PONTE
VEDRA, Fla., Aug. 7, 2024
/PRNewswire/ -- Cadrenal Therapeutics, Inc., (Nasdaq: CVKD), a
biopharmaceutical company developing tecarfarin, a late-stage,
next-generation Vitamin K Antagonist (VKA) oral and reversible
anticoagulant (blood thinner) designed to prevent heart attacks,
strokes, and deaths due to blood clots in patients with implanted
cardiac devices and those with rare cardiovascular conditions,
today provided a corporate update coinciding with the filing of its
Quarterly Report on Form 10-Q for the quarter ended June 30, 2024.
Recent Highlights
- Cadrenal and Abbott initiated a collaborative effort to advance
tecarfarin for patients with left ventricular assist devices
(LVADs). The only LVAD available in the U.S. is the HeartMate 3™,
manufactured by Abbott, which has been shown to be superior to all
prior LVADs.
- In April 2024, tecarfarin
received FDA Orphan Drug Designation (ODD) to prevent blood clots
and strokes in patients with LVADs and other implanted mechanical
circulatory support devices.
- At the International Society for Heart & Lung
Transplantation 44th Annual Meeting & Scientific Sessions in
April 2024, Dr. Mandeep Mehra made a groundbreaking presentation
of a secondary data analysis from the ARIES-HM3 study sponsored by
Abbott that underscored the deficiencies of warfarin and the need
for a new VKA therapy for patients with rare cardiovascular
conditions. Dr. Mehra commented, "Tecarfarin could potentially be
an important therapy for patients with LVADs who all require
chronic anticoagulation since it does not get affected by drug-drug
interactions or changes in kidney function like warfarin and
deserves further study."
- Engaged pharmaceutical contract development and manufacturing
organizations to supply active pharmaceutical ingredients and
clinical trial materials.
- Q2 2024 operating expenses (excluding non-cash items) totaled
$2.3 million.
- Cash used in operating activities totaled $1.5 million during Q2 2024.
- As of June 30, 2024, cash
balances were $5.0 million.
"We have made significant progress with advancing our planned
pivotal trial to evaluate tecarfarin's effectiveness for LVAD
patients, including collaborative efforts with Abbott," commented
Quang Pham, Founder, Chairman and
Chief Executive Officer of Cadrenal Therapeutics. "Following the
receipt of tecarfarin's orphan drug designation to prevent blood
clots and strokes in patients with LVADs and other implanted
mechanical circulatory support devices in April 2024, we expanded conversations with
Abbott, the leading global manufacturer of LVADs, to determine the
next steps in accelerating tecarfarin development. Our team is
developing an LVAD study protocol and is eager to move ahead with
Phase 3 trials to evaluate tecarfarin's superiority to warfarin in
LVAD patients and potentially bring our better anticoagulation
solution to those in need."
Tecarfarin, the only oral anticoagulant in development worldwide
for patients with implanted cardiac devices and other rare
cardiovascular conditions, has been uniquely designed to overcome
many of the challenges patients experience with warfarin. If
approved, tecarfarin has the potential to be the only on-label drug
for LVAD patients in the U.S.
In addition, tecarfarin may prove valuable for other patients
where warfarin is not providing recommended anticoagulation because
of genetic warfarin resistance or renal impairment making warfarin
metabolism difficult. These include individuals with end-stage
renal disease and atrial fibrillation or those with mechanical
heart valves and hard-to-control International Normalized Ratio,
which measures how long it takes the blood to clot.
Upcoming Conference Presentations
The Company will be presenting at the following investment
conferences:
- Sidoti Micro Cap Conference – August
14-15, 2024
- Summer 2024 Investor Summit – August 20,
2024
- Emerging Growth Conference – August 21,
2024
- H.C. Wainwright 26th Annual Global Investment Conference -
September 9-11, 2024
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
implanted cardiac devices and those with rare cardiovascular
conditions. Tecarfarin has orphan drug designation for the
prevention of thrombosis and thromboembolism in patients with
ventricular assist devices (VADs). Tecarfarin also 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 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 our planned pivotal trial to evaluate tecarfarin's
effectiveness for LVAD patients, including collaborative efforts
with Abbott, tecarfarin potentially being an important therapy for
patients with LVADs who all require chronic anticoagulation, trials
to evaluate tecarfarin's superiority to warfarin in LVAD patients
and potentially bring the Company's better anticoagulation solution
to those in need, tecarfarin proving valuable for other
patients where warfarin is not providing recommended
anticoagulation because of genetic warfarin resistance or renal
impairment making warfarin metabolism difficult and tecarfarin
having the potential to be the only on-label drug for LVAD patients
in the U.S. 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, including the ability of tecarfarin to
improve anticoagulation treatment in patients, the ability of the
Company to advance tecarfarin with patients with left ventricular
assist devices (LVADs),the collaborative efforts with Abbott being
successful and those with AFib and ESKD, the collaboration
with Abbott being successful 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.