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

PART I. FINANCIAL INFORMATION This section provides unaudited condensed financial statements and management's discussion and analysis for the reporting period Item 1. Condensed Financial Statements (Unaudited) This section presents Contineum Therapeutics, Inc.'s unaudited condensed financial statements and accompanying notes for the periods ended June 30, 2025, and December 31, 2024 Condensed Balance Sheets The condensed balance sheets reflect a decrease in total assets and stockholders' equity from December 2024 to June 2025, mainly due to reduced marketable securities and an accumulated deficit Condensed Balance Sheets (in thousands) | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :----------------------------- | :------------------------------- | | 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 | | Total current liabilities | $7,214 | $9,974 | | Total liabilities | $11,498 | $14,781 | | Total stockholders' equity | $171,390 | $198,066 | | Accumulated deficit | $(149,432) | $(117,402) | Condensed Statements of Operations and Comprehensive Loss Net losses increased for both three and six months ended June 30, 2025, driven by higher research and development and general and administrative expenses Condensed Statements of Operations and Comprehensive Loss (in thousands) | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $14,063 | $7,901 | $27,775 | $15,679 | | General and administrative | $3,839 | $3,043 | $8,237 | $5,195 | | Total operating expenses | $17,902 | $10,944 | $36,012 | $20,874 | | Net loss | $(16,040) | $(9,009) | $(32,030) | $(17,426) | | Net loss per share, basic and diluted | $(0.62) | $(0.39) | $(1.24) | $(1.35) | Condensed Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) Stockholders' equity decreased from December 2024 to June 2025 due to net loss, partially offset by stock-based compensation, after convertible preferred stock converted to common stock in the 2024 IPO Condensed Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) (in thousands) | Metric (in thousands) | Balance at Dec 31, 2024 | Balance at Mar 31, 2025 | Balance at Jun 30, 2025 | | :-------------------- | :---------------------- | :---------------------- | :---------------------- | | Total Stockholders' Equity | $198,066 | $184,768 | $171,390 | | Accumulated Deficit | $(117,402) | $(133,392) | $(149,432) | | Stock-based compensation | $2,569 (Q1 2025) | $2,418 (Q2 2025) | $4,987 (6M 2025) | Condensed Statements of Cash Flows For the six months ended June 30, 2025, significant cash used in operating activities was largely offset by cash from investing activities, resulting in a net decrease in cash and cash equivalents Condensed Statements of Cash Flows (in thousands) | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(30,073) | $(16,474) | | Net cash provided by (used in) investing activities | $28,799 | $(30,168) | | Net cash provided by financing activities | $115 | $108,346 | | Net increase (decrease) in cash and cash equivalents | $(1,159) | $61,704 | | Cash and cash equivalents at end of period | $20,784 | $77,230 | Notes to Unaudited Condensed Financial Statements These notes provide detailed explanations of the company's organization, accounting policies, financial instruments, equity, the J&J License Agreement, and other financial reporting specifics Note 1. Organization and Basis of Presentation Contineum Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on NI&I indications, which completed an IPO in April 2024 and maintains sufficient liquidity for at least 12 months - Contineum Therapeutics, Inc. is a clinical-stage biopharmaceutical company specializing in neuroscience, inflammation, and immunology (NI&I) indications[29] - The company completed its Initial Public Offering (IPO) on April 9, 2024, issuing 6,875,000 shares at $16.00 per share, with an additional 548,682 shares sold to underwriters, resulting in net proceeds of approximately $107.9 million[31] - As of June 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $175.5 million, which management expects to be sufficient to fund operations for at least 12 months[34] Note 2. Summary of Significant Accounting Policies Significant accounting policies remained consistent with the 2024 Annual Report, with retrospective adoption of ASU 2023-07 having no material impact, while ASU 2023-09 and ASU 2024-03 are under evaluation - No significant changes to accounting policies occurred during the six months ended June 30, 2025, compared to the Annual Report on Form 10-K for December 31, 2024[38] - The company adopted ASU 2023-07, Segment Reporting, retrospectively for the fiscal year ended December 31, 2024, and subsequent interim periods, with no material impact on financial position or results[41] - The company is currently evaluating the impact of ASU 2023-09 (Income Taxes) and ASU 2024-03 (Expense Disaggregation) on its financial statements[42][43] Note 3. Marketable Securities Marketable securities decreased to $154.7 million by June 30, 2025, from $182.8 million at December 31, 2024, with some in an unrealized loss position but not intended for early sale Marketable Securities Fair Value (in thousands) | Investment Category | June 30, 2025 Fair Value (in thousands) | December 31, 2024 Fair Value (in thousands) | | :------------------ | :-------------------------------------- | :---------------------------------------- | | U.S. Government agency securities | $55,804 | $57,155 | | Corporate debt securities | $67,370 | $80,822 | | Commercial paper | $10,612 | $22,275 | | Total | $154,700 | $182,817 | - As of June 30, 2025, 62 out of 237 available-for-sale debt securities were in an aggregate gross unrealized loss position of $(43) thousand, compared to 86 out of 252 securities with $(175) thousand in unrealized losses as of December 31, 2024[45][46] Note 4. Fair Value Measurements Financial assets are measured at fair value using a three-tier hierarchy, totaling $174.5 million as of June 30, 2025, with $75.7 million in Level 1 and $98.9 million in Level 2 Financial Asset Fair Value Measurements (in thousands) | Financial Asset Category (in thousands) | Total Fair Value (June 30, 2025) | Level 1 (June 30, 2025) | Level 2 (June 30, 2025) | | :-------------------------------------- | :------------------------------- | :---------------------- | :---------------------- | | Cash equivalents | $19,848 | $19,848 | $— | | U.S. Government agency securities | $55,804 | $55,804 | $— | | Certificates of deposits | $6,200 | $— | $6,200 | | Corporate debt securities | $67,370 | $— | $67,370 | | Commercial paper | $10,612 | $— | $10,612 | | Yankee debt | $2,336 | $— | $2,336 | | Asset-backed securities | $12,378 | $— | $12,378 | | Total financial assets | $174,548 | $75,652 | $98,896 | Note 5. Accrued Expenses Total accrued expenses decreased from $6.7 million at December 31, 2024, to $3.7 million at June 30, 2025, mainly due to reduced compensation and R&D accruals Accrued Expense Categories (in thousands) | Accrued Expense Category (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------------------------- | :------------ | :---------------- | | Accrued compensation expenses | $1,770 | $3,338 | | Accrued research and development expenses | $1,686 | $3,151 | | Total accrued expenses | $3,747 | $6,711 | Note 6. Stockholders' Equity (Deficit) Stockholders' equity decreased to $171.4 million by June 30, 2025, primarily due to net losses, with $4.987 million in stock-based compensation for the six-month period - In May 2025, the company entered into a Sales Agreement for an at-the-market (ATM) offering of up to $75.0 million in Class A common stock, but no shares were sold under this agreement during the three months ended June 30, 2025[53] Common Stock Outstanding and Reserved | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------------- | :------------ | :---------------- | | Class A common stock outstanding | 19,190,723 | 19,125,377 | | Class B common stock outstanding | 6,729,172 | 6,729,172 | | Total common stock reserved for future issuance | 7,769,503 | 5,997,577 | - The company recorded $4.987 million in total stock-based compensation for the six months ended June 30, 2025, with $2.8 million in general and administrative and $2.2 million in research and development[26][67] Note 7. License Agreement The J&J license agreement for PIPE-307, with a $50.0 million upfront payment and potential $1.0 billion in milestones, saw no revenue recognized from a Phase 2 trial modification as of June 30, 2025 - The company granted J&J an exclusive, worldwide license for PIPE-307 in February 2023, receiving a $50.0 million upfront payment[72][74] - The company is eligible to receive approximately $1.0 billion in non-refundable, non-creditable milestone payments and tiered royalties (low-double digit to high-teen percent range) on net sales of products containing PIPE-307[72] - In August 2023, the company elected to conduct a Phase 2 trial for PIPE-307 in multiple sclerosis, which was treated as a contract modification. No revenue related to this modification had been recognized as of June 30, 2025[75] Note 8. Commitments and Contingencies Primary commitments are $5.75 million in operating lease liabilities for office and lab space, with $6.89 million in future minimum payments, and no material legal proceedings as of June 30, 2025 Operating Lease Metrics (in thousands) | Operating Lease Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :------------ | :---------------- | | Operating lease right-of-use assets | $5,007 | $5,467 | | Total lease liability obligations | $5,750 | $6,259 | | Weighted-average remaining lease term | 4.3 years | 4.4 years | | Weighted-average discount rate | 9.0% | 9.0% | Future Minimum Lease Payments (in thousands) | Future Minimum Lease Payments (in thousands) | Amount | | :------------------------------------------- | :----- | | 2025 | $763 | | 2026 | $1,564 | | 2027 | $1,611 | | 2028 | $1,660 | | 2029 | $1,292 | | Total minimum lease payments | $6,890 | - The company is not currently a party to any material legal proceedings[83] Note 9. Net Loss Per Share Basic and diluted net loss per share were $(0.62) for three months and $(1.24) for six months ended June 30, 2025, with dilutive securities excluded due to anti-dilutive effects Net Loss Per Share Calculation (in thousands, except per share data) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss applicable to common stockholders (in thousands) | $(16,040) | $(9,009) | $(32,030) | $(17,426) | | Weighted average shares outstanding (basic and diluted) | 25,895,996 | 23,355,588 | 25,882,540 | 12,862,328 | | Net loss per share (basic and diluted) | $(0.62) | $(0.39) | $(1.24) | $(1.35) | - Potentially dilutive securities (common stock options and warrants) were excluded from diluted EPS calculations for all periods presented because their inclusion would be anti-dilutive[87] Note 10. Segment Reporting The company operates as a single reportable segment focused on NI&I therapies, with the CODM assessing performance and allocating resources based on operating expenses and net loss - The company operates in one reportable segment, focusing on differentiated therapies for neuroscience, inflammation, and immunology (NI&I) indications[89] - The CODM (President and CEO) uses operating expenses and net loss to make decisions on resource allocation and assess business performance[90] Significant Segment Expenses (in thousands) | Significant Segment Expenses (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | | | | | | PIPE-791 | $6,178 | $2,028 | $11,732 | $4,889 | | PIPE-307 | $2,160 | $2,258 | $4,775 | $4,333 | | CTX-343 | $1,059 | $574 | $2,437 | $886 | | Discovery programs | $1,328 | $1,244 | $2,710 | $2,348 | | Unallocated internal costs | $3,338 | $1,797 | $6,121 | $3,223 | | General and administrative | $3,839 | $3,043 | $8,237 | $5,195 | | Interest income | $2,029 | $2,001 | $4,279 | $3,637 | | Net loss | $(16,040) | $(9,009) | $(32,030) | $(17,426) | Note 11. Subsequent Events In July 2025, an ATM offering sold 2,122,000 Class A common shares at $4.03 per share, generating $8.4 million in net proceeds - In July 2025, the company closed an ATM offering, selling 2,122,000 shares of Class A common stock at a weighted average price of $4.03 per share[94] - The ATM offering resulted in gross proceeds of $8.6 million and net proceeds of $8.4 million after deducting sales agent commissions[94] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's analysis of financial condition and operations, focusing on NI&I therapies, clinical trial progress, financial performance, liquidity, and future funding requirements Overview Contineum Therapeutics is a clinical-stage biopharmaceutical company developing small molecule drug candidates for NI&I indications, with key programs PIPE-791 and PIPE-307, expecting increased operating expenses - Contineum Therapeutics is a clinical-stage biopharmaceutical company focused on developing differentiated therapies for neuroscience, inflammation, and immunology (NI&I) indications[99] - Lead asset PIPE-791 (LPA1R inhibitor) is in development for idiopathic pulmonary fibrosis (IPF), progressive multiple sclerosis (PrMS), and chronic pain, with Phase 1b PET trial topline data expected in Q3 2025 and a Phase 2 IPF trial planned for Q4 2025[101] - PIPE-307 (M1R inhibitor), partnered with J&J, is in Phase 2 trials for relapse-remitting multiple sclerosis (RRMS) (topline data expected Q4 2025) and major depressive disorder (MDD) (J&J initiated Phase 2 recruitment)[102] Collaboration The J&J collaboration grants exclusive worldwide rights for PIPE-307, with Contineum conducting a Phase 2 RRMS trial (topline data Q3 2025) and J&J recruiting for a Phase 2 MDD trial - The J&J License Agreement grants J&J an exclusive, worldwide license to develop, manufacture, and commercialize PIPE-307 in all indications[109] - Contineum is conducting a Phase 2 clinical trial of PIPE-307 in RRMS patients, with enrollment completed in December 2024 and topline data expected in Q3 2025[111] - J&J began recruiting for a Phase 2 trial of PIPE-307/JNJ-89495120 for the potential treatment of major depressive disorder (MDD) in December 2024[111] Financial Operations Overview No revenue was recognized for the periods ended June 30, 2025 or 2024, due to constrained J&J License Agreement milestones, while operating expenses, especially R&D, are expected to increase significantly - The company did not recognize any revenue for the three and six months ended June 30, 2025 or 2024, as all variable consideration under the J&J License Agreement was fully constrained[114] - Research and development expenses are expensed as incurred and include direct costs (e.g., clinical trials, manufacturing) and unallocated internal costs (e.g., personnel, stock-based compensation, facilities)[115][116][120] - General and administrative expenses are expected to increase due to expanded R&D, business growth, increased headcount, and costs associated with operating as a public company[124] Results of Operations Net losses increased for both three and six months ended June 30, 2025, driven by substantial increases in research and development and general and administrative expenses, partially offset by higher interest income Comparison of the Three Months Ended June 30, 2025 and 2024 Net loss increased to $(16.0) million for the three months ended June 30, 2025, from $(9.0) million in 2024, primarily due to higher R&D and G&A expenses Three Months Ended June 30, 2025 and 2024 (in thousands) | Metric (in thousands) | June 30, 2025 | June 30, 2024 | Change | | :-------------------- | :------------ | :------------ | :----- | | Research and development | $14,063 | $7,901 | $6,162 | | General and administrative | $3,839 | $3,043 | $796 | | Net loss | $(16,040) | $(9,009) | $(7,031) | - Research and development expenses increased by $6.1 million, primarily due to a $4.3 million increase in CRO costs for PIPE-791 trials (IPF, chronic pain, PET) and a $1.5 million increase in personnel-related expenses[128][135] - General and administrative expenses increased by $0.8 million, driven by a $0.5 million increase in non-cash stock-based compensation and a $0.5 million increase in personnel-related expenses[129] Comparison of the Six Months Ended June 30, 2025 and 2024 Net loss increased to $(32.0) million for the six months ended June 30, 2025, from $(17.4) million in 2024, driven by higher R&D and G&A expenses, partially offset by increased interest income Six Months Ended June 30, 2025 and 2024 (in thousands) | Metric (in thousands) | June 30, 2025 | June 30, 2024 | Change | | :-------------------- | :------------ | :------------ | :----- | | Research and development | $27,775 | $15,679 | $12,096 | | General and administrative | $8,237 | $5,195 | $3,042 | | Interest income | $4,279 | $3,637 | $642 | | Net loss | $(32,030) | $(17,426) | $(14,604) | - Research and development expenses increased by $12.1 million, primarily due to an $8.1 million increase in CRO costs for PIPE-791 and PIPE-307 trials, a $2.3 million increase in personnel-related expenses, and a $1.2 million increase in non-cash stock-based compensation[130][136] - General and administrative expenses increased by $3.0 million, mainly from a $1.6 million increase in non-cash stock-based compensation and a $1.2 million increase in personnel-related expenses[130] Liquidity and Capital Resources The company, historically incurring net losses, funds operations through various sources, holding $175.5 million in liquidity as of June 30, 2025, sufficient for 12 months, with future funding dependent on drug development needs - The company has incurred net losses and negative cash flows from operations since inception and expects this trend to continue[133] - As of June 30, 2025, the company had $175.5 million in cash, cash equivalents, and marketable securities, which management believes will be sufficient to meet operating expenses and capital expenditure requirements for at least the next 12 months[137] - Future capital requirements are substantial and depend on factors such as clinical trial progress, regulatory approvals, manufacturing costs, and the expansion of operations and intellectual property[145][146][159] Sources of Liquidity Liquidity sources include convertible notes, preferred stock, the $50.0 million J&J License Agreement, $107.9 million IPO proceeds, and $8.4 million from a July 2025 ATM offering, totaling $175.5 million as of June 30, 2025 - The company has funded operations primarily through convertible promissory notes, convertible preferred stock financings, the J&J License Agreement ($50.0 million upfront payment), and $107.9 million net proceeds from its April 2024 IPO[33][134] - As of June 30, 2025, cash, cash equivalents, and marketable securities totaled $175.5 million, expected to be sufficient for at least 12 months of operations[34][137] - In July 2025, the company completed an ATM offering, raising $8.4 million in net proceeds from the sale of 2,122,000 shares of Class A common stock[94][139] Cash Flows Net cash used in operating activities was $(30.1) million for the six months ended June 30, 2025, largely offset by $28.8 million from investing activities, resulting in a $1.2 million net decrease in cash Cash Flow Activities (in thousands) | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(30,073) | $(16,474) | | Net cash provided by (used in) investing activities | $28,799 | $(30,168) | | Net cash provided by financing activities | $115 | $108,346 | | Net increase (decrease) in cash and cash equivalents | $(1,159) | $61,704 | - Net cash used in operating activities increased to $(30.1) million for the six months ended June 30, 2025, from $(16.5) million in the prior year, primarily due to higher net loss[142] - Net cash provided by investing activities was $28.8 million in 2025, a significant change from $(30.2) million used in 2024, driven by increased sales and maturities of marketable securities[143] Funding Requirements Operating expenses are expected to increase significantly for drug development and commercialization, with future capital requirements dependent on clinical outcomes and intellectual property, likely financed through equity, debt, or commercial arrangements - Operating expenses are expected to increase significantly due to ongoing drug development, regulatory approvals, expansion of drug candidate pipeline, and potential commercialization activities[145] - Future capital requirements are uncertain and depend on factors such as the type, scope, progress, and costs of clinical trials, regulatory review, manufacturing, and intellectual property protection[146][159] - The company expects to finance future cash needs through public or private equity/debt financings or commercial arrangements, which may involve dilution, restrictive covenants, or relinquishing valuable rights[147] Contractual Obligations and Commitments Total contractual commitments for operating lease agreements were approximately $6.9 million as of June 30, 2025, with other service contracts generally terminable with notice and not classified as long-term obligations - Total contractual commitments for operating lease agreements amounted to approximately $6.9 million as of June 30, 2025[149] - Contracts for research, manufacturing, and professional services are generally terminable with advanced written notice and payment for services received, and thus are not included in long-term contractual obligations[150] Off-Balance Sheet Arrangements The company did not have any off-balance sheet arrangements during the periods presented - The company did not have any off-balance sheet arrangements during the periods presented[152] Critical Accounting Policies and Significant Judgments and Estimates Financial statements rely on estimates for R&D accruals, lease rates, common stock fair value, and stock-based compensation, with no material changes since the 2024 Annual Report on Form 10-K - Key accounting estimates and judgments include accrual of research and development expenses, incremental borrowing rate for lease liabilities, fair value of common stock, and stock-based compensation[154] - There have been no material changes to the company's critical accounting estimates from those described in its Annual Report on Form 10-K for the year ended December 31, 2024[155] Emerging growth company and smaller reporting company status The company qualifies as an "emerging growth company" and "smaller reporting company," utilizing extended transition periods for accounting standards and scaled disclosures, which may affect comparability - The company is an "emerging growth company" under the JOBS Act and has elected to use the extended transition period for complying with new or revised accounting standards[157] - The company is also a "smaller reporting company" and takes advantage of scaled disclosures, which may affect comparability with other public companies[158] Item 3. Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, Contineum Therapeutics, Inc. is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, the registrant is not required to provide quantitative and qualitative disclosures about market risk[160] Item 4. Controls and Procedures Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control over financial reporting during the quarter Evaluation of Disclosure Controls and Procedures Management, including principal executive and financial officers, concluded that disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2025 - As of June 30, 2025, the company's disclosure controls and procedures were evaluated and deemed effective at the reasonable assurance level by management, including the principal executive and financial officers[161] Changes in Internal Control over Financial Reporting No material changes in internal control over financial reporting occurred during the quarter ended June 30, 2025 - No material changes in internal control over financial reporting occurred during the quarter ended June 30, 2025[162] PART II. OTHER INFORMATION This section covers legal proceedings, risk factors, equity sales, defaults, other information, and exhibits for the reporting period Item 1. Legal Proceedings The company is not currently a party to any material legal proceedings, though ordinary course claims may arise - The company is not currently a party to any material legal proceedings[165] Item 1A. Risk Factors Investing in the company's common stock involves high risk, including potential adverse effects from tax law changes and unstable global economic conditions impacting operations and financing - Investing in the company's common stock involves a high degree of risk, and additional risks not currently known may also adversely affect the business[166] - Changes in tax laws, such as the OBBB Act, could affect the company, though no material impact on its effective tax rate or cash flows is expected in the current fiscal year[167] - Unstable global economic conditions and geopolitical instability could adversely affect the company's business, financial condition, and ability to advance drug candidates, potentially making financing more difficult and costly[169] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds No unregistered sales of equity securities occurred, and the $107.9 million net IPO proceeds from April 2024 saw no material change in planned use - No unregistered sales of equity securities occurred during the period[170] - The company received approximately $107.9 million in aggregate net proceeds from its IPO in April 2024[171] - There has been no material change in the planned use of proceeds from the IPO[172] Item 3. Defaults Upon Senior Securities The company reported no defaults upon senior securities - The company reported no defaults upon senior securities[173] Item 4. Mine Safety Disclosures This item is not applicable to the company - This item is not applicable[174] Item 5. Other Information No directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter ended June 30, 2025 - None of the company's directors or officers adopted or terminated any Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement during the quarter ended June 30, 2025[175] Item 6. Exhibits This section lists exhibits filed with the Quarterly Report on Form 10-Q, including corporate documents, agreements, executive certifications, and Inline XBRL files - Exhibits include the Amended and Restated Certificate of Incorporation and Bylaws, Offer Letters for Tim Watkins, and a Sales Agreement with Leerink Partners[177][178] - Certifications from the Principal Executive Officer and Principal Financial Officer (pursuant to Sarbanes-Oxley Act Sections 302 and 906) are included[178][180] - Inline XBRL Instance Document, Taxonomy Extension Schema, and Cover Page Interactive Data File are also filed as exhibits[178] Signatures The report was duly signed by Carmine Stengone, President, CEO, and Director, and Peter Slover, CFO, on August 5, 2025 - The report was signed by Carmine Stengone, President, Chief Executive Officer and Director, and Peter Slover, Chief Financial Officer, on August 5, 2025[185]