Edoxaban Tosylate

PONTE VEDRA, Fla., March 11, 2024 /PRNewswire/ -- Cadrenal Therapeutics, Inc., (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a late-stage novel oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes and deaths due to blood clots in patients with rare cardiovascular conditions, today provided a corporate update in connection with the filing of its Annual Report on Form 10-K for the year ended December 31, 2023. Recent Highlights Expanded focus for tecarfarin development beyond end-stage kidney disease (ESKD) with atrial fibrillation (AFib), to include patients with implanted medical devices such as left ventricular assist devices (LVADs) for heart failure as well as for the treatment of patients with antiphospholipid syndrome (APS) who require chronic anticoagulation. These two new potential rare medical conditions increase the total addressable market for tecarfarin in excess of $2 billion in the U.S. annually. Engaged The Sage Group to assist the company in exploring strategic partnerships, co-development, and licensing agreements for tecarfarin. Appointed Jeff Cole to the newly created position of Chief Operating Officer, responsible for the Company's manufacturing and supply chain operations, intellectual property, commercialization strategies, and supporting partnering activities for tecarfarin. Engaged pharmaceutical contract development and manufacturing organizations (CDMOs) to supply active pharmaceutical ingredients (API) and clinical trial materials. Highlighted recent peer-reviewed article in the Journal of the American College of Cardiology (JACC) titled, "When Direct Oral Anticoagulants Should Not Be Standard Treatment" by Antoine Bejjani, MD, et.al examined the numerous medical conditions where direct oral anticoagulants (DOACs), such as Eliquis, Xarelto, Pradaxa, and Savaysa, should not be prescribed. The article is consistent with the evolving evidence documenting the need for improved VKA-based anticoagulant therapy. Tecarfarin is the only new molecular entity (NME) that has been developed specifically to address this need. Q4 2023 operating expenses (excluding non-cash items) totaled $1,160,000. Cash used in operating activities totaled $694,000 during Q4 2023. As of December 31, 2023, cash balances were $8.5 million. Recent Reports and Presentations Noble Capital Markets initiated equity research coverage on the Company with an "Outperform" rating and a price target of US$4.00 per share. The full report by Noble Capital Markets Senior Life Sciences Analyst Robert LeBoyer can be obtained from . Douglas Losordo, M.D., Chief Medical Officer of Cadrenal, participated in a fireside chat moderated by Joe Pantginis, Ph.D., Managing Director of Research at H.C. Wainwright & Co., at the Lytham Partners 2024 Investor Select Conference. The webcast can be accessed HERE. Company presented at Biotech Showcase™ 2024, alongside the J.P. Morgan 42nd Annual Healthcare Conference. Participated in the Technology and Heart Failure Therapeutics Conference (THT 2024), which is produced by the Cardiovascular Research Foundation (CRF). Filed updated corporate slide presentation in January 2024 highlighting the opportunity for tecarfarin. Quang Pham, Founder, Chairman and Chief Executive Officer of Cadrenal Therapeutics, commented, "We believe there is a significant unmet need and market opportunity for tecarfarin in patients with rare cardiovascular conditions requiring chronic anticoagulation. Specifically, there is a lack of approved anticoagulation therapies for patients with left ventricular assist devices (LVADs), patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib), and patients with thrombotic anti-phospholipid syndrome (APS)." "During the past year, an increasing number of industry articles and presentations have concurred with our positioning, which we believe enhances our opportunity from both a regulatory and commercial perspective. We have enhanced our intellectual property protection through the application and receipt of orphan drug designations, which provides for 7 years of market exclusivity, engaged industry leaders to explore strategic partnerships, co-development and licensing agreements for tecarfarin, and have expanded our manufacturing and supply chain capabilities in preparation of an expected pivotal trial. These activities pave the way for what we believe will be an exciting year for Cadrenal." ABOUT CADRENAL THERAPEUTICS, INC. Cadrenal Therapeutics is developing tecarfarin for unmet needs in anticoagulation therapy. Tecarfarin is a late-stage novel oral and reversible anticoagulant (blood thinner) to prevent heart attacks, strokes, and deaths due to blood clots in patients with rare cardiovascular conditions. Tecarfarin has orphan drug and fast track designations from the FDA for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib). Cadrenal is also pursuing additional regulatory strategies for unmet needs in anticoagulation therapy for patients with left ventricular assist devices (LVADs) and those with thrombotic antiphospholipid syndrome (APS). Tecarfarin is specifically designed to leverage a different metabolism pathway than the oldest and most commonly prescribed Vitamin K Antagonist (warfarin). Tecarfarin has been evaluated in eleven (11) human clinical trials and more than 1,000 individuals. In Phase 1, Phase 2, and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic kidney disease. For more information, please visit: . Safe Harbor Statement 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." These statements include statements regarding the two new potential rare medical conditions increasing the total addressable market for tecarfarin to in excess of $2 billion in the U.S. annually, exploring strategic partnerships, co-development, and licensing agreements for tecarfarin, there being a significant unmet need and market opportunity for tecarfarin in patients with rare cardiovascular conditions requiring chronic anticoagulation, the increasing number of industry articles and presentations having concurred with the Company's positioning, enhancing the Company's opportunity from both a regulatory and commercial perspective, engaging industry leaders to explore strategic partnerships, co-development and licensing agreements for tecarfarin, 2024 being an exciting year . The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, the ability to enter into strategic partnerships, the ability to treat patients with rare cardiovascular conditions requiring chronic anticoagulation with tecarfarin, the ability to enhance the Company's opportunity from both a regulatory and commercial perspective and the other risk factors described in the Company's Annual Report on Form 10-K for the year ended December 31, 2023, and the Company's subsequent filings with the SEC, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise. For more information, please contact: Cadrenal Therapeutics: Matthew Szot, CFO 858-337-0766 [email protected] Investors: Lytham Partners, LLC Robert Blum, Managing Partner 602-889-9700 [email protected] SOURCE Cadrenal Therapeutics, Inc.

An expansion process has already kicked off in Germany, with work on the project expected to wrap up by 2030 “at the latest,” Daiichi Sankyo said last week. After laying out plans to absorb a pair of production subsidiaries in October, Japan’s Daiichi Sankyo is doubling down on its quest to dominate the red-hot antibody-drug conjugate (ADC) field. Aiming to create an “international innovation center,” Daiichi is plugging roughly 1 billion euros ($1.08 billion) into an expansion of its production and development site in Pfaffenhofen an der Ilm, just north of the company’s European headquarters in Munich. The project—which is expected to create at least 350 new jobs by 2030—will equip the site to develop and manufacture future ADCs targeting malignancies like breast, lung and stomach cancers, Daiichi said in a recent press release. The expansion process has already kicked off, with work on the project expected to wrap up by 2030 “at the latest,” Daiichi said. The new ADC infrastructure being added at Pfaffenhofen is slated for completion by the end of 2026. Once the site’s ADC facilities are up and running, Daiichi figures it will “most likely rise to the top league of biotech companies” in the region. With a legacy spanning more than 60 years, the Pfaffenhofen site contributes “significantly” to Daiichi Sankyo’s global production capacity, the company says on its European website. Traditionally, the site has focused on manufacturing and developing medicines for cardiovascular diseases, including the stroke, thrombosis and pulmonary embolism drug edoxaban and the olmesartan product line for hypertension. Aside from adding ADC capabilities, the expansion has been tipped to boost capacity for the Pfaffenhofen site’s bread-and-butter work in cardiovascular disease. The investment will also strengthen the site’s quality assurance and logistics and help bring more renewable energy online, Daiichi added. The site manufactures both active pharmaceutical ingredients and solid dose forms like tablets and film-coated capsules, which Daiichi ships from Pfaffenhofen to more than 50 countries. “The fact that we will focus more on oncological therapies in Pfaffenhofen in the future is positive in two respects,” Matthias Kühn, Daiichi’s site manager at the facility, said in a statement. “On the one hand, we can make a significant contribution to the increased global demand for ADC cancer therapies. On the other hand, we are demonstrating our future viability and the top quality that we provide here.” The ADC field has been on the rise in recent years, yielding investments and acquisitions across the biopharma industry. While companies like Pfizer and Roche originally beat Daiichi to the regulatory finish line with their own ADCs, Daiichi and its AstraZeneca-partnered treatment Enhertu helped put the modality on the map. Daiichi is slated to keep that winning streak rolling through the rest of the decade, too, analysts at GlobalData predicted last summer. The analysts expect Daiichi’s ADC sales will top $10 billion by 2029, well ahead of the respective $5.8 billion and $3.6 billion GlobalData figures Seagen and Roche will generate with their ADCs in that same span. Looking beyond its pipeline and portfolio, Daiichi charted another ADC manufacturing move last fall when it unveiled an absorption-type merger of two of its subsidiaries—Daiichi Sankyo Propharma and Daiichi Sankyo Chemical Pharma—which is expected to go into effect on April 1, 2025. At the time, Daiichi said the merger was necessary to “stably supply” ADCs and accelerate the development of new modalities.