Contineum Therapeutics, Inc. (CTNM) closed the last trading session at $6.73, gaining 67% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $22.6 indicates a 235.8% upside potential.The mean estimate comprises five short-term price targets with a standard deviation of $4.93. While the lowest estimate of $16.00 indicates a 137.7% increase from the current price level, the most optimis ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 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 June 30, 2025 Delaware 27-1467257 (I.R.S. Employer Identification No.) (858) 333-5280 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission File Number: 001-42001 Contineum Therapeu ...

Exhibit 99.1 CONTINEUM THERAPEUTICS REPORTS SECOND-QUARTER 2025 FINANCIAL RESULTS; UPDATES KEY CLINICAL DEVELOPMENT MILESTONES - Topline data from the PIPE-307 Phase 2 VISTA trial for the treatment of relapsing-remitting multiple sclerosis (RRMS) is anticipated in the fourth quarter of 2025 - Initiation of a global Phase 2 proof-of-concept clinical trial of PIPE-791 in idiopathic pulmonary fibrosis (IPF) in the fourth quarter of 2025 - Cash runway projected to fund operations through 2027 SAN DIEGO – August ...

Summary of Contineum Therapeutics (CTNM) 2025 Conference Call Company Overview - **Company**: Contineum Therapeutics (CTNM) - **Focus**: Development of LPA1 receptor antagonists for indications including Idiopathic Pulmonary Fibrosis (IPF) and Multiple Sclerosis (MS) Key Points Industry and Product Development - **LPA1 Receptor Antagonists**: The company is developing a molecule, referred to as type 791, which has a unique pharmacokinetic profile allowing for prolonged target coverage and high receptor occupancy [4][6][10] - **Clinical Trials**: The company plans to initiate a Phase II study for IPF and MS, with a focus on receptor occupancy data expected to be released by the end of the current quarter [7][11] - **Market Position**: CTNM aims to differentiate itself in a competitive market with multiple LPA receptor antagonists by demonstrating superior receptor occupancy and safety profiles [15][16] Clinical Data and Results - **Phase II Study Results**: Previous studies indicated a 46-47% change in FPC in Phase II, but the lowest dose tested showed no difference from placebo [2][3] - **Receptor Occupancy Studies**: The company is set to release data on receptor occupancy, which is critical for determining effective dosing for upcoming Phase II and III studies [5][7] - **Challenges in Interpretation**: Differences in receptor occupancy between brain and lung tissues are acknowledged, with a focus on maximizing receptor occupancy in both areas [8][9] Leadership and Strategy - **New Chief Medical Officer**: The recruitment of Tim Watkins, with extensive experience in IPF and immunology, is expected to enhance the company's clinical strategy and regulatory approach [11][12] - **Regulatory Path**: The company is cautious about the design of its studies, preferring longer study durations to ensure data reliability [13][14] Future Directions - **Multiple Indications**: The company is exploring the use of type 791 in MS, focusing on its potential to impact remyelination and inflammation [17][18] - **Chronic Pain Studies**: CTNM is also investigating the role of LPA1 antagonism in chronic pain, with a Phase Ib study currently underway [19][20][21] - **Pipeline Programs**: The company is advancing other programs, including type 307 for relapsing remitting MS, with a focus on remyelination [27][28] Financial Position - **Funding**: As of the end of the last quarter, the company reported $191 million in cash, which is expected to fund operations through the end of 2027 [42] Intellectual Property - **Patent Status**: All compounds in development are internally generated, with specific patents covering the composition and polymorphs of type 307 and type 791 [40][41] Market Outlook - **Unmet Needs**: The company acknowledges the presence of existing treatments but emphasizes the unmet medical needs in the IPF and MS markets, positioning itself to address these gaps [15][16] Additional Insights - **Exploratory Studies**: The company is conducting exploratory studies in chronic pain, emphasizing the importance of both central and peripheral mechanisms in pain management [22][24][26] - **Collaboration with J&J**: CTNM has partnered with Johnson & Johnson for the development of type 307, which is being explored for its potential in treating major depressive disorder [33][35] This summary encapsulates the key discussions and insights from the conference call, highlighting the strategic direction, clinical developments, and market positioning of Contineum Therapeutics.

Pipeline Overview - Contineum Therapeutics is advancing internally-developed treatments for neuroscience, inflammation, and immunology indications[6] - The company's pipeline includes PIPE-791 (LPA1R antagonist) for IPF, PrMS, and chronic pain, CTX-343 (LPA1R antagonist) for peripheral indications, and PIPE-307 (M1R antagonist) for RRMS and MDD[8] - Contineum expects to have cash runway through 2027 to support key milestones[6] PIPE-791 (LPA1R Antagonist) - PIPE-791 is being developed for Idiopathic Pulmonary Fibrosis (IPF), a disease affecting over 130,000 patients in the US and 3 million patients globally[13] - In a bleomycin-induced in vivo lung fibrosis model, PIPE-791 at 03 mg/kg showed maximal effect with once-daily dosing, reducing lung collagen[28] - Phase 1 healthy volunteer trials showed no dose-limiting adverse events or toxicity[34] - PIPE-791 achieved EC50 and EC90 receptor occupancy at 24-hour trough after a single 1 mg dose[37] - PIPE-791 is also being developed for Progressive Multiple Sclerosis (PrMS), which affects over 750,000 patients globally[45] PIPE-307 (M1R Antagonist) - Contineum has a partnering agreement with J&J for PIPE-307, potentially worth over $1 billion, for all indications[73, 75] - Phase 2 VISTA trial enrollment in RRMS was completed in December 2024, with topline data expected in 2H25[75, 95] - Phase 1 PET trial established brain receptor uptake and PK relationship at pharmacologically active doses for CNS indications[91]

Exhibit 99.1 CONTINEUM THERAPEUTICS REPORTS FIRST-QUARTER 2025 FINANCIAL RESULTS; AFFIRMS KEY CLINICAL DEVELOPMENT MILESTONES - Topline data from PIPE-791 Phase 1b positron emission tomography (PET) trial expected in the second quarter of 2025 About Contineum Therapeutics Contineum Therapeutics (Nasdaq: CTNM) is a clinical-stage biopharmaceutical company pioneering novel, oral small molecule therapies for NI&I indications with significant unmet need. Contineum is advancing a pipeline of internally-developed ...

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].