Monte Rosa Therapeutics Files 8-K

Ticker: GLUE · Form: 8-K · Filed: Dec 5, 2024 · CIK: 1826457

Monte Rosa Therapeutics, Inc. 8-K Filing Summary
FieldDetail
CompanyMonte Rosa Therapeutics, Inc. (GLUE)
Form Type8-K
Filed DateDec 5, 2024
Risk Levellow
Pages5
Reading Time6 min
Key Dollar Amounts$0.0001
Sentimentneutral

Sentiment: neutral

Topics: 8-K, disclosure, financials

TL;DR

Monte Rosa Therapeutics filed an 8-K on Dec 5, 2024, covering Reg FD, other events, and financials.

AI Summary

Monte Rosa Therapeutics, Inc. filed an 8-K on December 5, 2024, to report on various events. The filing includes information related to Regulation FD disclosures, other events, and financial statements and exhibits. The company is incorporated in Delaware and its principal executive offices are located in Boston, MA.

Why It Matters

This 8-K filing provides important updates and disclosures from Monte Rosa Therapeutics, Inc. to investors and the public regarding company events and financial information.

Risk Assessment

Risk Level: low — This filing is a routine disclosure and does not appear to contain significant negative news or events.

Key Players & Entities

  • Monte Rosa Therapeutics, Inc. (company) — Registrant
  • December 5, 2024 (date) — Date of earliest event reported
  • Delaware (jurisdiction) — State of incorporation
  • Boston, MA (location) — Address of principal executive offices

FAQ

What is the primary purpose of this Form 8-K filing?

The primary purpose of this Form 8-K filing is to report on Regulation FD disclosures, other events, and financial statements and exhibits of Monte Rosa Therapeutics, Inc.

When was the earliest event reported in this filing?

The earliest event reported in this filing was on December 5, 2024.

In which state is Monte Rosa Therapeutics, Inc. incorporated?

Monte Rosa Therapeutics, Inc. is incorporated in Delaware.

What is the address of Monte Rosa Therapeutics, Inc.'s principal executive offices?

The address of Monte Rosa Therapeutics, Inc.'s principal executive offices is 321 Harrison Avenue, Suite 900, Boston, MA 02118.

What is the telephone number for Monte Rosa Therapeutics, Inc.?

The telephone number for Monte Rosa Therapeutics, Inc. is (617) 949-2643.

Filing Stats: 1,461 words · 6 min read · ~5 pages · Grade level 13.6 · Accepted 2024-12-05 07:03:23

Key Financial Figures

  • $0.0001 — nge on which registered Common Stock, $0.0001 par value per share GLUE The Nasdaq

Filing Documents

01. Regulation FD Disclosure

Item 7.01. Regulation FD Disclosure On December 5, 2024, Monte Rosa Therapeutics, Inc. (the "Company") issued a press release titled "Monte Rosa Therapeutics Provides Development Progress Update for Ongoing MRT-2359 Phase 1/2 Study in Patients with MYC-driven Solid Tumors". The press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. On December 5, 2024, the Company also issued a corporate presentation that it intends to utilize in various meetings with securities analysts, investors and others. A copy of the corporate presentation is furnished as Exhibit 99.2 to this Current Report on Form 8-K. The information in this Form 8-K (including Exhibits 99.1 and 99.2) 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 a filing.

01. Other Events

Item 8.01. Other Events On December 5, 2024, the Company reported an update from its ongoing Phase 1/2 open-label, multicenter study of MRT-2359 in patients with MYC-driven solid tumors. Summary of Interim Data on Enrollment, Safety & Pharmacodynamics Enrollment Highlights Patients have been dosed with MRT-2359 in 6 dose levels across two dosing schedules, namely a 5 days on, 9 days off drug (5/9) dosing schedule and a 21 days on, 7 days off drug (21/7) dosing schedule. The study has enrolled patients with a diverse set of tumor types, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), neuroendocrine (NE) tumors of the prostate, bladder and other organs of origin, androgen receptor-positive prostate cancer, and estrogen receptor-positive breast cancer. Safety Highlights Using the 5/9 dosing schedule, doses of 0.5 mg and 1 mg per day were identified as having a generally favorable safety profile, while doses of 1.5 mg or higher were above the maximum tolerated dose (MTD) with thrombocytopenia being a dose limiting toxicity (DLT). Using the 21/7 schedule, both 0.5 and 0.75 mg were identified as having a generally favorable safety profile. 0.5 mg using the 21/7 dose schedule was selected as the recommended phase 2 dose (RP2D) for any expansion cohorts of the Phase 1/2 study. Safety assessments of MRT-2359 in combination with enzalutamide in previously treated metastatic prostate cancer as well as with fulvestrant in previously treated metastatic estrogen receptor-positive breast cancer have been initiated. No signs of hypotension, cytokine release syndrome or clinically significant hypocalcemia observed at any dose level and regimen. Pharmacodynamic Highlights Pharmacodynamic effects were assessed utilizing mass spectrometry measurements of GSPT1 protein levels from paired tumor biopsies. The target levels of approximately 60% GSPT1 degradation were observed in tumor biopsies across all dose levels in relevant tumor t

Forward-Looking Statements

Forward-Looking Statements This communication includes express and implied "forward-looking statements," including forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical facts and in some cases, can be identified by terms such as "may," "might," "will," "could," "would," "should," "expect," "intend," "plan," "objective," "anticipate," "believe," "estimate," "predict," "potential," "continue," "ongoing," or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward-looking statements contained herein include, but are not limited to, statements about our ongoing clinical development of our GSPT1 degrader referred to as MRT-2359, including our expectations for the nature, efficiency of clinical trial design, significance, and timing for our disclosure of any updated data from our Phase 1/2 clinical trial of MRT-2359 in MYC-driven solid tumors in the first quarter of 2025, the timing of enrollment of potential Phase 2 expansion cohorts and around the potential of the recommended Phase 2 dose for MRT-2359 to have a generally favorable safety profile and be more patient compliance friendly, expectation that clinical results will support MRT-2359's safety and activity profile, statements around the advancement and application of our pipeline and platform, statements around our ability to capitalize on and potential benefits resulting from our research and translational insights, our expectations of success for our programs, among others. By their nature, these statements are subject to numerous risks and uncertainties, including those risks and uncertainties set forth in our most recent Annual Report on Form 10-K for the year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission on March 14, 2024, and any subsequent filings, that could cause actual results, perfo

01. Financial Statements and Exhibits

Item 9.01. Financial Statements and Exhibits (d) Exhibits 99.1 Press Release issued by Monte Rosa Therapeutics, Inc. dated December 5, 2024. 99.2 Corporate Presentation furnished by Monte Rosa Therapeutics, Inc. on December 5, 2024. 104 Cover Page Interactive Data File (embedded within the Inline XBRL document). SIGNATURE 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. Monte Rosa Therapeutics, Inc. Date: December 5, 2024 By: /s/ Markus Warmuth Markus Warmuth President and Chief Executive Officer

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