PONTE
VEDRA, Fla., May 10, 2023
/PRNewswire/ -- Cadrenal Therapeutics, Inc., (Nasdaq: CVKD)
a biopharmaceutical company focused on developing tecarfarin, a
late-stage novel cardiorenal therapy with orphan drug and Fast
Track designations, today provided a corporate update in connection
with today's filing of its Quarterly Report on Form 10-Q for the
quarter ended March 31, 2023.
Recent Highlights
- In January 2023, U.S. Food and
Drug Administration ("FDA") granted Fast Track designation for
tecarfarin for the prevention of systemic thromboembolism of
cardiac origin in patients with end-stage renal disease and atrial
fibrillation.
- In January 2023, successfully
completed its initial public offering on Nasdaq, raising
$7.0 million in gross proceeds.
- Formed Scientific Advisory Board (SAB) in support of the
development of tecarfarin for the prevention of systemic
thromboembolism.
- Rang the Nasdaq closing bell on February
8, 2023.
- Q1 2023 operating expenses (excluding non-cash items) totaled
$913,653.
- As of March 31, 2023, cash
balances were $4.0 million. The
Company believes it has sufficient capital to fund operations
through Q2 2024.
"The first quarter of 2023 was one of tremendous progress for
Cadrenal following the receipt of Fast Track designation for
tecarfarin, and the completion of our initial public
offering," commented Quang
Pham, CEO of Cadrenal Therapeutics. "We are following the
FDA's guidance, including the granting of an orphan drug
designation, as well as that of industry-leading cardiologists and
nephrologists, to pursue approval for tecarfarin in patients with
end-stage renal disease and AFib to meet the widely acknowledged
lack of effective treatment options for this patient population. We
believe the successful completion of our planned Phase 3 trial will
be the final step before submitting our New Drug Application for
approval review. We look forward to working closely with the FDA to
evaluate this therapy as a potential new treatment option."
Tecarfarin
Tecarfarin, which has been granted orphan drug and Fast Track
designations by the U.S. FDA, for the prevention of systemic
thromboembolism (blood clots) of cardiac origin in patients with
end-stage renal disease (ESRD) and atrial fibrillation (AFib), is a
Vitamin K antagonist oral anticoagulant designed to target a
different pathway than the most commonly prescribed drugs used in
the treatment of thrombosis and AFib. Tecarfarin has been evaluated
in 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. Cadrenal secured the rights
to tecarfarin on April 1, 2022 via an
asset purchase agreement. Approximately $90
million has been invested to date in clinical and regulatory
work by previous owners of tecarfarin.
Cadrenal believes its planned Phase 3 will be the remaining
pivotal trial. The Phase 3 trial, called Anti-Coagulation with
Tecarfarin on Outcomes in Renal disease and AFib (ACTOR-AF), is
designed as a Phase 3, 492-patient, randomized, double-blind,
placebo-controlled outcomes study of tecarfarin vs. placebo in
subjects with ESRD and AFib not currently treated with chronic oral
anticoagulation.
Market Opportunity
The presence of either chronic kidney disease (CKD) or AFib
increases the risk of serious thromboembolic adverse clinical
outcomes, such as stroke and death. AFib increases the risk of
stroke by 5 times and is the most common arrhythmia. ESRD further
doubles the risk of stroke. Antithrombotic therapy is typically
recommended to decrease this risk in AFib patients, but there are
no therapies for patients that have ESRD with AFib that have been
proven to lower the risk of stroke.
Overall, CKD affects almost 40 million American adults, with as
many as 90% of Americans who have CKD not knowing they have the
disease until it is very advanced. A more dire subset is the more
than 800,000 Americans with ESRD, or permanent kidney failure that
requires life-long dialysis or a kidney transplant. Nearly 20% of
ESRD patients also have AFib or an irregular heartbeat, which
nearly doubles the anticipated mortality and increases the stroke
risk by approximately five-fold in these patients. There is
evidence that AFib is an independent risk factor for developing
ESRD in CKD patients. Both diseases share common risk factors
including hypertension, diabetes, vascular disease, and advancing
age. Cardiovascular disease contributes to more than half of all
deaths among patients with ESRD.
Based upon a 2019 study, adjusted for inflation, the U.S. market
potential for tecarfarin is estimated at up to $1 billion annually if approved by the FDA.
Orphan Drug and Fast Track Designations
The FDA has granted tecarfarin both orphan drug designation
(ODD) and Fast Track designation to tecarfarin for the prevention
of systemic thromboembolism, more commonly referred to as blood
clots, of cardiac origin in patients with ESRD and AFib.
The FDA grants ODD status to drugs that are intended for the
treatment, diagnosis, or prevention of rare diseases or conditions,
which are defined as a disease or condition that affects fewer than
200,000 people in the U.S. The ODD program provides a drug
developer with certain benefits and incentives, including seven
years of U.S. marketing exclusivity from the date of marketing
authorization, waiver of FDA user fees, and tax credits for
clinical research.
Fast Track is a process designed to facilitate the development
and expedite the review of drugs to treat serious conditions and
fill an unmet medical need. The purpose of Fast Track is to get
important new drugs to the patient earlier. Fast Track addresses a
broad range of serious conditions.
ABOUT CADRENAL THERAPEUTICS, INC.
Cadrenal Therapeutics is focused on developing tecarfarin, a
novel cardiorenal therapy with orphan drug and Fast Track
designations for the prevention of systemic thromboembolism (blood
clots) of cardiac origin in patients with end-stage renal disease,
or ESRD, and atrial fibrillation (irregular heartbeat), or AFib.
Tecarfarin is a Vitamin K antagonist oral anticoagulant designed to
target a different pathway than the most commonly prescribed drugs
used in the treatment of thrombosis and AFib. 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 CKD. 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 pursuing approval for tecarfarin in patients with
end-stage renal disease and AFib to meet the widely acknowledged
lack of effective treatment options for this patient population,
the successful completion of the Company's planned Phase 3 trial
being the final step before submitting its New Drug Application for
approval review, working closely with the FDA to evaluate this
therapy as a potential new treatment option and the U.S. market
potential for tecarfarin being up to $1
billion annually if approved by the FDA. 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 Company's ability to obtain regulatory
approval for the commercialization of tecarfarin or to comply with
ongoing regulatory requirements, the Company's ability to complete
its planned Phase 3 trial on time and achieve desired results and
benefits as expected, and the 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 Forms 10-Q and 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, Cadrenal
Therapeutics 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.