Relay Therapeutics Files 8-K
Ticker: RLAY · Form: 8-K · Filed: Dec 11, 2024 · CIK: 1812364
| Field | Detail |
|---|---|
| Company | Relay Therapeutics, Inc. (RLAY) |
| Form Type | 8-K |
| Filed Date | Dec 11, 2024 |
| Risk Level | low |
| Pages | 6 |
| Reading Time | 7 min |
| Key Dollar Amounts | $0.001 |
| Sentiment | neutral |
Sentiment: neutral
Topics: financial-reporting, sec-filing
TL;DR
Relay Therapeutics filed an 8-K on 12/11/24, mostly financial docs and other events.
AI Summary
On December 11, 2024, Relay Therapeutics, Inc. filed an 8-K report. The filing primarily concerns financial statements and exhibits, along with other events and a Regulation FD disclosure. No specific financial figures or new material events were detailed in the provided excerpt.
Why It Matters
This 8-K filing indicates Relay Therapeutics is providing updated financial statements and potentially disclosing other material information to the SEC.
Risk Assessment
Risk Level: low — The filing is a standard 8-K for financial reporting and other events, with no immediate indication of significant negative news.
Key Players & Entities
- Relay Therapeutics, Inc. (company) — Registrant
- December 11, 2024 (date) — Date of earliest event reported
FAQ
What specific financial statements are included in this 8-K filing?
The provided excerpt indicates that 'Financial Statements and Exhibits' are part of the filing, but does not specify which particular statements are included.
What 'Other Events' are being reported by Relay Therapeutics in this 8-K?
The excerpt lists 'Other Events' as an item in the filing, but does not provide details on what those events are.
What is the purpose of the 'Regulation FD Disclosure' mentioned in the filing?
A Regulation FD Disclosure is typically made to ensure that material information is broadly disseminated to the public, rather than selectively disclosed.
What is Relay Therapeutics' principal executive office address?
Relay Therapeutics' principal executive offices are located at 399 Binney Street, Cambridge, Massachusetts, 02142.
When is Relay Therapeutics' fiscal year end?
Relay Therapeutics' fiscal year ends on December 31st.
Filing Stats: 1,723 words · 7 min read · ~6 pages · Grade level 15.1 · Accepted 2024-12-11 07:00:15
Key Financial Figures
- $0.001 — ch registered Common Stock, par value $0.001 per share RLAY Nasdaq Global Market
Filing Documents
- rlay-20241211.htm (8-K) — 61KB
- rlay-ex99_1.htm (EX-99.1) — 50KB
- rlay-ex99_2.htm (EX-99.2) — 42KB
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- 0000950170-24-135207.txt ( ) — 16691KB
- rlay-20241211.xsd (EX-101.SCH) — 23KB
- rlay-20241211_htm.xml (XML) — 4KB
01 Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure. On December 11, 2024, Relay Therapeutics, Inc. (the "Company") issued a press release announcing updated interim clinical data, as of a November 4, 2024 data cut-off date (the "Data Cut-off Date"), for RLY-2608, the first known allosteric, pan-mutant and isoform-selective inhibitor of phosphoinostide 3 kinase alpha ("PI3K"), a copy of which is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K. The Company intends to host a conference call and live webcast to discuss the updated interim clinical data on December 11, 2024 at 7:00 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.
01 Other Events
Item 8.01 Other Events. On December 11, 2024, the Company announced updated interim clinical data for RLY-2608 that were presented at the San Antonio Breast Cancer Symposium 2024. RLY-2608 is currently being evaluated in the Company's ReDiscover Study, an ongoing first-in-human study, which was designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of RLY-2608 in combination with fulvestrant, and in combination with fulvestrant and ribociclib or atirmociclib. As of the Data Cut-off Date, the RLY-2608 and fulvestrant combination arm of the study had enrolled 118 patients with PI3K-mutated, HR+, HER2- locally advanced or metastatic breast cancer across all doses in both the dose escalation and dose expansion portions of the study, including 64 patients at the Company's recommended Phase 2 dose ("RP2D") of 600mg twice daily ("BID"). Among these 64 patients, 31 had a kinase mutation and 33 had a non-kinase mutation. Twelve patients also had a PTEN or AKT co-mutation and were therefore excluded from the efficacy analysis, consistent with the planned pivotal population. All patients in the RLY-2608 and fulvestrant combination arm across doses had received a significant level of prior therapy in the advanced setting, including at least one prior endocrine therapy and at least one prior CDK4/6 inhibitor. Among the 64 patients who received the RP2D: 41% of patients (n=26) had received two or more prior lines of therapy; 52% of patients (n=33) had received a prior selective estrogen-receptor degrader ("SERD"), such as fulvestrant or a novel SERD; 25% of patients (n=16) had received chemotherapy or an ADC; 59% of patients (n=38) had visceral metastases; and 34% of patients (n=22) had a BMI of at least 30 and/or HbA1c of at least 5.7%. Among the 52 patients in the RLY-2608 and fulvestrant combination arm who received the RP2D and did not have a PTEN or AKT co-mutation: The median progression fre
01 Financial Statements and Exhibits
Item 9.01 Financial Statements and Exhibits. 99.1 Press release issued by Relay Therapeutics, Inc. on December 11, 2024, furnished herewith. 99.2 Corporate presentation, dated December 11, 2024, furnished herewith. 104 Cover Page interactive Data File (embedded within Inline XBRL document)
SIGNATURES
SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. RELAY THERAPEUTICS, INC. Date: December 11, 2024 By: /s/ Brian Adams Brian Adams Chief Legal Officer