Relay Therapeutics
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Relay Therapeutics(RLAY) - 2025 Q1 - Quarterly Report
2025-05-05 20:15
[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)
Relay Therapeutics(RLAY) - 2025 Q1 - Quarterly Results
2025-05-05 20:10
Exhibit 99.1 Relay Therapeutics Reports First Quarter 2025 Financial Results and Corporate Updates Cash runway extended into 2029 Initiation of Phase 3 ReDiscover-2 trial on track for mid-2025 Initiated Phase 1 RLY-2608 vascular malformations clinical trial in Q1 Extended cash runway expected to fully fund the Company meaningfully past topline data for ReDiscover-2 trial and through clinical proof-of-concept data in Vascular Malformations Approximately $710 million in cash, cash equivalents and investments ...
Relay Therapeutics Reports First Quarter 2025 Financial Results and Corporate Updates
Globenewswire· 2025-05-05 20:05
Core Insights - Relay Therapeutics has extended its cash runway into 2029, with approximately $710 million in cash, cash equivalents, and investments as of March 31, 2025, which is expected to fund key initiatives including the ReDiscover-2 trial and vascular malformations clinical trial [1][5][6] Financial Performance - Revenue for Q1 2025 was $7.7 million, a decrease from $10.0 million in Q1 2024, primarily due to the completion of performance obligations under an Exclusive License Agreement with Elevar [6] - Research and development expenses decreased to $73.8 million in Q1 2025 from $82.4 million in Q1 2024, attributed to strategic cost reductions [7] - General and administrative expenses also saw a decline, totaling $18.7 million in Q1 2025 compared to $19.8 million in Q1 2024 [8] - The net loss for Q1 2025 was $77.1 million, or $0.46 per share, an improvement from a net loss of $81.4 million, or $0.62 per share, in Q1 2024 [9][14] Strategic Initiatives - The company has implemented strategic cost reductions aimed at fully funding key value drivers, including the completion of the ReDiscover-2 Phase 3 trial and the initiation of the RLY-2608 Phase 1 trial for vascular malformations [2][4] - Specific cost-saving measures included reducing the research run rate spend by approximately 80% and decreasing research-stage programs from four to one [4] - A reduction in workforce by approximately 70 people was executed, alongside a global out-license of RLY-4008 with Elevar Therapeutics, which has potential for downstream economics [4] Clinical Development - The initiation of the Phase 3 ReDiscover-2 trial of RLY-2608 in combination with fulvestrant for advanced breast cancer is on track for mid-2025 [4] - An abstract has been accepted for presentation at ASCO, focusing on updated efficacy data for RLY-2608 in combination with fulvestrant [4] - The Phase 1 trial for vascular malformations was initiated in Q1 2025 [4]
Relay Therapeutics to Announce First Quarter 2025 Financial Results and Corporate Highlights on May 5, 2025
Globenewswire· 2025-04-28 20:05
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] Financial Results Announcement - Relay Therapeutics will report its first quarter 2025 financial results and corporate highlights on May 5, 2025, after U.S. financial markets close [1] Company Overview - The company utilizes its Dynamo® platform, which integrates various computational and experimental approaches to target previously challenging protein targets in drug discovery [2] - Relay Therapeutics aims to enhance small molecule therapeutic discovery specifically in targeted oncology and genetic disease indications [2]
Cogent Biosciences (COGT) FY Conference Transcript
2023-01-12 16:30
Summary of Cogent Biosciences Conference Call Company Overview - **Company**: Cogent Biosciences - **Lead Product**: Bezuclasinib, a drug targeting KIT mutations, particularly D816V, associated with systemic mastocytosis and gastrointestinal stromal tumors (GIST) [4][6] Key Points and Arguments Product Development and Pipeline - **Bezuclasinib** is in development for two subgroups of mastocytosis and in a global Phase III trial for GIST [4][6] - The company has a strong cash position, expected to last until 2025, allowing for continued development of its pipeline [6][40] - The company is running three clinical studies: APeX, SUMMIT, and PEEK, which could serve as the basis for registration if successful [6][14] Competitive Landscape - In GIST, the current standard of care is **Sunitinib**, which has limitations against certain mutations [10][12] - Bezuclasinib is positioned to cover all secondary resistance mutations, potentially leading to better outcomes in combination with Sunitinib [12][30] - In systemic mastocytosis, Bezuclasinib competes with **Avapritinib** and **BLU-263**, with a focus on a better tolerability profile [13][61] Market Potential - The total available market in the U.S. for the targeted indications is estimated at **$2.5 billion**, with a global potential of **$3.5 billion** [14][65] - The systemic mastocytosis market is projected to be around **$300 million** in the U.S. and **$500 million** globally [65] Clinical Data and Efficacy - The APeX study has shown an objective response rate of **73%**, increasing to **89%** in treatment-naive patients [19][20] - The safety profile of Bezuclasinib is favorable, with no significant cognitive effects or bleeding events reported [21][22] - The company plans to initiate investigations of Bezuclasinib in combination with other therapies to enhance its market position [24] Future Catalysts - Upcoming milestones include updates from the APeX study, results from the Phase III PEEK study, and progress on early-stage programs targeting FGFR2 and ErbB2 [38][39][40] Important but Overlooked Content - The company emphasizes the unmet need for effective therapies in systemic mastocytosis, particularly for the indolent form of the disease, where current options are limited [15][17] - The potential for Bezuclasinib to be used alongside other hematologic therapies could unlock significant market opportunities that competitors may not address effectively [65] Conclusion Cogent Biosciences is strategically positioned in the precision medicine space with its lead product, Bezuclasinib, targeting rare diseases driven by genetic mutations. The company is focused on demonstrating clinical efficacy and safety to capture a significant share of the market, while navigating a competitive landscape with limited alternatives for patients.
Relay Therapeutics(RLAY) - 2021 Q1 - Quarterly Report
2021-05-13 20:31
[PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements for Q1 2021 and 2020, including balance sheets, operations, cash flows, and key accounting notes [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$771.3 million** as of March 31, 2021, primarily due to a reduction in cash offset by increased investments Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2021 | December 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $262,720 | $447,646 | | Investments | $463,355 | $230,415 | | Total current assets | $742,434 | $770,100 | | **Total assets** | **$771,346** | **$799,829** | | **Liabilities & Equity** | | | | Total current liabilities | $16,083 | $13,632 | | **Total liabilities** | **$38,560** | **$36,536** | | **Total stockholders' equity** | **$732,786** | **$763,293** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company recognized its first collaboration revenue while operating expenses significantly increased, widening the net loss to **$42.2 million** for Q1 2021 Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended Mar 31, 2021 | Three Months Ended Mar 31, 2020 | | :--- | :--- | :--- | | Collaboration revenue | $952 | $0 | | Research and development expenses | $30,622 | $21,700 | | General and administrative expenses | $12,735 | $4,758 | | Loss from operations | ($42,405) | ($26,458) | | **Net loss** | **($42,184)** | **($24,886)** | | **Net loss per share, basic and diluted** | **($0.47)** | **($5.99)** | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash provided by operating activities significantly improved to **$46.6 million** in Q1 2021, driven by Genentech receivable collection, while investing activities used **$233.6 million** Cash Flow Summary (in thousands) | Cash Flow Activity | Three Months Ended Mar 31, 2021 | Three Months Ended Mar 31, 2020 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $46,640 | ($22,334) | | Net cash provided by (used in) investing activities | ($233,621) | $50,371 | | Net cash provided by financing activities | $2,055 | $351 | | **Net (decrease) increase in cash** | **($184,926)** | **$28,388** | [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes detail the Genentech collaboration, the subsequent acquisition of ZebiAI Therapeutics, and commitments under the D.E. Shaw Research agreement - In December 2020, the company entered into a collaboration and license agreement with Genentech for RLY-1971, receiving a **$75 million** upfront payment in January 2021. The company is eligible for up to **$695 million** in additional milestones plus tiered royalties[49](index=49&type=chunk)[50](index=50&type=chunk) - As a subsequent event, on April 15, 2021, the company acquired ZebiAI Therapeutics, Inc. for approximately **$85 million** in upfront consideration (**$20 million** cash, **$65 million** stock) plus potential future milestone payments[70](index=70&type=chunk) - The collaboration agreement with D. E. Shaw Research was amended to increase the annual fee from **$7.9 million** to **$9.875 million**, commencing August 16, 2021[66](index=66&type=chunk) Stock-Based Compensation Expense (in thousands) | Expense Category | Three Months Ended Mar 31, 2021 | Three Months Ended Mar 31, 2020 | | :--- | :--- | :--- | | Research and development | $4,151 | $897 | | General and administrative | $5,520 | $558 | | **Total** | **$9,671** | **$1,455** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the clinical pipeline, increased operating expenses, **$1.0 million** in collaboration revenue, and the company's liquidity position expected to fund operations into 2024 - The company's cash, cash equivalents, and investments of **$726.1 million** as of March 31, 2021, are expected to fund operating expenses and capital expenditure requirements into 2024[85](index=85&type=chunk)[111](index=111&type=chunk) Comparison of Results of Operations (in thousands) | Metric | Three Months Ended Mar 31, 2021 | Three Months Ended Mar 31, 2020 | | :--- | :--- | :--- | | Revenue | $952 | $0 | | Research and development | $30,622 | $21,700 | | General and administrative | $12,735 | $4,758 | | **Loss from operations** | **($42,405)** | **($26,458)** | - R&D expenses increased by **$8.9 million** year-over-year, primarily due to a **$5.5 million** increase in employee-related costs (including **$3.3 million** in stock-based compensation) and a **$1.7 million** increase in clinical trial expenses for RLY-1971 and RLY-4008[100](index=100&type=chunk) - G&A expenses increased by **$8.0 million** year-over-year, mainly due to a **$6.2 million** increase in personnel costs (including **$5.0 million** in stock-based compensation) and a **$1.7 million** increase in other expenses like insurance[101](index=101&type=chunk) - In April 2021, the company acquired ZebiAI Therapeutics for upfront consideration of approximately **$85.0 million** (**$20.0 million** in cash and **$65.0 million** in common stock), with potential for additional milestone payments[86](index=86&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=24&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 exchange risk due to U.S.-denominated operations - The company's main market risk is interest rate sensitivity on its cash and investment portfolio. A hypothetical **100 basis point** adverse movement is not expected to have a material impact[123](index=123&type=chunk) - Foreign currency exchange risk is not significant as operations are located in the United States and expenses are generally denominated in U.S. dollars[125](index=125&type=chunk) [Controls and Procedures](index=25&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2021, with no material changes to internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report[127](index=127&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[128](index=128&type=chunk) [PART II. OTHER INFORMATION](index=26&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=26&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings expected to have a material adverse effect on its business - The company is not currently involved in any legal proceedings expected to have a material adverse effect on its business[132](index=132&type=chunk) [Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including limited operating history, reliance on third parties for clinical development, need for substantial funding, and challenges related to competition and regulatory hurdles - The company has a limited operating history, has never successfully completed any clinical trials, and has incurred significant operating losses since inception, with an accumulated deficit of **$446.4 million** as of March 31, 2021[134](index=134&type=chunk)[207](index=207&type=chunk) - The business is highly dependent on its collaboration with D. E. Shaw Research and its proprietary supercomputer, Anton 2, for the Dynamo™ platform. Termination of this agreement could materially harm the business[174](index=174&type=chunk)[175](index=175&type=chunk) - The company relies on third parties to conduct clinical trials and manufacture product candidates, increasing risks related to quality, compliance, and supply chain disruptions[181](index=181&type=chunk)[188](index=188&type=chunk) - Substantial additional funding will be required to continue operations. Failure to raise capital when needed could force the company to delay, reduce, or eliminate development programs[212](index=212&type=chunk) - The COVID-19 pandemic poses a risk of material adverse effects on the business, including potential disruptions to clinical trials, supply chains, and employee productivity[221](index=221&type=chunk) - The company is an "emerging growth company" and a "smaller reporting company," which allows for reduced disclosure requirements that could make its common stock less attractive to investors[327](index=327&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=65&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 period covered by this Form 10-Q - There were no unregistered sales of equity securities during the quarter[352](index=352&type=chunk) [Other Information](index=65&type=section&id=Item%205.%20Other%20Information) This section discloses significant agreements, including an amended collaboration with D. E. Shaw Research and a retention agreement with a key executive - On May 12, 2021, the company amended its agreement with D. E. Shaw Research (DESRES), increasing the annual fee from **$7.9 million** to approximately **$9.9 million**, effective August 16, 2021[353](index=353&type=chunk) - On May 10, 2021, the company entered into a retention agreement with Donald Bergstrom, M.D., Ph.D., providing for two potential cash retention payments of **$600,000** each on May 31, 2023, and May 31, 2024, contingent on his continued employment[355](index=355&type=chunk)[356](index=356&type=chunk) [Exhibits](index=66&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the quarterly report, including the ZebiAI merger agreement, D. E. Shaw Research amendment, and executive retention agreement - Key exhibits filed include the merger agreement for ZebiAI, amendments to the D. E. Shaw Research collaboration, and an executive retention agreement[358](index=358&type=chunk) [Signatures](index=67&type=section&id=Signatures) - The report was duly signed on May 13, 2021, by Sanjiv K. Patel, M.D., President and Chief Executive Officer, and Thomas Catinazzo, Senior Vice President, Finance[364](index=364&type=chunk)