Rapport Therapeutics, Inc.(RAPP) - 2025 Q2 - Quarterly Report

PART I. FINANCIAL INFORMATION Item 1. Financial Statements (Unaudited) Presents unaudited condensed consolidated financial statements, including balance sheets, operations, equity, cash flows, and detailed notes Condensed Consolidated Balance Sheets Summarizes the company's assets, liabilities, and equity at specific points in time Condensed Consolidated Balance Sheets (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :---------------------------------- | :-------------- | :---------------- | | Cash and cash equivalents | $55,067 | $56,805 | | Short-term investments | $205,380 | $248,475 | | Total current assets | $270,242 | $309,802 | | Total assets | $285,495 | $314,933 | | Total current liabilities | $11,879 | $8,767 | | Total liabilities | $21,983 | $9,506 | | Total stockholders' equity | $263,512 | $305,427 | Condensed Consolidated Statements of Operations and Comprehensive Loss Details the company's revenues, expenses, and net loss over specific periods Condensed Consolidated Statements of Operations and Comprehensive Loss (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 | | :------------------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development expenses | $22,680 | $15,689 | $42,252 | $28,193 | | General and administrative expenses | $6,816 | $5,111 | $14,352 | $9,701 | | Total operating expenses | $29,496 | $20,800 | $56,604 | $37,894 | | Loss from operations | $(29,496) | $(20,800) | $(56,604) | $(37,894) | | Interest income | $2,764 | $2,679 | $5,809 | $4,494 | | Change in fair value of preferred stock tranche right liability | $0 | $0 | $0 | $(7,390) | | Net loss | $(26,732) | $(18,121) | $(50,795) | $(40,790) | | Net loss per share, basic and diluted | $(0.75) | $(1.70) | $(1.44) | $(6.42) | | Weighted-average common shares outstanding | 35,444,635 | 10,666,528 | 35,356,098 | 6,356,700 | | Comprehensive loss | $(26,713) | $(18,144) | $(50,349) | $(40,977) | Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) Outlines changes in convertible preferred stock and stockholders' equity over reporting periods - Total stockholders' equity decreased from $305.4 million at December 31, 2024, to $263.5 million at June 30, 2025, primarily due to net loss and stock-based compensation[30] - Stock-based compensation expense for the six months ended June 30, 2025, was $8.4 million, contributing to the change in additional paid-in capital[30] - The company reported a net loss of $26.7 million for the three months ended June 30, 2025, and $50.8 million for the six months ended June 30, 2025, increasing the accumulated deficit[24][30] Condensed Consolidated Statements of Cash Flows Reports cash inflows and outflows from operating, investing, and financing activities Condensed Consolidated Statements of Cash Flows (in thousands) | Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------ | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(45,307) | $(33,967) | | Net cash provided by (used in) investing activities | $43,627 | $(149,030) | | Net cash (used in) provided by financing activities | $(58) | $223,012 | | Net (decrease) increase in cash, cash equivalents, and restricted cash | $(1,738) | $40,015 | | Cash, cash equivalents, and restricted cash at end of period | $55,172 | $110,269 | Notes to Unaudited Condensed Consolidated Financial Statements Provides detailed explanations and breakdowns for figures presented in the financial statements - Rapport Therapeutics, Inc. is a clinical-stage biotechnology company focused on neurological or psychiatric disorders, incorporated in February 2022[34] - The company has incurred recurring losses since inception, with an accumulated deficit of $174.5 million as of June 30, 2025, and expects to continue generating operating losses[37] - Cash, cash equivalents, and short-term investments totaled $260.4 million as of June 30, 2025, expected to fund operations for at least 12 months from the financial statement issuance date[37] - The company completed its IPO and concurrent private placement in June 2024, raising net proceeds of $157.6 million[37] - Significant estimates in financial statements include research and development expenses, valuation of common stock and stock-based awards, and preferred stock tranche right liability[45] - Short-term investments, classified as available-for-sale debt securities, consist of U.S. Treasury bills, government securities, and government agency securities, carried at fair market value[48] Short-term investments (in thousands) | Type | June 30, 2025 Fair Value | December 31, 2024 Fair Value | | :-------------------------- | :----------------------- | :------------------------- | | U.S. Treasury bills | $26,867 | $28,723 | | Government securities | $91,979 | $136,514 | | Government agency securities | $86,534 | $83,238 | | Total | $205,380 | $248,475 | - The Series B preferred stock tranche right liability was settled in March 2024, resulting in no balance as of June 30, 2024, and no further changes in fair value recognized[73] Property and equipment, net (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :-------------------------- | :-------------- | :---------------- | | Lab equipment | $4,261 | $3,716 | | Computer equipment | $93 | $67 | | Leasehold improvements | $281 | $281 | | Construction in process | $0 | $430 | | Total property and equipment | $4,635 | $4,494 | | Less: Accumulated depreciation | $(1,463) | $(965) | | Net property and equipment | $3,172 | $3,529 | Accrued expenses and other current liabilities (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :-------------- | :---------------- | | Research and development | $2,974 | $1,664 | | Professional fees | $759 | $235 | | Employee related | $3,141 | $3,708 | | Accrued other | $70 | $469 | | Total | $6,944 | $6,076 | - Prior to the June 2024 IPO, all outstanding Series A and Series B convertible preferred stock converted into 22,146,816 shares of common stock[79] - In June 2024, the company issued and sold 9,200,000 shares of common stock in its IPO and 1,058,824 shares in a concurrent private placement, generating $140.9 million and $16.7 million in net proceeds, respectively[94][95] - As of June 30, 2025, 9,096,166 shares of common stock were reserved for issuance under the 2022 Plan, 2024 Plan, and 2024 ESPP[96] - Stock-based compensation expense for stock options was $3.8 million and $7.2 million for the three and six months ended June 30, 2025, respectively[119] - The company entered into new operating leases in San Diego, CA (commenced Jan 2025) and Boston, MA (commenced June 2025) for laboratory and office space[121][123] - Related party transactions with Janssen Pharmaceutical NV and Third Rock Ventures LLC decreased to zero for the six months ended June 30, 2025, from $69 thousand and $0.1 million, respectively, in 2024[124][125] - The company entered into a Master Services Agreement with NeuroPace Inc. in November 2023 for data services related to the RAP-219 Phase 2a clinical trial, with payments up to $3.7 million[128][131] - The company operates as a single operating and reportable segment, focused on developing medicines for neurological or psychiatric disorders in the United States[132][133][134] - Basic and diluted net loss per common share was $(0.75) and $(1.44) for the three and six months ended June 30, 2025, respectively[138] - On July 1, 2025, the company filed an S-3 registration statement for up to $400.0 million in securities, including an at-the-market (ATM) offering program for up to $150.0 million in common stock[140] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Analyzes Rapport Therapeutics' financial condition, operations, clinical progress, product candidates, and future funding needs Overview Provides a high-level summary of the company's business, lead product candidates, and financial performance - Rapport Therapeutics is a clinical-stage biotechnology company developing small molecule precision medicines for neurological or psychiatric disorders using its RAP technology platform[144] - RAP-219, the lead product candidate, is an AMPA receptor negative allosteric modulator (NAM) targeting TARPγ8 for focal onset seizures, bipolar disorder, and peripheral neuropathic pain[145] - Phase 2a proof-of-concept trial in drug-resistant focal onset seizures is on track for topline results in September 2025[147] - Phase 2 proof-of-concept trial in bipolar mania has been initiated, with topline results expected in the first half of 2027[147] - The IND for a Phase 2a trial of RAP-219 for diabetic peripheral neuropathic pain (DPNP) was placed on clinical hold by the FDA in Q4 2024, pending additional information[147] - The company has incurred significant operating losses since inception, with net losses of $26.7 million and $50.8 million for the three and six months ended June 30, 2025, respectively, and an accumulated deficit of $174.5 million[150] - As of June 30, 2025, cash, cash equivalents, and short-term investments totaled $260.4 million, expected to fund operations through the end of 2026[149][155] License and Collaboration Agreements Details key agreements with third parties for product development and data services - The company holds an exclusive option and license agreement with Janssen Pharmaceutical NV for TARPγ8 AMPAR products and a non-exclusive license for nACh products[156] - Payments to Janssen include a $1.0 million upfront payment, a $4.0 million option fee, and potential future development and sales milestone payments up to $76.0 million and $40.0 million, respectively, for the lead TARPγ8 product, plus royalties[157][158] - A Master Services Agreement with NeuroPace Inc. provides data services for the RAP-219 Phase 2a clinical trial in drug-resistant focal onset seizures, with payments up to $3.7 million over two years[160][161] Components of Results of Operations Explains the primary drivers and nature of the company's operating expenses, interest income, and other financial items - Research and development expenses include personnel, external costs (CMOs, CROs), intellectual property licenses, lab supplies, and facility costs, and are expected to increase substantially[162][163][165] - General and administrative expenses cover personnel, legal, professional, office, IT, and facility costs, and are anticipated to rise due to public company operations and growth[167][168] - Interest income is derived from cash, cash equivalents, and short-term investments[169] - The Series B preferred stock tranche right liability was settled in March 2024, eliminating future changes in fair value recognition[171] - No income tax provision was recorded for the periods, with a full valuation allowance against net deferred tax assets[172] Results of Operations Compares the company's financial performance across different reporting periods, highlighting key changes in expenses and net loss Results of Operations (Three Months Ended June 30, in thousands) | Metric | 2025 | 2024 | Change | | :-------------------------- | :--- | :--- | :----- | | Research and development | $22,680 | $15,689 | $6,991 | | General and administrative | $6,816 | $5,111 | $1,705 | | Total operating expenses | $29,496 | $20,800 | $8,696 | | Loss from operations | $(29,496) | $(20,800) | $(8,696) | | Interest income | $2,764 | $2,679 | $85 | | Net loss | $(26,732) | $(18,121) | $(8,611) | Results of Operations (Six Months Ended June 30, in thousands) | Metric | 2025 | 2024 | Change | | :------------------------------------------------ | :--- | :--- | :----- | | Research and development | $42,252 | $28,193 | $14,059 | | General and administrative | $14,352 | $9,701 | $4,651 | | Total operating expenses | $56,604 | $37,894 | $18,710 | | Loss from operations | $(56,604) | $(37,894) | $(18,710) | | Interest income | $5,809 | $4,494 | $1,315 | | Change in fair value of preferred stock tranche right liability | $0 | $(7,390) | $7,390 | | Net loss | $(50,795) | $(40,790) | $(10,005) | - The increase in R&D expenses for both periods was primarily driven by higher RAP-219 program costs (clinical trials, manufacturing) and increased personnel-related costs, partially offset by decreased preclinical program costs[178][185] - General and administrative expenses increased due to higher workforce expenses (salaries, bonuses, stock-based compensation) and administrative costs associated with public company operations, partially offset by reduced professional and consulting fees post-IPO[177][182][184][186][187] - Interest income increased due to higher cash, cash equivalents, and short-term investment balances following the IPO and Series B financing[179][188] Liquidity and Capital Resources Assesses the company's ability to meet its short-term and long-term financial obligations and its funding strategies - As of June 30, 2025, the company had $260.4 million in cash, cash equivalents, and short-term investments, excluding restricted cash[190] - Historically, operations have been funded by convertible notes, preferred stock, and common stock (IPO and private placement), totaling $424.4 million in gross proceeds[190] - The company filed an S-3 registration statement for up to $400.0 million in securities, including an ATM program for up to $150.0 million in common stock, to fund future operations[191] Cash Flows Summary (Six Months Ended June 30, in thousands) | Activity | 2025 | 2024 | | :------------------------------------------ | :--- | :--- | | Net cash used in operating activities | $(45,307) | $(33,967) | | Net cash provided by (used in) investing activities | $43,627 | $(149,030) | | Net cash (used in) provided by financing activities | $(58) | $223,012 | | Net increase (decrease) in cash, cash equivalents and restricted cash | $(1,738) | $40,015 | - Operating activities used $45.3 million in cash in H1 2025, an increase from $34.0 million in H1 2024, primarily due to net loss and increased prepaid expenses[193][194] - Investing activities provided $43.6 million in cash in H1 2025, a significant shift from using $149.0 million in H1 2024, driven by maturities of short-term investments[195][196] - Financing activities used $0.1 million in cash in H1 2025, compared to providing $223.0 million in H1 2024, reflecting deferred offering costs in 2025 versus IPO and preferred stock proceeds in 2024[197][198] - Existing cash, cash equivalents, and short-term investments are projected to fund operating expenses and capital expenditure requirements through the end of 2026[199] - Future funding requirements are substantial and depend on the progress of product candidates, clinical trials, manufacturing, regulatory approvals, and commercialization efforts[200][205] - Contractual obligations include $14.2 million in future minimum operating lease payments over a weighted average remaining lease term of 5.0 years[203] - The Janssen License includes potential milestone payments up to $76.0 million for development and $40.0 million for sales, plus tiered royalties[204] - The NeuroPace Agreement involves payments up to $3.7 million over approximately two years for services and milestone achievement[206] Critical Accounting Policies and Estimates Highlights key accounting policies and estimates that require significant judgment and can materially impact financial reporting - There were no material changes to the critical accounting policies and estimates previously disclosed in the Annual Report on Form 10-K for the year ended December 31, 2024[210] Emerging Growth Company and Smaller Reporting Company Status Discusses the company's status as an emerging growth company and smaller reporting company, and the associated reduced disclosure requirements - The company qualifies as an 'emerging growth company' (EGC) and has elected to use the extended transition period for complying with new or revised accounting standards[211][507] - As an EGC, the company benefits from reduced reporting requirements, including fewer years of audited financial statements and reduced executive compensation disclosures[505] - The company also qualifies as a 'smaller reporting company,' allowing for scaled disclosures[213][508] Item 3. Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, detailed quantitative and qualitative disclosures about market risk are not required - The company is a smaller reporting company and is not required to provide the information required by this Item[213] Item 4. Controls and Procedures Management concluded disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control - Management, including the principal executive officer and principal financial officer, concluded that disclosure controls and procedures were effective as of June 30, 2025, at the reasonable assurance level[215] - There have been no material changes in internal control over financial reporting during the quarter ended June 30, 2025[216] PART II. OTHER INFORMATION Item 1. Legal Proceedings The company is not currently involved in legal proceedings expected to have a material adverse effect on its business - The company is not currently a party to any litigation or legal proceedings that are probable to have a material adverse effect on its business[219] Item 1A. Risk Factors Outlines risks and uncertainties impacting Rapport Therapeutics, covering operations, finances, product development, third parties, and intellectual property Risks Related to Our Limited Operating History, Financial Condition and Need for Additional Capital Highlights risks associated with the company's early stage, recurring losses, and substantial future funding requirements - As a clinical-stage biotechnology company formed in February 2022, Rapport Therapeutics has a limited operating history and has not generated any revenue from product sales[222] - The company has incurred significant net losses since inception, totaling $50.8 million for the six months ended June 30, 2025, and an accumulated deficit of $174.5 million[223] - Additional funding will be required to finance operations and product development, and the inability to raise capital on acceptable terms could force delays or elimination of programs[227][231] - Raising additional capital through equity or convertible debt securities will dilute existing stockholders' ownership interests[232] - Obligations under the Janssen License, including substantial contingent milestone payments, could be a significant drain on cash resources or necessitate incurring debt[238] Risks Related to Our Business Covers risks concerning product development, resource allocation, acquisitions, data security, and the use of new technologies - The business is highly dependent on the successful clinical development, regulatory approval, and commercialization of product candidates, particularly RAP-219 for focal onset seizures[239] - The successful development of pharmaceutical products is a lengthy, expensive, and highly uncertain process, with many product candidates failing to reach the market[242] - The FDA placed a clinical hold on the Phase 2a proof-of-concept trial of RAP-219 for diabetic peripheral neuropathic pain (DPNP) in Q4 2024, requesting additional information[242] - Due to significant resource requirements, the company must prioritize certain product candidates, potentially diverting resources from more profitable opportunities[248][249] - Growth through acquisitions or investments in new businesses, products, or technologies carries numerous risks, including integration difficulties, unanticipated costs, and diversion of management attention[250][251] - The company is subject to stringent and evolving privacy and data security laws (e.g., CCPA, GDPR, NIS 2), with potential for significant fines, penalties, and business disruption from non-compliance or breaches[253][254][260][262][266][270] - Information technology systems and data are vulnerable to cyber-attacks, cybersecurity incidents, and breaches, which could result in substantial costs, revenue loss, and operational disruption[272][278] - The use of new technologies like AI/ML introduces risks related to intellectual property, compliance with evolving regulations (e.g., EU AI Act), and potential for reputational harm or liability[281][282] Risks Related to the Discovery and Development of Our Current or Future Product Candidates Addresses challenges in regulatory approval, clinical trials, potential side effects, market acceptance, patient enrollment, and reliance on third-party manufacturing - The regulatory approval processes of the FDA, EMA, MHRA, and other authorities are lengthy, time-consuming, and inherently unpredictable, with no guarantee of approval[285] - Clinical trials are expensive, difficult to design, and have a high failure rate; positive results from early stages may not be replicated in later-stage trials[286][293][295] - Product candidates may cause undesirable side effects or have other properties that could delay or prevent regulatory approval or limit commercialization[303][305] - Even if approved, product candidates may fail to achieve sufficient market acceptance by physicians, patients, and third-party payors, hindering commercial success[322] - Concentrating R&D efforts on nervous system disorders presents challenges due to reliance on subjective patient-reported outcomes and the placebo effect[315] - Difficulties in enrolling patients in clinical trials, influenced by eligibility criteria, competition, and patient drop-out rates, could significantly delay or adversely affect development activities[317][318][321] - Reliance on third parties (CROs, CMOs, NeuroPace) for clinical trials and manufacturing introduces risks related to control, timing, expense, quality, and compliance with regulatory requirements[351][353][354][358][361][366] - Geopolitical events and trade policies, particularly concerning manufacturers located outside the United States (e.g., China), could disrupt supply chains and increase costs[365] - Establishing collaborations on commercially reasonable terms is challenging, and reliance on collaborators' efforts and resources poses risks to product development and commercialization[370][371][376] - Scaling up manufacturing production or changes in product candidate manufacturing methods/formulation may result in additional costs or delays[379][380] Risks Related to Government Regulation Examines regulatory approval complexities, ongoing compliance, expedited pathways, funding impacts, healthcare laws, reimbursement, and international regulations - Obtaining regulatory approval in one jurisdiction does not guarantee approval in others, and foreign regulatory requirements can be more extensive and time-consuming[381][382] - Approved products are subject to ongoing regulatory obligations, including manufacturing, labeling, safety reporting, and compliance with cGMP and GCP, with potential penalties for non-compliance[383][386] - While the company may seek expedited approval pathways (e.g., Fast Track, Breakthrough Therapy), there is no assurance of obtaining such designations or realizing their intended benefits[389][390][391][392] - Accelerated approval pathways require confirmatory trials, and failure to verify clinical benefit or comply with post-marketing requirements could lead to withdrawal of approval[395][396] - Inadequate funding for the FDA or other government agencies could hinder their ability to review and approve new products in a timely manner, negatively impacting the business[398][401] - Relationships with healthcare providers and payors are subject to anti-kickback, fraud and abuse, and other healthcare laws, risking criminal sanctions, civil penalties, and reputational harm[403][405] - Coverage and adequate reimbursement from third-party payors are critical for product success, but may be limited or unavailable, making profitable sales difficult[406][408][409] - Ongoing healthcare legislative and regulatory reforms, such as the Inflation Reduction Act and OBBBA, could reduce Medicare/Medicaid spending, impact drug pricing, and adversely affect revenue and commercial prospects[414][415][416][418] - Employee misconduct or off-label use of product candidates could lead to regulatory sanctions, product liability suits, and reputational harm[422][423] - EU drug marketing and reimbursement regulations, including governmental price controls and anti-bribery laws, could materially affect the ability to market and receive coverage for products[424][425][428] - The company is subject to export/import controls, economic sanctions, and anti-corruption laws (e.g., FCPA), with potential for criminal liability and other serious consequences for violations[429] - Failure to comply with environmental, health, and safety laws by the company or third-party manufacturers could result in fines, penalties, or liabilities[430][433] Risks Related to Our Intellectual Property Details risks concerning in-licensed IP, patent protection, challenges, foreign laws, term extensions, infringement claims, trade secrets, and trademarks - The company depends on in-licensed intellectual property, and failure to comply with license obligations could lead to the loss of important rights[435] - Inability to obtain and maintain broad patent protection for product candidates, or challenges to existing patents, could allow competitors to commercialize similar products[437][438][439][443] - Changes to patent law in the United States and foreign jurisdictions could diminish the value of patents and impair the ability to protect product candidates[455][456] - The company may not be able to protect its intellectual property rights throughout the world, as foreign laws may offer less extensive protection[457][459] - Failure to obtain patent term extension for product candidates could allow competitors to enter the market sooner[460] - Third parties may initiate legal proceedings alleging infringement or misappropriation of their intellectual property, leading to substantial damages, injunctions, or costly licensing requirements[461][462][465] - Intellectual property litigation is expensive, time-consuming, and can divert management's attention, potentially harming the business[471] - Inability to protect the confidentiality of trade secrets would harm the business and competitive position[473][474] - Claims challenging inventorship or ownership of patents and other intellectual property could be expensive and time-consuming[472] - Inadequate protection of trademarks and trade names could hinder name recognition and adversely affect the business[476] - European patents and applications could be challenged in the Unified Patent Court (UPC), potentially leading to a loss of patent protection across multiple European countries[477] Risks Related to Ownership of Our Common Stock Addresses stock price volatility, fluctuating operating results, analyst coverage, significant stockholder control, dilution, dividend policy, and anti-takeover provisions - The trading price of the common stock may be volatile due to factors such as clinical trial results, regulatory decisions, competition, and general market conditions[480][481] - Quarterly and annual operating results may fluctuate significantly, making future predictions difficult and potentially causing results to fall below expectations[482] - Inaccurate or unfavorable research, or cessation of coverage by securities or industry analysts, could lead to a decline in stock price and trading volume[484] - Executive officers, directors, and principal stockholders own a significant percentage of common stock, allowing them to exert substantial control over corporate actions[487] - Sales of a substantial number of shares of common stock in the public market could cause the stock price to fall[488] - Future issuances of additional capital stock in connection with financings, acquisitions, or incentive plans will dilute existing stockholders' ownership interests[492] - The company does not currently intend to pay dividends on its common stock, meaning investment return will depend solely on stock price appreciation[493] - Provisions in corporate charter documents and Delaware law could make an acquisition of the company more difficult and prevent attempts to replace current directors and management[494][495] - Bylaw provisions designating specific courts as the sole forum for certain actions may limit stockholders' ability to choose favorable judicial forums[496][497] - Failure to continue satisfying Nasdaq listing requirements could lead to delisting, impairing stockholders' ability to trade common stock and affecting its market price[500] Other General Risks Covers risks from global economic conditions, business interruptions, public company operations, internal controls, tax law changes, and various litigations - Unfavorable global economic conditions, political instability, and geopolitical events (e.g., conflicts, trade tensions, inflation) could adversely affect the business, financial condition, and stock price[501][502][503] - Natural disasters, public health crises, or other business interruptions could severely disrupt operations and delay clinical trials or regulatory approvals[504] - The company's status as an 'emerging growth company' and 'smaller reporting company' with reduced reporting requirements may make its common stock less attractive to investors[505][506] - Operating as a public company incurs significant legal, accounting, and compliance costs, diverting management time and potentially increasing net loss[511][512] - Failure to establish and maintain an effective system of internal control over financial reporting could lead to inaccurate financial reporting, fraud, and loss of investor confidence[513][515] - The ability to use net operating loss carryforwards and other tax attributes may be limited by ownership changes or regulatory changes, even if profitability is achieved[517][518] - Changes in tax law, such as the OBBBA or Section 174 of the Code, could adversely affect the business and financial condition[519] - Clinical trial and product liability lawsuits could divert resources, result in substantial liabilities, and limit commercialization of any developed products[520][521] - General litigation, including securities class action lawsuits, could be expensive, divert management's attention, and harm the business[522] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds Confirms no unregistered equity sales and no material changes to IPO and private placement proceeds use - No unregistered sales of equity securities occurred during the period[524] - There has been no material change in the planned use of proceeds from the initial public offering and concurrent private placement[525] Item 3. Defaults Upon Senior Securities Reports no defaults upon senior securities during the period - No defaults upon senior securities were reported[527] Item 4. Mine Safety Disclosures This item is not applicable to the registrant - This item is not applicable to the registrant[528] Item 5. Other Information No directors or officers adopted, modified, or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements - None of the directors or officers adopted, modified, or terminated a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement during the quarter ended June 30, 2025[529] Item 6. Exhibits Lists all exhibits filed as part of the Form 10-Q, including corporate governance documents, agreements, and certifications - Key exhibits filed include the Third Amended and Restated Certificate of Incorporation, Amended and Restated Bylaws, Specimen Common Stock Certificate, Amended and Restated Investors' Rights Agreement, and a Lease Agreement[531] - Certifications from the Principal Executive Officer and Principal Financial Officer pursuant to the Securities Exchange Act of 1934 and Sarbanes-Oxley Act of 2002 are included[531] Signatures Contains required signatures of the CEO and CFO, certifying the accuracy and completeness of the quarterly report - The report is duly signed on August 7, 2025, by Abraham N. Ceesay, Chief Executive Officer and Director, and Troy Ignelzi, Chief Financial Officer (Principal Financial and Accounting Officer)[537]