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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event reported):
October 19, 2025
Verastem,
Inc.
(Exact Name of Registrant as Specified in
Charter)
| Delaware |
|
001-35403 |
|
27-3269467 |
(State or Other Jurisdiction
of Incorporation) |
|
(Commission
File Number) |
|
(IRS Employer
Identification No.) |
| 117 Kendrick Street, Suite 500, Needham, MA |
|
02494 |
| (Address of Principal Executive Offices) |
|
(Zip Code) |
Registrant’s telephone number, including
area code: (781) 292-4200
(Former Name or Former Address, if Changed
Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under
the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under
the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under
the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under
the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b)
of the Act:
| Title of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
| Common stock, $0.0001 par value per share |
|
VSTM |
|
The Nasdaq Capital Market |
Indicate by check mark whether the registrant is an emerging
growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities
Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ¨
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 7.01 Regulation FD Disclosure
On October 19, 2025,
Verastem, Inc. (the “Company”) issued a press release announcing updated safety and efficacy data from the GFH375 (known
as VS-7375 in the U.S.) (“VS-7375”) Phase 1/2 monotherapy study in patients with advanced KRAS G12D mutant pancreatic ductal
adenocarcinoma (“PDAC”), a subset of the study population, conducted in China by the Company’s partner, GenFleet Therapeutics
(Shanghai), Inc. (“GenFleet”). The updated data were featured in a late-breaking abstract for oral presentation by GenFleet
at the European Society for Medical Oncology 2025 on October 19, 2025, in Berlin, Germany.
A copy of this press release
is furnished hereto as Exhibit 99.1 to this Current Report on Form 8-K.
Item 8.01 Other Events
Recent Developments
Updated Data from VS-7375 Phase 1/2 Monotherapy
Study in Advanced KRAS G12D Mutant PDAC
GenFleet reported updated safety and efficacy data
specific to patients with advanced KRAS G12D mutant PDAC from the Phase 1/2 monotherapy study in China. The study population includes
66 patients with advanced KRAS G12D mutant PDAC, of which 59 were heavily pre-treated patients with at least two prior lines of anticancer
therapy. As of the data cutoff of September 27, 2025, 59 efficacy-evaluable patients had at least one post-treatment tumor assessment
and achieved an overall response rate of 40.7% (24/59) (confirmed and unconfirmed) and a disease control rate of 96.7% (57/59), with the
majority of patients (91.5%) experiencing a reduction in target lesions when treated with 600 mg of VS-7375 monotherapy per day. Overall
Survival (“OS”) observed at month four was 92.2%. The median OS was not reached as of the data cutoff, with a median follow-up
time of 5.65 months. The median progression-free survival (“PFS”) was 5.52 months with a median follow-up time of 5.65 months
and a four-month PFS rate of 78.2%. At evaluation, 31 (47%) of patients were still on treatment with the longest duration of treatment
eclipsing one year (367 days).
The safety profile in PDAC patients was consistent
with the previously reported data at recent medical congresses. As of the data cutoff date of August 27, 2025, the most frequent
treatment-related adverse events (“TRAEs”) occurring in at least 20% of patients were diarrhea, neutrophil count decreased,
vomiting, nausea, anemia, white blood cell count decreased, decreased appetite, hypoalbuminemia, platelet count decreased, asthenia, aspartate
aminotransferase increased, and alanine transferase increased. Grade 3 TRAEs occurred in 20 patients (30.3%) and a Grade 4 TRAE (neutropenia)
occurred in one patient (1.5%). Of the 66 patients in the safety population, four patients (6.1%) had a dose reduction, and two (3%) discontinued
due to TRAEs. No TRAE-related deaths were reported. The mean relative dose intensity was 93%.
VS-7375 is the lead program from the Verastem Oncology’s
discovery and development collaboration with GenFleet. The Company announced in April 2025 that the U.S. Investigational New Drug
(“IND”) application for VS-7375 was cleared and initiated a Phase 1/2a clinical trial in June 2025. GenFleet’s
IND for VS-7375 (known as GFH375 in China) was approved in China in June 2024, and the first patient was dosed in a Phase 1/2 study
in July 2024.
Item 9.01 Financial Statements and Exhibits
| Exhibit No. |
|
Description |
| 99.1 |
|
Press Release, dated October 19,
2025 |
| 104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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.
| |
VERASTEM, INC. |
| |
|
|
| Dated: October 20, 2025 |
By: |
/s/ Daniel W. Paterson |
| |
|
Daniel W. Paterson |
| |
|
Chief Executive Officer |
