Relay Therapeutics Reports First Quarter 2025 Financial Results and Corporate Updates
- Extended cash runway into 2029, sufficient to fund key clinical trials and operations
- 80% reduction in research run rate spend through strategic portfolio focusing
- Phase 3 ReDiscover-2 trial initiation on track for mid-2025
- Successfully launched Phase 1 RLY-2608 vascular malformations trial in Q1 2025
- Reduced net loss per share to $0.46 from $0.62 year-over-year
- Revenue decreased to $7.7 million from $10.0 million year-over-year
- Significant workforce reduction of approximately 70 people
- Reduced research-stage programs from four to one
- Net loss of $77.1 million in Q1 2025
Insights
Relay's strategic pipeline focus on RLY-2608 balances extended runway into 2029 against significant R&D reductions, creating a high-stakes clinical execution phase.
Relay Therapeutics is executing a significant operational shift, dramatically reducing research breadth to extend their runway into 2029. The 80% reduction in research spending and 70-person workforce reduction signals a concentrated bet on their lead PI3Kα inhibitor RLY-2608 across two key indications. For their HR+/HER2- breast cancer program, the Phase 3 ReDiscover-2 trial remains on schedule for mid-2025 initiation, with 12+ month follow-up data from the Phase 1b trial to be presented at ASCO. This extended dataset will provide crucial insights into durability of response ahead of the pivotal trial.
Simultaneously, Relay has expanded RLY-2608's potential by initiating a Phase 1 trial in vascular malformations during Q1 – representing diversification beyond oncology applications. The strategic pruning of research-stage programs from four to one, combined with out-licensing RLY-4008 to Elevar Therapeutics, reveals a clinical strategy concentrated on near-term value inflection points rather than broader platform exploitation.
This focused approach creates a binary outcome scenario where success in the ReDiscover-2 trial becomes disproportionately important to the company's future. While the extended cash runway provides operational security, the significant reduction in research capabilities may limit discovery of future pipeline candidates, potentially creating a long-term innovation challenge if current clinical assets don't deliver positive results.
Relay implements dramatic cost reductions extending runway into 2029, concentrating resources on lead assets while significantly downsizing research operations.
Relay Therapeutics has implemented sweeping financial restructuring, extending their cash runway into 2029 – an exceptionally long horizon for a clinical-stage biotech company. With $710.3 million in cash and investments as of Q1 2025 (down from $781.3 million at 2024 year-end), the company has prioritized capital preservation through dramatic operational changes. Most notable is the 80% reduction in research spending rate and workforce reduction of approximately 70 employees.
Q1 financial results show revenue of $7.7 million from completing obligations under their Elevar licensing agreement (compared to $10 million in Q1 2024). R&D expenses decreased to $73.8 million from $82.4 million year-over-year, reflecting initial impact from research organization streamlining. G&A expenses slightly decreased to $18.7 million, while net loss improved modestly to $77.1 million ($0.46 per share) from $81.4 million ($0.62 per share) in Q1 2024.
The strategic pivot to concentrate resources on the ReDiscover-2 Phase 3 trial and vascular malformations program prioritizes assets with nearer-term clinical readouts over broader pipeline development. By reducing research-stage programs from four to one and phasing development timelines for Fabry and NRAS programs, management is making a calculated trade-off: sacrificing research breadth for extended operational runway. This approach provides financial stability through anticipated clinical milestones but potentially limits future pipeline optionality.
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
CAMBRIDGE, Mass., May 05, 2025 (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 first quarter 2025 financial results and corporate updates.
“2025 is a year of execution across a range of high value clinical programs,” said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics. “The ongoing changes to our cost base are designed to enable a full funding of key initiatives including generating topline data from the ReDiscover-2 trial and clinical proof-of-concept data in vascular malformations.”
Strategic Cost Reductions Implemented to Extend Runway into 2029 and to Fully Fund Key Value Drivers
- These reductions help extend operating runway into 2029 and are aimed at funding key objectives, including:
- Completion of ReDiscover-2 Phase 3 trial of RLY-2608 + fulvestrant in metastatic breast cancer well past topline data readout and additional breast cancer clinical trials
- Execution of RLY-2608 Phase 1 vascular malformations trial through clinical proof-of-concept data
- Advance Fabry and NRAS program to Investigational New Drug application (IND) readiness
- Advance one research-stage program
- Specific cost reductions include:
- Over the past year, focused the research portfolio and platform on the highest value areas resulting in a reduction in the research run rate spend by approximately
80% - Reduced research-stage programs from four to one
- Recent reduction in force by approximately 70 people
- Executed a global out-license of RLY-4008 with Elevar Therapeutics, Inc. (Elevar) with potential for downstream economics
- Phased the timing of entry into the clinic for Fabry and NRAS targeted programs
- Over the past year, focused the research portfolio and platform on the highest value areas resulting in a reduction in the research run rate spend by approximately
RLY-2608 Highlights
- Breast Cancer
- Initiation of Phase 3 ReDiscover-2 trial of RLY-2608 + fulvestrant in PI3Kα-mutated, CDK4/6 pre-treated, HR+/HER2- advanced breast cancer remains on track for mid-2025
- Abstract accepted to ASCO for update of Phase 1b ReDiscover trial of RLY-2608 + fulvestrant
- Focus of the abstract is updated 600mg BID (fasted) doublet data with median follow-up now greater than 12 months
- Poster Title: Updated efficacy of mutant-selective PI3Kα inhibitor RLY-2608 in combination with fulvestrant in patients with PIK3CA-mutant HR+HER2- advanced breast cancer: ReDiscover trial
- Date/Time: Monday, June 2, 10:00-1:00 p.m. ET (9:00-12:00 p.m. CT)
- Continued advancement of the ongoing triplet cohorts with RLY-2608 + fulvestrant + atirmociclib or ribociclib
- Planning continues for development of next-generation endocrine therapy combinations with RLY-2608
- Vascular Malformations
- Initiation of Phase 1 vascular malformations clinical trial in the first quarter of 2025
First Quarter 2025 Financial Results
Cash, Cash Equivalents and Investments: As of March 31, 2025, cash, cash equivalents and investments totaled
Revenue: Revenue was
R&D Expenses: Research and development expenses were
G&A Expenses: General and administrative expenses were
Net Loss: Net loss was
About Relay Therapeutics
Relay Therapeutics (Nasdaq: RLAY) 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 of the programs across Relay Therapeutics’ portfolio; 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, as well as the clinical data for RLY-2608; the interactions with regulatory authorities and any related approvals; the potential market opportunity for RLY-2608; the cash runway projection; the expected benefits resulting from the implementation of the cost saving measures and potential ability to fund key value drivers; and the expectations regarding Relay Therapeutics’ use of capital and expenses. 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: Relay Therapeutics’ restructuring activities may be more costly or time-consuming than we expect or may not achieve their intended results; the timing, execution, and expected impact of Relay Therapeutics’ restructuring plans (including the scope and timing of workforce reductions); the expected decrease in annual spending; the expected sufficiency of Relay Therapeutics’ existing cash resources; the internal and external costs required for Relay Therapeutics’ ongoing and planned activities, and the resulting impact on expense and use of cash, may be higher than expected, which may cause the company to use cash more quickly than expected or to change or curtail some of Relay Therapeutics’ plans or both; 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; significant political, trade, or regulatory developments, such as tariffs, beyond Relay Therapeutics’ control; 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:
Pete Rahmer
prahmer@relaytx.com
Media:
Dan Budwick
1AB
973-271-6085
dan@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 March 31, | |||||||
2025 | 2024 | ||||||
Revenue: | |||||||
License and other revenue | $ | 7,679 | $ | 10,007 | |||
Total revenue | 7,679 | 10,007 | |||||
Operating expenses: | |||||||
Research and development expenses | $ | 73,809 | $ | 82,403 | |||
Change in fair value of contingent consideration liability | — | (1,832 | ) | ||||
General and administrative expenses | 18,739 | 19,799 | |||||
Total operating expenses | 92,548 | 100,370 | |||||
Loss from operations | (84,869 | ) | (90,363 | ) | |||
Other income: | |||||||
Interest income | 7,813 | 8,951 | |||||
Other (expense) income | (9 | ) | 25 | ||||
Total other income, net | 7,804 | 8,976 | |||||
Net loss | $ | (77,065 | ) | $ | (81,387 | ) | |
Net loss per share, basic and diluted | $ | (0.46 | ) | $ | (0.62 | ) | |
Weighted average shares of common stock, basic and diluted | 169,233,155 | 130,843,013 | |||||
Other comprehensive income (loss): | |||||||
Unrealized holding gain (loss) | 1,029 | (962 | ) | ||||
Total other comprehensive income | 1,029 | (962 | ) | ||||
Total comprehensive loss | $ | (76,036 | ) | $ | (82,349 | ) | |
Relay Therapeutics, Inc. Selected Condensed Consolidated Balance Sheet Data (In thousands) (Unaudited) | |||||||
March 31, 2025 | December 31, 2024 | ||||||
Cash, cash equivalents and investments | $ | 710,355 | $ | 781,323 | |||
Working capital (1) | 702,607 | 758,475 | |||||
Total assets | 799,362 | 871,296 | |||||
Total liabilities | 78,281 | 93,504 | |||||
Total stockholders’ equity | 721,081 | 777,792 | |||||
Restricted cash | 2,119 | 2,119 | |||||
(1) Working capital is defined as current assets less current liabilities.
