Relay Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Highlights
- Completed enrollment in initial dose expansion cohort of RLY-2608 600mg BID + fulvestrant in patients with PI3Kα-mutant, HR+, HER2- locally advanced or metastatic breast cancer.
- Initiated two additional dose expansion cohorts of RLY-2608 in combination with fulvestrant.
- Published preclinical profile and clinical proof-of-concept of RLY-2608 in Cancer Discovery.
- Deprioritized further clinical development of RLY-5836.
- Presented initial clinical data of lirafugratinib in patients with FGFR2-altered solid tumors.
- Anticipated milestones for 2024 include data updates on RLY-2608 and lirafugratinib, and the disclosure of new pre-clinical programs.
- Cash, cash equivalents, and investments totaled $750.1 million as of December 31, 2023, expected to fund operations into the second half of 2026.
- Revenue increased to $25.5 million for the full year 2023, primarily due to milestone payments under the Collaboration and License Agreement with Genentech, Inc.
- R&D expenses and G&A expenses saw an increase in 2023 compared to 2022, leading to a higher net loss for the company.
- Increase in net loss for the fourth quarter of 2023 compared to the same period in 2022.
- Higher research and development expenses in 2023 due to additional clinical trial expenses and employee-related costs.
- General and administrative expenses also increased in 2023, impacting the company's financial performance.
Insights
The financial results of Relay Therapeutics indicate a significant increase in R&D expenses from $246.4 million in the full year 2022 to $330.0 million in 2023, reflecting an aggressive investment in clinical trials and research personnel. This uptick is aligned with the company's strategic focus on advancing its clinical programs, particularly RLY-2608 and investing in its proprietary Dynamo platform. The reported net loss has widened year-over-year, from $290.5 million to $342.0 million, which is not uncommon for clinical-stage biotech companies prioritizing research and development over immediate profitability.
The company's liquidity position, with $750 million in cash and equivalents, is sufficient to fund operations into the second half of 2026. This runway is crucial for investors as it provides a buffer for the company to reach key milestones without the immediate need for additional capital raises, which could dilute existing shareholders. However, the burn rate and future funding requirements should be monitored closely, especially in the context of the biotech industry's cyclical nature and the capital markets' volatility.
Relay Therapeutics' focus on the RLY-2608 program in PI3Kα-mutated HR+/HER2- metastatic breast cancer represents a significant stride in precision medicine. The initiation of additional dose expansion cohorts and a triplet combination study with ribociclib are indicative of the compound's potential and the company's commitment to addressing this subset of breast cancer. The absence of wildtype PI3Kα-related toxicities in preclinical studies suggests a favorable safety profile, which, if confirmed in clinical trials, could position RLY-2608 as a strong contender in the competitive oncology market.
From a medical research perspective, the deprioritization of RLY-5836 and the cautious approach to lirafugratinib (RLY-4008) signal a strategic allocation of resources towards the most promising candidates. The anticipation of data updates in the second half of 2024 will be critical for assessing the clinical viability and potential market impact of these therapies. Relay's scientific approach, leveraging the Dynamo platform, could yield first-in-class drug candidates, potentially revolutionizing treatment paradigms in their respective indications.
The oncology drug market is highly competitive, with a strong emphasis on targeted therapies and precision medicine. Relay Therapeutics' progress in advancing RLY-2608 and the planned update on clinical data in 2024 could be a significant catalyst for the company's valuation. The market's response to these updates will likely hinge on the strength of the clinical data, particularly in terms of efficacy and safety, as well as the drug's potential market size and competitive landscape.
Investors will also assess the potential impact of the Dynamo platform's productivity. The platform's ability to produce viable drug candidates efficiently can be a differentiator in the biotech industry. A new program disclosure in 2024, especially one with first-in-class potential, could further validate the platform's value and Relay's long-term growth prospects. The company's strategic deprioritization of certain assets to focus on more promising ones is a prudent move that aligns with industry norms for resource allocation and pipeline management.
Completed enrollment in initial RLY-2608 600mg + fulvestrant dose expansion cohort & initiated additional dose expansion cohorts with RLY-2608 400mg & 600mg
Initiated RLY-2608 + fulvestrant + ribociclib triplet combination in PI3Kα-mutated HR+/HER2- metastatic breast cancer
Approximately
CAMBRIDGE, Mass., Feb. 22, 2024 (GLOBE NEWSWIRE) -- 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 2023 financial results and corporate highlights.
“We made important progress across our portfolio during 2023, advancing multiple clinical programs and continuing to invest significantly in our research engine – the Dynamo platform,” said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics. “We are very pleased with the RLY-2608 data disclosed to-date and how its clinical profile continued to mature throughout last year. Our clinical team is focused on advancing this program in the near term in both a doublet and a triplet combination, and we look forward to sharing additional data in the second half of 2024. Our Dynamo platform continues to demonstrate precision and productivity with each target we’ve chosen to-date, and we are excited to disclose at least one new program that has come out of it later this year, which is being designed to have first-in-class potential.”
Recent Corporate Highlights
PI3Kα
- RLY-2608 doublet
- Completed enrollment in initial dose expansion cohort of RLY-2608 600mg BID + fulvestrant in patients with PI3Kα-mutant, HR+, HER2- locally advanced or metastatic breast cancer
- Initiated two additional dose expansion cohorts of RLY-2608 in combination with fulvestrant – a second 600mg BID cohort as well as one at 400mg BID
- Published RLY-2608 preclinical profile and clinical proof-of-concept in Cancer Discovery (Discovery and Clinical Proof-of-Concept of RLY-2608, a First-in-Class Mutant-Selective Allosteric PI3Kα Inhibitor That Decouples Antitumor Activity from Hyperinsulinemia) with vignettes from two patients with advanced HR+ breast cancer with kinase or helical mutations, with no observed wildtype PI3Kα-related toxicities
- RLY-2608 triplet
- Initiated RLY-2608 + fulvestrant + ribociclib triplet combination in patients with PI3Kα-mutant, HR+, HER2- locally advanced or metastatic breast cancer
- RLY-5836
- Deprioritized further clinical development
Lirafugratinib (RLY-4008)
- Presented initial clinical data in patients with FGFR2-altered solid tumors at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics
- As previously disclosed, the company will minimize resource allocation in 2024 to allow data to mature and inform future clinical development decisions
Anticipated 2024 Milestones
- RLY-2608
- RLY-2608 + fulvestrant data update in the second half of 2024
- RLY-2608 + fulvestrant + ribociclib initial safety data in the second half of 2024
- RLY-2608 + fulvestrant data update in the second half of 2024
- Lirafugratinib: tumor agnostic data and regulatory update in the second half of 2024
- Pre-clinical: disclose new program(s) in 2024
Fourth Quarter and Full Year 2023 Financial Results
Cash, Cash Equivalents and Investments: As of December 31, 2023, cash, cash equivalents and investments totaled
Revenue: There was no material revenue for the fourth quarter of 2023 or 2022. Revenue was
R&D Expenses: Research and development expenses were
G&A Expenses: General and administrative expenses were
Net Loss: Net loss was
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, potential efficacy and tolerability, and the timing and success of interactions with and approval of regulatory authorities; the timing of a clinical data update for the PI3Kα franchise, the progress of doublet and triplet combinations for RLY-2608, the timing of clinical updates for RLY-2608, the timing of a clinical data and regulatory update for lirafugratinib, and the timing of disclosure of additional pre-clinical programs; expectations regarding Relay Therapeutics’ pipeline, operating plan, use of capital, expenses and other financial results; 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 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 results of its pre-clinical 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:
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) | |||||||||||||||
| Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||||||||||
| 2023 | 2022 | 2023 | 2022 | ||||||||||||
| Revenue: | |||||||||||||||
| License and other revenue | $ | — | $ | 253 | $ | 25,546 | $ | 1,381 | |||||||
| Total revenue | — | 253 | 25,546 | 1,381 | |||||||||||
| Operating expenses: | |||||||||||||||
| Research and development expenses | $ | 77,496 | $ | 67,277 | $ | 330,018 | $ | 246,355 | |||||||
| Change in fair value of contingent consideration liability | (2,066 | ) | (10,544 | ) | (6,422 | ) | (11,677 | ) | |||||||
| General and administrative expenses | 16,766 | 16,371 | 74,950 | 65,978 | |||||||||||
| Total operating expenses | 92,196 | 73,104 | 398,546 | 300,656 | |||||||||||
| Loss from operations | (92,196 | ) | (72,851 | ) | (373,000 | ) | (299,275 | ) | |||||||
| Other income: | |||||||||||||||
| Interest income | 8,700 | 5,372 | 31,045 | 8,786 | |||||||||||
| Other income (expense) | 1 | (24 | ) | (18 | ) | (20 | ) | ||||||||
| Total other income, net | 8,701 | 5,348 | 31,027 | 8,766 | |||||||||||
| Net loss | $ | (83,495 | ) | $ | (67,503 | ) | $ | (341,973 | ) | $ | (290,509 | ) | |||
| Net loss per share, basic and diluted | $ | (0.67 | ) | $ | (0.56 | ) | $ | (2.79 | ) | $ | (2.59 | ) | |||
| Weighted average shares of common stock, basic and diluted | 124,752,843 | 120,966,401 | 122,576,527 | 112,233,649 | |||||||||||
| Other comprehensive loss: | |||||||||||||||
| Unrealized holding gain (loss) | 3,210 | (2,969 | ) | 10,224 | (9,332 | ) | |||||||||
| Total other comprehensive gain (loss) | 3,210 | (2,969 | ) | 10,224 | (9,332 | ) | |||||||||
| Total comprehensive loss | $ | (80,285 | ) | $ | (64,534 | ) | $ | (331,749 | ) | $ | (299,841 | ) | |||
| Relay Therapeutics, Inc. Selected Condensed Consolidated Balance Sheet Data (In thousands) (Unaudited) | |||||||
| December 31, 2023 | December 31, 2022 | ||||||
| Cash, cash equivalents and investments | $ | 750,086 | $ | 998,917 | |||
| Working capital (1) | 739,834 | 955,796 | |||||
| Total assets | 843,980 | 1,099,771 | |||||
| Total liabilities | 91,977 | 149,553 | |||||
| Total stockholders’ equity | 752,003 | 950,218 | |||||
| Restricted cash | 2,707 | 2,578 | |||||
(1) Working capital is defined as current assets less current liabilities.
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