Summary of Corbus Pharmaceuticals Holdings (CRBP) 2025 Conference Call Company Overview - **Company**: Corbus Pharmaceuticals Holdings (CRBP) - **Date of Conference**: May 21, 2025 - **Key Speaker**: Yuval Cohen, CEO Key Points Discussed ADC CRB-701 Development - **Data Presentation**: Recent data from the first Western dataset for CRB-701 shows safety and efficacy comparable to existing treatments like PADCEV, particularly in bladder and cervical cancers [5][6] - **Ocular Prophylaxis Impact**: The use of ocular prophylaxis in Western trials resulted in significantly fewer ocular events compared to trials in China [5] - **Head and Neck Cancer**: Initial data from head and neck cancer patients is promising, with a small cohort showing encouraging results [6][8] - **Safety Profile**: CRB-701 demonstrates a markedly safer profile than PADCEV, with fewer adverse events and lower dropout rates [8] - **Market Strategy**: The company aims to target "empty swim lanes" in oncology, focusing on tumor types where PADCEV is not currently used [9][10] Future Data Expectations - **Project OPTIMIZ**: The company is conducting Project OPTIMIZ, which includes trials for bladder, head and neck, and cervical cancers, with significant patient enrollment expected [13][14] - **Data Release Timeline**: More mature data is anticipated to be presented at a major oncology conference later in the year, with a marked increase in patient numbers [14][36] Head and Neck Cancer Focus - **Market Size**: Head and neck cancer represents a significant market opportunity, with approximately 80,000 patients in the US, half of whom may become metastatic [35] - **Regulatory Path**: The regulatory path for head and neck cancer may be more complex compared to cervical cancer, which has a smaller patient population but potentially faster approval timelines [36][37] Combination Therapy Insights - **Checkpoint Inhibitor Combinations**: The company is exploring combinations of CRB-701 with checkpoint inhibitors, with a focus on patient selection based on immune-related biomarkers [23][24] - **Data-Driven Decisions**: Future strategies will be guided by data outcomes, particularly in relation to competing therapies in the market [25][27] Other Drug Developments - **CB1 Inverse Agonist (CRB-913)**: The company is developing CRB-913, which aims to have a safer profile with significantly lower brain penetration compared to competitors, potentially reducing neuropsych adverse events [41][42] - **Phase Ib Studies**: The design of Phase Ib studies will focus on safety and tolerability, with results expected in the second half of the year [49][50] Upcoming Milestones - **Phase One Data**: The company plans to present data for multiple assets in the second half of the year, indicating a busy and potentially impactful period ahead [61] Additional Insights - **Market Competition**: The competitive landscape includes other modalities targeting similar indications, with a focus on differentiating CRB-701 based on its unique safety and efficacy profile [20][21] - **Regulatory Considerations**: The company is aware of the challenges in navigating regulatory pathways, especially for larger indications like head and neck cancer [36][37] This summary encapsulates the key discussions and strategic directions of Corbus Pharmaceuticals as presented in the conference call, highlighting their focus on innovative cancer therapies and the importance of data in guiding their development strategies.

Company Overview - Corbus Pharmaceuticals Holdings, Inc. is 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; CRB-601, an anti-integrin monoclonal antibody blocking TGFβ activation; and CRB-913, a CB1 receptor inverse agonist for obesity treatment [2] Event Participation - Yuval Cohen, Ph.D., CEO of Corbus, will participate in a fireside chat and one-on-one investor meetings at the 2025 RBC Capital Markets Global Healthcare Conference on May 20-21, 2025 [1][2] - The conference will take place in New York, NY, with the fireside chat scheduled for May 21, 2025, at 8:30 a.m. ET [2]

[PART I: FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%3A%20FINANCIAL%20INFORMATION) [Item 1. Condensed Consolidated Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) Unaudited Q1 2025 financials show a **$17.0 million** net loss, driven by R&D, with total assets at **$139.9 million** [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$139.9 million** by March 31, 2025, from **$155.9 million** at year-end 2024 Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $18,900 | $17,198 | | Investments | $113,887 | $131,864 | | Total current assets | $137,360 | $152,976 | | **Total assets** | **$139,931** | **$155,879** | | **Liabilities & Equity** | | | | Total current liabilities | $11,620 | $11,818 | | **Total liabilities** | **$12,825** | **$13,451** | | **Total stockholders' equity** | **$127,106** | **$142,428** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss increased to **$17.0 million** in Q1 2025 from **$6.9 million** in Q1 2024, primarily due to higher R&D Statement of Operations Highlights (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | 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) | | **Net loss** | **($16,978)** | **($6,899)** | | Net loss per share, basic and diluted | ($1.39) | ($0.83) | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations increased to **$16.4 million** in Q1 2025, with **$18.1 million** provided by investing activities Cash Flow Summary (in thousands) | Cash Flow Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($16,421) | ($7,967) | | Net cash provided by (used in) investing activities | $18,123 | ($98,236) | | Net cash provided by financing activities | $0 | $106,582 | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's oncology and obesity pipeline, liquidity, license agreements, and the January 2024 public offering - The company is an oncology and obesity company with a pipeline of three main experimental drugs: **CRB-701** (ADC for solid tumors), **CRB-601** (monoclonal antibody for solid tumors), and **CRB-913** (CB1 receptor inverse agonist for obesity)[24](index=24&type=chunk) - The company expects its cash, cash equivalents, and investments of approximately **$132.8 million** at March 31, 2025, will be sufficient to meet operating and capital requirements for at least twelve months from the report's issuance[29](index=29&type=chunk) - In January 2024, the company completed a public offering, raising gross proceeds of approximately **$94.5 million** and net proceeds of **$88.6 million**[58](index=58&type=chunk) - A milestone payment of **$0.4 million** related to the **CRB-913** program under the Jenrin License Agreement was achieved and recorded as R&D expense in Q1 2025[38](index=38&type=chunk)[45](index=45&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the oncology and obesity pipeline, increased R&D expenses, and liquidity, projecting funding through Q2 2027 [Overview](index=23&type=section&id=Overview) Corbus focuses on oncology and obesity, advancing **CRB-701**, **CRB-601**, and **CRB-913** in clinical trials - **CRB-701** (Nectin-4 ADC): Phase 1 dose optimization study is ongoing in the U.S., U.K., and Europe[94](index=94&type=chunk) - **CRB-601** (anti-αvβ8 mAb): A Phase 1 dose escalation study began in December 2024[94](index=94&type=chunk) - **CRB-913** (obesity): Dosed the first participant in a Phase 1 SAD/MAD study in Q1 2025[91](index=91&type=chunk) [Results of Operations](index=25&type=section&id=Results%20of%20Operations) Operating expenses rose **105%** to **$19.8 million** in Q1 2025, primarily due to a **171%** increase in R&D costs Research and Development Expenses by Program (in thousands) | Program | Q1 2025 | Q1 2024 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | CRB-601 | $3,237 | $1,334 | $1,903 | 143% | | CRB-701 | $7,133 | $2,461 | $4,672 | 190% | | CRB-913 | $2,753 | $578 | $2,175 | 376% | | **Total program specific costs** | **$13,243** | **$4,373** | **$8,870** | **203%** | - The increase in R&D costs for **CRB-701** was due to higher clinical and drug supply costs as the Phase 1 trial is ongoing. **CRB-601** costs rose as the Phase 1 dose escalation study is ongoing. **CRB-913** costs increased due to drug supply manufacturing and the start of the Phase 1 clinical study[99](index=99&type=chunk) - General and administrative expenses increased by **$0.3 million**, primarily due to higher stock-based compensation costs[101](index=101&type=chunk) [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) The company has **$133.5 million** in liquidity, sufficient through Q2 2027, but requires significant additional capital for trials - Based on current plans, the company expects its cash, cash equivalents, and investments of **$132.8 million** (as of March 31, 2025) to be sufficient to fund operations through the second quarter of 2027[108](index=108&type=chunk) - The company will need to raise significant additional capital to continue funding clinical trials for **CRB-701**, **CRB-601**, and **CRB-913**[109](index=109&type=chunk) - The company has potential future milestone payments of up to **$18.4 million** to Jenrin (per compound), **$150.8 million** to UCSF, and up to **$130.0 million** in development/regulatory and **$555.0 million** in commercial milestones to CSPC[111](index=111&type=chunk)[113](index=113&type=chunk)[115](index=115&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This section is not applicable for the current reporting period - Not Applicable[117](index=117&type=chunk) [Item 4. Controls and Procedures](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective, with no material changes in internal control - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective as of March 31, 2025[119](index=119&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, the company's internal control[120](index=120&type=chunk) [PART II: OTHER INFORMATION](index=31&type=section&id=PART%20II%3A%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=31&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings - The company is not currently a party to any material legal proceedings[121](index=121&type=chunk) [Item 1A. Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) No material changes or additions to risk factors were reported from the 2024 Annual Report - There have been no material changes in or additions to the risk factors included in the 2024 Annual Report[122](index=122&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=31&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds were reported for the period - None[123](index=123&type=chunk) [Item 5. Other Information](index=31&type=section&id=Item%205.%20Other%20Information) CEO and CFO adopted Rule 10b5-1 trading plans on March 14, 2025, with sales commencing October 24, 2025 - On March 14, 2025, the CEO and CFO adopted Rule 10b5-1 trading plans for the potential sale of common stock, with sales permitted to begin on October 24, 2025[126](index=126&type=chunk)[127](index=127&type=chunk) [Item 6. Exhibits](index=32&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Quarterly Report on Form 10-Q, including CEO and CFO certifications

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].