PONTE VEDRA, Fla.,
May 9,
2024 /PRNewswire/ -- Cadrenal Therapeutics, Inc.,
(Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin,
a late-stage novel oral and reversible anticoagulant (blood
thinner) designed to prevent heart attacks, strokes and deaths due
to blood clots in patients with rare cardiovascular conditions,
today provided a corporate update in connection with the filing of
its Quarterly Report on Form 10-Q for the quarter ended
March 31, 2024.
Recent Highlights
- In April 2024, received FDA
Orphan Drug Designation for tecarfarin for the prevention of
thromboembolism and thrombosis in patients with an implanted
mechanical circulatory support device, including (left ventricular
assist devices (LVADs), right ventricular assist devices (RVADs),
collectively known as ventricular assist devices (VADs),
biventricular assist device, and total artificial heart.
- Engaged pharmaceutical contract development and manufacturing
organizations (CDMOs) to supply active pharmaceutical ingredients
(API) and clinical trial materials.
- Appointed Jeff Cole to the newly
created position of Chief Operating Officer, responsible for the
Company's manufacturing and supply chain operations, intellectual
property, commercialization strategies, and supporting partnering
activities for tecarfarin.
- Engaged The Sage Group to assist the company in exploring
strategic partnerships, co-development, and licensing agreements
for tecarfarin.
- Extensive peer-reviewed articles and industry presentations
continue to document the need for improved VKA-based anticoagulant
therapy. Tecarfarin is the only New Chemical Entity (NCE) that has
been developed specifically to address this need.
- Q1 2024 operating expenses (excluding non-cash items) totaled
$1.6 million.
- Cash used in operating activities totaled $1.8 million during Q1 2024.
- As of March 31, 2024, cash
balances were $6.6 million.
Recent Reports and Presentations
- Quang Pham, Chief Executive
Officer, and Douglas Losordo, M.D.,
Chief Medical Officer of Cadrenal, participated in a company
presentation and fireside chat at the Noble Capital Markets
Emerging Growth Virtual Healthcare Equity Conference. The webcast
can be accessed HERE.
- Douglas Losordo, M.D., Chief Medical Officer of Cadrenal,
participated in a fireside chat at the Lytham Partners 2024
Investor Select Conference. The webcast can be accessed HERE.
- Company presented at Biotech Showcase™ 2024, alongside the J.P.
Morgan 42nd Annual Healthcare Conference.
- Participated in the Technology and Heart Failure Therapeutics
Conference (THT 2024), which is produced by the Cardiovascular
Research Foundation (CRF).
- Filed updated corporate slide presentation in April 2024 highlighting the opportunity for
tecarfarin.
"The past few months was highlighted by the receipt of the
orphan drug designation for tecarfarin by the FDA for the
prevention of thromboembolism and thrombosis in patients with an
implanted mechanical circulatory support device, including LVADs,"
commented Quang Pham, Founder,
Chairman and Chief Executive Officer of Cadrenal Therapeutics.
"This latest regulatory development significantly enhances
optionality regarding the pathways to approval and the marketing
exclusivity for tecarfarin. Further, over the last few months, we
have seen an increasing number of industry articles and data
presentations concurring with our belief that there is a desperate
need for a new solution to prevent heart attacks, strokes and
deaths due to blood clots in patients with rare cardiovascular
conditions who require chronic anticoagulation."
Pham concluded, "Given the absence of FDA-approved drugs for our
targeted indications and our accelerated regulatory pathway with
orphan and fast-track designations, tecarfarin is just one pivotal
study away from NDA submission and possible approval. We are
committed to swiftly advancing tecarfarin through clinical
development options to provide these patients with the much-needed
solution they deserve."
ABOUT CADRENAL THERAPEUTICS, INC.
Cadrenal Therapeutics is developing tecarfarin for unmet needs
in anticoagulation therapy. Tecarfarin is a late-stage novel oral
and reversible anticoagulant (blood thinner) to prevent heart
attacks, strokes, and deaths due to blood clots in patients with
rare cardiovascular conditions. Tecarfarin has orphan drug and
fast-track designations from the FDA for the prevention of systemic
thromboembolism (blood clots) of cardiac origin in patients with
end-stage kidney disease (ESKD) and atrial fibrillation
(AFib). Tecarfarin also has orphan drug designation for the
prevention of thrombosis and thromboembolism in patients with
ventricular assist devices (VADs). Cadrenal is also pursuing
additional regulatory strategies for unmet needs in anticoagulation
therapy for patients with thrombotic antiphospholipid syndrome
(APS). Tecarfarin is specifically designed to leverage a different
metabolism pathway than the oldest and most commonly prescribed
Vitamin K Antagonist (warfarin). Tecarfarin has been evaluated in
eleven (11) human clinical trials and more than 1,000 individuals.
In Phase 1, Phase 2, and Phase 2/3 clinical trials, tecarfarin has
generally been well-tolerated in both healthy adult subjects and
patients with chronic kidney disease. For more information, please
visit: www.cadrenal.com.
Safe Harbor Statement
Any statements contained in this press release about future
expectations, plans, and prospects, as well as any other statements
regarding matters that are not historical facts, may constitute
"forward-looking statements." These statements include statements
regarding the receipt of the orphan drug designation for tecarfarin
by the FDA, significantly enhancing optionality regarding the
pathways to approval and the marketing exclusivity for tecarfarin,
there being a desperate need for a new solution to prevent heart
attacks, strokes and deaths due to blood clots in patients with
rare cardiovascular conditions who require chronic anticoagulation,
tecarfarin being just one pivotal study away from NDA submission
and possible approval and swiftly advancing tecarfarin through
clinical development options to provide patients with the
much-needed solution they deserve. The words "anticipate,"
"believe," "continue," "could," "estimate," "expect," "intend,"
"may," "plan," "potential," "predict," "project," "should,"
"target," "will," "would" and similar expressions are intended to
identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Actual
results may differ materially from those indicated by such
forward-looking statements as a result of various important
factors, the Company's ability to derive the anticipated benefits
from the orphan drug designation for tecarfarin, the
Company's ability to advance tecarfarin through clinical
development and the other risk factors described in the Company's
Annual Report on Form 10-K for the year ended December 31,
2023, and the Company's subsequent filings with the SEC, including
subsequent periodic reports on Quarterly Reports on Form 10-Q and
Current Reports on Form 8-K. Any forward-looking statements
contained in this press release speak only as of the date hereof
and, except as required by federal securities laws, the Company
specifically disclaims any obligation to update any forward-looking
statement, whether as a result of new information, future events,
or otherwise.
For more information, please contact:
Cadrenal Therapeutics:
Matthew Szot, CFO
858-337-0766
press@cadrenal.com
Investors:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
CVKD@lythampartners.com
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SOURCE Cadrenal Therapeutics, Inc.