8-K
0001812364false00018123642022-05-052022-05-05

 

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): May 5, 2022

 

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.)

Relay Therapeutics, Inc.

399 Binney Street, 2nd Floor

Cambridge, Massachusetts 02139

(Address of principal executive offices, including zip code)

(617) 370-8837

(Registrant’s telephone number, including area code)

Not Applicable

(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, $0.001 par value per share

 

RLAY

 

The 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 May 5, 2022, Relay Therapeutics, Inc. announced its financial results for the quarter ended March 31, 2022. A copy of the press release is being furnished as Exhibit 99.1 to this Report on Form 8-K.

The information in this Report on Form 8-K and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (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 or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 9.01. Exhibits.

(d) Exhibits

 

99.1

 

Press release issued by Relay Therapeutics, Inc. on May 5, 2022, furnished herewith.

104

 

Cover Page Interactive Data File (embedded within Inline XBRL document).

 

 


 

SIGNATURE

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 thereunto duly authorized.

 

 

 

RELAY THERAPEUTICS, INC.

 

 

 

 

Date: May 5, 2022

 

By:

/s/ Brian Adams

 

 

 

Brian Adams, J.D.

 

 

 

Chief Legal Officer

 

 


EX-99.1

Exhibit 99.1

https://cdn.kscope.io/1eed32fd97e205ec79a971d4006a94d6-img175089203_0.jpg 

 

Relay Therapeutics Reports First Quarter 2022 Financial Results and Corporate Highlights

 

Initiated the fulvestrant combination arm of the first-in-human trial for RLY-2608, a pan-mutant and isoform-selective PI3Kα inhibitor, and continued to enroll patients in the single agent arm

 

Continued to enroll expansion cohorts for RLY-4008, a potent, selective and oral small molecule inhibitor of FGFR2

 

Company will host a virtual analyst and investor event on June 27, 2022 to announce a new target

 

Cambridge, MA – May 5, 2022 – Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, today reported first quarter 2022 financial results and corporate highlights.

 

“We have continued our execution focus into 2022, as we advance our portfolio of precision medicines towards patients,” said Sanjiv Patel, M.D., Relay Therapeutics' president and chief executive officer. “With three programs in the clinic, we believe our platform and approach have the potential to address some of the hardest-to-treat diseases. We look forward to disclosing another innovative target next month as we continue on our journey of bringing life-changing therapies to patients.”

 

 

Recent Corporate Highlights

Continued to enroll patients in the first arm of the dose escalation part of the first-in-human trial for RLY-2608, a pan-mutant and isoform-selective PI3Kα inhibitor, assessing it as a single agent for patients with unresectable or metastatic solid tumors with PI3Kα mutation
Initiated the second arm of the dose escalation part of the first-in-human trial for RLY-2608, evaluating RLY-2608 in combination with fulvestrant for patients with HR+, HER2–, PI3Kα-mutated, locally advanced or metastatic breast cancer
Anticipate disclosing initial clinical data of RLY-2608 in the first half of 2023
Received orphan drug designation from the FDA for RLY-4008 for the treatment of cholangiocarcinoma in January 2022 and continued to enroll patients in expansion cohorts
Presented poster at AACR in April 2022 summarizing RLY-1971/GDC-1971 preclinical data including newly disclosed preclinical combination data with GDC-6036, Genentech’s KRAS G12C inhibitor
Aligned with current guidance of disclosing a new target in the first half of 2022, announced a virtual analyst and investor event on June 27, 2022

 

 


First Quarter 2022 Financial Results

 

Cash, Cash Equivalents and Investments: As of March 31, 2022, cash, cash equivalents and investments totaled approximately $898 million compared to $958 million as of December 31, 2021. Relay Therapeutics expects its current cash, cash equivalents and investments will be sufficient to fund its current operating plan into at least 2025.

 

R&D Expenses: Research and development expenses were $51.7 million for the first quarter of 2022, as compared to $30.6 million for the first quarter of 2021. The increase of $21.0 million was primarily due to $9.4 million of additional employee related costs, including an increase in stock-based compensation of $3.0 million, $6.0 million related to clinical trial expenses and $4.6 million related to pre-clinical development candidates.

 

G&A Expenses: General and administrative expenses were $16.1 million for first quarter of 2022, as compared to $12.7 million for the first quarter of 2021. The increase of $3.3 million was primarily due to $3.0 million of additional employee related costs, including an increase in stock-based compensation of $0.8 million.

 

Net Loss: Net loss was $62.0 million for the first quarter of 2022, or a net loss per share of $0.57, as compared to a net loss of $42.2 million for the first quarter of 2021, or a net loss per share of $0.47.

 

 

About Relay Therapeutics

 

Relay Therapeutics (Nasdaq: RLAY) is a clinical-stage precision medicines company transforming the drug discovery process by combining leading-edge computational and experimental technologies with the goal of bringing life-changing therapies to patients. As the first of a new breed of biotech created at the intersection of disparate technologies, Relay Therapeutics aims to push the boundaries of what’s possible in drug discovery. Its Dynamo™ platform integrates an array of leading-edge computational and experimental approaches designed to drug protein targets that have previously been intractable. Relay Therapeutics’ initial focus is on enhancing small molecule therapeutic discovery in targeted oncology and genetic disease indications. For more information, please visit www.relaytx.com or follow us on Twitter.

 

 

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 updates on the clinical development of the programs across Relay Therapeutics’ portfolio, including the timing of a clinical data update for RLY-4008, RLY-2608 and RLY-1971/GDC-1971, and the disclosure of an additional target; expected therapeutic benefits of its programs; whether preclinical or early clinical results of Relay Therapeutics’ product candidates will be predictive of future clinical trials; ability to optimize the impact of collaborations on Relay Therapeutics’ programs; expectations regarding Relay Therapeutics’ use of capital, expenses, future accumulated deficit and other financial results during 2022 and in the future; and Relay Therapeutics’ cash runway projection. 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 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 the ongoing COVID-19 pandemic 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 and future operations; the delay of any current or planned clinical trials or the development of Relay Therapeutics’ drug candidates; the risk that the results of its clinical trials may not be predictive of future results in connection with future clinical trials; 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 or 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:
Caroline Glen

617-370-8837

cglen@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)

 

 

 

 

 

Three Months Ended
March 31,

 

 

 

2022

 

 

2021

 

Revenue:

 

 

 

 

 

 

License and other revenue

 

$

419

 

 

$

952

 

Total revenue

 

 

419

 

 

 

952

 

Operating expenses:

 

 

 

 

 

 

Research and development expenses

 

$

51,667

 

 

$

30,622

 

Change in fair value of contingent consideration liability

 

 

(4,595

)

 

 

 

General and administrative expenses

 

 

16,068

 

 

 

12,735

 

Total operating expenses

 

 

63,140

 

 

 

43,357

 

Loss from operations

 

 

(62,721

)

 

 

(42,405

)

Other income (expense):

 

 

 

 

 

 

Interest income

 

 

696

 

 

 

226

 

Other income (expense)

 

 

(21

)

 

 

(5

)

Total other income (expense), net

 

 

675

 

 

 

221

 

Net loss

 

$

(62,046

)

 

$

(42,184

)

Net loss per share, basic and diluted

 

$

(0.57)

 

 

$

(0.47

)

Weighted average shares of common stock, basic and diluted

 

 

108,293,251

 

 

 

90,197,579

 

Other comprehensive (loss) income:

 

 

 

 

 

 

Unrealized holding (loss) gain

 

 

(8,130

)

 

 

(52

)

Total other comprehensive (loss) income

 

 

(8,130

)

 

 

(52

)

Total comprehensive loss

 

$

(70,176

)

 

$

(42,236

)

 


 


 

 

Relay Therapeutics, Inc.

Selected Condensed Consolidated Balance Sheet Data

(In thousands)

(Unaudited)

 

 

 

March 31,

2022

 

 

December 31,

2021

 

Cash, cash equivalents and investments

 

$

898,178

 

 

$

958,073

 

Working capital (1)

 

 

874,097

 

 

 

951,921

 

Total assets

 

 

949,878

 

 

 

1,008,443

 

Total liabilities

 

 

107,908

 

 

 

110,635

 

Total stockholders’ equity

 

 

841,970

 

 

 

897,808

 

Restricted cash

 

 

2,578

 

 

 

2,578