Relay Therapeutics, Inc.: Q3 FY2026 earnings call

What management said about Q3 FY2026, from the documents filed with the SEC on 4 November 2026: press release. The quarter’s numbers.

Key takeaways

Net loss widened to $81.7 million: The company reported a third-quarter net loss of $81.7 million, or $0.37 per share, compared with $74.1 million, or $0.43 per share, a year earlier. No revenue was recorded in either quarter. Source
Cash ended the quarter at $848.6 million: Cash, cash equivalents and investments were $848.6 million at September 30, 2026, down from $910.9 million at June 30, 2026. Source
R&D expense rose $8.8 million: R&D expenses were $77.1 million, up $8.8 million, reflecting higher costs across ongoing clinical trials and non-recurring costs from terminating the One Kendall Square lease. Source
ReDiscover-2 Phase 3 execution continues: The company said it continues executing the Phase 3 ReDiscover-2 trial of zovegalisib plus fulvestrant in second-line, PI3Kα-mutated, HR+/HER2- breast cancer. Source
Updated ReInspire data at ASH: An abstract covering updated clinical data for zovegalisib in vascular anomalies was accepted for an oral presentation at the 68th ASH Annual Meeting. Source
Dynamo platform's first approved medicine: The company describes lirafugratinib as the first approved medicine to emerge from its Dynamo platform. Source

“This quarter, we are very pleased by the pace of enrollment of our ReDiscover-2 trial for second-line breast cancer and also look forward to sharing updated ReInspire data for vascular anomalies at ASH.”
Sanjiv Patel, M.D., President and Chief Executive Officer

Guidance

Area	Period	Figure
Cash runway Source	Into 2029	into 2029
ReDiscover-2 enrollment completion Source	Mid-2027	mid-2027
Regulatory update on frontline Phase 3 design Source	By year-end 2026	by year-end 2026
Frontline Phase 3 trial start Source	Early 2027	early 2027
ReDiscover triplet combination data Source	2027	2027

What changed from last quarter

New: The FDA granted full approval for lirafugratinib (LYRFIGTU) in FGFR2-fusion cholangiocarcinoma, the first approved medicine from the Dynamo platform. Source
New: Shannon Campbell joined the company as Head of Commercial. Source
New: The company announced a research program for a mutant-selective TIE2 inhibitor, described as its second vascular anomalies program. Source
New: An amendment dated August 6, 2026 raised the stated amount of the common stock sales agreement with TD Securities from $250,000,000 to $462,978,049.
New: The amendment replaced Brian Adams, Chief Legal Officer, with Soo-Yeun Lim, General Counsel, in the sales agreement schedule.

Third-quarter results and cash

Net loss widened to $81.7 million: The company reported a third-quarter net loss of $81.7 million, or $0.37 per share, compared with $74.1 million, or $0.43 per share, a year earlier. No revenue was recorded in either quarter. Source
Nine-month net loss rose: The nine-month net loss was $238.7 million, or $1.19 per share, against $221.6 million, or $1.30 per share, in the prior-year period. Nine-month license revenue was $3.4 million. Source
Cash ended the quarter at $848.6 million: Cash, cash equivalents and investments were $848.6 million at September 30, 2026, down from $910.9 million at June 30, 2026. Source
Interest income rose year over year: Interest income was $8.5 million in the third quarter, up from $6.4 million a year earlier, and total other income, net was $8.5 million. Source

Operating expenses rose

R&D expense rose $8.8 million: R&D expenses were $77.1 million, up $8.8 million, reflecting higher costs across ongoing clinical trials and non-recurring costs from terminating the One Kendall Square lease. Source
G&A rose $1.0 million: G&A expenses were $13.1 million, up $1.0 million, mainly from non-recurring lease termination costs and other miscellaneous G&A increases. Source
Earlier streamlining partly offset R&D: Management said strategic choices made to streamline the research organization before 2026 partly offset the R&D increase. Source

“As we move toward potential launches, we are excited to bring Shannon Campbell onto the Relay team, where she will bring decades of experience in helping companies like ours prepare for commercialization.”
Sanjiv Patel, M.D., President and Chief Executive Officer

Breast cancer program progress

ReDiscover-2 Phase 3 execution continues: The company said it continues executing the Phase 3 ReDiscover-2 trial of zovegalisib plus fulvestrant in second-line, PI3Kα-mutated, HR+/HER2- breast cancer. Source
Frontline combination trial preparation continues: Management said it continues to prepare a frontline breast cancer trial testing zovegalisib with atirmociclib, which it describes as a selective-selective combination. Source
Pfizer FourLight-1 data encouraged management: Management said it was highly encouraged by Pfizer's FourLight-1 data, which it believes showed a potential advantage of a CDK4-selective approach. Source

Vascular anomalies data at ASH

Updated ReInspire data at ASH: An abstract covering updated clinical data for zovegalisib in vascular anomalies was accepted for an oral presentation at the 68th ASH Annual Meeting. Source
Expansion and pediatric cohorts continue: ReInspire enrollment continues in expansion cohorts for adults and adolescents aged 12 and older, and dose escalation continues for pediatric patients aged 6 to 11. Source
Presenter and study title: The presentation is titled as updated part 1 ReInspire results in adults and adolescents with PIK3CA-driven vascular malformations, and Dr. Bryan Sisk is the presenter. Source

“we were highly encouraged by the data we saw from Pfizer’s FourLight-1 trial, which we believe showed the potential advantage of a CDK4-selective approach”
Sanjiv Patel, M.D., President and Chief Executive Officer

Lirafugratinib licensing and pipeline

Elevar holds lirafugratinib license: Relay licensed worldwide development and commercialization rights for lirafugratinib to Elevar Therapeutics in December 2024. Source
Dynamo platform's first approved medicine: The company describes lirafugratinib as the first approved medicine to emerge from its Dynamo platform. Source
Pipeline includes three further programs: The pipeline also includes programs for NRAS-driven solid tumors, Fabry disease, and TIE2-driven vascular anomalies. Source

Mutant-selective TIE2 research program

Large unmet need in venous malformations: The company estimates 50,000 to 60,000 people in the U.S. have TIE2-mutated venous malformations, and no approved systemic therapy exists for venous malformations. Source
Ocular toxicity tied to wild-type TIE2: Management said off-target inhibition of wild-type TIE2 is implicated in severe ocular toxicities, which the mutant-selective design is intended to address. Source
Program in late-stage preclinical development: The company said the mutant-selective TIE2 inhibitor program is currently in late-stage preclinical development. Source

Share sale agreement amendment

Outbound investment representation added: The amendment adds a representation that the company is not a covered foreign person under the Outbound Investment Security Program rules.
Sales agreement counsel changed to Cooley: Counsel named in the sales agreement changed from Dechert LLP to Cooley LLP, and the notice address changed to 60 Hampshire Street, Cambridge.
Prospectus supplement required within two days: The company agreed to file a Rule 424(b) prospectus supplement reflecting the amendment within two Business Days of its date.

Commercial leadership appointment

Campbell to lead commercial preparations: Shannon Campbell will lead commercial preparations for zovegalisib in breast cancer and vascular anomalies. Source
Campbell brings three decades experience: Campbell has more than 30 years of commercial leadership experience and previously served as Chief Commercial Officer at Merus. Source
Campbell holds three board seats: Campbell also serves on the boards of directors of Zentalis, Hansa Biopharma, and Black Diamond Therapeutics. Source

Coming up, as management said on 4 November 2026

ASH oral presentation on December 14: The ReInspire abstract is scheduled for oral presentation on December 14, 2026, at 4:00-4:15 pm E.T. (3:00-3:15 pm C.T.). Source
Corporate call after ASH presentation: The company plans a corporate call on December 14 to review the presented data, give a regulatory update, and outline next steps; call details are to follow. Source

Figures management reported

Figure	Reported
R&D expenses, third quarter 2026 Source	$77.1 million
Approval Source	Full FDA approval of LYRFIGTU (lirafugratinib) for FGFR2-fusion cholangiocarcinoma

Earlier plans management reported on

Ahead: Management said the estimated enrollment completion is approximately one year faster than recent benchmarks. Source
Not stated: Management cited earlier streamlining decisions as partly offsetting R&D cost growth; the documents give no status for them. 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 Third Quarter 2026 Financial Results and Corporate Updates

Phase 3 ReDiscover-2 trial in 2L breast cancer expected to complete enrollment in mid-2027

Updated data from ongoing Phase 1/2 ReInspire trial of zovegalisib in vascular anomalies to be featured in oral presentation at the 68th American Society of Hematology (ASH) Annual Meeting and Exposition; Relay to hold conference call to discuss data and provide regulatory update

Shannon Campbell to lead commercial preparations for zovegalisib in breast cancer and vascular anomalies

Announced second vascular anomalies program for mutant-selective TIE2 inhibitor

Approximately $849 million in cash, cash equivalents and investments at end of Q3 2026

Cambridge, Mass. - November 4, 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 third quarter 2026 financial results and corporate updates.

“This quarter, we are very pleased by the pace of enrollment of our ReDiscover-2 trial for second-line breast cancer and also look forward to sharing updated ReInspire data for vascular anomalies at ASH. In addition, we continue to prepare for our frontline breast cancer trial testing the selective-selective combination of zovegalisib and atirmociclib, and we were highly encouraged by the data we saw from Pfizer’s FourLight-1 trial, which we believe showed the potential advantage of a CDK4-selective approach,” said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics. “As we move toward potential launches, we are excited to bring Shannon Campbell onto the Relay team, where she will bring decades of experience in helping companies like ours prepare for commercialization. All of this drives us toward our mission of bringing potentially life-changing therapies to patients across multiple PI3Kα opportunities.”

Corporate Highlights

ReDiscover-2 Trial in Second-Line (2L) Breast Cancer Estimated to Complete Enrollment in Mid-2027

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

The ReDiscover-2 trial is estimated to complete enrollment in mid-2027 based on current enrollment trajectory, approximately one year faster than recent benchmarks

Vascular Anomalies Data and Regulatory Update at ASH Annual Meeting in December

Abstract accepted for the 68th American Society of Hematology (ASH) Annual Meeting and Exposition covering updated clinical data for zovegalisib in vascular anomalies

Oral presentation date: Monday, December 14, 2026

Presentation time: 4:00-4:15 pm E.T. / 3:00-3:15 pm C.T.

Abstract Number: 878

Title: Updated results from part 1 of the ReInspire study evaluating zovegalisib, a mutant-selective PI3Kα inhibitor, in adults and adolescents with PIK3CA-driven vascular malformations

Presenter: Dr. Bryan Sisk

Relay Therapeutics plans to host a corporate conference call on December 14 after the ASH presentation to review the presented data, provide a regulatory update, and provide an overview of next steps (call details to be provided at a later date)

Continued enrollment of expansion cohorts for adults and adolescents ages 12+ and dose escalation for pediatric patients ages 6-11 in the Phase 1/2 ReInspire trial to further evaluate zovegalisib in patients with PIK3CA-driven vascular anomalies

Shannon Campbell Joins Relay Therapeutics as Head of Commercial

Ms. Campbell brings more than 30 years of commercial leadership experience across the pharmaceutical and biotechnology industries, with a track record of building commercial capabilities and preparing organizations for the transition to commercial-stage operations

Most recently, Ms. Campbell served as Executive Vice President and Chief Commercial Officer at Merus, where she led commercial-readiness and launch planning for zenocutuzumab and petosemtamab in oncology indications through Merus’ acquisition by Genmab

Previously, she held senior leadership roles at Novartis Pharmaceuticals, including U.S. franchise leadership across solid tumor oncology and rare diseases, where her responsibilities included breast cancer and vascular anomalies

Ms. Campbell also serves on the board of directors for Zentalis, Hansa Biopharma, and Black Diamond Therapeutics

Newly Announced Research Program: Mutant-Selective TIE2 Inhibitor

TIE2 is a receptor tyrosine kinase that, when mutated, is among the most common drivers of venous malformations and other vascular anomalies; an estimated 50,000-60,000 people have TIE2-mutated venous malformations in the U.S.

There are currently no approved systemic therapies for venous malformations, and non-selective approaches, either in development or used off-label, inhibit the wild-type TIE2 protein or target other downstream parts of the pathway, which can lead to significant off-target toxicity and limit efficacy

Off-target inhibition of wild-type TIE2 is implicated in severe ocular toxicities

Relay Therapeutics has discovered a novel modulation hypothesis leading to the discovery of the first known mutant-selective TIE2 inhibitor, which has been designed to address the liabilities of non-selective approaches

The program is currently in late-stage preclinical development

First FDA Approval of Molecule Discovered by Relay Therapeutics: LYRFIGTU™ (Lirafugratinib)

The FDA granted full approval for LYRFIGTU™ (lirafugratinib) as a treatment option for patients with cholangiocarcinoma (CCA) with FGFR2 fusion or other rearrangement. Relay Therapeutics entered into a global licensing agreement with Elevar Therapeutics (Elevar) in December 2024, granting Elevar worldwide rights to develop and commercialize lirafugratinib

This is the first approved medicine to emerge from Relay Therapeutics’ Dynamo® platform

Anticipated Milestones:

Breast Cancer

Complete enrollment of Phase 3 ReDiscover-2 trial in 2L breast cancer estimated in mid-2027

Regulatory update to confirm design for planned Phase 3 trial in 1L endocrine-sensitive breast cancer by year-end 2026

Initiation of Phase 3 trial in 1L breast cancer in early 2027

Data update for Phase 1/2 ReDiscover trial triplet combination in 2027

Vascular Anomalies

Data and regulatory update at ASH 2026

Third Quarter 2026 Financial Results

Cash, Cash Equivalents and Investments: As of September 30, 2026, cash, cash equivalents and investments totaled $848.6 million, as compared to $910.9 million as of June 30, 2026. The company expects its current cash, cash equivalents, and investments will be sufficient to fund its operating expenses and capital expenditure requirements into 2029.

R&D Expenses: Research and development expenses were $77.1 million for the third quarter of 2026, as compared to $68.3 million for the third quarter of 2025. The increase of $8.8 million was primarily due to increases in costs across ongoing clinical trials, as well as non-recurring costs related to the termination of the company’s operating lease at One Kendall Square, partially offset by the impact from strategic choices made to streamline the research organization prior to 2026.

G&A Expenses: General and administrative expenses were $13.1 million for the third quarter of 2026, as compared to $12.1 million for the third quarter of 2025. The increase of $1.0 million was primarily due to non-recurring costs related to the termination of the company’s operating lease at One Kendall Square, as well as increases in other miscellaneous general and administrative costs.

Net Loss: Net loss was $81.7 million for the third quarter of 2026, or a net loss per share of $0.37, as compared to a net loss of $74.1 million for the third quarter of 2025, or a net loss per share of $0.43.

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. Relay Therapeutics’ 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, Fabry disease, and TIE2-driven vascular anomalies. 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; the timing of clinical data readouts and trial enrollments for zovegalisib; the expected therapeutic benefits and potential efficacy and tolerability profile 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 launch, commercialization and market opportunity for zovegalisib; the progress and anticipated results of the mutant-selective TIE2 inhibitor program 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 September 30,		Nine Months Ended September 30,
	2026	2025	2026	2025
Revenue:
License and other revenue	$ -	$ -	$3,350	$8,355
Total revenue	-	-	3,350	8,355
Operating expenses:
Research and development expenses	$77,138	$68,262	$224,184	$205,968
General and administrative expenses	13,107	12,129	38,825	44,495
Total operating expenses	90,245	80,391	263,009	250,463
Loss from operations	(90,245)	(80,391)	(259,659)	(242,108)
Other income:
Interest income	8,502	6,407	20,969	21,325
Other expense	(2)	(165)	(53)	(806)
Total other income, net	8,500	6,242	20,916	20,519
Net loss	$(81,745)	$(74,149)	$(238,743)	$(221,589)
Net loss per share, basic and diluted	$(0.37)	$(0.43)	$(1.19)	$(1.30)
Weighted average shares of common stock, basic and diluted	219,157,506	172,389,209	200,762,690	170,973,889
Other comprehensive (loss) income:
Unrealized holding (loss) gain	(3,810)	656	(6,096)	1,484
Total other comprehensive (loss) income	(3,810)	656	(6,096)	1,484
Total comprehensive loss	$(85,555)	$(73,493)	$(244,839)	$(220,105)

Relay Therapeutics, Inc.

Selected Condensed Consolidated Balance Sheet Data

(In thousands)

(Unaudited)

	September 30,2026	December 31,2025
Cash, cash equivalents and investments	$848,642	$554,518
Working capital (1)	805,696	552,701
Total assets	901,692	621,331
Total liabilities	82,696	54,271
Total stockholders’ equity	818,996	567,060
Restricted cash	1,197	1,336

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

Contacts
Mitch Maisel mmaisel@relaytx.com
Katie Engleman
1AB
919-333-7722 katie@1abmedia.com
Relay Therapeutics, Inc.