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Corbus Pharmaceuticals to Participate in the BMO 2026 Metabolic Health Summit
Globenewswire· 2026-03-18 12:00
NORWOOD, Mass., March 18, 2026 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings Inc. (NASDAQ: CRBP), a clinical-stage company focused promising new therapies in oncology and obesity, today announced that Yuval Cohen, Ph.D., Chief Executive Officer of Corbus, will participate in a moderated panel discussion at the BMO 2026 Metabolic Health Summit, to be held in New York, NY, on Tuesday, March 24, 2026. Corbus is advancing CRB-913, an orally delivered highly peripherally restricted CB1 inverse agonist for ...
How Much Upside is Left in Corbus Pharmaceuticals (CRBP)? Wall Street Analysts Think 318.33%
ZACKS· 2026-03-11 14:55
Core Viewpoint - Corbus Pharmaceuticals (CRBP) has shown a significant price increase of 26.8% over the past four weeks, with a mean price target of $42 indicating a potential upside of 318.3% from the current price of $10.04 [1] Price Targets and Estimates - The mean estimate consists of nine short-term price targets with a standard deviation of $8.99, where the lowest estimate is $28.00 (178.9% increase) and the highest is $53.00 (427.9% increase) [2] - A low standard deviation suggests a strong agreement among analysts regarding the stock's price movement, which can serve as a starting point for further research [9] Analyst Sentiment and Earnings Estimates - There is increasing optimism among analysts about CRBP's earnings prospects, as indicated by a positive trend in earnings estimate revisions, which correlates with potential stock price movements [11] - Over the last 30 days, two earnings estimates have been revised higher, leading to a 14% increase in the Zacks Consensus Estimate for the current year [12] Zacks Rank and Investment Potential - CRBP holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates, indicating a strong potential for upside in the near term [13] - While the consensus price target may not be entirely reliable, the implied direction of price movement appears to be a useful guide for investors [14]
Corbus Pharmaceuticals(CRBP) - 2025 Q4 - Annual Report
2026-03-09 20:16
Drug Development and Clinical Trials - Corbus Pharmaceuticals is focused on developing innovative therapies in oncology and obesity, with a pipeline that includes CRB-701 and CRB-913[17]. - CRB-701 is currently in a Phase 1/2 study, with 167 patients enrolled, showing an unconfirmed objective response rate (ORR) of 33.3% for HNSCC at a 2.7 mg/kg dose and 47.6% at a 3.6 mg/kg dose[25][27]. - For cervical cancer patients, CRB-701 demonstrated an ORR of 22.2% at 2.7 mg/kg and 37.5% at 3.6 mg/kg, while mUC patients showed an ORR of 50.0% at 2.7 mg/kg and 55.6% at 3.6 mg/kg[31][34]. - The most common treatment-emergent adverse events (TEAEs) were fatigue (21.6%), alopecia (24.0%), and keratitis (32.3%), with no dose-limiting toxicities reported[40]. - CRB-913, an oral small molecule for obesity treatment, completed a Phase 1a study with no serious treatment-emergent adverse events and no gastrointestinal intolerability reported[49]. - The Phase 1a study for CRB-913 included 64 participants in the single ascending dose (SAD) portion and 48 in the multiple ascending dose (MAD) portion, with a maximum dose of 600 mg/day[48]. - CRB-701 has received fast track designation from the FDA for treating relapsed or refractory metastatic cervical cancer and recurrent or metastatic HNSCC[20]. - The company plans to meet with the FDA in Q1 2026 to discuss clinical data and registrational study protocols for HNSCC and cervical tumors[45]. - CRB-701's pharmacokinetic profile indicates a longer half-life and lower free-MMAE exposure compared to PADCEV® at comparable dose levels[45]. - The company initiated a Phase 1b dose-range finding study ("CANYON-1") in December 2025, involving 240 U.S. subjects randomized into 4 arms over a 12-week treatment period[60]. - The CANYON-1 study is expected to complete in summer 2026, further advancing the development of CRB-913[60]. - 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[84]. Financial Performance and Funding - As of December 31, 2025, the company had an accumulated deficit of approximately $555.4 million, with net losses of approximately $78.5 million and $40.2 million for the years ended December 31, 2025 and 2024, respectively[134]. - The company held cash, cash equivalents, and investments of approximately $163.3 million as of December 31, 2025, which will fund operations for a limited time[136]. - The company sold an aggregate of 563,504 shares of common stock for net proceeds of approximately $7.0 million under the Open Market Sale Agreement during the year ended December 31, 2025[137]. - On November 3, 2025, the company completed a public offering raising net proceeds of $70.2 million after deducting underwriting discounts and commissions[139]. - The company has never generated any product revenues and expects to incur significant losses for the foreseeable future, indicating a high degree of risk for investors[131]. - The company may need to raise additional capital through private and public equity offerings, debt financings, and strategic collaborations to support its development efforts[140]. - The company expects to continue incurring substantial expenses without corresponding revenues until it can obtain regulatory approval and successfully commercialize its drug candidates[134]. Regulatory Environment - The regulatory approval process for drug candidates requires substantial time and financial resources, with potential delays or rejections impacting commercialization[78]. - The FDA requires a clinical plan submission before trials begin, and can suspend or terminate studies if safety concerns arise[85]. - Post-approval studies, or Phase 4 trials, may be mandated by the FDA to gather additional data on safety and efficacy after initial marketing approval[86]. - Clinical trial results may not fully predict a product's safety and effectiveness, and unforeseen issues can arise that delay commercialization[87]. - The FDA's Special Protocol Assessment allows for agreement on clinical trial design, but the agency retains the right to change its assessment based on new findings[89]. - The FDA may impose conditions on approvals, including risk evaluation strategies, which could restrict marketing and distribution[93]. - The Orphan Drug Act provides potential benefits such as grant funding of up to $400,000 per year for four years for drugs treating rare diseases[97]. - The U.S. Patent Term Restoration Act allows for a patent restoration term of up to five years, but cannot extend beyond a total of 14 years from the product's approval date[105]. - The company must navigate complex regulatory environments in both the U.S. and EU, which include extensive monitoring and compliance requirements post-approval[114][115]. Competition and Market Dynamics - The company faces competition from major pharmaceutical and biotechnology companies, including Novo Nordisk A/S and Pfizer Inc., in the obesity treatment market[77]. - Competition in the biotechnology and pharmaceutical industries is intense, with established competitors potentially making the company's drug candidates obsolete or uneconomical[170]. - Legislative changes, such as the Inflation Reduction Act of 2022, may limit pricing and reimbursement for drug candidates, adversely affecting profitability[176]. - The company's future growth depends on successful market entry and commercialization of drug candidates in non-U.S. markets, which involves additional regulatory and commercial risks[177]. Manufacturing and Supply Chain - The Company relies on third-party contract manufacturing organizations for the supply of drugs for clinical studies, which could impact clinical trial timelines if delays occur[72]. - The company is completely dependent on third parties for manufacturing drug candidates, which could halt or delay commercialization if these parties fail to meet regulatory standards[182]. - Contract manufacturers must comply with current good manufacturing practices (cGMPs), and failure to do so could impact the company's ability to obtain regulatory approval[183]. - The company relies on contract manufacturers for drug production, which are subject to FDA inspections and compliance with cGMPs, posing risks of sanctions and operational disruptions[184]. - There is a risk of supply interruptions if third-party manufacturers face difficulties, which could adversely affect the ability to produce drug candidates[185]. - The company depends on foreign third parties for materials and services in clinical trials, with potential impacts from tariffs and trade restrictions that could increase costs and disrupt supply chains[186]. - Manufacturing costs for drug candidates may exceed expectations, impacting operating results and necessitating process improvements subject to regulatory approval[187]. - Scaling up manufacturing to commercial levels carries risks such as cost overruns and technical problems, which could delay regulatory approval and commercialization[188]. Intellectual Property and Legal Risks - The company faces challenges in protecting intellectual property rights, with potential impacts on competitive advantage and revenue generation[202]. - There is uncertainty regarding the enforceability of existing patents and the potential for third-party challenges to intellectual property rights[203]. - The company relies on trade secrets for technology protection, which are difficult to safeguard and may be compromised[204]. - The company has licensed intellectual property from partners, and failure to comply with obligations could result in loss of rights or damages[207]. - The company is subject to potential claims of patent infringement, which could lead to costly litigation and delays in product commercialization[209]. - The company may face significant litigation costs and distractions from management due to claims related to the use of confidential information or trade secrets[214].
Corbus Pharmaceuticals(CRBP) - 2025 Q4 - Annual Results
2026-03-09 11:43
Financial Performance - Corbus Pharmaceuticals reported a net loss of approximately $20.6 million for Q4 2025, compared to a net loss of $9.5 million in Q4 2024, representing a 117% increase in losses year-over-year [12]. - The company reported a net loss per share of $1.25 for Q4 2025, compared to $0.78 for Q4 2024 [12]. - Total stockholders' equity increased to $147.5 million as of December 31, 2025, up from $142.4 million in 2024 [24]. Operating Expenses - Operating expenses increased by $9.4 million to approximately $22.0 million in Q4 2025, primarily due to higher clinical development expenses [13]. Funding and Cash Position - The company completed a public offering in Q4 2025, raising $75 million in gross proceeds, extending its cash runway into 2028 [6][14]. - The company had $163.3 million in cash, cash equivalents, and investments on hand as of December 31, 2025, expected to fund operations into 2028 [14]. Clinical Development - CRB-701 demonstrated an unconfirmed objective response rate of 47.6% in HNSCC, 37.5% in cervical cancer, and 55.6% in bladder cancer at the 3.6 mg/kg dose [7]. - CRB-913 showed a potent and rapid weight loss of 2.9% at 14 days in a dedicated obesity cohort, with favorable gastrointestinal safety [6][10]. - CRB-913's 12-week obesity study (n=240) is on schedule for completion in summer 2026 [6]. - Corbus anticipates key data readouts for CRB-701 and CRB-913 in mid-2026, focusing on efficacy, safety profiles, and clinical utility [4][10].
Corbus Pharmaceuticals Reports Q4 and 2025 Financial Results and Provides a Corporate Update
Globenewswire· 2026-03-09 11:30
Core Insights - Corbus Pharmaceuticals is focused on developing new therapies in oncology and obesity, with promising data for CRB-701 and CRB-913 expected to drive significant developments in 2026 [2][11]. Corporate and Program Updates - CRB-701 is a next-generation antibody-drug conjugate targeting Nectin-4, with Fast Track designations from the FDA for treating head and neck squamous cell carcinoma (HNSCC) and cervical cancer [3]. - CRB-913 is an oral CB1 inverse agonist aimed at obesity treatment, showing rapid weight loss and favorable gastrointestinal tolerability [4]. - Data presented at ESMO 2025 indicated an unconfirmed objective response rate for CRB-701 of 47.6% in HNSCC, 37.5% in cervical cancer, and 55.6% in bladder cancer, with no severe treatment-related adverse events reported [5][6]. Financial Results - For Q4 2025, the company reported a net loss of approximately $20.6 million, compared to a net loss of $9.5 million in Q4 2024, reflecting an increase in operating expenses primarily due to clinical development [8][9]. - Operating expenses rose to approximately $22.0 million in Q4 2025 from $12.6 million in Q4 2024 [9]. - The company had $163.3 million in cash and equivalents as of December 31, 2025, following a public offering that raised $75 million, which is expected to fund operations into 2028 [10].
Corbus Pharmaceuticals (NasdaqCM:CRBP) FY Conference Transcript
2026-02-25 21:20
Summary of Corbus Pharmaceuticals FY Conference Call Company Overview - **Company**: Corbus Pharmaceuticals (NasdaqCM:CRBP) - **Location**: Norwood, Massachusetts - **Size**: 36 employees - **Pipeline**: Focus on oncology with lead asset CRB-701 (Nectin-4 ADC) and obesity with CRB-913 (CB1 inverse agonist) [4][5] Key Points on CRB-701 (Nectin-4 ADC) - **Mechanism**: CRB-701 is a Nectin-4 targeting ADC armed with MMAE, designed to have better internalization and stability compared to PADCEV [6][9] - **Differentiation**: CRB-701 targets a different epitope and has a precise drug-to-antibody ratio (DAR) of 2, leading to lower levels of circulating MMAE and reduced side effects [7][10] - **Safety Profile**: Notable for low levels of peripheral neuropathy and skin issues, but potential ocular toxicity is acknowledged [15][16] - **Clinical Data**: Preliminary efficacy signals observed in second-line head and neck and cervical cancers, with expectations for more mature data in mid-2026 [30][31] - **Market Strategy**: Focus on tumor types where PADCEV is not a competitor, aiming for "empty swim lanes" in the competitive landscape [11] Key Points on CRB-913 (CB1 Inverse Agonist) - **Mechanism**: CRB-913 is a peripherally restricted CB1 inverse agonist, expected to lead to weight loss with a favorable safety profile [65][66] - **Efficacy Data**: Early data shows significant weight loss (almost 3% at 2 weeks) across all patients, with ongoing studies to assess longer-term effects [66][67] - **Safety Profile**: Minimal neuropsychiatric adverse events reported, indicating a favorable safety profile compared to previous CB1 antagonists [68][69] - **Market Potential**: Positioned to compete in the obesity market, with expectations for transformative data by the end of summer 2026 [70][75] Other Important Insights - **Tivdak Comparison**: CRB-701 is positioned to potentially replace Tivdak in the cervical cancer market, which had $300 million in sales despite its high cost and limited patient eligibility [32][33] - **Regulatory Pathway**: Plans for FDA discussions regarding phase 3 trials for both CRB-701 and CRB-913, with updates expected in Q1 2026 [55][56] - **Market Dynamics**: The oncology market is competitive, with a focus on differentiating CRB-701 from existing therapies like Genmab's peto and exploring combination therapies with KEYTRUDA [49][50] This summary encapsulates the key points discussed during the conference call, highlighting the strategic direction and clinical developments of Corbus Pharmaceuticals.
Corbus Pharmaceuticals (NasdaqCM:CRBP) Earnings Call Presentation
2026-02-25 12:00
Connecting Innovation to Purpose Corporate Presentation February 25, 2026 www.corbuspharma.com @corbuspharma NASDAQ: CRBP 1 Forward-Looking Statements This presentation 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, market op ...
Corbus Pharmaceuticals to Present at the 36th Annual Oppenheimer Healthcare Life Sciences Conference
Globenewswire· 2026-02-12 13:00
Core Insights - Corbus Pharmaceuticals Holdings Inc. is set to present a corporate overview and engage in investor meetings at the 36th Annual Oppenheimer Healthcare Life Sciences Conference on February 25, 2026 [1][2]. Company Overview - Corbus Pharmaceuticals is a clinical-stage company focused on oncology and obesity, with a diversified portfolio aimed at addressing serious illnesses through innovative scientific approaches [2]. - The company's pipeline includes: - CRB-701: A next-generation antibody drug conjugate targeting Nectin-4 on cancer cells to deliver a cytotoxic payload [2]. - CRB-601: An anti-integrin monoclonal antibody that inhibits the activation of TGFβ on cancer cells [2]. - CRB-913: A highly peripherally restricted CB1 inverse agonist designed for obesity treatment [2]. - Corbus is headquartered in Norwood, Massachusetts [2].
Corbus Pharmaceuticals Holdings, Inc. (CRBP) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript
Seeking Alpha· 2026-01-15 20:15
Core Insights - Corbus Pharmaceuticals is presenting at the 44th Annual JPMorgan Healthcare Conference, focusing on key assets and upcoming milestones [1][2] Group 1: Upcoming Milestones - The company plans to highlight important milestones for its ADC (Antibody-Drug Conjugate) this year [2] - A significant focus will be on the maturing data for CRB-701, particularly regarding its second-line monotherapy in head and neck cancer [3] Group 2: Data Presentation - Updated data on CRB-701 was presented at ESMO, indicating an increase in patient numbers and longer duration of response [3] - The company aims to present further maturing data at a large oncology conference later this year, emphasizing the duration of response for patients [4]
Corbus Pharmaceuticals (NasdaqCM:CRBP) FY Conference Transcript
2026-01-15 17:17
Summary of Corbus Pharmaceuticals FY Conference Call Company Overview - **Company**: Corbus Pharmaceuticals (NasdaqCM:CRBP) - **Date of Conference**: January 15, 2026 - **Key Speaker**: CEO Yuval Cohen Key Points on Drug Development and Pipeline CRB-701 (Oncology) - **Indications**: Focus on second-line monotherapy for head and neck cancer and cervical cancer - **Data Presentation**: Updated data presented at ESMO, with emphasis on the duration of response for patients in second-line head and neck cancer [3] - **FDA Discussions**: Ongoing discussions with the FDA regarding the registrational pathway for CRB-701 in both head and neck and cervical cancers, with expectations of clarity on the regulatory process [4][5] - **Durability of Response**: Key question remains on how durable the response is for patients treated with CRB-701 in both indications [3][4] - **First-Line Treatment**: Emerging data from a study combining CRB-701 with Keytruda in first-line head and neck cancer, with expectations for data maturation later in the year [5][6] CRB-913 (Obesity) - **Mechanism**: A once-a-day oral small molecule CB1 inverse agonist, with a focus on obesity treatment [8] - **Comparison with Monlunabant**: CRB-913 is more restricted in the brain compared to Monlunabant, leading to potentially fewer adverse effects [10][11] - **Safety Profile**: Initial phase 1A data shows a mild profile of gastrointestinal adverse events, significantly better than Monlunabant, which had higher GI toxicity [15][19] - **Neuropsychiatric Events**: No clinical events of neuropsychiatric adverse events reported in CRB-913 trials, contrasting with Monlunabant's high incidence [18][19] - **Weight Loss Results**: Significant weight loss observed in participants, with an average of nearly 3% weight loss after one week of dosing [20][21] - **Efficacy Comparison**: CRB-913 shows potential to be more potent than Rimonabant and Monlunabant, with a promising safety profile [25][27] Financial Position - **Cash Reserves**: Corbus Pharmaceuticals reported having $172 million in cash, providing a runway for both oncology and obesity programs into 2028 [44] Additional Insights - **Regulatory Environment**: The current FDA environment is perceived as less welcoming to single-arm accelerated approval studies compared to previous years [4] - **Market Positioning**: The company aims to position CRB-701 in a competitive landscape dominated by EGFR combinations in first-line head and neck cancer [6] - **Future Milestones**: Anticipated data releases and regulatory updates for both CRB-701 and CRB-913 throughout 2026 [33] Conclusion Corbus Pharmaceuticals is actively advancing its oncology and obesity drug pipelines, with significant upcoming milestones and a strong financial position to support its initiatives. The focus on safety and efficacy in both CRB-701 and CRB-913 highlights the company's commitment to addressing unmet medical needs in these therapeutic areas.