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Associated Press
15-05-2025
- Business
- Associated Press
Cadrenal Therapeutics Announces Tecarfarin Manufacturing Progress in Support of Clinical Trial Readiness
PONTE VEDRA, Fla.--(BUSINESS WIRE)--May 15, 2025-- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing therapeutics for patients with cardiovascular disease, today announced manufacturing and supply chain milestones for its lead drug candidate, tecarfarin, a novel oral vitamin K antagonist (VKA) anticoagulant that is designed to address unmet needs in anticoagulation therapy. Cadrenal completed the technical transfer and manufacturing of its tecarfarin drug substance in accordance with current good manufacturing practices (cGMP) earlier this year at a U.S. site of a leading global Contract Development and Manufacturing Organization (CDMO). Manufacturing of the tecarfarin drug product candidate is currently underway. 'We are pleased with the important progress we have made with the supply chain and cGMP manufacturing process for tecafarin,' said Quang X. Pham, Chairman & CEO. 'This is a key milestone as we support our clinical development strategy and tecarfarin's potential to provide clinical benefits for patients with cardiovascular disease who require chronic VKA anticoagulation.' 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 several indications, extensive clinical and real-world data have shown it can have significant, serious side effects. 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 and connect with us on LinkedIn. Safe Harbor 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 tecarfarin's potential to provide clinical benefits for patients with cardiovascular disease who require chronic VKA anticoagulation and pursuing business development initiatives with a longer-term focus on creating a pipeline of 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 of tecarfarin to provide clinical benefits for patients with cardiovascular disease who require chronic VKA anticoagulation, 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. View source version on CONTACT: Corporate and Investor Relations Paul Sagan LaVoieHealthScience (617) 865-0041 [email protected] Andrew Korda LaVoieHealthScience (617) 865-0043 [email protected] KEYWORD: UNITED STATES NORTH AMERICA FLORIDA INDUSTRY KEYWORD: HEALTH OTHER HEALTH GENERAL HEALTH CLINICAL TRIALS PHARMACEUTICAL CARDIOLOGY BIOTECHNOLOGY SOURCE: Cadrenal Therapeutics, Inc. Copyright Business Wire 2025. PUB: 05/15/2025 07:30 AM/DISC: 05/15/2025 07:29 AM
Yahoo
15-05-2025
- Business
- Yahoo
Cadrenal Therapeutics Announces Tecarfarin Manufacturing Progress in Support of Clinical Trial Readiness
PONTE VEDRA, Fla., May 15, 2025--(BUSINESS WIRE)--Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing therapeutics for patients with cardiovascular disease, today announced manufacturing and supply chain milestones for its lead drug candidate, tecarfarin, a novel oral vitamin K antagonist (VKA) anticoagulant that is designed to address unmet needs in anticoagulation therapy. Cadrenal completed the technical transfer and manufacturing of its tecarfarin drug substance in accordance with current good manufacturing practices (cGMP) earlier this year at a U.S. site of a leading global Contract Development and Manufacturing Organization (CDMO). Manufacturing of the tecarfarin drug product candidate is currently underway. "We are pleased with the important progress we have made with the supply chain and cGMP manufacturing process for tecafarin," said Quang X. Pham, Chairman & CEO. "This is a key milestone as we support our clinical development strategy and tecarfarin's potential to provide clinical benefits for patients with cardiovascular disease who require chronic VKA anticoagulation." 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 several indications, extensive clinical and real-world data have shown it can have significant, serious side effects. 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 and connect with us on LinkedIn. Safe Harbor 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 tecarfarin's potential to provide clinical benefits for patients with cardiovascular disease who require chronic VKA anticoagulation and pursuing business development initiatives with a longer-term focus on creating a pipeline of 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 of tecarfarin to provide clinical benefits for patients with cardiovascular disease who require chronic VKA anticoagulation, 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. View source version on Contacts Corporate and Investor Relations Paul SaganLaVoieHealthScience(617) 865-0041psagan@ Media Andrew KordaLaVoieHealthScience(617) 865-0043akorda@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
15-05-2025
- Business
- Business Wire
Cadrenal Therapeutics Announces Tecarfarin Manufacturing Progress in Support of Clinical Trial Readiness
PONTE VEDRA, Fla.--(BUSINESS WIRE)-- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing therapeutics for patients with cardiovascular disease, today announced manufacturing and supply chain milestones for its lead drug candidate, tecarfarin, a novel oral vitamin K antagonist (VKA) anticoagulant that is designed to address unmet needs in anticoagulation therapy. 'This is a key milestone as we support our clinical development strategy and tecarfarin's potential to provide clinical benefits for patients with cardiovascular disease who require chronic VKA anticoagulation.' Cadrenal completed the technical transfer and manufacturing of its tecarfarin drug substance in accordance with current good manufacturing practices (cGMP) earlier this year at a U.S. site of a leading global Contract Development and Manufacturing Organization (CDMO). Manufacturing of the tecarfarin drug product candidate is currently underway. 'We are pleased with the important progress we have made with the supply chain and cGMP manufacturing process for tecafarin,' said Quang X. Pham, Chairman & CEO. 'This is a key milestone as we support our clinical development strategy and tecarfarin's potential to provide clinical benefits for patients with cardiovascular disease who require chronic VKA anticoagulation.' 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 several indications, extensive clinical and real-world data have shown it can have significant, serious side effects. 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 and connect with us on LinkedIn. Safe Harbor 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 tecarfarin's potential to provide clinical benefits for patients with cardiovascular disease who require chronic VKA anticoagulation and pursuing business development initiatives with a longer-term focus on creating a pipeline of 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 of tecarfarin to provide clinical benefits for patients with cardiovascular disease who require chronic VKA anticoagulation, 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.
Business Wire
08-05-2025
- Business
- Business Wire
Cadrenal Therapeutics Reports First-Quarter 2025 Financial Results and Provides Corporate Update
PONTE VEDRA, Fla.--(BUSINESS WIRE)-- 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 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: Leadership Advances 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. Regulatory Update 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 43 rd 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 18 th 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 treatment options. 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 and connect with us on LinkedIn. Safe Harbor 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 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. (Tables to Follow) Cadrenal Therapeutics, Inc. Balance Sheets March 31, 2025 (unaudited) Assets: Current assets: Cash and cash equivalents $ 7,336,072 $ 10,017,942 Interest receivable 24,664 38,153 Prepaid expenses and other current assets 575,605 42,257 Deferred offering costs 8,451 14,445 Total current assets 7,944,792 10,112,797 Property, plant and equipment, net 4,678 6,944 Other assets 3,792 3,792 Total assets $ 7,953,262 $ 10,123,533 Liabilities and Stockholders' Equity: Current liabilities: Accounts payable $ 1,278,402 $ 1,502,468 Accrued liabilities 561,764 1,181,490 Total current liabilities 1,840,166 2,683,958 Total liabilities 1,840,166 2,683,958 Stockholders' equity: Preferred stock, $0.001 par value, 7,500,000 shares authorized, no shares issued and outstanding at March 31, 2025 and December 31, 2024 - - Common stock, $0.001 par value; 75,000,000 shares authorized, 1,909,732 shares issued and outstanding as of March 31, 2025; 1,782,486 shares issued and outstanding as of December 31, 2024 1,909 1,782 Additional paid-in capital 35,679,350 33,160,576 Accumulated deficit (29,568,163 ) (25,722,783 ) Total stockholders' equity 6,113,096 7,439,575 Total liabilities and stockholders' equity $ 7,953,262 $ 10,123,533 Expand (1) All share and per share information has been retroactively adjusted to reflect the 1-for-15 reverse stock split effected on August 20, 2024. 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Forbes
15-04-2025
- Business
- Forbes
War Refugee-Turned-CEO Presents Lessons In Grit, Leadership, And Success
'Underdog Nation' by Quang X. Pham is released with Forbes Books. NEW YORK (April 15, 2025) — Underdog Nation: Zero In On Effort and Results for Success by Quang X. Pham is available today on Amazon. The book is published with Forbes Books, the exclusive business book publishing imprint of Forbes. Success isn't reserved for the privileged—it belongs to those who fight for it. It belongs to the underdogs. In Underdog Nation, Quang X. Pham dismantles traditional myths about success, like what it looks like and who gets to define it. In the process, Pham proves that success is simple, and through effort, adaptability, and unshakable resolve, we can all achieve success that is entirely our own. Pham's story reads like a movie script. Fleeing Vietnam as a war refugee nearly 50 years ago this week, learning English on the fly, rising to become the first Vietnamese American U.S. Marine aviator, topping sales targets in biotech, and taking a company public on Wall Street—his life is proof that underdogs don't just survive—they thrive. At the heart of Underdog Nation is Pham's ER Approach™—a straightforward framework that strips away excuses and focuses on making clear, decisive moves, taking ownership, and outmaneuvering obstacles with calculated precision. Inside, readers will discover how to: ● Define success on their own terms. ● Turn setbacks into strategic pivots. ● Outthink, outwork, and outperform those who start ahead. ● Master the credibility game. ● Simplify decision-making for maximum impact. With rollicking storytelling, tactical insights, and a determination to challenge conventional wisdom, Underdog Nation is a battle cry for professionals, entrepreneurs, and ambitious thinkers who refuse to be counted out. This release is posted on behalf of Forbes Books (operated by Advantage Media Group under license). About the Author: Quang X. Pham is the founder and CEO of Cadrenal Therapeutics, a biopharmaceutical company developing tecarfarin, a novel blood thinner for patients with rare cardiovascular conditions. He is the first American of Vietnamese heritage to become a U.S. Marine Corps aviator and lead a biotech IPO on Nasdaq (CVKD). He is also the author of A Sense of Duty: Our Journey from Vietnam to America and has received the EY Entrepreneur Of the Year® award. A graduate of UCLA, he is a popular speaker and lives in Florida with his family. To keep up with Quang Pham's work, visit About Forbes Books: Launched in 2016 in partnership with Advantage Media Group, Forbes Books is the exclusive business book publishing imprint of Forbes. Forbes Books offers business and thought leaders an innovative, speed-to-market, fee-based publishing model and a suite of services designed to strategically and tactically support authors and promote their expertise. For more information, visit Media Contact: Krista Wignall, kwignall@
