Every 8-K that Relay Therapeutics, Inc. (RLAY) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow RLAY and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full RLAY filings page.
Relay Therapeutics increased the size of its at‑the‑market common stock sales program with TD Securities from $250,000,000 to an aggregate offering price of $462,978,049 and filed a new prospectus supplement covering up to $212,978,049 of additional common shares. As of this report, it has sold approximately $162,978,049 of stock under the program, paying TD Cowen a cash commission of up to 3.0% of gross proceeds, with either party able to suspend sales and no obligation to sell any shares.
For the quarter ended June 30, 2026, revenue was $0.4 million, research and development expenses were $76.5 million, general and administrative expenses were $14.7 million, and net loss was $83.7 million, or $0.41 per share. Cash, cash equivalents and investments totaled $910.9 million, including approximately $316 million of gross proceeds from a May 2026 follow‑on offering, and the company expects this balance to fund operations into 2029. Relay highlighted clinical progress for lead asset zovegalisib, including a 44% objective response rate in a triplet breast cancer regimen, 60% volumetric responses at 12 weeks in vascular anomalies, and ongoing/planned Phase 3 trials in second‑ and first‑line HR+/HER2‑ breast cancer.
Relay Therapeutics reported results from its 2026 annual stockholder meeting and a key charter change. Stockholders approved an amendment to increase authorized common stock from 300,000,000 to 450,000,000 shares, and the company filed a Certificate of Second Amendment in Delaware to implement this change.
Two Class III directors, Douglas S. Ingram and Claire Mazumdar, Ph.D., were elected for terms ending at the 2029 annual meeting. Stockholders also approved, on a non-binding basis, the compensation of named executive officers and ratified Ernst & Young LLP as independent registered public accounting firm for the fiscal year ending December 31, 2026.
Relay Therapeutics, Inc. entered into an underwriting agreement with Jefferies and TD Securities for an underwritten public offering of 22,916,667 shares of common stock at $12.00 per share. Underwriters received a 30-day option for up to 3,437,500 additional shares, which was exercised in full on May 21, 2026.
The company expects net proceeds of approximately $296.8 million after underwriting discounts and expenses. The offering, made off an effective Form S-3ASR shelf using a May 20, 2026 prospectus supplement, is expected to close on May 22, 2026, subject to customary conditions.
Relay Therapeutics reported initial Phase 2 ReInspire data for zovegalisib in PIK3CA‑driven vascular anomalies. As of the April 15, 2026 data cut-off, 32 adults and adolescents were enrolled across 100mg, 300mg and 400mg twice‑daily dose cohorts, with all patients remaining on treatment.
Among 20 response‑evaluable patients, 60% achieved a volumetric response, defined as at least a 20% MRI‑measured reduction in target lesion volume, and 95% experienced some lesion shrinkage. At week 12, investigator‑ and patient‑reported outcome scores showed clinical improvement in 89% and 79% of patients, respectively, while pain scores improved for 71% of pain symptoms.
Safety at 100mg and 300mg twice daily appeared manageable: 23% of patients had dose reductions, median dose intensity exceeded 99%, and only 2 patients (9%) experienced Grade 3 or higher treatment‑related adverse events, with no discontinuations due to adverse events. The 400mg twice‑daily dose showed a less favorable safety profile and has been deprioritized, while expansion cohorts are open at 300mg twice daily and 400mg once daily.
Relay Therapeutics reported first quarter 2026 results and highlighted major clinical progress for its lead PI3Kα inhibitor zovegalisib.
Revenue was $3.0 million for Q1 2026 versus $7.7 million a year earlier, while R&D expenses were $70.6 million and G&A expenses $11.0 million. Net loss narrowed to $73.3 million, or $0.41 per share, compared with a net loss of $77.1 million, or $0.46 per share, in Q1 2025.
Cash, cash equivalents and investments rose to $642.1 million as of March 31, 2026, helped by $137.1 million in at-the-market equity proceeds, and are expected to fund operations into 2029. Strategically, zovegalisib received FDA Breakthrough Therapy designation in advanced HR+/HER2- breast cancer, showed 11.1‑month median progression-free survival in a Phase 1/2 trial, and delivered a 44% objective response rate in a triplet regimen in heavily pre-treated patients. The company also initiated a Phase 1/2 trial for RLY‑8161, an NRAS-selective inhibitor, and plans a Phase 3 frontline breast cancer study in early 2027.
Relay Therapeutics reported early clinical data for its PI3Kα inhibitor zovegalisib in a triplet regimen with atirmociclib and fulvestrant in heavily pre‑treated HR+/HER2‑ metastatic breast cancer. Among 34 patients with measurable disease, the objective response rate was 44% (15/34), similar in kinase and non‑kinase PIK3CA mutations, and 85% showed tumor shrinkage.
Safety in 62 treated patients appeared manageable: only 3% discontinued and 10% dose‑reduced zovegalisib for treatment‑related adverse events, with a 40% grade 3+ TRAE rate primarily due to neutropenia and no febrile neutropenia. As of the April 13, 2026 data cut‑off, 77% (48/62) of patients remained on study with a median follow‑up of 7.4 months, and median progression‑free survival has not yet been reached.
Based on these data, Relay plans, subject to regulatory feedback, a randomized Phase 3 frontline trial in endocrine‑sensitive, PIK3CA‑mutated HR+/HER2‑ advanced or metastatic breast cancer, testing zovegalisib plus atirmociclib and an aromatase inhibitor versus an investigator’s‑choice CDK4/6 inhibitor plus aromatase inhibitor. Pfizer will supply atirmociclib and palbociclib, while Relay sponsors and funds the trial.
Relay Therapeutics reported new Phase 1/2 data for its PI3Kα inhibitor zovegalisib combined with fulvestrant at the recommended Phase 3 dose of 400mg twice daily with food in PI3Kα‑mutated, HR+/HER2- metastatic breast cancer.
Among 57 efficacy-evaluable patients as of the January 13, 2026 cut-off, median progression-free survival was 11.1 months, with similar outcomes for kinase and non‑kinase mutations. In 35 patients with measurable disease, the confirmed objective response rate was 43%, and 52% in second-line-only patients. The regimen was generally well tolerated in 60 treated patients, with mostly low‑grade, manageable adverse events, a hyperglycemia profile dominated by Grade 1 events, and only four discontinuations due to treatment-related side effects. These data support use of the 400mg fed dose in the ongoing global Phase 3 ReDiscover‑2 trial, for which the combination has FDA Breakthrough Therapy designation.
Relay Therapeutics, Inc. updated its corporate bylaws to change where certain securities-related lawsuits can be filed. On March 6, 2026, the Board approved second amended and restated bylaws that designate the federal district courts of the United States as the exclusive forum for complaints asserting causes of action under the Securities Act of 1933, the Securities Exchange Act of 1934, or related rules and regulations, unless the company consents in writing to a different forum.
Relay Therapeutics reported narrower losses for 2025 and highlighted key 2026 clinical milestones. Cash, cash equivalents and investments were $554.5 million as of December 31, 2025, compared with $781.3 million a year earlier, and the company expects this cash to fund operations into 2029.
Revenue was $7.0 million in Q4 2025 and $15.4 million for the full year, up from $0 and $10.0 million in 2024, driven by its Elevar license. Research and development expenses fell to $261.4 million for 2025 from $319.1 million, while general and administrative expenses declined to $56.7 million from $76.6 million.
Net loss improved to $54.9 million in Q4 2025, or $0.32 per share, and $276.5 million for the year, or $1.61 per share, versus $76.0 million and $337.7 million in 2024. The company is entering a “pivotal period” in 2026, with initial Phase 1 data for zovegalisib in PIK3CA‑driven vascular anomalies expected in the first half of the year, breast cancer triplet data and frontline Phase 3 plans expected in 2026, and initial Phase 1/2 breast cancer data at the ESMO TAT Congress on March 16, 2026.
Relay Therapeutics, Inc. reported that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to its drug candidate zovegalisib (RLY-2608) in combination with fulvestrant. This designation covers adults with PIK3CA mutant HR+/HER2- locally advanced or metastatic breast cancer that has recurred or progressed after treatment with a CDK4/6 inhibitor.
Relay Therapeutics (RLAY) furnished a press release announcing financial results for the quarter ended September 30, 2025, and expanded its Board of Directors from seven to nine members.
The Board appointed Lonnel Coats (Class I, term expiring at the 2027 annual meeting) and Habib Dable (Class II, term expiring at the 2028 annual meeting), each determined independent under Nasdaq rules. Mr. Coats joined the Audit Committee and Mr. Dable joined the Nominating and Corporate Governance Committee. As non‑employee directors, each received an initial option to purchase 207,931 shares at an exercise price of $6.86 per share, vesting in equal monthly installments over 36 months. The company stated there are no related‑party transactions requiring disclosure.