Espero Pharmaceuticals, Inc.

PONTE VEDRA, Fla., Feb. 8, 2024 /PRNewswire/ -- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a novel Vitamin K Antagonist (VKA) for unmet needs in anticoagulation (blood thinning) therapy, today announced the appointment of Jeff Cole to the newly created position of Chief Operating Officer. In this role, Mr. Cole will be responsible for the Company's manufacturing and supply chain operations, intellectual property, commercialization strategies, and supporting partnering activities for tecarfarin. Mr. Cole brings over 25 years of experience in global pharmaceutical manufacturing and commercial operations, finance, and corporate development to the Company. This includes senior executive roles at both private and publicly-traded companies such as Espero BioPharma, Valeant Pharmaceuticals International (now Bausch Health Companies), and Legacy Pharmaceuticals. Mr. Cole co-founded Espero, a biopharmaceutical company focusing on the late-stage development and commercialization of medicines to treat cardiovascular diseases, and served as Board Director, President, and Chief Financial Officer where he was responsible for the company's supply chain, commercialization, and multiple licensing and M&A transactions. "Jeff is an extremely accomplished pharmaceutical operations executive with a deep understanding of product development, manufacturing, and commercialization. His experience will serve Cadrenal well as we advance our tecarfarin clinical program and evaluate partnering opportunities," commented Quang Pham, Founder, Chairman and Chief Executive Officer of Cadrenal Therapeutics. While at Valeant, Mr. Cole held roles of increasing responsibility, including as General Manager, Vice President of Corporate Development, and Chief Financial Officer of North America, where revenue more than tripled during his tenure. As General Manager at Valeant, Mr. Cole managed a division of U.S. prescription and OTC products across multiple therapeutic areas with responsibility for product development, supply, and commercial operations. Prior to the pharmaceutical industry, Mr. Cole served as Principal in the Financial Management Consulting practice at PricewaterhouseCoopers. "I am excited to be joining the team at Cadrenal at a pivotal time when demand is increasing for a new anticoagulation therapy to address the unmet needs for patients with left ventricular assist devices (LVADs), antiphospholipid syndrome (APS), and those with end-stage kidney disease (ESKD) and atrial fibrillation (AFib)," added Jeff Cole. "I look forward to leveraging my experience to advance tecarfarin to the market and help those underserved patient groups." Mr. Cole holds an MBA with honors from the University of Michigan and a BS in accounting from the University of Southern California. 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 certain medical 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 Mr. Cole's experience serving the Company well as it advances its tecarfarin clinical program and evaluates partnering opportunities and leveraging Mr. Cole's experience to advance tecarfarin to the market and help underserved patient groups. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the expected contribution from Mr. Cole and the ability to advance tecarfarin with patients with left ventricular assist devices (LVADs), thrombotic APS, and those with AFib and ESKD and the other risk factors described in the Company's Annual Report on Form 10-K for the year ended December 31, 2022, and the Company's subsequent filings with the SEC, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise. For more information, please contact: Cadrenal Therapeutics: Matthew Szot, CFO 858-337-0766 [email protected] Investors: Lytham Partners, LLC Robert Blum, Managing Partner 602-889-9700 [email protected] SOURCE Cadrenal Therapeutics, Inc.

The Annual Conference Fuels Growth with a Focus on Elevating Florida's Position on the Global Stage PONTE VEDRA, Fla., Oct. 16, 2023 /PRNewswire/ -- The 26th BioFlorida Annual Conference united 500+ statewide leaders from Florida's life sciences industry, representing biopharmaceutical, medical technology, digital health, and health systems, globally recognized research universities and research institutions, investors, policymakers, and economic development agencies, to spotlight the momentum and success in science, business, and public policy and spur collaboration and future global growth for Florida's companies. BioFlorida also announced a strategic partnership with BIOQuébec aiming to facilitate collaboration and bolster industry growth in both regions. "Florida's life sciences continue to expand, further establishing Florida as a global life sciences destination – and today our industry represents 8,600 establishments and research organizations that employ nearly 107,000 Floridians," said Nancy K. Bryan, President and CEO of BioFlorida. "The BioFlorida Annual Conference provides us an opportunity to showcase recent innovations, spur collaborations, explore policy solutions to fuel future growth, and drive global excellence, which was front and center with the launch of our strategic partnership with BIOQuébec." Three distinct tracks – BioScience, BioTrends, and BioBusiness – explored topics ranging from inflammation and its impact on diseases; innovation in cell and gene therapies; next generation cancer treatments; advancements in neurodegeneration; breakthroughs in medical devices; drug delivery and pre-clinical testing; AI; post-pandemic workforce and facility planning; and financing insights. State Representative Karen Gonzalez Pittman also joined experts to discuss unlocking the potential of biomarkers and the state legislature's role from her perspective as sponsor of legislation to require insurance coverage for cancer biomarker testing. State Representative Kelly Skidmore also joined life science leaders at the Conference to collaborate on solutions to drive Florida's health care industry forward. All conversations were led by CEOs, executives, and top scientists and researchers from Florida-based companies, universities, research organizations, and health systems. Panels also explored collaborative opportunities to propel growth and innovation throughout the state and strategies for attracting global technology and companies to Florida. Prominent Florida company executives also shared their dos and don'ts for successful commercialization. Attendees heard from keynote speakers who drew from their personal experiences and passion for their work. W. Gregory Sawyer, PhD of the Moffitt Cancer Center discussed strategies for success in today's environment drawing from his work on the original Mars Rover design team at the NASA's Jet Propulsion Laboratory and his own fight with cancer which led to the establishment of his own Cancer Engineering Center at the University of Florida and the creation of Aurita Biosciences, a company connecting the lab to the clinical setting through a platform for 3D bioscience. Alfredo Quiñones-Hinojosa, MD, or Dr. Q, of the Mayo Clinic focused on global growth strategies. Dr. Q's journey took him from a challenging upbringing in Mexico to becoming a world-famous neurosurgeon developing leading, innovative research in brain cancer treatment. In addition to his clinical activities, Dr. Q leads NIH-funded research to find a cure for brain cancer. His cutting-edge research focuses on brain tumors and cell migration, health care disparities and clinical outcomes for neurosurgical patients in which the operating room is used as an extension for his research scenario. He has authored numerous high-impact scientific journal articles, chapters, abstracts, and books. The Spotlight on Innovation session showcased three companies that have exhibited transformational growth: Medtronic (Miami); iTolerance, Inc. (Miami); and Johnson & Johnson Vision (Jacksonville). Seed and early-stage companies competed in BioPitch, an opportunity for some of the state's most innovative companies to pitch to 35+ life sciences investors. Winners will receive cash prize totaling $50,000. BioFlorida received a record number of BioPitch applicants with HEMOTAG (Boca Raton), an innovative medical technology allowing detection of heart disease before symptoms occur, winning the BioPitch competition. Runners-up included EVQLV (Miami); Feldan Therapeutics (Quebec); and PriZm Therapeutics (University of Miami spin-off). K-Lab Therapeutics (Alachua), a company developing novel immunotherapies with the goal of curing advanced and metastatic solid cancers won the newly introduced "Moonshot" award recognizing promising, very early-stage companies. During the Conference, BioFlorida recognized individuals and organizations throughout six unique categories for their incredible achievements. This year's award recipients include: Researcher of the Year Award The Researcher of the Year award recognizes distinguished researchers whose achievements have significantly advanced scientific knowledge with a proven impact on innovation and public health. This year's award was presented to Stephen D. Nimer, M.D., director of the National Cancer Institute (NCI)-designated Sylvester Comprehensive Cancer Center. He is also the executive dean for research and a professor of medicine, biochemistry, and molecular biology at the University of Miami Miller School of Medicine. Dr. Nimer is a physician scientist who has dedicated his career to the study and treatment of leukemia. During the last ten years, the focus of the Nimer lab has been on the epigenetic basis of acute myeloid leukemia (AML) and other myeloid malignancies. In the last year, Dr. Nimer began his second five-year Leukemia & Lymphoma Society Specialized Center of Research program (LLS SCOR) grant working with renowned investigators at Memorial Sloan Kettering Cancer Center and Dana-Farber Cancer Institute. This award supports a breadth of work from basic laboratory research to therapeutics in the clinic. Over the past 37 years, Dr. Nimer has also received continuous funding from the NIH. He has conducted clinical and laboratory research on bone marrow failure states and AML and participated in pivotal clinical trials that led to the FDA approvals of therapeutics for patients with myelodysplastic syndrome (MDS). Therapies are now being tested in patients based on targets identified in his lab. He has authored more than 250 peer-reviewed scientific publications, many in high-impact journals including Cell, Science, Nature, Nature Medicine, and Cancer Cell. Sylvester, which sits at the "gateway" to the Caribbean and Latin America, became an NCI-designated center in July 2019. In his time as director, Dr. Nimer has hired more than 250 world-class physicians and researchers, creating an environment of excellence and collaboration. Dr. Nimer currently holds the Oscar de La Renta Endowed Chair in Cancer Research. Deal of the Year Award The Deal of the Year Award recognizes a deal, whether it be an equity investment, key license agreement, significant grant award, or other agreement, with a significant impact on innovation, public health, and the deal-flow ecosystem within Florida's life sciences industry. The 2023 Deal of the Year Award was presented to Quang Pham, Chief Executive Officer of Cadrenal Therapeutics (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a late-stage novel oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes and deaths due to blood clots in patients with certain rare medical conditions. In 2021, he founded Cadrenal Therapeutics in Ponte Vedra and acquired tecarfarin from Horizon Technology Finance (Nasdaq: HRZN). Tecarfarin was invented by a chemist from the University of Florida. The Deal of The Year is Cadrenal's closing of its initial public offering (IPO) in January 2023, with the Company raising $7 million. Cadrenal Therapeutics was the first biopharma IPO of 2023 and the first-ever in Northeast Florida. Subsequently, the Company raised an additional $7.5 million in a private placement priced at-the-market under Nasdaq rules from a single institutional investor. The two offerings provided capital to the Company to continue to advance tecarfarin through its regulatory and developmental goals. Tecarfarin has FDA orphan drug and Fast Track designations. Quang Pham has significant business, mergers and acquisitions, and fundraising experience, as well as numerous interactions with the FDA and extensive knowledge of the pharmaceutical industry. He previously served as Chief Executive Officer of Espero BioPharma. He has a Bachelor of Arts in Economics from UCLA and served as a U.S. Marine Corps Officer. He is also a past recipient of the EY Entrepreneur of the Year and BioFlorida's Entrepreneur of the Year awards. Weaver H. Gaines Entrepreneur of the Year Award The Weaver H. Gaines Entrepreneur of the Year Award honors an individual who has made extraordinary contributions to the growth of Florida's life sciences industry. The 2023 Weaver H. Gaines Entrepreneur of the Year Award was presented to W. Greg Sawyer, Ph.D., Chief Bioengineering Officer at Moffitt Cancer Center. Dr. Sawyer is an mechanical engineer who started his career working with NASA on the first Mars rover. He later built instruments to evaluate nanocomposites in low Earth orbit as they were exposed to the space environment on the International Space Station. But in 2013 after a surprise late-stage metastatic cancer diagnosis, Dr. Sawyer shifted his focus to cancer bioengineering. His mission became finding a way to 3D print cancer and tumors in a way that could help researchers study how the disease grows and reacts to therapies. In 2015, while a professor at the University of Florida, Dr. Sawyer collaborated with students Jack Famiglietti and Ryan Smolcheck to develop a 3D culture platform to model to mimic human tissues and organs. Together, they founded Aurita Biosciences, which has developed several tools to expand the use of their 3D culture platform. This year, Dr. Sawyer joined Moffitt Cancer Center as the Chief Bioengineering Officer and Chair of its new Bioengineering Department. This new department is the first of its kind for any cancer center. Its goal of the department mimics Dr. Sawyer's focus nearly a decade ago – to accelerate cancer research by providing 3D cancer models to see how cells interact, metastasize and respond to therapies. A full circle moment that will help countless cancer patients here in Florida and beyond. The Department of Bioengineering will be one of the key basic science departments at Moffitt's Center for Innovation, a new 300,000-square-foot research facility in Speros, FL and designed to stimulate entrepreneurship. The cancer center broke ground on the Pasco County project in January. David J. Gury Company of the Year Award The David J. Gury Company of the Year Award honors a company that has achieved significant milestones and has contributed to the growth of Florida's life sciences industry. The 2023 David J. Gury Company of the Year Award was presented to Maurice R. Ferré MD, Chairman and CEO of the Board of Directors at Insightec, a global healthcare company dedicated to using acoustic energy to transform patient care. Founded in Haifa, Israel with headquarters in both Israel and Miami, Insightec has been a pioneer in focused ultrasound (FUS) technology for more than 25 years with a continued focus on realizing the therapeutic power of acoustic energy. The company's Exablate Neuro platform focuses sound waves, safely guided by MRI, to provide tremor treatment to patients with medication-refractory essential tremor and Parkinson's disease. Affecting approximately 60 million people globally, essential tremor is the most common movement disorder in the world and is often misdiagnosed. Essential tremor commonly affects both sides of the body, and in December 2022, Insightec received FDA approval to allow appropriate patients to have their second side treated at least nine months after treatment of the first side, potentially meaning tremor relief on both sides of the body. The technology also received a CE mark for second side treatment in European countries in 2023. Research for future applications in the neuroscience space is underway in partnership with leading academic and medical institutions including a new pivotal trial, known as LIBERATE (Liquid Biopsy with Low Intensity Ultrasound in Brain Tumors), designed to assess for the first time the clinical benefit of using low-intensity focused ultrasound to transiently increase the permeability of the BBB and enable incisionless liquid biopsy in brain tumors. Insightec is also exploring other treatment applications in the body, such as prostate disease and uterine fibroids. BioFlorida Leadership Award The BioFlorida Leadership Award recognizes the BioFlorida volunteer who has taken on a leadership role within the organization, dedicated significant time to BioFlorida's mission, and has acted as a true ambassador to BioFlorida and the industry. Juan Carlos Varela, Vice President and Senior Client Partner at Globant, was honored with the 2023 BioFlorida Leadership Award. With over 25 years of experience in healthcare, life sciences, and MedTech, Varela's strategic leadership at Globant, Medtronic, and Johnson & Johnson has consistently driven high-growth businesses and delivered substantial value for clients. Within BioFlorida, Varela's impact is deeply felt. From Board Member to Chairman of the Board and various other roles, his visionary contributions have been instrumental in shaping the organization's trajectory. His creation of the International Development Committee promises enduring value for BioFlorida, reflecting his forward-thinking vision. Varela's role as a connector of people has furthered the organization's mission, making him an invaluable ambassador, not only for BioFlorida but for the entire industry. BioFlorida Lifetime Achievement Award The BioFlorida Lifetime Achievement Award recognizes an individual's outstanding career achievements, leadership and contributions that have significantly contributed to the growth of his or her respective industry. This year we acknowledge the visionary leadership and remarkable contributions of Patrick J. McEnany, a distinguished co-founder, Chairman, President, and Chief Executive Officer of Catalyst Pharmaceuticals. McEnany has played a pivotal role since the Company's inception in January 2002, serving as CEO and a dedicated board member. His roles as Chairman and President were assumed in March 2006, marking a significant milestone in his exceptional leadership journey. Throughout his illustrious career and leadership journey, McEnany's accomplishments have been truly transformative. He founded Catalyst Pharmaceuticals in 2002 and successfully led the Company to go public in 2016, steering it toward remarkable growth. His consistent demonstration of exceptional vision, dedication, and unwavering commitment to enhancing the quality of life for individuals facing rare and challenging diseases has been remarkable. His pioneering spirit has been a driving force behind the company's success, including achieving a market capitalization of $1.3 billion. Under his guidance, Catalyst Pharmaceuticals has experienced substantial growth through successful product development and strategic acquisitions, enriching the company's product portfolio and contributing to an annual revenue base exceeding $200 million. McEnany's dedication extends well beyond the corporate realm, leaving a positive impact on both his immediate community in Coral Gables and the entire state of Florida. His achievements, exemplified by the well-deserved BioFlorida Lifetime Achievement Award, serve as a testament to his profound influence within the biotechnology field and the broader Florida community. His unwavering commitment to the community is evident through his active involvement in philanthropic ventures. He currently serves on the emeritus board of directors of the Jackson Health Foundation and the board of directors of the Humane Society of Greater Miami. For over three decades, he has generously shared his expertise as a director with numerous public companies, leveraging his extensive knowledge and leadership acumen to help drive their growth and prosperity. The Nancy K. Bryan Organizational Impact Award With the introduction of the Nancy K. Bryan Organizational Impact Award, BioFlorida celebrated the organization's progress but also the guidance of President and CEO, Nancy K. Bryan. Bryan's visionary leadership and commitment to innovation has left a lasting mark on BioFlorida's legacy, a testament to her extraordinary dedication over the past 11 years. Through pioneering initiatives and an unwavering commitment to member value, Bryan has elevated BioFlorida to unprecedented levels of achievement. BioFlorida's President & CEO, Nancy K. Bryan, has announced her retirement. The organization is in the process of identifying her successor. As the organization bids farewell to a chapter marked by Nancy's leadership, BioFlorida looks forward to a future of continued growth and impact. About BioFlorida BioFlorida is the voice of Florida's life sciences industry, representing 8,600 establishments and research organizations in BioPharma, MedTech, Digital Health, and Health Systems that collectively employ nearly 107,000 Floridians (Source: TEConomy/BIO). BioFlorida's member driven initiatives provide a strong business climate for the advancement of innovative products and technology that improve lives and promote economic benefits to the state. SOURCE BioFlorida

Los Angeles, USA, April 26, 2021 (GLOBE NEWSWIRE) -- Atrial Fibrillation Pipeline Drugs and Companies Insight Report: Analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments The global demand for Atrial Fibrillation treatment options is emerging swiftly, driven by consumption in major emerging markets. As more growth opportunities will surge, several companies such as ARCA biopharma, AbbVie, Hanmi Pharmaceutical, Espero BioPharma, Vivasc Therapeutics, HUYA Bioscience, Novartis, Acesion Pharma, and others are working on Atrial Fibrillation pipeline. DelveInsight’s “Atrial Fibrillation Pipeline Insight” report provides comprehensive insights about 17+ companies and 17+ pipeline drugs in the Atrial Fibrillation pipeline landscapes. It comprises Atrial Fibrillation pipeline drug profiles, including clinical and non-clinical stage products. It also includes the Atrial Fibrillation therapeutics assessment by product type, stage, route of administration, and molecule type and further highlights the inactive Atrial Fibrillation pipeline products. Some of the key takeaways of the Atrial Fibrillation Pipeline Report Get an overview of pipeline landscape @ Atrial Fibrillation Clinical Trials Analysis Atrial Fibrillation is an irregular heartbeat that can lead to blood clots, stroke, heart failure and other heart-related complications. The atria beat chaotically and irregularly out of coordination with the ventricles of the heart. Atrial Fibrillation Emerging Drugs Etripamil, the lead investigational product, is developed to be a rapid-response therapy for episodic cardiovascular conditions. The novel calcium channel blocker is self-administered through a nasal spray that may shift the current treatment paradigm for many patients with Paroxysmal supraventricular tachycardia (PSVT) in the emergency department to the at-home setting. Milestone is conducting a thorough development program for etripamil, with Phase 3 trials underway in PSVT, and intends to start a Phase 2 proof-of-concept trial in patients with atrial fibrillation with rapid ventricular rate, with subsequent studies anticipated in other conditions where calcium channel blockers are utilised. OMT-28 is a stable synthetic small molecule analogue of the natural omega-3 fatty acid metabolite 17, 18-EEQ, which has a structure optimised to confer efficacy, safety, and oral availability. The compound has shown its anti-arrhythmic, cardioprotective, and anti-fibrotic potential in different in vivo models. Presently, it is in phase 2 of clinical trials for the Atrial Fibrillation treatment. HBI-3000 is a multi-ion channel blocker with effects on INa-Peak, INa-Late, ICa, L, and IKr with similar in vitro potencies across these several ion channels in human atrial cardiomyocytes. It is being developed by HUYA Bioscience International® (HUYABIO™) for the conversion of recent-onset Atrial Fibrillation. It is currently undergoing phase 1 of clinical trials. It is based on the inhibition of SK channels - ion channels present in the atria that regulate the cardiac rhythm. Inhibiting these ion channels with a functionally atrial selective drug help avoid harmful effects on the ventricles. Targeting the SK channels thereby comprises a novel and promising approach for an effective treatment for Atrial Fibrillation with an anticipated higher safety and tolerability profile. For further information, refer to the detailed report @ Atrial Fibrillation Pipeline Therapeutics Scope of Atrial Fibrillation Pipeline Drug Insight Key Questions regarding Current Atrial Fibrillation Treatment Landscape and Emerging Therapies Answered in the Pipeline Report Table of Contents Get a customised pipeline report @ Atrial Fibrillation Drugs Pipeline Report Related Reports DelveInsight's Atrial Fibrillation - Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease and a depth understanding of historical and forecasted epidemiology. DelveInsight's Atrial Fibrillation - Epidemiology Forecast 2030 report delivers an in-depth understanding of the disease, historical, and forecasted epidemiology of Atrial Fibrillation in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. DelveInsight’s Atrial Flutter Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease and a depth understanding of historical and forecasted epidemiology. DelveInsight's Cystic fibrosis - Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease and a depth understanding of historical and forecasted epidemiology. DelveInsight’s Fibrocystic Breast Condition Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease and a depth understanding of historical and forecasted epidemiology. About DelveInsightDelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.  It also proffers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach.