Corbus Pharmaceuticals(CRBP) - 2025 Q2 - Quarterly Results

Report Overview Corbus Pharmaceuticals reported Q2 2025 financial results and corporate updates, with CEO Yuval Cohen highlighting anticipated data readouts for all three clinical programs in H2 2025 Introduction and CEO Commentary Corbus Pharmaceuticals reported its Q2 2025 financial results and provided a corporate update, with CEO Yuval Cohen highlighting the second half of 2025 as impactful due to anticipated data readouts for all three clinical programs - Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) is a clinical stage oncology and obesity company[1] - The second half of 2025 is expected to be impactful with scheduled data readouts for all three clinical programs (CRB-701, CRB-913, CRB-601)[2][5] - Strong enrollment in the CRB-701 study and upcoming Phase 1/2 dose expansion data presentation at ESMO in October, including data from over 100 participants[2] - SAD/MAD data for obesity drug CRB-913 expected later this year, with a Phase 1b dose-range finding study to initiate in Q4 2025[2] Key Corporate and Program Updates This section details the progress of Corbus's clinical programs, including CRB-701, CRB-913, and CRB-601, with upcoming data readouts and regulatory designations CRB-701 (Nectin-4 ADC) CRB-701, a next-generation Nectin-4 targeting antibody-drug conjugate (ADC) for solid tumors, is undergoing dose optimization in its Phase 1/2 study. Key data will be presented at ESMO 2025, and it has received FDA Fast Track designation for metastatic cervical cancer - CRB-701 is a next-generation antibody drug conjugate (ADC) targeting Nectin-4 for the treatment of solid tumors[3][10] - Phase 1/2 dose expansion data will be presented at the European Society for Medical Oncology (ESMO) Congress on October 19, 2025[5][6] - The U.S. FDA has granted Fast Track designation to CRB-701 for the treatment of relapsed or refractory metastatic cervical cancer[6] - Dose optimization in the Phase 1/2 study is ongoing, with dosing at 2.7 mg/kg and 3.6 mg/kg in HNSCC, cervical, and urothelial tumors[6] - The first participant in the combination arm of the study was dosed with pembrolizumab in June 2025[6] CRB-913 (Obesity Drug) CRB-913, a highly peripherally restricted CB1 receptor inverse agonist for obesity, initiated the multiple ascending dose (MAD) portion of its Phase 1 trial in June 2025. Pre-clinical data demonstrates significantly reduced brain penetration compared to previous drugs, with no treatment-related neuropsychiatric events observed to date - CRB-913 is a second-generation, highly peripherally restricted, oral small molecule CB1 receptor inverse agonist designed for the treatment of obesity[4][10] - The Company initiated the multiple ascending dose (MAD) portion of the Phase 1 trial in June 2025, following safety and pharmacokinetics data analysis of the single ascending dose (SAD) portion[4][5] - No treatment-related neuropsychiatric events have been seen to date in the SAD portion of the study[7] - Pre-clinical data shows CRB-913 is markedly more peripherally restricted, with a brain to plasma ratio 50-times lower than rimonabant and 15-times more peripherally restricted than monlunabant[7] - SAD/MAD data is expected later this year, and the initiation of a Phase 1b dose-range finding study in obese non-diabetic individuals is on track for Q4 2025[7] CRB-601 (Anti-αvβ8 Integrin mAB) CRB-601, a potent and selective anti-αvβ8 integrin monoclonal antibody designed to block TGFβ activation in the tumor micro-environment, dosed its first participant in December 2024 in a Phase 1 study. Dose escalation data is anticipated in Q4 2025 - 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[7][10] - The first participant was dosed in December 2024 in the dose escalation monotherapy portion of a Phase 1 study[7] - The Company is on track to report dose escalation data in Q4 2025[7] Financial Results for the Quarter Ended June 30, 2025 Corbus Pharmaceuticals reported its Q2 2025 financial performance, including a net loss increase and details on liquidity and capital resources Summary of Financial Performance Corbus reported a net loss of $17.7 million for Q2 2025, an increase from $10.0 million in Q2 2024, primarily driven by a significant rise in clinical development expenses - Net loss for the three months ended June 30, 2025, was approximately $17.7 million, or $1.44 per basic and diluted share[8] - This compares to a net loss of $10.0 million, or $0.90 per basic and diluted share, for the three months ended June 30, 2024[8] - Operating expenses increased by $8.2 million to approximately $19.2 million for Q2 2025, up from $11.0 million in Q2 2024, primarily due to increased clinical development expenses[9] Key Financial Performance (Three Months Ended June 30) | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | Change (YoY) | | :----------------------- | :--------------------- | :--------------------- | :----------- | | Net Loss | $(17,662) | $(9,997) | $(7,665) | | Net Loss per Share | $(1.44) | $(0.90) | $(0.54) | | Total Operating Expenses | $19,152 | $10,988 | $8,164 | | Research and development | $15,187 | $6,865 | $8,322 | | General and administrative | $3,965 | $4,123 | $(158) | Liquidity and Capital Resources As of June 30, 2025, Corbus held $116.6 million in cash, cash equivalents, and investments, which is anticipated to fund operations through Q2 2027 - As of June 30, 2025, the Company had $116.6 million of cash, cash equivalents, and investment on hand[9] - This capital is expected to fund operations through Q2 2027 based on planned expenditures[9] About Corbus Pharmaceuticals Corbus Pharmaceuticals is a clinical-stage oncology and obesity company dedicated to addressing serious illnesses through innovative scientific approaches. Its pipeline includes CRB-701, CRB-601, and CRB-913 - Corbus Pharmaceuticals Holdings, Inc. is a clinical stage oncology and obesity company[10] - The company is committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways[10] - Corbus' pipeline includes CRB-701 (Nectin-4 ADC), CRB-601 (anti-integrin monoclonal antibody), and CRB-913 (peripherally restricted CB1 receptor inverse agonist)[10] Forward-Looking Statements This press release contains forward-looking statements regarding the Company's clinical trials, product development, regulatory timelines, market opportunities, and future financial performance. These statements are based on current expectations and are subject to known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially - The press release contains forward-looking statements as defined by Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934[11] - These statements relate to future events or financial performance and involve known and unknown risks, uncertainties, and other factors[12] - Prospective investors are cautioned not to place undue reliance on such statements, and the Company undertakes no obligation to publicly update them[12] Investor Contact The document provides contact information for investor inquiries, including Corbus' Chief Financial Officer and LifeSci Advisors. It also includes a standard disclaimer regarding trademarks - Investor contact information is provided for Sean Moran, Chief Financial Officer of Corbus Pharmaceuticals, and Dan Ferry, Managing Director at LifeSci Advisors, LLC[14] - All product names, logos, brands, and company names mentioned are trademarks or registered trademarks of their respective owners[13] Condensed Consolidated Financial Statements This section presents the unaudited condensed consolidated statements of operations, comprehensive loss, and balance sheets for specified periods Statements of Operations and Comprehensive Loss The unaudited condensed consolidated statements of operations and comprehensive loss detail the financial performance for the three and six months ended June 30, 2025, and 2024, showing increased net losses and operating expenses year-over-year Condensed Consolidated Statements of Operations and Comprehensive Loss (Three Months Ended June 30, in thousands, except per share amounts) | Metric | 2025 | 2024 | | :------------------------------------------ | :--- | :--- | | Research and development | $15,187 | $6,865 | | General and administrative | $3,965 | $4,123 | | Total operating expenses | $19,152 | $10,988 | | Operating loss | $(19,152) | $(10,988) | | Interest and investment income, net | $1,314 | $1,600 | | Interest expense | — | $(652) | | Other income, net | $176 | $43 | | Total other income, net | $1,490 | $991 | | Net loss | $(17,662) | $(9,997) | | Net loss per share, basic and diluted | $(1.44) | $(0.90) | | Weighted average common shares outstanding | 12,240,443 | 11,053,241 | | Total comprehensive loss | $(17,678) | $(10,056) | Condensed Consolidated Statements of Operations and Comprehensive Loss (Six Months Ended June 30, in thousands, except per share amounts) | Metric | 2025 | 2024 | | :------------------------------------------ | :--- | :--- | | Research and development | $30,829 | $12,627 | | General and administrative | $8,098 | $7,984 | | Total operating expenses | $38,927 | $20,611 | | Operating loss | $(38,927) | $(20,611) | | Interest and investment income, net | $2,995 | $2,628 | | Interest expense | — | $(1,491) | | Other income, net | $1,292 | $2,578 | | Total other income, net | $4,287 | $3,715 | | Net loss | $(34,640) | $(16,896) | | Net loss per share, basic and diluted | $(2.83) | $(1.75) | | Weighted average common shares outstanding | 12,221,373 | 9,681,875 | | Total comprehensive loss | $(34,714) | $(17,283) | Balance Sheets The unaudited condensed consolidated balance sheets present the Company's financial position as of June 30, 2025, compared to December 31, 2024, showing a decrease in total assets and stockholders' equity Condensed Consolidated Balance Sheets (in thousands) | ASSETS | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Cash and cash equivalents | $20,044 | $17,198 | | Investments | $96,548 | $131,864 | | Restricted cash | $285 | $285 | | Prepaid expenses and other current assets | $5,948 | $3,629 | | Total current assets | $122,825 | $152,976 | | Restricted cash (non-current) | $385 | $385 | | Property and equipment, net | $251 | $385 | | Operating lease right-of-use assets | $1,624 | $2,133 | | Total assets | $125,085 | $155,879 | | LIABILITIES AND STOCKHOLDERS' EQUITY | | | | Accounts payable | $3,988 | $4,786 | | Accrued expenses | $7,650 | $5,426 | | Operating lease liabilities, current | $1,695 | $1,606 | | Total current liabilities | $13,333 | $11,818 | | Operating lease liabilities, noncurrent | $761 | $1,633 | | Total liabilities | $14,094 | $13,451 | | Common stock | $1 | $1 | | Additional paid-in capital | $622,562 | $619,285 | | Accumulated deficit | $(511,533) | $(476,893) | | Accumulated other comprehensive (loss) gain | $(39) | $35 | | Total stockholders' equity | $110,991 | $142,428 | | Total liabilities and stockholders' equity | $125,085 | $155,879 |