Full Press Release Details
Therapeutics Reports Full Year 2024 Results, Business
Highlights, and Path Forward for Clinical Advancement
Collaboration Agreement with Abbott Global Enterprises Limited ("Abbott") in support of
3 randomized, multicenter study, entitled TECH-LVAD
FDA Type D Meeting provides additional guidance for advancing clinical development of tecarfarin
appointments to strengthen development capabilities
VEDRA, Fla., March 13, 2025 -- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company focused on the
development of tecarfarin, a new Phase 3 ready oral vitamin K antagonist, today reported full year results for the period ended December
31, 2024, and provided a business update and highlights of the path forward for the clinical advancement of tecarfarin.
for Cadrenal was a year of focus and laying the foundations for advancing tecarfarin into Phase 3 clinical development. With our eyes
squarely centered on unmet needs in anticoagulation therapy, we have made strong progress on the partnering, regulatory, and financing
fronts," said Quang X. Pham, Chairman & CEO. "Throughout 2025, our primary focus is on execution, as we move forward
to assessing the efficacy and safety of tecarfarin in patients with left ventricular assist devices (LVAD) and consider other important
areas of unmet need that a more reliable vitamin K antagonist could address."
Year 2024 Key Accomplishments and Recent Highlights
Agreement with Abbott
March 4, 2025, we announced a Collaboration Agreement with Abbott (NYSE: ABT) to support Cadrenal's 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
February 3, 2025, the Company had a Type D meeting with the U.S. Food and Drug Administration (FDA). The FDA provided additional guidance
on the design of a future Phase 3 trial of tecarfarin and has requested the Company provide a full study design synopsis and detailed
clinical trial design for review.
appointed James J. Ferguson, MD, FACC, FAHA, as Chief Medical Officer to lead the late-stage clinical development of tecarfarin and other
indications in rare cardiovascular conditions requiring life-long anticoagulation therapy as well as other business development opportunities
to build the Company's pipeline. Cadrenal also appointed Jeff Cole as Chief Operating Officer to oversee manufacturing, supply
chain operations, intellectual property, and pre-commercialization strategies.
Company and its pharmaceutical Contract Development and Manufacturing Organization (CDMO) completed necessary operational readiness activities
to supply clinical trial materials for the upcoming tecarfarin pivotal Phase 3 trial in compliance with current Good Manufacturing Practices
(cGMP). Cadrenal has also conducted market research in multiple indications, including LVAD, reinforcing Cadrenal's commitment
to continuing pre-commercial work for tecarfarin.
Development Collaborations
continues to explore collaboration with potential development partners to advance tecarfarin's pivotal clinical trial for patients
with LVAD and other rare cardiovascular conditions as well as other opportunities to advance the Company's clinical pipeline.
Growth and Fundraising Success
the year ended December 31, 2024, Cadrenal raised approximately $9.8 million in financing transactions, including $5.1 million through
an at-the-market (ATM) facility and $4.7 million from warrant exercises.
Recognition and Engagement
October 2024, Cadrenal joined the Corporate Council of the Anticoagulation Forum (AC Forum). This association will enable the Company
to collaborate with anticoagulation therapy thought leaders and 15,000 healthcare professionals to improve anticoagulation outcomes for
patients globally. In November 2024, Cadrenal Therapeutics was named Anticoagulation Therapy Company of the Year by Pharma Tech Outlook,
an industry publication focused on breakthrough pharmaceutical technologies.
Drug Designation for Tecarfarin
April 2024, Cadrenal received FDA Orphan Drug Designation (ODD) for tecarfarin to prevent thromboembolism in patients with implanted
mechanical circulatory support devices, including LVADs, underscoring the investigational drug's potential impact on rare cardiovascular
conditions. Tecarfarin already has ODD and Fast Track designation from the FDA for the prevention of systemic thromboembolism of cardiac
origin in patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib).
Advocacy and Clinical Evidence
clinical need for tecarfarin was highlighted at the November 2024 European Association for Cardio-thoracic Surgery (EACTS) Mechanical
Circulatory Support Summit in an address by Mandeep R. Mehra, MD, The William Harvey Distinguished Chair in Advanced Cardiovascular Medicine and Professor, Harvard
Medical School. Dr. Mehra presented compelling data on the limitations of warfarin for LVAD patients and the potential of tecarfarin,
if approved, to provide a safer alternative to these patients.
and development expenses for the year ended December 31, 2024, were $4.2 million compared to $4.1 million for the year ended December
31, 2023. General and administrative expenses for the year ended December 31, 2024, were $6.8 million compared to $3.5 million for the
year ended December 31, 2023. Cadrenal reported a net loss of $10.7 million for the year ended December 31, 2024, compared to $8.4 million
for the year ended December 31, 2023.
cash and cash equivalents totaled $10.0 million as of December 31, 2024, compared to $8.4 million as of December 31, 2023. The Company
had approximately 1.8 million shares of common stock outstanding as of December 31, 2024.
Cadrenal Therapeutics, Inc.
Therapeutics, Inc. is a late-stage biopharmaceutical company focused on the development of late-stage asset tecarfarin, a new oral
vitamin K antagonist to address unmet needs in anticoagulation therapy. Tecarfarin is 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 rare cardiovascular
conditions requiring chronic anticoagulation. Although warfarin is widely used off-label for several rare cardiovascular conditions,
extensive clinical and real-world data have shown it to have significant serious side effects. With its innovation, Cadrenal aims to
meet the unmet needs of this patient population by relieving them and their healthcare providers of some of warfarin's greatest
clinical challenges.
is pursuing a product-in-a-pipeline approach with tecarfarin. Tecarfarin received Orphan Drug designation (ODD) for advanced heart failure
patients with implanted mechanical circulatory support devices, including LVADs. The Company also received ODD and fast-track status
for tecarfarin in end-stage kidney disease and atrial fibrillation (ESKD+AFib).
is opportunistically pursuing business development initiatives with a longer-term focus to build a pipeline of specialized cardiovascular
therapeutics. For more information, visit www.cadrenal.com and connect with us on LinkedIn.
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." 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 Company's ability to assess the efficacy and
safety of tecarfarin in patients with left ventricular assist devices (LVAD); Abbott supporting Cadrenal with trial design, site identification,
trial awareness, and HeartMate 3 expertise, including sharing insights from its HeartMate 3 clinical trials; the late-stage
clinical development of tecarfarin and other indications in rare cardiovascular conditions requiring life-long anticoagulation therapy
as well as other business development opportunities to build the Company's pipeline; the Company continuing to explore collaborations
with potential development partners to advance tecarfarin's pivotal clinical trial for patients with LVAD and other rare cardiovascular
conditions as well as other opportunities; advancing the Company's clinical pipeline; the Company's association with the
AC Forum enabling the Company to collaborate with anticoagulation therapy thought leaders and 15,000 healthcare professionals to improve
anticoagulation outcomes for patients globally; the potential impact of tecarfarin on rare cardiovascular conditions; the potential of
tecarfarin, if approved, to provide a safer alternative to LVAD patients; meeting the unmet needs of patients with rare cardiovascular
conditions requiring chronic anticoagulation by relieving them and their healthcare providers of some of warfarin's greatest clinical
challenges, and Cadrenal building a pipeline of specialized cardiovascular therapeutics. 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 Cadrenal to provide improved patients outcomes and efficacy and safety for LVAD patients;
the ability of Cadrenal to build a pipeline of specialized cardiovascular therapeutics 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,
and Investor Relations
| December 31, 2024 | December 31, 2023 | |||||||
| Assets: | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 10,017,942 | $ | 8,402,500 | ||||
| Interest receivable | 38,153 | 37,248 | ||||||
| Prepaid expenses and other current assets | 42,257 | 52,425 | ||||||
| Deferred offering costs | 14,445 | - | ||||||
| Total current assets | 10,112,797 | 8,492,173 | ||||||
| Property, plant and equipment, net | 6,944 | 2,287 | ||||||
| Right of use assets | - | 20,998 | ||||||
| Other assets | 3,792 | 3,792 | ||||||
| Total assets | $ | 10,123,533 | $ | 8,519,250 | ||||
| Liabilities and Stockholders' Equity: | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,502,468 | $ | 167,319 | ||||
| Accrued liabilities | 1,181,490 | 638,206 | ||||||
| Operating lease liability | - | 21,350 | ||||||
| Total current liabilities | 2,683,958 | 826,875 | ||||||
| Total liabilities | 2,683,958 | 826,875 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock, $0.001 par value, 7,500,000 shares authorized, no shares issued and outstanding at December 31, 2024 and December 31, 2023 | - | - | ||||||
| Common stock, $0.001 par value; 75,000,000 shares authorized, 1,782,486 shares issued and outstanding as of December 31, 2024; 868,184 shares issued and outstanding as of December 31, 2023 (1) | 1,782 | 868 | ||||||
| Additional paid-in capital (1) | 33,160,576 | 22,762,922 | ||||||
| Accumulated deficit | (25,722,783 | ) | (15,071,415 | ) | ||||
| Total stockholders' equity | 7,439,575 | 7,692,375 | ||||||
| Total liabilities and stockholders' equity | $ | 10,123,533 | $ | 8,519,250 |
OF OPERATIONS AND COMPREHENSIVE LOSS