Financial Performance - The company reported net losses of $221.6 million and $261.7 million for the nine months ended September 30, 2025 and 2024, respectively, with an accumulated deficit of $2.0 billion as of September 30, 2025[108]. - For the three months ended September 30, 2025, the company reported a net loss of $74.1 million, a decrease of $14.0 million compared to a net loss of $88.1 million for the same period in 2024[129]. - The company recognized $8.4 million in revenue during the nine months ended September 30, 2025, compared to $10.0 million in the same period of 2024, a decrease of $1.6 million[137]. - Other income, net, was $20.5 million for the nine months ended September 30, 2025, compared to $25.8 million in 2024, a decrease of $5.3 million due to changes in investment amounts and interest rate fluctuations[142]. - The company has not generated any revenue from product sales since its inception and does not expect to do so for several years[144]. - For the nine months ended September 30, 2024, the company reported a net loss of $261.7 million, with cash used in operating activities amounting to $191.2 million[153]. Cash and Financing - The company has cash, cash equivalents, and investments totaling $596.4 million as of September 30, 2025, which are expected to fund operations into 2029[113]. - Cash used in operating activities for the nine months ended September 30, 2025, was $190.6 million, slightly lower than $191.2 million in 2024[151]. - The company generated $269.4 million in net cash from financing activities for the nine months ended September 30, 2024, mainly from private placements and stock option exercises[157]. - The company anticipates needing additional financing to support ongoing operations and drug development efforts[111]. - The company may need to raise substantial additional funds to achieve its business objectives, with potential dilution of ownership interests if equity is sold[162]. Research and Development - The lead product candidate, RLY-2608, demonstrated a median progression-free survival (PFS) of 10.3 months overall and 11.0 months in second-line patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer[100]. - The company initiated a global Phase 3 registrational study, the ReDiscover-2 Trial, in the second quarter of 2025 to evaluate RLY-2608 plus fulvestrant in advanced breast cancer patients[100]. - The company incurred significant operating losses primarily due to research and development activities, licensing, and general administrative costs[108]. - The company expects to continue incurring significant expenses related to clinical trials and commercialization efforts for its product candidates[109]. - Research and development expenses for the three months ended September 30, 2025, were $68.3 million, down from $76.6 million in 2024, reflecting a decrease of $8.4 million due to strategic choices made to streamline operations[132]. - Total research and development expenses for the nine months ended September 30, 2025, were $206.0 million, down from $251.0 million in 2024, a decrease of $45.0 million attributed to strategic operational changes[139]. Administrative Expenses - General and administrative expenses decreased to $12.1 million for the three months ended September 30, 2025, from $19.8 million in 2024, a reduction of $7.6 million primarily due to lower stock compensation expenses[134]. - There were no material changes to the company's contractual obligations and commitments during the three months ended September 30, 2025[164]. - The company has no outstanding debt as of September 30, 2025, thus not exposed to interest rate risk related to debt[170]. Foreign Currency and Hedging - Foreign currency transaction gains and losses have not been material, with a 10% change in exchange rates estimated to have no significant effect on financial results[171]. - The company is evaluating the potential for a hedging program for foreign currency transactions as it expands international operations[171]. Licensing and Agreements - The company entered into an exclusive global licensing agreement with Elevar Therapeutics, receiving $5.0 million upfront and eligible for up to $495.0 million in milestone payments[102]. - The company entered into the Elevar Agreement in December 2024, receiving $5.0 million in upfront consideration and $3.4 million for the transfer of materials as of September 30, 2025[145]. Stock Sales - The company has not sold any shares under the 2024 Sales Agreement, which allows for gross proceeds of up to $250.0 million[104].
Relay Therapeutics(RLAY) - 2025 Q3 - Quarterly Report