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Cadrenal Therapeutics Reports First-Quarter 2025 Financial Results and Provides Corporate Update Leadership appointment strengthens strategic and development capabilities. FDA Type D Meeting provides additional guidance

Key Takeaway: Cadrenal Therapeutics reported its first-quarter financial results for 2025, highlighting a new leadership appointment and recent advancements in the clinical development of tecarfarin. The company received guidance from the FDA regarding a pivotal trial for tecarfarin, which is intended for patients with left ventricular assist devices. Additionally, a collaboration agreement with Abbott was announced to support the trial, underlining the market's demand for new anticoagulation therapies. Despite an increase in expenses and reported losses, the company's strategic direction remains focused on addressing unmet needs in cardiovascular treatment.

Market Sentiment Analysis

POSITIVE FACTORS

  • Leadership appointment of James Ferguson, M.D. strengthens strategic direction.
  • FDA Type D Meeting provided valuable guidance for tecarfarin trials.
  • Collaboration with Abbott validates the need for new anticoagulant options.
  • Research indicates tecarfarin's potential in rapidly growing LVAD market.

Full Press Release Details

Cadrenal Therapeutics
Reports First-Quarter 2025 Financial
Results and Provides Corporate Update
Leadership appointment
strengthens strategic and development capabilities.
FDA Type D Meeting provides additional guidance
for advancing the clinical development of tecarfarin
Collaboration Agreement with Abbott (NYSE:
ABT) validates the need for new anticoagulation options
PONTE VEDRA, Fla., May
8, 2025 -- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical
company developing therapeutics for patients with cardiovascular disease, today reported its financial results for the first quarter
ended March 31, 2025, and provided an update on the strategic focus of the company and clinical development of tecarfarin.
"In the first quarter of 2025, Cadrenal
continued to build on the momentum we achieved during 2024," said Quang X. Pham, Chairman & CEO. "The appointment of
James Ferguson, M.D., FACC, FAHA, as our Chief Medical Officer we believe positions us for success in reviewing potential assets to add
to our portfolio and designing and executing our clinical program for tecarfarin. The finalized Collaboration Agreement with Abbott validates
the critical need in the market for a new anticoagulant for patients with left ventricular assist devices (LVADs). And our meeting with
the FDA provided additional guidance in the design of a pivotal trial."
Highlights from the Quarter Ended March 31,
2025, and Other Recent Events:
In February 2025, Cadrenal appointed James J.
Ferguson, M.D., FACC, FAHA, as Chief Medical Officer to lead the review of business development opportunities to expand the Company's
pipeline and drive the late-stage clinical development of tecarfarin for conditions requiring chronic anticoagulation therapy.
In February 2025, Cadrenal met with the U.S.
Food and Drug Administration (FDA) for a Type D meeting. The FDA provided additional guidance on the appropriate design for a Phase 3
tecarfarin trial and welcomed submission of a final study design for review.
Collaboration Agreement with Abbott
In March 2025, we announced a Collaboration Agreement
with Abbott (NYSE: ABT) to support our pivotal TECarfarin Anticoagulation and Hemocompatibility with Left Ventricular Assist Devices
(TECH-LVAD) trial. Under the agreement, Abbott will share insights from recent HeartMate 3 clinical trials and will support Cadrenal
with trial design, site identification, trial awareness, and HeartMate 3 expertise.
Operational Milestones
During the quarter, Cadrenal successfully completed
the technical transfer and manufacturing of its tecarfarin drug substance (API) from a CDMO site located in Asia to a CDMO site in the
United States. This initiative was done to support the company's clinical and regulatory development strategy for tecarfarin and
to improve supply chain security.
Cadrenal also conducted strategic market opportunity
research for multiple indications, including patients with left ventricular assist devices. This research indicates that tecarfarin is
uniquely positioned to provide clinical value to patients in the rapidly growing LVAD market, which is projected to nearly double by
2032. This research also showed that tecarfarin has the potential to provide clinical benefit in additional high-need cardiovascular,
renal, and mechanical heart valve indications, reinforcing tecarfarin's potential value proposition for patients.
Participation in Key Investor, Medical, and
Business Development Conferences
Cadrenal was active during the first quarter
in several significant conferences to build corporate visibility and underscore its commitment to advancing innovation in anticoagulation
therapy. Investor interactions included participation at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco,
a Company presentation at the BIO CEO and Investor Conference in New York, and, after the close of the quarter, a Company presentation
at the Centri Capital Conference at Nasdaq headquarters in New York. Shortly after the quarter's close, Cadrenal participated in the
18th National Conference on Anticoagulation Therapy in Washington, D.C.
Strategic Development Collaborations
Cadrenal continues to explore opportunities to
add to the Company's clinical pipeline and collaborate with potential development partners to advance the development of tecarfarin
for patients with LVADs and for other indications requiring chronic anticoagulation.
First Quarter 2025 Financial Highlights
Research and development expenses for the quarter
ended March 31, 2025, were $1.7 million compared to $0.6 million for the same period in 2024. General and administrative expenses for
the quarter ended March 31, 2025, were $2.3 million compared to $1.1 million for the same period in 2024. Cadrenal reported a net loss
of $3.8 million for the quarter ending March 31, 2025, compared to $1.7 million for the same period in 2024.
On March 31, 2025, Cadrenal had cash and cash
equivalents of $7.3 million, compared to $10.0 million as of December 31, 2024. The Company had approximately 1.9 million shares of common
stock outstanding as of March 31, 2025.
About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. is a biopharmaceutical
company developing therapeutics for patients with cardiovascular disease. Cadrenal's lead investigational product is tecarfarin,
a novel oral vitamin K antagonist anticoagulant that addresses unmet needs in anticoagulation therapy. Tecarfarin is a reversible anticoagulant
(blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation.
Although warfarin is widely used off-label for a number of indications, extensive clinical and real-world data have shown it can have
significant serious side effects. With tecarfarin, Cadrenal is advancing an innovative solution to address the unmet needs in anticoagulation
therapy, aiming to reduce the clinical complexities of warfarin and capture value in a market with high demand for safer, more manageable
Cadrenal is pursuing a pipeline-in-a-product
approach with tecarfarin. Tecarfarin received Orphan Drug designation (ODD) for advanced heart failure patients with implanted mechanical
circulatory support devices, including Left Ventricular Assisted Devices (LVADs). The Company also received ODD and fast-track status
for tecarfarin in end-stage kidney disease and atrial fibrillation (ESKD+AFib).
Cadrenal is opportunistically pursuing business
development initiatives with a longer-term focus on creating a pipeline of cardiovascular therapeutics. For more information, visit https://www.cadrenal.com/
and connect with us on LinkedIn.
Any statements 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." The words "anticipate," "believe," "continue," "could," "estimate,"
"expect," "intend," "may," "plan," "potentially," "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. These statements
include statements regarding the The the appointment of James Ferguson, M.D., FACC, FAHA, as the Company's Chief Medical Officer
positioning the Company for success in reviewing potential assets to add to its portfolio and designing and executing its clinical program
for tecarfarin; the finalized Collaboration Agreement with Abbott validating the critical need in the market for a new anticoagulant
for patients with left ventricular assist devices (LVADs); Abbott sharing insights from recent HeartMate 3 clinical trials and
supporting Cadrenal with trial design, site identification, trial awareness, and HeartMate 3 expertise; the LVAD market projected
to nearly double by 2032; and tecarfarin having the potential to provide clinical benefit in additional high-need cardiovascular, renal,
and mechanical heart valve indications, reinforcing tecarfarin's potential value proposition for patients Actual results may differ
materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to
utilize Abbott's expertise to advance tecarfarin, the ability to successfully collaborate with Abbott, the initiation of the pivotal
clinical trial for tecarfarin in LVAD patients by Cadrenal; for tecarfarin to provide clinical benefit in additional high-need cardiovascular,
renal, and mechanical heart valve indications, reinforcing tecarfarin's potential value proposition for patients; the ability of
Cadrenal to build a pipeline of specialized cardiovascular therapeutics and other assets and the other risk factors described in the
Company's Annual Report on Form 10-K for the year ended December 31, 2024, 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.

Frequently Asked Questions

What financial results did Cadrenal report for Q1 2025?

Cadrenal reported a net loss of $3.8 million for Q1 2025.

Who was appointed Chief Medical Officer in February 2025?

James Ferguson, M.D., FACC, FAHA, was appointed as Chief Medical Officer.

What is the main product Cadrenal is developing?

Cadrenal is developing tecarfarin, an oral anticoagulant for cardiovascular patients.

What collaboration agreement did Cadrenal finalize in March 2025?

Cadrenal finalized a collaboration agreement with Abbott to support tecarfarin trials.

What guidance did the FDA provide in February 2025?

The FDA provided guidance for the design of a Phase 3 tecarfarin trial.

Last updated: May 8, 2025