]. - The FDA may not accept data from trials conducted outside the U.S., which could result in the need for additional costly and time-consuming trials[176]. - The process of obtaining regulatory approvals is expensive and can take many years, with significant discretion from regulatory authorities impacting the approval timeline[127]. Intellectual Property and Licensing - The Company obtained a license from CSPC Megalith Biopharmaceutical Co. Ltd. to develop and commercialize CRB-701 in multiple regions including the U.S., Canada, and the EU[17]. - The company has exclusive licenses for CRB-701 and CRB-601, with patent expirations projected between 2042 and 2045[46][47]. - The Jenrin License Agreement for CRB-913 provides intellectual property protection in the U.S. until November 2028[48]. - The company relies on patent protection for its technologies, but the patent landscape is uncertain and may not adequately protect its competitive advantage[180]. Manufacturing and Supply Chain Risks - The company relies on third-party manufacturers for drug supply, which poses risks for clinical trial timelines[52]. - The company is completely dependent on third parties for manufacturing drug candidates, which could lead to delays or reduced profitability if these parties fail to meet regulatory or quality standards[159]. - Compliance with current good manufacturing practices (cGMPs) is critical, and any failure by contract manufacturers could lead to significant sanctions, including fines and delays in regulatory approvals[161]. - Increased tariffs and trade restrictions globally could disrupt material procurement and increase costs, adversely affecting the company's operations[163]. Market Competition and Challenges - The competitive landscape includes major players like Novo Nordisk and Skye Bioscience targeting the CB-1 receptor[57]. - The company faces intense competition from established biotechnology and pharmaceutical companies, which may invest heavily to develop novel compounds that could render the company's drug candidates obsolete[148]. - Future growth depends on the ability to enter non-U.S. markets, which involves additional regulatory and commercial risks, including reliance on third-party collaborations[154]. Employment and Workforce - As of December 31, 2024, the company had 28 full-time employees and plans to expand its workforce to support development and commercialization efforts[196]. - The company faces intense competition for skilled personnel in the pharmaceuticals industry, which may limit its ability to attract and retain qualified employees[200]. Financial and Economic Risks - Adverse global conditions and economic uncertainty may negatively impact the company's financial results[214]. - Dislocations in the financial markets could adversely affect the company's business[214]. - Changes in U.S.-China trade relations could adversely impact the company's operations and financial condition due to its licensing agreement with a Chinese partner[210]. - Inflation may increase costs associated with clinical trials and research and development, potentially leading to a need for additional capital[213].

Financial Performance - Corbus Pharmaceuticals reported a net loss of approximately $9.5 million for Q4 2024, compared to a net loss of $8.0 million in Q4 2023, representing a 18.75% increase in losses year-over-year[10] - For the full year 2024, the net loss was approximately $40.2 million, a decrease from a net loss of $44.6 million in 2023, indicating a 9.8% improvement[10] - Total operating expenses for the year ended December 31, 2024, were approximately $48.7 million, compared to $45.1 million in 2023, reflecting a 5.9% increase[20] Operating Expenses - Operating expenses for Q4 2024 increased by $2.5 million to approximately $12.6 million, primarily due to product development and stock-based compensation costs[11] - The weighted average number of common shares outstanding increased to 12,179,482 in 2024 from 4,423,683 in 2023, indicating a significant increase in share issuance[20] Cash and Investments - As of December 31, 2024, the company had $149 million in cash and investments, which is expected to fund operations through Q3 2027[6] Product Development - CRB-701 received Fast Track designation from the FDA for the treatment of relapsed or refractory metastatic cervical cancer, with dose optimization expected to be completed by Q4 2025[7] - The Phase 1 study for CRB-601 commenced in December 2024, with expectations to complete dose escalation by Q4 2025[9] - CRB-913, a new obesity treatment, is set to begin its first human dosing in March 2025, with a Phase 1 dose-range finding study expected to start in Q4 2025[14] - The company presented pre-clinical data showing CRB-913 is significantly more peripherally restricted than existing treatments, with a brain to plasma ratio fifty times lower than rimonabant[14]

Core Insights - Corbus Pharmaceuticals Holdings, Inc. has made significant advancements in its oncology and obesity pipeline, with promising data from its CRB-701 program and the upcoming first human dosing of CRB-913 [2][5] Corporate and Program Updates - CRB-701 is a next-generation antibody drug conjugate targeting Nectin-4, showing a promising safety profile and efficacy in advanced tumors [3][5] - CRB-913 is a highly peripherally restricted CB1 receptor inverse agonist designed for obesity treatment, demonstrating a brain to plasma ratio fifty times lower than rimonabant [4][5] - The FDA granted Fast Track designation to CRB-701 for treating metastatic cervical cancer, with ongoing studies in the U.S. and Europe [6][5] Financial Results - For Q4 2024, the company reported a net loss of approximately $9.5 million, compared to a net loss of $8.0 million in Q4 2023 [8] - The total operating expenses for Q4 2024 increased to approximately $12.6 million, primarily due to product development and stock-based compensation costs [9] - As of December 31, 2024, the company had $149.1 million in cash and investments, expected to fund operations through Q3 2027 [9]