PONTE
VEDRA, Fla., Nov. 9, 2023
/PRNewswire/ -- Cadrenal Therapeutics, Inc., (Nasdaq: CVKD)
("Cadrenal Therapeutics" or the "Company") 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
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 September 30,
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 diseases as well as for the
treatment of patients with antiphospholipid syndrome (APS) who
require chronic anticoagulation. These two new potential rare
medical conditions represent an addressable market opportunity in
excess of $1.5 billion per year in
the U.S., bringing the total addressable market for tecarfarin in
excess of $2 billion in the U.S.
annually.
- The need for a new Vitamin K Antagonist (VKA) was highlighted
at the recent European Society of Cardiology Congress. Tecarfarin
is the only known novel VKA in development.
- Hired consultants to advance the Company's drug chemistry,
manufacturing, and controls (CMC) program, including active
pharmaceutical ingredient (API), drug substance, and drug
product.
- Completed a $7.5 million private
placement priced at-the-market under Nasdaq rules at a purchase
price of $1.75 per common share in
July 2023.
- Q3 2023 operating expenses (excluding non-cash items) totaled
$989,000.
- Cash used in operating activities totaled $628,000 during Q3 2023.
- As of September 30, 2023, cash
balances were $9.1 million.
"Cadrenal has expanded its development efforts for tecarfarin to
three key rare medical conditions: ESKD with AFib, LVADs, and APS.
In each of these areas, warfarin, the 'legacy' Vitamin K antagonist
(VKA), has failed to achieve sufficiently reliable anticoagulation
and the direct oral anticoagulant (DOAC) class, such as Eliquis,
are not prescribed for these rare medical conditions as they are
contraindicated or not used. If approved, tecarfarin could fill an
important void in the market by providing a VKA blood thinner that
has more stable anticoagulation than warfarin due to its
metabolism, and therefore decreases the risk of stroke and
bleeding. This market void was further highlighted at the recent
European Society of Cardiology Congress with the presentation of
data from the open-label 'FRAIL-AF' trial," commented Quang Pham, CEO of Cadrenal Therapeutics.
"Additionally, 2023 Eliquis direct-to-consumer radio advertising
specifically mentions the prohibition of Eliquis usage in patients
with artificial heart valves and APS."
Matthew Szot, CFO of Cadrenal
Therapeutics, commented, "We continue to be highly efficient in our
cash management, having utilized only $628,000 of cash during the most recent quarter.
With $9 million of cash on the
balance sheet, we believe we have sufficient flexibility to
continue to progress our path to initiate a pivotal trial in
2024."
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 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 addressable market opportunity for two new potential
rare medical conditions being in excess of $1.5 billion per year in the U.S., bringing the
total addressable market for tecarfarin in excess of $2 billion in the U.S. annually, tecarfarin
filling an important void in the market by providing a VKA blood
thinner that has more stable anticoagulation than warfarin due to
its metabolism, and therefore decreases the risk of stroke and
bleeding, continuing to be highly efficient in the Company's cash
management, and having sufficient flexibility to continue to
progress the Company's path to initiate a pivotal trial in
2024..
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 as well as for the treatment of patients with
antiphospholipid syndrome who require chronic anticoagulation, the
ability to penetrate the U.S. market for patients with LVADs and
APS, the ability to advance patient care in cardiovascular 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.