Relay Therapeutics Q3 2024 Financial Results and Corporate Highlights

Relay Therapeutics, Inc., a clinical-stage precision medicine company known for advancing the drug discovery process through computational and experimental technologies, recently released financial results for the third quarter of 2024 and provided updates on their corporate activities.

In the third quarter, Relay Therapeutics presented promising interim data for their drug candidate RLY-2608 combined with fulvestrant in patients with PI3Kα-mutated, HR+, HER2- metastatic breast cancerHR. These patients had previously undergone at least one CDK4/6 inhibitor treatment. The data, as of August 12, 2024, demonstrated a median progression-free survival (PFS) of 9.2 months across all mutations and 10.3 months among those with kinase mutations. Additionally, the objective response rate (ORR) was 33% across all patients and 53% in patients with kinase mutations, at the recommended Phase 2 dose (RP2D). The tolerability of the treatment was favorable, with only two patients discontinuing due to adverse events and one patient experiencing Grade 3 hyperglycemia. These findings will be presented at the San Antonio Breast Cancer Symposium in December 2024.

Relay Therapeutics plans to initiate a Phase 3 pivotal trial for RLY-2608 plus fulvestrant in 2025. They are also advancing two front-line triplet regimens for patients with PI3Kα-mutated, HR+, HER2- metastatic breast cancer. These include a combination of RLY-2608 with ribociclib and fulvestrant, and another with atirmociclib and fulvestrant. The ribociclib combination is currently in dose escalation to identify a biologically active dose of RLY-2608 that can be combined with full-dose ribociclib, with expansion cohorts starting in the first half of 2025. The trial for the combination with atirmociclib is set to commence by the end of 2024.

Another significant highlight is the progress of Lirafugratinib (RLY-4008), which showed updated FGFR2 fusion tumor agnostic data at a recent international cancer conference. The FDA has suggested that Relay Therapeutics first file a new drug application (NDA) for cholangiocarcinoma, followed by a supplemental NDA for FGFR2 fusions with further patient data. The company is also seeking a global commercialization partner for Lirafugratinib to maintain its focus on the rest of its portfolio.

Relay Therapeutics has raised $230 million through a public offering in September 2024 and has streamlined its research organization, resulting in expected annual savings of $50 million and a 15% workforce reduction. These changes are part of the company's shift towards a more development-focused approach in preparation for the upcoming RLY-2608 pivotal trial and other programs entering the clinic in 2025.

Financially, Relay Therapeutics reported $839.6 million in cash, cash equivalents, and investments as of September 30, 2024, an increase from $750.1 million at the end of 2023. This is expected to fund their operations into the second half of 2027. The company had no revenue in the third quarter of 2024, compared to $25.2 million in the third quarter of 2023, which was primarily due to previously recognized milestone payments from a collaboration agreement. Research and development expenses decreased to $76.6 million from $81.5 million, attributed to the prioritization of certain programs. General and administrative expenses increased to $19.8 million, mainly due to higher stock compensation expenses. The net loss for the third quarter was $88.1 million, or $0.63 per share, compared to a net loss of $65.7 million, or $0.54 per share, in the same period in 2023.

Relay Therapeutics is dedicated to transforming drug discovery by leveraging advanced computational and experimental techniques. Their Dynamo® platform aims to target previously intractable or inadequately addressed protein targets, with an initial focus on small molecule therapeutic discovery in oncology and genetic disease indications.