Curis, Inc. Files 8-K Report

Ticker: CRIS · Form: 8-K · Filed: May 14, 2024 · CIK: 1108205

Curis INC 8-K Filing Summary
FieldDetail
CompanyCuris INC (CRIS)
Form Type8-K
Filed DateMay 14, 2024
Risk Levellow
Pages6
Reading Time8 min
Key Dollar Amounts$0.01
Sentimentneutral

Sentiment: neutral

Topics: sec-filing, 8-k, reporting

TL;DR

Curis filed a standard 8-K, no major news.

AI Summary

On May 14, 2024, Curis, Inc. filed an 8-K report to disclose other events and financial statements. The filing does not contain specific details on new material events, agreements, or financial results beyond the standard reporting requirements.

Why It Matters

This 8-K filing indicates Curis, Inc. is fulfilling its regular reporting obligations with the SEC, but does not announce any specific material events that would immediately impact its stock.

Risk Assessment

Risk Level: low — The filing is a routine 8-K report and does not contain any new material information that would inherently increase risk.

Key Players & Entities

FAQ

What is the primary purpose of this 8-K filing by Curis, Inc.?

The primary purpose of this 8-K filing is to report other events and financial statements as required by the SEC.

What is the date of the earliest event reported in this filing?

The date of the earliest event reported in this filing is May 14, 2024.

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

Curis, Inc.'s principal executive offices are located at 128 Spring Street, Building C - Suite 500, Lexington, MA 02421.

What is the Standard Industrial Classification (SIC) code for Curis, Inc.?

The SIC code for Curis, Inc. is 2836, which corresponds to Biological Products (No Diagnostic Substances).

Does this 8-K filing announce any specific new material agreements or events?

Based on the provided text, this 8-K filing does not explicitly announce any specific new material agreements or events beyond the general categories of 'Regulation FD Disclosure', 'Other Events', and 'Financial Statements and Exhibits'.

Filing Stats: 1,923 words · 8 min read · ~6 pages · Grade level 15.3 · Accepted 2024-05-14 16:04:35

Key Financial Figures

Filing Documents

01. Regulation FD Disclosure

Item 7.01. Regulation FD Disclosure. On May 14, 2024, Curis, Inc. ("Curis" or the "Company") issued a press release announcing updated data from the ongoing TakeAim Leukemia study (CA-4948-102) in relapsed/refractory ("R/R") Acute Myelogenous Leukemia ("AML") to be presented at the American Society of Clinical Oncology ("ASCO") and the European Hematology Association ("EHA") conferences. The updated data includes data for 25 new patients in the FLT3 mutation ("FLT3m") and U2AF1/SF3B1 Splicing Factor mutation ("SFm") cohorts who had received fewer than 3 lines of prior therapy and were treated with emavusertib as monotherapy at the Recommended Phase 2 Dose ("RP2D") of 300 mg twice daily ("BID"). The full text of the press release issued in connection with this announcement is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference. From time to time, the Company conducts meetings with third parties in which the Company utilizes a corporate slide presentation. A copy of the Company's current corporate slide presentation is attached as Exhibit 99.2 to this Current Report on Form 8-K and 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 (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 or the Exchange Act, except as expressly set forth by specific reference in such a filing.

01. Other Events

Item 8.01. Other Events. TakeAim Leukemia Study The updated data from the Company's ongoing TakeAim Leukemia study (CA-4948-102) includes data for 25 new patients in the FLT3 mutation (FLT3m) and U2AF1/SF3B1 Splicing Factor mutation (SFm) cohorts who had received fewer than 3 lines of prior therapy and were treated with emavusertib as monotherapy at the Recommended Phase 2 Dose (RP2D) of 300 mg BID. Prior Data New Data* Total FLT3m AML 3 9 12 SFm AML 3 17 20 adjustment for patients with dual mutation** (1) (1) (2) 5 25 30 * data cut-off as of February 26, 2024 ** 2 patients had both FLT3m and SFm (dual mutation) 1 patient in the initial group of 5 patients; 1 patient in the new group of 25 additional patients FLT3m Cohort – 12 relapsed/refractory patients enrolled to date 12 R/R AML patients with FLT3m were treated with emavusertib. Prior therapies included venetoclax (8/12), hypomethylating agents or HMA (9/12), and FLT3 inhibitors (9/12). Preliminary data show 6 objective responses in 11 response-evaluable patients: 3 complete remission (CR), 1 CR with partial hematologic recovery (CRh) and 2 morphologic leukemia-free state (MLFS) with on-treatment duration range of 46-324 days. 4 patients are ongoing at the data-cutoff, including 1 CRh and 1 MLFS. 3 of 3 patients who were nave to FLT3i treatment achieved objective response (2 CR, 1 MLFS) 3 of 8 patients who progressed on, or following, prior FLT3i treatment achieved objective response (1 CR, 1 CRh, 1 MLFS) 1 patient is not response-evaluable All responders demonstrated complete normalization of blast counts in the bone marrow. One of these patients proceeded to allogenic stem cell transplantation. Responses were achieved rapidly in this population, with 5 of 6 responses occurring within one cycle of treatment. SFm Cohort – 20 relapsed/refractory patients enrolled to date 20 R/R AML patients with SFm were treated with emavusertib. Prior therapies included venetoclax (18/20) and HMA (1

01. Financial Statements and Exhibits

Item 9.01. Financial Statements and Exhibits. Exhibit Number Description 99.1 Press Release 99.2 Corporate Presentation 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. Curis, Inc. Date: May 14, 2024 By: /s/ Diantha Duvall Diantha Duvall Chief Financial Officer

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