STOCK TITAN

Relay Therapeutics (Nasdaq: RLAY) widens stock sale plan and reports Q2 2026 loss

(Moderate)
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Relay Therapeutics increased the size of its at‑the‑market common stock sales program with TD Securities from $250,000,000 to an aggregate offering price of $462,978,049 and filed a new prospectus supplement covering up to $212,978,049 of additional common shares. As of this report, it has sold approximately $162,978,049 of stock under the program, paying TD Cowen a cash commission of up to 3.0% of gross proceeds, with either party able to suspend sales and no obligation to sell any shares.

For the quarter ended June 30, 2026, revenue was $0.4 million, research and development expenses were $76.5 million, general and administrative expenses were $14.7 million, and net loss was $83.7 million, or $0.41 per share. Cash, cash equivalents and investments totaled $910.9 million, including approximately $316 million of gross proceeds from a May 2026 follow‑on offering, and the company expects this balance to fund operations into 2029. Relay highlighted clinical progress for lead asset zovegalisib, including a 44% objective response rate in a triplet breast cancer regimen, 60% volumetric responses at 12 weeks in vascular anomalies, and ongoing/planned Phase 3 trials in second‑ and first‑line HR+/HER2‑ breast cancer.

Positive

  • None.

Negative

  • None.

Filing Explained

The added $212,978,049 is potential common-stock selling capacity, not a reported completed issuance, so dilution remains conditional on sales.

The August 6, 2026 amendment is effective and expands the authorized ATM program to $462,978,049; with approximately $162,978,049 reported sold, the added capacity is not a completed issuance, so potential dilution to existing holders depends on future sales.

The arrangement allows common shares to be sold from time to time through TD Cowen, including negotiated or block transactions and other permitted ATM methods; Relay has no obligation to sell, and either party may suspend sales.

The next lifecycle marker is the prospectus supplement reflecting the amendment, which the agreement requires within two business days. Until a sale from the added capacity is disclosed, the filing does not establish related proceeds, timing, or final dilution.

Item 1.01 Entry into a Material Definitive Agreement Business
The company signed a significant contract such as a merger agreement, credit facility, or major partnership.
Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
ATM program size $462,978,049 Aggregate offering price for the at-the-market program after the August 6, 2026 amendment
Additional ATM capacity $212,978,049 Dollar amount of Additional Shares covered by the new prospectus supplement
Cash, cash equivalents and investments $910.9 million Balance as of June 30, 2026
Revenue Q2 2026 $0.4 million License and other revenue for the quarter ended June 30, 2026
R&D expenses Q2 2026 $76.5 million Research and development expenses for the quarter ended June 30, 2026
Net loss Q2 2026 $83.7 million Net loss for the quarter ended June 30, 2026
Follow-on offering proceeds $316 million Approximate gross proceeds from an underwritten follow-on public offering in May 2026
at-the-market offering financial
"may be made in negotiated transactions, including block trades or block sales, or by any method permitted by law to be an “at-the-market” offering"
An at-the-market offering is a method companies use to sell new shares of stock directly into the open market over time, rather than all at once. This allows them to raise money gradually, similar to selling small pieces of a product instead of a large batch. For investors, it means the company can access funding more flexibly, but it may also increase the supply of shares and influence the stock’s price.
objective response rate medical
"44% objective response rate (ORR) reported in heavily pre-treated CDK4/6-experienced patients"
The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors measurably shrink or disappear according to preset rules. Investors use it as a quick, objective signal of a drug’s ability to produce a clear treatment effect—like counting how many plants visibly respond after applying a new fertilizer—and higher ORR can improve odds of regulatory approval, commercial success, and company valuation.
Outbound Investment Security Program regulatory
"A new paragraph 6(ccc) shall be added as follows Outbound Investment Security Program."
covered foreign person regulatory
"Neither the Company nor any of its subsidiaries is a “covered foreign person”, as that term is defined in 31 C.F.R. § 850.209."
Phase 3 ReDiscover-2 trial medical
"Continued to execute on the Phase 3 ReDiscover-2 trial of zovegalisib + fulvestrant"
Revenue Q2 2026 $0.4 million from $0.7 million in the second quarter of 2025
Net loss Q2 2026 $83.7 million from $70.4 million in the second quarter of 2025
R&D expenses Q2 2026 $76.5 million from $63.9 million in the second quarter of 2025
Cash, cash equivalents and investments $910.9 million from $642.1 million as of March 31, 2026
Guidance

The company expects its current cash, cash equivalents and investments will be sufficient to fund operating expenses and capital expenditure requirements into 2029.

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FAQ

What change did Relay Therapeutics (RLAY) make to its stock sales program?

Relay Therapeutics amended its common stock sales agreement with TD Securities to expand its at-the-market program to an aggregate offering price of $462,978,049. A new prospectus supplement covers up to $212,978,049 of additional shares, with TD Cowen earning up to 3.0% of gross proceeds.

How much cash does Relay Therapeutics (RLAY) have after Q2 2026?

As of June 30, 2026, Relay Therapeutics held $910.9 million in cash, cash equivalents and investments. This balance reflects net proceeds from a May 2026 follow-on public offering that raised approximately $316 million of gross proceeds and is expected to fund operations into 2029.

What were Relay Therapeutics' (RLAY) key Q2 2026 financial results?

For Q2 2026, Relay Therapeutics reported $0.4 million in revenue, research and development expenses of $76.5 million, and general and administrative expenses of $14.7 million. Net loss was $83.7 million, equivalent to a net loss per share of $0.41 on 202.8 million weighted-average shares.

What clinical progress did Relay Therapeutics (RLAY) report for zovegalisib?

Relay reported a 44% objective response rate for a zovegalisib plus atirmociclib triplet in median third-line PI3Kα-mutated HR+/HER2- breast cancer. It also noted 60% volumetric response at 12 weeks in vascular anomalies and ongoing Phase 3 development in second-line breast cancer, with a first-line Phase 3 trial planned.

What upcoming milestones did Relay Therapeutics (RLAY) highlight?

Relay plans an enrollment update for the Phase 3 ReDiscover-2 trial in second-line breast cancer and a regulatory design update for a planned first-line Phase 3 trial by year-end 2026. It also expects vascular anomalies data and regulatory updates by year-end 2026 and a triplet data update in 1H 2027.

What did Relay Therapeutics (RLAY) disclose about its NRAS program RLY-8161?

Relay Therapeutics stated it is continuing execution of a Phase 1/2 clinical trial for RLY-8161, an NRAS-selective inhibitor, in patients with NRAS-mutant melanoma and other NRAS-mutant solid tumors. No efficacy or safety data were detailed in this disclosure.
false000181236400018123642026-08-062026-08-06

 

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

Date of Report (Date of earliest event reported): August 06, 2026

 

 

RELAY THERAPEUTICS, INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-39385

47-3923475

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

60 Hampshire Street

 

Cambridge, Massachusetts

 

02139

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (617) 370-8837

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

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:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, par value $0.001 per share

 

RLAY

 

Nasdaq Global Market

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

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 1.01 Entry into a Material Definitive Agreement.

Relay Therapeutics, Inc. (the “Company”) previously entered into a common stock sales agreement (the “Original Sales Agreement”), dated August 6, 2024, with TD Securities (USA) LLC (“TD Cowen” or the “Sales Agent”), relating to shares of the Company’s common stock, par value $0.001 per share (the “Common Stock”), having an aggregate offering price of up to $250,000,000, through TD Cowen. Pursuant to the Original Sales Agreement, the sale and issuance of the shares under the Original Sales Agreement were made pursuant to a registration statement on Form S-3ASR (File No. 333-281308) filed on August 6, 2024 (the “Existing Registration Statement”) and a prospectus supplement filed on August 6, 2024 (together with the Existing Registration Statement, the “Existing Prospectus”) with the Securities and Exchange Commission under the Securities Act of 1933, as amended (the “Securities Act”).

On August 6, 2026, the Company entered into an amendment to the Original Sales Agreement (the “Sales Agreement Amendment,” and collectively with the Original Sales Agreement, the “Sales Agreement”) to increase the size of the at-the-market offering program from $250,000,000 to $462,978,049. As of the date of this Current Report on Form 8-K, the Company has sold approximately $162,978,049 of shares of Common Stock under the Sales Agreement pursuant to the Existing Prospectus. On August 6, 2026, the Company will file a prospectus supplement (the “New Prospectus Supplement”) to the Company’s Existing Registration Statement. The New Prospectus Supplement covers the offer and sale of up to $212,978,049 of shares of Common Stock (the “Additional Shares”) from time to time through TD Cowen, acting as the Company’s sales agent.

Upon delivery of a placement notice and subject to the terms and conditions of the Sales Agreement, sales of the shares of Common Stock under the Sales Agreement may be made in negotiated transactions, including block trades or block sales, or by any method permitted by law to be an “at-the-market” offering as defined in Rule 415(a)(4) under the Securities Act. The Company is not obligated to make any sales of shares of Common Stock under the Sales Agreement.

Under the Sales Agreement, the Company or TD Cowen may suspend the offering of shares being made through the Sales Agent, upon proper written notice to the other party. TD Cowen will act as sales agent and has agreed to use its commercially reasonable efforts consistent with its normal trading and sales practices and applicable state and federal laws, rules and regulations and the rules of the Nasdaq Global Market to sell shares of Common Stock up to the number or amount specified in, and otherwise in accordance with the terms of, a placement notice delivered pursuant to the Sales Agreement.

The Company will continue to pay TD Cowen compensation for its services in cash up to 3.0% of the gross proceeds from the sale of shares of Common Stock pursuant to the terms of the Sales Agreement. The Company also agreed to provide indemnification and contribution to TD Cowen with respect to certain liabilities.

TD Cowen and/or its affiliates have provided, and may in the future provide various investment banking, commercial banking and other financial services to the Company and/or its affiliates, for which services they have received, or may in the future receive, customary fees.

The foregoing description of the material terms of the Sales Agreement is qualified in its entirety by reference to the full text of the Original Sales Agreement, a copy of which was filed as Exhibit 1.2 to the Existing Registration Statement, which is incorporated herein by reference, and the Sales Agreement Amendment, which is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. Goodwin Procter LLP, counsel to the Company, has issued a legal opinion relating to the Additional Shares being offered pursuant to the New Prospectus Supplement. A copy of such legal opinion, including the consent included therein, is attached as Exhibit 5.1 to this Current Report on Form 8-K. This Current Report on Form 8-K shall not constitute an offer to sell or solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities law of such state or jurisdiction.

Item 2.02 Results of Operations and Financial Condition.

On August 6, 2026, the Company announced its financial results for the quarter ended June 30, 2026. A copy of the press release is being furnished as Exhibit 99.2 to this Current Report on Form 8-K.

The information in this Item 2.02, including Exhibit 99.2, of this Current Report on Form 8-K 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, 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, except as expressly set forth by specific reference in such filing.


Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

5.1

Opinion of Goodwin Procter LLP regarding the issue of Common Stock being registered.

23.1

Consent of Goodwin Procter LLP (included in Exhibit 5.1).

99.1

Amendment to Sales Agreement, dated as of August 6, 2026, by and between Relay Therapeutics, Inc. and TD Securities (USA) LLC.

99.2

Press release issued by Relay Therapeutics, Inc. on August 6, 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.

 

 

 

RELAY THERAPEUTICS, INC.

 

 

 

 

Date:

August 6, 2026

By:

/s/ Soo-Yeun Lim

 

 

 

Soo-Yeun Lim
General Counsel

 


Exhibit 99.1

AMENDMENT NO. 1 TO THE COMMON STOCK SALES AGREEMENT

 

August 6, 2026

 

TD Securities (USA) LLC

1 Vanderbilt Avenue

New York, New York 10017

 

Ladies and Gentlemen:

 

 

This Amendment No. 1 to the Sales Agreement, dated as of August 6, 2026, is entered into by and between Relay Therapeutics, Inc. (the “Company”) and TD Securities (USA) LLC (the “Agent”). Capitalized terms used but not otherwise defined herein shall have the respective meanings ascribed to them in the Sales Agreement (as defined below).

 

WHEREAS, the Company and the Agent have entered into that certain Common Stock Sales Agreement, dated August 6, 2024 (the “Sales Agreement”), with respect to the issuance and sale of the Common Stock; and

 

WHEREAS, the Company and the Agent desire to amend the Sales Agreement as set forth herein.

 

NOW, THEREFORE, in consideration of the foregoing, the Company and the Agent hereby amend the Sales Agreement as follows:

 

1.
The title of the Sales Agreement shall be amended such that the reference to “$250,000,000” shall be “$462,978,049”.
2.
The first sentence of numbered paragraph 1 shall be amended such that the reference to “$250,000,000” shall be “$462,978,049”.
3.
The fourth sentence of numbered paragraph 3 shall be amended and restated as follows:

TD Cowen may sell Placement Shares in negotiated transactions, including block trades or Block Sales, or by any method permitted by law deemed to be an “at the market” offering as defined in Rule 415 of the Securities Act, including without limitation sales made through Nasdaq or on any other existing trading market for the Common Stock, or by any other method permitted by law.

4.
A new paragraph 6(ccc) shall be added as follows:

Outbound Investment Security Program. Neither the Company nor any of its subsidiaries is a “covered foreign person”, as that term is defined in 31 C.F.R. § 850.209. Neither the Company nor any of its subsidiaries currently engages,

 

 

 


 

or has plans to engage, directly or indirectly, in a “covered activity”, as that term is defined in in 31 C.F.R. § 850.208 (“Covered Activity”). The Company does not have any joint ventures that engages in or plans to engage in any Covered Activity. The Company also does not, directly or indirectly, hold a board seat on, have a voting or equity interest in, or have any contractual power to direct or cause the direction of the management or policies of any person or persons that engages or plans to engage in any Covered Activity.

5.
The first sentence of numbered paragraph 7(p) shall be amended such that the reference to “Dechert LLP” shall be “Cooley LLP”.
6.
The first sentence of numbered paragraph 12 shall be amended such that the reference to “399 Binney Street, Cambridge, Massachusetts 02139” shall be replaced with “60 Hampshire Street, Cambridge, Massachusetts 02139”.
7.
The first sentence of the Form of Placement Notice attached as Schedule 1 to the Sales Agreement is amended to add the words “as amended on August 6, 2026” immediately after 2024.
8.
Schedule 2 of the Sales Agreement shall be amended such that the reference to “Brian Adams Chief Legal Officer” shall be replaced with “Soo-Yeun Lim General Counsel”.
9.
The first sentence of the Officer Certificate attached as Exhibit 7(m) to the Sales Agreement is amended to add the words “as amended on August 6, 2026” immediately after 2024.
10.
The Company shall file a Prospectus Supplement pursuant to Rule 424(b) of the Securities Act of 1933, as amended, reflecting this Amendment within two Business Days of the date hereof.
11.
This Amendment shall be and is hereby incorporated in and forms a part of the Sales Agreement.
12.
This Amendment shall be effective as of the date first above written.
13.
This Amendment may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. Delivery of an executed Amendment by one party to the other may be made by facsimile or electronic transmission.
14.
This Amendment shall, by this express agreement of the parties, be governed by, and construed and enforced in accordance with, the laws of the State of New York, without regard to the conflicts of law provisions of the laws of the State of New York. The Company and the Agent each hereby consents to the application of New York civil law to the construction, interpretation and enforcement of this Amendment, and to the application of New York civil law to the procedural aspects of any suit, action or proceeding relation thereto, including but not limited to legal process, execution of judgments and other legal remedies.
15.
Except as set forth herein, the Sales Agreement shall remain in full force and effect.

2

 

 


 

 

 

[Signature Pages Follow]

 

3

 

 


 

IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be duly executed as of the date first above written.

 

RELAY THERAPEUTICS, INC.


By
/s/ Sanjiv Patel
Name: Sanjiv Patel
Title: Chief Executive Officer

 

TD SECURITIES (USA) LLC


By
/s/ Michael Murphy
Name: Michael Murphy
Title: Managing Director

 

 

 


Exhibit 99.2

img176012724_0.jpg

 

Relay Therapeutics Reports Second Quarter 2026 Financial Results and Corporate Updates

 

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, subject to regulatory feedback

 

Presented initial positive clinical data from Phase 1/2 ReInspire trial in vascular anomalies

at the ISSVA World Congress 2026 and opened expansion cohorts

 

Continued execution of ongoing Phase 3 ReDiscover-2 trial in 2L breast cancer

 

Approximately $911 million in cash, cash equivalents and investments at end of Q2 2026

 

Cambridge, Mass. – August 6, 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 second quarter 2026 financial results and corporate updates.

 

“The second quarter marked continued momentum across our zovegalisib program, with advances in our frontline breast cancer development strategy and the presentation of initial clinical data at ISSVA 2026 for zovegalisib in patients with vascular anomalies,” said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics. “This progress, including the ongoing Phase 3 trial in second-line breast cancer and the triplet combination work to support development in frontline breast cancer, reinforces the promise of mutant-selective PI3Kα inhibition and strengthens our confidence in zovegalisib's potential across multiple patient populations. Supported by a strong cash position with expected runway into 2029, we continue to focus on the execution of several clinical and regulatory milestones expected for zovegalisib this year as we work to develop potentially life-changing therapies for patients living with cancer and genetic disease.”

 

Corporate Highlights

Second-line (2L) Breast Cancer

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

 

Front-line (1L) Breast Cancer

Announced clinical data for zovegalisib plus atirmociclib triplet combination, plans for 1L breast cancer study, and clinical supply agreement with Pfizer
o
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

 

o
Phase 3 1L trial in patients with endocrine-sensitive breast cancer expected to initiate in early 2027, subject to regulatory feedback
Pfizer agreed to supply atirmociclib for the experimental arm and the palbociclib portion of the control arm for use in the planned study, and Relay will retain full global rights for zovegalisib
Continued to execute the Phase 1/2 ReDiscover trial, advancing the ongoing triplet cohorts with zovegalisib + atirmociclib + endocrine therapy

 

Vascular Anomalies

Presented initial clinical data from the Phase 1/2 ReInspire trial of zovegalisib in vascular anomalies at the International Society for the Study of Vascular Anomalies (ISSVA) World Congress 2026
o
In the Part 1 dose randomization portion of the study for adults and adolescents ages 12 and up, 60% of patients achieved a volumetric response at the earliest time point (12 weeks)
o
Nearly all patients experienced symptomatic improvement at 12 weeks while maintaining a safety and tolerability profile showing the potential for chronic use
Opened expansion cohorts for adults and adolescents and continued dose escalation for pediatric patients age 6-11 in the Phase 1/2 ReInspire trial to further evaluate zovegalisib in patients with PIK3CA-driven vascular anomalies

 

NRAS Selective Inhibitor: RLY-8161

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

 

Corporate

Raised approximately $316 million of gross proceeds in an underwritten follow-on public offering in May 2026

 

Anticipated Milestones:

Breast Cancer

Enrollment update for ongoing Phase 3 ReDiscover-2 trial in 2L breast cancer by year-end 2026
Regulatory update to confirm design for planned Phase 3 trial in 1L endocrine sensitive breast cancer by year-end 2026
Data update for Phase 1/2 triplet combination in 1H 2027

 

Vascular Anomalies

Data and regulatory update by year-end 2026

 

 

Second Quarter 2026 Financial Results

 

Cash, Cash Equivalents and Investments: As of June 30, 2026, cash, cash equivalents and investments totaled $910.9 million, as compared to $642.1 million as of March 31, 2026. The increase in cash is primarily due to net proceeds from the underwritten follow-on public offering in May 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.


 

 

Revenue: Revenue was $0.4 million for the second quarter of 2026, as compared to $0.7 million for the second 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 $76.5 million for the second quarter of 2026, as compared to $63.9 million for the second quarter of 2025. The increase of $12.6 million was primarily due to increases in costs across ongoing clinical trials for zovegalisib, 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 $14.7 million for the second quarter of 2026, as compared to $13.6 million for the second quarter of 2025. The increase of $1.1 million was primarily due to increased legal expenses, offset by decreases in employee compensation costs, including stock compensation expense.



Net Loss: Net loss was $83.7 million for the second quarter of 2026, or a net loss per share of $0.41, as compared to a net loss of $70.4 million for the second quarter of 2025, or a net loss per share of $0.41.

 

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 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, including zovegalisib and RLY-8161; 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:

Mitch Maisel

mmaisel@relaytx.com

 

Media:

Katie Engleman

1AB

919-333-7722

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Relay Therapeutics, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share data)

(Unaudited)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2026

 

 

2025

 

 

2026

 

 

2025

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

License and other revenue

 

$

350

 

 

$

677

 

 

$

3,350

 

 

$

8,355

 

Total revenue

 

 

350

 

 

 

677

 

 

 

3,350

 

 

 

8,355

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

$

76,483

 

 

$

63,897

 

 

$

147,046

 

 

$

137,706

 

General and administrative expenses

 

 

14,691

 

 

 

13,627

 

 

 

25,718

 

 

 

32,366

 

Total operating expenses

 

 

91,174

 

 

 

77,524

 

 

 

172,764

 

 

 

170,072

 

Loss from operations

 

 

(90,824

)

 

 

(76,847

)

 

 

(169,414

)

 

 

(161,717

)

Other income:

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

7,115

 

 

 

7,105

 

 

 

12,467

 

 

 

14,918

 

Other expense

 

 

2

 

 

 

(633

)

 

 

(51

)

 

 

(641

)

Total other income, net

 

 

7,117

 

 

 

6,472

 

 

 

12,416

 

 

 

14,277

 

Net loss

 

$

(83,707

)

 

$

(70,375

)

 

$

(156,998

)

 

$

(147,440

)

Net loss per share, basic and diluted

 

$

(0.41

)

 

$

(0.41

)

 

$

(0.82

)

 

$

(0.87

)

Weighted average shares of common stock, basic and diluted

 

 

202,849,466

 

 

 

171,264,622

 

 

 

191,412,839

 

 

 

170,254,500

 

Other comprehensive (loss) income:

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized holding (loss) gain

 

 

(1,381

)

 

 

(201

)

 

 

(2,286

)

 

 

828

 

Total other comprehensive (loss) income

 

 

(1,381

)

 

 

(201

)

 

 

(2,286

)

 

 

828

 

Total comprehensive loss

 

$

(85,088

)

 

$

(70,576

)

 

$

(159,284

)

 

$

(146,612

)

 


 

Relay Therapeutics, Inc.

Selected Condensed Consolidated Balance Sheet Data

(In thousands)

(Unaudited)

 

June 30,

2026

December 31,

2025

Cash, cash equivalents and investments

$

910,934

$

554,518

Working capital (1)

877,278

552,701

Total assets

967,457

621,331

Total liabilities

77,448

54,271

Total stockholders’ equity

890,009

567,060

Restricted cash

1,336

1,336

 

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

 


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