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:
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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:
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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 24, 2022, Relay Therapeutics, Inc. announced its financial results for the quarter ended and year ended December 31, 2021. 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 |
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Press release issued by Relay Therapeutics, Inc. on February 24, 2022, 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 24, 2022 |
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By: |
/s/ Brian Adams |
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Brian Adams, J.D. |
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Chief Legal Officer |
Exhibit 99.1
Relay Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Corporate Highlights
Announced RLY-4008 interim clinical data that suggest it is the first investigational therapy that selectively binds to FGFR2 and avoids off-isoform toxicities in the treatment of patients with FGFR2-altered tumors
Shared preclinical data for RLY-2608, the first known allosteric, pan-mutant and isoform-selective PI3Kα inhibitor and dosed the first patient in a first-in-human trial
Continued to advance three additional oncology preclinical programs and two genetic disease preclinical programs, while expanding the capabilities of the Dynamo™ platform
Raised $382 million in net proceeds from a follow-on financing in October 2021
$958 million in cash, cash equivalents and investments at end of 2021 expected to fund operations into at least 2025
Cambridge, MA – February 24, 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 fourth quarter and full year 2021 financial results and corporate highlights.
“2021 was the year that Relay Therapeutics showed clinical data for the first time, with the RLY-4008 disclosure supporting our belief that our approach of integrating experimental techniques and computational power can make the discovery of medicines more efficient and effective,” said Sanjiv Patel, M.D., president and chief executive officer. “We also grew our team, continued to execute against our deep and broad precision medicine pipeline and pushed the boundaries of our Dynamo platform, through both internal innovation and the integration of an acquisition. We’ve entered 2022 with three clinical stage programs, a robust preclinical pipeline and a cash runway into at least 2025. We are excited to continue our efforts to achieve our goal of bringing life-changing therapies to patients.”
2021 Corporate Highlights
RLY-4008
RLY-2608
Corporate Highlights
2022 Anticipated Milestones and Objectives
Fourth Quarter and Full Year 2021 Financial Results
Cash, Cash Equivalents and Investments: As of December 31, 2021, cash, cash equivalents and investments totaled approximately $958.1 million, compared to $678.1 million as of December 31, 2020. The change in cash reflects the addition of $382.2 million in net proceeds from Relay Therapeutics’ public financing in October 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 $51.9 million for the fourth quarter of 2021, as compared to $32.1 million for the fourth quarter of 2020. This increase was primarily due to $4.2 million of increased employee related costs, $7.9 million of increased outside and consulting expense and $6.9 million of increased clinical trial and related costs. Research and development expenses were $172.7 million for the full year 2021, as compared to $99.9 million for the full year 2020. The increase was primarily due to $30.0 million of increased employee related costs, including $10.2 million of additional stock-based compensation expense, $25.3 million of increased external R&D expenses and $10.9 million of increased clinical trial expenses.
G&A Expenses: General and administrative expenses were $15.5 million in each of the three-month periods ended December 31, 2021 and 2020. General and administrative expenses were $57.4 million for the full year 2021, as compared to $38.6 million for the full year 2020. The increase was primarily due to $12.8 million of increased employee related costs, including $6.3 million of additional stock-based compensation expense, and $6.0 million of other general and administrative expenses.
Net Income/Loss: Net loss was $67.5 million for the fourth quarter of 2021, as compared to net income of $35.3 million for the fourth quarter of 2020. Net loss was $363.9 million for the full year 2021, or a net loss per share of $3.82, as compared to a net loss of $52.4 million for the full year 2020, or a net loss per
share of $5.40. The increase in net loss included one-time expenses of $134.9 million in 2021 associated with the acquisition of ZebiAI Therapeutics, Inc.
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. Relay Therapeutics is the first of a new breed of biotech created at the intersection of disparate technologies. Relay Therapeutics’ 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 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:
Hannah Mae Bohn
617-370-8814
hbohn@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)
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Year Ended December 31, |
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2021 |
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2020 |
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2019 |
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Revenue: |
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License and other revenue |
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$ |
3,029 |
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$ |
82,654 |
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$ |
— |
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Total revenue |
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3,029 |
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82,654 |
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— |
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Operating expenses: |
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Research and development expenses |
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172,650 |
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99,862 |
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70,306 |
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In-process research and development expenses |
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123,000 |
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— |
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— |
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Loss on initial consolidation of variable interest entity |
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11,855 |
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— |
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— |
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Change in fair value of contingent consideration liability |
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2,836 |
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— |
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— |
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General and administrative expenses |
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57,386 |
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38,588 |
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13,742 |
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Total operating expenses |
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367,727 |
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138,450 |
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84,048 |
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Loss from operations |
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(364,698 |
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(55,796 |
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(84,048 |
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Other income (expense): |
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Interest income |
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830 |
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3,400 |
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8,801 |
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Other expense |
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(4 |
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(16 |
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(58 |
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Total other income, net |
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826 |
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3,384 |
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8,743 |
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Net loss |
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$ |
(363,872 |
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$ |
(52,412 |
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$ |
(75,305 |
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Deemed dividend resulting from extinguishment upon modification of Series C preferred stock |
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— |
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(177,789 |
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— |
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Net loss attributable to common stockholders |
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$ |
(363,872 |
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$ |
(230,201 |
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$ |
(75,305 |
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Net loss attributable to common stockholders per share, basic and diluted |
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$ |
(3.82 |
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$ |
(5.40 |
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$ |
(21.82 |
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Weighted average shares of common stock, basic and diluted |
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95,136,719 |
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42,619,582 |
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3,450,500 |
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Other comprehensive income (loss): |
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Unrealized holding (loss) gain |
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(1,152 |
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(261 |
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325 |
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Total other comprehensive (loss) income |
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(1,152 |
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(261 |
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325 |
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Total comprehensive loss |
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$ |
(365,024 |
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$ |
(52,673 |
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$ |
(74,980 |
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Relay Therapeutics, Inc.
Selected Condensed Consolidated Balance Sheet Data
(In thousands)
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December 31, 2021 |
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December 31, 2020 |
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Cash, cash equivalents and investments |
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$ |
958,073 |
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$ |
678,061 |
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Working capital (1) |
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951,921 |
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756,468 |
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Total assets |
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1,008,443 |
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799,829 |
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Total liabilities |
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110,635 |
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36,536 |
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Total stockholders’ equity |
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897,808 |
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763,293 |
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Restricted cash |
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2,578 |
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878 |
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