Contineum Therapeutics, Inc.(CTNM) - 2025 Q1 - Quarterly Results

Company Overview & Highlights Contineum Therapeutics reported Q1 2025 financial results, reaffirmed key clinical milestones for PIPE-791 and PIPE-307, and projected a cash runway through 2027, with the CEO emphasizing strong execution and a solid balance sheet Executive Summary Contineum Therapeutics reported its first-quarter 2025 financial results and reaffirmed key clinical development milestones, including upcoming topline data for PIPE-791 and PIPE-307, completion of PIPE-791 chronic toxicity studies, and a projected cash runway through 2027 - Topline data from PIPE-791 Phase 1b PET trial expected in the second quarter of 2025[1] - PIPE-791 chronic toxicity studies completed to support future Phase 2 trials[1] - Topline data from PIPE-307 Phase 2 VISTA trial for RRMS anticipated in the second half of 2025[1] - Cash runway projected through 2027[1] CEO Commentary CEO Carmine Stengone affirmed the company's progress on clinical operations milestones and data readouts, highlighting the potential of their LPA1 and M1 receptor antagonists and emphasizing execution of clinical development objectives with a strong balance sheet - Company remains on track to achieve all clinical operations milestones and significant clinical data readouts[3] - Focus on executing against clinical development objectives, supported by a solid balance sheet that extends through 2027[3] Key Clinical Development Milestones The company is advancing its clinical pipeline with anticipated topline data for PIPE-791 and PIPE-307 in 2025, initiation of new Phase 2 trials, and an IND filing for CTX-343 in H2 2025 PIPE-791 Program Updates The PIPE-791 program is advancing with expected topline data from its Phase 1b PET trial in Q2 2025, completion of chronic toxicity studies, and plans to initiate Phase 2 proof-of-concept trials in IPF and PrMS in H2 2025. Topline data from the Phase 1b chronic pain trial is anticipated in early 2026 - Topline data from PIPE-791 Phase 1b PET trial expected in the second quarter of 2025, measuring pharmacokinetics to receptor occupancy in healthy volunteers, IPF, and PrMS patients[6] - Completed PIPE-791 chronic toxicity studies required to support future Phase 2 trials[6] - Plans to initiate Phase 2 proof-of-concept clinical trials in IPF and PrMS in the second half of 2025[6] - Topline data from PIPE-791 Phase 1b chronic pain trial (for OA and LBP) anticipated in early 2026, with patient dosing initiated in March 2025[6] PIPE-307 Program Updates The PIPE-307 program expects topline data from its Phase 2 VISTA RRMS trial in H2 2025. Additionally, Johnson & Johnson commenced recruiting for a Phase 2 trial of PIPE-307/JNJ-89495120 for Major Depressive Disorder (MDD) in December 2024 - Topline data from PIPE-307 Phase 2 VISTA RRMS trial expected in the second half of 2025, assessing safety and efficacy[6] - Johnson & Johnson began recruiting for a Phase 2 trial of PIPE-307/JNJ-89495120 in adult participants with Major Depressive Disorder (MDD) in December 2024[6] CTX-343 Program Updates Contineum Therapeutics plans to file an Investigational New Drug (IND) application for CTX-343 with the FDA in the second half of 2025 - Company plans to file an Investigational New Drug (IND) application for CTX-343 with the U.S. Food and Drug Administration (FDA) in the second half of 2025[6] First-Quarter 2025 Financial Results Contineum Therapeutics reported a net loss of $16.0 million for Q1 2025, driven by increased R&D and G&A expenses, while maintaining a strong cash position of $190.7 million with a projected runway through 2027 Financial Highlights Contineum Therapeutics reported a net loss of $16.0 million for Q1 2025, an increase from $8.4 million in Q1 2024. Research and development expenses significantly increased by 76% to $13.7 million, driven by clinical program advancements. General and administrative expenses also rose to $4.4 million. The company maintains a strong cash position of $190.7 million, projected to fund operations through 2027 Financial Performance Summary | Financial Metric | Q1 2025 (Millions USD) | Q1 2024 (Millions USD) | Change (%) | | :----------------- | :------------------- | :------------------- | :--------- | | Net Loss | $(16.0) | $(8.4) | 90.5% | | R&D Expenses | $13.7 | $7.8 | 75.6% | | G&A Expenses | $4.4 | $2.2 | 100.0% | - Cash, cash equivalents and marketable securities were $190.7 million as of March 31, 2025, with sufficient resources projected to fund planned operations through 2027[9] - Research and development expenses increased by 76% to $13.7 million, primarily due to higher clinical development expenses for PIPE-791 and PIPE-307 programs and increased employee-related costs[9] - General and administrative expenses increased by $2.2 million to $4.4 million, mainly due to higher stock-based compensation and employee-related costs[9] Condensed Statements of Operations and Comprehensive Loss The condensed statements of operations show a significant increase in operating expenses and net loss for the three months ended March 31, 2025, compared to the prior-year quarter, primarily driven by higher research and development and general and administrative costs Condensed Statements of Operations and Comprehensive Loss | (in thousands USD, except share and per share data) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :---------------------------------------------- | :-------------------------------- | :-------------------------------- | | Operating expenses: | | | | Research and development | $13,712 | $7,778 | | General and administrative | $4,398 | $2,152 | | Total operating expenses | $18,110 | $9,930 | | Loss from operations | $(18,110) | $(9,930) | | Other income (expense): | | | | Interest income | $2,250 | $1,636 | | Change in fair value of warrant liability | — | $(117) | | Other expense, net | $(130) | $(6) | | Total other income, net | $2,120 | $1,513 | | Net loss | $(15,990) | $(8,417) | | Comprehensive loss | $(15,891) | $(8,583) | | Net loss per share, basic and diluted | $(0.62) | $(3.55) | | Weighted-average shares outstanding | 25,868,935 | 2,369,067 | Condensed Balance Sheets As of March 31, 2025, Contineum Therapeutics reported total assets of $198.3 million, a decrease from $212.8 million at December 31, 2024. This change was primarily driven by a reduction in marketable securities. Total liabilities also decreased, while total stockholders' equity saw a slight reduction Condensed Balance Sheets | (in thousands USD) | March 31, 2025 | December 31, 2024 | | :--------------- | :------------- | :---------------- | | Assets: | | | | Cash and cash equivalents | $22,470 | $21,943 | | Marketable securities | $168,240 | $182,817 | | Total current assets | $192,134 | $206,388 | | Total assets | $198,264 | $212,847 | | Liabilities: | | | | Total current liabilities | $8,949 | $9,974 | | Total liabilities | $13,496 | $14,781 | | Stockholders' Equity: | | | | Additional paid-in-capital | $317,964 | $315,371 | | Accumulated deficit | $(133,392) | $(117,402) | | Total stockholders' equity | $184,768 | $198,066 | | Total liabilities and stockholders' equity | $198,264 | $212,847 | About Contineum Therapeutics Contineum Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel, oral small molecule therapies for neuroscience, inflammation, and immunology (NI&I) indications with significant unmet needs. Their pipeline includes PIPE-791, an LPA1 receptor antagonist, and PIPE-307, a selective M1 receptor inhibitor, both in clinical development for multiple indications - Contineum Therapeutics is a clinical-stage biopharmaceutical company pioneering novel, oral small molecule therapies for NI&I indications with significant unmet need[7] - PIPE-791 is an LPA1 receptor antagonist in clinical development for idiopathic pulmonary fibrosis, progressive multiple sclerosis, and chronic pain[7] - PIPE-307 is a selective inhibitor of the M1 receptor in clinical development for relapsing-remitting multiple sclerosis and major depressive disorder[7] Forward-Looking Statements & Contact This section contains forward-looking statements regarding the company's clinical trials, product development, financial outlook, and business strategies, which are subject to known and unknown risks and uncertainties. The company disclaims any obligation to update these statements. Contact information for investor relations is also provided - Forward-looking statements involve known and unknown risks, uncertainties, and other important factors that may cause actual results to differ materially[8] - The company undertakes no obligation to update publicly or revise any forward-looking statements, except as required by applicable law[8] - Contact information for Steve Kunszabo, Senior Director, Investor Relations & Corporate Communications, is provided[9]