Contineum Therapeutics, Inc.(CTNM) - 2025 Q2 - Quarterly Results

Company Overview and Q2 2025 Highlights Contineum Therapeutics, a clinical-stage biopharma, provided Q2 2025 updates on PIPE-307 and PIPE-791 trials, projecting cash runway into 2027 About Contineum Therapeutics Contineum Therapeutics is a clinical-stage biopharmaceutical company developing oral small molecule therapies for neuroscience, inflammation, and immunology - Contineum Therapeutics is a clinical-stage biopharmaceutical company focused on oral small molecule therapies in neuroscience, inflammation, and immunology (NI&I)[7] - Key drug candidates include PIPE-791 (LPA1 receptor antagonist for idiopathic pulmonary fibrosis, progressive multiple sclerosis, and chronic pain) and PIPE-307 (M1 receptor selective inhibitor for relapsing-remitting multiple sclerosis and major depressive disorder)[7] Q2 2025 Key Highlights Contineum Therapeutics reported Q2 2025 financial results and clinical updates, with key data readouts and trial initiations expected in Q4 2025 and cash runway into 2027 - Topline data from the PIPE-307 Phase 2 VISTA trial for relapsing-remitting multiple sclerosis (RRMS) is anticipated in Q4 2025[1][4][5] - A global Phase 2 proof-of-concept clinical trial for PIPE-791 in idiopathic pulmonary fibrosis (IPF) is planned to commence in Q4 2025[1][4][5] - The company's cash runway is projected to support operations into 2027[1][4][9] Key Clinical Development Milestones This section details progress for PIPE-307 and PIPE-791 programs, outlining expected data readouts and strategic adjustments to clinical development PIPE-307 Program Updates PIPE-307 shows progress in RRMS and MDD, with VISTA Phase 2 RRMS data expected in Q4 2025 and J&J initiating a Phase 2 MDD trial - Topline data from the PIPE-307 Phase 2 VISTA RRMS trial, evaluating safety, efficacy, and myelin regeneration endpoints, is anticipated in Q4 2025[4][5] - Johnson & Johnson initiated the Phase 2 Moonlight-1 trial for PIPE-307/JNJ-89495120 in major depressive disorder (MDD) in December 2024, assessing efficacy, safety, and tolerability as a monotherapy[5] PIPE-791 Program Updates PIPE-791 advances in IPF, PrMS, and chronic pain, with a global Phase 2 IPF trial planned for Q4 2025 and data readouts expected in Q3 2025 and H1 2026 - Regulatory submissions are underway for a global Phase 2 proof-of-concept clinical trial of PIPE-791 in idiopathic pulmonary fibrosis (IPF), with initiation expected in Q4 2025[4][5] - Topline data from the PIPE-791 Phase 1b PET trial, correlating pharmacokinetics with LPA1 receptor occupancy, is anticipated in Q3 2025[5] - Topline data from the exploratory Phase 1b trial of PIPE-791 for chronic pain (chronic osteoarthritis pain and chronic low back pain), which began patient dosing in March 2025, is expected in H1 2026[5] Strategic Program Prioritization The company has deferred the PIPE-791 PrMS Phase 2 trial and CTX-343's first-in-human study to focus internal clinical resources on the PIPE-791 IPF program - The initiation of the PIPE-791 Phase 2 clinical trial for progressive multiple sclerosis (PrMS) and the advancement of CTX-343 into first-in-human studies have been deferred[4][5] - This strategic decision aims to concentrate internal clinical resources on the PIPE-791 IPF program[4][5] Second-Quarter 2025 Financial Results This section presents Contineum Therapeutics' Q2 2025 financial performance, detailing cash position, increased R&D and G&A expenses, and expanded net loss Financial Highlights As of June 30, 2025, cash, cash equivalents, and marketable securities totaled $175.5 million, supporting operations into 2027, while R&D and G&A expenses increased, leading to a $16 million net loss Q2 2025 Financial Highlights | Metric | Q2 2025 (million USD) | Q2 2024 (million USD) | YoY Change | Change Rate | Notes | | :--- | :---: | :---: | :---: | :---: | :--- | | Cash, Cash Equivalents, and Marketable Securities (as of June 30) | 175.5 | N/A | N/A | N/A | Projected to support operations into 2027 | | Research & Development Expenses | 14.1 | 7.9 | +6.2 | +78% | Primarily due to PIPE-791 and PIPE-307 program advancements and increased personnel costs | | General & Administrative Expenses | 3.8 | 3.0 | +0.8 | +26% | Primarily due to stock-based compensation and increased personnel costs | | Net Loss | (16.0) | (9.0) | (7.0) | +78% | | - In July 2025, the company issued 2,122,000 shares of Class A common stock through an At-The-Market (ATM) offering, raising approximately $8.4 million in net proceeds at a weighted average price of $4.03 per share[9] Condensed Statements of Operations and Comprehensive Loss Contineum Therapeutics' total operating expenses significantly increased to $17.902 million in Q2 2025, resulting in an expanded net loss of $16.04 million and a basic and diluted net loss per share of $0.62 Condensed Statements of Operations and Comprehensive Loss (For the Three and Six Months Ended) | Metric (thousand USD) | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :---: | :---: | :---: | :---: | | Research & Development Expenses | 14,063 | 7,901 | 27,775 | 15,679 | | General & Administrative Expenses | 3,839 | 3,043 | 8,237 | 5,195 | | Total Operating Expenses | 17,902 | 10,944 | 36,012 | 20,874 | | Loss from Operations | (17,902) | (10,944) | (36,012) | (20,874) | | Interest Income | 2,029 | 2,001 | 4,279 | 3,637 | | Net Loss | (16,040) | (9,009) | (32,030) | (17,426) | | Comprehensive Loss | (16,063) | (9,078) | (31,954) | (17,661) | | Net Loss Per Share (Basic and Diluted) | (0.62) | (0.39) | (1.24) | (1.35) | | Weighted-Average Common Shares Outstanding | 25,895,996 | 23,355,588 | 25,882,540 | 12,862,328 | Condensed Balance Sheets As of June 30, 2025, Contineum Therapeutics' total assets decreased to $182.888 million, with declines in cash, marketable securities, total liabilities, and stockholders' equity Condensed Balance Sheets (As of) | Metric (thousand USD) | June 30, 2025 | December 31, 2024 | | :--- | :---: | :---: | | Cash and cash equivalents | 20,784 | 21,943 | | Marketable securities | 154,700 | 182,817 | | Total current assets | 176,839 | 206,388 | | Total assets | 182,888 | 212,847 | | Accounts payable | 2,001 | 1,811 | | Accrued expenses | 3,747 | 6,711 | | Total current liabilities | 7,214 | 9,974 | | Total liabilities | 11,498 | 14,781 | | Additional paid-in capital | 320,649 | 315,371 | | Accumulated deficit | (149,432) | (117,402) | | Total stockholders' equity | 171,390 | 198,066 | | Total liabilities and stockholders' equity | 182,888 | 212,847 | Forward-Looking Statements This press release contains forward-looking statements regarding clinical trials, product development, cash flow, and market opportunities, subject to risks including trial success, regulatory uncertainty, and economic conditions, with no obligation to update - Forward-looking statements cover clinical trials, product development plans, timelines, regulatory submissions, data release dates, cash runway, drug candidate indications, anticipated benefits, and market opportunities[8] - Key risks include high dependence on the success of PIPE-791 and PIPE-307, unpredictability of early clinical results, uncertainties in clinical trials and regulatory review, reliance on third parties for trials, and unstable market and economic conditions[8] - The company undertakes no obligation to update or revise any forward-looking statements, except as required by applicable law[8]