Cogent Biosciences Reports Recent Business Highlights and Fourth Quarter and Full Year 2022 Financial Results
March 14 2023 - 8:00AM
Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology
company focused on developing precision therapies for genetically
defined diseases, today provided a business update and reported
financial results for the fourth quarter and full year of 2022.
“2022 was a pivotal year for Cogent marked by our promising
clinical data with bezuclastinib in systemic mastocytosis, the
initiation of our Phase 3 PEAK trial in GIST, and the build-out of
the Cogent Research Team,” said Andrew Robbins, the company’s
President and Chief Executive Officer. “We have laid the foundation
for multiple catalysts in 2023 across all our programs. Based on
the clinical performance of bezuclastinib, we believe it has the
potential to be a best-in-class therapy for patients living with
systemic mastocytosis and GIST. We continue to advance therapies
that improve the lives of patients with genetically defined rare
diseases while positioning ourselves as an industry leader in
precision medicine.”
Recent Highlights
- In March 2023, Cogent received approvals from European
regulatory authorities to initiate the Phase 2 SUMMIT trial in
patients with nonadvanced systemic mastocytosis (NonAdvSM).
Beginning in April 2023, the company expects to start activating
clinical trial sites across major countries in the European
Union.
- In December 2022, Cogent reported positive updated clinical
data from the ongoing Phase 2 APEX trial evaluating bezuclastinib
in patients with advanced systemic mastocytosis (AdvSM) at the
American Society of Hematology (ASH) annual meeting.
- As of the cutoff date, October 26, 2022, 11 patients were
evaluable for response per the modified IWG-MRT-ECNM criteria. 89%
ORR (including centrally adjudicated confirmed and unconfirmed
responses) was seen in TKI therapy naïve patients, including 67% of
patients achieving CR, CRh or PR, and 22% of patients achieving CR
or CRh. Additionally, bezuclastinib demonstrated rapid reductions
in serum tryptase, with an 85% mean reduction in serum tryptase,
14/16 patients achieving ≥ 50% reduction in serum tryptase levels,
and eight of these patients achieving serum tryptase of
<20ng/mL. Bezuclastinib was generally well-tolerated at all
doses. There were no related cases of cognitive impairment and no
reported bleeding events, which have been associated with other KIT
inhibitors.
- In November 2022, Cogent reported positive clinical lead-in
data from the ongoing Phase 3 PEAK trial evaluating bezuclastinib
in combination with sunitinib in patients with Gastrointestinal
Stromal Tumors (GIST) at the Connective Tissue Oncology Society
(CTOS) annual meeting.
- As of the cutoff date, September 26, 2022, 17 of 19 patients
remained on study. Early data suggested an encouraging safety and
tolerability profile consistent with the previous Phase 1/2 study
and the known safety profile for sunitinib monotherapy.
- In October 2022, Cogent reported preclinical data at the
EORTC-NCI-AACR (ENA) annual meeting on a next-generation fibroblast
growth factor receptor 2 (FGFR2) program, which retains potency
across all primary, gatekeeper and molecular brake resistance
mutations, including N549K and V564I, while sparing FGFR1
inhibition. Also, Cogent presented preclinical data at ENA on a
novel ErbB2 mutant selective program which demonstrates robust
cellular inhibition of all key resistance and primary driver
mutations, including L755S, V842I and S310F/Y, while sparing wild
type EGFR target engagement.
- Appointed Rachael Easton, MD, Ph.D., Vice President, Head of
Clinical Development.
- Prior to joining Cogent, Dr. Easton was Group Senior
Medical Director, Oncology Clinical Development at GSK. Prior
to GSK, she held clinical development roles of increasing
responsibility at Immunocore and Sanofi. Before transitioning into
the biotechnology industry, Dr. Easton was an instructor at the
University of Pennsylvania School of Medicine where she conducted
research in growth and metabolism and provided outpatient care for
patients with endocrine disorders.
- Appointed Sylvia Adams, MD to Cogent’s Scientific Advisory
Board.
- Dr. Adams is a Professor of Medicine at the NYU Grossman School
of Medicine and Director of the Breast Cancer Center at the Laura
and Isaac Perlmutter Cancer Center. As an internationally
recognized expert in breast cancer immunotherapy, she has led
groundbreaking research and clinical studies leading to the first
chemo-immunotherapy approval for breast cancer. She is a member of
the ECOG-ACRIN Breast Cancer Committee and at present, co-chairs
the NCI Breast Cancer Immuno-Oncology Task Force.
Upcoming Milestones
- Present updated clinical data from refractory GIST patients in
the lead-in cohort of the Phase 3 PEAK trial of bezuclastinib plus
sunitinib during the first half of 2023.
- Provide a mid-year update on the planned initiation of APEX
Part 2 based on clinical data from approximately 25-30 patients in
APEX Part 1.
- Present initial clinical data from SUMMIT, a randomized,
double-blind, placebo-controlled, global, multicenter, Phase 2
clinical trial of bezuclastinib in patients with NonAdvSM in the
second half of 2023. Clinical data is expected to include
safety/tolerability, pharmacokinetics and measures of clinical
activity.
- Present updated preclinical data from Cogent’s selective FGFR2
and ErbB2 research programs at the American Association for Cancer
Research annual meeting taking place April 14-19, 2023 in Orlando,
Florida.
Fourth Quarter and Full Year 2022 Financial
Results
Cash and Cash Equivalents: As
of December 31, 2022, Cogent had cash, cash equivalents and
marketable securities of $259.3 million. The company believes
that its cash, cash equivalents and marketable securities will be
sufficient to fund its operating expenses and capital expenditure
requirements into 2025. Cogent holds a de minimis amount of cash
related balances at Silicon Valley Bank.
R&D Expenses: Research and development
expenses were $36.7 million for the fourth quarter of 2022 and
$121.6 million for the year ended December 31, 2022, as compared to
$20.5 million for the fourth quarter of 2021 and $55.9 million for
the year ended December 31, 2021. The increase is primarily a
result of bezuclastinib clinical trial activities. R&D expenses
include non-cash stock compensation expense of $2.4 million for the
fourth quarter of 2022 and $8.5 million for the year ended December
31, 2022, as compared to $1.7 million for the fourth quarter of
2021 and $4.4 million for the year ended December 31, 2021.
G&A Expenses: General and
administrative expenses were $7.0 million for the fourth quarter of
2022 and $26.2 million for the year ended December 31, 2022, as
compared to $5.1 million for the fourth quarter of 2021 and $19.6
million for the year ended December 31, 2021. G&A expenses
include non-cash stock compensation expense of $2.6 million for the
fourth quarter of 2022 and $9.9 million for the year ended December
31, 2022, as compared to $2.1 million for the fourth quarter of
2021 and $7.3 million for the year ended December 31, 2021.
Net Loss: Net loss was $39.6 million for
the fourth quarter of 2022 and $140.2 million for the year ended
December 31, 2022, as compared to a net loss of $24.9 million for
the fourth quarter of 2021 and $72.3 million for the year ended
December 31, 2021.
About Cogent Biosciences, Inc.Cogent
Biosciences is a biotechnology 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
mutation as 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 gastrointestinal stromal
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, genetically driven diseases initially
targeting FGFR2 and ErbB2. 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:
Twitter and LinkedIn. Information that may be important to
investors will be routinely posted on our website and Twitter.
Forward Looking StatementsThis press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995, including, but
not limited to, statements regarding the company’s cash runway, the
potential for bezuclastinib to become a best-in-class treatment
option for patients living with systemic mastocytosis and GIST,
plans to provide a mid-year update on the planned initiation of
APEX Part 2 based on clinical data from approximately 25-30
patients in APEX Part 1, plans to present updated clinical data
from the Phase 3 PEAK lead-in study during the first half of 2023,
plans to start activating clinical trial sites across major
countries in the European Union for SUMMIT in April 2023 and to
present initial clinical data from SUMMIT in the second half of
2023, and plans to present updated preclinical data from the
company’s research programs in April 2023. 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,
our clinical 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 our forward-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
Quarterly Report 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 to publicly 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 date subsequent to the date
hereof.
COGENT BIOSCIENCES,
INC.CONSOLIDATED STATEMENTS OF
OPERATIONS(in thousands, except share and per share
amounts)(unaudited)
|
|
Three Months EndedDecember
31, |
|
|
Year EndedDecember 31, |
|
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
|
| Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
36,742 |
|
|
$ |
20,514 |
|
|
$ |
121,627 |
|
|
$ |
55,913 |
|
|
General and administrative |
|
7,003 |
|
|
|
5,125 |
|
|
|
26,212 |
|
|
|
19,638 |
|
|
Total operating expenses |
|
43,745 |
|
|
|
25,639 |
|
|
|
147,839 |
|
|
|
75,551 |
|
| Loss from operations |
|
(43,745 |
) |
|
|
(25,639 |
) |
|
|
(147,839 |
) |
|
|
(75,551 |
) |
| Other income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
2,110 |
|
|
|
106 |
|
|
|
3,989 |
|
|
|
467 |
|
|
Other income, net |
|
657 |
|
|
|
621 |
|
|
|
2,249 |
|
|
|
2,468 |
|
|
Change in fair value of CVR liability |
|
1,360 |
|
|
|
— |
|
|
|
1,360 |
|
|
|
343 |
|
|
Total other income, net |
|
4,127 |
|
|
|
727 |
|
|
|
7,598 |
|
|
|
3,278 |
|
| Net loss |
$ |
(39,618 |
) |
|
$ |
(24,912 |
) |
|
$ |
(140,241 |
) |
|
$ |
(72,273 |
) |
| Net loss per share attributable
to common stockholders, basic and diluted |
$ |
(0.56 |
) |
|
$ |
(0.60 |
) |
|
$ |
(2.39 |
) |
|
$ |
(1.87 |
) |
| Weighted average common shares
outstanding, basic and diluted |
|
70,489,607 |
|
|
|
41,666,415 |
|
|
|
58,739,713 |
|
|
|
38,730,813 |
|
COGENT BIOSCIENCES, INC.
SELECTED CONSOLIDATED BALANCE
SHEET DATA (in thousands) (unaudited)
| |
|
December 31, |
|
|
December 31, |
|
| |
|
2022 |
|
|
2021 |
|
|
Cash, cash equivalents and marketable securities |
|
$ |
259,276 |
|
|
$ |
219,684 |
|
| Working capital |
|
$ |
238,117 |
|
|
$ |
205,556 |
|
| Total assets |
|
$ |
300,810 |
|
|
$ |
232,092 |
|
| Total liabilities |
|
$ |
45,075 |
|
|
$ |
17,908 |
|
| Total stockholders’ equity |
|
$ |
255,735 |
|
|
$ |
214,184 |
|
Contact:Christi WaarichSenior Director,
Investor Relationschristi.waarich@cogentbio.com617-830-1653
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