Atirmociclib

NEW YORK--( BUSINESS WIRE )--Pfizer Inc. (NYSE: PFE) will highlight the latest advancements from its growing hematology and breast cancer portfolios at the American Society of Hematology (ASH) Annual Meeting & Exposition (December 7-10) and the San Antonio Breast Cancer Symposium (SABCS, December 10-13). Data from more than 100 company-sponsored, investigator-sponsored, and collaborative research abstracts, including 13 oral presentations and four poster spotlights, will be shared across the company’s approved medicines and expanding portfolio of potential breakthroughs for patients with blood and breast cancers, as well as rare blood disorders. “ Our robust presence at ASH and SABCS reinforces Pfizer’s legacy of scientific innovation for people living with blood disorders and breast cancer,” said Chris Boshoff, Chief Oncology Officer and Executive Vice President, Pfizer. “ We are pleased to share the latest updates for some of our key approved medicines, including ADCETRIS, ELREXFIO, and IBRANCE, which continue to generate compelling data as foundations of care in their respective indications. We are also excited to present new results in hemophilia and from our expanding pipeline of innovative, next-generation therapy candidates for both blood and breast cancers, including new data on combination approaches across our core scientific modalities.” Key ASH Presentations Data from more than 75 company-sponsored, investigator-sponsored, and collaborative research abstracts will be presented at ASH, including updated analyses from the pivotal ECHELON-3 trial supporting the clinical benefit of ADCETRIS ® (brentuximab vedotin) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). New data for ELREXFIO ® (elranatamab-bcmm) in relapsed/refractory multiple myeloma (RRMM) will also be presented from the pivotal MagnetisMM-3 trial, as well as Phase 1 combination data from the MagnetisMM-20 trial. Pfizer will also present updates from its growing Hematology-Oncology pipeline, which includes next-generation CD30 antibody-drug conjugates and other novel and differentiated molecules, including the first presentation of combination data for SEA-CD70 in high-risk myelodysplastic syndromes. Additionally, Pfizer will present results across its portfolio of investigational and approved medicines in benign hematology. ADCETRIS: Additional analyses from the Phase 3 ECHELON-3 trial will be presented, highlighting the durability of complete responses and consistent benefit of ADCETRIS in combination with lenalidomide and rituximab in patients with relapsed/refractory DLBCL, including enrollment of elderly patients, those who are refractory to most recent treatment, and those who have received prior CAR-T therapy. These findings also underscore the overall survival (OS) advantage over lenalidomide and rituximab plus placebo in patients who have received at least two prior lines of therapy. In addition, updated two-year follow-up data from a Phase 2 study investigating the combination of ADCETRIS, nivolumab, doxorubicin, and dacarbazine in newly diagnosed early-stage classical Hodgkin lymphoma (cHL) will be presented highlighting promising efficacy and safety of this investigational novel combination. ELREXFIO: A post hoc analysis of the Phase 2 MagnetisMM-3 trial continues to show deep and durable responses after longer-term follow-up of nearly three years, and these responses were also maintained with a reduction to once-monthly dosing in RRMM. Data will also be shared from the ongoing Phase 1b MagnetisMM-20 trial that indicate encouraging clinical efficacy and predictable safety signals with ELREXFIO in combination with carfilzomib and dexamethasone after a median of two prior lines of therapy (range: one to three). SEA-CD70 (PF-08046040): Encouraging preliminary data from the ongoing Phase 1 study with PF-08046040, also known as SEA-CD70, a nonfucosylated monoclonal antibody targeting CD70 that is designed to enhance effector function, will be shared for the first time from the combination dose-optimization cohort with azacitidine in patients with higher-risk myelodysplastic syndromes (MDS). SEA-CD70 is being developed with the goal of being a best-in-class foundational medicine either alone or as combination treatment in myeloid malignancies. Key SABCS Presentations Data from 30 company-sponsored, investigator-sponsored, and collaborative research abstracts will be presented at SABCS, including nine real-world analyses affirming IBRANCE ® (palbociclib) as a first-line standard-of-care treatment for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC). The company will also present new data from its expanding pipeline of innovative, next-generation therapy candidates that have the potential to address critical unmet patient needs across all subtypes and stages of breast cancer, including new and updated Phase 1 data for atirmociclib, vepdegestrant, and the novel KAT6 inhibitor, PF-07248144. IBRANCE : In P-VERIFY, the largest-ever real-world comparative overall survival analysis of first-line CDK4/6 inhibitors plus aromatase inhibitor (AI) therapy in HR+/HER2- MBC, numerically similar overall survival rates were observed across CDK4/6 inhibitor groups at 12, 24, and 30 months. Atirmociclib (PF-07220060): Updated data will be presented from a Phase 1/2a study of atirmociclib, a next-generation, highly selective CDK4 inhibitor, in combination with letrozole as a potential first-line treatment for patients with HR+/HER2- MBC. Atirmociclib is being developed as a potential future CDK inhibitor backbone therapy in HR+ MBC, and a Phase 3 study in the first-line setting is anticipated to start by early 2025. Vepdegestrant: For the first time, initial Phase 1b data will be shared from the Phase 1b/2 TACTIVE-U trial evaluating the combination of vepdegestrant, a potential first-in-class PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader, in combination with abemaciclib in patients with ER+/HER2- locally advanced or MBC. These data reinforce the potential of vepdegestrant as a new backbone endocrine therapy, and Pfizer and Arvinas anticipate topline Phase 3 data evaluating vepdegestrant as a monotherapy in the first quarter of 2025. KAT6 (PF-07248144) : Updated efficacy and safety data will be presented from a Phase 1 dose-expansion study of PF-07248144, a novel KAT6 inhibitor, in heavily pretreated ER+/HER2- MBC. These early data continue to provide strong clinical proof of concept for this novel target as a potential new treatment approach for ER+/HER2- MBC, and Pfizer anticipates initiating a Phase 3 study for PF-07248144 in the post-CDK4/6 inhibitor setting in mid-2025. Additional information on key Pfizer-sponsored abstracts at ASH and SABCS, including date and time of presentation, follow in the chart below. A complete list of Pfizer-sponsored accepted abstracts is available here: https://www.pfizer.com/ASH_and_SABCS_2024_Sponsored_Abstracts . Blood Cancers Updated Analysis of Brentuximab Vedotin, Nivolumab, Doxorubicin, and Dacarbazine for Nonbulky, Early-Stage Classical Hodgkin Lymphoma (Abstract #460) Abramson J Oral Presentation Sunday, December 8, 9:30-11:00 AM PST Presentation Time: 10:15 AM PST Efficacy of Elranatamab (ELRA) in Combination with Carfilzomib (CFZ) and Dexamethasone (DEX) in the Phase 1b MagnetisMM-20 Trial in Relapsed or Refractory Multiple Myeloma (RRMM) (Abstract #1024) Tomasson MH Oral Presentation Monday, December 9, 4:30-5:30 PM PST Presentation Time: 5:15 PM PST PF-08046040 (SEA-CD70), a Nonfucosylated CD70-Directed Antibody, in Combination with Azacitidine for Patients with Myelodysplastic Syndromes (MDS): A Phase 1 Dose-Finding and Dose Expansion Study (Abstract #1840) Poster Presentation Saturday, December 7, 5:30-7:30 PM PST Durability of Complete Responses in Patients from the ECHELON-3 Study (Abstract #3101) Yasenchak C Poster Presentation Sunday, December 8, 6:00-8:00 PM PST MagnetisMM-3: Long-Term Update and Efficacy and Safety of Less Frequent Dosing of Elranatamab in Patients with Relapsed or Refractory Multiple Myeloma (Abstract #4738) Prince M Poster Presentation Monday, December 9, 6:00-8:00 PM PST Outcomes in Older Patients with Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) from the ECHELON-3 Study (Abstract #4483) Bartlett N Poster Presentation Monday, December 9, 6:00-8:00 PM PST Outcomes by Refractory Status and Prior Therapies Received in Patients with Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) from the ECHELON-3 Study (Abstract #4489) Hahn U Poster Presentation Monday, December 9, 6:00-8:00 PM PST Hemophilia Efficacy and Safety of Giroctocogene Fitelparvovec in Adults with Moderately Severe to Severe Hemophilia Α: Primary Analysis Results from the Phase 3 AFFINE Gene Therapy Trial (Abstract #1053) Leavitt AD Oral Presentation Monday, December 9, 4:30-6:00 PM PST Presentation Time: 5:00 PM PST Descriptive Characterization of Bleeding Events in Participants with Severe Hemophilia Α or B without Inhibitors, Receiving Prophylactic Marstacimab Treatment (Abstract #716) Matino D Oral Presentation Monday, December 9, 10:30 AM-12:00 PM PST Presentation Time: 10:45 AM PST Sickle Cell Disease Qualitative Interview Study to Characterize the Treatment Experiences of Participants with Sickle Cell Disease and Assess Perceptions of Red Blood Cell Transfusions (Abstract #3691) Kosa K Poster Presentation Sunday, December 8, 6:00-8:00 PM PST Breast Cancer Comparative overall survival of CDK4/6is plus an aromatase inhibitor (AI) in HR+/HER2- MBC in the US real-world setting Rugo et al Poster Spotlight Presentation (PS2-03) Thursday, December 12, 7:00-8:30 AM CST PF-07248144, a first-in-class KAT6 inhibitor, in patients with HR+ HER2− metastatic breast cancer: Updated results from phase 1 dose expansion study Mukohara et al Poster Presentation (P4-10-28) Thursday, December 12, 5:30-7:00 PM CST Vepdegestrant, a PROteolysis TArgeting Chimera (PROTAC) Estrogen Receptor (ER) Degrader, Plus Abemaciclib in ER-Positive/Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Advanced or Metastatic Breast Cancer: TACTIVE-U Preliminary Phase 1b Results Hilton et al Poster Presentation ​(P4-12-03) Thursday, December 12, 5:30-7:00 PM CST The next-generation CDK4-selective inhibitor atirmociclib (PF-07220060) in combination with letrozole as first-line treatment in patients with HR+/HER2+ metastatic breast cancer Giordana et al Poster Presentation (P5-07-28) Friday, December 13, 12:30-2:00 PM CST About Pfizer Oncology At Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and bispecific antibodies, including other immune-oncology biologics. We are focused on delivering transformative therapies in some of the world’s most common cancers, including breast cancer, genitourinary cancer, hematology-oncology, and thoracic cancers, which includes lung cancer. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives. About Pfizer Rare Disease There are over 10,000 known rare diseases that affect approximately 400 million people worldwide. 80% of these diseases have genetic origins and 50% affect children. Collectively, people living with a rare disease represent one of the largest underserved patient communities in the world, with less than 10% of known rare diseases having one or more approved treatments. At Pfizer, we believe that people living with a rare disease, along with the untold number of family members and caregivers who support them, deserve more. For more than 40 years, we have provided critical treatment options for patients with rare diseases including 11 Pfizer Rare Disease medicines that have received regulatory approval. Prescribing Information for Pfizer Medicines Please read full Prescribing Information , including BOXED WARNING, for ADCETRIS. Please read full Prescribing Information , including BOXED WARNING, for ELREXFIO. Please read full Prescribing Information for HYMPAVZI. Please see full Prescribing Information for IBRANCE ® (palbociclib) tablets and IBRANCE ® (palbociclib) capsules . About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety, and value in the discovery, development, and manufacture of healthcare products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments, and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with healthcare providers, governments, and local communities to support and expand access to reliable, affordable healthcare around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com . In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer_News , LinkedIn , YouTube , and like us on Facebook at www.facebook.com/Pfizer/ . Disclosure notice The information contained in this release is as of December 5, 2024. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Pfizer’s hematology and breast cancer portfolio and pipeline, ADCETRIS (brentuximab vedotin), ELREXFIO (elranatamab-bcmm), SEA-CD70 (PF-08046040), IBRANCE (palbociclib), atirmociclib (PF-07220060), vepdegestrant, and the novel KAT6 inhibitor, PF-07248144 , including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of Pfizer’s breast cancer and hematology products and product candidates; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any applications may be filed with any regulatory authorities for any potential indications for brentuximab vedotin, elranatamab-bcmm, PF-08046040, palbociclib, PF-07220060, vepdegestrant, and PF-07248144, or any other product candidates; whether and when any applications that may be pending or filed for brentuximab vedotin, elranatamab-bcmm, PF-08046040 or any such other product candidates may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether brentuximab vedotin, elranatamab-bcmm, PF-08046040, palbociclib, PF-07220060, vepdegestrant, and PF-07248144, or any such other product candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of brentuximab vedotin, elranatamab-bcmm, PF-08046040, palbociclib, PF-07220060, vepdegestrant, and PF-07248144, or any such other product candidates; uncertainties regarding the impact of COVID-19 on our business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “ Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com .

Reported interim RLY-2608 data demonstrating 9.2-month median PFS in heavily pre-treated patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer at RP2D Plan to initiate 2L pivotal trial of RLY-2608 + fulvestrant in 2025 Approximately $840 million in cash, cash equivalents and investments at end of Q3 2024, expected to fund operations into second half of 2027 CAMBRIDGE, Mass., Nov. 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, today reported third quarter 2024 financial results and recent corporate highlights. “In the third quarter, we reported very encouraging interim data showing that RLY-2608 + fulvestrant led to clinically meaningful progression free survival in heavily pre-treated patients with PI3Kα-mutated, HR+, HER2- metastatic breast cancer,” said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics. “Based on these data, we are preparing to initiate a pivotal trial in 2L breast cancer in 2025, which we expect to be able to fully fund through top-line readout with our existing cash on hand. We also continue to progress our pre-clinical programs and look forward to bringing new programs into the clinic in 2025.” Recent Corporate Highlights RLY-2608 (ReDiscover study) RLY-2608 doublet: Reported interim data for RLY-2608 + fulvestrant in patients with PI3Kα-mutated, HR+, HER2- metastatic breast cancer who had previously received at least one prior CDK4/6 inhibitor. The data demonstrated clinically meaningful progression free survival (PFS) at the company’s recommended Phase 2 dose (RP2D) of 600mg BID. The cut-off date for these data was August 12, 2024. Key highlights included: 9.2-month median PFS across all mutations & 10.3 months among patients with kinase mutations33% objective response rate (ORR) across all patients & 53% ORR in patients with kinase mutations at the RP2DFavorable overall tolerability profile; at RP2D, only two patients discontinued treatment due to adverse events & only 1 patient experienced Grade 3 hyperglycemiaRLY-2608 + fulvestrant data will be presented at the San Antonio Breast Cancer Symposium, taking place December 10-13, 2024. Details of the poster spotlight presentation are as follows: Abstract Title: PS7-01: Efficacy of RLY-2608, a mutant-selective PI3Kα inhibitor in patients with PIK3CA-mutant HR+HER2- advanced breast cancer: ReDiscover trialAbstract Number: SESS-2211Session: Concurrent Poster Spotlight Session 7: Targeting the ER and PI3K pathway: Novel drugs and combinationsDate/Time: Wednesday, December 11, 8:00-9:30 a.m. ET (7:00-8:30 a.m. CT) Data support planned initiation of Phase 3 pivotal trial for RLY-2608 + fulvestrant in 2025 RLY-2608 triplet: Continued to progress two potential front-line triplet regimens in patients with PI3Kα-mutated, HR+, HER2- metastatic breast cancer who had previously received at least one prior CDK4/6 inhibitor, including: CDK4/6: RLY-2608 + ribociclib + fulvestrant dose escalation is currently testing biologically active doses of RLY-2608 and is on track to identify a dose of RLY-2608 that is combinable with full-dose ribociclib. Expansion cohorts are expected to initiate in the first half of 2025CDK4: RLY-2608 + atirmociclib + fulvestrant trial on track to initiate by the end of 2024 Lirafugratinib (RLY-4008) Presented updated FGFR2 fusion tumor agnostic data at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, October 23-25, 2024Provided regulatory update regarding lirafugratinib regulatory path in which the FDA suggested that the company first file a new drug application (NDA) in cholangiocarcinoma, followed by a tumor agnostic supplemental NDA for FGFR2 fusions with data from more patients and more follow upDisclosed plans to seek a global commercialization partner for lirafugratinib in order to maintain company’s focus on the remainder of the portfolio Corporate Highlights Raised $230 million of gross proceeds in an underwritten follow-on public offering in September 2024Completed series of changes to streamline the research organization, collectively resulting in an expected $50 million in annual savings and workforce reduction of approximately 15%. Changes are part of the company’s shift to becoming more development-focused in preparation for the upcoming RLY-2608 pivotal trial as well as new programs entering the clinic over the course of 2025 Anticipated Upcoming Milestones Breast Cancer RLY-2608 + fulvestrant + ribociclib initial safety data in the fourth quarter of 2024RLY-2608 + fulvestrant + atirmociclib clinical trial initiation by the end of 2024RLY-2608 + fulvestrant + ribociclib dose expansion initiation in the first half of 2025RLY-2608 + fulvestrant 2L Phase 3 trial initiation in 2025 Pre-clinical Vascular malformations: RLY-2608 clinical trial initiation in the first quarter of 2025Fabry disease: clinical start in the second half of 2025NRAS: clinical start in the second half of 2025 Third Quarter 2024 Financial Results Cash, Cash Equivalents and Investments: As of September 30, 2024, cash, cash equivalents and investments totaled $839.6 million compared to $750.1 million as of December 31, 2023. The company expects its current cash, cash equivalents and investments will be sufficient to fund its current operating plan into the second half of 2027. Revenue: Revenue was $0 for the third quarter of 2024, as compared to $25.2 million for the third quarter of 2023. The decrease was primarily due to the recognition of previously received milestone payments under the company’s Collaboration and License Agreement with Genentech, Inc. during the third quarter of 2023. R&D Expenses: Research and development expenses were $76.6 million for the third quarter of 2024, as compared to $81.5 million for the third quarter of 2023. The decrease was primarily due to the impact of prioritization of certain programs in the company’s pipeline, as previously disclosed in 2023 and earlier in 2024. G&A Expenses: General and administrative expenses were $19.8 million for the third quarter of 2024, as compared to $18.5 million for the third quarter of 2023. The increase was primarily due to an increase in stock compensation expense, partially offset by decreases in other employee compensation costs and certain other general and administrative expenses. Net Loss: Net loss was $88.1 million for the third quarter of 2024, or a net loss per share of $0.63, as compared to a net loss of $65.7 million for the third quarter of 2023, or a net loss per share of $0.54. About Relay Therapeutics Relay Therapeutics is a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies with the goal of bringing life-changing therapies to patients. As the first of a new breed of biotech created at the intersection of complementary techniques and technologies, Relay Therapeutics aims to push the boundaries of what’s possible in drug discovery. Its Dynamo® platform integrates an array of leading-edge computational and experimental approaches designed to drug protein targets that have previously been intractable or inadequately addressed. Relay Therapeutics’ initial focus is on enhancing small molecule therapeutic discovery in targeted oncology and genetic disease indications. For more information, please visit www.relaytx.com or follow us on Twitter. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding Relay Therapeutics’ strategy, business plans and focus; the progress and timing of the clinical development and clinical initiation of the programs across Relay Therapeutics’ portfolio; the progress toward bringing Relay Therapeutics’ pre-clinical programs to the clinic, including anticipated timing; the expected therapeutic benefits and potential efficacy and tolerability of RLY-2608, both as a monotherapy and in combination with other agents, and its other programs, including lirafugratinib; the timing and scope of clinical updates for RLY-2608; Relay Therapeutics’ plan to seek a global commercialization partner for lirafugratinib; the interactions with regulatory authorities and any related approvals; the potential market opportunity for RLY-2608; the cash runway projection and the expectations regarding Relay Therapeutics’ use of capital, expenses and potential cost savings. The words “may,” “might,” “will,” “could,” “would,” “should,” “plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,” “seek,” “predict,” “future,” “project,” “potential,” “continue,” “target” and similar words or expressions, or the negative thereof, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: the impact of global economic uncertainty, geopolitical instability and conflicts, or public health epidemics or outbreaks of an infectious disease on countries or regions in which Relay Therapeutics has operations or does business, as well as on the timing and anticipated results of its clinical trials, strategy, future operations and profitability; the delay or pause of any current or planned clinical trials or the development of Relay Therapeutics’ drug candidates; the risk that the preliminary or interim results of its preclinical or clinical trials may not be predictive of future or final results in connection with future clinical trials of its product candidates and that interim and early clinical data may change as more patient data become available and are subject to audit and verification procedures; Relay Therapeutics’ ability to successfully demonstrate the safety and efficacy of its drug candidates; the timing and outcome of its planned interactions with regulatory authorities; and obtaining, maintaining and protecting its intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Relay Therapeutics’ most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Relay Therapeutics' views only as of today and should not be relied upon as representing its views as of any subsequent date. Relay Therapeutics explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Contact:Megan Goulart617-545-5526mgoulart@relaytx.com Media:Dan Budwick1AB973-271-6085dan@1abmedia.com Relay Therapeutics, Inc.Condensed Consolidated Statements of Operations and Comprehensive Loss(In thousands, except share and per share data)(Unaudited) Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Revenue: License and other revenue $— $25,202 $10,007 $25,547 Total revenue — 25,202 10,007 25,547 Operating expenses: Research and development expenses $76,619 $81,494 $251,014 $252,522 Change in fair value of contingent consideration liability — (1,200) (13,206) (4,355)General and administrative expenses 19,750 18,485 59,688 58,184 Total operating expenses 96,369 98,779 297,496 306,351 Loss from operations (96,369) (73,577) (287,489) (280,804)Other income: Interest income 8,274 7,845 25,772 22,345 Other (expense) income (10) (2) 13 (19)Total other income, net 8,264 7,843 25,785 22,326 Net loss $(88,105) $(65,734) $(261,704) $(258,478)Net loss per share, basic and diluted $(0.63) $(0.54) $(1.94) $(2.12)Weighted average shares of common stock, basic and diluted 140,229,056 122,231,255 134,651,728 121,843,116 Other comprehensive income (loss): Unrealized holding gain 3,849 2,695 2,705 7,034 Total other comprehensive income 3,849 2,695 2,705 7,034 Total comprehensive loss $(84,256) $(63,039) $(258,999) $(251,444) Relay Therapeutics, Inc.Selected Condensed Consolidated Balance Sheet Data(In thousands)(Unaudited) September 30, 2024 December 31, 2023 Cash, cash equivalents and investments $839,609 $750,086 Working capital (1) 818,161 739,834 Total assets 930,115 843,980 Total liabilities 91,254 91,977 Total stockholders’ equity 838,861 752,003 Restricted cash 2,119 2,707 (1) Working capital is defined as current assets less current liabilities.