Cogent Biosciences Reports First Quarter 2024 Financial Results
07 5월 2024 - 9:00PM
Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology
company focused on developing precision therapies for genetically
defined diseases, today provided a business update and announced
financial results for the first quarter ended March 31, 2024.
“Our team made important progress in the first quarter,” said
Andrew Robbins, the Company’s President and Chief Executive
Officer. “Based on the emerging clinical results demonstrating the
potential of bezuclastinib in both systemic mastocytosis and GIST
patients, we have experienced very strong interest in our ongoing
clinical trials from patients and investigators. We remain on track
to complete enrollment in APEX and PEAK by the end of this year,
and to complete enrollment in SUMMIT during 2Q 2025. This should
allow us to report topline results from all three
registration-directed trials during 2025. Following our successful
financing in February, we are well positioned with a cash runway
into 2027, allowing us to complete our ongoing studies while
continuing to broaden our portfolio with a robust research pipeline
of novel compounds.”
Recent Business Highlights
- Reported positive Part 1b data from the Company’s ongoing
SUMMIT trial evaluating bezuclastinib in patients with nonadvanced
systemic mastocytosis (NonAdvSM) at the 2024 American Academy of
Allergy Asthma & Immunology Annual Meeting (AAAAI) meeting and
initiated the registration-directed SUMMIT Part 2.
- Selected the 100 mg once-daily recommended Phase 2 dose (RP2D)
based on:
- 51% week 12 mean improvement in Total Symptom Score (TSS),
including 70% of patients achieving ≥50% reduction in TSS at week
12
- 49% week 12 mean improvement in quality-of-life (MC-QoL)
- Safety and tolerability profile generally similar to placebo
with no grade 3/4 events, and no bleeding, edema or cognitive
events, no dose reductions and no discontinuations
- Presented preclinical data from the company’s ErbB2 candidate
at the American Association of Cancer Research (AACR) annual
meeting.
- The new preclinical data described CGT4255’s exceptional
stability in human whole blood and liver cytosol fractions, high
oral bioavailability and low clearance across preclinical species.
CGT4255 also demonstrated 80% brain penetrance in mice and was
well-tolerated at 10x maximally efficacious concentration,
resulting in mouse tumor regression, suggesting potential
best-in-class properties.
- Completed oversubscribed private placement, resulting in $213.4
million net proceeds, extending the company’s cash runway into
2027.
Upcoming Milestones
- Share updated clinical data from the lead-in portion of the
PEAK trial at the American Society of Clinical Oncology (ASCO)
annual meeting taking place May 31-June 4, 2024. PEAK is the
Company’s ongoing Phase 3 trial evaluating bezuclastinib in
combination with sunitinib in patients with Gastrointestinal
Stromal Tumors (GIST). Cogent remains on track to complete
enrollment in PEAK by the end of 2024 and report top-line results
by the end of 2025. ASCO Poster
detailsTitle: Peak part 1 summary: A
phase 3, randomized, open-label multicenter clinical study of
bezuclastinib (CGT9486) and sunitinib combination versus sunitinib
in patients with gastrointestinal stromal tumors
(GIST)Session Type and Title: Poster Session –
SarcomaSession Date and Time: June 1, 2024,
1:30 PM-4:30 PM CDT
- Complete enrollment in APEX in patients with advanced systemic
mastocytosis (AdvSM) by the end of 2024 and report top-line results
mid-2025.
- Complete enrollment in SUMMIT Part 2 in the second quarter of
2025 and report top-line results by the end of 2025.
First Quarter 2024 Financial Results
Cash and Cash Equivalents: As
of March 31, 2024, cash, cash equivalents and marketable
securities were $435.7 million as compared to $273.2 million
as of December 31, 2023. Total cash spend in the quarter was $51.2
million, including a non-recurring payment of $8.6 million related
to annual performance-based bonus compensation. Based on its
current plans, the company expects its existing cash, cash
equivalents and marketable securities will be sufficient to fund
its operating expenses and capital expenditure requirements into
2027 and through clinical readouts from ongoing SUMMIT, PEAK, and
APEX registration-directed trials.
R&D Expenses: Research and development
expenses were $52.7 million for the first quarter of 2024 compared
to $36.0 million for the first quarter of 2023. The increase was
primarily due to costs associated with accelerating enrollment in
both SUMMIT and PEAK clinical trials, on-going APEX costs and
costs related to development of the research pipeline. R&D
expenses include non-cash stock compensation expense of $4.4
million for the first quarter of 2024 as compared to $3.0 million
for the first quarter of 2023.
G&A Expenses: General and
administrative expenses were $9.7 million for the first quarter of
2024 compared to $7.2 million for the first quarter of 2023. The
increase was primarily due to the growth of the organization.
G&A expenses include non-cash stock compensation expense of
$5.0 million for the first quarter of 2024 as compared to $2.9
million for the first quarter of 2023.
Net Loss: Net loss was $58.3 million for
the first quarter of 2024 compared to a net loss of $38.6 million
for the first quarter of 2023.
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 mutations in FGFR2, ErbB2 and PI3Kα. 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.
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 clinical
development plans and timelines, including the expectation to
complete enrollment in APEX by the end of 2024 and to report
top-line results mid-2025, the expectation to complete enrollment
in SUMMIT Part 2 in the second quarter of 2025 and to report
top-line results by the end of 2025, the expectation to complete
enrollment in PEAK by the end of 2024 and to report top-line
results by the end of 2025, plans to share updated clinical data
from the lead-in portion of PEAK at the ASCO annual meeting in the
second quarter of 2024, the Company’s projected cash runway into
2027, the therapeutic potential of bezuclastinib in both systemic
mastocytosis and GIST patients, and the potential best-in-class
properties of the Company’s preclinical ErbB2 candidate. 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 Annual Report on Form 10-K filed with
the SEC, as well as discussions of potential risks,
uncertainties, and other important factors in our subsequent
filings 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. |
|
|
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
|
|
(in thousands, except share and per share amounts) |
|
|
(unaudited) |
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2024 |
|
|
2023 |
|
| Operating expenses: |
|
|
|
|
|
|
Research and development |
$ |
52,705 |
|
|
$ |
36,038 |
|
|
General and administrative |
|
9,699 |
|
|
|
7,199 |
|
|
Total operating expenses |
|
62,404 |
|
|
|
43,237 |
|
| Loss from operations |
|
(62,404 |
) |
|
|
(43,237 |
) |
| Other income: |
|
|
|
|
|
|
Interest income |
|
4,057 |
|
|
|
2,268 |
|
|
Other income, net |
|
(1 |
) |
|
|
682 |
|
|
Change in fair value of CVR liability |
|
— |
|
|
|
1,700 |
|
|
Total other income, net |
|
4,056 |
|
|
|
4,650 |
|
| Net loss |
$ |
(58,348 |
) |
|
$ |
(38,587 |
) |
| Net loss per share attributable
to common stockholders, basic and diluted |
$ |
(0.62 |
) |
|
$ |
(0.55 |
) |
| Weighted average common shares
outstanding, basic and diluted |
|
94,804,659 |
|
|
|
70,734,950 |
|
| |
|
|
|
|
|
|
|
|
COGENT BIOSCIENCES, INC. |
|
SELECTED CONDENSED CONSOLIDATED BALANCE SHEET
DATA |
|
(in thousands) |
|
(unaudited) |
| |
|
|
|
|
|
| |
March 31, |
|
|
December 31, |
|
| |
2024 |
|
|
2023 |
|
|
Cash, cash equivalents and marketable securities |
$ |
435,740 |
|
|
$ |
273,170 |
|
| Working capital |
$ |
405,217 |
|
|
$ |
232,603 |
|
| Total assets |
$ |
476,111 |
|
|
$ |
313,437 |
|
| Total liabilities |
$ |
53,777 |
|
|
$ |
55,635 |
|
| Total stockholders’ equity |
$ |
422,334 |
|
|
$ |
257,802 |
|
| |
|
|
|
|
|
|
|
Contact:Christi WaarichSenior Director,
Investor Relationschristi.waarich@cogentbio.com617-830-1653
Cogent Biosciences (NASDAQ:COGT)
과거 데이터 주식 차트
부터 11월(11) 2024 으로 12월(12) 2024
Cogent Biosciences (NASDAQ:COGT)
과거 데이터 주식 차트
부터 12월(12) 2023 으로 12월(12) 2024
