8-K: Relay Therapeutics Announces Positive 2024 Results and Advances Breast Cancer Program

Relay Therapeutics reports promising progress in its RLY-2608 breast cancer program and a strong cash position to fund a pivotal Phase 3 trial.

Summary

• Relay Therapeutics announced its fourth quarter and full year 2024 financial results and corporate updates.
• A Phase 3 trial (ReDiscover-2) of RLY-2608 + fulvestrant is anticipated to begin in mid-2025 for PI3K-mutated, CDK4/6 pre-treated, HR+/HER2advanced breast cancer.
• Interim data for RLY-2608 + fulvestrant showed an 11.4-month median PFS in 2L patients with PI3K-mutated, HR+/HER2advanced breast cancer.
• The company had approximately $780 million in cash, cash equivalents, and investments at the end of Q4 2024.
• This cash will be used to fully fund the execution of the ReDiscover-2 Phase 3 trial.
• 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 for the full year 2024 was $10.0 million, compared to $25.5 million for the full year 2023.
• Research and development expenses were $319.1 million for the full year 2024, compared to $330.0 million for the full year 2023.
• Net loss was $337.7 million for the full year 2024, or a net loss per share of $2.36, compared to a net loss of $342.0 million for the full year 2023, or a net loss per share of $2.79.

Sentiment

Score: 7

Explanation: The announcement is generally positive due to the progress of the RLY-2608 program and the strong cash position, but the decrease in revenue and continued net losses temper the overall sentiment.

Positives

• The company has a strong cash position of approximately $780 million.
• 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.
• RLY-2608 + fulvestrant showed an 11.4-month median PFS in second-line patients.
• The company is advancing front-line triplet regimens for breast cancer.

Negatives

• Revenue decreased to $10.0 million for the full year 2024, compared to $25.5 million for the full year 2023.
• The decrease was primarily due to the timing of milestones achieved, as well as revenue recognized thereon, under the company's Collaboration and License Agreement with Genentech, Inc.
• The company experienced a net loss of $337.7 million for the full year 2024.

Risks

• The success of the Phase 3 trial is crucial for the future of RLY-2608.
• Clinical trial results may not be predictive of future outcomes.
• Regulatory approvals are not guaranteed.
• The company faces risks associated with 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.
• The company faces risks associated with significant political, trade, or regulatory developments beyond Relay Therapeutics control.

Future Outlook

Relay Therapeutics plans to advance its clinical programs, including initiating the RLY-2608 + fulvestrant Phase 3 trial in breast cancer patients, and expects its current cash to fund operations into the second half of 2027.

Management Comments

• Our RLY-2608 breast cancer program continued to advance and develop rapidly in 2024, driven by positive maturation of the RLY-2608 + fulvestrant doublet dataset, now with over 100 patients dosed and median PFS of 11.4 months in second-line patients, said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics.
• We also continue to make progress with our investigational triplet combinations, which we believe could potentially allow RLY-2608 to address patients in earlier settings.
• Looking forward into 2025, it is our top priority to continue advancing our clinical programs, including the initiation of the RLY-2608 + fulvestrant Phase 3 trial in breast cancer patients.
• With a strong capital position that supports the execution of that pivotal trial, and a team with proven development experience, I am confident in our abilities to meaningfully advance these programs towards patients in oncology and genetic disease areas.

Industry Context

Relay Therapeutics is focused on precision medicine, a growing area in oncology, and is competing with other companies developing targeted therapies for breast cancer. The initiation of a Phase 3 trial for RLY-2608 is a significant step in this competitive landscape.

Comparison to Industry Standards

• The 11.4-month median PFS observed with RLY-2608 + fulvestrant in second-line patients is a competitive result compared to other PI3K inhibitors in similar patient populations.
• For example, Alpelisib (Novartis' Piqray) has shown efficacy in PIK3CA-mutated breast cancer, but is associated with significant toxicities.
• Capivasertib + fulvestrant is being used as the comparator arm in the Phase 3 trial.
• The target enrollment of 540 patients in the Phase 3 trial is a standard size for registrational studies in advanced breast cancer.

Stakeholder Impact

• Positive news for shareholders due to the advancement of the RLY-2608 program and strong cash position.
• Potential benefit for breast cancer patients if RLY-2608 proves to be an effective treatment.
• Employees are likely to be positively impacted by the company's progress and financial stability.

Next Steps

• Initiation of Phase 3 trial of RLY-2608 + fulvestrant in the middle of 2025.
• Additional Phase 1b doublet data in 2025.
• RLY-2608 clinical trial initiation in vascular malformations in the first quarter of 2025.
• NRAS and Fabry programs continue to advance towards IND and timing of clinical start for each program will be phased to optimize resources to ensure the execution of the ReDiscover-2 Phase 3 trial.

Key Dates