Company Overview - Relay Therapeutics, Inc. is a clinical-stage precision medicine company focused on transforming the drug discovery process through advanced computational and experimental technologies [4] - The company aims to enhance small molecule therapeutic discovery in targeted oncology and genetic disease indications [4] Leadership Appointment - Claire Mazumdar, Ph.D., has been appointed to the Board of Directors of Relay Therapeutics, effective June 9, 2025 [1] - Dr. Mazumdar brings extensive strategic and operational experience in clinical-stage oncology, which will be valuable as the company prepares to initiate its Phase 3 ReDiscover-2 trial in breast cancer [2][3] Dr. Mazumdar's Background - Dr. Mazumdar is the founding CEO of Bicara Therapeutics and has held significant roles in business development and corporate strategy at Rheos Medicines and Third Rock Ventures [3] - She holds a B.S. in biological engineering from MIT, an MBA from Stanford, and a Ph.D. in cancer biology from Stanford [3] Clinical Development Focus - Relay Therapeutics is preparing to initiate the Phase 3 ReDiscover-2 trial, which focuses on breast cancer [2] - The company utilizes its Dynamo® platform to address previously intractable protein targets in drug discovery [4]

Summary of the Conference Call Company Overview - The conference call features Relay Therapeutics, focusing on their Dynamo platform and pipeline strategy, particularly in the biotechnology sector [1][2]. Key Points on the Dynamo Platform and Pipeline - The Dynamo platform integrates computational and experimental techniques for drug discovery, leading to several programs entering clinical trials [2]. - Relay has streamlined its research portfolio to focus on generating clinical data and value for stakeholders due to current capital market conditions [2]. - The company has cash reserves projected to last until 2029, providing a strong runway for upcoming clinical catalysts [4]. Pipeline Developments - The FGFR2 program has been out-licensed to Elavar, which is expected to file an NDA soon [3][40]. - The PI3K alpha mutant selective program (ROI 2,608) is set to begin a pivotal Phase III trial, targeting a large patient population [3]. - Other pipeline assets include a vascular malformations program and two assets nearing IND status: an NRAS selective program and a fibrous program [3]. Clinical Data and Competitive Landscape - The PI3K alpha inhibitor targets a large patient population with a 40% mutation rate in hormone receptor-positive, HER2-negative breast cancer [5]. - Current therapies have shown a progression-free survival (PFS) of 5-7 months, while Relay's data indicates a PFS of over 10 months in heavily pretreated patients [11][15]. - The company aims to differentiate itself from competitors like AstraZeneca's capivasertib, which has a PFS benchmark of 5.5 months [14][15]. Safety and Efficacy - Relay's PI3K alpha inhibitor has demonstrated a clean safety profile with low rates of common toxicities associated with non-selective inhibitors [12]. - The confirmed objective response rate across all PI3K alpha mutations is 39%, with a 67% response rate in a subset of kinase domain mutations [11]. Future Trials and Strategy - The Phase III trial will focus on patients pretreated with CDK4/6 inhibitors, with plans to explore triplet combinations for earlier lines of therapy [16][24]. - The company is also considering expanding into other tumor types beyond breast cancer, such as colon and lung cancers, but will maintain focus on the current pivotal trials [31]. Vascular Malformations Program - Relay is targeting vascular malformations, a condition affecting approximately 300,000 patients in the US, with a focus on two phenotypes: PI3K-related overgrowth spectrum and lymphatic malformations [33][34]. - The company acknowledges the need for education and identification of patients due to the broad manifestations of the condition [38][39]. Manufacturing and Commercialization - Manufacturing for the small molecules is outsourced, allowing flexibility in scaling up production as needed [48]. - The company is preparing for potential commercial supply for ROI 2608, anticipating a launch later this decade [48]. Research and Development Focus - Relay is committed to generating proof of concept data and engaging with the FDA regarding accelerated approval pathways for their programs [36][46]. - The company emphasizes the importance of tangible clinical data and successful execution of pivotal trials as key to their strategy [55]. Conclusion - Relay Therapeutics is positioned strongly within the biotechnology sector, focusing on innovative drug discovery and development, with a clear strategy for clinical trials and commercialization. The company is optimistic about its pipeline and the potential for significant advancements in treating various cancers and vascular malformations [55].

Summary of Relay Therapeutics Conference Call Company Overview - **Company**: Relay Therapeutics (Ticker: RLAY) - **Focus**: Development of selective PI3K alpha inhibitors for breast cancer and vascular malformations Key Points on Breast Cancer Treatment - **Mechanism**: Relay Therapeutics is developing a selective PI3K alpha inhibitor, ROI 2,608, which has shown promising results in clinical trials - **Clinical Data**: - Achieved an **11-month progression-free survival (PFS)** in the second line of therapy combined with fulvestrant - Reported a **39% overall response rate** and a **67% response rate** in the kinase-only subset of patients [4][9] - **Patient Population**: Approximately **40%** of hormone receptor-positive, HER2-negative breast cancer patients have a PI3K alpha mutation, indicating a significant market opportunity [5] - **Comparison with Competitors**: - ROI 2,608's PFS is **2x** that of capivasertib, which has a PFS of **5.5 months** [10] - Relay's drug is positioned to have a better safety profile, addressing issues like grade three hyperglycemia and diarrhea seen with other treatments [12][13] - **Future Trials**: Plans to initiate pivotal trials in the post-CDK4/6 population, aiming to establish ROI 2,608 as a frontline therapy [8][20] Insights on Competitive Landscape - **Roche's Data**: Roche has shown an overall survival benefit with a **15-month PFS** in a triplet therapy setting, but concerns about toxicity remain [14][16] - **Patient Selection**: Relay's trials are designed to include a broader patient population, allowing for those with pre-diabetic conditions, which may enhance the applicability of their treatment [27] Vascular Malformations Opportunity - **Market Size**: Approximately **170,000** patients in the U.S. have PI3KCA mutation-driven vascular malformations, with **5,000 to 15,000** specifically in the PIK3CA-related overgrowth spectrum [46][47] - **Current Treatments**: - Sirolimus is used off-label, and alpelisib (Vijoice) has received accelerated approval but has shown significant side effects like hyperglycemia [50][54] - **Relay's Approach**: The company aims to provide a more effective and tolerable treatment option, starting with a **400 mg BID** dosing regimen in their studies [57] Regulatory Path and Future Studies - **Accelerated Approval**: There is potential for an accelerated approval pathway due to the lack of fully approved treatments in the vascular malformations space [55] - **Study Design**: The upcoming trials will utilize a randomized dose selection approach, starting at the oncology phase three dose [57] Conclusion - Relay Therapeutics is positioned to capitalize on significant unmet needs in both breast cancer and vascular malformations through innovative therapies that promise improved efficacy and safety profiles. The company is actively preparing for pivotal trials and regulatory discussions to advance its promising drug candidates.

Group 1: Amgen (AMGN.US) - Amgen's Imdelltra shows positive results in Phase 3 trial for small cell lung cancer, significantly extending patient survival compared to chemotherapy [2][3] - The trial involved 509 patients, with Imdelltra reducing the risk of death by 40%, leading to an average survival of 13.6 months versus 8.3 months for chemotherapy [2][3] - Imdelltra also demonstrated a 29% reduction in the risk of disease progression or death, with improved patient-reported symptoms and a lower incidence of severe adverse events compared to chemotherapy [3][2] - Goldman Sachs rates Amgen as "Buy" with a 12-month target price of $400, indicating a 38% upside potential from the June 3 closing price [3] Group 2: Regeneron Pharmaceuticals (REGN.US) - Regeneron's linvoseltamab shows promising results in Phase 1b LINKER-MM2 trial for relapsed/refractory multiple myeloma, achieving an 85% objective response rate (ORR) when combined with bortezomib [4][5] - The combination therapy demonstrated a 50% complete response rate (CR) and a 78% six-month progression-free survival (PFS) rate [4] - In another cohort with carfilzomib, linvoseltamab achieved a 90% ORR and a 76% CR rate, with an estimated 12-month PFS rate of 83% [7] - Goldman Sachs rates Regeneron as "Buy" with a 12-month target price of $804, indicating a 35% upside potential from the June 3 closing price [8] Group 3: Relay Therapeutics (RLAY.US) - Relay's RLY-2608 combined with fulvestrant shows encouraging results in treating PIK3CA-mutated HR+/HER2- advanced breast cancer, with a median PFS of 10.3 months [9][10] - The trial included 118 patients, with a clinical benefit rate of 67% and an objective response rate of 67% in patients with kinase mutations [9][10] - Goldman Sachs rates Relay as "Buy" with a 12-month target price of $11, indicating a 234% upside potential from the June 3 closing price [11]

Core Insights - Relay Therapeutics announced updated interim clinical data for RLY-2608, showing a median progression-free survival (PFS) of 11.0 months in second-line patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer [1][2] - The company plans to initiate a pivotal Phase 3 trial, ReDiscover-2, in mid-2025 [2][16] - RLY-2608 is the first known allosteric, pan-mutant, and isoform-selective inhibitor of PI3Kα, designed to improve tolerability and efficacy compared to standard treatments [11][12] Clinical Data Summary - The updated data indicate a median PFS of 10.3 months overall and 11.0 months for second-line patients, with a clinical benefit rate of 67% [7][8] - Among 64 patients receiving the recommended Phase 3 dose (RP3D) of 600mg BID, 44% had received two or more prior lines of therapy [5][8] - The study enrolled 118 patients with PI3Kα-mutated, HR+, HER2- locally advanced or metastatic breast cancer [4][8] Safety and Tolerability - RLY-2608 + fulvestrant was generally well tolerated, with low-grade treatment-related adverse events (TRAEs) being manageable and reversible [8][15] - Only 36% of patients experienced a Grade 3 TRAE, with no Grade 4-5 TRAEs reported [15] Future Directions - The company is progressing two front-line triplet regimens, one with atirmociclib and another with ribociclib, both currently in dose escalation [9][16] - Continued enrollment in the Phase 1/2 ReInspire study for vascular malformations is also planned [16]

Core Insights - Relay Therapeutics is a clinical-stage precision medicine company focused on transforming the drug discovery process through advanced computational and experimental technologies [2] Group 1: Company Overview - Relay Therapeutics aims to bring life-changing therapies to patients by integrating cutting-edge computational and experimental approaches [2] - The company utilizes its Dynamo® platform to target previously intractable protein targets, enhancing small molecule therapeutic discovery in oncology and genetic diseases [2] Group 2: Upcoming Events - Management will participate in two fireside chats in June 2025, specifically at the Jefferies Global Healthcare Conference on June 4 and the Goldman Sachs Global Healthcare Conference on June 11 [3] - The fireside chats will be webcast live and available for replay for up to 30 days after the events [1]

Summary of Relay Therapeutics (RLAY) FY Conference Call - May 27, 2025 Company Overview - **Company**: Relay Therapeutics (RLAY) - **Event**: Sixth Annual Oncology Innovation Summit - **Key Speakers**: Sajeev Patel (President and CEO), Don Bergstrom (President of R&D), Peter Romer (Chief Commercial Development Officer) Key Industry Insights - **Focus Area**: Oncology, specifically targeting hormone receptor positive, HER2 negative breast cancer with PI3K alpha mutations - **Market Size**: Approximately 40% of patients with hormone receptor positive, HER2 negative breast cancer have a PI3K alpha mutation, indicating a significant patient segment that is poorly treated [7][8] Core Data and Efficacy - **Drug in Focus**: RLY2608, a selective PI3K alpha inhibitor - **Clinical Data**: - Previous data showed a median progression-free survival (PFS) of 9.2 months with RLY2608 compared to 5.5 months for the control (TruCap) [4][5] - Objective response rate (ORR) for RLY2608 was 39%, with 67% in kinase mutant patients [5][10] - Upcoming ASCO presentation expected to show over a year of follow-up data, aiming to confirm the durability and consistency of these results [6][50] Clinical Trial Insights - **Phase III Trial**: Focused on CDK4 experienced patients, with a randomized design of 540 patients comparing RLY2608 to capivasertib [41][42] - **Patient Population**: Primarily second-line patients, with potential inclusion of first-line patients who have received adjuvant CDK4 inhibitors [17][29] - **Exclusion Criteria**: Patients with prior PI3K pathway inhibitors will be excluded from the trial [48] Competitive Landscape - **Current Treatments**: Previous generation non-selective PI3K inhibitors have shown limited efficacy, with PFS typically between 5.5 to 7.5 months [8] - **Market Dynamics**: The approval of Roche's triplet therapy presents competition, but RLY2608's data suggests a strong position in the market [28] Financial Position - **Cash Position**: As of Q1 2025, the company reported a cash position of $710 million, sufficient to fund the phase III trial and other ongoing studies through 2029 [85][86] - **Partnership Considerations**: The company is open to partnerships, especially given current capital market conditions [87][88] Additional Considerations - **Vascular Malformations**: The company is also exploring RLY2608 for vascular malformations, with an estimated 170,000 patients in the U.S. having PIK3CA-related conditions, of which 5,000 to 15,000 are within the PROS population [64][65] - **Regulatory Landscape**: The failure of a confirmatory study for a competing drug (Alpalocep) leaves Relay Therapeutics in a favorable position as there are currently no fully approved agents for vascular malformations [66] Conclusion - The upcoming ASCO presentation is critical for Relay Therapeutics to validate its clinical data and establish its competitive edge in the oncology market, particularly for patients with PI3K alpha mutations in breast cancer. The company is well-positioned financially and strategically to advance its clinical programs and explore potential partnerships.

Core Viewpoint - Relay Therapeutics, Inc. (RLAY) has been upgraded to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system emphasizes the correlation between changes in earnings estimates and stock price movements, indicating that revisions in earnings estimates can lead to significant price changes [4][6]. - For Relay Therapeutics, the rising earnings estimates suggest an improvement in the company's underlying business, which is expected to positively influence its stock price [5]. Earnings Estimate Revisions - For the fiscal year ending December 2025, Relay Therapeutics is projected to earn -$1.85 per share, reflecting a 21.6% change from the previous year's reported figure [8]. - Over the past three months, the Zacks Consensus Estimate for Relay Therapeutics has increased by 32.4%, indicating a positive trend in earnings expectations [8]. Zacks Rank System - The Zacks Rank system classifies stocks based on earnings estimate revisions, with only the top 20% of stocks receiving a 'Strong Buy' or 'Buy' rating, highlighting their potential for market-beating returns [9][10]. - The upgrade of Relay Therapeutics to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting a favorable outlook for the stock in the near term [10].

Summary of Relay Therapeutics Conference Call Company Overview - **Company**: Relay Therapeutics (Ticker: RLAY) - **Event**: BofA Annual Healthcare Conference - **Date**: May 14, 2025 Key Industry Insights - **Focus on Precision Oncology**: The company has faced challenges in precision oncology and is now prioritizing its PI3K program for breast cancer, indicating a strategic shift in resource allocation towards this program [2][4] - **Restructuring and Cost Management**: Relay Therapeutics has made significant reductions in its research footprint due to limited access to capital, focusing on maximizing value from its balance sheet over the next three to five years [4][5] Financial Position - **Cash Reserves**: The company currently holds $710 million in cash, which is expected to sustain operations and support studies through 2029 [5] Clinical Development - **PI3K Alpha Program**: The PI3K alpha immune selective molecule (02/1400) is identified as a key driver for the company, with plans to advance through pivotal studies [5][9] - **Upcoming Studies**: The company is preparing for the Rediscover II Phase III study, with expectations of presenting updated data at the upcoming ASCO conference [9][10] - **Vascular Malformation Study**: A new study has been initiated for a PIK3CA mutant-driven genetic disease, with an estimated 170,000 patients in the U.S. [6][53] Competitive Landscape - **Benchmarking Against Competitors**: The company is comparing its clinical data against competitors, noting that its median progression-free survival (PFS) is significantly better than the competitive benchmark of 5.5 months [12][14] - **Differentiation Strategy**: Relay Therapeutics aims to establish a next-generation profile compared to existing therapies, emphasizing the importance of being first to market in a large patient population [19][20] Regulatory Considerations - **Potential Labeling Strategies**: The company is considering the evolving landscape of CDK4/6 therapies and aims to construct studies that could lead to line-agnostic approvals [21][23] Market Opportunity - **Vascular Malformations Market**: The potential market for PIK3CA-driven vascular malformations is significant, with estimates suggesting that 10-40% of patients may seek systemic therapy, translating to a meaningful commercial opportunity [53][54] Future Directions - **Ongoing Research**: The company plans to advance its Fabry and NRAS programs to IND readiness, with decisions on further development contingent on the macro environment and business considerations [57] Additional Notes - **Safety and Efficacy**: The company believes that its experience in oncology has de-risked safety profiles for its new indications, allowing for a more favorable assessment of efficacy in younger patient populations [43][44] - **Strategic Focus**: Relay Therapeutics is maintaining a small research footprint focused on high-value oncology targets while exploring additional preclinical programs as opportunities arise [57]

[PART I. FINANCIAL INFORMATION](index=7&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements (Unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The company reported total assets of **$799.4 million** and a net loss of **$77.1 million** for Q1 2025, with revenue from a new agreement and reduced R&D expenses Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :--- | :--- | :--- | | Cash, cash equivalents, and investments | $710,355 | $781,323 | | Total Assets | $799,362 | $871,296 | | Total Liabilities | $78,281 | $93,504 | | Total Stockholders' Equity | $721,081 | $777,792 | Condensed Consolidated Statements of Operations (in thousands, except per share data) | Metric | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | :--- | :--- | :--- | | License and other revenue | $7,679 | $10,007 | | Research and development expenses | $73,809 | $82,403 | | General and administrative expenses | $18,739 | $19,799 | | Loss from operations | $(84,869) | $(90,363) | | Net loss | $(77,065) | $(81,387) | | Net loss per share, basic and diluted | $(0.46) | $(0.62) | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | $(73,210) | $(50,323) | | Net cash provided by investing activities | $42,465 | $10,531 | | Net cash provided by financing activities | $0 | $48,922 | - The company is a clinical-stage precision medicine company focused on targeted oncology and genetic diseases, with **RLY-2608** as its lead product candidate in clinical development[31](index=31&type=chunk) - The collaboration agreement with Genentech terminated in January 2025, resulting in **$0 revenue** from this source in Q1 2025 compared to **$10.0 million** in Q1 2024[69](index=69&type=chunk)[71](index=71&type=chunk)[72](index=72&type=chunk) - A new exclusive license agreement with Elevar Therapeutics for **lirafugratinib (RLY-4008)** generated **$7.7 million** in Q1 2025 revenue from upfront and material transfer payments[73](index=73&type=chunk)[75](index=75&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's pipeline advancement, reporting a Q1 2025 net loss of **$77.1 million** and a strong liquidity position of **$710.4 million** projected to fund operations into 2029 - The lead product candidate, **RLY-2608**, is in the ReDiscover Trial for breast cancer and a global Phase 2 trial for PIK3CA-related overgrowth spectrum (PROS) initiated in Q1 2025[84](index=84&type=chunk)[88](index=88&type=chunk) Comparison of Operations for the three months ended March 31 (in thousands) | Item | 2025 (in thousands) | 2024 (in thousands) | Change (in thousands) | | :--- | :--- | :--- | :--- | | License and other revenue | $7,679 | $10,007 | $(2,328) | | Research and development expenses | $73,809 | $82,403 | $(8,594) | | General and administrative expenses | $18,739 | $19,799 | $(1,060) | | Net loss | $(77,065) | $(81,387) | $4,322 | - Research and development expenses decreased by **$8.6 million** year-over-year due to strategic streamlining of the research organization[122](index=122&type=chunk) - As of March 31, 2025, the company held **$710.4 million** in cash, cash equivalents, and investments, projected to fund operations into 2029[142](index=142&type=chunk) - In Q1 2024, the company raised **$48.9 million** through various financing activities, with no financing activities in Q1 2025[140](index=140&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=35&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity on its investment portfolio, with minimal foreign currency exposure and no outstanding debt - The primary market risk is interest income sensitivity from its investment portfolio, with a hypothetical **100 basis point** adverse movement in interest rates not expected to have a material impact[152](index=152&type=chunk) - Foreign currency exchange risk is not considered material as operations are primarily U.S.-based and denominated in U.S. dollars[154](index=154&type=chunk) - As of March 31, 2025, the company had no outstanding debt, eliminating interest rate risk related to debt[153](index=153&type=chunk) [Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting during the quarter - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of **March 31, 2025**[157](index=157&type=chunk) - No material changes occurred in internal control over financial reporting during the quarter ended **March 31, 2025**[158](index=158&type=chunk) [PART II. OTHER INFORMATION](index=38&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings) The company is a nominal defendant in a stockholder derivative lawsuit filed in December 2024, alleging excessive compensation to directors and officers - A derivative complaint was filed on **December 18, 2024**, alleging excessive compensation awarded to certain directors and officers from **2021 to 2023**[162](index=162&type=chunk) - The company is unable to predict the outcome or any reasonably possible loss related to this matter[162](index=162&type=chunk) [Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) The company faces extensive risks including clinical development uncertainty, reliance on third parties, significant capital needs, intellectual property challenges, and complex regulatory environments [Risks Related to Clinical Development and Commercialization](index=38&type=section&id=Risks%20Related%20to%20Clinical%20Development%20and%20Commercialization) The company faces inherent risks in clinical development, including trial uncertainties, patient enrollment challenges, and the potential for early-stage data not to predict later success - The company has never successfully completed any large-scale, pivotal clinical trials and may be unable to do so for any product candidates[164](index=164&type=chunk) - Positive data from preclinical or early clinical studies are not necessarily predictive of later clinical study results[178](index=178&type=chunk) - The company faces substantial competition, potentially leading to others more successfully discovering, developing, or commercializing products[201](index=201&type=chunk) - Failure to obtain or maintain adequate insurance coverage and reimbursement for approved products could limit marketability and revenue generation[206](index=206&type=chunk) [Risks Related to Reliance on Third Parties](index=51&type=section&id=Risks%20Related%20to%20Reliance%20on%20Third%20Parties) The company's high dependence on third-party CROs and CMOs, including sole-source suppliers, creates significant risks for clinical trials, manufacturing, and supply chain continuity - The company relies on third-party CROs for clinical trials, and their unsuccessful performance could hinder regulatory approval or commercialization[211](index=211&type=chunk) - Contracting with third parties for manufacturing increases the risk of insufficient quantities, unacceptable cost, or quality, potentially impairing development[222](index=222&type=chunk) - Active pharmaceutical ingredients (API) and other starting materials are supplied by single-source suppliers, whose loss could significantly harm the business[230](index=230&type=chunk) - Collaboration with **D.E. Shaw Research (DESRES)** for protein models using their proprietary supercomputer, **Anton 2**, is critical, and any termination could adversely affect research[242](index=242&type=chunk) [Risks Related to Financial Position and Capital Needs](index=62&type=section&id=Risks%20Related%20to%20Financial%20Position%20and%20Capital%20Needs) The company, a clinical-stage entity with limited operating history, had an accumulated deficit of **$1.8 billion** and will require substantial additional funding, which may dilute stockholders - The company, a biopharmaceutical entity with limited operating history, had an accumulated deficit of **$1.8 billion** as of **March 31, 2025**[250](index=250&type=chunk) - Substantial additional funding is required; failure to raise capital could force delays, reductions, or elimination of product development programs[258](index=258&type=chunk) - Raising additional capital may dilute stockholders, restrict operations, or necessitate relinquishing rights to technologies or product candidates[264](index=264&type=chunk) [Risks Related to Intellectual Property](index=70&type=section&id=Risks%20Related%20to%20Intellectual%20Property) The company's success relies heavily on obtaining and maintaining intellectual property protection, facing risks of patent invalidation, infringement claims, and the need to protect trade secrets - Obtaining and maintaining broad patent protection for its technology and products is uncertain but critical for commercial success[273](index=273&type=chunk) - Third parties may initiate legal proceedings alleging infringement of their intellectual property rights, with uncertain outcomes that could materially affect the business[292](index=292&type=chunk) - The company may face expensive and time-consuming lawsuits to protect or enforce its own patents and intellectual property rights[295](index=295&type=chunk) - Changes to patent law in the U.S. and other jurisdictions could diminish patent value and impair product candidate protection[312](index=312&type=chunk) [Risks Related to Government Regulation and Healthcare Reform](index=82&type=section&id=Risks%20Related%20to%20Government%20Regulation%20and%20Healthcare%20Reform) Operating in a highly regulated environment, the company faces risks from ongoing regulatory obligations, data privacy laws, healthcare reforms like the IRA, and potential FDA policy shifts impacting product development and pricing - Even with product approval, extensive ongoing regulatory obligations apply, and non-compliance can lead to significant penalties or market withdrawal[316](index=316&type=chunk)[317](index=317&type=chunk) - Restrictive data privacy regulations, including **GDPR** and **CCPA**, impose significant compliance costs and risks on the company[322](index=322&type=chunk)[328](index=328&type=chunk) - Healthcare legislative reforms, such as the **Inflation Reduction Act of 2022 (IRA)**, may materially affect the business by impacting drug pricing and reimbursement[358](index=358&type=chunk)[360](index=360&type=chunk) - Disruptions at the **FDA** and other government agencies due to funding shortages or policy changes could hinder timely product review and approval[365](index=365&type=chunk) [Risks Related to Operations, Personnel, and Corporate Governance](index=99&type=section&id=Risks%20Related%20to%20Operations%2C%20Personnel%2C%20and%20Corporate%20Governance) Internal risks include retaining key personnel, managing growth, cybersecurity threats, stock price volatility, and concentrated insider ownership, alongside anti-takeover provisions - Future success depends on retaining key executives and scientists and attracting qualified personnel in a highly competitive environment[370](index=370&type=chunk) - Internal IT systems are vulnerable to cybersecurity breaches, potentially disrupting development programs and compromising sensitive information[382](index=382&type=chunk) - The common stock's trading price has been and may remain volatile, potentially leading to securities class action litigation[394](index=394&type=chunk) - Executive officers, directors, and principal stockholders control approximately **42.8%** of outstanding common stock, limiting other stockholders' influence on corporate matters[399](index=399&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=115&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of its equity securities during the three months ended **March 31, 2025** - The company reported no unregistered sales of equity securities for the period[416](index=416&type=chunk) [Other Information](index=116&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted, modified, or terminated Rule 10b5-1 trading plans during the first quarter of **2025** - During the three months ended **March 31, 2025**, no directors or officers adopted, modified, or terminated a Rule 10b5-1 trading plan[418](index=418&type=chunk) [Exhibits](index=117&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate governance documents and officer certifications required by the **Sarbanes-Oxley Act** - The report includes a list of filed exhibits, such as corporate governance documents and officer certifications required under the **Sarbanes-Oxley Act (SOX)**[419](index=419&type=chunk)