[Company Overview & Highlights](index=1&type=section&id=Company%20Overview%20%26%20Highlights) 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](index=1&type=section&id=Executive%20Summary) 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](index=1&type=chunk) - PIPE-791 chronic toxicity studies completed to support future Phase 2 trials[1](index=1&type=chunk) - Topline data from PIPE-307 Phase 2 VISTA trial for RRMS anticipated in the **second half of 2025**[1](index=1&type=chunk) - Cash runway projected through **2027**[1](index=1&type=chunk) [CEO Commentary](index=1&type=section&id=CEO%20Commentary) 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](index=3&type=chunk) - Focus on executing against clinical development objectives, supported by a **solid balance sheet** that extends through **2027**[3](index=3&type=chunk) [Key Clinical Development Milestones](index=1&type=section&id=Key%20Clinical%20Development%20Milestones) 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](index=1&type=section&id=PIPE-791%20Program%20Updates) 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](index=6&type=chunk) - Completed PIPE-791 chronic toxicity studies required to support future Phase 2 trials[6](index=6&type=chunk) - Plans to initiate Phase 2 proof-of-concept clinical trials in IPF and PrMS in the **second half of 2025**[6](index=6&type=chunk) - 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](index=6&type=chunk) [PIPE-307 Program Updates](index=1&type=section&id=PIPE-307%20Program%20Updates) 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](index=6&type=chunk) - 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](index=6&type=chunk) [CTX-343 Program Updates](index=1&type=section&id=CTX-343%20Program%20Updates) 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](index=6&type=chunk) [First-Quarter 2025 Financial Results](index=1&type=section&id=First-Quarter%202025%20Financial%20Results) 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](index=1&type=section&id=Financial%20Highlights) 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](index=9&type=chunk) - 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](index=9&type=chunk) - 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](index=9&type=chunk) [Condensed Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) 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](index=5&type=section&id=Condensed%20Balance%20Sheets) 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](index=2&type=section&id=About%20Contineum%20Therapeutics) 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](index=7&type=chunk) - PIPE-791 is an LPA1 receptor antagonist in clinical development for idiopathic pulmonary fibrosis, progressive multiple sclerosis, and chronic pain[7](index=7&type=chunk) - PIPE-307 is a selective inhibitor of the M1 receptor in clinical development for relapsing-remitting multiple sclerosis and major depressive disorder[7](index=7&type=chunk) [Forward-Looking Statements & Contact](index=2&type=section&id=Forward-Looking%20Statements%20%26%20Contact) 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](index=8&type=chunk) - The company undertakes no obligation to update publicly or revise any forward-looking statements, except as required by applicable law[8](index=8&type=chunk) - Contact information for Steve Kunszabo, Senior Director, Investor Relations & Corporate Communications, is provided[9](index=9&type=chunk)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Commission File Number: 001-42001 Contineum Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 27-1467257 (State or other jurisdiction of incorporation or organization) FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECU ...

Drug Development and Clinical Trials - The company is heavily dependent on the success of its lead drug candidates PIPE-791 and PIPE-307, which are in early clinical development stages [304]. - The company currently has no products approved for commercial sale and has invested a significant portion of its resources in the development of PIPE-791 and PIPE-307 [305]. - PIPE-791 is being developed for the treatment of IPF, PrMS, and chronic pain associated with OA and LBP, while PIPE-307 is being developed for RRMS and MDD [305]. - The company completed a Phase 1 clinical trial of PIPE-791 and received FDA authorization for a Phase 1b study in chronic pain [310]. - J&J began recruiting 124 adult participants for a Phase 2 trial of PIPE-307 for MDD in December 2024 [305]. - The regulatory approval process for PIPE-791 and PIPE-307 is lengthy and unpredictable, with no current NDA submissions made [318]. - Delays in clinical trials could increase costs and harm the commercial prospects of PIPE-791 and PIPE-307 [313]. - The company faces significant risks related to clinical trial outcomes, including potential failure to demonstrate safety and efficacy [312]. - The FDA or comparable foreign regulatory authorities may delay, limit, or deny approval of drug candidates such as PIPE-791 and PIPE-307, which could significantly harm the company's business and prospects [321]. - The company intends to explore additional indications for PIPE-791 beyond idiopathic pulmonary fibrosis (IPF), including chronic pain associated with osteoarthritis (OA) and low back pain (LBP) [323]. - The company has designated CTX-343 as a new drug candidate, focusing on a peripherally-restricted LPA1R antagonist [323]. - The company has previously conducted clinical trials outside the United States, including a Phase 1 clinical trial of PIPE-307 in Australia and a Phase 1b PET study in the United Kingdom [327]. - The company may face challenges in enrolling and retaining patients for clinical trials, which could lead to increased costs and program delays [331]. - The company acknowledges that interim and preliminary data from clinical trials may change as more patient data becomes available, impacting business prospects [333]. - The company may not be successful in identifying additional therapeutic opportunities or developing suitable drug candidates due to limited resources [326]. - Regulatory authorities may require additional clinical testing or may not accept data from trials conducted outside the United States, potentially delaying development plans [327]. - The company must prioritize a limited number of drug candidates due to financial constraints, which may result in missed opportunities [325]. - The approval policies or regulations of the FDA or comparable foreign regulatory authorities may change, rendering clinical data insufficient for approval [324]. - The administration of PIPE-791 and PIPE-307 may cause serious adverse events, potentially halting clinical development and delaying marketing approval [336]. - If approved, undesirable side effects could lead to market withdrawal, additional warnings, or restrictions on sales [337]. - Regulatory authorities may require product recalls or impose additional restrictions on marketing and manufacturing processes [338]. - The market opportunities for PIPE-791 and PIPE-307 may be smaller than anticipated, limiting commercial opportunities [342]. - The company has never obtained marketing approval for any drug candidate, which may delay revenue generation [343]. - Approval by the FDA does not guarantee approval in other jurisdictions, limiting market potential [344]. - Regulatory requirements can vary widely, potentially delaying product introduction in international markets [346]. - Even with marketing approval, ongoing regulatory obligations may result in significant additional expenses [347]. - The company may seek breakthrough therapy or orphan drug designation for PIPE-791, but such designations do not guarantee faster approval [352]. - Orphan drug designation may provide financial incentives but does not shorten development or review times [353]. - The company expects to incur substantial additional operating losses over the next several years as it develops PIPE-791 and completes the Phase 2 clinical trial for PIPE-307 [364]. Financial and Operational Risks - The company has incurred significant operating expenses since inception and anticipates continued increases, potentially impacting profitability [362]. - Future funding requirements will depend on various factors, including the costs associated with clinical trials for PIPE-791 and PIPE-307 [371]. - The company may require significant additional capital to complete development activities and implement commercialization plans, which may not be available on acceptable terms [373]. - The FDA's accelerated approval pathway does not guarantee faster development or marketing approval for drug candidates [356]. - The company may face substantial liabilities from product liability lawsuits, which could limit commercialization efforts [357]. - The company has not demonstrated the ability to manufacture a commercial-scale product or conduct necessary sales and marketing activities [367]. - The company plans to expand product development programs and may seek regulatory approvals for multiple drug candidates [366]. - The company may need to relinquish valuable rights or grant licenses on unfavorable terms if it raises funds through future licensing arrangements [373]. - If the collaboration with J&J does not succeed, the company may not receive any future milestone or royalty payments, adversely impacting its financial condition [379]. - The company may seek additional strategic alliances or collaborations to support the development of PIPE-791 and other drug candidates, which could involve significant operational and financial risks [380]. - The company faces competition in establishing future collaborations, as potential partners may view its drug candidates as too early in development [381]. - The company may pursue in-licensing or acquisition transactions for drug candidates or complementary products, which could involve significant costs and risks [386]. Intellectual Property and Legal Risks - The company’s ability to protect its intellectual property is crucial for its success, as competitors could develop similar technologies if protection is insufficient [388]. - The patent prosecution process is complex and costly, and the company may not be able to maintain or enforce all necessary patent rights [390]. - The company’s patent rights may be challenged, which could reduce their scope or invalidate them, allowing competitors to commercialize similar technologies [393]. - Patent terms for drug candidates may be inadequate, with a typical lifespan of 20 years from the earliest filing date, potentially exposing the company to competition from generics or biosimilars shortly after commercialization [395]. - The Hatch-Waxman Act allows for a patent term extension of up to 5 years, but extensions cannot exceed a total of 14 years from the date of product approval, creating uncertainty regarding the duration of market exclusivity [397]. - The company may not be granted patent term extensions due to various factors, including failure to meet application deadlines or requirements, which could materially harm its business [398]. - Changes in patent laws, such as the Leahy-Smith America Invents Act, could increase uncertainties and costs related to patent prosecution and enforcement, adversely affecting the company's financial condition [400]. - Recent U.S. Supreme Court rulings have narrowed patent protection, creating uncertainty regarding the validity and enforceability of patents, which could impact the company's ability to protect its intellectual property [401]. - The company may face challenges in obtaining necessary licenses from third parties for patented technology, which could hinder the development or commercialization of drug candidates [403]. - If the company fails to comply with license agreements, it may face termination of these agreements, adversely affecting the development and marketing of drug candidates [405]. - The company may become involved in costly and time-consuming litigation to protect its intellectual property rights, which could distract management and impact financial resources [406]. - Adverse outcomes in legal proceedings could result in the invalidation of patents or restrict the company's ability to use certain technologies, significantly harming its business prospects [407]. - The company may face infringement claims from third parties, which could lead to substantial damages or the need to redesign products, impacting its ability to commercialize drug candidates [414]. Manufacturing and Supply Chain Risks - The company relies on third-party CMOs for the production of clinical supplies of PIPE-791 and PIPE-307, which may impair the development and commercialization of drug candidates [435]. - The company does not own manufacturing facilities for PIPE-791, PIPE-307, or any drug candidates in development, increasing reliance on CMOs [435]. - If the current CMO, WuXi AppTec, experiences delays, the company may not have sufficient quantities of PIPE-791 for clinical trials, negatively impacting development timelines [435]. - Transitioning to a new CMO is time-consuming and costly, which could further delay clinical trials and commercial launches [435]. - The company relies on third-party suppliers for APIs and raw materials, which may face supply interruptions, potentially delaying clinical trials or commercial launches [436]. - Manufacturing facilities for drug candidates must comply with FDA regulations, and any deficiencies could lead to significant delays in development and regulatory approval [439]. - The company is subject to risks related to patent exclusivity and potential infringement on others' patents, which could impact commercialization efforts [438]. - The company relies heavily on contract research organizations (CROs) for clinical trials, and any failure by these parties to meet obligations could harm regulatory approval and commercialization [442]. - Compliance with Good Clinical Practices (GCP) is essential, and any violations could lead to unreliable clinical data and additional trials being required [446]. - The company faces risks related to the potential unauthorized disclosure of intellectual property by CROs, which could harm competitive positioning [451]. - Transitioning to new CROs involves significant costs and time, which may impact preclinical development timelines [452]. - The company must ensure that all clinical trials are conducted according to applicable protocols and regulatory standards, or face potential enforcement actions [445]. - The manufacturing of the API for PIPE-791 is solely dependent on a third-party manufacturer located in China, exposing the company to significant risks related to production disruptions and increased costs due to geopolitical factors [454]. - The company relies on third-party contract manufacturing organizations (CMOs) for the production of clinical supplies, which may impair the development and commercialization of drug candidates, adversely impacting the business and financial position [454]. Regulatory and Compliance Risks - Recent healthcare legislation, including the Inflation Reduction Act of 2022, introduces price negotiation for certain high-spend Medicare drugs starting in 2026, which could negatively affect the company's profitability and future revenues [460]. - The Budget Control Act of 2011 has resulted in Medicare payment reductions, currently set at 2%, increasing to 4% by fiscal year 2031, which may impact the company's financial condition [458]. - The company faces potential penalties and civil monetary fines for non-compliance with healthcare laws and regulations, which could significantly harm its business operations and reputation [455]. - Legislative changes at the state level may establish upper payment limits for high-cost drugs, potentially reducing demand or pricing for the company's drug candidates [461]. - The company is subject to risks associated with misconduct by employees and contractors, which could lead to regulatory sanctions and significant financial penalties [455]. - The evolving healthcare policies may increase the difficulty and costs associated with obtaining marketing approval for drug candidates, adversely affecting commercialization efforts [457]. - The company is exposed to risks from tariffs and export controls affecting products manufactured in China, which could disrupt supply chains and increase operational costs [454]. - Future changes in healthcare regulations may lead to reduced funding for Medicare and other healthcare programs, negatively impacting the company's revenues and operational results [460]. - The company faces potential challenges under U.S. federal laws such as the False Claims Act (FCA) and the Anti-Kickback Statute (AKS), which could lead to substantial costs for compliance and potential penalties [465]. - Non-compliance with healthcare laws may result in civil, criminal, and administrative penalties, including potential treble damages and exclusion from federal healthcare programs [468]. - The company is subject to the General Data Protection Regulation (GDPR) in the European Economic Area, which imposes strict operational requirements and potential fines of up to €20 million or 4% of total worldwide annual revenue [469]. - Compliance with the GDPR and local laws is expected to be costly and time-consuming, requiring substantial resources [470]. - The company is subject to various U.S. and foreign anti-corruption and trade laws, which prohibit corrupt payments and could result in significant penalties for violations [473]. Human Resources and Management Risks - The company relies heavily on key personnel, and losing any of them could severely impact its ability to implement business strategies successfully [477]. - Competition for hiring qualified personnel in the biotechnology and pharmaceutical sectors is intense, which may hinder the company's ability to attract and retain talent [478]. - The company engages consultants and advisors for research and development strategies, but their availability may be limited due to commitments to other organizations [479]. - The company anticipates significant growth in employee numbers and operational scope, particularly in clinical development, regulatory affairs, and sales and marketing [480]. - The company may face challenges in managing growth due to limited financial resources and management experience, which could disrupt operations [480]. Security and Operational Risks - The company has not experienced any material security breaches to date, but potential breaches could lead to significant costs and operational disruptions [482]. - The company relies on third parties for drug manufacturing and clinical trials, making it vulnerable to system failures that could delay research and development programs [481]. - The company faces intense competition from large pharmaceutical and biotechnology companies, which could adversely affect its operating results [485]. - The company is aware of multiple competitors developing drug candidates for indications it is pursuing, including IPF and MS [487][488]. Market Access and Commercialization Risks - The successful commercialization of PIPE-791 and PIPE-307 will depend on obtaining adequate coverage and reimbursement from governmental and private payors [501]. - The company currently lacks sales and marketing capabilities and must either build its own team or collaborate with third parties for commercialization [497][498]. - Failure to achieve market acceptance for PIPE-791 or PIPE-307 could significantly harm the company's business and financial condition [495][496]. - The company must navigate regulatory approval processes and market dynamics to ensure the successful launch of its drug candidates [496].

[Report Highlights and CEO Commentary](index=1&type=section&id=Report%20Highlights%20and%20CEO%20Commentary) Contineum Therapeutics reported Q4 2024 results, highlighting 2025 as a pivotal year with key clinical data readouts and a projected cash runway into 2027 - The company anticipates sponsoring up to **six clinical trials** during 2025, marking it as a pivotal year[2](index=2&type=chunk) - Key topline data is expected from the PIPE-791 Phase 1b PET trial in **Q2 2025** and the PIPE-307 Phase 2 VISTA trial in **H2 2025**[1](index=1&type=chunk)[2](index=2&type=chunk) - The company projects its cash runway will fund operations through critical milestones in **2027**[1](index=1&type=chunk)[2](index=2&type=chunk) [Key Clinical Development Milestones & Outlook](index=1&type=section&id=Key%20Clinical%20Development%20Milestones%20%26%20Outlook) The company detailed its clinical pipeline, anticipating key data readouts for PIPE-791 and PIPE-307 in 2025, alongside new trial initiations and IND filings - **PIPE-791:** Topline data from the Phase 1b PET trial is expected in **Q2 2025** Phase 2 trials for idiopathic pulmonary fibrosis (IPF) and progressive multiple sclerosis (PrMS) are planned for **H2 2025**, pending successful completion of chronic toxicity studies[5](index=5&type=chunk) - **PIPE-307:** Topline data from the Phase 2 VISTA trial for relapsing-remitting multiple sclerosis (RRMS) is anticipated in **H2 2025**[5](index=5&type=chunk) - **Partnered Program:** Johnson & Johnson began recruiting for a Phase 2 trial of PIPE-307 (JNJ-89495120) for major depressive disorder (MDD) in **December 2024**[5](index=5&type=chunk) - **New Program:** The company plans to file an Investigational New Drug (IND) application for CTX-343 with the FDA in the **second half of 2025**[5](index=5&type=chunk) [Fourth-Quarter 2024 Financial Results](index=1&type=section&id=Fourth-Quarter%202024%20Financial%20Results) Contineum reported a Q4 2024 net loss of $14.6 million due to increased R&D expenses, ending the year with $204.8 million in cash Q4 2024 Financial Performance | Metric | Q4 2024 | Q4 2023 | Change | | :--- | :--- | :--- | :--- | | Research and Development Expenses | $13.0M | $8.0M | +62% | | General and Administrative Expenses | $4.0M | $1.7M | +$2.3M | | Net Loss | $14.6M | $7.8M | Increased Loss | - Cash, cash equivalents, and marketable securities totaled **$204.8 million** as of December 31, 2024[8](index=8&type=chunk) - The company projects full-year 2025 R&D expenses will be **significantly higher** than in 2024 due to increased clinical development activity[8](index=8&type=chunk) [Financial Statements](index=4&type=section&id=Financial%20Statements) Detailed financial statements reveal a significant increase in cash and total assets, alongside a shift to positive stockholders' equity by December 31, 2024 [Balance Sheets](index=4&type=section&id=BALANCE%20SHEETS) Balance sheets show total assets increased to $212.8 million and stockholders' equity turned positive to $198.1 million by December 31, 2024 Balance Sheet Summary | Account (in thousands) | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Cash, cash equivalents & marketable securities | $204,760 | $125,190 | | **Total Assets** | **$212,847** | **$130,386** | | Total Liabilities | $14,781 | $5,702 | | **Total Stockholders' Equity (Deficit)** | **$198,066** | **($67,936)** | [Statements of Operations and Comprehensive Income (Loss)](index=5&type=section&id=STATEMENTS%20OF%20OPERATIONS%20AND%20COMPREHENSIVE%20INCOME%20(LOSS)) Q4 2024 net loss widened to $14.6 million, and full-year 2024 saw a $42.3 million net loss, primarily due to increased R&D expenses and no license revenue Q4 2024 Operations Summary | Metric (in thousands, except per share data) | Q4 2024 | Q4 2023 | | :--- | :--- | :--- | | Total operating expenses | $17,047 | $9,676 | | **Net loss** | **($14,565)** | **($7,769)** | | **Net loss per share, basic** | **($0.56)** | **($3.32)** | Full Year 2024 Operations Summary | Metric (in thousands) | Full Year 2024 | Full Year 2023 | | :--- | :--- | :--- | | License revenue | $0 | $50,000 | | Research and development | $38,422 | $27,603 | | **Net income (loss)** | **($42,258)** | **$22,720** |

Financial Performance - The company reported a total research and development expense of $9.728 million for the three months ended September 30, 2024, compared to $6.499 million for the same period in 2023, reflecting a 49% increase [100]. - License revenue for the nine months ended September 30, 2024, was $0, a decrease of $50.0 million compared to the same period in 2023 [110]. - Research and development expenses increased to $25.4 million for the nine months ended September 30, 2024, from $19.6 million in 2023, an increase of $5.8 million [111]. - General and administrative expenses rose to $8.4 million for the nine months ended September 30, 2024, compared to $4.7 million in 2023, an increase of $3.8 million [112]. - Interest income increased to $6.4 million for the nine months ended September 30, 2024, from $2.8 million in 2023, an increase of $3.6 million [113]. - Net cash used in operating activities was $22.6 million for the nine months ended September 30, 2024, compared to a net cash provided of $30.1 million in 2023 [122]. - Net cash used in investing activities was $60.4 million for the nine months ended September 30, 2024, compared to $74.6 million in 2023 [123]. - Net cash provided by financing activities was $108.4 million for the nine months ended September 30, 2024, compared to $56.5 million in 2023 [124]. - As of September 30, 2024, the company had cash, cash equivalents, and marketable securities totaling $213.9 million [118]. - The accumulated deficit as of September 30, 2024, was $102.8 million [117]. Research and Development - PIPE-791, the lead asset, is in development for idiopathic pulmonary fibrosis (IPF) and progressive multiple sclerosis (Progressive MS), with a Phase 1 clinical trial completed and a Phase 1b trial application submitted in September 2024 [86]. - PIPE-307, the second drug candidate, is being developed for depression and relapse-remitting multiple sclerosis (RRMS), with two Phase 1 trials completed and a Phase 2 trial named VISTA currently underway [87]. - The company has incurred direct external development program expenses of $3.214 million for PIPE-307 in Q3 2024, compared to $1.159 million in Q3 2023, indicating a 177% increase [100]. - The company is actively conducting preclinical studies for CTX-343, a peripherally-restricted LPA1R antagonist, as part of its drug discovery efforts [88]. - The company expects to incur substantial expenditures as it advances its drug candidates through clinical development and regulatory approval processes [116]. - The company expects operating expenses to significantly increase due to ongoing development and regulatory approvals for drug candidates, with existing cash and marketable securities projected to support operations for at least 12 months [125]. Licensing and Agreements - The company received an upfront payment of $50 million from Johnson & Johnson (J&J) in May 2023 as part of the licensing agreement for PIPE-307, with potential milestone payments totaling approximately $1 billion [95]. - The company has the option to fund a portion of Phase 3 and subsequent development costs for PIPE-307, which could increase the royalties received from J&J by one to two percentage points [92]. Future Outlook and Financing - Future capital requirements will depend on various factors including clinical trial costs, regulatory review outcomes, and manufacturing expenses [126]. - The company may finance cash needs through public or private equity or debt financings, which could dilute existing stockholder ownership [128]. - The company may need to delay or limit product development if unable to raise additional funds through equity or debt financings [128]. Accounting and Compliance - The company is classified as an "emerging growth company" and will use an extended transition period for new accounting standards until certain revenue or market value thresholds are met [133]. - The company is also a "smaller reporting company," allowing it to take advantage of scaled disclosures as long as certain market value and revenue conditions are satisfied [134]. - The company has made significant estimates and judgments in preparing financial statements, which may differ from actual results [131]. - The company has no material changes to critical accounting estimates since the last report [132]. - The company has no off-balance sheet arrangements as defined under SEC rules [130]. Operating Expenses - Total operating expenses are expected to significantly increase as the company continues to develop its drug candidates and expand operations, with net losses anticipated to fluctuate based on clinical trial timing and scope [89]. - The company anticipates that general and administrative expenses will increase to support research and development activities and compliance with public company regulations [105]. - Total contractual commitments for lease agreements amount to approximately $7.8 million as of September 30, 2024 [129].

Financial Position - Contineum Therapeutics reported a strong cash position of $214 million at the end of Q3 2024, expected to support operations through 2027[1]. - Contineum's total assets increased to $216 million as of September 30, 2024, compared to $130.4 million at the end of 2023[9]. Clinical Trials and Development - As of September 30, 2024, Contineum achieved two-thirds enrollment in its VISTA trial for PIPE-307, ahead of initial projections, with full enrollment expected in the first half of 2025[2]. - Contineum plans to initiate a Phase 1b open-label clinical trial of PIPE-791 in December 2024, pending authorization from the MHRA[3]. - The company anticipates multiple potential clinical readouts in 2025, supported by its strong cash balance[2]. - Contineum expects to nominate a development candidate from its discovery portfolio by the end of 2024[4]. - The company has a pipeline focused on high unmet needs in neuroscience, inflammation, and immunology indications[7]. Expenses and Losses - Research and development expenses increased to $9.7 million in Q3 2024, up from $6.5 million in Q3 2023, primarily due to ongoing clinical trials and toxicology studies[5]. - General and administrative expenses rose to $3.3 million in Q3 2024, compared to $1.6 million in Q3 2023, driven by increases in stock-based compensation and personnel-related expenses[6]. - The net loss for Q3 2024 was $10.3 million, compared to a net loss of $6.3 million in Q3 2023[10].

Research and Development - The company reported a total research and development expense of $7.9 million for the three months ended June 30, 2024, compared to $9.5 million for the same period in 2023, reflecting a decrease of approximately 16.5%[96] - PIPE-791, the lead asset, is in development for idiopathic pulmonary fibrosis (IPF) and progressive multiple sclerosis (Progressive MS), with plans to submit a clinical trial application for a Phase 1b trial in 2024[82] - PIPE-307, the second drug candidate, has completed two Phase 1 trials and has initiated a Phase 2 trial for relapse-remitting multiple sclerosis (RRMS), making it the most clinically advanced selective M1R antagonist[83] - The company anticipates that its research and development expenses will increase substantially in connection with planned preclinical and clinical development activities[98] - The company has incurred direct external development program expenses of $2.3 million for PIPE-307 in the first half of 2024, compared to $1.3 million in the same period of 2023, indicating an increase of approximately 75%[96] - The company is leveraging its drug discovery capabilities and has commenced preclinical studies for CTX-343, a peripherally-restricted LPA1R antagonist targeting other NI&I indications[84] - Research and development expenses decreased to $7.9 million for the three months ended June 30, 2024, from $9.5 million in 2023, a reduction of $1.6 million[104] - Research and development expenses for the six months ended June 30, 2024, were $15.7 million, up from $13.1 million in 2023, an increase of $2.6 million[111] Financial Performance - License revenue for the three months ended June 30, 2024, was $0, compared to $50.0 million for the same period in 2023, resulting in a decrease of $50.0 million[103] - The net loss for the three months ended June 30, 2024, was $9.0 million, compared to a net income of $41.6 million for the same period in 2023, a decrease of $50.6 million[103] - For the six months ended June 30, 2024, license revenue was $0, down from $50.0 million in 2023, a decrease of $50.0 million[110] - Interest income rose to $2.0 million for the three months ended June 30, 2024, compared to $0.7 million in 2023, an increase of $1.3 million[106] - General and administrative expenses increased to $3.0 million for the three months ended June 30, 2024, from $1.6 million in 2023, an increase of $1.4 million[105] Cash Flow and Financing - As of June 30, 2024, the company had cash, cash equivalents, and marketable securities totaling $218.7 million[116] - The company raised approximately $107.9 million in net proceeds from its IPO in April 2024[115] - Net cash used in operating activities was $16.5 million for the six months ended June 30, 2024, compared to $35.4 million provided in the same period of 2023[120] - Net cash used in investing activities was $30.2 million for the six months ended June 30, 2024, primarily due to $99.6 million in purchases of marketable securities[121] - Net cash provided by financing activities was $108.3 million for the six months ended June 30, 2024, mainly from $108.2 million in net proceeds from the issuance of common stock in the IPO[122] - The company expects to finance operations through public and private sales of equity, debt financings, or other commercial arrangements, but there is no assurance that additional financing will be available on acceptable terms[86] - The company may finance cash needs through public or private equity or debt financings, which could dilute existing stockholders' ownership[126] Future Outlook - Total operating expenses are expected to significantly increase as the company continues to develop its drug candidates and expand operations[85] - The company expects to incur substantial expenditures as it advances its drug candidates through clinical development and regulatory approval processes[114] - The company anticipates that existing cash, cash equivalents, and marketable securities will be sufficient to support operations for at least 12 months from the date of the report[123] - Future capital requirements will depend on the progress and costs of clinical trials and regulatory reviews[124] Licensing and Agreements - The company received an upfront payment of $50 million from Johnson & Johnson (J&J) in May 2023 as part of the licensing agreement for PIPE-307, with potential milestone payments totaling approximately $1 billion[91] - The J&J License Agreement allows for tiered royalties in the low-double digit to high-teen percent range on net sales of products containing PIPE-307[91] Company Classification - The company is classified as an "emerging growth company" and a "smaller reporting company," allowing it to take advantage of scaled disclosures[131][132] - There were no off-balance sheet arrangements during the periods presented[128]

Financial Position - Contineum Therapeutics reported a strong cash position of $218.7 million as of June 30, 2024, up from $125.2 million at the end of 2023, supporting multiple clinical readouts[8] - The total assets of Contineum increased to $221.4 million as of June 30, 2024, compared to $130.4 million at the end of 2023[14] - The company completed its initial public offering (IPO) in April 2024, resulting in net proceeds of $107.9 million[8] Research and Development - Research and development expenses decreased to $7.9 million for Q2 2024, down from $9.5 million in Q2 2023, primarily due to a $4.8 million decrease in consulting and manufacturing expenses[9] - Research and development expenses for the six months ended June 30, 2024, were $15,679, up from $13,092 in the same period in 2023[15] - PIPE-307, a selective inhibitor of the M1 receptor, is being developed for relapsed-remitting multiple sclerosis (RRMS) and is expected to initiate a Phase 1b trial for PIPE-791 in Q4 2024[2] - Enrollment in the Phase 2 VISTA clinical trial for PIPE-307 is on track, with completion expected in 2025[4] - PIPE-791, an LPA1 receptor antagonist, showed promising preclinical results in treating neuropathic pain, presented at the IASP World Congress on Pain[6] - The company has a pipeline of drug candidates targeting high unmet needs in neuroscience, inflammation, and immunology indications[11] Operating Expenses - General and administrative expenses increased to $3.0 million for Q2 2024, compared to $1.6 million in Q2 2023, driven by a $0.6 million increase in consulting expenses and a $0.7 million increase in personnel costs[10] - Total operating expenses for the three months ended June 30, 2024, were $10,944, a decrease from $11,063 in the previous quarter[15] Income and Loss - Net loss for the three months ended June 30, 2024, was $(9,009), compared to a net income of $41,564 for the same period in 2023[15] - Net income per share, basic, for the three months ended June 30, 2024, was $(0.39), compared to $2.56 for the same period in 2023[15] - Comprehensive loss for the three months ended June 30, 2024, was $(9,078), compared to a comprehensive income of $41,508 for the same period in 2023[15] - Income (loss) from operations for the three months ended June 30, 2024, was $(10,944), compared to $38,937 in the previous quarter[15] Other Income - License revenue for the six months ended June 30, 2024, was $50,000, compared to $50,000 for the same period in 2023[15] - Interest income for the three months ended June 30, 2024, was $2,001, compared to $679 in the previous quarter[15] - Total other income for the three months ended June 30, 2024, was $1,935, compared to $3,356 in the previous quarter[15] Leadership - Contineum appointed experienced biotech leaders to its Board of Directors, including Troy Ignelzi and Sarah Boyce, enhancing its leadership team[2]

Financial Performance - Net loss for Q1 2024 was $8.4 million, up from a net loss of $4.8 million in Q1 2023, representing a 75% increase in losses[138]. - Cash used in operating activities was $8.0 million in Q1 2024, compared to $5.2 million in Q1 2023, indicating a 54% increase in cash outflow[138]. - Interest income grew to $1.6 million in Q1 2024 compared to $0.4 million in Q1 2023, reflecting a 300% increase due to higher investments in marketable securities[130]. - General and administrative expenses rose to $2.2 million in Q1 2024 from $1.5 million in Q1 2023, an increase of 47%[129]. - Research and development expenses increased to $7.8 million in Q1 2024 from $3.6 million in Q1 2023, a rise of 114%[128]. Funding and Financial Position - The company raised approximately $194.0 million from the issuance of convertible preferred stock and promissory notes, along with a $50.0 million upfront payment from the J&J License Agreement[133]. - As of March 31, 2024, the company had cash, cash equivalents, and marketable securities totaling $117.9 million[134]. - The company anticipates that existing cash and marketable securities will be sufficient to support operations for at least 12 months from the date of the report[134]. - The total contractual commitments for lease agreements amounted to approximately $7.8 million as of March 31, 2024[147]. Research and Development - Total research and development costs for the three months ended March 31, 2024, were $7.778 million, a significant increase from $3.632 million in the same period of 2023[120]. - PIPE-791's development is supported by preclinical studies and Phase 1 data, with plans to submit a clinical trial application in 2024 for a Phase 1b trial[104]. - PIPE-307 is in a Phase 2 trial for relapse-remitting multiple sclerosis (RRMS) and is the most clinically advanced selective M1R antagonist in development[105]. - The company has completed two Phase 1 trials of PIPE-307 and is conducting a Phase 2 trial at its own expense[113]. - The company plans to leverage its drug discovery capabilities with preclinical studies for CTX-343, a peripherally-restricted LPA1R antagonist[106]. - The company expects substantial increases in research and development expenses in connection with planned preclinical and clinical development activities[121]. - The company expects to incur substantial expenses related to clinical trials and product development activities in the near term[132]. Operational Expectations - The company expects operating expenses to significantly increase as it continues clinical trials and seeks regulatory approvals for its drug candidates[108]. - The company anticipates that general and administrative expenses will rise due to increased research and development activities and operating as a public company[124]. - The company may need to delay or reduce product development if additional funding is not obtained, which could adversely affect its business[109]. Internal Controls - As of March 31, 2024, the company's disclosure controls and procedures were evaluated as effective at the reasonable assurance level by the principal executive officer and principal financial officer[157]. - There have been no changes in the internal control over financial reporting during the quarter ended March 31, 2024, that materially affected or are likely to materially affect the internal control over financial reporting[158].

Financial Performance - Contineum completed its initial public offering (IPO) in April 2024, resulting in net proceeds of $108.0 million, increasing its proforma cash balance to $225.9 million as of March 31, 2024, which is expected to fund operations until the end of 2027[3] - Research and development expenses for Q1 2024 were $7.8 million, a 115% increase from $3.6 million in Q1 2023, primarily due to increased development activities[9] - General and administrative expenses rose to $2.2 million in Q1 2024 from $1.5 million in Q1 2023, reflecting a 47% increase driven by higher consulting and personnel costs[10] - The net loss for Q1 2024 was $8.4 million, compared to a net loss of $4.8 million in Q1 2023, indicating a 75% increase in losses year-over-year[15] - Contineum's cash, cash equivalents, and marketable securities decreased to $117.9 million as of March 31, 2024, down from $125.2 million at the end of 2023[8] Clinical Development - The company initiated a Phase 2 trial of PIPE-307 in relapse-remitting multiple sclerosis (RRMS) and plans to start a Phase 1b trial of PIPE-791 in Q4 2024[2] - Contineum nominated a third development candidate, CTX-343, in January 2024, with preclinical studies underway and an Investigational New Drug Application (IND) expected to be submitted in 2025[5] - The Phase 1 clinical trial of PIPE-791 met its primary and secondary objectives, demonstrating safety and tolerability, with plans for a Phase 1b trial to assess pharmacokinetics[4] - The company presented positive LPA1 expression data for PIPE-791 at the Myelin Gordon Conference, supporting its clinical development in progressive multiple sclerosis[6] Leadership Changes - Contineum appointed Olivia Ware to its Board of Directors, bringing over 20 years of experience in pharmaceutical drug development and commercialization[7]