PONTE
VEDRA, Fla., Nov. 7, 2024
/PRNewswire/ -- Cadrenal Therapeutics, Inc., (Nasdaq: CVKD) (the
"Company" or "Cadrenal"), a late-stage biopharmaceutical company
developing tecarfarin, a new vitamin K antagonist (VKA) designed to
provide safer and superior anticoagulation for patients with
implanted cardiac devices or rare cardiovascular conditions, today
provided a corporate update coinciding with the filing of its
Quarterly Report on Form 10-Q for the quarter ended September
30, 2024.
Recent Highlights
- In early September, Cadrenal leadership met with the U.S. Food
and Drug Administration (FDA) to discuss its tecarfarin Phase 3
clinical trial protocol in left ventricular assist device (LVAD)
patients and is continuing these discussions.
- Cadrenal advanced Abbott collaboration discussions regarding
Cadrenal's pivotal clinical trial in patients with the Abbott LVAD
HeartMate 3, the only LVAD available in the U.S.
- Also, in October 2024,
Cadrenal joined the Corporate Council of the Anticoagulation Forum
(AC Forum), the largest professional organization of
anticoagulation specialists committed to advancing the quality and
safety of chronic anticoagulation care globally. Through
participation in the Corporate Council, Cadrenal will collaborate
with the AC Forum as it works to educate and engage the
organization's 15,000 healthcare professional members to improve
outcomes for patients on anticoagulants.
- Cadrenal and its pharmaceutical contract development and
manufacturing organization (CDMO) completed the operational
readiness activities necessary to supply active pharmaceutical
ingredients and clinical trial materials in accordance with current
good manufacturing principles (cGMP).
- On October 24,
2024, Cadrenal announced that it successfully raised
approximately $5.1 million through its at-the-market
facility (ATM).
- On November 1,
2024, Cadrenal announced the exercise of warrants generating
gross proceeds of approximately $4.7
million.
- Recent financing transactions totaling $9.8 million increased its cash balance to
approximately $11.3 million and strengthened its balance
sheet. The net proceeds provide Cadrenal with additional working
capital as it advances tecarfarin toward a pivotal Phase 3
trial.
- Q3 2024 operating expenses were $2.5
million, including $0.3
million of non-cash expenses.
- Cash used in operating activities totaled $2.2
million during Q3 2024.
- Cash and cash equivalent balance of $11.3 million as of November 7, 2024.
"Momentum is building from our achievement of several critical
milestones toward beginning a pivotal clinical trial to evaluate
tecarfarin's superiority to warfarin in LVAD patients," said
Quang X. Pham, Founder, Chairman,
and Chief Executive Officer of Cadrenal Therapeutics. "These
accomplishments span finance, operations, partner relations, and
clinical development and enhance our ability to execute our
strategic plan going into 2025.
"Efficiently raising nearly $10
million in recent weeks bolsters funds for operational and
clinical development needs. At the same time, we are progressing
our dialogue with the FDA and Abbott and moving ahead with our CDMO
to manufacture tecarfarin for our Phase 3 trial," continued Pham.
Tecarfarin is the only anticoagulant in development worldwide
for patients with implanted cardiac devices and other rare
cardiovascular conditions. The oral and reversible drug has been
uniquely designed to overcome many of the challenges patients
experience with warfarin and to fill a need unmet by direct oral
anticoagulants (DOACs) that are contraindicated or not recommended
by leading cardiology associations for these individuals. If
approved, tecarfarin may be a safer and more effective chronic
anticoagulant 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 anticoagulation, as determined by
International Normalized Ratio (INR) measurements of how long it
takes the blood to clot.
ABOUT CADRENAL THERAPEUTICS, INC.
Cadrenal Therapeutics is a late-stage biopharmaceutical company
developing tecarfarin, a new vitamin K antagonist (VKA) designed to
offer safer, more effective chronic anticoagulation for patients
with implanted cardiac devices or rare cardiovascular conditions.
Tecarfarin is anticipated to result in fewer adverse events such as
strokes, heart attacks, bleeds, and deaths than warfarin, the most
commonly used anticoagulant for these patients, despite its
prevalent adverse events, drug-to-drug interactions, and frequent
dosing changes. Cadrenal is focused on evaluating tecarfarin's
superiority to warfarin in these patients where DOACs are not
recommended in the treatment guidelines of leading cardiology
associations. Tecarfarin received an orphan drug designation for
advanced heart failure patients with implanted LVADs as well as
both orphan drug and fast-track status for end-stage kidney disease
patients with atrial fibrillation. Cadrenal is opportunistically
planning pivotal clinical trials and pursuing clinical and
commercial partnerships to advance tecarfarin. The company's plans
also include studying tecarfarin in patients with mechanical heart
valves experiencing anticoagulation difficulties.
Visit www.cadrenal.com to learn more.
About Tecarfarin
Tecarfarin is a Phase 3-ready drug candidate that Cadrenal is
developing to overcome many of warfarin's challenges and fill the
need for a safer and more effective VKA chronic anticoagulant.
Tecarfarin is anticipated to improve outcomes and result in fewer
major events for warfarin-dependent patients. Extensive data
indicates that the efficacy of tecarfarin, metabolized via a
different pathway than warfarin, is not affected by drug-drug
interactions and kidney impairment, which are common in these
patients. Phase 2/3 clinical trials show that tecarfarin may offer
enhanced stability and time in therapeutic range (TTR) that
inversely correlate with major events. Tecarfarin is the only new
anticoagulant being developed for patients with implanted cardiac
devices or rare cardiovascular conditions. Treatment with
tecarfarin aims to improve anticoagulation for these underserved
patients and their healthcare providers who face difficulties in
managing warfarin's wide variability and risk of gastrointestinal
bleeds.
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, the success of the Company's
collaborative efforts with Abbott, tecarfarin potentially being a
safer and more effective chronic anticoagulant for patients with
LVADs, tecarfarin filling a need unmet by DOACs that are
contraindicated or not recommended, the commencement of trials to
evaluate tecarfarin's superiority to warfarin in LVAD patients and
potentially bring the Company's better anticoagulation solution to
those in need, and 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. 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
Securities and Exchange Commission, 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.
