0000950170-22-021868.txt : 20221103 0000950170-22-021868.hdr.sgml : 20221103 20221103161123 ACCESSION NUMBER: 0000950170-22-021868 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20221103 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20221103 DATE AS OF CHANGE: 20221103 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Relay Therapeutics, Inc. CENTRAL INDEX KEY: 0001812364 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 000000000 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-39385 FILM NUMBER: 221358101 BUSINESS ADDRESS: STREET 1: 399 BINNEY STREET STREET 2: 2ND FLOOR CITY: CAMBRIDGE STATE: MA ZIP: 02139 BUSINESS PHONE: 617-370-8837 MAIL ADDRESS: STREET 1: 399 BINNEY STREET STREET 2: 2ND FLOOR CITY: CAMBRIDGE STATE: MA ZIP: 02139 8-K 1 rlay-20221103.htm 8-K 8-K
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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 3, 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 November 3, 2022, Relay Therapeutics, Inc. announced its financial results for the quarter ended September 30, 2022. 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 Current 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, 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 9.01. Exhibits.

(d) Exhibits

 

99.1

 

Press release issued by Relay Therapeutics, Inc. on November 3, 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: November 3, 2022

 

By:

/s/ Brian Adams

 

 

 

Brian Adams, J.D.

 

 

 

Chief Legal Officer

 

 

 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 2022 Financial Results and Corporate Highlights

 

Shared 88% overall response rate (ORR) from interim data of RLY-4008 in pan-FGFR treatment (FGFRi)-naïve

 

FGFR2-fusion cholangiocarcinoma (CCA) patients treated at the pivotal dose at European Society for Medical Oncology (ESMO) Congress

 

$1.1 billion in cash, cash equivalents and investments at the end of third quarter 2022

 

Cambridge, MA – November 3, 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 third quarter 2022 financial results and recent corporate highlights.

 

“We continue to deliver on our execution focus for 2022 and the third quarter uniquely exemplified this,” said Sanjiv Patel, M.D., Relay Therapeutics’ president and chief executive officer. “We presented interim data at the ESMO Congress that demonstrate an 88% overall response rate at the pivotal dose of RLY-4008 and further support our hypothesis that selective inhibition of FGFR2 can improve the treatment for patients with FGFR2-driven tumors. The interim data demonstrate the potential power of our Dynamo platform to build transformative therapies for patients. We continue to build momentum upon our achievements this year and we believe we have the team, platform and capital to deliver upon numerous milestones.”

 

Recent Corporate Highlights

•
Continued to enroll patients across both dose escalation cohorts 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 and evaluating RLY-2608 in combination with fulvestrant for patients with HR+, HER2–, PI3Kα-mutated, locally advanced or metastatic breast cancer.
•
Presented updated RLY-4008 data as of the August 1, 2022 cut-off date at ESMO Congress 2022, including key highlights:
o
15 out of 17 of the FGFRi-naïve FGFR2-fusion CCA efficacy evaluable patients at the pivotal dose experienced a partial response resulting in an 88% interim ORR (14 confirmed, 1 unconfirmed in an ongoing patient).
•
13 out of these 15 responders remain on treatment; 1 responder came off study to be resected with curative intent.
o
More broadly across all dose levels and schedules, 38 FGFRi-naïve FGFR2-fusion CCA patients were eligible for efficacy evaluation, of which 24 experienced a partial response resulting in a 63% interim ORR (22 confirmed, 2 unconfirmed).
o
Most treatment emergent adverse events were expected FGFR2 on-target, low-grade, monitorable, manageable and largely reversible.
•
There were no observed Grade 4 or 5 adverse events, and off-target toxicities of hyperphosphatemia and diarrhea continued to be clinically insignificant.
•
Raised $300 million of gross proceeds in an underwritten follow-on public offering.

 

 

Third Quarter 2022 Financial Results

Cash, Cash Equivalents and Investments: As of September 30, 2022, cash, cash equivalents and investments totaled approximately $1.1 billion 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 2025.

 

R&D Expenses: Research and development expenses were $66.9 million for the third quarter of 2022, as compared to $45.0 million for the third quarter of 2021. The increase was primarily due to $11.9 million related to clinical trial expenses, $5.6 million of additional employee related costs, which includes $1.7 million in stock-based compensation, and $2.7 million related to preclinical programs and platform technologies.

 

G&A Expenses: General and administrative expenses were $16.1 million for third quarter of 2022, as compared to $14.7 million for the third quarter of 2021. The increase was primarily due to additional employee related costs.

 

Net Loss: Net loss was $84.2 million for the third quarter of 2022, or a net loss per share of $0.76, as compared to a net loss of $60.8 million for the third quarter of 2021, or a net loss per share of $0.66.

 

About Relay Therapeutics

 

Relay Therapeutics (Nasdaq: RLAY) is a clinical-stage precision medicine 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 expected therapeutic benefits of its programs, including potential efficacy and tolerability; whether preliminary results from Relay Therapeutics’ preclinical or clinical trials will be predictive of the final results of the trials or any future clinical trials of its product candidates; the possibility that unconfirmed results from these trials will not be confirmed by additional data as the clinical trials progress; Relay Therapeutics’ expectations with respect to its potential pivotal dose for RLY-4008, including potential regulatory filings and interactions; expectations regarding Relay Therapeutics’ operating plan, use of capital, expenses 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 global economic uncertainty, geopolitical instability, or 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 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:
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
September 30,

 

 

Nine Months Ended
September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

License and other revenue

 

$

344

 

 

$

666

 

 

$

1,128

 

 

$

2,462

 

Total revenue

 

 

344

 

 

 

666

 

 

 

1,128

 

 

 

2,462

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

$

66,900

 

 

$

44,974

 

 

$

179,078

 

 

$

120,743

 

In-process research and development expenses

 

 

—

 

 

 

—

 

 

 

—

 

 

 

123,000

 

Loss on initial consolidation of variable interest entity

 

 

—

 

 

 

—

 

 

 

—

 

 

 

11,855

 

Change in fair value of contingent consideration liability

 

 

3,262

 

 

 

2,000

 

 

 

(1,133

)

 

 

2,000

 

General and administrative expenses

 

 

16,074

 

 

 

14,682

 

 

 

49,607

 

 

 

41,839

 

Total operating expenses

 

 

86,236

 

 

 

61,656

 

 

 

227,552

 

 

 

299,437

 

Loss from operations

 

 

(85,892

)

 

 

(60,990

)

 

 

(226,424

)

 

 

(296,975

)

Other income:

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

1,713

 

 

 

157

 

 

 

3,414

 

 

 

563

 

Other income (expense)

 

 

7

 

 

 

—

 

 

 

4

 

 

 

(4

)

Total other income, net

 

 

1,720

 

 

 

157

 

 

 

3,418

 

 

 

559

 

Net loss

 

$

(84,172

)

 

$

(60,833

)

 

$

(223,006

)

 

$

(296,416

)

Net loss per share, basic and diluted

 

$

0.76

 

 

$

0.66

 

 

$

2.04

 

 

$

3.20

 

Weighted average shares of common stock, basic and diluted

 

 

110,905,940

 

 

 

92,692,515

 

 

 

109,290,743

 

 

 

92,599,781

 

Other comprehensive (loss) income:

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized holding (loss) gain

 

 

(1,483

)

 

 

74

 

 

 

(12,301

)

 

 

(54

)

Total other comprehensive (loss) income

 

 

(1,483

)

 

 

74

 

 

 

(12,301

)

 

 

(54

)

Total comprehensive loss

 

$

(85,655

)

 

$

(60,759

)

 

$

(235,307

)

 

$

(296,470

)

 

 


 

 

 

 

 

Relay Therapeutics, Inc.

Selected Condensed Consolidated Balance Sheet Data

(In thousands)

(Unaudited)

 

 

 

 

September 30,

2022

 

 

December 31,

2021

 

Cash, cash equivalents and investments

 

$

1,053,792

 

 

$

958,073

 

Working capital (1)

 

 

1,015,870

 

 

 

951,921

 

Total assets

 

 

1,168,718

 

 

 

1,008,443

 

Total liabilities

 

 

168,949

 

 

 

110,635

 

Total stockholders’ equity

 

 

999,769

 

 

 

897,808

 

Restricted cash

 

 

2,578

 

 

 

2,578

 

 

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

 

 

 

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Document And Entity Information
Nov. 03, 2022
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Nov. 03, 2022
Entity Registrant Name RELAY THERAPEUTICS, INC.
Entity Central Index Key 0001812364
Entity Emerging Growth Company false
Securities Act File Number 001-39385
Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 47-3923475
Entity Address, Address Line One 399 Binney Street, 2nd Floor
Entity Address, City or Town Cambridge
Entity Address, State or Province MA
Entity Address, Postal Zip Code 02139
City Area Code (617)
Local Phone Number 370-8837
Entity Information, Former Legal or Registered Name Not Applicable
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, $0.001 par value per share
Trading Symbol RLAY
Security Exchange Name NASDAQ
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