Relay Therapeutics, Inc.

false 0001812364 0001812364 2026-05-19 2026-05-19 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 19, 2026 RELAY THERAPEUTICS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-39385 47-3923475 (State or Other Jurisdiction of Incorporation) (Commission File Number) (IRS Employer Identification No.) 60 Hampshire Street Cambridge , Massachusetts 02139 (Address of Principal Executive Offices) (Zip Code) Registrant’s Telephone Number, Including Area Code: (617) 370-8837 (Former Name or Former Address, if Changed Since Last Report) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.001 per share RLAY Nasdaq Global Market Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter). Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ Item 7.01 Regulation FD Disclosure. On May 19, 2026, Relay Therapeutics, Inc. (the "Company") issued a press release announcing initial clinical data from the Phase 2 ReInspire trial of zovegalisib in vascular anomalies, a copy of which is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K. The Company hosted a conference call and live webcast to discuss the initial clinical data on May 19, 2026 at 8:00 a.m. E.T. The Company has made available a slide presentation to accompany the call, a copy of which is being furnished as Exhibit 99.2 to this Current Report on Form 8-K. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.2. The information in this Item 7.01, including Exhibit 99.1 and Exhibit 99.2 attached hereto, is intended to be furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing. Item 8.01 Other Events. On May 19, 2026, the Company announced initial clinical data from the Phase 2 ReInspire trial of zovegalisib in vascular anomalies. The ReInspire trial is an ongoing Phase 2 study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of zovegalisib in adults and children with vascular anomalies driven by PIK3CA mutation. The data reported today are from Part 1 of the study in the adults and adolescents cohort (patients 12 years or older), which featured randomized dose selection across three doses. As of the April 15, 2026 data cut-off date (the "Data Cut-Off Date"), 32 total patients were enrolled and randomized to the following dose cohorts: N=11 at 100mg twice daily ("BID"), N=11 at 300mg BID, and N=10 at 400mg BID. Of the patients enrolled, 22 had PIK3CA-related overgrowth spectrum ("PROS"), 8 had a lymphatic malformation ("LM"), and 2 had a venous malformation ("VeM"). 23 patients (72%) had prior treatment with sirolimus and/or alpelisib, which was allowed in the study. Unless indicated otherwise, all data reported are as of the Data Cut-Off Date. Initial Efficacy Data Of the 32 patients enrolled, 20 have been evaluated for efficacy per volumetric response assessment by blinded independent central review ("BICR"), which is assessed by MRI every 12 weeks. The remaining 12 patients had not reached the 12-week timepoint. A response is defined by a 20% or greater reduction in target lesion(s) volume from baseline. Of the 20 response-evaluable patients, 15 had PROS, 4 had a LM, and 1 had a VeM. Of patients with a confirmed PIK3CA mutation, 25% of patients had a kinase mutation and 55% had a non-kinase mutation, while 20% had no PIK3CA mutation documented at the time of the Data Cut-Off Date. 65% had been previously treated with alpelisib or sirolimus (35% had been treated by both). All 32 patients remained on treatment as of the Data Cut-Off Date. For the 20 response-evaluable patients: • 60% of patients had a volumetric response with all responses coming at the first MRI; o Of the 13 patients treated at 300mg BID or 100mg BID, 8 (62%) had a volumetric response; o Of the 13 patients previously treated with alpelisib and/or sirolimus, 8 (62%) had a volumetric response; o Responses were observed in patients with PROS and LM; o Responses were observed across a spectrum of PIK3CA mutations; • Four responding patients had a 24-week scan, and all showed confirmation of response with deepening of reduction of lesion volume; • 95% of patients experienced lesion reduction; • After the Data Cut-Off Date, one 100mg BID patient that did not have a volumetric response as of the Data Cut-Off Date has converted to an unconfirmed response resulting in a 100mg BID volumetric response rate of 43% (3/7), a volumetric response rate of 69% (9/13) for patients treated at 300mg BID or 100mg BID, and a volumetric response rate of 65%(13/20) across doses; and o None of the other response-evaluable patients' response statuses have changed since the Data Cut-Off Date. Initial Patient and Clinician Reported Outcomes Clinical outcome assessments of symptoms, including investigator- and patient-global impression of change ("IGIC" and "PGIC") and pain measured by investigator assessment of disease-related signs and symptoms ("IADRSS"), are being measured as secondary endpoints in the study. IGIC, PGIC, and IADRSS measures are each a seven point, single-item scale asking patients and clinicians to rate how their condition has improved or worsened since the start of treatment. At week 12, IGIC and PGIC scores demonstrated clinical improvement in 89% and 79% of patients, respectively, and IADRSS Pain scores demonstrated clinical improvement for 71% of pain symptoms. Clinical outcome scores across all three measures trended towards further improvement for later timepoints. The Company has developed a fit-for-purpose patient-reported outcome tool specifically for use within the trial patient population, which is in the process of being incorporated into the ReInspire trial. Initial Safety and Tolerability Data The safety profile of zovegalisib was assessed across a wide dose range, spanning from 100mg BID to 400mg BID (the dose being evaluated in the ongoing Phase 3 trial in metastatic breast cancer). The overall tolerability profile was generally as expected and consistent with mutant-selective PI3Kα inhibition. Rates of treatment-related adverse events ("TRAEs") and dose modifications were proportional to dose level, allowing for further dose optimization intended to identify go-forward doses suitable for chronic treatment. Among the 22 patients treated at 100mg and 300mg BID: • Dose reductions were seen in 23% of patients, with no dose disconti