UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
(Exact name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
Relay Therapeutics, Inc.
(Address of principal executive offices, including zip code)
(Registrant’s telephone number, including area code)
(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) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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 |
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Trading Symbol(s) |
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Name of each exchange on which registered |
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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 February 23, 2023, Relay Therapeutics, Inc. announced its financial results for the quarter and year ended December 31, 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 |
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Press release issued by Relay Therapeutics, Inc. on February 23, 2023, furnished herewith. |
104 |
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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.
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RELAY THERAPEUTICS, INC. |
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Date: February 23, 2023 |
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By: |
/s/ Brian Adams |
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Brian Adams |
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Chief Legal Officer |
Exhibit 99.1
Relay Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Corporate Highlights
Advanced RLY-4008: Reported interim data with 88% overall response rate at pivotal dose and 63% across all doses in pan-FGFR treatment-naïve, FGFR2-fusion cholangiocarcinoma patients & announced anticipated registrational path
Progressed & expanded breast cancer portfolio: Continued monotherapy and initiated combination arms in study of PI3Kα inhibitor RLY-2608 & disclosed 3 new pre-clinical programs
Raised $300.0 million of gross proceeds in underwritten follow-on public offering
Approximately $1 billion in cash, cash equivalents and investments at end of 2022, expected to fund operations into 2025
Cambridge, Mass. – February 23, 2023 – 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 fourth quarter and full year 2022 financial results and corporate highlights.
“We successfully executed against our strategy in 2022, advancing multiple clinical and pre-clinical programs and continuing to demonstrate the power of our Dynamo platform,” said Sanjiv Patel, M.D., president and chief executive officer of Relay Therapeutics. “We reported additional RLY-4008 interim data showing an overall response rate of 63% across all doses and 88% at the pivotal dose, building on the previously reported early data and supporting our belief that limiting off-target effects and toxicity can allow us to improve efficacy. We also expanded our breast cancer portfolio, continuing clinical development of RLY-2608 and announcing three new programs. With a robust pipeline and cash in hand to fund us into 2025, we are excited to continue to execute on our plans and deliver against our milestones this year, as we work toward our goal of bringing life-changing therapies to patients.”
2022 Corporate Highlights
RLY-4008 (FGFR2 inhibitor)
Breast Cancer Portfolio
Corporate Highlights
2023 Anticipated Milestones
Fourth Quarter and Full Year 2022 Financial Results
Cash, Cash Equivalents and Investments: As of December 31, 2022, cash, cash equivalents and investments totaled approximately $1 billion compared to $958.1 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 $67.3 million for the fourth quarter of 2022, as compared to $51.9 million for the fourth quarter of 2021. The increase was primarily due to $6.8 million of additional clinical trial expenses and $6.3 million of additional employee related costs, which includes $3.1 million of additional stock-based compensation expense. Research and development expenses were $246.4 million for the full year 2022, as compared to $172.7 million for the full year 2021. The increase was primarily due to $32.7 million of additional clinical trial expenses, $24.7 million of additional employee related costs, which includes $5.7 million of additional stock-based compensation expense, and $10.8 million of additional preclinical programs and platform technologies.
G&A Expenses: General and administrative expenses were $16.4 million for the fourth quarter of 2022, as compared to $15.5 million for the fourth quarter of 2021. The increase was primarily due to additional employee related costs, which includes $0.5 million of additional stock-based compensation expense. General and administrative expenses were $66.0 million for the full year 2022, as compared to $57.4 million for the full year 2021. The increase was primarily due to additional employee related costs, which includes $1.9 million of additional stock-based compensation expense.
Net Loss: Net loss was $67.5 million for the fourth quarter of 2022, or a net loss per share of $0.56, as compared to a net loss of $67.5 million for the fourth quarter of 2021, or a net loss per share of $0.64. Net loss was $290.5 million for the full year 2022, or a net loss per share of $2.59, as compared to a net loss of $363.9 million for the full year 2021, or a net loss per share of $3.82. Net loss for the full year 2021 included one-time expenses of $134.9 million associated with the acquisition of ZebiAI Therapeutics, Inc.
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 complementary techniques and 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 or inadequately addressed. 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 the clinical development of the programs across Relay Therapeutics’ portfolio, including the expected therapeutic benefits of its programs, timing of enrollment completion, and potential efficacy and tolerability; the timing of a clinical data update for RLY-4008 and RLY-2608, the clinical initiation of RLY-5836 and Relay Therapeutics’ selective CDK2 inhibitor, and the nomination of a development candidate for Relay Therapeutics’ ERα degrader program; 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’ pipeline, 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, 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, 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, future operations and profitability; the delay of any current or planned clinical trials or the development of Relay Therapeutics’ drug candidates; the risk that the preliminary 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; 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.
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
(Unaudited)
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Three Months Ended |
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Twelve Months Ended |
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2022 |
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2021 |
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2022 |
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2021 |
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Revenue: |
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License and other revenue |
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$ |
253 |
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$ |
567 |
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$ |
1,381 |
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$ |
3,029 |
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Total revenue |
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253 |
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567 |
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1,381 |
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3,029 |
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Operating expenses: |
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Research and development expenses |
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$ |
67,277 |
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$ |
51,907 |
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$ |
246,355 |
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$ |
172,650 |
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In-process research and development expenses |
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— |
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— |
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— |
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123,000 |
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Loss on initial consolidation of variable interest entity |
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— |
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— |
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— |
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11,855 |
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Change in fair value of contingent consideration liability |
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(10,544) |
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836 |
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(11,677 |
) |
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2,836 |
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General and administrative expenses |
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16,371 |
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15,547 |
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65,978 |
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57,386 |
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Total operating expenses |
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73,104 |
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68,290 |
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300,656 |
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367,727 |
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Loss from operations |
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(72,851 |
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(67,723 |
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(299,275 |
) |
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(364,698 |
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Other income: |
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Interest income |
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5,372 |
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267 |
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8,786 |
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830 |
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Other (expense) income |
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(24) |
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— |
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(20) |
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(4 |
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Total other income, net |
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5,348 |
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267 |
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8,766 |
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826 |
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Net loss |
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$ |
(67,503 |
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$ |
(67,456 |
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$ |
(290,509 |
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$ |
(363,872 |
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Net loss per share, basic and diluted |
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$ |
0.56 |
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$ |
0.64 |
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$ |
2.59 |
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$ |
3.82 |
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Weighted average shares of common stock, basic and diluted |
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120,966,401 |
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105,584,819 |
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112,233,649 |
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95,136,719 |
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Other comprehensive income (loss): |
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Unrealized holding gain (loss) |
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2,969 |
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(1,098) |
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(9,332 |
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(1,152 |
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Total other comprehensive (loss) income |
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2,969 |
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(1,098) |
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(9,332 |
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(1,152 |
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Total comprehensive loss |
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$ |
(64,534 |
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$ |
(68,554 |
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$ |
(299,841 |
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$ |
(365,024 |
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Relay Therapeutics, Inc.
Selected Condensed Consolidated Balance Sheet Data
(In thousands)
(Unaudited)
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December 31, 2022 |
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December 31, 2021 |
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Cash, cash equivalents and investments |
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$ |
998,917 |
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$ |
958,073 |
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Working capital (1) |
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955,796 |
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951,921 |
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Total assets |
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1,099,771 |
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1,008,443 |
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Total liabilities |
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149,553 |
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110,635 |
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Total stockholders’ equity |
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950,218 |
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897,808 |
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Restricted cash |
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2,578 |
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2,578 |
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(1) Working capital is defined as current assets less current liabilities.