PONTE VEDRA, Fla.,
March 11,
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 Annual Report on Form 10-K for the year ended December 31, 2023.
Recent Highlights
- Expanded focus for tecarfarin development beyond end-stage
kidney disease (ESKD) with atrial fibrillation (AFib), to include
patients with implanted medical devices such as left ventricular
assist devices (LVADs) for heart failure as well as for the
treatment of patients with antiphospholipid syndrome (APS) who
require chronic anticoagulation. These two new potential rare
medical conditions increase the total addressable market for
tecarfarin in excess of $2 billion in
the U.S. annually.
- Engaged The Sage Group to assist the company in exploring
strategic partnerships, co-development, and licensing agreements
for tecarfarin.
- 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 pharmaceutical contract development and manufacturing
organizations (CDMOs) to supply active pharmaceutical ingredients
(API) and clinical trial materials.
- Highlighted recent peer-reviewed article in the Journal of the
American College of Cardiology (JACC) titled, "When Direct Oral
Anticoagulants Should Not Be Standard Treatment" by Antoine Bejjani, MD, et.al examined the numerous
medical conditions where direct oral anticoagulants (DOACs), such
as Eliquis, Xarelto, Pradaxa, and Savaysa, should not be
prescribed.
- The article is consistent with the evolving evidence
documenting the need for improved VKA-based anticoagulant therapy.
Tecarfarin is the only new molecular entity (NME) that has been
developed specifically to address this need.
- Q4 2023 operating expenses (excluding non-cash items) totaled
$1,160,000.
- Cash used in operating activities totaled $694,000 during Q4 2023.
- As of December 31, 2023, cash
balances were $8.5 million.
Recent Reports and Presentations
- Noble Capital Markets initiated equity research coverage on the
Company with an "Outperform" rating and a price target of
US$4.00 per share. The full report by
Noble Capital Markets Senior Life Sciences Analyst Robert LeBoyer can be obtained from
https://www.channelchek.com/research-reports/26351.
- Douglas Losordo, M.D., Chief
Medical Officer of Cadrenal, participated in a fireside chat
moderated by Joe Pantginis, Ph.D.,
Managing Director of Research at H.C. Wainwright & Co., 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 January 2024 highlighting the opportunity for
tecarfarin.
Quang Pham, Founder, Chairman and
Chief Executive Officer of Cadrenal Therapeutics, commented, "We
believe there is a significant unmet need and market opportunity
for tecarfarin in patients with rare cardiovascular conditions
requiring chronic anticoagulation. Specifically, there is a lack of
approved anticoagulation therapies for patients with left
ventricular assist devices (LVADs), patients with end-stage kidney
disease (ESKD) and atrial fibrillation (AFib), and patients with
thrombotic anti-phospholipid syndrome (APS)."
"During the past year, an increasing number of industry articles
and presentations have concurred with our positioning, which we
believe enhances our opportunity from both a regulatory and
commercial perspective. We have enhanced our intellectual property
protection through the application and receipt of orphan drug
designations, which provides for 7 years of market exclusivity,
engaged industry leaders to explore strategic partnerships,
co-development and licensing agreements for tecarfarin, and
have expanded our manufacturing and supply chain capabilities in
preparation of an expected pivotal trial. These activities pave the
way for what we believe will be an exciting year for Cadrenal."
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).
Cadrenal is also pursuing additional regulatory strategies for
unmet needs in anticoagulation therapy for patients with left
ventricular assist devices (LVADs) and those 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 two new potential rare medical conditions
increasing the total addressable market for tecarfarin to in excess
of $2 billion in the U.S. annually,
exploring strategic partnerships, co-development, and licensing
agreements for tecarfarin, there being a significant unmet
need and market opportunity for tecarfarin in patients with rare
cardiovascular conditions requiring chronic anticoagulation, the
increasing number of industry articles and presentations having
concurred with the Company's positioning, enhancing the Company's
opportunity from both a regulatory and commercial perspective,
engaging industry leaders to explore strategic partnerships,
co-development and licensing agreements for tecarfarin, 2024 being
an exciting year . 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 ability to
enter into strategic partnerships, the ability to treat patients
with rare cardiovascular conditions requiring chronic
anticoagulation with tecarfarin, the ability to enhance the
Company's opportunity from both a regulatory and commercial
perspective 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.