Relay Therapeutics, Inc.: Q1 FY2026 earnings call

What management said about Q1 FY2026, from the documents filed with the SEC on 5 May 2026: press release. Guidance figures: 1 new, 2 kept. The quarter’s numbers.

Key takeaways

Net loss narrowed to $73.3 million: Net loss was $73.3 million, or $0.41 per share, against $77.1 million, or $0.46 per share, in the first quarter of 2025. Source
ESMO data showed 11.1-month PFS: Doublet data at the Phase 3 dose showed 11.1-month median PFS in heavily pre-treated patients, consistent with previously reported data. Source
Triplet response rate of 44%: Triplet data in median third-line patients showed a 44% objective response rate at unoptimized doses, with adverse events matching prior reports for each molecule. Source
Initial data call set for May 19: The company plans a corporate call on May 19 at 8:00am ET during the ISSVA World Congress to announce initial zovegalisib results in vascular anomalies. Source
RLY-8161 Phase 1/2 trial started: The company started a Phase 1/2 trial of RLY-8161, an NRAS-selective inhibitor, in NRAS-mutant melanoma and other NRAS-mutant solid tumors. Source
Cash rose to $642.1 million: Cash, cash equivalents and investments were $642.1 million at March 31, 2026, up from $554.5 million at December 31, 2025. Source

“We have made important progress so far in 2026, highlighted by promising data supporting further development for the zovegalisib plus atirmociclib triplet combination in frontline breast cancer,”
Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics

Guidance

Area	Period	Figure	Against last quarter
Cash runway Source	into 2029	into 2029	Kept
Frontline Phase 3 trial start Source	Early 2027	early 2027	New
Vascular anomalies initial clinical data Source	2026	conference call May 19, 2026	Kept

What changed from last quarter

New: Zovegalisib plus atirmociclib was selected as the go-forward triplet regimen for first-line breast cancer. The prior update had said triplet data and frontline study plans were expected in 2026. Source
New: The company initiated a Phase 1/2 trial of RLY-8161, an NRAS-selective inhibitor. The prior update listed NRAS-driven solid tumors among pipeline programs without a trial start. Source
New: Pfizer agreed to supply clinical material for the planned frontline study, a supply arrangement not described in the prior update. Source

Financial results and revenue

Net loss narrowed to $73.3 million: Net loss was $73.3 million, or $0.41 per share, against $77.1 million, or $0.46 per share, in the first quarter of 2025. Source
Revenue declined year over year: Total revenue was $3.0 million against $7.7 million a year earlier. Source
Revenue tied to Elevar license: Revenue in each period was recognized under the company's exclusive license agreement with Elevar Therapeutics. Source
Weighted average share count rose: Weighted average shares of common stock were 179.8 million, against 169.2 million a year earlier. Source

Zovegalisib in 2L breast cancer

FDA Breakthrough designation granted: The FDA granted Breakthrough Therapy designation for zovegalisib with fulvestrant in PIK3CA-mutant HR+/HER2- advanced breast cancer, based on ReDiscover trial data. Source
ESMO data showed 11.1-month PFS: Doublet data at the Phase 3 dose showed 11.1-month median PFS in heavily pre-treated patients, consistent with previously reported data. Source
Kinase and non-kinase mutations similar: Median PFS was 11.2 months for kinase domain mutations and 11.0 months for non-kinase domain mutations. Source
Safety in line with earlier data: Safety and tolerability of the 400mg BID doublet were consistent with previously reported data for the 600mg BID fasted regimen. Source

“With initial clinical data in vascular anomalies expected at ISSVA and preparations underway for our planned Phase 3 frontline study in endocrine-sensitive patients with metastatic breast cancer, we are entering a data-rich period for zovegalisib.”
Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics

Frontline triplet and study cohorts

Triplet response rate of 44%: Triplet data in median third-line patients showed a 44% objective response rate at unoptimized doses, with adverse events matching prior reports for each molecule. Source
Relay keeps global zovegalisib rights: Relay Tx retains full global rights to zovegalisib under the Pfizer supply arrangement. Source
Triplet cohorts continue in ReDiscover: The ReDiscover trial continues to advance ongoing triplet cohorts combining zovegalisib, atirmociclib and endocrine therapy. Source

Vascular anomalies program

Initial data call set for May 19: The company plans a corporate call on May 19 at 8:00am ET during the ISSVA World Congress to announce initial zovegalisib results in vascular anomalies. Source
ReInspire trial continues: The Phase 1/2 ReInspire trial continues to evaluate zovegalisib in PIK3CA-driven vascular anomalies. Source
Large vascular anomaly population estimate: The company estimates about 170,000 patients per year in the United States have vascular anomalies driven by a PI3Kα mutation. Source

“We remain focused on executing across these priorities to bring differentiated therapies to patients.”
Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics

NRAS and other pipeline programs

RLY-8161 Phase 1/2 trial started: The company started a Phase 1/2 trial of RLY-8161, an NRAS-selective inhibitor, in NRAS-mutant melanoma and other NRAS-mutant solid tumors. Source
Zovegalisib described as first-in-class: Zovegalisib is described as the first pan-mutant selective PI3Kα inhibitor to enter clinical development. Source

Operating costs

R&D expenses slightly lower: R&D expenses were $70.6 million, against $73.8 million a year earlier. Source
Streamlining offset by ReDiscover-2 costs: Lower R&D reflects earlier streamlining of the research organization, offset by higher costs for the ReDiscover-2 trial. Source
G&A expenses fell to $11.0 million: G&A expenses were $11.0 million, against $18.7 million a year earlier. Source
Lower compensation drove G&A decline: The G&A decrease reflected lower employee compensation, including stock compensation expense. Source

Cash and at-the-market share sales

Cash rose to $642.1 million: Cash, cash equivalents and investments were $642.1 million at March 31, 2026, up from $554.5 million at December 31, 2025. Source
Share sales added $137.1 million: Net proceeds of $137.1 million from at-the-market offerings under the TD Securities sales agreement drove the cash increase. Source
April share sales add $22.1 million: A further $22.1 million in net proceeds from April at-the-market offerings is not included in the March 31 balance. Source

Coming up, as management said on 5 May 2026

Late-breaking abstract May 20: A late-breaking abstract with clinical data is to be presented May 20 from 4:45pm to 4:49pm ET. Source
Preclinical data presentation May 22: Preclinical vascular anomalies data is to be presented May 22 at 11:10am ET. Source
Frontline Phase 3 start in early 2027: The Phase 3 first-line trial in endocrine-sensitive patients is expected to initiate in early 2027. Source

Figures management reported

Figure	Reported
Median PFS, zovegalisib doublet at ESMO TAT Source	11.1 months
Objective response rate, triplet (median 3L) Source	44%
R&D expenses, first quarter 2026 Source	$70.6 million
Regulatory designation, 2L breast cancer Source	Breakthrough Therapy designation granted

Risks management discussed

Regulatory: The start of the frontline Phase 3 trial is subject to regulatory feedback, according to the company. Source

Earlier plans management reported on

Met: The company reported presenting zovegalisib doublet data at the Phase 3 dose at ESMO TAT, as the prior update planned. Source
Not stated: The prior update planned initial ReInspire data for 1H 2026; the current update sets a May 19 call during the ISSVA World Congress.
Not stated: The company reported triplet clinical data and frontline study plans; the documents do not state status against the prior 2026 timing.

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 First Quarter 2026 Financial Results and Corporate Updates

FDA Breakthrough Therapy designation granted to zovegalisib for PIK3CA-mutant, HR+/HER2- advanced breast cancer, the Phase 3 ReDiscover-2 trial population in 2L breast cancer

Presented zovegalisib doublet data at Phase 3 dose in CDK4/6-experienced patients at ESMO TAT, demonstrating 11.1-month median PFS with similar efficacy in kinase and non-kinase mutations

Selected zovegalisib plus atirmociclib as go-forward triplet regimen for 1L breast cancer; Phase 3 1L trial in endocrine-sensitive patients expected to initiate in early 2027

Initiated Phase 1/2 trial of RLY-8161, a NRAS-selective molecule, in patients with NRAS-mutant solid tumors

Initial vascular anomalies clinical data conference call planned for May 19 during the ISSVA World Congress 2026

Approximately $642 million in cash, cash equivalents and investments at end of Q1 2026

Cambridge, Mass. - May 5, 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 first quarter 2026 financial results and corporate updates.

“We have made important progress so far in 2026, highlighted by promising data supporting further development for the zovegalisib plus atirmociclib triplet combination in frontline breast cancer,” said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics. “With initial clinical data in vascular anomalies expected at ISSVA and preparations underway for our planned Phase 3 frontline study in endocrine-sensitive patients with metastatic breast cancer, we are entering a data-rich period for zovegalisib. Additionally, RLY-8161, our NRAS-selective molecule, has entered clinical development for patients with NRAS-mutant solid tumors. We remain focused on executing across these priorities to bring differentiated therapies to patients.”

Corporate Highlights

2L Breast Cancer

U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation (BTD) to zovegalisib in combination with fulvestrant for PIK3CA-mutant, HR+/HER2- advanced breast cancer

Designation supported by robust clinical data from the Phase 1/2 ReDiscover trial of 600mg twice daily (BID) fasted and 400mg BID fed regimens of zovegalisib in combination with fulvestrant

Presented 400mg BID zovegalisib doublet data at the European Society for Medical Oncology (ESMO) Targeted Anticancer Therapies (TAT) Congress 2026

11.1-month median progression-free survival (PFS) observed in heavily pre-treated patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer, consistent with previously reported data

Efficacy in patients with kinase and non-kinase domain mutations was similar, with median PFS of 11.2 and 11.0 months, respectively

Safety and tolerability data were consistent with previously reported 600mg BID fasted data

Relay Tx continues to execute on the Phase 3 ReDiscover-2 trial of zovegalisib + fulvestrant in PI3Kα-mutated, CDK4/6 pre-treated, HR+/HER2- advanced breast cancer

1L Breast Cancer

Announced clinical data for zovegalisib plus atirmociclib triplet combination, plans for frontline breast cancer study, and clinical supply agreement with Pfizer

Compelling efficacy and tolerability data presented for zovegalisib triplet in median third-line (3L) patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer

44% objective response rate (ORR) reported in heavily pre-treated CDK4/6-experienced patients (median 3L) at unoptimized doses and ORR was similar across kinase and non-kinase PIK3CA mutations

Adverse events were consistent with those previously reported by each molecule

Phase 3 1L trial in patients with endocrine-sensitive breast cancer expected to initiate in early 2027, subject to regulatory feedback

Pfizer has agreed to supply atirmociclib for the experimental arm and the palbociclib portion of the control arm for use in the planned study, and Relay Tx will retain full global rights for zovegalisib

Relay Tx continues to execute the Phase 1/2 ReDiscover trial, advancing the ongoing triplet cohorts with zovegalisib + atirmociclib + endocrine therapy

Vascular Anomalies

Corporate conference call planned for May 19 at 8:00am ET during the International Society for the Study of Vascular Anomalies (ISSVA) World Congress 2026 to announce initial clinical results for zovegalisib in vascular anomalies

Late breaking abstract for clinical data to be presented May 20 from 4:45pm-4:49pm ET

Pre-clinical data presentation May 22 at 11:10am ET

Conference call details to be shared at a later date

Continued execution of the Phase 1/2 ReInspire trial, evaluating zovegalisib in PIK3CA-driven vascular anomalies

NRAS Selective Inhibitor: RLY-8161

Initiated Phase 1/2 clinical trial for RLY-8161, a NRAS-selective inhibitor, in patients with NRAS-mutant melanoma and other NRAS-mutant solid tumors

First Quarter 2026 Financial Results

Cash, Cash Equivalents and Investments: As of March 31, 2026, cash, cash equivalents and investments totaled $642.1 million, as compared to $554.5 million as of December 31, 2025. The increase in cash was due to $137.1 million in net proceeds from "at-the-market" offerings under our sales agreement with TD Securities (USA) LLC during the quarter. This figure does not include an additional $22.1 million in net proceeds received from "at-the-market" offerings in April. 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 $3.0 million for the first quarter of 2026, as compared to $7.7 million for the first quarter of 2025. The revenue recognized in each period was under the company's Exclusive License Agreement with Elevar Therapeutics, Inc.

R&D Expenses: Research and development expenses were $70.6 million for the first quarter of 2026, as compared to $73.8 million for the first quarter of 2025. The decrease was primarily due to the series of strategic choices made to streamline the research organization prior to 2026, offset by increases in costs related to the ReDiscover-2 trial.

G&A Expenses: General and administrative expenses were $11.0 million for the first quarter of 2026, as compared to $18.7 million for the first quarter of 2025. The decrease was primarily due to decreases in employee compensation costs, including stock compensation expense, and costs to obtain the Exclusive License Agreement with Elevar Therapeutics, Inc., which were expensed during the three months ended March 31, 2025.

Net Loss: Net loss was $73.3 million for the first quarter of 2026, or a net loss per share of $0.41, as compared to a net loss of $77.1 million for the first quarter of 2025, or a net loss per share of $0.46.

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 Phase 1/2 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 Therapeutics’ 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 Therapeutics’ 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, including zovegalisib and RLY-8161; the timing of clinical data readouts and presentations 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)

	Three Months Ended March 31,
	2026	2025
Revenue:
License and other revenue	$3,000	$7,679
Total revenue	3,000	7,679
Operating expenses:
Research and development expenses	$70,563	$73,809
General and administrative expenses	11,027	18,739
Total operating expenses	81,590	92,548
Loss from operations	(78,590)	(84,869)
Other income:
Interest income	5,352	7,813
Other expense	(53)	(9)
Total other income, net	5,299	7,804
Net loss	$(73,291)	$(77,065)
Net loss per share, basic and diluted	$(0.41)	$(0.46)
Weighted average shares of common stock, basic and diluted	179,849,137	169,233,155
Other comprehensive (loss) income:
Unrealized holding (loss) gain	(172)	1,029
Total other comprehensive (loss) income	(172)	1,029
Total comprehensive loss	$(73,463)	$(76,036)

Relay Therapeutics, Inc.

Selected Condensed Consolidated Balance Sheet Data

(In thousands)

(Unaudited)

	March 31,2026	December 31,2025
Cash, cash equivalents and investments	$642,065	$554,518
Working capital (1)	628,711	552,701
Total assets	699,613	621,331
Total liabilities	57,430	54,271
Total stockholders’ equity	642,183	567,060
Restricted cash	1,336	1,336

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

Contacts
Mitch Maisel mmaisel@relaytx.com
Dan Budwick
1AB
973-271-6085 dan@1abmedia.com
Relay Therapeutics, Inc.