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2024-09-03
2024-09-03
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):
September 3, 2024
COGENT BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)
Delaware 001-38443 46-5308248
(State or other jurisdiction (Commission (I.R.S. Employer
of incorporation) File Number) Identification No.)
275 Wyman Street 02451
,
3rd Floor
Waltham
,
Massachusetts
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (
617
)
945-5576
Not Applicable
(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 Name of each exchange
Symbol(s) on which registered
Common stock, $0.001 Par Value COGT The Nasdaq Global Select Market
Indicate by check mark whether the registrant is an emerging growth company as
defined in Rule 405 of the Securities Act of 1933 or Rule
12b-2
of the Securities Exchange Act of 1934.
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.
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Item 8.01. Other Events.
Cogent Biosciences, Inc. (the "Company") announced today that its Phase 3 PEAK
clinical trial in patients with gastrointestinal stromal tumors ("GIST") has
completed enrollment and advanced past the
pre-planned
interim futility analysis. The Company also announced that its Phase 2 SUMMIT
clinical trial in patients with nonadvanced systemic mastocytosis ("NonAdvSM")
is now expected to complete enrollment during the first quarter of 2025,
approximately three months earlier than originally projected.
The full text of the press release issued in connection with the announcement
is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. Description
99.1 Press release dated September 3, 2024.
104 The cover page from the Company's Current Report on Form
8-K
formatted in Inline XBRL.
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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.
Date: September 3, 2024 COGENT BIOSCIENCES, INC.
By: /s/ Evan Kearns
Evan Kearns
Chief Legal Officer and Corporate Secretary
Exhibit 99.1
Cogent Biosciences Announces Phase 3 PEAK Trial in Patients with Gastrointestina
l
Stromal Tumors (GIST) Has Completed Enrollment and
Advanced Past Interim Futility Analysis
413 patients enrolled in PEAK Phase 3 GIST trial, exceeding enrollment target;
top-line
resultsexpected by end of 2025
PEAK interim futility analysis completed with no changes to study
Registration-directed SUMMIT trial in NonAdvanced Systemic Mastocytosis
(NonAdvSM) now on
track to complete enrollment in Q1 2025;
top-line
results expected 2H 2025
WALTHAM, Mass. and BOULDER, Colo., September
3, 2024
-
Cogent Biosciences, Inc.
(Nasdaq: COGT), a biotechnology companyfocused on developing precision
therapies for genetically defined diseases, today provided several updates
from the company's ongoing registration-directed clinical trials of its
potential
best-in-class
KIT mutant inhibitor, bezuclastinib.
Patient enrollment is now complete in Cogent's Phase 3PEAK trial evaluating
bezuclastinib in combination with sunitinib for the treatment of patients with
gastrointestinal stromal tumors (GIST). Based on strong global patient
interest, a total of 413 patients were enrolled in the study. Inaddition,
Cogent recently completed a
pre-planned
interim futility analysis, and the Independent Data Monitoring Committee
(IDMC) recommended continuing the PEAK study without modification. This
pre-specified
analysis was based on an assessment of progression-free survival (PFS) as
determined by independent central review and did not include the option for
early stopping due to efficacy.
Separately, based on significant patient interest in the ongoing SUMMIT trial
in nonadvanced systemic mastocytosis (NonAdvSM), Cogent also announced
todaythat it expects to complete enrollment in this study during Q1 2025,
approximately three months earlier than originally projected.
"We are excitedto announce these important updates to the PEAK and SUMMIT
studies today," said Andrew Robbins, Cogent's President and Chief Executive
Officer. "Strong continued interest from patients around the world to
participate in ourbezuclastinib trials has allowed us to accelerate
development and surpass our original enrollment timelines. Completing
enrollment in our Phase 3 PEAK trial of bezuclastinib and sunitinib for
second-line GIST patients several months ahead ofschedule represents a
significant milestone for the program and we are extremely grateful to the
patients, families, caregivers, advocacy groups and clinical investigators for
their participation in, and support of, the PEAK trial."
PEAK is a randomized, open-label, global Phase 3 clinical trial evaluating
bezuclastinib in combination with sunitinib vs. sunitinib alone in GIST
patientspreviously treated with imatinib. The primary endpoint of the trial is
median progression free survival (mPFS). PEAK is a registration study intended
to support a New Drug Application (NDA) in GIST.
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SUMMIT is a randomized, blinded, global, registration-directed clinical trial
evaluating bezuclastinib vs.placebo in NonAdvSM patients. The primary endpoint
of the trial is mean improvement in patient symptoms measured at 24 weeks.
SUMMIT is intended to be a registrational study designed to support a New Drug
Application (NDA) in NonAdvSM.
Appointment of Darara Dibabu as Vice President of Marketing
In addition to the updates to PEAK and SUMMIT trials, Cogent announced today
that Mr. Dibabu has joined Cogent as the VP of Marketing. Mr. Dibabu has25
years of experience in the biopharmaceutical industry, most recently as the
Global Brand Lead of TUKYSA at Pfizer and SeaGen, where he led the global
launch and marketing strategy of the product for metastatic breast cancer
patients. Previously,he served in various roles of increasing responsibility
at Seagen, Bayer and Merck. Mr. Dibabu holds a bachelor's degree in Biology
from the University of Southern California. In connection with Mr. Dibabu
joining the company, he wasgranted an "inducement" equity award in accordance
with Listing Rule 5635(c)(4) of the corporate governance rules of the Nasdaq
Stock Market. The award was approved by the Compensation Committee of Cogent's
Board of Directors, made upentirely of independent directors, as an inducement
material to Mr. Dibabu's employment. The award consists of nonqualified
options to purchase 100,000 shares of Cogent common stock with a
10-year
term, at an exercise price of $10.74 per share, and a
4-year
vesting schedule with 25% vesting on the
1-year
anniversary of Mr. Dibabu's employment and theremainder vesting in equal
monthly installments over the subsequent 36 months, provided Mr. Dibabu's
remains employed through each such vesting date.
About Cogent Biosciences, Inc.
Cogent Biosciences is abiotechnology company focused on developing precision
therapies for genetically defined diseases. The most advanced clinical
program, bezuclastinib, is a selective tyrosine kinase inhibitor that is
designed to potently inhibit the KIT D816V mutationas well as other mutations
in KIT exon 17. KIT D816V is responsible for driving systemic mastocytosis, a
serious disease caused by unchecked proliferation of mast cells. Exon 17
mutations are also found in patients with advanced gastrointestinalstromal
tumors (GIST), a type of cancer with strong dependence on oncogenic KIT
signaling. In addition to bezuclastinib, the Cogent Research Team is
developing a portfolio of novel targeted therapies to help patients fighting
serious, geneticallydriven diseases initially targeting mutations in FGFR2,
ErbB2 and PI3K. Cogent Biosciences is based in Waltham, MA and Boulder, CO.
Visit our website for more information at www.cogentbio.com. Follow Cogent
Biosciences on social media:
X
(formerly known as Twitter) and
LinkedIn
. Information that may be important to investors will be routinely posted on
our website and
X
.
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Forward-Looking Statements
This press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995, including, but not
limitedto, statements regarding: the expectation to report
top-line
results from the PEAK trial by the end of 2025, the expectation to complete
enrollment in SUMMIT Part 2 in Q1 2025, three months earlier thanoriginally
projected, and to report
top-line
results in the second half of 2025, the potential for bezuclastinib to be a
best-in-class
KIT mutant inhibitor, the expectation for PEAK to support an NDA in GIST and
the intention for SUMMIT to be a registrational study designed to support
anNDA in NonAdvSM. The use of words such as, but not limited to, "anticipate,"
"believe," "continue," "could," "estimate," "expect," "intend," "may,"
"might,""plan," "potential," "predict," "project," "should," "target," "will,"
or "would" and similar words expressions are intended to identify
forward-looking statements.Forward-looking statements are neither historical
facts nor assurances of future performance. Instead, they are based on our
current beliefs, expectations and assumptions regarding the future of our
business, future plans and strategies, ourclinical results, the rate of
enrollment in our clinical trials and other future conditions. New risks and
uncertainties may emerge from time to time, and it is not possible to predict
all risks and uncertainties. No representations or warranties(expressed or
implied) are made about the accuracy of any such forward-looking statements.
We may not actually achieve the forecasts or milestones disclosed in our
forward-looking statements, and you should not place undue reliance on
ourforward-looking statements. Such forward-looking statements are subject to
a number of material risks and uncertainties including but not limited to
those set forth under the caption "Risk Factors" in Cogent's most recent
QuarterlyReport on Form
10-Q
filed with the SEC. Any forward-looking statement speaks only as of the date
on which it was made. Neither we, nor our affiliates, advisors or
representatives, undertake any obligation topublicly update or revise any
forward-looking statement, whether as result of new information, future events
or otherwise, except as required by law. These forward-looking statements
should not be relied upon as representing our views as of any datesubsequent
to the date hereof.
Contact:
ChristiWaarich
Senior Director, Investor Relations
christi.waarich@cogentbio.com
617-830-1653
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