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

Rhea-AI Summary

Relay Therapeutics (Nasdaq: RLAY) reported Q4 and full-year 2025 results and outlined 2026 clinical milestones for zovegalisib. Key financials: $554.5M cash and investments at 12/31/25, $15.4M 2025 revenue, and $276.5M net loss for 2025. Clinical highlights include FDA Breakthrough Therapy designation, ESMO TAT presentation on March 16, 2026, and planned 1H 2026 data in PIK3CA-driven vascular anomalies.

Positive

• Cash runway into 2029 supported by $554.5M liquidity
• Revenue increased to $15.4M in 2025 (+54% vs 2024)
• Net loss narrowed to $276.5M in 2025 (vs $337.7M)
• FDA Breakthrough Therapy designation for zovegalisib
• Planned clinical readouts: ESMO TAT Mar 16, 2026 and 1H 2026 vascular data

Negative

• Cash and investments declined to $554.5M from $781.3M (2024)
• Research and development spend remains high at $261.4M in 2025
• Net loss still substantial at $276.5M for full year 2025

Key Figures

Cash & investments: $554.5M Cash & investments: $781.3M Q4 2025 revenue: $7.0M +5 more

8 metrics

Cash & investments $554.5M As of December 31, 2025

Cash & investments $781.3M As of December 31, 2024

Q4 2025 revenue $7.0M Fourth quarter 2025 vs $0 in Q4 2024

FY 2025 revenue $15.4M Full year 2025 vs $10.0M in 2024

FY 2025 R&D $261.4M Full year 2025 vs $319.1M in 2024

FY 2025 net loss $276.5M Full year 2025 vs $337.7M in 2024

Median PFS 10.3 months All patients (n=52) in ReDiscover Phase 1/2 cohort

ORR (measurable) 39% 31 patients with measurable disease in ReDiscover cohort

Market Reality Check

Price: $10.26 Vol: Volume 1,011,769 is below...

low vol

$10.26 Last Close

Volume Volume 1,011,769 is below recent activity, with relative volume at 0.49 versus 20-day levels. low

Technical Price $9.22 is trading above the 200-day MA at $5.58, reflecting a pre-news uptrend.

Peers on Argus

RLAY was modestly higher pre-news, while key biotech peers like TNGX and NRIX sh...

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RLAY was modestly higher pre-news, while key biotech peers like TNGX and NRIX showed declines and VIR had mixed intraday momentum, indicating stock-specific rather than sector-driven dynamics.

Previous Earnings Reports

5 past events · Latest: Nov 06 (Neutral)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 06	Q3 2025 earnings	Neutral	-7.3%	Reported Q3 2025 financials, cash runway into 2029, and clinical trial progress.
Aug 07	Q2 2025 earnings	Neutral	-7.7%	Q2 2025 results with promising RLY-2608 data and strong cash reserves.
May 05	Q1 2025 earnings	Neutral	-5.1%	Q1 2025 results highlighting runway to 2029 and major cost reductions.
Feb 26	FY 2024 earnings	Neutral	-13.3%	Q4/FY 2024 results with breast cancer progress and sizable year-end cash.
Nov 06	Q3 2024 earnings	Neutral	-1.8%	Q3 2024 financials, RLY-2608 interim data, and follow-on offering details.

Pattern Detected

Past earnings releases have often coincided with negative single-digit price moves despite highlighting cash runway and clinical progress.

Recent Company History

Over the last five earnings cycles (Nov 2024–Nov 2025), Relay emphasized extending cash runway into 2029, progressively advancing zovegalisib into Phase 3 ReDiscover-2 and the ReInspire vascular trial, and implementing cost controls. Shares typically fell mid-single to low-double digits after these reports, even as R&D and G&A trended lower and pipeline updates remained constructive. Today’s 2025 results continue this theme of sizeable cash balance, disciplined spend, and focus on pivotal trials.

Historical Comparison

-7.1% avg move · In the past year, RLAY’s five earnings-related releases averaged a -7.06% move, typically negative d...

earnings

-7.1%

Average Historical Move earnings

In the past year, RLAY’s five earnings-related releases averaged a -7.06% move, typically negative despite highlighting runway into 2029 and pipeline advances. Today’s modest positive reaction is milder than that pattern.

Earnings updates show a progression from planning pivotal trials in 2024 to actively running Phase 3 ReDiscover-2 and the ReInspire trial in 2025, while repeatedly reaffirming a cash runway extending into 2029 and lowering operating expenses.

Market Pulse Summary

This announcement highlights Relay’s year-end $554.5M cash position, reduced 2025 R&D and G&A spendi...

Analysis

This announcement highlights Relay’s year-end $554.5M cash position, reduced 2025 R&D and G&A spending, and guidance that current resources fund operations into 2029. Clinically, the update reinforces zovegalisib’s Phase 3 progression and meaningful PFS and ORR metrics in breast cancer. Historically, earnings have triggered choppy trading around the stock. Investors should monitor future quarters for expense discipline, cash runway updates, and delivery on 2026 zovegalisib milestones.

Key Terms

breakthrough therapy designation, phase 3, median progression free survival (pfs), objective response rate (orr), +4 more

8 terms

breakthrough therapy designation regulatory

"zovegalisib program, which recently received Breakthrough Therapy designation from the FDA"

A breakthrough therapy designation is a regulatory fast-track given to a drug or treatment that shows early signs of providing a major improvement over existing options for a serious condition. Think of it as a VIP lane that can speed up development and more intensive guidance from regulators, which matters to investors because it can shorten time to market, reduce development risk and potentially increase a company’s value — though it does not guarantee approval.

phase 3 medical

"frontline Phase 3 plans expected to be announced in 2026"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

median progression free survival (pfs) medical

"The median progression free survival (PFS) was 10.3 months for all patients"

Median progression free survival (PFS) is the midpoint time in a clinical study by which half the patients have experienced disease worsening and half have not; it measures how long a treatment can keep the condition from getting worse. For investors, it’s a key signal of a drug’s effectiveness and commercial potential—longer median PFS can raise chances of regulatory approval, wider use, and stronger sales, much like a longer-lasting warranty increasing a product’s market appeal.

objective response rate (orr) medical

"objective response rate (ORR) was 39%. For second line (2L) patients"

The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors shrink by a pre-set amount for a minimum time, counting both complete disappearance and meaningful partial shrinkage. Investors watch ORR because it gives an early, quantitative signal that a treatment is having a direct effect on disease—like the percent of people whose fever drops after taking a medicine—which can influence expectations for later trial success, regulatory approval, and market potential.

cdk4/6 inhibitor medical

"have previously been treated with a CDK4/6 inhibitorOral Proffered Paper Session"

A CDK4/6 inhibitor is a type of cancer drug that blocks two proteins (CDK4 and CDK6) that tell cells to divide, effectively slowing or stopping the growth of tumors. Think of it as cutting power to a photocopier that keeps making cancer cells; that control can shrink tumors or delay progression. For investors, these drugs matter because clinical trial results, regulatory approvals, patent life, safety issues and competition directly affect sales potential and company value.

serd medical

"For patients who received prior SERD, median PFS was 11.4 months"

A SERD is a type of drug that binds to and helps remove or disable estrogen receptors on cancer cells, preventing estrogen from telling those cells to grow. For investors, SERDs matter because they represent potential treatments for hormone-driven cancers; clinical trial results, regulatory approvals, and competition can strongly affect a drug developer’s sales prospects, valuation, and partnership or acquisition opportunities, much like a new technology changing a market leader’s outlook.

esr1 mutation medical

"patients who had a detectable ESR1 mutation at baseline, median PFS was 8.8 months"

An ESR1 mutation is a change in the gene that makes the estrogen receptor, a protein that acts like a lock on certain cells; when altered, that lock can behave differently. For investors, these mutations matter because they can make hormone drugs less effective or change which treatments and tests are needed, much like a changed lock driving demand for new keys and locksmith services — affecting drug sales, clinical trial success, and the market for diagnostics and follow‑on therapies.

pi3kα inhibitor medical

"zovegalisib, a novel PI3Kα inhibitor, in patients with PIK3CA-mutant"

A PI3Kα inhibitor is a type of drug that blocks the alpha form of the PI3K enzyme, which helps control cell growth and survival. In many cancers this pathway is overactive, so these inhibitors aim to slow tumor growth or make other treatments work better; for investors, progress or setbacks in clinical trials, approval, safety, and companion tests can strongly affect a biotech’s value and market potential, much like a key part in a machine deciding if the whole system runs.

AI-generated analysis. Not financial advice.

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., Feb. 26, 2026 (GLOBE NEWSWIRE) -- 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

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.

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.

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)
		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.

FAQ

When will Relay Therapeutics (RLAY) present Phase 1/2 breast cancer data at ESMO TAT 2026?

Relay will present on March 16, 2026 at 4:00 p.m. CET (11:00 a.m. ET). According to the company, the oral proffered paper covers dose optimization in 57 patients treated at the Phase 3 dose of 400mg BID fed.

What clinical data for zovegalisib in vascular anomalies will RLAY report in 1H 2026?

Initial Phase 1 ReInspire data are expected in first half of 2026. According to the company, approximately 20 patients (including an opened pediatric cohort) will be reported at disclosure.

How much cash did Relay Therapeutics (RLAY) hold at the end of Q4 2025 and how long will it fund operations?

Cash, cash equivalents, and investments totaled $554.5 million at 12/31/2025. According to the company, this liquidity is expected to fund operations into 2029.

What were Relay Therapeutics' (RLAY) full-year 2025 revenue and net loss figures?

Revenue was $15.4 million and net loss was $276.5 million for full-year 2025. According to the company, 2025 revenue was primarily from an Exclusive License Agreement with Elevar Therapeutics.

What clinical progress does zovegalisib (RLY-2608) have for breast cancer as of February 26, 2026?

Zovegalisib received FDA Breakthrough Therapy designation and has ongoing Phase 3 ReDiscover-2 execution. According to the company, Phase 1/2 data and triplet cohort results will inform frontline Phase 3 planning in 2026.

How did Relay Therapeutics' (RLAY) operating expenses change in 2025 versus 2024?

R&D decreased to $261.4M in 2025 from $319.1M in 2024; G&A decreased to $56.7M from $76.6M. According to the company, reductions reflect organizational streamlining and lower certain program costs.