Recognized as innovative biopharma developing a potentially safer and superior anticoagulant for patients with implanted cardiac devices and rare cardiovascular conditions PONTE VEDRA, Fla., Nov. 19, 2024 /PRNewswire/ — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage…

Tecarfarin, which recently received Orphan Drug Designation from the FDA for the prevention of thromboembolism and thrombosis in patients with an implanted mechanical circulatory support device, has the potential to improve the time in therapeutic range a factor correlated in the ARIES-HM3 trial with better patient outcomes
PONTE VEDRA, Fla., June 3, 2024 /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 rare cardiovascular conditions, today highlighted a groundbreaking presentation at the International Society for Heart & Lung Transplantation (ISHLT) 44th Annual Meeting & Scientific Sessions.
These new findings from secondary analyses of the ARIES-HM3 trial were released in a presentation titled, “Impact of Vitamin K Antagonist (VKA) Therapy On Outcomes In a Randomized Controlled Trial of Aspirin Removal In Left Ventricular Assist Device (LVAD) Patients – A Pre-Specified Analysis From the Aspirin and Hemocompatibility Events With a Left Ventricular Assist Device in Advanced Heart Failure, or the ARIES-HM3, Randomized Clinical Trial.”
The ARIES-HM3 trial data demonstrated that lower time in therapeutic range, or TTR, translated directly to excessive bleeding events. The “average” patient in the ARIES-HM3 study had a 30% rate of serious bleeding events even after aspirin was eliminated as part of the antithrombotic regimen, and persistent bleeding was inversely correlated with TTR.
The ARIES-HM3 clinical study was sponsored by Abbott (NYSE: ABT), which evaluated a new clinical approach to patient management that included removal of aspirin as part of the antithrombotic regimen warfarin. The data is currently under review by the FDA. Labeling changes related to the antithrombotic regimen have not been approved by the FDA at this time.
Dr. Mandeep Mehra, who chaired the ARIES-HM3 study, holds the William Harvey Distinguished Chair in Advanced Cardiovascular Medicine and is Executive Director of the Center for Advanced Heart Disease at Brigham and Women’s Hospital, commented, “This comprehensive analysis identifies adequacy of VKA use (as measured by TTR) as a significant risk marker for bleeding events and provides new clinical direction for further mitigation of bleeding to enhance hemocompatibility with the HeartMate 3 LVAD.” Mehra continued, “Each incremental improvement of 10% above the median of 56% TTR trends in a significant further reduction in bleeding rate. Tecarfarin could potentially be an important therapy for patients with LVADs who all require chronic anti-coagulation since it does not get affected by drug-drug interactions or changes in kidney function like warfarin and deserves further study.”
“The ARIES-HM3 trial data underscores the deficiencies of warfarin and the need for a new VKA therapy for patients with LVADs. We believe our drug candidate, the next-generation VKA tecarfarin, with its unique retrometabolic design that provides for more stable anticoagulation than warfarin, is the much-needed replacement therapy. We intend to pursue a pivotal trial evaluating tecarfarin effectiveness for LVAD patients,” said Quang Pham, Founder, Chairman and Chief Executive Officer of Cadrenal Therapeutics. “Cadrenal commends Abbott’s commitment to LVAD patients in sponsoring this important trial and analyses.”
On April 9, 2024, Cardenal Therapeutics announced that the United States Food and Drug Administration (FDA) had granted tecarfarin Orphan Drug Designation for the prevention of thromboembolism and thrombosis in patients with an implanted mechanical circulatory support device, which includes the left ventricular assist device (LVAD).
The current market-leading direct oral anticoagulants (DOACs), such as Eliquis, are not indicated for patients with LVADs due to a lack of evidence of benefit, while the level of anticoagulation achieved with warfarin was achieved in the target range only 56% of the time in the ARIES-HM3 trial. Patients whose level of anticoagulation was in the therapeutic range > 56% had better outcomes than those with lower levels. This highlights the potential role for investigating new VKA agents in improving clinical outcomes in LVAD patients.
VKA anticoagulation is prescribed for the prevention of LVAD-related clotting. However, the only available VKA is warfarin, which was approved for human use in 1954. Tecarfarin has been shown to improve TTR, particularly in patients taking multiple medications, and be more stable in patients with renal dysfunction which is common in LVAD patients.
ABOUT CADRENAL THERAPEUTICS, INC.Cadrenal Therapeutics is developing tecarfarin for unmet needs in anticoagulation therapy. Tecarfarin is a late-stage novel oral and reversible anticoagulant (blood thinner) to prevent heart attacks, strokes, and deaths due to blood clots in patients with rare cardiovascular conditions. Tecarfarin has orphan drug and fast-track designations from the FDA for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib) and just received orphan drug designation for the prevention of thrombosis and thromboembolism in patients with ventricular assist devices (VADs). Cadrenal is also pursuing additional regulatory strategies for unmet needs in anticoagulation therapy for patients with thrombotic antiphospholipid syndrome (APS). Tecarfarin is a next-generation Vitamin K Antagonist (VKA) specifically designed to use a different metabolism pathway than the oldest and most commonly prescribed VKA 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.  
Safe Harbor StatementAny 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 tecarfarin having the potential to improve the time in therapeutic range which analysis of the ARIES-HM3 trial reveals is associated with better patient outcomes. TTRs as predicting increased risk for bleeding events, the VKA tecarfarin, filling the market void for a next-generation VKA, the Company pursuing a pivotal trial evaluating tecarfarin effectiveness for LVAD patients. 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 the time in therapeutic range, the ability of the Company  to advance tecarfarin with patients with left ventricular assist devices (LVADs), thrombotic APS, and those with AFib and ESKD 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 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, CFO858-337-0766[email protected] 
Investors:Lytham Partners, LLCRobert Blum, Managing Partner602-889-9700[email protected] 
SOURCE Cadrenal Therapeutics, Inc.

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 StatementAny 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, CFO858-337-0766[email protected] 
Investors:Lytham Partners, LLCRobert Blum, Managing Partner602-889-9700[email protected] 
For more information about Cadrenal and partnering opportunities for tecarfarin, please contact:
Dr. Bill MasonThe Sage Group IncThe StockyardCreake Road, Syderstone  PE31 8SG  UKTel: +44 (0) 7785 950134[email protected]  
Or
Wayne PambianchiThe Sage Group Inc.24 E. Main Street, Box 5365Clinton, New Jersey 08809Phone: +1 908 2306170[email protected]  
SOURCE Cadrenal Therapeutics, Inc.

PONTE VEDRA, Fla., Aug. 1, 2023 /PRNewswire/ — Cadrenal Therapeutics, Inc., (Nasdaq: CVKD) a biopharmaceutical company focused on developing tecarfarin, a late-stage novel oral and reversible anticoagulant (blood thinner) for certain rare medical conditions, today announced that the Company is expanding its focus for […]