Cash guidance remains unchanged, and is expected to fund operations into second half of 2026 CAMBRIDGE, Mass., June 06, 2024 (GLOBE NEWSWIRE) -- Relay Therapeutics, Inc. (NASDAQ:RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, will provide details on the company's portfolio during its New Program & Platform event today, June 6, 2024, from 8:00 to 10:00 a.m. ET. As part of the event, the company w ...

CAMBRIDGE, Mass., May 21, 2024 (GLOBE NEWSWIRE) -- Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, today announced that management will participate in two upcoming fireside chats: The fireside chats will be webcast live and may be accessed through Relay Therapeutics' website under Events in the News & Events section through the following link: https://ir.relaytx ...

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) The unaudited financial statements show a net loss of $81.4 million, an improvement from the prior year, with total assets at $841.4 million and strong liquidity [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets were $841.4 million as of March 31, 2024, with total liabilities at $95.7 million, maintaining strong liquidity Balance Sheet Items (In thousands) | Balance Sheet Items (In thousands) | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $152,866 | $143,736 | | Investments | $596,742 | $606,350 | | Total current assets | $770,100 | $770,103 | | **Total assets** | **$841,441** | **$843,980** | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $37,144 | $30,269 | | **Total liabilities** | **$95,677** | **$91,977** | | **Total stockholders' equity** | **$745,764** | **$752,003** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Total revenue reached $10.0 million, leading to a net loss of $81.4 million, an improvement from $94.2 million in the prior-year quarter Income Statement Items (In thousands, except per share data) | Income Statement Items (In thousands, except per share data) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | License and other revenue | $10,007 | $226 | | Research and development expenses | $82,403 | $82,827 | | General and administrative expenses | $19,799 | $19,579 | | Loss from operations | ($90,363) | ($101,177) | | **Net loss** | **($81,387)** | **($94,239)** | | **Net loss per share, basic and diluted** | **($0.62)** | **($0.78)** | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations was $50.3 million, offset by $48.9 million from financing, resulting in a $9.1 million cash increase Cash Flow Activities (In thousands) | Cash Flow Activities (In thousands) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | ($50,323) | ($67,130) | | Net cash provided by investing activities | $10,531 | $75,314 | | Net cash provided by financing activities | $48,922 | $1,297 | | **Net increase in cash, cash equivalents, and restricted cash** | **$9,130** | **$9,481** | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's clinical-stage business, $10.0 million Genentech revenue, and capital raises, confirming sufficient funding for one year - The company is a clinical-stage precision medicine company with lead product candidates RLY-2608, RLY-4008 (lirafugratinib), and GDC-1971 (migoprotafib) in clinical development[30](index=30&type=chunk) - The company expects its existing cash, cash equivalents, and investments of **$749.6 million** will fund planned operating expenses and capital expenditures for at least one year from the date of the financial statements[34](index=34&type=chunk) - In Q1 2024, the company sold **1,889,597 shares** under its At-the-Market (ATM) offering, receiving net proceeds of **$17.9 million**[54](index=54&type=chunk) - In January 2024, the company completed a private placement of **2,500,000 shares**, receiving net proceeds of **$29.8 million**[55](index=55&type=chunk) - The company recognized **$10.0 million** in revenue from the Genentech Agreement during Q1 2024, related to the achievement of a specified milestone[62](index=62&type=chunk)[64](index=64&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses improved Q1 2024 net loss of $81.4 million due to milestone revenue, with $749.6 million cash expected to fund operations into 2026 - The company is advancing its pipeline, including Lirafugratinib (FGFR2 inhibitor), RLY-2608 (PI3Kα inhibitor), and Migoprotafib (SHP2 inhibitor), with several clinical trials ongoing[74](index=74&type=chunk)[75](index=75&type=chunk)[76](index=76&type=chunk) - The company believes its cash, cash equivalents, and investments of **$749.6 million** as of March 31, 2024, will be sufficient to fund operating expenses and capital expenditure requirements into the second half of 2026[88](index=88&type=chunk)[124](index=124&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) Revenue increased by $9.8 million due to a Genentech milestone, leading to an improved net loss of $81.4 million for Q1 2024 Financial Metric (In thousands) | Financial Metric (In thousands) | Q1 2024 | Q1 2023 | Change | | :--- | :--- | :--- | :--- | | License and other revenue | $10,007 | $226 | $9,781 | | Research and development expenses | $82,403 | $82,827 | ($424) | | General and administrative expenses | $19,799 | $19,579 | $220 | | **Net loss** | **($81,387)** | **($94,239)** | **$12,852** | - The increase in revenue was primarily due to a **$10.0 million** milestone payment achieved under the Genentech Agreement in Q1 2024[105](index=105&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) The company holds $749.6 million in cash and investments, with $50.3 million used in operations, sufficient to fund into 2026 Cash Flow Summary (In thousands) | Cash Flow Summary (In thousands) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Cash used in operating activities | ($50,323) | ($67,130) | | Cash provided by investing activities | $10,531 | $75,314 | | Cash provided by financing activities | $48,922 | $1,297 | - In Q1 2024, the company received **$29.8 million** in net proceeds from a private placement and **$17.9 million** from at-the-market offerings[113](index=113&type=chunk)[114](index=114&type=chunk)[122](index=122&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=35&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Primary market risk is interest rate sensitivity on investments, with minimal impact from a 100 basis point change and negligible foreign currency risk - The company's main market risk is interest rate sensitivity on its investment portfolio, but a hypothetical **100 basis point** adverse movement is not expected to have a material impact[133](index=133&type=chunk) - Foreign currency exchange risk is not material as expenses are generally denominated in U.S. dollars[135](index=135&type=chunk) [Item 4. Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were effective as of March 31, 2024, with no material changes to internal control over financial reporting - Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2024[137](index=137&type=chunk) - No material changes were made to the company's internal control over financial reporting during the first quarter of 2024[138](index=138&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings deemed to have a material adverse effect on its business - The company is not currently a party to any material legal proceedings[141](index=141&type=chunk) [Item 1A. Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) Key risks include clinical development uncertainty, reliance on third parties, financial losses, need for capital, competition, and intellectual property protection - The company has a limited operating history, has incurred significant operating losses since inception, and anticipates continued losses for the foreseeable future[9](index=9&type=chunk)[225](index=225&type=chunk)[227](index=227&type=chunk) - Clinical product development is a lengthy, expensive process with an uncertain outcome, and positive data from early studies are not necessarily predictive of later results[9](index=9&type=chunk)[145](index=145&type=chunk)[155](index=155&type=chunk) - The company relies on third parties to conduct clinical trials and manufacture its product candidates, which poses risks to timelines, quality, and regulatory compliance[9](index=9&type=chunk)[189](index=189&type=chunk)[197](index=197&type=chunk) - The company will need to raise substantial additional funding, and an inability to do so could force it to delay, reduce, or eliminate product development programs[9](index=9&type=chunk)[231](index=231&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=104&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) In January 2024, the company completed a private placement, selling 2,500,000 shares for net proceeds of $29.8 million - In January 2024, the company sold **2,500,000 shares** of common stock in a private placement for net proceeds of **$29.8 million**[375](index=375&type=chunk) [Item 5. Other Information](index=105&type=section&id=Item%205.%20Other%20Information) This section discloses the adoption and termination of Rule 10b5-1 trading plans by several executive officers during the quarter Name (Title) | Name (Title) | Action Taken (Date) | Type of Arrangement | | :--- | :--- | :--- | | Sanjiv K. Patel (CEO) | Termination (02/26/2024) | Rule 10b5-1 trading arrangement | | Sanjiv K. Patel (CEO) | Adoption (02/27/2024) | Rule 10b5-1 trading arrangement | | Thomas Catinazzo (CFO) | Termination (01/26/2024) | Rule 10b5-1 trading arrangement | | Thomas Catinazzo (CFO) | Adoption (02/15/2024) | Rule 10b5-1 trading arrangement | | Peter Rahmer (Chief Corp. Dev. Officer) | Termination (02/15/2024) | Rule 10b5-1 trading arrangement | | Peter Rahmer (Chief Corp. Dev. Officer) | Adoption (02/22/2024) | Rule 10b5-1 trading arrangement | | Brian Adams (Chief Legal Officer) | Termination (01/23/2024) | Rule 10b5-1 trading arrangement | [Item 6. Exhibits](index=106&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed, including the Securities Purchase Agreement and certifications from the Principal Executive and Financial Officers - The report includes required certifications from the CEO and CFO (Exhibits 31.1, 31.2, 32.1) and the Securities Purchase Agreement from the January 2024 private placement (Exhibit 10.1)[379](index=379&type=chunk)

Exhibit 99.1 Relay Therapeutics Reports First Quarter 2024 Financial Results and Corporate Highlights Approximately $750 million in cash, cash equivalents and investments at end of Q1 2024, expected to fund operations into second half of 2026 Cambridge, Mass. – May 2, 2024 – Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, today reported first quarter 2024 financ ...

Part I [Business](index=6&type=section&id=Item%201.%20Business) Relay Therapeutics is a clinical-stage precision medicine company utilizing its proprietary Dynamo™ platform to design therapies against previously intractable protein targets, focusing on oncology and genetic diseases [Overview and Pipeline](index=6&type=section&id=Overview%20and%20Pipeline) Relay Therapeutics is a clinical-stage precision medicine company using its Dynamo™ platform, which integrates computational and experimental methods to target protein motion for drug discovery - The company's core drug discovery approach, termed Motion-Based Drug Design®, analyzes protein motion to identify novel ways to drug targets, moving beyond the industry-standard static view of protein structures[24](index=24&type=chunk) Clinical and Preclinical Pipeline Overview | Target/Franchise | Program | Stage | | :--- | :--- | :--- | | **PI3Kα** | RLY-2608 (Monotherapy, Doublet, Triplet) | Early Clinical | | **FGFR2** | Lirafugratinib (RLY-4008) | Early Clinical | | **SHP2** | Migoprotafib (GDC-1971) with Genentech | Early Clinical (3 ongoing combo studies) | | **CDK2** | RLY-2139 | Preclinical (Paused; IND ready) | | **ERα** | RLY-1013 (Degrader) | Preclinical (Paused at DC) | | **Solid Tumor** | 2 programs | Preclinical | | **Genetic Disease** | 2 programs | Preclinical | [Clinical Stage Programs](index=11&type=section&id=Clinical%20Stage%20Programs) The company is advancing three product candidates in clinical trials, including RLY-2608 for breast cancer, lirafugratinib for FGFR2-altered solid tumors, and migoprotafib in collaboration with Genentech - **RLY-2608 (PI3Kα Inhibitor):** The ReDiscover trial is evaluating RLY-2608 as a monotherapy, in combination with fulvestrant, and in a triplet combination for HR+, HER2–, PI3Kα-mutated breast cancer, showing a clinical benefit rate (CBR) of **86%** in seven evaluable patients at the 600 mg BID dose with fulvestrant[31](index=31&type=chunk)[67](index=67&type=chunk)[72](index=72&type=chunk) - **Lirafugratinib (FGFR2 Inhibitor):** The ReFocus trial has completed enrollment for its pivotal cohort in FGFR2-fusion cholangiocarcinoma (CCA) and has sufficient enrollment in tumor-agnostic arms, with interim data showing confirmed objective response rates (cORRs) between **58%** and **82%** in treatment-naïve, FGFR2-fusion CCA patients[75](index=75&type=chunk)[96](index=96&type=chunk)[99](index=99&type=chunk) - **Migoprotafib (SHP2 Inhibitor):** Development is led by Genentech under a global collaboration, with three Phase 1b combination trials initiated: with its KRAS G12C inhibitor (GDC-6036), its PD-L1 antibody (atezolizumab), and with EGFR inhibitors (osimertinib or cetuximab)[104](index=104&type=chunk) [Collaborations](index=27&type=section&id=Collaborations) Relay Therapeutics maintains two key strategic collaborations: one with D. E. Shaw Research for computational modeling and another with Genentech for the global development of migoprotafib - Under the DESRES Agreement, Relay pays an annual collaboration fee, increased to **$9.9 million** in 2021, and is obligated to pay development and regulatory milestones up to **$7.3 million** for each of the first three products, plus sales milestones and low single-digit royalties[125](index=125&type=chunk)[126](index=126&type=chunk) - The Genentech Agreement for migoprotafib provided a **$75.0 million** upfront payment and **$45.0 million** in milestones through the report date, with Relay eligible for up to **$675.0 million** in additional milestones and tiered low-to-mid teen royalties on worldwide net sales[132](index=132&type=chunk) [Intellectual Property](index=29&type=section&id=Intellectual%20Property) The company protects its technology through patents, trade secrets, and know-how, with key candidates having co-owned or wholly owned patent applications and issued patents covering composition of matter, methods of use, and manufacturing - **RLY-2608 (PI3Kα):** Co-owned pending U.S. and foreign patent applications covering composition of matter would expire in **2041**, while wholly owned pending applications for isotopologs and solid forms would expire in **2042**[141](index=141&type=chunk)[142](index=142&type=chunk) - **Lirafugratinib (FGFR2):** Co-owned pending U.S. and foreign applications covering the inhibitors would expire in **2040**, with wholly owned pending applications for salts and solid forms expiring in **2041**[143](index=143&type=chunk)[144](index=144&type=chunk) - **Migoprotafib (SHP2):** Wholly owns a U.S. patent for composition of matter scheduled to expire in **2039**, with other pending applications for solid forms and manufacturing methods expiring in **2040**[145](index=145&type=chunk) [Governmental Regulation](index=33&type=section&id=Governmental%20Regulation) The company's operations are subject to extensive regulation by the FDA and similar international authorities, covering all stages from research and development to manufacturing and commercialization - The FDA drug approval process involves extensive preclinical studies, an effective IND application, and adequate and well-controlled clinical trials (Phase 1, 2, 3) to establish safety and efficacy before an NDA can be submitted and approved[155](index=155&type=chunk)[162](index=162&type=chunk) - The Inflation Reduction Act of 2022 (IRA) could impact the business by allowing the U.S. government to negotiate Medicare drug prices, requiring rebates for price increases faster than inflation, and capping out-of-pocket costs for Medicare beneficiaries[203](index=203&type=chunk) - Operations in Europe are subject to the GDPR and UK GDPR, which impose strict rules on the processing and cross-border transfer of personal data, with significant fines for non-compliance[228](index=228&type=chunk)[229](index=229&type=chunk) [Human Capital Resources](index=49&type=section&id=Human%20Capital%20Resources) As of December 31, 2023, Relay Therapeutics had 323 full-time employees, with 80% engaged in research and development, emphasizing diversity and inclusion - As of December 31, 2023, the company had **323** full-time employees, of which **140** hold M.D. or Ph.D. degrees[230](index=230&type=chunk) - The workforce is **47%** female and **53%** male, with approximately **30%** of leadership (VP level and above) being female, and **29%** of employees identifying as being from diverse racial and ethnic groups[231](index=231&type=chunk) [Risk Factors](index=51&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks, including those related to its limited operating history, history of net losses, and the uncertain and expensive nature of clinical drug development - The company has a limited operating history, has never successfully completed a pivotal clinical trial, has no approved products, and has incurred significant operating losses since inception, with an accumulated deficit of **$1.4 billion** as of December 31, 2023[242](index=242&type=chunk)[320](index=320&type=chunk) - The business is highly dependent on third parties for conducting clinical trials (CROs) and manufacturing product candidates (CMOs), creating risks related to performance, regulatory compliance, and supply chain continuity[285](index=285&type=chunk)[294](index=294&type=chunk) - Substantial additional funding will be required to continue operations and advance the product pipeline, and failure to raise capital when needed could force the company to delay, reduce, or eliminate development programs[327](index=327&type=chunk) - The company's success depends on its ability to obtain and maintain patent protection for its technology and products, as the patent landscape is uncertain and competitors could develop similar products, impairing the company's ability to commercialize its technology[339](index=339&type=chunk) [Cybersecurity](index=99&type=section&id=Item%201C.%20Cybersecurity) Relay Therapeutics has implemented a cybersecurity risk management program overseen by the Director of IT Operations and Information Security, with governance involving senior leadership and Board oversight - The cybersecurity program is managed by the Director of IT Operations and Information Security, who reports to the VP of Information Technology and Facilities[466](index=466&type=chunk)[468](index=468&type=chunk) - Oversight is provided by the Audit Committee of the Board of Directors, which regularly receives reports on information security risks, mitigation strategies, and cyber initiatives[468](index=468&type=chunk)[470](index=470&type=chunk) - A Relay Information Security Council (RISC), composed of senior leaders from finance, legal, HR, and R&D, provides input on cyber strategies and assists in evaluating incidents[469](index=469&type=chunk) [Properties](index=100&type=section&id=Item%202.%20Properties) The company's corporate headquarters, including office and laboratory space, are located in Cambridge, Massachusetts, across two leased facilities totaling approximately 88,105 square feet - The company leases two primary facilities in Cambridge, MA: **46,631 sq. ft.** at 399 Binney Street (lease expires April 2029) and **41,474 sq. ft.** at 60 Hampshire Street (lease expires June 2032)[472](index=472&type=chunk) [Legal Proceedings](index=100&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently a party to any legal proceedings that are expected to have a material adverse effect on its business - As of the report date, Relay Therapeutics is not involved in any material legal proceedings[474](index=474&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=101&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on the Nasdaq Global Market under the symbol "RLAY" since its IPO on July 16, 2020, and it does not anticipate paying cash dividends in the foreseeable future - The company's common stock trades on the Nasdaq Global Market under the symbol "**RLAY**"[478](index=478&type=chunk) - The company has never declared or paid cash dividends and does not intend to in the foreseeable future[480](index=480&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=103&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) For the year ended December 31, 2023, Relay Therapeutics reported a net loss of **$342.0 million**, an increase from **$290.5 million** in 2022, driven by higher R&D expenses, with **$750.1 million** in cash expected to fund operations into the second half of 2026 [Results of Operations](index=109&type=section&id=Results%20of%20Operations) For FY 2023, revenue increased to **$25.5 million** from **$1.4 million** in FY 2022, primarily due to the Genentech agreement, while R&D expenses rose by **$83.7 million** to **$330.0 million**, resulting in a net loss of **$342.0 million** Comparison of Results of Operations (2023 vs. 2022) | (in thousands) | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | Change | | :--- | :--- | :--- | :--- | | **License and other revenue** | **$25,546** | **$1,381** | **$24,165** | | Research and development expenses | $330,018 | $246,355 | $83,663 | | General and administrative expenses | $74,950 | $65,978 | $8,972 | | **Total operating expenses** | **$398,546** | **$300,656** | **$97,890** | | Loss from operations | ($373,000) | ($299,275) | ($73,725) | | Other income, net | $31,027 | $8,766 | $22,261 | | **Net loss** | **($341,973)** | **($290,509)** | **($51,464)** | Research and Development Expenses Breakdown (2023 vs. 2022) | (in thousands) | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | Change | | :--- | :--- | :--- | :--- | | External costs for programs in clinical trials | $101,055 | $51,094 | $49,961 | | External costs for platform technologies and preclinical programs | $74,474 | $80,612 | ($6,138) | | Employee related expenses | $125,471 | $93,118 | $32,353 | | Other expenses | $29,018 | $21,531 | $7,487 | | **Total R&D expenses** | **$330,018** | **$246,355** | **$83,663** | [Liquidity and Capital Resources](index=113&type=section&id=Liquidity%20and%20Capital%20Resources) As of December 31, 2023, the company had **$750.1 million** in cash, cash equivalents, and investments, expected to fund operations into the second half of 2026, supplemented by recent financing activities - The company ended 2023 with **$750.1 million** in cash, cash equivalents, and investments, which is expected to fund operations and capital expenditures into the second half of 2026[511](index=511&type=chunk)[545](index=545&type=chunk)[564](index=564&type=chunk) Summary of Cash Flows | (in thousands) | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | Year Ended Dec 31, 2021 | | :--- | :--- | :--- | :--- | | Cash used in operating activities | ($300,316) | ($229,490) | ($74,406) | | Cash provided by (used in) investing activities | $257,634 | ($188,745) | ($479,511) | | Cash provided by financing activities | $34,753 | $289,910 | $388,090 | - In January 2024, the company raised approximately **$30.0 million** in gross proceeds through a private placement of **2,500,000** shares of common stock[500](index=500&type=chunk)[552](index=552&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=120&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk exposure is to interest rate changes affecting its investment portfolio, with foreign currency exchange risk currently not material - The primary market risk is interest rate sensitivity on the investment portfolio, where a hypothetical **100 basis point** adverse change in interest rates is estimated to not have a material impact on financial results[588](index=588&type=chunk) - Foreign currency exchange risk is not considered material as operations are U.S.-based and expenses are generally denominated in U.S. dollars, with no formal hedging program implemented[590](index=590&type=chunk) [Financial Statements and Supplementary Data](index=120&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section contains the company's audited consolidated financial statements for the fiscal years ended December 31, 2023, 2022, and 2021, along with the independent registered public accounting firm's report [Report of Independent Registered Public Accounting Firm](index=123&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) Ernst & Young LLP issued an unqualified opinion on Relay Therapeutics' consolidated financial statements and the effectiveness of its internal control over financial reporting, identifying the valuation of contingent milestone payments as a critical audit matter - The auditor, Ernst & Young LLP, issued an unqualified opinion on the consolidated financial statements and on the effectiveness of internal control over financial reporting[605](index=605&type=chunk)[633](index=633&type=chunk) - A Critical Audit Matter was identified relating to the valuation of the Contingent Milestone Payments Liability from the ZebiAI acquisition, due to the subjective and judgmental nature of estimating the probability of milestone achievement[637](index=637&type=chunk)[639](index=639&type=chunk)[640](index=640&type=chunk) [Controls and Procedures](index=120&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures and internal control over financial reporting were effective as of December 31, 2023, with no material changes identified - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2023[595](index=595&type=chunk) - Management concluded that the company's internal control over financial reporting was effective as of December 31, 2023, and the independent auditor issued an unqualified opinion on its effectiveness[598](index=598&type=chunk)[599](index=599&type=chunk)[605](index=605&type=chunk) Part III [Directors, Executive Officers, Corporate Governance, Executive Compensation, Security Ownership, and Principal Accounting Fees](index=125&type=section&id=Items%2010%2C%2011%2C%2012%2C%2013%20and%2014) Information for Items 10 through 14, covering directors, executive officers, corporate governance, executive compensation, security ownership, and principal accounting fees, will be incorporated by reference from the company's forthcoming 2024 Proxy Statement - The information for Items 10, 11, 12, 13, and 14 is incorporated by reference from the company's forthcoming 2024 Proxy Statement[617](index=617&type=chunk)[618](index=618&type=chunk)[619](index=619&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=126&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists the financial statements and exhibits filed as part of the Annual Report on Form 10-K, with financial statement schedules omitted as not applicable or included elsewhere - This item provides an index of the financial statements and exhibits filed with the 10-K report[627](index=627&type=chunk)

Exhibit 99.1 Relay Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Highlights Completed enrollment in initial RLY-2608 600mg + fulvestrant dose expansion cohort & initiated additional dose expansion cohorts with RLY-2608 400mg & 600mg Initiated RLY-2608 + fulvestrant + ribociclib triplet combination in PI3Kα-mutated HR+/HER2- metastatic breast cancer Approximately $750 million in cash, cash equivalents and investments at end of Q4 2023, expected to fund operations into ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39385 RELAY THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of incorpo ...

PART I. FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Unaudited H1 2023 financial statements show decreased assets, widened net loss, and increased operating cash outflow, driven by higher R&D expenses [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2023, total assets decreased to **$962.0 million** from **$1.1 billion**, primarily due to reduced cash and investments Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $145,902 | $151,794 | | Investments | $725,671 | $847,123 | | **Total Assets** | **$962,016** | **$1,099,771** | | **Liabilities & Equity** | | | | Total Liabilities | $151,897 | $149,553 | | Total Stockholders' Equity | $810,119 | $950,218 | | **Total Liabilities and Stockholders' Equity** | **$962,016** | **$1,099,771** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net losses increased for Q2 and H1 2023, driven by substantially higher research and development expenses Statement of Operations Highlights (in thousands, except per share data) | Metric | Q2 2023 | Q2 2022 | H1 2023 | H1 2022 | | :--- | :--- | :--- | :--- | :--- | | Total Revenue | $119 | $365 | $345 | $784 | | Research and development expenses | $88,201 | $60,511 | $171,028 | $112,178 | | General and administrative expenses | $20,120 | $17,465 | $39,699 | $33,533 | | Loss from operations | $(106,050) | $(77,811) | $(207,227) | $(140,532) | | Net loss | $(98,505) | $(76,788) | $(192,744) | $(138,834) | | Net loss per share, basic and diluted | $(0.81) | $(0.71) | $(1.59) | $(1.28) | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased for H1 2023, while investing activities provided cash, mainly from investment maturities Cash Flow Summary for the Six Months Ended June 30 (in thousands) | Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(135,731) | $(106,266) | | Net cash provided by (used in) investing activities | $126,591 | $(68,996) | | Net cash provided by financing activities | $3,377 | $2,879 | | **Net decrease in cash, cash equivalents, and restricted cash** | **$(5,763)** | **$(172,383)** | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's clinical-stage business, accumulated deficit, fair value measurements, and collaboration agreements - The company is a clinical-stage precision medicine company with lead product candidates RLY-4008, RLY-2608, GDC-1971, and RLY-5836 in clinical development[30](index=30&type=chunk) - As of June 30, **2023**, the company had an **accumulated deficit of $1.3 billion** and expects existing cash to **fund operations for at least one year** from the issuance date of the financial statements[34](index=34&type=chunk) - The **fair value of the contingent consideration liability related to the ZebiAI acquisition was $29.2 million** as of June 30, **2023**, a decrease from **$32.4 million** at year-end **2022**[49](index=49&type=chunk) - **Revenue recognized from the Genentech Agreement was $0.1 million and $0.3 million** for the three and six months ended June 30, **2023**, respectively[63](index=63&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the clinical-stage pipeline, increased operating expenses from R&D, and liquidity, projecting funds sufficient into H2 2025 [Overview](index=18&type=section&id=Overview) The company is a clinical-stage precision medicine company advancing key oncology and genetic disease programs, financed through equity and collaborations - The company is advancing a pipeline of medicines including RLY-4008, RLY-2608, GDC-1971, and RLY-5836, all in clinical development[76](index=76&type=chunk) - RLY-4008 is being developed for FGFR2-altered solid tumors, with a potential registrational path in CCA. Interim data showed an **88% ORR** in treatment-naïve, FGFR2-fusion CCA patients at the pivotal dose[77](index=77&type=chunk) - RLY-2608, a pan-mutant PI3Kα inhibitor, is in a first-in-human trial. Initial data showed selective target engagement and a favorable safety profile with **no Grade 3 hyperglycemia**, diarrhea, or rash[77](index=77&type=chunk)[78](index=78&type=chunk) - The company has financed operations through public offerings, including a September **2022** offering that **raised $284.7 million** net, and has **received $110.0 million** from its Genentech agreement as of June 30, **2023**[80](index=80&type=chunk)[81](index=81&type=chunk) [Results of Operations](index=23&type=section&id=Results%20of%20Operations) Operating results for Q2 and H1 2023 show increased R&D and G&A expenses, leading to larger net losses, partially offset by higher other income Comparison of Results for the Six Months Ended June 30 (in thousands) | Metric | 2023 | 2022 | Change | | :--- | :--- | :--- | :--- | | License and other revenue | $345 | $784 | $(439) | | Research and development expenses | $171,028 | $112,178 | $58,850 | | General and administrative expenses | $39,699 | $33,533 | $6,166 | | Net loss | $(192,744) | $(138,834) | $(53,910) | - The **$58.9 million increase** in H1 **2023** R&D expenses was driven by a **$29.9 million rise** in external costs for clinical trials (RLY-4008, RLY-2608, RLY-5836) and an **$18.6 million increase** in employee-related costs[118](index=118&type=chunk) - The **$6.2 million increase** in H1 **2023** G&A expenses was primarily due to a **$6.8 million rise** in employee-related costs, mostly from increased stock compensation[120](index=120&type=chunk) [Liquidity and Capital Resources](index=25&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2023, the company held **$871.6 million** in cash and investments, projected to fund operations into H2 2025 - The company had **cash, cash equivalents, and investments of $871.6 million** as of June 30, **2023**[122](index=122&type=chunk) - Management projects the current cash position will **fund operating expenses and capital requirements into the second half of 2025**[135](index=135&type=chunk) Cash Flow Summary for the Six Months Ended June 30 (in thousands) | Activity | 2023 | 2022 | | :--- | :--- | :--- | | Cash used in operating activities | $(135,731) | $(106,266) | | Cash provided by (used in) investing activities | $126,591 | $(68,996) | | Cash provided by financing activities | $3,377 | $2,879 | [Quantitative and Qualitative Disclosures About Market Risk](index=29&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Primary market risk is interest rate exposure on investments, with foreign currency risk deemed immaterial - The company is exposed to interest rate risk on its portfolio of cash equivalents and investments. A hypothetical **100 basis point** adverse change is **not expected to have a material impact**[146](index=146&type=chunk) - Foreign currency exchange risk is **not material** as operations are located in the U.S. and expenses are generally denominated in U.S. dollars[148](index=148&type=chunk) [Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were **effective as of June 30, 2023**, with **no material changes in internal control over financial reporting** - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were **effective as of June 30, 2023**[150](index=150&type=chunk) - **No changes in internal control over financial reporting occurred** during the quarter ended June 30, **2023**, that materially affected or are likely to materially affect internal controls[151](index=151&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) The company is **not currently a party to any 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[154](index=154&type=chunk) [Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) The company faces extensive risks including clinical trial uncertainty, third-party dependence, capital needs, competition, intellectual property, and regulatory challenges - The company has **never successfully completed any clinical trials** and may be unable to do so, which could lead to delays or failure in commercializing its product candidates[156](index=156&type=chunk) - The company relies on a collaboration with D. E. Shaw Research and its proprietary supercomputer, Anton 2, for its drug discovery platform; termination of this agreement could materially harm the business[204](index=204&type=chunk) - The company has incurred significant operating losses since inception, with an **accumulated deficit of $1.3 billion** as of June 30, **2023**, and will **need to raise substantial additional funding** to continue operations[238](index=238&type=chunk)[246](index=246&type=chunk) - The company faces **substantial competition** from major pharmaceutical and biotechnology companies with greater financial resources and expertise[195](index=195&type=chunk)[197](index=197&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=71&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - **None**[388](index=388&type=chunk) [Other Information](index=71&type=section&id=Item%205.%20Other%20Information) On August 3, 2023, the company entered a retention agreement with Peter Rahmer for a cash award, contingent on continued employment - On August 3, **2023**, the company entered into a retention agreement with Peter Rahmer, Chief Corporate Development Officer, for a **cash award totaling up to $600,000**, payable in two tranches in **2024**, contingent on continued employment[389](index=389&type=chunk)[390](index=390&type=chunk) [Exhibits](index=73&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate governance, collaboration amendments, and SEC certifications - Key exhibits filed include Amendment No. AR4 to the DESRES Agreement, an Amended and Restated Non-Employee Director Compensation Policy, and a Retention Agreement with Peter Rahmer[393](index=393&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39385 RELAY THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 47-3923475 (State or other jurisdi ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number: 001-39385 RELAY THERAPEUTICS, INC. (Exact name of Registrant as specified in its Charter) | Delaware | 47-3923475 | | --- | --- | | (Sta ...