Core Insights - Corbus Pharmaceuticals has initiated the dosing of the first participant in the PD-1 combination arm of its Phase 1 study for CRB-701, targeting solid tumors [1] - The company is experiencing a strong enrollment rate in the CRB-701 program, with a focus on advanced solid tumors associated with high Nectin-4 expression [2] Company Overview - Corbus Pharmaceuticals is a clinical-stage company focused on oncology and obesity, aiming to develop innovative treatments targeting well-understood biological pathways [4] - The company's pipeline includes CRB-701, an antibody-drug conjugate targeting Nectin-4, CRB-601, an anti-integrin monoclonal antibody, and CRB-913, a CB1 receptor inverse agonist for obesity [4] Study Details - The Phase 1 study (NCT06265727) consists of three parts: Part A (dose escalation), Part B (dose optimization), and Part C (dose expansion), with the company expecting to provide a data update and establish the recommended Phase 2 dose in Q4 2025 [2] - The initial dose escalation evaluated four doses: 1.8 mg/kg, 2.7 mg/kg, 3.6 mg/kg, and 4.5 mg/kg [2] Product Information - CRB-701 (SYS6002) is a next-generation antibody-drug conjugate that utilizes a cleavable linker and a homogeneous drug-antibody ratio of 2, with MMAE as the payload [3] - Nectin-4 is recognized as a clinically validated tumor-associated antigen in urothelial cancer [3] Enrollment and Data Update - Over 100 participants have been dosed in the monotherapy cohort, with a priority focus on Head and Neck Squamous Cell Carcinoma (HNSCC) and cervical cancer [7] - A data update is scheduled for later this year [7]

Group 1 - Corbus Pharmaceuticals Holdings, Inc. will participate in the Piper Sandler 3rd Annual Virtual Obesity Symposium on June 26, 2025, with CEO Yuval Cohen, Ph.D. engaging in a fireside chat [1][2] - The symposium will feature presentations from key opinion leaders and discussions with companies focused on obesity therapeutics [1] - Corbus is a clinical-stage company concentrating on oncology and obesity, with a commitment to innovative scientific approaches targeting well-understood biological pathways [2] Group 2 - Corbus' 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] - The company is headquartered in Norwood, Massachusetts, and provides additional information through its website and social media platforms [2]

Core Insights - Corbus Pharmaceuticals Holdings (NASDAQ: CRBP) experienced a significant increase in stock value, more than doubling over the course of 2024 before facing a sharp decline [1] Group 1: Company Overview - The stock value of Corbus Pharmaceuticals surged significantly, indicating potential investor interest and market volatility [1] - The analysis emphasizes the importance of understanding the science behind biotech investments, highlighting the complexities involved in clinical trials and the biotech sector [1] Group 2: Analyst Perspective - The analyst has a PhD in biochemistry and extensive experience in analyzing clinical trials and biotech companies, which adds credibility to the insights provided [1] - There is a potential for the analyst to initiate a long position in CRBP within the next 72 hours, suggesting a possible shift in investment strategy [2]

Summary of Corbus Pharmaceuticals Holdings (CRBP) 2025 Conference Call Company Overview - Corbus Pharmaceuticals is a drug discovery and development company based in Norwood, Massachusetts, with a team of approximately 33 employees [4][5] - The company has a pipeline consisting of three clinical assets: two in oncology and one in obesity, all of which are expected to have clinical readouts in the second half of 2025 [4][5] Key Points on Oncology Programs - The company is currently optimizing doses for its oncology program, specifically for MUC, cervical, and head and neck cancers, with results anticipated in Q4 2025 [6][7] - The focus is on three tumor types, with a significant number of patients expected to be presented at an upcoming oncology conference [8][12] - The company does not prioritize bladder cancer due to competition from established therapies like PADCEV plus Keytruda [9][10] - Benchmarks for head and neck and cervical cancers are established, with expected overall response rates (ORR) of 36% and 24%, respectively [10][11] Collaboration with CSPC - Corbus has a positive and constructive relationship with its partner CSPC, which is expected to present dose optimization data in the second half of the year [14][15] - The company has observed significant differences in patient management and trial design between the U.S. and China, particularly regarding patient adherence and quality of life considerations [17][18][19] Insights on Clinical Practices - The cultural differences in clinical practices between the West and China have led to lower discontinuation rates in Chinese trials compared to U.S. trials [17][19][20] - The company is focused on ensuring patient comfort while maintaining adherence to the study protocols [20][21] Obesity Program (CB1 Inverse Agonist) - The obesity program is entering a phase where data from a SAD/MAD study in healthy volunteers is expected, which will inform the next steps in the development plan [27][29] - The company anticipates that the obesity drug will lead to weight loss, supported by a clinically validated mechanism of action [30][31] - The focus is on ensuring a clean safety profile, particularly concerning neuropsychiatric adverse events [31][34] Competitive Landscape in Obesity - The obesity market is competitive, dominated by incretin-based therapies, but Corbus aims to position its CB1 inverse agonist as a complementary option for patients who are intolerant to existing therapies [50][54] - The potential for the drug to serve as a maintenance therapy after initial weight loss with injectable therapies is highlighted as a significant market opportunity [55][56] Financial Position - Corbus ended the quarter with $133 million in cash, providing a runway until mid-2027 [57] Future Outlook - The company is preparing for a monotherapy dose escalation study for its highest-risk program targeting TGF beta, with data expected by the end of the year [58][59]

Industry Overview - The obesity market is rapidly expanding, driven by the success of GLP-1 therapies Wegovy and Zepbound, and is projected to reach $100 billion by 2030 [1] - There is a growing interest in cannabinoid (CBD)-based therapies as companies seek to innovate beyond GLP-1s for weight management [2] - The cannabis industry is also experiencing significant growth, expected to surpass $200 billion by 2032, although direct investments in cannabis companies have been challenging due to regulatory issues [3] Company Analysis Novo Nordisk - Novo Nordisk is a leader in obesity treatments with its semaglutide products, Wegovy and Ozempic, but faces increasing competition from Eli Lilly [5] - The company entered the CBD space by acquiring Inversago Pharmaceuticals in 2023, adding monlunabant, an investigational oral cannabinoid drug for metabolic diseases [6] - A phase IIa study on monlunabant showed statistically significant weight loss compared to placebo, but higher doses had diminishing returns; a phase IIb study is planned to find an optimal dose [7] - EPS estimates for 2025 have increased from $3.81 to $3.84, while 2026 estimates have slightly decreased from $4.66 to $4.64; the stock has declined about 21% year to date due to competition and regulatory challenges [8] Corbus Pharmaceuticals - Corbus' lead CBD candidate, CRB-913, targets the same CB1 receptor as monlunabant and is currently in phase I studies, with results expected in Q3 2025 [9] - Preclinical data suggest CRB-913 may have advantages over previous therapies, with a significantly lower brain-to-plasma ratio, indicating reduced neuropsychiatric side effects [10] - Corbus is also developing two oncology drugs, CRB-701 and CRB-601, with CRB-701 in phase I/II studies [11] - Loss per share estimates for 2025 have increased from $5.47 to $6.34, and for 2026 from $5.30 to $5.39; the stock has declined 36% year to date, reflecting regulatory volatility [12][13] Skye Bioscience - Skye Bioscience is developing nimacimab, a monoclonal antibody targeting the CB1 pathway, currently in a phase II study evaluating its efficacy as a monotherapy and in combination with Wegovy [14] - Nimacimab is designed to minimize brain penetration while maintaining metabolic effects, with early studies showing no adverse psychiatric events [15] - Loss per share estimates for 2025 have widened from $1.27 to $1.31, and for 2026 from $1.48 to $1.52; the stock has lost 27% year to date due to financial concerns and lack of commercial revenues [16]

Company Overview - Corbus Pharmaceuticals Holdings, Inc. is a clinical-stage company focused on oncology and obesity, aiming to help patients overcome serious illnesses through innovative scientific approaches targeting well-understood biological pathways [2] - The company's pipeline includes three key products: CRB-701, a next-generation antibody drug conjugate targeting Nectin-4 on cancer cells; CRB-601, an anti-integrin monoclonal antibody blocking TGFβ activation on cancer cells; and CRB-913, a highly peripherally restricted CB1 receptor inverse agonist for obesity treatment [2] Upcoming Events - Yuval Cohen, Ph.D., CEO of Corbus, will provide a corporate update and engage in one-on-one investor meetings at the Jefferies Global Healthcare Conference scheduled for June 3-5, 2025, in New York [1] - The presentation by Corbus is set for June 4, 2025, at 4:55 p.m. ET [2]

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 a clinical-stage company focused on oncology and obesity, committed to innovative scientific approaches to address serious illnesses [5] - 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 on cancer cells; and CRB-913, a CB1 receptor inverse agonist for obesity treatment [5] Leadership Changes - Rachelle Jacques has been appointed as Chair of the Board of Directors, effective May 15, succeeding Alan Holmer, who will remain on the Board [1][2] - Rachelle Jacques has over 25 years of leadership experience in biopharmaceuticals, having served in various roles including CEO and board member at multiple biotechnology companies [3][4] Strategic Vision - The company anticipates clinical readouts from all three drugs in its pipeline in the second half of the year, marking a pivotal time for Corbus [2] - Rachelle Jacques emphasized the potential of the company's oncology programs and obesity treatment to drive meaningful change for patients [3]

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