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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): November 04, 2025

 

 

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 2.02 Results of Operations and Financial Condition.

On November 6, 2025, Relay Therapeutics, Inc. (the "Company") announced its financial results for the quarter ended September 30, 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 Item 2.02, including Exhibit 99.1, 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 (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 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

On November 4, 2025, upon the recommendation of its Nominating and Corporate Governance Committee, the Board of Directors (the "Board") of the Company increased the number of members of the Board from seven to nine and appointed each of Lonnel Coats and Habib Dable as members of the Board, effective as of November 4, 2025. The Board determined that each of Mr. Coats and Mr. Dable is independent under the listing standards of Nasdaq and the Company’s corporate governance guidelines. Mr. Coats will serve as a Class I director with a term expiring at the annual meeting of stockholders to be held in 2027, and Mr. Dable will serve as a Class II director with a term expiring at the annual meeting of stockholders to be held in 2028. Mr. Coats was appointed to serve as a member of the Audit Committee of the Board as of November 4, 2025. Mr. Dable was appointed to serve as a member of the Nominating and Corporate Governance Committee of the Board as of November 4, 2025.

 

As non-employee directors, each of Mr. Coats and Mr. Dable will receive cash compensation and equity awards for their Board service in accordance with the Company’s amended and restated non-employee director compensation policy. In connection with each of their appointments, Mr. Coats and Mr. Dable received an initial option to purchase up to 207,931 shares of the Company’s common stock, par value $0.001 per share, with an exercise price per share of $6.86, the closing price of the Common Stock on the Nasdaq Global Market on November 4, 2025, vesting in equal monthly installments over thirty six months.

Neither Mr. Coats nor Mr. Dable is party to any transaction with the Company that would require disclosure under Item 404(a) of Regulation S-K. There are no arrangements or understandings between either Mr. Coats or Mr. Dable and any other persons pursuant to which Mr. Coats or Mr. Dable was selected as a director. In addition, each of Mr. Coats and Mr. Dable will enter into an indemnification agreement with the Company consistent with the form of indemnification agreement entered into between the Company and its existing non-employee directors.

Item 7.01. Regulation FD Disclosure.

On November 6, 2025, the Company issued a press release relating to the matters above, a copy of which is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information in this Item 7.01, including Exhibit 99.1, 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 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.

Exhibit No.

Description

99.1

Press Release issued by Relay Therapeutics, Inc. on November 6, 2025

104

Cover page interactive data file (embedded within the 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:

November 6, 2025

By:

/s/ Soo-Yeun Lim

 

 

 

Soo-Yeun Lim
General Counsel

 


EX-99.1 2 rlay-ex99_1.htm EX-99.1 EX-99.1

Exhibit 99.1

img175089203_0.jpg

 

Relay Therapeutics Reports Third Quarter 2025 Financial Results and Corporate Updates

 

Continued focused execution of RLY-2608 clinical trials in PI3Kα-mutated

breast cancer and vascular malformations

 

Appointed Lonnel Coats and Habib Dable, former biotech CEOs with launch and commercialization expertise, to the Company’s Board of Directors

 

Approximately $596 million in cash, cash equivalents and investments at end of Q3 2025

 

Cambridge, Mass. – November 6, 2025 – 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 2025 financial results and corporate updates.

 

“We are pleased with the clinical progress we’ve made across all three of our RLY-2608 trials in breast cancer and vascular malformations,” said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics. “In conjunction with our company’s focus on clinical execution, we are pleased to welcome to our Board, Mr. Coats and Mr. Dable, whose extensive experiences in late-stage development and commercialization will help to guide us as we advance our programs.”

 

Board of Directors Updates

Effective November 4, 2025, Lonnel Coats and Habib Dable were appointed to Relay Therapeutics’ Board of Directors.

 

Lonnel Coats is the former Chief Executive Officer and director of Lexicon Pharmaceuticals, Inc., a biopharmaceutical company. Prior to his time at Lexicon, from 1996 to 2014, Mr. Coats served in a series of leadership positions at Eisai Inc. and Eisai Corporation of North America, U.S. subsidiaries of Tokyo-based Eisai Co., Ltd., a Japanese pharmaceutical company, including as Chief Executive Officer of Eisai Inc. from 2010 to 2014 and as President and Chief Operating Officer of Eisai Inc. from 2004 to 2010. As President and Chief Executive Officer of Eisai, Mr. Coats oversaw the commercialization of Eisai products in the therapeutic areas of oncology, neurology, gastro-intestinal, epilepsy and metabolic disorders. Prior to joining Eisai, Mr. Coats spent eight years with Janssen Pharmaceuticals, Inc., a division of Johnson & Johnson, where he held a variety of management and sales positions. Mr. Coats is a former member of the board of directors of Blueprint Medicines and Verve Therapeutics. Mr. Coats holds a B.S. in Public Administration from Oakland University.

 

Habib Dable has over 30 years of experience in the healthcare industry and is currently an advisor at RA Capital Management, L.P. Most recently, Mr. Dable was President and Chief Executive Officer of Acceleron Pharma Inc., a biopharmaceutical company targeting leading-edge therapies for patients with serious and rare diseases, until its acquisition by Merck in 2021. Prior to joining Acceleron in 2016, Mr. Dable spent 22 years at Bayer AG where he served as President of U.S. Pharmaceuticals; Executive Vice President, Global Head Specialty Medicine; Vice President, Ophthalmology; Global Launch Team Head, EYLEA®; Global Head, Neurology and Ophthalmology; and Vice President, Regional Head, Hematology and Cardiology.


 

He also serves on the board of directors of Day One Biopharmaceuticals, PepGen Inc. and BioLink.org. Mr. Dable is also a former member of the board of directors of Blueprint Medicines, Millendo Therapeutics, Aerovate Therapeutics and Albireo Pharma. Mr. Dable received a B.B.A and M.B.A. from the University of New Brunswick.

 

RLY-2608 Highlights

Breast Cancer Clinical Trial Execution
o
Continued Phase 3 ReDiscover-2 trial of RLY-2608 + fulvestrant in PI3Kα-mutated, CDK4/6 pre-treated, HR+/HER2- advanced breast cancer
o
Continued Phase 1/2 ReDiscover trial, advancing the ongoing triplet cohorts with RLY-2608 + fulvestrant + atirmociclib, palbociclib, or ribociclib
Vascular Malformations Clinical Trial
o
Continued execution of ongoing Phase 1/2 ReInspire clinical trial in vascular malformations

 

Third Quarter 2025 Financial Results

 

Cash, Cash Equivalents and Investments: As of September 30, 2025, cash, cash equivalents and investments totaled $596.4 million, as compared to $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.

 

R&D Expenses: Research and development expenses were $68.3 million for the third quarter of 2025, as compared to $76.6 million for the third quarter of 2024. The decrease of $8.4 million was primarily due to the series of strategic choices made to streamline the research organization throughout 2024 and 2025, as well as cost avoidance on continued development of lirafugratinib after execution of the license agreement with Elevar Therapeutics, Inc. in December 2024, offset by increases in costs for the ReDiscover-2 Trial and ReInspire Trial.



G&A Expenses: General and administrative expenses were $12.1 million for the third quarter of 2025, as compared to $19.8 million for the third quarter of 2024. The decrease of $7.6 million was primarily due to a decrease in stock compensation expense, as well as other employee compensation costs.

 

Net Loss: Net loss was $74.1 million for the third quarter of 2025, or a net loss per share of $0.43, as compared to a net loss of $88.1 million for the third quarter of 2024, or a net loss per share of $0.63.

 

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, RLY-2608, 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. RLY-2608 is also being investigated in a group of genetic disease indications called PI3Kα-driven vascular malformations. Relay's pipeline also includes late-stage research 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 expected therapeutic benefits of Relay Therapeutics’ programs; results of Relay Therapeutics’ current and future preclinical studies and clinical trials; the potential market opportunity for Relay Therapeutics’ programs; 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 timing, execution, and expected impact of Relay Therapeutics’ restructuring activities (including the scope and timing of workforce reductions); the expected decrease in annual spending; the expected sufficiency of Relay Therapeutics’ existing cash resources; the internal and external costs required for Relay Therapeutics’ ongoing and planned activities, and the resulting impact on expense and use of cash, may be higher than expected, which may cause the company to use cash more quickly than expected or to change or curtail some of Relay Therapeutics’ plans or both; 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, including Relay Therapeutics’ Phase 3 Re-Discover-2 trial, 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; the design and rate of enrollment for current clinical trials may not enable successful completion of the trial(s); Relay Therapeutics’ ability to successfully demonstrate the safety and efficacy of its drug candidates; the timing and outcome of its planned interactions with regulatory authorities; and obtaining, maintaining and protecting its intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Relay Therapeutics’ most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Relay Therapeutics' views only as of today and should not be relied upon as representing its views as of any subsequent date. Relay Therapeutics explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.


 

 

Contact:

Pete Rahmer

prahmer@relaytx.com

 

Media:

Dan Budwick

1AB

973-271-6085

dan@1abmedia.com

 


 

Relay Therapeutics, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share data)

(Unaudited)

 

 

 

3 Months Ended September 30,

 

 

9 Months Ended September 30,

 

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

License and other revenue

 

$

 

 

$

 

 

$

8,355

 

 

$

10,007

 

Total revenue

 

 

 

 

 

 

 

 

8,355

 

 

 

10,007

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

$

68,262

 

 

$

76,619

 

 

$

205,968

 

 

$

251,014

 

Change in fair value of contingent consideration liability

 

 

 

 

 

 

 

 

 

 

 

(13,206

)

General and administrative expenses

 

 

12,129

 

 

 

19,750

 

 

 

44,495

 

 

 

59,688

 

Total operating expenses

 

 

80,391

 

 

 

96,369

 

 

 

250,463

 

 

 

297,496

 

Loss from operations

 

 

(80,391

)

 

 

(96,369

)

 

 

(242,108

)

 

 

(287,489

)

Other income:

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

6,407

 

 

 

8,274

 

 

 

21,325

 

 

 

25,772

 

Other (expense) income

 

 

(165

)

 

 

(10

)

 

 

(806

)

 

 

13

 

Total other income, net

 

 

6,242

 

 

 

8,264

 

 

 

20,519

 

 

 

25,785

 

Net loss

 

$

(74,149

)

 

$

(88,105

)

 

$

(221,589

)

 

$

(261,704

)

Net loss per share, basic and diluted

 

$

(0.43

)

 

$

(0.63

)

 

$

(1.30

)

 

$

(1.94

)

Weighted average shares of common stock, basic and diluted

 

 

172,389,209

 

 

 

140,229,056

 

 

 

170,973,889

 

 

 

134,651,728

 

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized holding gain

 

 

656

 

 

 

3,849

 

 

 

1,484

 

 

 

2,705

 

Total other comprehensive income

 

 

656

 

 

 

3,849

 

 

 

1,484

 

 

 

2,705

 

Total comprehensive loss

 

$

(73,493

)

 

$

(84,256

)

 

$

(220,105

)

 

$

(258,999

)

 


 

Relay Therapeutics, Inc.

Selected Condensed Consolidated Balance Sheet Data

(In thousands)

(Unaudited)

 

September 30,

2025

December 31,

2024

Cash, cash equivalents and investments

$

596,431

$

781,323

Working capital (1)

591,409

758,475

Total assets

670,000

871,296

Total liabilities

62,291

93,504

Total stockholders’ equity

607,709

777,792

Restricted cash

2,258

2,119

 

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