PONTE
VEDRA, Fla., Aug. 10,
2023 /PRNewswire/ -- Cadrenal Therapeutics,
Inc., (Nasdaq: CVKD) a biopharmaceutical company developing
tecarfarin, a late-stage novel oral and reversible anticoagulant
(blood thinner) to prevent heart attacks, strokes and deaths due to
blood clots in patients with certain rare medical conditions, today
provided a corporate update in connection with the filing of its
Quarterly Report on Form 10-Q for the quarter ended June 30, 2023.
Recent Highlights
- Expanded focus for tecarfarin development for patients with
implanted medical devices such as left ventricular assist devices
(LVADs) for heart diseases, an addressable market opportunity of
approximately $600 million per year
in the U.S.
- Completed a $7.5 million private
placement priced at-the-market under Nasdaq rules at a purchase
price of $1.75 per share.
- Appointed accomplished cardiovascular pharmaceutical executive
Robert Lisicki to the board of
directors.
- Q2 2023 operating expenses (excluding non-cash items) totaled
$835,000.
- As of August 14, 2023, cash
balances were $9.6 million.
"Over the past few months, it has become increasingly clear that
the opportunity for tecarfarin reaches beyond patients with
end-stage kidney disease (ESKD) and atrial fibrillation (AFib). A
much larger opportunity exists where Vitamin K antagonists
(warfarin) are prescribed, yet are unreliable and have failed to
achieve sufficient anticoagulation," commented Quang Pham, CEO of Cadrenal Therapeutics. "Based
on our clinical data, extensive market research, and insights from
key industry experts, we believe implanted medical devices for
heart diseases, such as LVADs, could be a potential additional
indication for tecarfarin."
There are estimated to be over 14,000 patients in the U.S. with
LVADs who struggle with stable anticoagulation provided by
warfarin. Based on Company estimates, this is a potential
addressable market opportunity of approximately $600 million per year in the U.S. The
direct-acting oral anticoagulants such as Eliquis and Xarelto are
not prescribed for these patients. Management estimates that
the addressable market opportunity for ESKD and AFib is an
additional $1 billion per year in the
U.S.
Mr. Pham expanded, "Tecarfarin is specifically designed to solve
warfarin's metabolism problem via the cytochrome p450 pathway.
Tecarfarin is metabolized via an alternate pathway that is abundant
and essentially insaturable, providing a much more reliable
pharmacokinetic profile. Key patient groups that incur irregular
blood clotting could benefit from a new, and potentially more
effective and safer, blood thinner like tecarfarin. Unlike other
drug categories, such as cholesterol-lowering and high blood
pressure, there have been no other blood thinners on the market
since warfarin was approved in 1954. We look forward to advancing
tecarfarin to fill what we believe is an important void in the
market."
Matthew Szot, CFO of Cadrenal
Therapeutics, commented, "We successfully completed an important
private placement financing, which was priced at the market under
Nasdaq rules, with an institutional investor. As of August 14, 2023, our cash and cash equivalents
totaled $9.6 million. This raise,
coupled with our highly efficient expense management, has
strengthened our balance sheet and provides capital and flexibility
to continue to progress our path to regulatory approval and
commercialization."
ABOUT CADRENAL THERAPEUTICS, INC.
Cadrenal Therapeutics is developing tecarfarin, a late-stage
novel oral and reversible anticoagulant (blood thinner), to prevent
heart attacks, strokes, and deaths due to blood clots in patients
with certain rare medical conditions. Tecarfarin has orphan
drug and Fast Track designations for the prevention of systemic
thromboembolism (blood clots) of cardiac origin in patients with
end-stage kidney disease, or ESKD, and atrial fibrillation, or
AFib. Tecarfarin is specifically designed to leverage a different
metabolism pathway than the oldest and most commonly prescribed
Vitamin K antagonist (warfarin) used in the prevention of
thrombosis. 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 approach that LVAD patients are a potential
additional indication for tecarfarin, expanding the Company's focus
for tecarfarin within patients with implanted medical devices for
heart diseases, the estimated 14,000 patients in the U.S. with
LVADs who struggle with stable anticoagulation with warfarin, the
estimated addressable market opportunity of approximately
$600 million per year in the U.S.,
the estimated addressable market opportunity for ESKD and AFib of
approximately $1 billion per year in
the U.S. and advancing tecarfarin to fill an important void in the
market.
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 to advance
tecarfarin within patients with implanted medical devices for
heart diseases, the ability to penetrate the U.S. market for
patients with LVADs who struggle with stable anticoagulation with
warfarin, the ability to advance patient care in cardiorenal
diseases and the other risk factors described in the Company's
Annual Report on Form 10-K for the year ended December 31, 2022, 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.