UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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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:
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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 November 6, 2024, Relay Therapeutics, Inc. announced its financial results for the quarter ended September 30, 2024. 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 Financial Statements and Exhibits.
(d) Exhibits.
99.1 |
Press release issued by Relay Therapeutics, Inc. on November 6, 2024, 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.
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RELAY THERAPEUTICS, INC. |
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Date: |
November 6, 2024 |
By: |
/s/ Brian Adams |
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Brian Adams |
Exhibit 99.1
Relay Therapeutics Reports Third Quarter 2024 Financial Results and Corporate Highlights
Reported interim RLY-2608 data demonstrating 9.2-month median PFS in heavily pre-treated patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer at RP2D
Plan to initiate 2L pivotal trial of RLY-2608 + fulvestrant in 2025
Approximately $840 million in cash, cash equivalents and investments at end of Q3 2024, expected to fund operations into second half of 2027
Cambridge, Mass. – November 6, 2024 – 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 2024 financial results and recent corporate highlights.
“In the third quarter, we reported very encouraging interim data showing that RLY-2608 + fulvestrant led to clinically meaningful progression free survival in heavily pre-treated patients with PI3Kα-mutated, HR+, HER2- metastatic breast cancer,” said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics. “Based on these data, we are preparing to initiate a pivotal trial in 2L breast cancer in 2025, which we expect to be able to fully fund through top-line readout with our existing cash on hand. We also continue to progress our pre-clinical programs and look forward to bringing new programs into the clinic in 2025.”
Recent Corporate Highlights
RLY-2608 (ReDiscover study)
Lirafugratinib (RLY-4008)
Corporate Highlights
Anticipated Upcoming Milestones
Third Quarter 2024 Financial Results
Cash, Cash Equivalents and Investments: As of September 30, 2024, cash, cash equivalents and investments totaled $839.6 million compared to $750.1 million as of December 31, 2023. The company expects its current cash, cash equivalents and investments will be sufficient to fund its current operating plan into the second half of 2027.
Revenue: Revenue was $0 for the third quarter of 2024, as compared to $25.2 million for the third quarter of 2023. The decrease was primarily due to the recognition of previously received milestone payments under the company’s Collaboration and License Agreement with Genentech, Inc. during the third quarter of 2023.
R&D Expenses: Research and development expenses were $76.6 million for the third quarter of 2024, as compared to $81.5 million for the third quarter of 2023. The decrease was primarily due to the impact of prioritization of certain programs in the company’s pipeline, as previously disclosed in 2023 and earlier in 2024.
G&A Expenses: General and administrative expenses were $19.8 million for the third quarter of 2024, as compared to $18.5 million for the third quarter of 2023. The increase was primarily due to an increase in stock compensation expense, partially offset by decreases in other employee compensation costs and certain other general and administrative expenses.
Net Loss: Net loss was $88.1 million for the third quarter of 2024, or a net loss per share of $0.63, as compared to a net loss of $65.7 million for the third quarter of 2023, or a net loss per share of $0.54.
About Relay Therapeutics
Relay Therapeutics 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 and clinical initiation of the programs across Relay Therapeutics’ portfolio; the progress toward bringing Relay Therapeutics’ pre-clinical programs to the clinic, including anticipated timing; the expected therapeutic benefits and potential efficacy and tolerability of RLY-2608, both as a monotherapy and in combination with other agents, and its other programs, including lirafugratinib; the timing and scope of clinical updates for RLY-2608; Relay Therapeutics’ plan to seek a global commercialization partner for lirafugratinib; the interactions with regulatory authorities and any related approvals; the potential market opportunity for RLY-2608; the cash runway projection and the expectations regarding Relay Therapeutics’ use of capital, expenses and potential cost savings. 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; 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:
Megan Goulart
617-545-5526
mgoulart@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)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2024 |
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2023 |
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2024 |
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2023 |
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Revenue: |
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License and other revenue |
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$ |
— |
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$ |
25,202 |
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$ |
10,007 |
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$ |
25,547 |
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Total revenue |
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— |
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25,202 |
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10,007 |
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25,547 |
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Operating expenses: |
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Research and development expenses |
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$ |
76,619 |
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$ |
81,494 |
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$ |
251,014 |
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$ |
252,522 |
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Change in fair value of contingent consideration liability |
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— |
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(1,200 |
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(13,206 |
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(4,355 |
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General and administrative expenses |
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19,750 |
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18,485 |
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59,688 |
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58,184 |
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Total operating expenses |
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96,369 |
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98,779 |
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297,496 |
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306,351 |
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Loss from operations |
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(96,369 |
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(73,577 |
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(287,489 |
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(280,804 |
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Other income: |
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Interest income |
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8,274 |
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7,845 |
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25,772 |
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22,345 |
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Other (expense) income |
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(10 |
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(2 |
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13 |
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(19 |
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Total other income, net |
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8,264 |
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7,843 |
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25,785 |
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22,326 |
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Net loss |
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$ |
(88,105 |
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$ |
(65,734 |
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$ |
(261,704 |
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$ |
(258,478 |
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Net loss per share, basic and diluted |
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$ |
(0.63 |
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$ |
(0.54 |
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$ |
(1.94 |
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$ |
(2.12 |
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Weighted average shares of common stock, basic and diluted |
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140,229,056 |
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122,231,255 |
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134,651,728 |
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121,843,116 |
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Other comprehensive income (loss): |
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Unrealized holding gain |
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3,849 |
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2,695 |
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2,705 |
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7,034 |
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Total other comprehensive income |
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3,849 |
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2,695 |
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2,705 |
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7,034 |
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Total comprehensive loss |
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$ |
(84,256 |
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$ |
(63,039 |
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$ |
(258,999 |
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$ |
(251,444 |
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Relay Therapeutics, Inc.
Selected Condensed Consolidated Balance Sheet Data
(In thousands)
(Unaudited)
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September 30, 2024 |
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December 31, 2023 |
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Cash, cash equivalents and investments |
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$ |
839,609 |
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$ |
750,086 |
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Working capital (1) |
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818,161 |
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739,834 |
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Total assets |
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930,115 |
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843,980 |
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Total liabilities |
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91,254 |
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91,977 |
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Total stockholders’ equity |
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838,861 |
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752,003 |
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Restricted cash |
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2,119 |
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2,707 |
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(1) Working capital is defined as current assets less current liabilities.