Relay Therapeutics, Inc.: Q4 FY2025 earnings call

What management said about Q4 FY2025, from the documents filed with the SEC on 26 February 2026: press release. Guidance figures: 3 new, 1 kept. The quarter’s numbers.

Key takeaways

Fourth-quarter net loss narrowed: Fourth-quarter net loss was $54.9 million, or $0.32 per share, compared with $76.0 million, or $0.45 per share, in the fourth quarter of 2024. Source
Fourth-quarter revenue reached $7.0 million: Fourth-quarter 2025 revenue was $7.0 million, compared with zero in the fourth quarter of 2024. Source
Median PFS of 10.3 months: Phase 1/2 data with a October 15, 2025 cut-off showed median PFS of 10.3 months across 52 patients, and 11.4 months in second-line patients. Source
Objective response rate of 39%: Among 31 patients with measurable disease, objective response rate was 39%, and 47% in second-line patients, with median follow-up of 20.2 months. Source
Cash balance $554.5 million at year-end: Cash, cash equivalents and investments totaled $554.5 million at December 31, 2025, down from approximately $781.3 million at December 31, 2024. Source
Dynamo platform yields mutant-selective inhibitor: Management said the Dynamo platform enabled zovegalisib, described as the first known allosteric, pan-mutant and isoform-selective PI3Kα inhibitor. Source

“Our focus on disciplined execution to date has strengthened the foundation of Relay, aligning our organization to support long-term success.”
Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics

Guidance

Area	Period	Figure	Against last quarter
Liquidity Source	Through 2029	into 2029	Kept
Clinical data timing, vascular anomalies Source	First half of 2026	1H 2026	New
Patients in vascular anomalies data Source	At time of initial disclosure	approximately 20 patients	New
Breast cancer triplet data and frontline Phase 3 plan Source	2026	2026	New

What changed from last quarter

New: Zovegalisib received Breakthrough Therapy designation from the FDA, as management states in the release. Source
New: The lead asset, named RLY-2608 in the third-quarter release, is now referred to as zovegalisib. Source

Net loss and revenue

Fourth-quarter net loss narrowed: Fourth-quarter net loss was $54.9 million, or $0.32 per share, compared with $76.0 million, or $0.45 per share, in the fourth quarter of 2024. Source
Full-year net loss narrowed: Full-year 2025 net loss was $276.5 million, or $1.61 per share, compared with $337.7 million, or $2.36 per share, for 2024. Source
Fourth-quarter revenue reached $7.0 million: Fourth-quarter 2025 revenue was $7.0 million, compared with zero in the fourth quarter of 2024. Source

Revenue sources

Full-year revenue rose year on year: Full-year 2025 revenue was $15.4 million, compared with $10.0 million for 2024. Source
Current revenue from Elevar license: Revenue recognized in the current-year periods came under the exclusive license agreement with Elevar Therapeutics, Inc. Source
Prior-year revenue from Genentech deal: Revenue recognized in the prior-year periods came under the collaboration and license agreement with Genentech, Inc. Source

“These milestones position us to deliver meaningful updates in areas with significant unmet need for patients, while continuing to build momentum toward potential commercialization.”
Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics

Breast cancer program

Median PFS of 10.3 months: Phase 1/2 data with a October 15, 2025 cut-off showed median PFS of 10.3 months across 52 patients, and 11.4 months in second-line patients. Source
Objective response rate of 39%: Among 31 patients with measurable disease, objective response rate was 39%, and 47% in second-line patients, with median follow-up of 20.2 months. Source
Treatment-related events mostly low-grade: Management described the tolerability profile as consistent with mutant-selective PI3Kα inhibition, with treatment-related adverse events mostly low-grade and reversible. Source
Phase 3 ReDiscover-2 trial continuing: The company continued execution of the Phase 3 ReDiscover-2 trial of zovegalisib plus fulvestrant in CDK4/6 pre-treated patients. Source
About 140,000 patients cited: Management said zovegalisib could address a significant portion of approximately 140,000 patients with HR+/HER2- breast cancer carrying a PI3Kα mutation. Source

Vascular anomalies and other programs

ReInspire trial continuing: The Phase 1 ReInspire trial of zovegalisib in PIK3CA-driven vascular anomalies continued; the third-quarter release called these vascular malformations. Source
About 170,000 US patients a year: Management cited an estimated 170,000 patients per year in the United States with vascular anomalies driven by a PI3Kα mutation. Source
NRAS and Fabry programs in pipeline: The pipeline also includes programs for NRAS-driven solid tumors and Fabry disease, described as programs rather than late-stage research programs. Source

Operating costs and cash

R&D fell on streamlining: Management attributed lower R&D expense mainly to strategic choices to streamline the research organization across 2024 and 2025. Source
Lirafugratinib spend lower after license: Lower costs for continued lirafugratinib development followed the Elevar license agreement executed in December 2024. Source
Trial costs rose in ReDiscover-2 and ReInspire: Partly offsetting lower R&D costs, spending increased for the ReDiscover-2 and ReInspire trials. Source
G&A fell on stock compensation: Quarterly G&A was $12.2 million against $16.9 million a year earlier; full-year G&A was $56.7 million against $76.6 million, mainly from lower stock compensation and employee costs. Source
Cash balance $554.5 million at year-end: Cash, cash equivalents and investments totaled $554.5 million at December 31, 2025, down from approximately $781.3 million at December 31, 2024. Source
Cash lower than at third quarter: The third-quarter release reported $596.4 million in cash, cash equivalents and investments at September 30, 2025. Source

Platform and mechanism

Dynamo platform yields mutant-selective inhibitor: Management said the Dynamo platform enabled zovegalisib, described as the first known allosteric, pan-mutant and isoform-selective PI3Kα inhibitor. Source
Orthosteric inhibitors limited on selectivity: The company said orthosteric PI3Kα inhibitors have limited therapeutic index because they lack clinically meaningful selectivity for mutant versus wild-type PI3Kα. Source
Cryo-EM structure of PI3Kα solved: Relay said it solved the full-length cryo-EM structure of PI3Kα and used molecular dynamics simulations to support zovegalisib's design. Source

Coming up, as management said on 26 February 2026

ESMO TAT oral presentation March 16: An oral proffered paper session in Paris on Monday, March 16, 2026, at 11:00 a.m. ET covers the 57-patient cohort at the 400mg BID fed Phase 3 dose. Source

Figures management reported

Figure	Reported
R&D expenses, full year 2025 Source	$261.4 million
R&D expenses, fourth quarter 2025 Source	$55.4 million
Median PFS, all patients (SABCS data cut-off October 15, 2025) Source	10.3 months (n=52)
Objective response rate, measurable disease Source	39% (n=31)

Earlier plans management reported on

Ahead: The pediatric cohort in the ReInspire trial opened ahead of schedule because enrollment was faster than expected. Source
Not stated: Triplet cohorts combining zovegalisib with atirmociclib, ribociclib or palbociclib are ongoing to inform the frontline Phase 3 regimen. Source

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.

As filed with the SEC

Open the filing on EDGAR

Relay Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Outlines Anticipated 2026 Milestones

Initial Phase 1 data of zovegalisib in PIK3CA-driven vascular anomalies expected to be announced in first half of 2026

Breast cancer triplet data and frontline Phase 3 plans expected to be announced in 2026

Initial Phase 1/2 data of zovegalisib + fulvestrant at 400mg BID fed (Phase 3 dose) in CDK4/6-experienced patients to be presented at ESMO TAT on March 16, 2026

Approximately $555 million in cash, cash equivalents and investments at end of Q4 2025

Cambridge, Mass. - February 26, 2026 - Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage, small molecule precision medicine company developing potentially life-changing therapies for patients living with cancer and genetic disease, today reported fourth quarter and full year 2025 financial results and 2026 guidance.

“Our focus on disciplined execution to date has strengthened the foundation of Relay, aligning our organization to support long-term success. In 2026, Relay is entering a pivotal period defined by multiple upcoming clinical milestones across our zovegalisib program, which recently received Breakthrough Therapy designation from the FDA,” said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics. “We anticipate presenting Phase 1/2 breast cancer data at the upcoming ESMO TAT Congress, reporting initial data in PIK3CA-driven vascular anomalies, and providing updates on our breast cancer triplet data and frontline Phase 3 development plans. These milestones position us to deliver meaningful updates in areas with significant unmet need for patients, while continuing to build momentum toward potential commercialization.”

Anticipated 2026 Milestones

Breast Cancer

Abstract accepted to European Society for Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Congress 2026 for initial data from the Phase 1/2 ReDiscover trial of zovegalisib (RLY-2608) + fulvestrant at the Phase 3 dose

The abstract is focused on 57 patients treated at the recommended Phase 3 dose of 400mg twice daily (BID) fed that have HR+/HER2-, PI3Kα-mutated metastatic breast cancer and have previously been treated with a CDK4/6 inhibitor

Oral Proffered Paper Session: Dose optimization of zovegalisib, a novel PI3Kα inhibitor, in patients with PIK3CA-mutant HR+/HER2- advanced breast cancer: results from the first-in-human study to support the recommended Phase 3 dose

Location/Date/Time: Paris, France; Monday, March 16, 2026; 4:00 p.m. CET/11:00 a.m. ET

Triplet clinical data and frontline Phase 3 study design plan anticipated in 2026

Vascular Anomalies

Initial clinical data disclosure from the Phase 1 ReInspire trial in PIK3CA-driven vascular anomalies planned for 1H 2026

The pediatric cohort in the trial recently opened ahead of schedule due to faster than expected enrollment and the company anticipates reporting on approximately 20 patients at time of disclosure

Zovegalisib 2025 Highlights

Breast Cancer

Continued execution of the Phase 3 ReDiscover-2 trial of zovegalisib + fulvestrant in PI3Kα-mutated, CDK4/6 pre-treated, HR+/HER2- advanced breast cancer

Presented data from Phase 1/2 ReDiscover trial of zovegalisib + fulvestrant at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting and the 2025 San Antonio Breast Cancer Symposium (SABCS). SABCS summary with a data cut-off date of October 15, 2025:

The median progression free survival (PFS) was 10.3 months for all patients (n=52).

Among the total of 31 patients with measurable disease, objective response rate (ORR) was 39%. For second line (2L) patients, median PFS was 11.4 months and ORR was 47%. Median follow-up was 20.2 months.

Efficacy was generally consistent across other subsets of patients. For patients who received prior SERD, median PFS was 11.4 months and ORR was 44% (7/16), and for patients who had a detectable ESR1 mutation at baseline, median PFS was 8.8 months and ORR was 60% (6/10).

The overall tolerability profile remained consistent with mutant-selective PI3Kα inhibition, with treatment-related adverse events that were mostly low-grade, manageable and reversible.

Triplet cohorts of zovegalisib in combination with atirmociclib, ribociclib, or palbociclib are ongoing to inform frontline Phase 3 preferred regimen and plans

Vascular Anomalies

Continued execution of Phase 1 ReInspire trial of zovegalisib in PIK3CA-driven vascular anomalies

Fourth Quarter and Full Year 2025 Financial Results

Cash, Cash Equivalents and Investments: As of December 31, 2025, cash, cash equivalents, and investments totaled $554.5 million compared to approximately $781.3 million as of December 31, 2024. The company expects its current cash, cash equivalents, and investments will be sufficient to fund its operating expenses and capital expenditure requirements into 2029.

Revenue: Revenue was $7.0 million for the fourth quarter of 2025, as compared to $0 for the fourth quarter of 2024. Revenue was $15.4 million for the full year 2025, as compared to $10.0 million for the full year 2024. The revenue recognized in the current year periods was under our Exclusive License Agreement with Elevar Therapeutics, Inc. The revenue recognized in the prior year periods was under our Collaboration and License Agreement with Genentech, Inc.

R&D Expenses: Research and development expenses were $55.4 million for the fourth quarter of 2025, as compared to $68.1 million for the fourth quarter of 2024. Research and development expenses were $261.4 million for the full year 2025, as compared to $319.1 million for the full year 2024. The decreases were primarily due to the series of strategic choices to streamline the research organization throughout 2024 and 2025, as well as decreases in costs incurred on continued development of lirafugratinib after execution of the Exclusive License Agreement with Elevar Therapeutics, Inc. in December 2024, offset by increases in costs related to the ReDiscover-2 trial and ReInspire trial.

G&A Expenses: General and administrative expenses were $12.2 million for the fourth quarter of 2025, as compared to $16.9 million for the fourth quarter of 2024. General and administrative expenses were $56.7 million for the full year 2025, as compared to $76.6 million for the full year 2024. The decreases were primarily due to decreases in stock compensation expense and other employee costs.

Net Loss: Net loss was $54.9 million for the fourth quarter of 2025, or a net loss per share of $0.32, as compared to a net loss of $76.0 million for the fourth quarter of 2024, or a net loss per share of $0.45. Net loss was $276.5 million for the full year 2025, or a net loss per share of $1.61, as compared to a net loss of $337.7 million for the full year 2024, or a net loss per share of $2.36.

About Zovegalisib

Zovegalisib is the lead program in Relay Therapeutics’ efforts to discover and develop mutant selective inhibitors of PI3Kα, the most frequently mutated kinase in all cancers and all vascular anomalies. Zovegalisib has the potential, if approved, to address a significant portion of the approximately 140,000 patients with HR+/HER2- breast cancer with a PI3Kα mutation and the estimated 170,000 patients with vascular anomalies driven by a PI3Kα mutation per year in the United States, one of the largest patient populations for a precision medicine.

Traditionally, the development of PI3Kα inhibitors has focused on the active, or orthosteric, site. The therapeutic index of orthosteric inhibitors is limited by the lack of clinically meaningful selectivity for mutant versus wild-type (WT) PI3Kα and off-isoform activity. Toxicity related to inhibition of WT PI3Kα and other PI3K isoforms results in sub-optimal inhibition of mutant PI3Kα with reductions in dose intensity and frequent discontinuation. The Dynamo® platform enabled the discovery of zovegalisib, the first known allosteric, pan-mutant, and isoform-selective PI3Kα inhibitor, designed to overcome these limitations. Relay Therapeutics solved the full-length cryo-EM structure of PI3Kα, performed computational long time-scale molecular dynamic simulations to elucidate conformational differences between WT and mutant PI3Kα, and leveraged these insights to support the design of zovegalisib. Zovegalisib is currently being evaluated in multiple metastatic breast cancer studies and a first-in-human study designed to treat patients with PIK3CA (PI3Kα) mutation driven vascular anomalies. For more information on zovegalisib, please visit here.

About Relay Therapeutics

Relay Therapeutics (Nasdaq: RLAY) is a clinical-stage, small molecule precision medicine company developing potentially life-changing therapies for patients living with cancer and genetic disease. Relay's 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. The company’s lead clinical asset, zovegalisib, is the first pan-mutant selective PI3Kα inhibitor to enter clinical development and is currently in a Phase 3 clinical trial (ReDiscover-2) in HR+/HER2- metastatic breast cancer. Zovegalisib is also being investigated in a group of genetic disease indications called PI3Kα-driven vascular anomalies. Relay's pipeline also includes programs for NRAS-driven solid tumors and Fabry disease. For more information, please visit www.relaytx.com or follow us on LinkedIn.

Cautionary Note Regarding Forward-Looking Statements

Forward-looking statements notice

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 timing of clinical data readouts for zovegalisib; the expected therapeutic benefits and potential efficacy and tolerability of zovegalisib, both as a monotherapy and in combination with other agents, and its other programs; the clinical data for zovegalisib; the interactions with regulatory authorities and any related approvals; the potential commercialization and market opportunity for zovegalisib; and the cash runway projection 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.

Forward-looking statements notice

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; 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.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share data)

(Unaudited)

	3 Months Ended December 31,		12 Months Ended December 31,
	2025	2024	2025	2024
Revenue:
License and other revenue	$7,000	$ -	$15,355	$10,007
Total revenue	7,000	-	15,355	10,007
Operating expenses:
Research and development expenses	$55,415	$68,075	$261,383	$319,089
Change in fair value of contingent consideration liability	-	-	-	(13,206)
General and administrative expenses	12,215	16,904	56,710	76,592
Total operating expenses	67,630	84,979	318,093	382,475
Loss from operations	(60,630)	(84,979)	(302,738)	(372,468)
Other income:
Interest income	5,710	8,974	27,035	34,746
Other income (expense)	31	1	(776)	14
Total other income, net	5,741	8,975	26,259	34,760
Net loss	$(54,889)	$(76,004)	$(276,479)	$(337,708)
Net loss per share, basic and diluted	$(0.32)	$(0.45)	$(1.61)	$(2.36)
Weighted average shares of common stock, basic and diluted	173,404,585	167,337,579	171,586,558	142,867,844
Other comprehensive income (loss):
Unrealized holding gain (loss)	240	(3,500)	1,724	(795)
Total other comprehensive income (loss)	240	(3,500)	1,724	(795)
Total comprehensive loss	$(54,649)	$(79,504)	$(274,755)	$(338,503)

Relay Therapeutics, Inc.

Selected Condensed Consolidated Balance Sheet Data

(In thousands)

(Unaudited)

	December 31,2025	December 31,2024
Cash, cash equivalents and investments	$554,518	$781,323
Working capital (1)	552,701	758,475
Total assets	621,331	871,296
Total liabilities	54,271	93,504
Total stockholders’ equity	567,060	777,792
Restricted cash	1,336	2,119

(1) Working capital is defined as current assets less current liabilities.

Contacts
Pete Rahmer prahmer@relaytx.com
Dan Budwick
1AB
973-271-6085 dan@1abmedia.com
Relay Therapeutics, Inc.