PONTE
VEDRA, Fla., Dec. 12,
2023 /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 certain orphan
diseases), today announced an engagement with The Sage Group
(www.sagehealthcare.com) to assist the company in exploring
strategic partnerships, co-development and licensing agreements for
tecarfarin.
The Sage Group is a leader in providing strategic and
transactional advice to healthcare and life science companies in
the pharmaceutical, diagnostics, medical devices, biotech,
regenerative medicine, and cell and gene therapy fields. This
partnership will give Cadrenal access to The Sage Group's clinical
and regulatory expertise, capital resources, and network of
contacts, including innovators and large pharma companies.
Tecarfarin is a novel chemical entity that provides stable
anticoagulation to patients with certain orphan diseases, including
End-Stage Kidney Disease (ESKD) with Atrial Fibrillation (AFib);
Left Ventricular Assist Devices (LVADs); and Antiphospholipid
Syndrome (APS). The currently available blood thinners, including
warfarin, Pradaxa, Xarelto, Eliquis, and Savaysa, fail to achieve
sufficiently stable anticoagulation in these patients and are not
widely prescribed for these rare medical conditions. In recent
advertisements for Eliquis, the narration specifically states,
'Don't take Eliquis if you have an artificial heart valve…' and
'Eliquis is not for patients who have antiphospholipid syndrome
(APS).'
Tecarfarin was designed to solve one of warfarin's major
problems, namely warfarin's unreliable pharmacokinetic (PK)
profile, due to its metabolism via the cytochrome P450
pathway. This pathway is responsible for the metabolism of many
other drugs, resulting in drug-drug interactions that can lead to
unstable anticoagulation. Tecarfarin was specifically designed to
be metabolized via an alternate pathway, resulting in a more
reliable, stable PK and anticoagulation, as evidenced in clinical
trials in over 1,000 patients.
"Patients with certain orphan diseases, including ESKD with
AFib, LVADs, and APS, suffer from a lack of options to achieve
sufficiently stable anticoagulation," said Quang Pham, CEO of
Cadrenal. "With The Sage Group's support, we look forward to
identifying the right partner to help us advance clinical
development globally in an effort to bring a much-needed blood
thinner solution to the market for these underserved patients."
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.
The FDA has granted tecarfarin orphan drug and fast-track
designations for ESKD with AFib. Cadrenal is also
developing expanded regulatory strategies for LVAD and APS.
Cadrenal estimates that in the treatment of these orphan diseases,
the combined addressable market opportunity is in excess of US
$2 billion per year in the U.S.
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 has been specifically and deliberately 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.
ABOUT THE SAGE GROUP, INC.
The Sage Group Inc. is a
leader in the provision of strategic and transactional advice to
health care companies in the pharmaceutical, diagnostics, medical
device, biotechnology and life science fields. Sage currently
maintains offices in USA, Europe,
Israel and Japan. Since its founding in 1994, The Sage
Group has served more than 200 clients in the US, Europe and Asia, and completed numerous transactions
including alliances, acquisitions, divestitures, and financings
with values ranging from $5 million
to $500 million.
The Sage Group is an organization of experienced and successful
executives who are committed to the service of the very vital and
dynamic health care industry and its investors.
The range of services offered includes:
* Strategic alliances and licensing/partnering
* M&A, divestment, buy- and sell- side
* Global product and technology acquisition searches
* Strategic assessment and planning
* Due diligence, technology and molecule assessment, valuation
* New ventures, interim management
* Facilitating investment in R&D and/or company equity through
introductions, network and brokering
The Sage Group's Principals, each an Executive Director, have
been Founders, Chairmen, Presidents, CEO's and COO's of a number of
emerging health care companies. These Principals have also held
senior level management positions in large multi-national
organizations. In addition to their management backgrounds, The
Sage Group's Principals also have extensive experience in providing
professional management consulting services to healthcare industry
clients. All these experiences are being applied by The Sage Group
to assist industry participants. For more information, please
visit: www.sagehealthcare.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 partnership with
The Sage Group giving Cadrenal access to its clinical and
regulatory expertise, capital resources, and network of contacts,
including innovators and large pharma companies, the belief that
tecarfarin will provide LVAD and APS patients with stable
anticoagulation, identifying a partner to help Cadrenal advance
clinical development globally with The Sage Group's support,
developing expanded regulatory strategies for LVAD and APS, and the
estimated addressable market opportunity in excess of $2 billion per year 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 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
For more information about Cadrenal and partnering opportunities
for tecarfarin, please contact:
Dr. Bill Mason
The Sage Group Inc
The Stockyard
Creake Road, Syderstone PE31 8SG UK
Tel: +44 (0) 7785 950134
wtm@sagehealthcare.com
Or
Wayne Pambianchi
The Sage Group Inc.
24 E. Main Street, Box 5365
Clinton, New Jersey 08809
Phone: +1 908 2306170
wpambianchi@sagehealthcare.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/cadrenal-therapeutics-engages-the-sage-group-to-advance-tecarfarins-late-stage-development-and-commercialization-302012016.html
SOURCE Cadrenal Therapeutics, Inc.