OnKure Therapeutics Files 8-K: Corporate Details Updated

Ticker: OKUR · Form: 8-K · Filed: Dec 10, 2024 · CIK: 1637715

Sentiment: neutral

Topics: corporate-info, filing

Related Tickers: OKUR

TL;DR

OKUR filed an 8-K updating its address and confirming Nasdaq listing. No major news.

AI Summary

OnKure Therapeutics, Inc. filed an 8-K on December 10, 2024, reporting its principal executive offices located at 6707 Winchester Circle, #400, Boulder, Colorado, 80301. The company's Class A Common Stock trades under the symbol OKUR on The Nasdaq Stock Market LLC. The filing does not disclose any specific material events or financial transactions.

Why It Matters

This filing primarily serves to update the company's address and confirm its stock listing details, providing basic corporate information to investors.

Risk Assessment

Risk Level: low — The filing is routine and provides basic corporate information without disclosing any new material events or financial changes.

Key Players & Entities

FAQ

What is the primary purpose of this 8-K filing for OnKure Therapeutics, Inc.?

The primary purpose of this 8-K filing is to report the company's principal executive offices and confirm its stock listing details.

When was the earliest event reported in this filing?

The earliest event reported in this filing was on December 10, 2024.

Where are OnKure Therapeutics, Inc.'s principal executive offices located?

OnKure Therapeutics, Inc.'s principal executive offices are located at 6707 Winchester Circle, #400, Boulder, Colorado, 80301.

On which stock exchange is OnKure Therapeutics, Inc.'s Class A Common Stock traded?

OnKure Therapeutics, Inc.'s Class A Common Stock is traded on The Nasdaq Stock Market LLC.

What is the trading symbol for OnKure Therapeutics, Inc.'s Class A Common Stock?

The trading symbol for OnKure Therapeutics, Inc.'s Class A Common Stock is OKUR.

Filing Stats: 1,612 words · 6 min read · ~5 pages · Grade level 15.1 · Accepted 2024-12-10 07:05:15

Key Financial Figures

Filing Documents

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On December 10, 2024, OnKure Therapeutics, Inc. (the "Company") issued a press release announcing preliminary safety, tolerability, and pharmacokinetic data from its first-in-human PIKture-01 trial of OKI-219. The press release is attached hereto as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. On December 10, 2024, the Company also posted a presentation to its Investor Relations website ( https://investors.onkuretherapeutics.com ). A copy of the presentation is furnished as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference. The information in this Item 7.01, including Exhibits 99.1 and 99.2 attached hereto, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, 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, except as expressly set forth by specific reference in such filing.

01 Other Events

Item 8.01 Other Events. On December 10, 2024, the Company announced preliminary safety, tolerability, and pharmacokinetic ("PK") data from its first-in-human PIKture-01 trial of OKI-219. OKI-219 was well tolerated across all dose levels with no hyperglycemia, and only grade 1 treatment-related adverse events ("TRAEs") were reported. No dose interruptions, delays, reductions, or discontinuations were reported for any adverse events. OKI-219 dosed at 900 mg twice daily shows steady-state exposure levels with near-continuous coverage of the in vivo EC 80 for pAKT inhibition. These data support initiation of Part 1b of PIKture-01 evaluating OKI-219 in combination with fulvestrant, and the first patients have been dosed. The Company expects to provide additional single agent data and initial combination data with fulvestrant in the second half of 2025. In addition, the Company announced new pre-clinical data that show OKI-219's synergistic activity, inducing regressions, in combination with SERD + CDK4/6 inhibitors. Preliminary Safety Data (Data cutoff date for announcement: October 28, 2024) Patients have been treated with OKI-219 at three dose levels as a single agent: 300 mg BID, 600 mg BID, and 900 mg BID. Across all three levels, a total of 17 patients have been dosed, including 11 patients with HER2- breast cancer, two with HR+/HER2+ breast cancer, two with colorectal cancer, one with triple negative breast cancer and one with squamous cell carcinoma in the single-agent dose escalation. OKI-219 has been generally well tolerated, with no dose-limiting toxicities, dose interruptions, or dose reductions required. The most common TRAEs were Grade 1 diarrhea (N=4), Grade 1 nausea (N=2) and Grade 1 pruritus (N=2). Pharmacokinetic and Selectivity Profile OKI-219 has shown favorable PK data that support pharmacologically relevant exposures, even at the lowest assessed dose levels, with a safety profile that suggests little or no inhibition of wild-type PI3K. At s

Forward Looking Statements

Forward Looking Statements The Company cautions you that statements contained in this report regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential of, and expectations and plans regarding, the Company's product candidates and programs, including OKI-219; the timing of data release for the ongoing clinical trial of OKI-219; and the Company's ability to advance additional programs, including the Company's discovery programs and the timing of announcement of development candidates for such programs. Actual results may differ from those set forth in this presentation due to the risks and uncertainties inherent in the Company's business, including, without limitation: the Company's limited operating history; the significant net losses incurred since inception; the ability to raise additional capital to finance operations; the ability to advance product candidates through preclinical and clinical development; the ability to obtain regulatory approval for, and ultimately commercialize, the Company's product candidates; the outcome of preclinical testing and early clinical trials for the Company's product candidates, including the ability of those trials to satisfy relevant governmental or regulatory requirements and the potential that the outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials; the Company's limited resources; the risk of adverse events, toxicities or other undesirable side effects; potential delays or difficulties in the enrollment or maintenance of patients in clinical trials; the decision to develop or seek strategic collaborations to develop the Company's current or future product candidates in combination with other therapies and the cost of combination therapies; the Company's limited e

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits. Exhibit No. Description 99.1 Press Release, dated December 10, 2024 . 99.2 Presentation, dated December 10, 2024 . 104 Cover Page Interactive Data File (embedded within the 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. ONKURE THERAPEUTICS, INC. Date: December 10, 2024 By: /s/ Jason Leverone Name: Jason Leverone Title: Chief Financial Officer

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