CAMBRIDGE, Mass. – Relay Therapeutics, Inc. (NASDAQ:RLAY), a clinical-stage precision medicine company, today announced positive interim data from its ongoing ReDiscover study evaluating RLY-2608, a potential treatment for HR+/HER2- metastatic breast cancer with PI3Kα mutations. The study showed a median progression-free survival (PFS) of 9.2 months in heavily pretreated patients at the recommended Phase 2 dose (RP2D).
The data, from an interim analysis through August 12, 2024, included 118 patients who showed an objective response rate (ORR) of 33% in all patients and an ORR of 53% in those with RP2D kinase mutations. 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 regulatory authorities. The company is also advancing its triple combination treatments, expecting to move into dose expansion with ribociclib in the first half of 2025 and begin 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 dose expansion cohort for solid tumors by the end of 2024 and a study in vascular malformations 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 expected for the Fabry disease and NRAS programs in the second half of 2025.
Relay Therapeutics reported a cash position of approximately $688 million at the end of the second quarter of 2024, which is expected to fund operations through the second half of 2026.
The company will be holding a conference call today, Monday, to further discuss these updates. This report is based on a press release from Relay Therapeutics.
In other recent news, Relay Therapeutics has seen several significant developments. BofA Securities revised its price target on the company to $20.00 from $23.00, maintaining a Buy rating. This adjustment comes in anticipation of the upcoming release of Phase 1/2 dose expansion data for RLY-2608, a drug candidate for the treatment of second-line breast cancer and beyond.
Conversely, HC Wainwright cut his price target on Relay Therapeutics to $18.00 following the company’s termination of its partnership with Roche. Despite this, the company maintained its Buy rating on the stock. The termination of the deal with Genentech, a member of the Roche Group, halted any further financial benefits or milestone payments to Relay Therapeutics.
Further analyst reactions included Barclays 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 most recent available data and analyst notes.
InvestingPro Insights
As Relay Therapeutics (NASDAQ:RLAY) shares promising interim data from its ReDiscover study, investors and stakeholders are keeping a close eye on the company’s financial health and stock performance. Here are some key takeaways based on recent data from InvestingPro:
The company’s market cap stands at $835.47 million, reflecting its current valuation in the biotech sector. Despite Relay Therapeutics’ significant revenue growth over the past twelve months, with an increase of 3637.58%, the company’s gross profit margin remains negative at -836.59%, indicating substantial costs relative to its revenue.
InvestingPro tips indicate 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 rapidly burning cash. This could be a cause for concern for its long-term sustainability, especially given that the company plans to launch additional clinical trials and seeks global commercialization partners. Additionally, analysts have lowered their earnings estimates for the upcoming period, and the stock has experienced significant volatility, with a total price return of -35.87% over the past year.
Investors considering Relay Therapeutics should note that the company does not pay dividends to shareholders and is not expected to be profitable this year, as indicated by its negative P/E ratio of -2.51. However, InvestingPro’s 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 that may provide additional insight into the stock’s prospects. These can be found at https://www.investing.com/pro/RLAY.
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