CVKD

Late-breaking Phase 2 CAD-1005 data presented at ISTH support a late-stage portfolio organized around preoperative safety, orphan regulatory acceleration, and postoperative shielding PONTE VEDRA, Fla., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company advancing specialized therapies for critical care cardiology and orphan cardiovascular conditions, today reported financial results for the second quarter ended June 30, 2026, and provided a corporate update on the launch of a structured strategic partnering process following significant clinical, regulatory, and portfolio progress across its Cardiac Acute Critical Care Franchise. "The second quarter and subsequent weeks marked an important milestone for Cadrenal," said Quang X. Pham, Chairman and Chief Executive Officer of Cadrenal Therapeutics. "Our objective is to convert clinical and regulatory progress into strategic value while remaining capital disciplined. We are also pursuing multiple nondilutive grants to advance our programs. With CAD-1005, frunexian, and tecarfarin addressing complementary acute, critical care, and orphan cardiovascular opportunities, and CAD-2000 extending the 12-LOX platform to treat chronic conditions, we believe Cadrenal offers a differentiated pipeline that addresses critical unmet needs for high-risk patients." “Having achieved regulatory guidance on the Phase 3 path for CAD-1005, we delivered a late-breaking presentation to the global thrombosis community on Phase 2 data for CAD-1005, which demonstrated an absolute reduction of more than 25% in thrombotic events. Our portfolio, now organized into a Cardiac Acute Critical Care Franchise spanning pre-operative safety, orphan regulatory acceleration, and post-operative shielding, is structured to demonstrate to prospective partners how our assets can address multiple high-value needs across the cardiac surgery continuum." The strategic alignment of the Cardiac Acute Critical Care (CACC) Franchise organizes Cadrenal’s portfolio into three commercial pillars. Recent Highlights Presented late-breaking Phase 2 data on CAD-1005 at the International Society of Thrombosis and Hemostasis (ISTH) 2026 Congress in Paris. The randomized, blinded, placebo-controlled study demonstrated an absolute reduction of more than 25% in thrombotic events when CAD-1005 was added to standard anticoagulant therapy, with a favorable safety profile and renal-protective baseline. Launched a structured partnering process to explore development, licensing, and commercialization transactions for CAD-1005, frunexian, and tecarfarin. Cadrenal is pursuing a capital-efficient model focused on strategic out-licensing, portfolio monetization, and commercial co-development rather than independently funding large late-stage clinical trials. Solidified a multi-indication strategy for CAD-1005 in heparin-induced thrombocytopenia (HIT) and Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI). The Company believes that the shared cardiac intensive care infrastructure, intravenous administration, and complementary thrombotic and inflammatory mechanisms may create a differentiated critical care asset package for prospective partners. Submitted a request to the U.S. Food and Drug Administration on July 8, 2026, for Rare Pediatric Disease Designation for tecarfarin for the prevention of life-threatening blood clots inside coronary artery aneurysms in children with Kawasaki Disease. Signed an agreement with a global firm that has collectively secured over $500 million in non-dilutive funding for life science companies. Continued advancing CAD-2000, a highly selective, orally bioavailable preclinical 12-lipoxygenase (12-LOX) inhibitor designed for chronic cardiorenal inflammatory and thrombotic indications, as a potential follow-on companion to the Company's intravenous acute care platform. Signed a private placement that generated approximately $3.0 million in gross proceeds, with up to approximately $5.8 million in additional gross proceeds if the associated warrants are exercised in full for cash. There can be no assurance that any warrants will be exercised. Second Quarter 2026 Financial Highlights Research and development expenses for the quarter ended June 30, 2026, were $0.7 million compared to $1.1 million for the same period in 2025. General and administrative expenses were $2.6 million compared to $2.7 million for the same period in 2025. Total operating expenses were $3.3 million compared to $3.7 million for the same period in 2025. Cadrenal reported a net loss of $3.3 million for the quarter ended June 30, 2026, compared to $3.7 million for the same period in 2025. As of early August 2026, Cadrenal had approximately $4.2 million in cash and cash equivalents. Based on its current operating plan, the Company believes these resources are expected to fund operations through the first quarter of 2027. The Company's existing cash resources are not sufficient to advance its product candidates to clinical trial readiness or to commence and complete any clinical trials. Cadrenal does not plan to commence a clinical trial unless funding sufficient to complete that trial is in place, which may include capital raised through strategic partnerships, out-licensing agreements, non-dilutive grants, equity or debt financing, or a combination of these sources. About Cadrenal Therapeutics, Inc. Cadrenal Therapeutics, Inc. is a late-stage biopharmaceutical company advancing specialized therapies for critical care cardiology and orphan cardiovascular conditions. The Company’s pipeline includes CAD-1005, tecarfarin, and frunexian. CAD-1005 is a novel investigational therapeutic in development for the treatment of heparin-induced thrombocytopenia (HIT) and Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI). CAD-1005 is designed to selectively inhibit 12-lipoxygenase (12-LOX), an enzyme central to platelet immune activation and thrombo-inflammatory signaling in HIT. CAD-1005 is intended to be used alongside existing standards of care and is being developed to address the underlying biological mechanisms that drive disease progression. CAD-1005 has an Orphan Drug Designation (“ODD”) from the U.S. Food and Drug Administration (“FDA”) for prophylaxis of thrombosis in patients with HIT, FDA Fast Track designation for the treatment and prevention of HIT, and an orphan designation from the European Medicines Agency for the treatment of platelet-activating factor 4 disorders. Second-generation 12-LOX oral therapeutics (CAD-2000) are also in development for chronic indications. The Company’s broader pipeline includes tecarfarin, a late-stage oral vitamin K antagonist designed to prevent heart attacks, strokes, and deaths from blood clots in patients requiring chronic anticoagulation, including those with end-stage kidney disease and atrial fibrillation, those with left ventricular assist devices, and potentially those with Kawasaki disease (KD), an acute, self-limited, febrile illness that primarily affects children under 5 years old and is the leading cause of acquired heart disease in developed countries. The Company recently submitted a request for Rare Pediatric Disease Designation (RPDD) to the FDA for tecarfarin for “Prevention of the Formation of Life-Threatening Blood Clots Inside Coronary Artery Aneurysms in Children with Kawasaki Disease”. Tecarfarin has also received Orphan Drug and Fast Track designations from the FDA. For more information, visit https://www.cadrenal.com/ and connect with the Company 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, without limitation, statements regarding the Company converting clinical and regulatory progress into strategic value while remaining capital disciplined; pursuing multiple nondilutive grants to advance the Company’s programs; Cadrenal offering a differentiated pipeline that addresses critical unmet needs for high-risk patients; the CACC Franchise demonstrating to prospective partners how the Company’s assets can address multiple high-value needs across the cardiac surgery continuum; frunexian IV replacing volatile alternative anticoagulation protocols for HIT-susceptible patients undergoing CABG surgery and establishing a predictable safety profile; ODD for HIT supporting seven years of post-approval market exclusivity, fee waivers and targeted tax credits; CAD-1005 serving as a post-operative shield for Cardiac Surgery-Associated HIT and CSA-AKI; the Company’s ability to enter into development, licensing, and commercialization transactions for CAD-1005, frunexian, and tecarfarin; the shared cardiac intensive care infrastructure, intravenous administration, and complementary thrombotic and inflammatory mechanisms creating a differentiated critical care asset package for prospective partners; the FDA’s ultimate decision regarding the Company’s request for RPDD for tecarfarin for the prevention of life-threatening blood clots inside coronary artery aneurysms in children with Kawasaki Disease; CAD-2000 potentially being a follow-on companion to the Company's intravenous acute care platform; the potential exercise of the warrants issued in the Company’s private placement resulting in gross proceeds of up to $5.8 million; the Company’s belief that its resources will fund operations through the first quarter of 2027; the Company securing funding sufficient to complete a trial, which may include capital raised through strategic partnerships, out-licensing agreements, non-dilutive grants, equity or debt financing, or a combination of these sources; and tecarfarin, a late-stage oral vitamin K antagonist designed to prevent heart attacks, strokes, and deaths from blood clots in patients requiring chronic anticoagulation, potentially treating patients with Kawasaki disease. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Company’s ability to advance its programs to clinical trial readiness; the Company’s ability to enter into development, licensing, and commercialization transactions for CAD-1005, frunexian, and tecarfarin; the Company’s ability to secure nondilutive grants to advance its programs; and the other risk factors described in the Company's Annual Report on Form 10-K for the year ended December 31, 2025, 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: Lytham Partners, LLCRobert Blum, Managing [email protected]

Official FDA meeting minutes and Phase 2 data provide guidance on the pivotal Phase 3 registration path for CAD-1005 in heparin-induced thrombocytopenia (HIT) PONTE VEDRA, Fla., May 07, 2026 (GLOBE NEWSWIRE) -- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions, today reported its financial results for the first quarter ended March 31, 2026, and provided a corporate update highlighting continued progress in its CAD-1005 program for HIT. The Company has now received the official minutes from its End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA), which provided guidance on key elements of the planned pivotal Phase 3 registration trial for CAD-1005, Cadrenal's investigational first-in-class 12-lipoxygenase (12-LOX) inhibitor being developed to treat suspected heparin-induced thrombocytopenia (HIT). Based on this feedback and Phase 2 data, Cadrenal plans to advance directly to a randomized, blinded, placebo-controlled Phase 3 study evaluating CAD-1005 added to standard-of-care anticoagulation in patients with HIT. Recent Highlights Received official FDA EOP2 meeting minutes providing guidance on protocol design, study population, dosing, background therapy, exposure, safety database, and the primary endpoint of new or worsening thrombotic events. After considering FDA feedback on a pivotal registration study, Cadrenal plans to advance directly to a randomized, blinded, placebo-controlled Phase 3 study evaluating CAD-1005 added to the current standard of care for patients with HIT. Planned pivotal Phase 3 study, the first randomized, blinded, placebo-controlled registration trial in HIT, will evaluate CAD-1005 in approximately 120 patients across clinical centers worldwide and is intended to support a projected NDA submission in 2029. Primary endpoint, centrally adjudicated, is expected to be the incidence of new or worsening thrombotic events in patients with Serotonin Release Assay (SRA)-confirmed HIT, with at least one planned interim analysis. Phase 2 data showed an absolute reduction of more than 25% in thrombotic events when CAD-1005 was added to standard anticoagulant therapy, supporting the continued advancement of CAD-1005 as Cadrenal's near-term development priority. Continues to position CAD-1005 as a first-in-class, selective 12-LOX inhibitor and the only treatment in clinical development that targets the underlying immune drivers of HIT, supported by Orphan Drug and Fast Track designations from the FDA and by orphan drug status from the European Medicines Agency. "With the official EOP2 meeting minutes now in hand, we believe the registration path for CAD-1005 in HIT is clearly defined," commented Quang X. Pham, Chairman & CEO. "The FDA's guidance on trial design and the primary endpoint of new or worsening thrombotic events reinforces our confidence in advancing directly to a pivotal Phase 3 study. We believe CAD-1005 has the potential to be the first new therapy for HIT in more than two decades." First Quarter 2026 Financial Highlights Research and development expenses for the quarter ended March 31, 2026, were $0.8 million compared to $1.7 million for the same period in 2025. General and administrative expenses were $1.7 million compared to $2.3 million for the same period in 2025. Total operating expenses were $2.5 million compared to $3.9 million for the same period in 2025. Cadrenal reported a net loss of $2.5 million for the quarter ended March 31, 2026, compared to $3.8 million for the same period in 2025. As of March 31, 2026, Cadrenal had cash and cash equivalents of $2.3 million. Subsequent to quarter end, on April 1, 2026, the Company completed a $2.5 million financing, providing additional capital to support near-term development activities. The Company continues to evaluate financing and strategic alternatives to support its planned clinical development activities, including the anticipated pivotal Phase 3 trial of CAD-1005 in HIT. The Company is advancing Phase 3 readiness activities, including protocol finalization, and expects to provide further updates in the coming quarters. About Cadrenal Therapeutics, Inc. Cadrenal Therapeutics, Inc. is a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions. Its lead program, CAD-1005, is a first-in-class 12-LOX inhibitor being developed to treat heparin-induced thrombocytopenia (HIT), a deadly immune-mediated thrombotic disorder. CAD-1005 has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration and orphan drug status from the European Medicines Agency. Second-generation 12-LOX oral therapeutics are also in development for chronic indications. The Company’s broader pipeline includes tecarfarin, a late-stage oral vitamin K antagonist designed to prevent heart attacks, strokes, and deaths from blood clots in patients requiring chronic anticoagulation, including those with end-stage kidney disease and those with left ventricular assist devices, and frunexian, a parenteral Factor XIa inhibitor intended for use in acute hospital settings. For more information, visit https://www.cadrenal.com/ and connect with the Company 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, without limitation, statements regarding continued progress in its CAD-1005 program for HIT ; plans to advance directly to a randomized, blinded, placebo-controlled Phase 3 study evaluating CAD-1005 added to standard-of-care anticoagulation in patients with HIT; the planned pivotal Phase 3 study being the first randomized, blinded, placebo-controlled registration trial in HIT; the Phase 3 study evaluating CAD-1005 in approximately 120 patients across clinical centers worldwide; the trial supporting a projected NDA submission in 2029; the incidence of new or worsening thrombotic events in patients with Serotonin Release Assay (SRA)-confirmed HIT being the primary endpoint of the trial; the trial having at least one planned interim analysis; continuing to position CAD-1005 as a first-in-class, selective 12-LOX inhibitor and the only treatment in clinical development that targets the underlying immune drivers of HIT; the registration path for CAD-1005 in HIT being clearly defined; and CAD-1005 having the potential to be the first new therapy for HIT in more than two decades. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to raise sufficient capital to continue progress of CAD-1005; the ability to advance directly to a randomized, blinded, placebo-controlled Phase 3 study evaluating CAD-1005 added to standard-of-care anticoagulation in patients with HIT; the ability to successfully design and complete the Phase 3 study and derive the results needed for an NDA submission: and the other risk factors described in the Company's Annual Report on Form 10-K for the year ended December 31, 2025, 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: Lytham Partners, LLC Robert Blum, Managing Partner 602-889-9700 [email protected]

By David Bautz, PhD NASDAQ: CVKD READ THE FULL CVKD RESEARCH REPORT Business Update Published Results Show Potential for 12-LOX Inhibition in Obesity and Type 2 Diabetes On March 12, 2026, Cadrenal Therapeutics, Inc. (NASDAQ: CVKD) announced the publication of preclinical research findings that show the potential for its first-in-class 12-lipoxygenase (12-LOX) inhibitor, CAD-1005, as a treatment for the inflammatory effects of obesity and type 2 diabetes (T2D). The progression of obesity and T2D has previously been linked to signaling by the products of 12-LOX enzymes (Kulkarni et al., 2021). The LOX enzymes are responsible for the oxygenation of polyunsaturated fatty acids to form eicosanoids, with 12-LOX producing the pro-inflammatory metabolite 12-hydroxyeicosatetraenoid acid (12-HETE). The main 12-LOX enzyme that produces 12-HETE is encoded by the ALOX12 gene, however human 12-LOX is structurally distinct from its mouse orthologue so inhibitors of human 12-LOX can’t be tested in mice. Thus, the current study utilized a human gene replacement mouse model in which the mouse 12-LOX gene (Alox15) was replaced by the human ALOX12 gene prior to placing male mice on a high-fat diet and then treating with CAD-1005 (VLX-1005) (Kaylan et al., 2026). This work builds upon previously published research showing that VLX-1005 delayed the onset of autoimmune diabetes and reduced islet inflammation in nonobese diabetic mice in which human ALOX12 replaced mouse Alox15 (Nargis et al., 2024). The results of the study showed that treatment with VLX-1005 improved glucose homeostasis, reduced β-cell dedifferentiation, and alleviated macrophage-mediated inflammation in both pancreatic islets and adipose tissue. The decreased β-cell dedifferentiation was shown by a decrease in ALDH1A3 expression, which is a marker of β-cell failure and reduced glucose-stimulated insulin secretion (Kim-Muller et al., 2016). The decrease in ALDH1A3 following VLX-1005 treatment suggests that the drug improves β-cell health and may contribute to increased capacity to meet insulin secretory needs. Treatment with VLX-1005 also reduced macrophage infiltration and cytokine expression in adipose tissue, which are both implicated in obesity-associated inflammatory responses (Russo et al., 2018). While Cadrenal continues to be fully focused on advancing CAD-1005 as a treatment for heparin-induced thrombocytopenia (HIT), these results support the potential for 12-LOX inhibition as a therapeutic agent in managing obesity and altered glucose metabolism by targeting peripheral inflammation associated with visceral adiposity. Planning for Phase 3 Trial in HIT Cadrenal recently conducted an ‘End-of-Phase 2’ meeting with the U.S. Food and Drug Administration (FDA) to clarify the potential registration pathway for CAD-1005 in HIT. The company is currently in the process of incorporating the feedback into its proposed Phase 3 protocol. While we don’t know the specifics yet, we believe the company intends to use thrombotic event reduction as the primary endpoint in Phase 3, build on the safety profile observed to date, and leverage CAD-1005’s Orphan Drug Designation (ODD) and Fast Track status. Background on HIT HIT is a severe, immune-mediated prothrombotic disorder triggered by exposure to heparin, an anticoagulant used widely in clinical practice (e.g., surgery, dialysis). It is estimated to occur in approximately 1 in 1500 hospital admissions (Dhakal et al., 2018). Data shows that certain variables can increase the risk of developing HIT, including cardiac surgery (Pishko et al., 2017) and exposure to unfractionated heparin vs. low molecular weight heparin (Warkentin et al., 1995), while a shorter exposure to heparin appears to decrease the risk of developing HIT (Smythe et al., 2007). Diagnosis of HIT uses the “4Ts Score”, which is a pre-test scoring system that assesses the probability of HIT (Lo et al., 2006). It is calculated as a sum of points from four components: Thrombocytopenia, Timing of platelet count fall, Thrombosis or other sequelae, and oTher causes of thrombocytopenia. Laboratory diagnosis of HIT is divided into two steps: an immunoassay and a functional assay. The immunoassay examines for the presence of anti-platelet factor 4 (PF4)/heparin antibodies. If anti-PF4/heparin antibodies are identified, a functional assay is performed to determine if those antibodies are pathogenic. The 14C-serotonin release assay (SRA) is the “gold standard” functional assay and has both high sensitivity (~0.95) and specificity (~0.95) (Warkentin et al., 2015). Management for patients suspected of suffering from HIT includes 1) the avoidance of heparin, indefinitely if possible, and 2) use of non-heparin anticoagulation. The duration of non-heparin anticoagulation will be dictated by the presence of absence of thrombosis. Preferred agents for non-heparin anticoagulation therapy include argatroban and bivalirudin, which can be administered IV, or danaparoid, which can be administered subcutaneously. For patients who develop HIT, there are a number of potential negative outcomes, including thrombosis, bleeding, amputation, increased risk of hospital stay, and even death. Despite decades of research, no approved therapy directly targets the core immune and platelet activation mechanisms in HIT. Current anticoagulants decrease the risk of coagulation but do not modulate immune-mediated platelet activation, which leaves patients at persistent risk of thrombosis. CAD-1005 for HIT CAD-1005 is a highly selective inhibitor of human 12-LOX and is designed to reduce or prevent platelet activation and the downstream pro-thrombotic cascade in HIT. By inhibiting 12-LOX activity, CAD-1005 reduces the production of proinflammatory and procoagulant 12-LOX metabolites that feed into platelet activation loops. The drug also addresses the immune-driven aspect of HIT pathogenesis, which is the pathway that links immune complexes and platelet hyperactivity, a mechanism wholly distinct from direct anticoagulation. Lastly, preclinical and Phase 1 clinical trial results indicate there is no increased bleeding signal, which distinguishes CAD-1005 from traditional anticoagulants that reduce the risk of clotting at the cost of an increased risk of bleeding. Market Opportunity Currently approved HIT treatments focus on non-heparin anticoagulation, which mitigate clot propagation but do not directly modulate immune platelet activation, which is the core driver of HIT pathology. Thus, there is a high residual risk of thrombosis that persists in HIT patients despite anticoagulant therapy. In addition, there are no approved agents that target the immune-mediated platelet activation pathway, thus positioning CAD-1005 as a first-in-class drug. There are approximately 240,000 suspected cases and approximately 48,000 confirmed cases of HIT in the U.S. each year, thus offering a large patient population that could potentially benefit from a safe and effective HIT therapy. Financial Update On March 31, 2025, Cadrenal announced financial results for 20245. As expected, the company did not record any revenues in 2025. R&D expenses in 2025 were $4.1 million compared to $4.2 million in 2024. The decrease was primarily due to reduced consulting expenses partially offset by increased expenses associated with the asset purchase agreements in September and December 2025. G&A expenses were $9.4 million in 2025 compared to $6.8 million in 2024. The increase was primarily due to increased expenses related to being a public company, increased stock-based compensation, and increased consulting and professional fees. As of December 31, 2025, Cadrenal had approximately $4.0 million in cash and cash equivalents. Subsequent to the end of the year, the company sold 168,690 shares of common stock through its at-the-market (ATM) facility for net proceeds of approximately $1.3 million. Cadrenal is currently evaluating various financing and strategic alternatives to support its planned clinical development activities. As of March 27, 2026, the company had approximately 2.5 million shares outstanding and, when factoring in stock options and warrants, a fully diluted share count of approximately 4.0 million. Conclusion We look forward to additional details regarding the planned Phase 3 trial of CAD-1005 in HIT after the company is able to incorporate the FDA’s feedback into the trial plan. In addition, we will be interested to learn how the company is planning to finance the Phase 3 program for CAD-1005. The new results showing positive effects of 12-LOX inhibition in preclinical obesity models is very interesting as it shows the potential for pipeline expansion with CAD-1005. As we await word on next steps for the CAD-1005 program we have made no changes to our model and our valuation remains at $25.00 per share. SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR. 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Encouraging Phase 2 HIT data and recent FDA feedback support continued advancement of CAD-1005 as Cadrenal’s near-term development priority; broader 12-LOX platform remains a longer-term opportunity PONTE VEDRA, Fla., March 31, 2026 (GLOBE NEWSWIRE) -- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions, today reported its financial results for the fourth quarter and full year ended December 31, 2025, and provided a corporate update highlighting recent progress across its CAD-1005 program for HIT and broader 12-LOX inhibitor platform. The update reflects continued progress for CAD-1005, Cadrenal’s first-in-class 12-LOX inhibitor for suspected heparin-induced thrombocytopenia (HIT), including completion of its End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) on March 26, 2026, to align on the proposed Phase 3 pivotal trial of CAD-1005 in patients with HIT. Recent Highlights Reported encouraging results from a randomized, blinded, placebo-controlled Phase 2 study of CAD-1005 in HIT, with fewer new or worsening thrombotic events observed in patients treated with CAD-1005 on a background of standard anticoagulant therapy. Observed a greater than 25% absolute reduction in thrombotic events in the CAD-1005 treatment arm versus placebo, while also gaining important insight that platelet count recovery may not be an appropriate surrogate endpoint for clinical efficacy in HIT. On March 26, 2026, the Company completed its End-of-Phase 2 meeting with the FDA and clarified a potential registrational path for its planned Phase 3 pivotal trial. Incorporation of FDA feedback into Phase 3 protocol is currently underway. Continued to position CAD-1005 as the only selective 12-LOX inhibitor currently in clinical development, supported by Orphan Drug and Fast Track designations from the FDA and orphan drug status from the European Medicines Agency. While HIT remains the Company’s near-term development priority, it continues to see additional scientific support for 12-LOX inhibition beyond HIT, including research in obesity and type 2 diabetes showing potential improvements in glycemic control, pancreatic beta-cell preservation, and inflammatory signaling. “CAD-1005 continues to reinforce our conviction that selective 12-LOX inhibition may offer a differentiated approach for patients with HIT, a life-threatening, immune-mediated prothrombotic disorder, and a serious condition with substantial unmet need,” commented Quang X. Pham, Chairman & CEO. “Despite modern care, mortality remains high (up to 18-20% in some groups), with many survivors facing limb amputations. The encouraging Phase 2 results, including the reduction in thrombotic events observed on top of standard anticoagulant therapy, further strengthen our confidence in the program and in the decision to make CAD-1005 our lead development priority.” “The recent End-of-Phase 2 meeting with the FDA is an important milestone in clarifying the regulatory path forward for CAD-1005. As we incorporate FDA feedback and prepare for the next stage of development, we remain focused on advancing CAD-1005 as our lead priority in HIT. At the same time, we continue to evaluate longer-term opportunities across our broader 12-LOX platform and other pipeline assets to support future value creation.” Fourth Quarter 2025 Financial Highlights Research and development expenses for the quarter ended December 31, 2025, were $0.7 million compared to $1.5 million for the same period in 2024. General and administrative expenses for the quarter ended December 31, 2025, were $2.4 million compared to $2.7 million for the same period in 2024. Cadrenal reported a net loss of $3.0 million for the quarter ending December 31, 2025, compared to $4.2 million for the same period in 2024. On December 31, 2025, Cadrenal had cash and cash equivalents of $4.0 million. The Company is evaluating financing and strategic alternatives to support its planned clinical development activities. The Company had approximately 2.3 million shares of common stock outstanding as of December 31, 2025. About Cadrenal Therapeutics, Inc. Cadrenal Therapeutics, Inc. (Nasdaq: CVKD) is a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions. Its lead program, CAD-1005, is a first-in-class 12-LOX inhibitor for the treatment of heparin-induced thrombocytopenia (HIT), a deadly immune-mediated thrombotic disorder. CAD-1005 has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration and orphan drug status from the European Medicines Agency. Second-generation 12-LOX oral therapeutics are also under development for chronic indications. The Company’s broader pipeline features tecarfarin, a late-stage oral vitamin K antagonist designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation, including for patients with end-stage kidney disease and left ventricular assist devices, and frunexian, a parenteral Factor XIa inhibitor intended for use in acute hospital settings. For more information, visit https://www.cadrenal.com/ and connect with the Company 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, without limitation, statements regarding the continued progress for CAD-1005 for suspected heparin-induced thrombocytopenia; a potential registrational path for the Company’s planned Phase 3 pivotal trial; additional scientific support for 12-LOX inhibition beyond HIT; research in obesity and type 2 diabetes showing potential improvements in glycemic control, pancreatic beta-cell preservation, and inflammatory signaling; selective 12-LOX inhibition offering a differentiated approach for patients with HIT, a serious condition with substantial unmet need; continuing to evaluate longer-term opportunities across the Company’s broader 12-LOX platform and other pipeline assets to support future value creation; the Company’s clinical development plans and timing, regulatory pathway and potential registration strategy for CAD-1005; the design and initiation of its planned Phase 3 trial, the potential therapeutic and commercial opportunity for CAD-1005 and the Company’s broader pipeline, and the Company’s capital requirements and potential financing or strategic alternatives. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to continue progress CAD-1005; the ability to successfully plan a registrational path for the Company’s planned Phase 3 pivotal trial; the ability for 12-LOX inhibition to provide improvements in obesity and type 2 diabetes in glycemic control, pancreatic beta-cell preservation, and inflammatory signaling and support future value creation; the Company’s ability to raise sufficient funding to commence and complete its planned Phase 3 trial, and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, 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: Lytham Partners, LLC Robert Blum, Managing Partner 602-889-9700 [email protected]

By David Bautz, PhD NASDAQ:CVKD READ THE FULL CVKD RESEARCH REPORT Business Update Encouraging Results from Phase 2 HIT Trial On February 24, 2026, Cadrenal Therapeutics, Inc. (NASDAQ:CVKD) announced encouraging results from the Phase 2 trial of CAD-1005 (formerly CAD-1005) in heparin-induced thrombocytopenia (HIT). The results showed a meaningful reduction in thrombotic events despite not meeting the study’s primary endpoint of platelet count recovery. While platelet recovery did not differ between treatment groups, thrombotic events occurred in 50% of CAD-1005-treated patients compared with >75% in placebo-treated patients, which represents a >25% absolute reduction. Although the study was not powered for statistical significance, the signal is clinically compelling in a condition with a high morbidity and mortality, and no approved therapies specifically targeting the immune mechanism underlying HIT. The randomized, placebo controlled Phase 2 study evaluated CAD-1005, a selective inhibitor of 12-lipoxygenase (12-LOX) in patients with suspected HIT receiving standard anticoagulant therapy (argatroban or bivalirudin). The trial was initiated by Veralox Therapeutics, which selected platelet count recovery rate as the primary endpoint. The strategic intent of that design was to determine whether platelet count recovery could serve as a surrogate endpoint for clinical outcomes in a future registrational study. In other words, the Phase 2 trial was structured not only to evaluate efficacy, but to test whether platelet count recovery could reliably predict reductions in thrombotic events. Following the acquisition by Cadrenal, the study concluded with 24 randomized patients, 17 of whom had centrally confirmed HIT. The study did not demonstrate a difference in platelet count recovery between treatment arms. In addition, thrombotic events continued to occur even after platelet count recovery in both arms. This indicates that platelet count recovery may not function as a reliable surrogate marker for clinical efficacy in HIT, particularly in a setting where background event rates remain high despite standard anticoagulation. Rather than representing a setback for CAD-1005, the results help to clarify endpoint strategy. The study successfully answered the scientific question it was designed to address: platelet count recovery does not appear to predict thrombotic outcomes in this context. This now allows Cadrenal to align the development of CAD-1005 around clinically meaningful endpoints, such as thrombotic events. The key secondary endpoint, incidence of new or worsening thrombotic events, produced the most compelling signal in the dataset, with a >75% thrombotic event rate in placebo treated patients compared to a 50% thrombotic event rate in CAD-1005-treated patients. Although the study was not powered for statistical significance, the magnitude of the reduction in a small, blinded, placebo controlled trial in HIT is noteworthy. Current management of HIT relies on alternative anticoagulants, which address clot formation but do not target the upstream immune mechanism. CAD-1005’s inhibition of 12-LOX is designed to interrupt the immune signaling cascade responsible for platelet activation on thrombus propagation. The divergence between platelet recovery and thrombotic outcomes in the Phase 2 trial further reinforces the importance of targeting the underlying immune driver (which CAD-1005 does) rather than focusing solely on platelet counts. Cadrenal has been granted an ‘End-of-Phase 2’ meeting with the U.S. FDA in March 2026 to align with the agency on a Phase 3 registration strategy. The company intends to use thrombotic event reduction as the primary endpoint in Phase 3, build on the safety profile observed to date, and leverage CAD-1005’s Orphan Drug Designation (ODD) and Fast Track status. Background on HIT HIT is a severe, immune-mediated prothrombotic disorder triggered by exposure to heparin, an anticoagulant used widely in clinical practice (e.g., surgery, dialysis). It is estimated to occur in approximately 1 in 1500 hospital admissions (Dhakal et al., 2018). Data shows that certain variables can increase the risk of developing HIT, including cardiac surgery (Pishko et al., 2017) and exposure to unfractionated heparin vs. low molecular weight heparin (Warkentin et al., 1995), while a shorter exposure to heparin appears to decrease the risk of developing HIT (Smythe et al., 2007). Diagnosis of HIT uses the “4Ts Score”, which is a pre-test scoring system that assesses the probability of HIT (Lo et al., 2006). It is calculated as a sum of points from four components: Thrombocytopenia, Timing of platelet count fall, Thrombosis or other sequelae, and oTher causes of thrombocytopenia. Laboratory diagnosis of HIT is divided into two steps: an immunoassay and a functional assay. The immunoassay examines for the presence of anti-platelet factor 4 (PF4)/heparin antibodies. If anti-PF4/heparin antibodies are identified, a functional assay is performed to determine if those antibodies are pathogenic. The 14C-serotonin release assay (SRA) is the “gold standard” functional assay and has both high sensitivity (~0.95) and specificity (~0.95) (Warkentin et al., 2015). Management for patients suspected of suffering from HIT includes 1) the avoidance of heparin, indefinitely if possible, and 2) use of non-heparin anticoagulation. The duration of non-heparin anticoagulation will be dictated by the presence or absence of thrombosis. Preferred agents for non-heparin anticoagulation therapy include argatroban and bivalirudin, which can be administered IV, or danaparoid, which can be administered subcutaneously. For patients who develop HIT, there are a number of potential negative outcomes, including thrombosis, bleeding, amputation, increased risk of hospital stay, and even death. Despite decades of research, no approved therapy directly targets the core immune and platelet activation mechanisms in HIT. Current anticoagulants decrease the risk of coagulation but do not modulate immune-mediated platelet activation, which leaves patients at persistent risk of thrombosis. CAD-1005 for HIT CAD-1005 is a highly selective inhibitor of human 12-LOX and is designed to reduce or prevent platelet activation and the downstream pro-thrombotic cascade in HIT. By inhibiting 12-LOX activity, CAD-1005 reduces the production of proinflammatory and procoagulant 12-LOX metabolites that feed into platelet activation loops. The drug also addresses the immune-driven aspect of HIT pathogenesis, which is the pathway that links immune complexes and platelet hyperactivity, a mechanism wholly distinct from direct anticoagulation. Lastly, preclinical and Phase 1 clinical trial results indicate there is no increased bleeding signal, which distinguishes CAD-1005 from traditional anticoagulants that reduce the risk of clotting at the cost of an increased risk of bleeding. 12-LOX Biology 12-LOX (encoded by the ALOX12 gene) catalyzes the oxidation of arachidonic acid to proinflammatory lipid mediators such as 12-hydroxyeicosatetraenoic acid (12-HETE) (Dobrian et al., 2011). 12-LOX is expressed in platelets (Contursi et al., 2022), however, unlike cyclooxygenase-1 (COX-1), which drives thromboxane A2 (TXA2) production and classical platelet aggregation, 12-LOX does not primarily initiate aggregation but instead acts as a potentiator and amplifier of platelet activation. The main bioactive product of 12-LOX, 12-HETE, is a lipid molecule that easily transits cell membranes and can induce its effects both intracellularly, where it promotes oxidative stress, and extracellularly, where it impacts a variety of signaling pathways to modulate inflammatory activity. Importantly, 12-HETE does not cause strong platelet activation alone, it just lowers the activation threshold, thus making platelets hyper-responsive (Tamang et al., 2024). In HIT, platelets are activated via FcγRIIa binding of anti-PF4/heparin antibody complexes (Yeung et al., 2024). 12-LOX acts downstream of FcγRIIa signaling: FcγRIIa activation leads to phospholipase A2 activation that leads to arachidonic acid release. The arachidonic acid is then converted to 12-HETE, and it is the 12-HETE that feeds back to sustain and amplify the activation signal. By inhibiting 12-LOX, pathologic amplification is selectively inhibited by reducing 12-HETE generation. This targets the disease itself and as opposed to current HIT therapies does not result in a residual thrombotic risk. The high selectivity of CAD-1005 helps to preserve baseline platelet function and allows it to be used with standard anticoagulants while being short-lived and controllable in an in-patient setting. Phase 1 Results Veralox previously completed a Phase 1a study in healthy volunteers that consisted of a single ascending dose (SAD) and multiple ascending dose (MAD) portion to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CAD-1005. In that study, CAD-1005 was found to be well tolerated with no reports of serious adverse events (SAEs), dose-limiting toxicities (DLTs) or discontinuations. The data showed a dose linear increase in key PK metrics with no upper limits on tolerability to the maximum dose tested. Veralox also completed a Phase 1b drug-drug interaction (DDI) study of CAD-1005 in combination with argatroban, an anticoagulant drug approved for the treatment of HIT. The results showed that co-administration of CAD-1005 with argatroban was well tolerated with no SAEs. Analysis of the PK and PD data showed no evidence for DDI. Market Opportunity Currently approved HIT treatments focus on non-heparin anticoagulation, which mitigate clot propagation but do not directly modulate immune platelet activation, which is the core driver of HIT pathology. Thus, there is a high residual risk of thrombosis that persists in HIT patients despite anticoagulant therapy. In addition, there are no approved agents that target the immune-mediated platelet activation pathway, thus positioning CAD-1005 as a first-in-class drug. There are approximately 240,000 suspected cases and approximately 48,000 confirmed cases of HIT in the U.S. each year, thus offering a large patient population that could potentially benefit from a safe and effective HIT therapy. Conclusion The Phase 2 results for CAD-1005 in HIT were very encouraging as the trial successfully achieved its intended scientific objective (determining if platelet count recovery could be used as a surrogate endpoint) while also revealing a potentially practice-changing signal in thrombotic event reductions. We look forward to the outcome of the upcoming meeting with the FDA as well as additional details regarding the design and timeline for the Phase 3 study. With no changes to our model, our valuation remains at $25 per share. SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR. 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Greater than 25% absolute reduction in thrombotic events with CAD-1005 versus placebo on a background of standard anticoagulant therapy, despite no difference in platelet count recovery End-of-Phase 2 Meeting Scheduled for March 2026 PONTE VEDRA, Fla., Feb. 24, 2026 (GLOBE NEWSWIRE) -- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions, today announced encouraging results from a Phase 2 trial evaluating CAD-1005 (formerly VLX-1005) in patients with heparin-induced thrombocytopenia (HIT), a severe pro-thrombotic reaction to heparin, the most commonly used parenteral anticoagulant. This randomized, blinded, placebo-controlled trial evaluated the safety and efficacy of CAD-1005, a selective inhibitor of 12-lipoxygenase (12-LOX), a critical immune signaling pathway implicated in HIT, in patients receiving standard anticoagulant therapy. To potentially validate a new surrogate endpoint, the previous investigational new drug sponsor, Veralox Therapeutics, selected platelet count recovery rate as the primary endpoint. Their trial did not meet this primary endpoint. The secondary endpoint was the incidence of new or worsening thrombotic events, including radiologic progression, which showed encouraging results. The study concluded in December 2025 following the transfer of program ownership from Veralox to Cadrenal. Although CAD-1005 did not significantly affect platelet recovery rate, CAD-1005-treated patients had fewer thrombotic events. Highlights: Primary Endpoint: Thrombotic events continued to occur even after platelet count recovery in both groups. Platelet recovery rates were similar between the CAD-1005 and placebo arms. Platelet count recovery did not appear to be a surrogate marker for clinical efficacy. Key Secondary Endpoint: A high rate of thrombotic events (>75%) was observed in the placebo group, with fewer thrombotic events in the CAD-1005 group (50%), although the study was not powered to detect statistical significance. Adding an inhibitor of 12-LOX to standard anticoagulants to block the immunological mechanisms driving HIT may be more effective than anticoagulants alone in preventing thrombotic events. Building on these secondary endpoint results, Cadrenal has been granted an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) to align on a Phase 3 registration path. The Company considers this meeting a significant milestone in the development of CAD-1005, the only 12-LOX inhibitor in clinical development worldwide. “The encouraging trend toward reduced thrombotic events in the CAD-1005 treatment arm is strong support for the company’s decision to acquire this asset and rapidly progress its development,” said Quang X. Pham, CEO of Cadrenal Therapeutics. “Inhibition of 12-LOX is an exciting therapeutic frontier, potentially targeting numerous inflammatory, thrombotic, and metabolic conditions.” “We learned two very important things from this study, the only blinded placebo-controlled trial ever conducted in HIT,” said James Ferguson, MD, Chief Medical Officer of Cadrenal Therapeutics. “First, platelet count recovery was not an appropriate surrogate endpoint for clinical efficacy in a trial in which standard therapy event rates were strikingly high. Secondly, despite the relatively small number of patients, the reduction in thrombotic events with CAD-1005 is extremely encouraging. CAD-1005 could represent a major step forward as the only first-line therapy targeting the immune mechanisms responsible for HIT.” “Our field (HIT) is full of anticoagulant use in the absence of randomized prospective trials,” said Steven E. McKenzie, MD, PhD, Professor of Medicine at Thomas Jefferson University and a member of the study steering committee. “We are enthusiastic about CAD-1005 in addressing both the underlying immune mechanism and the unmet medical need for this serious thrombotic disorder.” Detailed trial results will be presented at a future scientific meeting. About Heparin-Induced Thrombocytopenia (HIT) Heparin is the most widely used in-hospital anticoagulant, with over 12 million patients receiving it in the United States each year. Heparin-induced thrombocytopenia (HIT) is a potentially life-threatening immune-mediated complication of heparin administration that occurs when antibodies to heparin activate platelets, leading to clots throughout the circulatory system, dramatically lowering platelet counts, and increasing the risk of bleeding. Complications of HIT include deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction, amputation, and death, with mortality rates for HIT exceeding 20% in some studies. CAD-1005 is the only treatment in clinical development that targets the underlying immune drivers of HIT. About CAD-1005 CAD-1005 is an investigational therapy being evaluated for the treatment of suspected HIT. CAD-1005 is designed to selectively inhibit 12-LOX, a pathway integral to the primary immune mechanisms driving HIT. Unlike existing therapies for HIT, which are only directed at preventing thrombotic complications, this approach addresses the primary underlying cause of HIT. In preclinical models of HIT, CAD-1005 has been shown to prevent or treat HIT and halt the development of both thrombocytopenia and blood clots. The drug has not been associated with increased bleeding in animals or healthy human volunteers. CAD-1005 has received Orphan Drug Designation (ODD) and Fast Track designation from the U.S. Food and Drug Administration, as well as orphan drug status from the European Medicines Agency. About the Study The study was originally planned to enroll 60 patients, but was stopped in December 2025 after program ownership transferred to Cadrenal. Analysis of all existing trial data was recently completed. The final dataset includes 24 patients with a presumptive diagnosis of HIT, randomized to receive either CAD-1005 or a matching placebo; all patients received concomitant standard anticoagulant therapy, either argatroban or bivalirudin. The primary endpoint was the rate of platelet count recovery; a key secondary endpoint was the development of new or worsening thrombotic events, the composite of death, stroke, systemic embolism, myocardial infarction, deep venous thrombosis, superficial vein thrombosis, or skin necrosis. Primary analyses focused on 17 patients in whom HIT was confirmed by a central lab functional assay. About Cadrenal Therapeutics, Inc. Cadrenal Therapeutics, Inc. (Nasdaq: CVKD) is a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions. Its lead program, CAD-1005, is a first-in-class 12-LOX inhibitor for the treatment of heparin-induced thrombocytopenia (HIT), a deadly immune-mediated thrombotic disorder. CAD-1005 has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration, as well as orphan drug status from the European Medicines Agency. Second-generation 12-LOX oral therapeutics are also under development. The Company’s broader pipeline includes tecarfarin, a Phase 3-ready oral vitamin K antagonist for the treatment of patients with end-stage kidney disease and those with left ventricular assist devices, and frunexian, a parenteral, clinical-stage Factor XIa inhibitor designed for use in acute hospital settings. For more information, visit https://www.cadrenal.com/ and connect with the Company 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 adding an inhibitor of 12-LOX to standard anticoagulants to block the immunological mechanisms driving HIT being more effective than anticoagulants alone in preventing thrombotic events; the encouraging trend toward reduced thrombotic events in the CAD-1005 treatment arm being strong support for the Cadrenal’s decision to acquire this asset and rapidly progress its clinical development; full trial results being presented at a future scientific meeting; the reduction in thrombotic events with CAD-1005 being extremely encouraging, despite the relatively small number of patients; CAD-1005 representing a major step forward as the only first-line therapy targeting the immune mechanisms responsible for HIT; The EOP2 meeting being a significant milestone in the development of CAD-1005; CAD-1005 addressing both the underlying immune mechanism and the unmet medical need for this serious thrombotic disorder; the encouraging trend toward reduced thrombotic events in the CAD-1005 treatment arm being strong support for Cadrenal’s decision to acquire this asset and rapidly progress its development; CAD -1005 addressing the underlying immune drivers of HIT; and presenting detailed trial results at a future scientific meeting. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including Cadrenal’s ability to advance the clinical development of CAD-1005 for the treatment of HIT, including designing a pivotal Phase 3 registration study acceptable to the FDA; CAD-1005 having the ability to address the underlying immune mechanism and the unmet medical need for the serious thrombotic disorder; Cadrenal’s ability to continue to advance novel therapeutics to treat or prevent thrombosis in high-risk patients; Cadrenal’s ability to successfully complete clinical trials on time and achieve desired results and benefits as expected including support for CAD-1005’s potential to be a treatment option for HIT, Cadrenal’s ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements 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. For more information, please contact: Cadrenal Therapeutics: Matthew Szot, CFO [email protected] Investors: Lytham Partners, LLC Robert Blum, Managing Partner 602-889-9700 [email protected]

PONTE VEDRA, Fla., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing transformative therapeutics to overcome current gaps in anticoagulation therapy, today reported its financial results for the third quarter ended September 30, 2025, and provided an update on the clinical development of tecarfarin and the acquisition and development of frunexian. Highlights Progressed clinical development of tecarfarin. Completed the manufacturing of tecarfarin drug product in accordance with current good manufacturing practices (cGMP). Ongoing activities in support of a single-site U.S. Phase 2 study of tecarfarin in LVAD patients as part of the collaboration agreement with Abbott. Investigator discussions for a potential multi-site Phase 2 study of tecarfarin in dialysis patients already treated with warfarin. Expanded Cadrenal’s portfolio through the acquisition of the assets of eXIthera Pharmaceuticals, including its proprietary portfolio of investigational intravenous (IV) and oral Factor XIa inhibitors, in September 2025. The lead asset, frunexian, is a first-in-class, Phase 2-ready IV Factor XIa inhibitor designed for acute care settings where contact activation of coagulation by medical devices plays a significant role, such as cardiopulmonary bypass, catheter thrombosis, and other blood-contacting implanted cardiac devices. “We have uniquely positioned ourselves to address gaps in anticoagulation treatment of multiple indications through the development of two differentiated anticoagulants (tecarfarin and frunexian) while benefitting from pathways that provide clear regulatory designations,” commented Quang X. Pham, Chairman & CEO. “Having multiple pathways has allowed us to be prudent and flexible in our strategic approach to achieving critical development milestones as we look to advance our therapies for patients where conventional anticoagulation does not provide sufficient safety or efficacy.” “Our focus as we finish 2025 is the progression of tecarfarin into clinical applications where significant anticoagulation challenges exist,” Pham continued. “We are in discussions with key partners to move forward a development strategy which we believe is critical to the broader anticoagulation industry to address gaps in care and unlock key value for shareholders.” Third Quarter 2025 Financial Highlights Research and development expenses for the quarter ended September 30, 2025, were $0.7 million compared to $0.8 million for the same period in 2024. General and administrative expenses for the quarter ended September 30, 2025, were $2.0 million compared to $1.7 million for the same period in 2024. Cadrenal reported a net loss of $2.7 million for the quarter ending September 30, 2025, compared to $2.4 million for the same period in 2024. On September 30, 2025, Cadrenal had cash and cash equivalents of $3.9 million. The Company had approximately 2.1 million shares of common stock outstanding as of September 30, 2025. About Cadrenal Therapeutics, Inc. Cadrenal Therapeutics, Inc. is a biopharmaceutical company with a mission to develop novel and differentiated biopharmaceutical products that bridge critical gaps in current acute and chronic anticoagulant therapy. We bridge these gaps by developing novel and differentiated anticoagulants, or blood thinners, designed to provide greater predictability, increased stability, more precise control, and fewer bleeding complications. We currently have two clinical-stage assets: tecarfarin, an oral vitamin K antagonist (VKA) for chronic use, and frunexian, a parenteral small-molecule Factor XIa antagonist for use in acute hospital settings. By targeting underserved patient populations and advancing therapies designed for both chronic and acute use, we aim to reshape standards of care in anticoagulation. For more information, visit https://www.cadrenal.com/ and connect with the Company 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 the Company’s ability to develop transformative therapeutics to overcome current gaps in anticoagulation therapy, the Company’s ongoing activities supporting a single-site U.S. Phase 2 study of tecarfarin in LVAD patients as part of the collaboration agreement with Abbott; the potential initiation of a multi-site Phase 2 study of tecarfarin in dialysis patients already treated with warfarin; the Company being uniquely positioned to address gaps in anticoagulation treatment of multiple indications through development of two differentiated anticoagulants (tecarfarin and frunexian); the Company achieving critical development milestones; the progression of tecarfarin into clinical applications where significant anticoagulation challenges exist; moving forward with a development strategy with key partners; addressing gaps in care and unlocking key value for shareholders. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Company’s ability to develop novel and differentiated biopharmaceutical products that bridge critical gaps in current acute and chronic anticoagulant therapy; the Company’s ability to achieve critical development milestones and commence clinical trials as anticipated; the Company having sufficient funding to achieve its clinical goals; the Company’s ability to target underserved patient populations and advance therapies designed for both chronic and acute use and to reshape standards of care in anticoagulation 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. For more information, please contact: Lytham Partners, LLC Robert Blum, Managing Partner 602-889-9700 [email protected]

Announces strategic clinical trial plans for tecarfarin in patients with End-Stage Kidney Disease (ESKD) transitioning to dialysis Tecarfarin can potentially address critical treatment gaps in patients with ESKD Pivotal step forward in pursuit of ESKD + Atrial Fibrillation (AFib) registration trial PONTE VEDRA, Fla., August 11, 2025--(BUSINESS WIRE)--Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company focused on developing transformative therapeutics that specifically address limitations of current anticoagulation therapy, today reported its financial results for the second quarter ended June 30, 2025, and provided an update on the strategic focus of the company and clinical development of tecarfarin. "We continue to advance our goal of developing transformative therapeutics to address the gaps in current anticoagulation therapy for patients with complex needs," said Quang X. Pham, Chairman & CEO. "This commitment is reflected in our strategic plan to initiate a clinical trial for tecarfarin in end-stage kidney disease (ESKD) for patients transitioning to dialysis. There is a critical need for safe, effective anticoagulants for use in ESKD patients, and tecarfarin’s orphan drug and fast-track designations in ESKD patients with atrial fibrillation (AFib) underscore this need. We are very excited to advance this program." "Strong operational execution is fundamental to advancing tecarfarin into late-stage trials," continued Pham. "By successfully completing the technical transfer of tecarfarin to a U.S. site of a leading global CDMO and manufacturing tecarfarin drug product, we have achieved critical steps in CMC readiness to supply our planned clinical trial and execute our development strategy." Highlights from the Quarter Ended June 30, 2025, and Other Recent Events: Clinical Trial Developments In August 2025, Cadrenal announced plans to initiate a clinical trial for its late-stage drug candidate, tecarfarin, in patients with ESKD who are transitioning to dialysis, including those with and without atrial fibrillation (AFib). Site activation and screening for patient enrollment are planned to begin later this year. The need is urgent for this population, as patients with severe kidney disease are at high risk for thrombotic cardiovascular events such as myocardial infarction and stroke, along with a much greater risk of AFib and venous thromboembolism compared to subjects with normal kidney function. When ESKD patients require dialysis, their transition period comes with even greater risk of myocardial infarction, stroke, and a substantial increase in mortality. Cadrenal expects that this study will be a significant step forward in the continued development of tecarfarin in ESKD and other areas with real opportunities to improve patient outcomes with a potentially better anticoagulant. Operational Milestones CMC Readiness: Successfully completed the technical transfer and manufacturing of its tecarfarin drug substance in accordance with current good manufacturing practices (cGMP) at a U.S. site of a leading global CDMO. During the second quarter of 2025, the Company manufactured tecarfarin clinical drug product and continued to make important advancements in CMC operations to support regulatory and clinical trial readiness. Market Opportunity Research: During the quarter, the Company performed market research in indications where gaps exist in current anticoagulation therapies. This research reinforced that tecarfarin is uniquely positioned to provide potential clinical benefits in certain populations, such as patients with high-need cardiovascular conditions or renal impairment, where anticoagulation safety and predictability are highly important and valued. Participation in Key Investor, Medical, and Business Development Conferences Cadrenal continued to be active during the quarter in conferences to build corporate visibility and underscore its commitment to advancing innovation in anticoagulation therapy. Key interactions included participation at the BIO International Convention in Boston, the Longwood Healthcare Leaders CEO conference in Miami, and the 18th National Conference on Anticoagulation Therapy in Washington, D.C. Strategic Development Collaborations Cadrenal continues to explore opportunities to expand the Company’s clinical pipeline and collaborate with potential development partners to advance the development of tecarfarin for patients with ESKD and AFib, LVADs, and for other indications requiring chronic anticoagulation. Stock Index Benchmarks Effective June 30, 2025, Cadrenal was added to multiple Russell indexes, including the Russell 3000E and Russell Microcap families. These indexes are widely tracked by institutional investors and index funds, potentially broadening the Company’s shareholder base. Second Quarter 2025 Financial Highlights Research and development expenses for the quarter ended June 30, 2025, were $1.1 million compared to $1.3 million for the same period in 2024. General and administrative expenses for the quarter ended June 30, 2025, were $2.7 million compared to $1.2 million for the same period in 2024. Cadrenal reported a net loss of $3.7 million for the quarter ending June 30, 2025, compared to $2.4 million for the same period in 2024. On June 30, 2025, Cadrenal had cash and cash equivalents of $5.6 million, compared to $10.0 million as of December 31, 2024. The Company had approximately 2.0 million shares of common stock outstanding as of June 30, 2025. About Cadrenal Therapeutics, Inc. Cadrenal Therapeutics, Inc. is a biopharmaceutical company developing transformative therapeutics to address limitations of current anticoagulation therapy. Cadrenal’s lead investigational product is tecarfarin, a novel oral vitamin K antagonist anticoagulant that is designed to address 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. With tecarfarin, Cadrenal is advancing an innovative solution to address the unmet needs in anticoagulation therapy, aiming to reduce the clinical complexities of managing Vitamin K antagonists and where DOACs remain inadequate or unproven. Tecarfarin received Orphan Drug Designation (ODD) and fast-track status for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease and atrial fibrillation (ESKD+AFib). The Company also received ODD for the prevention of thromboembolism and thrombosis in patients with implanted mechanical circulatory support devices, including Left Ventricular Assist Devices (LVADs). 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. 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 initiation of clinical trial for tecarfarin in patients with ESKD transitioning to dialysis; tecarfarin potentially addressing critical treatment gaps in patients with ESKD; planned clinical trial bringing a pivotal step forward in pursuit of ESKD+AFib registration trial; the Company’s execution of its development strategy; site activation and screening for patient enrollment are planned to begin later this year; the development of tecarfarin in ESKD and other areas improving patient outcomes with a potentially better anticoagulant; the Company’s advancements in CMC operations supporting regulatory and clinical trial readiness; tecarfarin being uniquely positioned to provide potential clinical benefits in certain populations where anticoagulation safety and predictability are highly important and valued; the Company’s ability to expand its clinical pipeline and collaborate with potential development partners to advance the development of tecarfarin for patients with ESKD and AFib, LVADs, and for other indications requiring chronic anticoagulation; the Company’s ability to develop transformative therapeutics to address limitations of current anticoagulation therapy; and the Company’s advancement of an innovative solution to address the unmet needs in anticoagulation therapy, aiming to reduce the clinical complexities of managing Vitamin K antagonists and where DOACs remain inadequate or unproven. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the initiation of clinical trial for tecarfarin in patients with ESKD transitioning to dialysis; the Company’s execution of its development strategy; the development of tecarfarin in ESKD and other areas improving patient outcomes with a potentially better anticoagulant; the Company’s advancements in CMC operations supporting regulatory and clinical trial readiness; the Company’s ability to expand its clinical pipeline and collaborate with potential development partners; the Company’s ability to develop transformative therapeutics to address limitations of current anticoagulation therapy; 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) View source version on businesswire.com: https://www.businesswire.com/news/home/20250811315782/en/ Contacts Corporate and Investor Relations Paul Sagan LaVoieHealthScience (617) 865-0041 [email protected] Media Andrew Korda LaVoieHealthScience (617) 865-0043 [email protected]

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 08, 2025--(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 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 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 https://www.cadrenal.com/ 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)   View source version on businesswire.com: https://www.businesswire.com/news/home/20250507038192/en/ Contacts Corporate and Investor RelationsPaul SaganLaVoieHealthScience(617) [email protected] Media Andrew KordaLaVoieHealthScience(617) [email protected]

Recent Collaboration Agreement with Abbott Global Enterprises Limited ("Abbott") in support of Phase 3 randomized, multicenter study, entitled TECH-LVAD Recent FDA Type D Meeting provides additional guidance for advancing clinical development of tecarfarin Leadership appointments to strengthen development capabilities PONTE VEDRA, Fla., March 13, 2025--(BUSINESS WIRE)--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. "2024 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." Full Year 2024 Key Accomplishments and Recent Highlights Collaboration Agreement with Abbott On 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™ expertise. TECH-LVAD Trial Update On 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. Leadership Advances Cadrenal 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. Operational Milestones The 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. Strategic Development Collaborations Cadrenal 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. Financial Growth and Fundraising Success During 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. Industry Recognition and Engagement In 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. Orphan Drug Designation for Tecarfarin In 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). Scientific Advocacy and Clinical Evidence The 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. Financial Results Research 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. Cadrenal’s 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. About Cadrenal Therapeutics, Inc. Cadrenal 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. Cadrenal 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). Cadrenal 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. Safe Harbor 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." 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, or otherwise. (Tables to Follow)   View source version on businesswire.com: https://www.businesswire.com/news/home/20250313043048/en/ Contacts Corporate and Investor Relations Lisa DeScenzaLaVoieHealthScience(978) [email protected] Media Andrew KordaLaVoieHealthScience(617) [email protected]