CAMBRIDGE, Mass. - Relay Therapeutics, Inc. (NASDAQ:RLAY), a clinical-stage precision medicine company, has announced positive interim data from its ongoing ReDiscover study evaluating RLY-2608, a potential treatment for PI3Kα-mutated, HR+/HER2- metastatic breast cancer. The study showed a median progression-free survival (PFS) of 9.2 months in heavily pre-treated patients at the recommended Phase 2 dose (RP2D).
The data, from an interim cut-off on August 12, 2024, included 118 patients who showed a 33% objective response rate (ORR) across all patients and a 53% ORR in those with kinase mutations at RP2D. The treatment, which combines RLY-2608 with fulvestrant, was generally well-tolerated, with only two patients discontinuing due to adverse events, and only one case of Grade 3 hyperglycemia reported.
Relay Therapeutics plans to initiate a pivotal study in 2025, pending discussions with regulators. Additionally, the company is progressing with its triplet combination treatments, expecting to move into dose expansion with ribociclib in the first half of 2025 and to initiate a combination with atirmociclib (CDK4) by the end of the year.
The company also provided updates on its portfolio, including the initiation of a monotherapy solid tumor dose expansion cohort(s) by the end of 2024 and a vascular malformations study in the first quarter of 2025. The company is seeking a global commercialization partner for lirafugratinib to maintain focus on its portfolio, with clinical starts for Fabry disease and NRAS programs anticipated in the second half of 2025.
Relay Therapeutics reported a cash position of approximately $688 million as of the end of the second quarter of 2024, which is expected to fund operations into the second half of 2026.
The company will host a conference call today, Monday, to discuss these updates further. This report is based on a press release statement from Relay Therapeutics.
In other recent news, Relay Therapeutics has been the subject of several significant developments. BofA Securities revised its price target for the company to $20.00 from $23.00, while maintaining a Buy rating. This adjustment comes in anticipation of Relay Therapeutics' upcoming Phase 1/2 dose expansion data release for RLY-2608, a drug candidate for second-line and beyond breast cancer treatment.
In contrast, H.C. Wainwright reduced its price target for Relay Therapeutics to $18.00 following the termination of the company's collaboration with Roche (LON:0QQ6). Despite this, the firm retained its Buy rating on the stock. The termination of the agreement with Genentech, a Roche Group member, has halted further financial benefits or milestone payments to Relay Therapeutics.
Additional analyst reactions include Barclays (LON:BARC) upgrading the company's stock to Overweight due to an improved outlook, while Oppenheimer lowered its price target to $25, but maintained an Outperform rating. TD Cowen reiterated a Buy rating on Relay Therapeutics as the company initiated three new drug development programs.
These recent developments reflect the ongoing dynamics within Relay Therapeutics, including significant changes in partnerships, analyst ratings, and drug development initiatives. All information presented is based on the latest available data and analyst notes.
InvestingPro Insights
As Relay Therapeutics (NASDAQ:RLAY) shares promising interim data for its ReDiscover study, investors and stakeholders are closely monitoring the company's financial health and stock performance. Here are some key insights based on recent data from InvestingPro:
The company's market capitalization stands at $835.47 million, reflecting its current valuation within the biotech industry. Despite Relay Therapeutics' significant revenue growth over the last twelve months, with an increase of 3637.58%, the company's gross profit margin remains in the negative at -836.59%, indicating substantial costs relative to its revenue.
InvestingPro Tips suggest that while Relay Therapeutics holds more cash than debt on its balance sheet, which is a positive sign for its financial stability, the company is quickly burning through cash. This could be a concern for long-term sustainability, especially as the company plans to initiate further clinical studies and seeks global commercialization partners. Additionally, analysts have revised their earnings downwards for the upcoming period, and the stock has experienced significant volatility, with a price total return of -35.87% over the last year.
Investors considering Relay Therapeutics should note that the company does not pay a dividend to shareholders and is not expected to be profitable this year, as indicated by its negative P/E ratio of -2.51. However, the InvestingPro Fair Value estimate stands at $7.11, suggesting potential undervaluation at the current price of $6.24.
For those looking for a more in-depth analysis, there are 10 additional InvestingPro Tips available which could provide further guidance on the stock's prospects. These insights can be found at https://www.investing.com/pro/RLAY.
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