Lirafugratinib

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.