RLAY — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-05

• We are a clinical-stage, small molecule precision medicine company developing potentially life-changing therapies for patients living with cancer and genetic disease. Our Dynamo® platform integrates an array of leading-edge computational and experimental approaches designed to drug protein targets t…

• Clinical Data. In June 2025, we announced updated interim clinical data for the zovegalisib plus fulvestrant arm of the ReDiscover Trial from patients receiving the 600mg twice daily, or BID, fasted dose and in December 2025, we announced an efficacy subset analysis of interim clinical data for zove…

• In addition to the programs mentioned above, we have initiated a clinical trial studying RLY-8161, our NRAS-selective inhibitor, in patients with NRAS-mutant melanoma and other NRAS-mutant solid tumors. In our research pipeline, we are advancing our non-inhibitory chaperone for Fabry disease, as wel…

• operations through private placements of preferred stock and common stock, convertible debt, and proceeds from public offerings of our common stock.

• In August 2024, we entered into a sales agreement, or the 2024 Sales Agreement, with TD Securities (USA) LLC, or TD Securities, pursuant to which we may offer and sell shares of our common stock having aggregate gross proceeds of up to $250.0 million from time to time in “at-the-market” offerings th…

Text removed vs the prior filing · source: 10-Q · 2025-11-06

• We are a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies with the goal of bringing life-changing therapies to patients. As we believe we are among the first of a new breed of biotech created at th…

• Clinical Data. In June 2025, we announced updated interim clinical data for the RLY-2608 plus fulvestrant arm of the ReDiscover Trial with a data cut-off date of March 26, 2025. This updated interim data is consistent with prior interim results, showing 10.3-month median progression free survival, o…

• In addition to the programs mentioned above, we are progressing our NRAS-selective inhibitor, RLY-8161, to address NRAS-mutated solid tumors as well as our non-inhibitory chaperone for Fabry disease. We also have one active early-stage discovery program. We are focused on using the novel insights de…

• planning, raising capital, and providing general and administrative support for these operations. To date, we have principally financed our operations through private placements of preferred stock and common stock, convertible debt, and proceeds from public offerings of our common stock.

• In August 2024, we entered into a sales agreement, or the 2024 Sales Agreement, with TD Securities (USA) LLC, or TD Securities, pursuant to which we may offer and sell shares of our common stock having aggregate gross proceeds of up to $250.0 million from time to time in “at-the-market” offerings th…

Text added vs the prior filing · source: 10-Q · 2026-05-05

• we may not be able to adequately project the timing and quantity of our product candidates or any other materials necessary to conduct clinical trials of our product candidates;

• the supply or quality of our product candidates, other therapies used in our clinical trials or any other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate or not available in a reasonable timeframe, and any transfer of manufacturing activitie…

• indicative of results obtained when such trials are completed. There is typically an extremely high rate of attrition from the failure of product candidates proceeding through clinical trials. Product candidates in later stages of clinical trials also may fail to show the desired safety and efficacy…

• We intend to develop zovegalisib and may develop our other current product candidates and future product candidates, for use in combination with one or more currently approved cancer or other therapies. Even if any product candidate we develop was to receive marketing approval or be commercialized f…

• FDA or similar regulatory authorities could revoke approval of the therapy used in combination with our product candidates or that safety, efficacy, manufacturing or supply issues could arise with these existing therapies. Combination therapies are commonly used for the treatment of cancer, and we w…

Text removed vs the prior filing · source: 10-Q · 2025-11-06

• we may not be able to adequately project the timing and quantity of our product candidates, other therapies used in our clinical trials or any other materials necessary to conduct clinical trials of our product candidates or the supply or quality of such product candidates, other therapies or materi…

• unacceptable safety issues, notwithstanding promising results in earlier trials. Most product candidates that commence clinical trials are never approved as products and there can be no assurance that any of our current or future clinical trials will ultimately be successful or support further clini…

• We intend to develop RLY-2608 and may develop our other current product candidates and future product candidates, for use in combination with one or more currently approved cancer or other therapies. Even if any product candidate we develop was to receive marketing approval or be commercialized for …

• drugs or for indications other than cancer. This could result in our own products being removed from the market or being less successful commercially.

• not include the labeling claims necessary or desirable for the successful commercialization of that product candidate. Any of the foregoing scenarios could materially harm the commercial prospects for our product candidates.