Relay Therapeutics (NASDAQ: RLAY) narrows 2025 loss and sets major 2026 zovegalisib data milestones
Rhea-AI Filing Summary
Relay Therapeutics reported narrower losses for 2025 and highlighted key 2026 clinical milestones. Cash, cash equivalents and investments were
Revenue was
Net loss improved to
Positive
- None.
Negative
- None.
Insights
Relay shows tighter cost control, solid cash runway, and multiple 2026 data catalysts.
Relay Therapeutics remains a development-stage company but is pairing pipeline progress with financial discipline. Full-year revenue rose to
Net loss narrowed to
On the clinical side, the lead PI3Kα inhibitor zovegalisib anchors the story. 2026 is slated to bring Phase 1/2 breast cancer data at ESMO TAT on
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On February 26, 2026, Relay Therapeutics, Inc. announced its financial results for the quarter and year ended December 31, 2025. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Current Report on Form 8-K and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
Description |
99.1 |
Press release issued by Relay Therapeutics, Inc. on February 26, 2026, furnished herewith. |
104 |
Cover Page Interactive Data File (embedded within Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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RELAY THERAPEUTICS, INC. |
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Date: |
February 26, 2026 |
By: |
/s/ Soo-Yeun Lim |
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Soo-Yeun Lim |
Exhibit 99.1
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
Zovegalisib 2025 Highlights
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)
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3 Months Ended December 31, |
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12 Months Ended December 31, |
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2025 |
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2024 |
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2025 |
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2024 |
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Revenue: |
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License and other revenue |
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$ |
7,000 |
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$ |
— |
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$ |
15,355 |
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$ |
10,007 |
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Total revenue |
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7,000 |
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— |
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15,355 |
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10,007 |
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Operating expenses: |
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Research and development expenses |
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$ |
55,415 |
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$ |
68,075 |
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$ |
261,383 |
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$ |
319,089 |
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Change in fair value of contingent consideration liability |
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— |
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— |
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— |
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(13,206 |
) |
General and administrative expenses |
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12,215 |
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16,904 |
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56,710 |
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76,592 |
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Total operating expenses |
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67,630 |
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84,979 |
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318,093 |
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382,475 |
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Loss from operations |
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(60,630 |
) |
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(84,979 |
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(302,738 |
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(372,468 |
) |
Other income: |
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Interest income |
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5,710 |
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8,974 |
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27,035 |
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34,746 |
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Other income (expense) |
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31 |
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1 |
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(776 |
) |
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14 |
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Total other income, net |
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5,741 |
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8,975 |
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26,259 |
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34,760 |
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Net loss |
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$ |
(54,889 |
) |
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$ |
(76,004 |
) |
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$ |
(276,479 |
) |
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$ |
(337,708 |
) |
Net loss per share, basic and diluted |
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$ |
(0.32 |
) |
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$ |
(0.45 |
) |
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$ |
(1.61 |
) |
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$ |
(2.36 |
) |
Weighted average shares of common stock, basic and diluted |
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173,404,585 |
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167,337,579 |
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171,586,558 |
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142,867,844 |
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Other comprehensive income (loss): |
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Unrealized holding gain (loss) |
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240 |
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(3,500 |
) |
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1,724 |
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(795 |
) |
Total other comprehensive income (loss) |
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240 |
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(3,500 |
) |
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1,724 |
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(795 |
) |
Total comprehensive loss |
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$ |
(54,649 |
) |
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$ |
(79,504 |
) |
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$ |
(274,755 |
) |
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$ |
(338,503 |
) |
Relay Therapeutics, Inc.
Selected Condensed Consolidated Balance Sheet Data
(In thousands)
(Unaudited)
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December 31, 2025 |
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December 31, 2024 |
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Cash, cash equivalents and investments |
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$ |
554,518 |
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$ |
781,323 |
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Working capital (1) |
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552,701 |
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758,475 |
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Total assets |
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621,331 |
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871,296 |
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Total liabilities |
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54,271 |
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93,504 |
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Total stockholders’ equity |
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567,060 |
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777,792 |
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Restricted cash |
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1,336 |
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2,119 |
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(1) Working capital is defined as current assets less current liabilities.
FAQ
How did Relay Therapeutics (RLAY) perform financially in full year 2025?
What were Relay Therapeutics’ (RLAY) fourth quarter 2025 results?
What is Relay Therapeutics’ (RLAY) cash position and runway after 2025?
How are Relay Therapeutics’ R&D and G&A expenses trending?
What are the key 2026 clinical milestones for Relay Therapeutics’ zovegalisib program?
What efficacy data did Relay report for zovegalisib in breast cancer?
What is Relay Therapeutics’ lead program zovegalisib targeting?
Filing Exhibits & Attachments
2 documentsPress Releases
