Florida-based Dyadic develops precision-engineered, animal-free proteins and enzymes for the life sciences, food and nutrition and industrial sectors. The company has already established relationships with a range of prospective partners and customers in Europe and sees substantial potential for its technologies in the region as it seeks to expand the commercial adoption of its recombinant protein technologies and establish new partnerships across life sciences markets.

Intralink is a business development consultancy which specialises in helping companies secure customers, partners and investors in overseas markets. It has a presence in 27 locations including Silicon Valley, Boston, London, Paris, Düsseldorf, Poznań, Tokyo, Shanghai, Taipei, Bangkok and New Delhi.

Intralink’s appointment to support Dyadic in Europe builds on the business development programmes it is already running on the company’s behalf in Japan and South Korea, which have created new strategic relationships and generated a range of significant commercial opportunities.

Initially, Dyadic aims to introduce two flagship products to the European market: DNase I (RNase-free), an enzyme used in biologics and mRNA manufacturing, and Human Transferrin, a recombinant form of transferrin widely used in research and cell culture media for biopharmaceutical production.

Intralink’s Europe-based team will deliver a targeted campaign to identify, prioritise and engage potential partners, distributors and customers. It will focus primarily on European reagent distributors, together with companies operating in the pharmaceutical and biotechnology sectors. The team’s goal is to strengthen Dyadic’s existing relationships, while securing additional direct supply partners, platform licensing opportunities and strategic collaborations.

Joe Hazelton, President & Chief Operating Officer of Dyadic Applied BioSolutions, said: “European pharma, biotech and life science companies are increasingly focused on improving manufacturing efficiency, securing reliable supply chains and transitioning towards high-performance animal-free components. Our recombinant protein platforms and wider product portfolio are designed to address these needs by enabling the scalable, cost-effective production of complex proteins and enzymes.

“We see significant opportunities in Europe for our commercial recombinant products, including DNase I and Human Transferrin, as well as for broader strategic collaborations involving strain licensing, platform access and custom protein development programmes.”

He added: “Following the strong engagement and increasing commercial interest in our products generated by Intralink in Japan and South Korea, we believe the company’s deep sector expertise and established European networks make it the ideal partner to now help us expand our footprint across this region, too.
“We look forward to building new relationships with European distributors, manufacturers and biotech innovators seeking next-generation recombinant production solutions.”

Dr Corey Monteith, a specialist in Intralink’s Medtech & Life Sciences Practice, explained: “Biotech and pharma companies across Europe are seeking partnerships and investment opportunities with innovative global businesses like Dyadic that offer the potential to produce high-quality products efficiently and at scale.

“We’re looking forward to helping Dyadic to build on the significant interest it has already established across Europe and to grow its presence in this essential biotech market.”

For more media information, interviews or images, please contact:
Rebecca George: rebecca.george@tk-associates.com | +44 7974 161 108

March 11, 2025


TAMPA, Fla. — Moffitt Cancer Center, a leading National Cancer Institute-designated comprehensive cancer center, and its wholly owned subsidiary SPEROS FL, a 775-acre global innovation campus in Pasco County, today announced Josh Carpenter, D.Phil., as the president of Speros and Moffitt’s chief integration officer. Carpenter, an accomplished leader with a proven track record in economic development and research commercialization, will lead Speros as it evolves into a premier destination for life sciences and biotechnology.

As president of Speros, Carpenter will unite Speros and Moffitt’s clinical and research expertise with commercial partners to accelerate breakthroughs in cancer prevention and treatment. Carpenter will also serve as the chief integration officer and vice president for Moffitt, overseeing strategic alignment between the cancer center and Speros. Carpenter’s leadership will be instrumental in transforming the campus into the premier Southeast location for breakthroughs and treatments requiring a creative blend of space, specialized equipment, talent and expertise — all bolstered by Moffitt’s legacy of innovation.

“Dr. Carpenter brings a rare blend of visionary leadership and economic expertise that will propel Speros into its next phase of growth,” said Patrick Hwu, M.D., president and CEO of Moffitt. “With his guidance, we will shape Speros into a global model for groundbreaking discoveries and patient outcomes.”

“We are delighted to welcome Dr. Carpenter to our mission. Speros is an ambitious endeavor that requires bold thinking, strategic vision and a relentless commitment to innovation — qualities that define Dr. Carpenter’s leadership,” said Marty Lanahan, Speros Board of Directors chair. “His ability to launch large-scale initiatives, develop strategic partnerships and secure critical investments will be invaluable as we unlock the full potential of Speros.”

Carpenter brings a strong background in translational research, biotech commercialization and economic development to his role. Most recently, he served as president and CEO of Southern Research, a nonprofit research institute dedicated to drug discovery, genomic data science and biotechnology. Under his leadership, the institute secured over $100 million in capital to modernize lab space and advance biotech initiatives, including the creation of a clinical-genomic database to expand clinical trial access for underserved communities. During his tenure, Carpenter also spearheaded efforts that awarded $44 million in federal funding to establish Birmingham as a designated Regional Tech Hub.

Prior to Southern Research, Carpenter was a senior executive in the city of Birmingham, where he led economic and real estate development initiatives. His work included launching the Birmingham Promise, which raised $24 million to fund apprenticeships and scholarships for public school students. He has also held leadership and faculty roles at the University of Alabama at Birmingham and was a nonresident senior fellow at the Brookings Institution. Recognized as one of Birmingham’s most influential executives, Carpenter has published research on economic development, workforce policy and public health.

A Rhodes scholar, Carpenter holds a doctorate in political economy from the University of Oxford. He has served on multiple national advisory boards, including the National Academy of Sciences’ STEMM Workforce Committee and the Association of American Rhodes Scholars. Known for his leadership in economic competitiveness and health policy, Carpenter is committed to advancing scientific research, fostering public-private partnerships and improving access to health care solutions.

“Speros is a derivative of a Latin word that means ‘to hope,’” Carpenter said. “At Speros, we’re bringing hope to cancer patients and their families. Hope for scientists on the verge of breakthroughs who need industry collaboration. Hope for physicians who want to integrate innovation into their daily practice. Hope for bringing quality jobs to Pasco County and securing Florida’s place in the global bioeconomy. Speros makes this hope possible. Together with Moffitt and our industry partners, we will build a place where science, technology and medicine unite to create a healthier future for all.”

About Moffitt Cancer Center

Moffitt is dedicated to one lifesaving mission: to contribute to the prevention and cure of cancer. The Tampa-based facility is one of only 57 National Cancer Institute-designated Comprehensive Cancer Centers, a distinction that recognizes Moffitt’s scientific excellence, multidisciplinary research, and robust training and education. Moffitt’s expert nursing staff is recognized by the American Nurses Credentialing Center with Magnet® status, its highest distinction. For more information, call 1-888-MOFFITT (1-844-495-1371), visit MOFFITT.org, and follow the momentum on Facebook, X, Instagram and YouTube.

About SPEROS FL

Speros FL is a 775-acre campus in Pasco County, Florida, designed to accelerate cancer prevention and treatment through strategic industry partnerships and by forging collaborative space for scientific research and clinical care. Propelled by Moffitt Cancer Center, Speros imagines a new frontier for research and development with a mission-driven real estate venture where groundbreaking discoveries become lifesaving treatments. For more information, visit SperosFL.org.

March 11, 2025


TAMPA, Fla. — Moffitt Cancer Center, a leading National Cancer Institute-designated comprehensive cancer center, and its wholly owned subsidiary SPEROS FL, a 775-acre global innovation campus in Pasco County, today announced Josh Carpenter, D.Phil., as the president of Speros and Moffitt’s chief integration officer. Carpenter, an accomplished leader with a proven track record in economic development and research commercialization, will lead Speros as it evolves into a premier destination for life sciences and biotechnology.

As president of Speros, Carpenter will unite Speros and Moffitt’s clinical and research expertise with commercial partners to accelerate breakthroughs in cancer prevention and treatment. Carpenter will also serve as the chief integration officer and vice president for Moffitt, overseeing strategic alignment between the cancer center and Speros. Carpenter’s leadership will be instrumental in transforming the campus into the premier Southeast location for breakthroughs and treatments requiring a creative blend of space, specialized equipment, talent and expertise — all bolstered by Moffitt’s legacy of innovation.

“Dr. Carpenter brings a rare blend of visionary leadership and economic expertise that will propel Speros into its next phase of growth,” said Patrick Hwu, M.D., president and CEO of Moffitt. “With his guidance, we will shape Speros into a global model for groundbreaking discoveries and patient outcomes.”

“We are delighted to welcome Dr. Carpenter to our mission. Speros is an ambitious endeavor that requires bold thinking, strategic vision and a relentless commitment to innovation — qualities that define Dr. Carpenter’s leadership,” said Marty Lanahan, Speros Board of Directors chair. “His ability to launch large-scale initiatives, develop strategic partnerships and secure critical investments will be invaluable as we unlock the full potential of Speros.”

Carpenter brings a strong background in translational research, biotech commercialization and economic development to his role. Most recently, he served as president and CEO of Southern Research, a nonprofit research institute dedicated to drug discovery, genomic data science and biotechnology. Under his leadership, the institute secured over $100 million in capital to modernize lab space and advance biotech initiatives, including the creation of a clinical-genomic database to expand clinical trial access for underserved communities. During his tenure, Carpenter also spearheaded efforts that awarded $44 million in federal funding to establish Birmingham as a designated Regional Tech Hub.

Prior to Southern Research, Carpenter was a senior executive in the city of Birmingham, where he led economic and real estate development initiatives. His work included launching the Birmingham Promise, which raised $24 million to fund apprenticeships and scholarships for public school students. He has also held leadership and faculty roles at the University of Alabama at Birmingham and was a nonresident senior fellow at the Brookings Institution. Recognized as one of Birmingham’s most influential executives, Carpenter has published research on economic development, workforce policy and public health.

A Rhodes scholar, Carpenter holds a doctorate in political economy from the University of Oxford. He has served on multiple national advisory boards, including the National Academy of Sciences’ STEMM Workforce Committee and the Association of American Rhodes Scholars. Known for his leadership in economic competitiveness and health policy, Carpenter is committed to advancing scientific research, fostering public-private partnerships and improving access to health care solutions.

“Speros is a derivative of a Latin word that means ‘to hope,’” Carpenter said. “At Speros, we’re bringing hope to cancer patients and their families. Hope for scientists on the verge of breakthroughs who need industry collaboration. Hope for physicians who want to integrate innovation into their daily practice. Hope for bringing quality jobs to Pasco County and securing Florida’s place in the global bioeconomy. Speros makes this hope possible. Together with Moffitt and our industry partners, we will build a place where science, technology and medicine unite to create a healthier future for all.”

About Moffitt Cancer Center

Moffitt is dedicated to one lifesaving mission: to contribute to the prevention and cure of cancer. The Tampa-based facility is one of only 57 National Cancer Institute-designated Comprehensive Cancer Centers, a distinction that recognizes Moffitt’s scientific excellence, multidisciplinary research, and robust training and education. Moffitt’s expert nursing staff is recognized by the American Nurses Credentialing Center with Magnet® status, its highest distinction. For more information, call 1-888-MOFFITT (1-844-495-1371), visit MOFFITT.org, and follow the momentum on Facebook, X, Instagram and YouTube.

About SPEROS FL

Speros FL is a 775-acre campus in Pasco County, Florida, designed to accelerate cancer prevention and treatment through strategic industry partnerships and by forging collaborative space for scientific research and clinical care. Propelled by Moffitt Cancer Center, Speros imagines a new frontier for research and development with a mission-driven real estate venture where groundbreaking discoveries become lifesaving treatments. For more information, visit SperosFL.org.

Beth Lindsay-Wood has joined Moffitt Cancer Center as the new senior vice president, chief informatics and technology officer (CITO). She is responsible for shaping and executing the organization’s overall technology strategy and operations. This includes aligning technology initiatives with business goals, driving transformation and ensuring that technology investments deliver maximum value to our patients and the organization with speed and agility.  

Lindsay-Wood oversees Moffitt’s IT infrastructure, clinical informatics, cybersecurity and IT applications throughout the enterprise. 

Lindsay-Wood brings more than 30 years of CIO/IT executive leadership experience to this role, including a senior executive role in IT at Tampa General Hospital, Sentara Healthcare and the City of Hope. She previously served as Moffitt’s chief information officer from 2020 to 2022, leading our information technology teams through a period of exceptional growth during the pandemic. As a partner in a health care consulting firm, she has provided strategic consulting services to large health care systems and cancer centers across the county, leading transformative clinical and business initiatives. 

Lindsay-Wood holds a bachelor’s degree in management information systems from the University of Tampa and a master’s degree in business administration from Troy University.

About Moffitt Cancer Center
Moffitt is dedicated to one lifesaving mission: to contribute to the prevention and cure of cancer. The Tampa-based facility is one of only 57 National Cancer Institute-designated Comprehensive Cancer Centers, a distinction that recognizes Moffitt’s scientific excellence, multidisciplinary research, and robust training and education. Moffitt’s expert nursing staff is recognized by the American Nurses Credentialing Center with Magnet^® status, its highest distinction. For more information, call 1-888-MOFFITT (1-888-663-3488), visit MOFFITT.org, and follow the momentum on Facebook, Twitter, Instagram and YouTube.

###

August 08, 2024 07:05 ET| Source: Axogen, Inc.

• The Board of Directors appoints Michael Dale as new CEO and Director, effective August 9, 2024
  
• Dale replaces Karen Zaderej, who will remain in an advisory role for nine months
• Current Member of the Board, Paul Thomas, will be the new Chairman of the Board, effective August 9, 2024
  

ALACHUA, Fla. and TAMPA, Fla., Aug. 08, 2024 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced that Michael Dale is appointed as chief executive officer and as a member of the Axogen Board of Directors effective August 9, 2024. He succeeds Karen Zaderej, who will remain in an advisory role for nine months.

The move aligns the executive team with the Company’s needs going forward as Axogen focuses on commercial expansion, broad-based revenue growth, and driving toward sustainable positive cash flow and profitability.

“On behalf of the Board of Directors, I offer my deep gratitude to Karen for her contributions over the past 18 years. Karen was integral to Axogen’s accomplishments and the development of the peripheral nerve repair market,” commented Amy Wendell, Axogen’s Lead Director. “The Board appreciates her countless contributions and wishes her well in her future endeavors.”

“We are thrilled to welcome Michael Dale as our new CEO and a director on our board. His strong track record as a global medical technology company executive makes him the right leader to advance Axogen’s mission to revolutionize the science of nerve repair. He brings a wealth of experience in strategic leadership, innovation, and operational excellence,” Wendell added.

An accomplished medical device executive, Mr. Dale has over 30 years of experience leading transformative, high-technology medical device companies in the cardiovascular, neuromodulation, diabetes, and electrophysiology markets. His past executive leadership roles span both public and private medical device companies.

“It is with pride and excitement that I embark today on a new mission as leader of Axogen,” commented Michael Dale. “I have been fortunate to be a part of many great healthcare businesses throughout my career. Each has been dedicated to fulfilling a credible business purpose based on unique advantages, hallmarks of a successful business. Axogen’s technologies and dedication to restoring peripheral nerve health and improving quality of life for patients who have lost sensory and or motor control function through trauma or disease embodies a unique combination of credible purpose and technological advantage. This is why I am excited to join Axogen.”

Dale continued, “To our shareholders and every stakeholder, my commitment on behalf of Axogen is to build upon our strong foundation by establishing the necessary objectives, strategies, and processes to attain profitably, standard-of-care status and ensure the fulfillment of our mission.”

Axogen has also named Paul Thomas as Chairman of the Board of Directors, effective August 9, 2024. Paul has served as a member of the Board since 2020 and has over 30 years of leadership experience in the healthcare industry.

“Paul has been an important contributor to the Board and has provided invaluable guidance to the Axogen leadership team,” said Wendell. “The Board is pleased with his appointment to Chairman, and we look forward to our continued collaboration. Together, we will support Micheal in executing on Axogen’s strategic priorities, mission, and vision.

“My conviction in Axogen continues to strengthen and I am honored to serve as Chairman of the Board at this critical juncture," remarked Paul Thomas. "I am encouraged by the strong foundation we built within the Company and look forward to working closely with Michael, the Board, and the leadership team as the Company narrows its focus on commercial expansion, broad-based revenue growth, and driving toward sustainable positive cash flow and profitability.”

In connection with commencement of Mr. Dale’s employment on August 9, 2024, and as a material inducement of employment under NASDAQ Listing Rule 5635(c)(4), Mr. Dale was granted 600,000 performance stock units (“PSUs”). Shares representing 450,000 PSUs will vest according to performance metrics tied to the achievement of Company stock price goals between February 22, 2024 and ending February 22, 2027 (“TSR PSUs”). Mr. Dale will earn from 0% to 200% of the TSR PSUs upon achievement of specific Company stock price goals. Shares representing 150,000 PSUs will fully vest upon approval of the Company’s biologics license application for Avance Nerve Graft® during the performance period beginning from January 1, 2024 and ending December 31, 2025.

About Axogen
Axogen (AXGN) is the leading Company focused specifically on the science, development, and commercialization of technologies for peripheral nerve regeneration and repair. Axogen employees are passionate about helping to restore peripheral nerve function and quality of life to patients with physical damage or transection to peripheral nerves by providing innovative, clinically proven, and economically effective repair solutions for surgeons and health care providers. Peripheral nerves provide the pathways for both motor and sensory signals throughout the body. Every day, people suffer traumatic injuries or undergo surgical procedures that impact the function of their peripheral nerves. Physical damage to a peripheral nerve, or the inability to properly reconnect peripheral nerves, can result in the loss of muscle or organ function, the loss of sensory feeling, or the initiation of pain.

Axogen's platform for peripheral nerve repair features a comprehensive portfolio of products used across various applications and surgical specialties, including traumatic injuries, oral and maxillofacial surgery, breast reconstruction, and the surgical treatment of pain. These applications encompass both scheduled and emergent procedures. Specifically, scheduled procedures are often pursued by patients seeking relief from conditions caused by a nerve defect or previous surgical interventions. Such procedures include providing sensation for women undergoing breast reconstruction following a mastectomy, nerve reconstruction after the surgical removal of painful neuromas, and oral and maxillofacial procedures, as well as nerve decompression. Conversely, emergent procedures typically arise from injuries that initially present in an emergency room, with specialists intervening either immediately or within a few days following the initial injury. This broad range of applications underscores Axogen’s vital role in addressing diverse patient needs in peripheral nerve repair.

Axogen's platform for peripheral nerve repair features a comprehensive portfolio of products, including Avance® Nerve Graft, a biologically active off-the-shelf processed human nerve allograft for bridging severed peripheral nerves without the comorbidities associated with a second surgical site; Axoguard Nerve Connector®, a porcine submucosa extracellular matrix (ECM) coaptation aid for tensionless repair of severed peripheral nerves; Axoguard Nerve Protector®, a porcine submucosa ECM product used to wrap and protect damaged peripheral nerves and reinforce the nerve reconstruction while preventing soft tissue attachments; Axoguard HA+ Nerve Protector™, a porcine submucosa ECM base layer coated with a proprietary hyaluronate-alginate gel, a next-generation technology designed to enhance nerve gliding and provide short- and long-term protection for peripheral nerve injuries; Avive+ Soft Tissue Matrix™, a multi-layer amniotic membrane allograft used to protect and separate tissues in the surgical bed during the critical phase of tissue repair; and Axoguard Nerve Cap®, a porcine submucosa ECM product used to protect a peripheral nerve end and separate the nerve from the surrounding environment to reduce the development of symptomatic or painful neuroma. The Axogen portfolio of products is available in the United States, Canada, the United Kingdom, South Korea, and several other European and international countries.

For more information, visit www.axogeninc.com.

June 25, 2024 07:30 ET| Source: Zevra Therapeutics

Rahsaan W. Thompson appointed as Chief Legal Officer, Secretary and Compliance Officer

Alison Peters appointed as Chief People Officer

CELEBRATION, Fla., June 25, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra or the Company), a rare disease therapeutics company, today announced the appointments of Rahsaan W. Thompson as Chief Legal Officer, Secretary and Compliance Officer, and Alison Peters as Chief People Officer. Both Mr. Thompson and Ms. Peters bring deep expertise in building high-performing teams which will be essential to deliver success through the Company's next phase of growth.

“We are thrilled to welcome both Rahsaan and Alison to the Zevra team as we continue the expansion and progress of our rare disease portfolio,” said Neil F. McFarlane, President and Chief Executive Officer of Zevra. “Their roles will be instrumental to driving our evolution into a leading rare disease therapeutics company.”

Mr. Thompson’s extensive experience handling domestic and international agreements and transactions, alongside his skills in litigation, government affairs, SEC compliance, and commercial management, make him well-poised to serve as Chief Legal Officer for Zevra. Ms. Peters brings a wealth of experience in executive coaching, culture design, and HR operations, making her an invaluable addition to our leadership team with a track record of high performance through progressive people strategies. Combined, their expertise in talent management and legal affairs will be instrumental as we continue to grow our commercial capabilities and advance the development of our rare disease assets.

“I am thrilled to join Zevra on their mission to provide novel therapeutics for unmet rare disease needs,” expressed Rahsaan Thompson. “I look forward to leveraging my diverse experience to support Zevra’s continued success.”

Mr. Thompson brings more than 25 years of experience as a business leader and attorney in the biotech industry. Mr. Thompson, previously the Chief Legal Officer at Lyell Immunopharma, a publicly traded and clinical-stage biotech corporation, has extensive experience handling corporate governance, clinical studies, intellectual property, licensing arrangements, and litigation, among other responsibilities. His knowledge of financing plans and partnerships as well as regulatory and compliance matters have led to his success throughout his career. Prior to his role at Lyell, he was the Executive Vice President, General Counsel, Corporate Secretary, and Chief Compliance Officer at Gritstone bio, a publicly traded, clinical-stage biotech company. He previously served as General Counsel at Opiant Pharmaceuticals and Actelion Pharmaceuticals. Earlier in his career, Mr. Thompson worked in General and Corporate Counsel roles at Quarles & Brady, Abraxis Bioscience, McKesson Corporation and Assistant District Attorney in the Philadelphia District Attorney’s Office. Mr. Thompson serves on the Board of Trustees for the Oakland Museum of California and formerly the American Kidney Fund. He received his J.D. from Hofstra University School of Law and his B.Sc. from Southern Methodist University. He has Bar Admissions in the States of Illinois, California, and Pennsylvania.

“I am pleased with the opportunity to join the Zevra team during this exciting time of growth for the company,” said Alison Peters. “As Zevra expands its footprint, I plan to leverage my expertise in talent acquisition and retention, as well as executive advisement and employee engagement, to promote a positive and effective company culture.”

Ms. Peters brings more than 20 years of experience in human capital management at biopharmaceutical and medtech companies. Ms. Peters was previously the Chief People Officer and Head of Corporate Communications at Scipher Medicine, a mid-sized precision medicine company, where she played a key role in shaping a culture of high performance through various talent management initiatives. Prior to that, she was the Human Capital Practice Lead at Dominis Group, a human capital and finance consulting firm, where she provided executive coaching on culture, performance, and change management. She previously served as Senior Director of Talent Management at Serica Technologies and VP of Human Resources at Quantia MD, leading HR services and ensuring talent acquisition and retention at each company. Earlier in her career, Ms. Peters worked in Talent Acquisitions and HR for PCI Corporation, Etex Corporation, Akamai Technologies, GTE Internetworking, and Fidelity Investments.

Inducement Awards

On June 21, 2024, the Compensation Committee of Zevra’s Board of Directors granted (i) to Mr. Thompson an inducement equity award consisting of a grant of 200,000 restricted stock units of Zevra’s common stock, vesting over three years, with 33 1/3% vesting on the first anniversary of Mr. Thompson’s start date, and the remainder vesting in two equal annual installments thereafter; (ii) to Ms. Peters an inducement equity award consisting of a grant of 150,000 restricted stock units of Zevra’s common stock, vesting over three years, with 33 1/3% vesting on the first anniversary of Ms. Peters’ start date, and the remainder vesting in two equal annual installments thereafter; and (iii) to three (3) individuals inducement equity awards consisting of restricted stock units to purchase an aggregate of 9,700 shares of Zevra’s common stock, vesting over three years, with 33 1/3% vesting on the first anniversary of each person’s respective start date, and the remainder vesting in two equal annual installments thereafter. The inducement awards were granted under the Zevra Therapeutics, Inc. 2023 Employment Inducement Award Plan (as amended and/or restated, the Inducement Award Plan) and, in each case, an award agreement thereunder.

The stock option awards were granted as inducement material to the individuals entering into employment with Zevra in accordance with Nasdaq Rule 5635(c)(4). The Inducement Award Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of Zevra, or following a bona fide period of non-employment, as an inducement material to such individuals’ entering into employment with Zevra.

About Zevra Therapeutics

Zevra Therapeutics is a rare disease company combining science, data, and patient needs to create transformational therapies for diseases with limited or no treatment options. Our mission is to bring life-changing therapeutics to people living with rare diseases. With unique, data-driven development and commercialization strategies, the Company is overcoming complex drug development challenges to make new therapies available to the rare disease community.

For more information, please visit www.zevra.com or follow us on X (formerly Twitter) and LinkedIn.

Cautionary Note Concerning Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts, including without limitation statements regarding the promise and potential impact of our preclinical or clinical trial data, the initiation, timing, design, or results of any clinical trials or readouts, the potential benefits of any of our products or product candidates for any specific disease indication or at any dosage. Forward-looking statements are based on information currently available to Zevra and its current plans or expectations. They are subject to several known and unknown uncertainties, risks, and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. These and other important factors are described in detail in the "Risk Factors" section of Zevra’s Annual Report on Form 10-K for the year ended December 31, 2023, Zevra’s quarterly report for the three months ended March 31, 2024, and Zevra’s other filings with the Securities and Exchange Commission. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we believe the expectations reflected in such forward-looking statements are reasonable, we cannot assure that such expectations will prove correct. These forward-looking statements should not be relied upon as representing our views as of any date after the date of this press release.

Zevra Contacts: 
Nichol Ochsner 
+1 (732) 754-2545 
nochsner@zevra.com 

Russo Partners Contacts
Adanna G. Alexander, Ph.D.
+1 (646) 942-5603
adanna.alexander@russopartnersllc.com
Ignacio Guerrero-Ros, Ph.D.
+1 (646) 942-5604
ignacio.guerrero-ros@russopartnersllc.com

Dr. Peacock to Oversee Upcoming Phase II Clinical Trial for Treating Concussion in the Emergency Department

May 22, 2024 08:00 ET| Source: OragenicsFollow

SARASOTA, Fla., May 22, 2024 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders, today announced it has appointed Dr. William “Frank” Peacock as its Chief Clinical Officer, who will conduct its anticipated Phase II clinical trial for treating concussion in the Emergency Department (“ED”). Oragenics’ lead drug candidate, ONP-002, is combined with its intranasal device intended for the treatment of mild Traumatic Brain Injury (mTBI), commonly known as concussion, in the field and emergency departments. ONP-002 is a new chemical entity (NCE) designed to target the brain through delivery into the nasal cavity and onward to the brain. A 40-patient Phase I study was completed and showed the drug to be safe and well-tolerated.

Dr. Peacock is currently the Vice Chair for Emergency Medicine Research at Baylor College of Medicine and a past Professor at the Cleveland Clinic Lerner College of Medicine. He is also the Principal Investigator of a trial for a company developing blood biomarkers for the identification of concussion in the emergency department, which is analyzing acute blood markers that are elevated after concussion to not only ensure concussion is identified but also as a predictor of potential severity and longer-term complications. Dr. Peacock is a world-renowned speaker and researcher. He has been instrumental in the approval and use of high sensitivity blood troponins for acute coronary syndrome failure in emergency settings, which can be seen in the JAMA Cardiology publication, Efficacy of High-Sensitivity Troponin T in Identifying Very-Low-Risk Patients with Possible Acute Coronary Syndrome, and he is the editor of the first book of “Biomarkers of Traumatic Brain Injury”.

“I am excited to join Oragenics as its Chief Clinical Officer at such an important and pivotal time in the company’s clinical program. I have been involved with concussion care in the emergency department throughout my 30-plus-year career. My role with the HeadSMART blood biomarker trial has shown me that we need biomarkers to trigger a treatment in the ER. We are searching for that treatment, and I am looking forward to testing ONP-002 to help determine if it can improve patient outcomes in our upcoming Phase II clinical trials,” said Dr. Peacock.

“We are fortunate to have such an esteemed emergency medicine physician and researcher join our team in this important role at Oragenics. Given his understanding of blood biomarkers, throughout his career, his intimate knowledge in emergency medicine protocols and close ties with leading enrollment centers for TBI clinical research, we believe he will play an invaluable role in the success of Oragenics and planned Phase II trials. We are currently working with Avance Clinical, CRO, for our Phase II trial,” stated Michael Redmond, President of Oragenics.

In preclinical animal models, ONP-002 has been shown to acutely improve molecular and behavioral outcomes following brain injury. In addition, intranasal delivery of the drug as a nanoparticle has been shown to enhance brain exposure and metabolism in animals. “Our Phase I human study has shown ONP-002 to be well tolerated in humans. The Phase II trial is designed to establish a time to first dose, relationships between drug application and blood biomarker levels, and the evaluation of patient symptom severity in the first few hours and days after injury,” said Dr. Peacock.

Concussion is an unmet medical need. There are an estimated 69 million concussions annually reported worldwide. Common causes of concussion include falls, motor vehicle accidents, and contact sports. Other neurological disorders, including Alzheimer’s Disease, Parkinson’s Disease, and Chronic Traumatic Encephalopathy (CTE), have been linked to concussion. Post-concussion syndrome is linked to long-term disability and occurs in as high as 20% of concussed patients.

About Oragenics
Oragenics is a development-stage biotechnology company focused on nasal delivery of pharmaceutical medications in neurology and fighting infectious diseases, including drug candidates for treating mild traumatic brain injury (mTBI), also known as concussion, and for treating Niemann Pick Disease Type C (NPC), as well as proprietary powder formulation and an intranasal delivery device. For more information, please visit www.oragenics.com.

Forward-Looking Statements
This communication contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the ability of the Company to timely and successfully undertake Phase II clinical trial using its novel drug-device combination for the treatment of mild Traumatic Brain Injury. These forward-looking statements are based on management’s beliefs and assumptions and information currently available. The words "believe," "expect," "anticipate," "intend," "estimate," "project" and similar expressions that do not relate solely to historical matters identify forward-looking statements. Investors should be cautious in relying on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. These factors include, but are not limited to: the Company’s ability to advance the development of its product candidates, including the neurology assets, under the timelines and in accord with the milestones it projects; the Company’s ability to raise capital and obtain funding, non-dilutive or otherwise, for the development of its product candidates; the regulatory application process, research and development stages, and future clinical data and analysis relating to its product candidates, including any meetings, decisions by regulatory authorities, such as the FDA and investigational review boards, whether favorable or unfavorable; the Company’s ability to obtain, maintain and enforce necessary patent and other intellectual property protection; the nature of competition and development relating to concussion treatments; the Company’s expectations as to the outcome of preclinical studies and clinical trials and the potential benefits, activity, effectiveness and safety of its product candidates including as to administration, transmission, manufacturing, storage and distribution; and general economic and market conditions and risks, as well as other uncertainties described in our filings with the U.S. Securities and Exchange Commission. All information set forth is as of the date hereof unless otherwise indicated. You should consider these factors in evaluating the forward-looking statements included and not place undue reliance on such statements. We do not assume any obligation to publicly provide revisions or updates to any forward-looking statements, whether as a result of new information, future developments or otherwise, should circumstances change, except as otherwise required by law.

Oragenics, Inc.
Janet Huffman, Chief Financial Officer
813-286-7900
jhuffman@oragenics.com

May 15, 2024 08:30 ET| Source: Veru Inc.Follow

MIAMI, FL, May 15, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle for high quality weight loss, oncology, and viral induced acute respiratory distress syndrome, today announced Steven B. Heymsfield, M.D., a Professor and the Director of the Body Composition-Metabolism Laboratory at the Pennington Biomedical Research Center in Baton Rouge, Louisiana, as the Principal Investigator for the Company’s Phase 2b clinical trial of enobosarm to preserve muscle while augmenting fat loss in patients receiving a GLP-1 RA for weight loss.

Dr. Heymsfield is a leading authority on body composition assessment and his research focuses primarily on human obesity, including energy balance regulation, weight loss treatments, co-morbidity effects, and development of related mathematical models. He has a long term-interest in the development of methods for evaluating body composition and the application of new technologies to the study of human metabolism.

Dr. Heymsfield received a degree in medicine from Mount Sinai School of Medicine, and he completed his internship, residency, and fellowship in pharmacology at Emory University. He then joined the Emory University School of Medicine faculty, holding positions there including Associate Professor of Medicine and Assistant Director of the NIH-funded Clinical Research Unit. Expanding on his interests in obesity and metabolism, Dr. Heymsfield next moved to Columbia University, College of Physicians and Surgeons and there he held positions as Professor of Medicine and Deputy Director, New York Obesity Research Center at St. Luke’s-Roosevelt Hospital. He and his Columbia colleagues conducted wide ranging clinical studies on obesity with a focus on energy metabolism, body composition, and pharmacologic weight control management. Prior to his Pennington Biomedical position, Dr. Heymsfield worked with Merck & Co. for 5 years, initially as Executive Director in the Obesity Group and then as Global Director of Scientific Affairs.

Dr. Heymsfield has published more than 600 peer-reviewed papers covering topics such as obesity, malnutrition, cachexia, body composition, and caloric expenditure. His contributions to the study of human nutrition led to the TOPS Award from The Obesity Society, the Rhoads Award from the American Society of Parenteral and Enteral Nutrition (ASPEN), the Robert H. Herman Memorial Award, American Society of Nutrition (ASN), the George Bray Founders Award from The Obesity Society, and he was honored for his role in the FDA ban on ephedra, receiving the 2004 NYC Mayor’s Award for Science and Technology. Dr. Heymsfield was elected Fellow of The Obesity Society in 2014, and he is an honorary member of the American Dietetic and Chilean Clinical Nutrition Associations. Dr. Heymsfield is past president of ASPEN and ASN and he is vice-president of The Obesity Society.

As the Principal Investigator for the Company’s enobosarm Phase 2b clinical trial, Dr. Heymsfield will lead the clinical trial sites. He will also participate in the study analysis and contribute to reporting the results to the FDA and scientific journals and meetings.

“I am pleased to serve as the Principal Investigator for this important Phase 2b enobosarm clinical trial. I am enthusiastic to be participating in enobosarm’s development, a medicine that has a novel established mechanism of action that has the potential to improve the quality of weight loss for these patients,” said Steven Heymsfield, MD, a Professor and the Director of the Body Composition-Metabolism Laboratory at the Pennington Biomedical Research Center in Baton Rouge, Louisiana.

"Dr. Heymsfield is an expert in body composition and obesity and an ideal clinical leader to serve as the Principal Investigator of the enobosarm Phase 2b clinical trial," said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru Inc. “Veru is proud to have Dr. Heymsfield as our partner with the enobosarm clinical trial. There is a significant unmet medical need for patients undergoing weight loss treatments with GLP-1 RAs to address the issue of muscle loss. We believe enobosarm could potentially be a great addition for patients to make their weight loss journey as healthy as possible. We look forward to enrolling this Phase 2b clinical trial expeditiously with data expected by year-end."

About the Enobosarm Phase 2b clinical trial
The Phase 2b, multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial is designed to evaluate the safety and efficacy of enobosarm 3mg, enobosarm 6mg, or placebo as a treatment to preserve muscle and augment fat loss in approximately 90 patients with sarcopenic obesity or overweight elderly (>60 years of age) patients receiving semaglutide (Wegovy®). The primary endpoint is difference in total lean body mass, and the key secondary endpoints are differences in total body fat mass and physical function as measured by stair climb test at 16 weeks. The Phase 2b clinical trial is actively enrolling patients from up to 15 clinical sites in the United States. Topline clinical results from the trial are expected by the end of calendar year 2024.

After completing the efficacy dose-finding portion of the Phase 2b clinical trial, it is expected that participants will then continue in blinded fashion into a Phase 2b extension clinical trial where all patients will stop receiving a GLP-1 RA, but will continue taking placebo, enobosarm 3mg, or enobosarm 6mg for an additional 12 weeks. The Phase 2b extension clinical trial will evaluate whether enobosarm can maintain muscle and prevent the fat and weight gain that occurs after discontinuing a GLP-1 RA. The topline results of the separate blinded Phase 2b extension clinical study are expected in calendar Q2 2025.

About Sarcopenic Obesity
According to the CDC, 41.5% of older adults have obesity in the United States and could benefit from a weight loss medication. Up to 34.4% of these obese patients over the age of 60 have sarcopenic obesity. This large subpopulation of sarcopenic obese patients is especially at risk for taking GLP-1 drugs for weight loss as they already have critically low amount of muscle due to age-related muscle loss. Further loss of muscle mass when taking a GLP-1 RA medication may lead to muscle weakness leading to poor balance, decreased gait speed, mobility disability, loss of independence, falls, bone fractures and increased mortality which is a condition like age-related frailty. Because of the magnitude and speed of muscle loss while on GLP-1 RA therapy for weight loss, GLP-1 RA drugs may accelerate the development of frailty in older obese or overweight elderly patients.

About Enobosarm
Enobosarm (aka ostarine, MK-2866, GTx-024, and VERU-024), a novel oral daily selective androgen receptor modulator (SARM), has been previously studied in 5 clinical studies involving 968 older normal men and postmenopausal women as well as older patients who have muscle wasting because of advanced cancer. Advanced cancer simulates a “starvation state” where there is significant unintentional loss or wasting of both muscle and fat mass which is similar to what is observed with in patients taking GLP-1 RA drugs. We believe the totality of the clinical data from these previous five clinical trials demonstrates that enobosarm treatment leads to dose-dependent increases in muscle mass with improvements in physical function as well as significant dose-dependent reductions in fat mass. The patient data that were generated from these five enobosarm clinical trials in both elderly patients and in patients with a cancer induced starvation-like state provide strong clinical rationale for enobosarm. The expectation is that enobosarm in combination with a GLP-1 RA would potentially augment the fat reduction and total weight loss while preserving muscle mass.

Importantly, enobosarm has a large safety database, which includes 27 clinical trials involving 1581 men and women, some of which included patients dosed for up to 3 years. In this large safety database, enobosarm was generally well tolerated with no increases in gastrointestinal side effects. This is important as there are already significant and frequent gastrointestinal side effects with a GLP-1 RA treatment alone.

About Veru Inc.
Veru is a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of metabolic diseases, oncology, and ARDS. The Company’s drug development program includes two late-stage novel small molecules, enobosarm and sabizabulin.

Enobosarm, a selective androgen receptor modulator (SARM), is being developed for two indications: (i) Phase 2b clinical study of enobosarm as a treatment to augment fat loss and to prevent muscle loss in sarcopenic obese or overweight elderly patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness and (ii) subject to the availability of sufficient funding, Phase 3 ENABLAR-2 clinical trial of enobosarm and abemaciclib for the treatment of androgen receptor positive (AR+), estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer in the 2nd line setting.

Sabizabulin, a microtubule disruptor, is being developed as a Phase 3 clinical trial for the treatment of hospitalized patients with viral-induced ARDS. The Company does not intend to undertake further development of sabizabulin for the treatment of viral-induced ARDS until we obtain funding from government grants, pharmaceutical company partnerships, or other similar third-party external sources.

The Company also has an FDA-approved commercial product, the FC2 Female Condom® (Internal Condom), for the dual protection against unplanned pregnancy and sexually transmitted infections.

Forward-Looking Statements
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, express or implied statements related to whether and when the phase 2b trial of enobosarm discussed above will produce topline data or patients will progress into the extension study, the planned design, number of sites, timing, endpoints, patient population and patient size of such trial and whether such trial will successfully meet any of its endpoints, whether enobosarm will enhance weight loss or preserve muscle in, or meet any unmet need for, obesity patients and whether it will enhance weight loss, whether the Company’s scientific advisors will make valuable contributions to the Company’s enobosarm program and whether the Company will be successful in its transformation into a late stage biopharmaceutical company focused on obesity and oncology. The words "anticipate," "believe," "could," "expect," "intend," "may," "opportunity," "plan," "predict," "potential," "estimate," "should," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based upon current plans and strategies of the Company and reflect the Company's current assessment of the risks and uncertainties related to its business and are made as of the date of this press release. The Company assumes no obligation to update any forward- looking statements contained in this press release because of new information or future events, developments or circumstances. Such forward-looking statements are subject to known and unknown risks, uncertainties and assumptions, and if any such risks or uncertainties materialize or if any of the assumptions prove incorrect, our actual results could differ materially from those expressed or implied by such statements. Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to: the development of the Company’s product portfolio and the results of clinical studies possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical studies and the ability to enroll subjects in accordance with planned schedules; the ability to fund planned clinical development as well as other operations of the Company; the timing of any submission to the FDA or any other regulatory authority and any determinations made by the FDA or any other regulatory authority; the Company’s existing product, FC2, and any future products, if approved, possibly not being commercially successful; the ability of the Company to obtain sufficient financing on acceptable terms when needed to fund development and operations; demand for, market acceptance of, and competition against any of the Company’s products or product candidates; new or existing competitors with greater resources and capabilities and new competitive product approvals and/or introductions; changes in regulatory practices or policies or government-driven healthcare reform efforts, including pricing pressures and insurance coverage and reimbursement changes; risks relating to the Company's development of its own dedicated direct to patient telehealth platform, including the Company's lack of experience in developing such a platform, potential regulatory complexity, development costs, and market awareness and acceptance of any telehealth platform we develop; risks relating to our ability to increase sales of FC2 after significant declines in recent periods due to telehealth industry consolidation and the bankruptcy of a large telehealth customer; the Company’s ability to protect and enforce its intellectual property; the potential that delays in orders or shipments under government tenders or the Company’s U.S. prescription business could cause significant quarter-to-quarter variations in the Company’s operating results and adversely affect its net revenues and gross profit; the Company’s reliance on its international partners and on the level of spending by country governments, global donors and other public health organizations in the global public sector; the concentration of accounts receivable with our largest customers and the collection of those receivables; the Company’s production capacity, efficiency and supply constraints and interruptions, including potential disruption of production at the Company’s and third party manufacturing facilities and/or of the Company’s ability to timely supply product due to labor unrest or strikes, labor shortages, raw material shortages, physical damage to the Company’s and third party facilities, product testing, transportation delays or regulatory actions; costs and other effects of litigation, including product liability claims and securities litigation; the Company’s ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives; the Company’s ability to successfully integrate acquired businesses, technologies or products; and other risks detailed from time to time in the Company’s press releases, shareholder communications and Securities and Exchange Commission filings, including the Company's Form 10-K for the year ended September 30, 2023, as amended by the Form 10-K/A, and subsequent quarterly reports on Form 10-Q. These documents are available on the “SEC Filings” section of our website at www.verupharma.com/investors.

* Wegovy^® is a registered trademark of Novo Nordisk A/S

Investor and Media Contact:
Samuel Fisch
Executive Director, Investor Relations and Corporate Communications
Email: veruinvestor@verupharma.com

May 15, 2024 08:30 ET| Source: Veru Inc.Follow

MIAMI, FL, May 15, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle for high quality weight loss, oncology, and viral induced acute respiratory distress syndrome, today announced Steven B. Heymsfield, M.D., a Professor and the Director of the Body Composition-Metabolism Laboratory at the Pennington Biomedical Research Center in Baton Rouge, Louisiana, as the Principal Investigator for the Company’s Phase 2b clinical trial of enobosarm to preserve muscle while augmenting fat loss in patients receiving a GLP-1 RA for weight loss.

Dr. Heymsfield is a leading authority on body composition assessment and his research focuses primarily on human obesity, including energy balance regulation, weight loss treatments, co-morbidity effects, and development of related mathematical models. He has a long term-interest in the development of methods for evaluating body composition and the application of new technologies to the study of human metabolism.

Dr. Heymsfield received a degree in medicine from Mount Sinai School of Medicine, and he completed his internship, residency, and fellowship in pharmacology at Emory University. He then joined the Emory University School of Medicine faculty, holding positions there including Associate Professor of Medicine and Assistant Director of the NIH-funded Clinical Research Unit. Expanding on his interests in obesity and metabolism, Dr. Heymsfield next moved to Columbia University, College of Physicians and Surgeons and there he held positions as Professor of Medicine and Deputy Director, New York Obesity Research Center at St. Luke’s-Roosevelt Hospital. He and his Columbia colleagues conducted wide ranging clinical studies on obesity with a focus on energy metabolism, body composition, and pharmacologic weight control management. Prior to his Pennington Biomedical position, Dr. Heymsfield worked with Merck & Co. for 5 years, initially as Executive Director in the Obesity Group and then as Global Director of Scientific Affairs.

Dr. Heymsfield has published more than 600 peer-reviewed papers covering topics such as obesity, malnutrition, cachexia, body composition, and caloric expenditure. His contributions to the study of human nutrition led to the TOPS Award from The Obesity Society, the Rhoads Award from the American Society of Parenteral and Enteral Nutrition (ASPEN), the Robert H. Herman Memorial Award, American Society of Nutrition (ASN), the George Bray Founders Award from The Obesity Society, and he was honored for his role in the FDA ban on ephedra, receiving the 2004 NYC Mayor’s Award for Science and Technology. Dr. Heymsfield was elected Fellow of The Obesity Society in 2014, and he is an honorary member of the American Dietetic and Chilean Clinical Nutrition Associations. Dr. Heymsfield is past president of ASPEN and ASN and he is vice-president of The Obesity Society.

As the Principal Investigator for the Company’s enobosarm Phase 2b clinical trial, Dr. Heymsfield will lead the clinical trial sites. He will also participate in the study analysis and contribute to reporting the results to the FDA and scientific journals and meetings.

“I am pleased to serve as the Principal Investigator for this important Phase 2b enobosarm clinical trial. I am enthusiastic to be participating in enobosarm’s development, a medicine that has a novel established mechanism of action that has the potential to improve the quality of weight loss for these patients,” said Steven Heymsfield, MD, a Professor and the Director of the Body Composition-Metabolism Laboratory at the Pennington Biomedical Research Center in Baton Rouge, Louisiana.

"Dr. Heymsfield is an expert in body composition and obesity and an ideal clinical leader to serve as the Principal Investigator of the enobosarm Phase 2b clinical trial," said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru Inc. “Veru is proud to have Dr. Heymsfield as our partner with the enobosarm clinical trial. There is a significant unmet medical need for patients undergoing weight loss treatments with GLP-1 RAs to address the issue of muscle loss. We believe enobosarm could potentially be a great addition for patients to make their weight loss journey as healthy as possible. We look forward to enrolling this Phase 2b clinical trial expeditiously with data expected by year-end."

About the Enobosarm Phase 2b clinical trial
The Phase 2b, multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial is designed to evaluate the safety and efficacy of enobosarm 3mg, enobosarm 6mg, or placebo as a treatment to preserve muscle and augment fat loss in approximately 90 patients with sarcopenic obesity or overweight elderly (>60 years of age) patients receiving semaglutide (Wegovy®). The primary endpoint is difference in total lean body mass, and the key secondary endpoints are differences in total body fat mass and physical function as measured by stair climb test at 16 weeks. The Phase 2b clinical trial is actively enrolling patients from up to 15 clinical sites in the United States. Topline clinical results from the trial are expected by the end of calendar year 2024.

After completing the efficacy dose-finding portion of the Phase 2b clinical trial, it is expected that participants will then continue in blinded fashion into a Phase 2b extension clinical trial where all patients will stop receiving a GLP-1 RA, but will continue taking placebo, enobosarm 3mg, or enobosarm 6mg for an additional 12 weeks. The Phase 2b extension clinical trial will evaluate whether enobosarm can maintain muscle and prevent the fat and weight gain that occurs after discontinuing a GLP-1 RA. The topline results of the separate blinded Phase 2b extension clinical study are expected in calendar Q2 2025.

About Sarcopenic Obesity
According to the CDC, 41.5% of older adults have obesity in the United States and could benefit from a weight loss medication. Up to 34.4% of these obese patients over the age of 60 have sarcopenic obesity. This large subpopulation of sarcopenic obese patients is especially at risk for taking GLP-1 drugs for weight loss as they already have critically low amount of muscle due to age-related muscle loss. Further loss of muscle mass when taking a GLP-1 RA medication may lead to muscle weakness leading to poor balance, decreased gait speed, mobility disability, loss of independence, falls, bone fractures and increased mortality which is a condition like age-related frailty. Because of the magnitude and speed of muscle loss while on GLP-1 RA therapy for weight loss, GLP-1 RA drugs may accelerate the development of frailty in older obese or overweight elderly patients.

About Enobosarm
Enobosarm (aka ostarine, MK-2866, GTx-024, and VERU-024), a novel oral daily selective androgen receptor modulator (SARM), has been previously studied in 5 clinical studies involving 968 older normal men and postmenopausal women as well as older patients who have muscle wasting because of advanced cancer. Advanced cancer simulates a “starvation state” where there is significant unintentional loss or wasting of both muscle and fat mass which is similar to what is observed with in patients taking GLP-1 RA drugs. We believe the totality of the clinical data from these previous five clinical trials demonstrates that enobosarm treatment leads to dose-dependent increases in muscle mass with improvements in physical function as well as significant dose-dependent reductions in fat mass. The patient data that were generated from these five enobosarm clinical trials in both elderly patients and in patients with a cancer induced starvation-like state provide strong clinical rationale for enobosarm. The expectation is that enobosarm in combination with a GLP-1 RA would potentially augment the fat reduction and total weight loss while preserving muscle mass.

Importantly, enobosarm has a large safety database, which includes 27 clinical trials involving 1581 men and women, some of which included patients dosed for up to 3 years. In this large safety database, enobosarm was generally well tolerated with no increases in gastrointestinal side effects. This is important as there are already significant and frequent gastrointestinal side effects with a GLP-1 RA treatment alone.

About Veru Inc.
Veru is a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of metabolic diseases, oncology, and ARDS. The Company’s drug development program includes two late-stage novel small molecules, enobosarm and sabizabulin.

Enobosarm, a selective androgen receptor modulator (SARM), is being developed for two indications: (i) Phase 2b clinical study of enobosarm as a treatment to augment fat loss and to prevent muscle loss in sarcopenic obese or overweight elderly patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness and (ii) subject to the availability of sufficient funding, Phase 3 ENABLAR-2 clinical trial of enobosarm and abemaciclib for the treatment of androgen receptor positive (AR+), estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer in the 2nd line setting.

Sabizabulin, a microtubule disruptor, is being developed as a Phase 3 clinical trial for the treatment of hospitalized patients with viral-induced ARDS. The Company does not intend to undertake further development of sabizabulin for the treatment of viral-induced ARDS until we obtain funding from government grants, pharmaceutical company partnerships, or other similar third-party external sources.

The Company also has an FDA-approved commercial product, the FC2 Female Condom® (Internal Condom), for the dual protection against unplanned pregnancy and sexually transmitted infections.

Forward-Looking Statements
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, express or implied statements related to whether and when the phase 2b trial of enobosarm discussed above will produce topline data or patients will progress into the extension study, the planned design, number of sites, timing, endpoints, patient population and patient size of such trial and whether such trial will successfully meet any of its endpoints, whether enobosarm will enhance weight loss or preserve muscle in, or meet any unmet need for, obesity patients and whether it will enhance weight loss, whether the Company’s scientific advisors will make valuable contributions to the Company’s enobosarm program and whether the Company will be successful in its transformation into a late stage biopharmaceutical company focused on obesity and oncology. The words "anticipate," "believe," "could," "expect," "intend," "may," "opportunity," "plan," "predict," "potential," "estimate," "should," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based upon current plans and strategies of the Company and reflect the Company's current assessment of the risks and uncertainties related to its business and are made as of the date of this press release. The Company assumes no obligation to update any forward- looking statements contained in this press release because of new information or future events, developments or circumstances. Such forward-looking statements are subject to known and unknown risks, uncertainties and assumptions, and if any such risks or uncertainties materialize or if any of the assumptions prove incorrect, our actual results could differ materially from those expressed or implied by such statements. Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to: the development of the Company’s product portfolio and the results of clinical studies possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical studies and the ability to enroll subjects in accordance with planned schedules; the ability to fund planned clinical development as well as other operations of the Company; the timing of any submission to the FDA or any other regulatory authority and any determinations made by the FDA or any other regulatory authority; the Company’s existing product, FC2, and any future products, if approved, possibly not being commercially successful; the ability of the Company to obtain sufficient financing on acceptable terms when needed to fund development and operations; demand for, market acceptance of, and competition against any of the Company’s products or product candidates; new or existing competitors with greater resources and capabilities and new competitive product approvals and/or introductions; changes in regulatory practices or policies or government-driven healthcare reform efforts, including pricing pressures and insurance coverage and reimbursement changes; risks relating to the Company's development of its own dedicated direct to patient telehealth platform, including the Company's lack of experience in developing such a platform, potential regulatory complexity, development costs, and market awareness and acceptance of any telehealth platform we develop; risks relating to our ability to increase sales of FC2 after significant declines in recent periods due to telehealth industry consolidation and the bankruptcy of a large telehealth customer; the Company’s ability to protect and enforce its intellectual property; the potential that delays in orders or shipments under government tenders or the Company’s U.S. prescription business could cause significant quarter-to-quarter variations in the Company’s operating results and adversely affect its net revenues and gross profit; the Company’s reliance on its international partners and on the level of spending by country governments, global donors and other public health organizations in the global public sector; the concentration of accounts receivable with our largest customers and the collection of those receivables; the Company’s production capacity, efficiency and supply constraints and interruptions, including potential disruption of production at the Company’s and third party manufacturing facilities and/or of the Company’s ability to timely supply product due to labor unrest or strikes, labor shortages, raw material shortages, physical damage to the Company’s and third party facilities, product testing, transportation delays or regulatory actions; costs and other effects of litigation, including product liability claims and securities litigation; the Company’s ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives; the Company’s ability to successfully integrate acquired businesses, technologies or products; and other risks detailed from time to time in the Company’s press releases, shareholder communications and Securities and Exchange Commission filings, including the Company's Form 10-K for the year ended September 30, 2023, as amended by the Form 10-K/A, and subsequent quarterly reports on Form 10-Q. These documents are available on the “SEC Filings” section of our website at www.verupharma.com/investors.

* Wegovy^® is a registered trademark of Novo Nordisk A/S

Investor and Media Contact:
Samuel Fisch
Executive Director, Investor Relations and Corporate Communications
Email: veruinvestor@verupharma.com

JACKSONVILLE, Fla. (April 22, 2024) – Nemours Children’s Health, Jacksonville announces the appointment of Andrew Stec, MD, as Vice President, Chief Medical Officer (CMO). Effective May 1, Dr. Stec will transition from his current role of Vice Chair of the Department of Surgery to CMO.

“After an extensive external and internal search, and vetting of the most qualified candidates, we are fortunate to have recruited a leader from within Nemours Children’s,” said Michael Erhard, MD, North Florida Region President, Nemours Children’s Health. “I look forward to working with Dr. Stec to create the healthiest generations of children in Northeast Florida and beyond.”

As CMO, Dr. Stec will provide oversight of the medical operations and faculty at Nemours Children’s Health, Jacksonville. He will also work with clinical and nonclinical leaders and team members across the organization to help maintain the highest levels of safe, quality care for Nemours patients and families.

Dr. Stec joined the urology team at Nemours Children’s as division chief in September 2019. Previously, he served for five years as the director of pediatric urology at the Medical University of South Carolina. He earned his medical degree at Emory University School of Medicine and completed a residency in urology at Vanderbilt University. He specialized in pediatric urology with a two-year fellowship at Johns Hopkins Hospital in Baltimore. Dr. Stec is currently an associate professor of urology at the Mayo Clinic College of Medicine and Science and is active in outcomes research, a branch of public health research that studies the end results of the structure and processes of the healthcare system on the health and well-being of patients.

Dr. Stec is a board-certified urologist with a subspecialty board certification in pediatric urology. He is an active member of numerous professional societies including the American Urological Association and the Society of Pediatric Urology. His clinical interests focus on robotic, minimally invasive surgery and complex urologic reconstruction. He is completing his master’s in business administration at Louisiana State University and is expected to graduate in August.

About Nemours Children’s Health

Nemours Children’s Health is one of the nation’s largest multistate pediatric health systems, which includes two free-standing children's hospitals and a network of more than 70 primary and specialty care practices. Nemours Children's seeks to transform the health of children by adopting a holistic health model that utilizes innovative, safe, and high-quality care, while also caring for the health of the whole child beyond medicine. Nemours Children's also powers the world’s most-visited website for information on the health of children and teens, Nemours KidsHealth.org.

The Nemours Foundation, established through the legacy and philanthropy of Alfred I. duPont, provides pediatric clinical care, research, education, advocacy, and prevention programs to the children, families and communities it serves. For more information, visit Nemours.org.

Contact: Leah Goodwyne, leah.goodwyne@nemours.org, (904) 676-2229.

April 18, 2024 07:05 AM Eastern Daylight Time

FT. MYERS, Fla.--(BUSINESS WIRE)--NeoGenomics, Inc. (NASDAQ: NEO), a leading oncology testing services company, today announced two promotions within its senior leadership team, effective immediately.

“As we enter our next phase of growth, these senior leadership appointments should drive operational efficiencies, strengthen commercial synergies, and accelerate innovation through R&D. We believe their extensive experience will enhance the operating structure of the organization, thereby improving our service to clinicians and patients.”

Post this

Warren Stone has been promoted to Chief Commercial Officer and will lead NeoGenomics’ clinical and pharma services commercial teams. Stone will be responsible for sales, marketing, pharma project management, commercial enablement, scientific affairs, and support functions.

Melody Harris has been promoted to Chief Operations Officer and President, Informatics. In this expanded role, Harris will oversee data-oriented teams and manage all enterprise operations.

“Warren and Melody have shown exceptional leadership and performance in their respective roles," said Chris Smith, CEO of NeoGenomics. “As we enter our next phase of growth, these senior leadership appointments should drive operational efficiencies, strengthen commercial synergies, and accelerate innovation through R&D. We believe their extensive experience will enhance the operating structure of the organization, thereby improving our service to clinicians and patients.”

Stone joined NeoGenomics in 2022 as President of Clinical Services. He has played a leading role in optimizing NeoGenomics’ salesforce and successfully implementing its commercial strategy and digital transformation of systems and tools. Prior to NeoGenomics, Stone served as President of Americas at Ortho Clinical Diagnostics and Senior Vice President, Life Sciences Division for MilliporeSigma. He holds an MBA from Suffolk University.

Harris joined NeoGenomics in 2022 as President of Enterprise Operations. She has led the company through a laboratory transformation including improvements in turnaround time and currently manages the consolidation of several laboratory information management systems (LIMS) into a single system. Prior to NeoGenomics, Harris served as President and Chief Operating Officer at SomaLogic and held several executive positions at Qualcomm Life’s digital health subsidiary and at HealthyCircles, a healthcare web platform. Harris holds a BA, cum laude, in Political Science from the University of Denver and a JD, cum laude, from Harvard Law School.

About NeoGenomics, Inc.

NeoGenomics, Inc. specializes in cancer genetics testing and information services, providing one of the most comprehensive oncology-focused testing menus in the world for physicians to help them diagnose and treat cancer. The Company's Pharma Services Division serves pharmaceutical clients in clinical trials and drug development.

Headquartered in Fort Myers, Fla., NeoGenomics operates CAP accredited and CLIA certified laboratories for full-service sample processing in Fort Myers, Florida; Aliso Viejo and San Diego, California; Research Triangle Park, North Carolina; and Houston, Texas; and a CAP accredited full-service, sample-processing laboratory in Cambridge, United Kingdom. NeoGenomics also has several, small, non-processing laboratory locations across the United States for providing analysis services. NeoGenomics serves the needs of pathologists, oncologists, academic centers, hospital systems, pharmaceutical firms, integrated service delivery networks, and managed care organizations throughout the United States, and pharmaceutical firms in Europe and Asia.

Forward-Looking Statements

This press release includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “plan,” “could,” “would,” “may,” “will,” “believe,” “estimate,” “forecast,” “goal,” “project,” “guidance,” “plan,” “potential” and other words of similar meaning, although not all forward-looking statements include these words. This press release includes forward-looking statements. These forward-looking statements address various matters, including statements regarding improving operational efficiency, returning to profitable growth and its ongoing executive recruitment process. Each forward-looking statement contained in this press release is subject to a number of risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the Company's ability to identify and implement appropriate financial and operational initiatives to improve performance, to identify and recruit executive candidates, to continue gaining new customers, offer new types of tests, integrate its acquisitions and otherwise implement its business plan, and the risks identified under the heading "Risk Factors" contained in the Company's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and the Company's other filings with the Securities and Exchange Commission.

We caution investors not to place undue reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document (unless another date is indicated), and we undertake no obligation to update or revise any of these statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Contacts

Investor Contact
Kendra Sweeney
kendra.sweeney@neogenomics.com

Media Contact
Andrea Sampson
asampson@sampsonprgroup.com

NEOGENOMICS, INC.

April 15, 2024 08:55 ET| Source: AIM ImmunoTech Inc.Follow

OCALA, Fla., April 15, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM”) today announced that Charles Lapp, MD, is joining the company to help lead its efforts to develop Ampligen (rintatolimod) as a potential treatment for Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and Long COVID.

Dr. Lapp has played a key role in AIM’s long-standing AMP-511 Expanded Access Program for the treatment of ME/CFS and Long COVID, having founded one of the clinical trial’s key sites, the Hunter-Hopkins Center in Charlotte, N.C., from which he recently retired. As a Consulting Medical Officer and an independent contractor, he will help manage the company’s research programs related to ME/CFS and Long COVID, including the development of protocols and new clinical trials.

Dr. Lapp states: “I’m eager and excited for the opportunity to continue working with Ampligen. Ampligen is the only treatment for people with ME/CFS that has shown efficacy in clinical trials and I believe this will be confirmed in further trials requested by the FDA in ME/CFS and also potential further trials in Long COVID. I am devoted to doing whatever I can to get Ampligen FDA-approved and available for commercial use.”

Dr. Lapp is a graduate of Albany Medical College. He has been the medical advisor to the Chronic Fatigue Syndrome Association of America, the American Fibromyalgia Syndrome Association, and the National Fibromyalgia Association; and a board member of the International Association for CFS and FM.

AIM Chief Executive Officer Thomas K. Equels states: “Having worked with Dr. Lapp for many years, I’m continually impressed by his knowledge, confidence and experience. He is one of the foremost experts in his field and we are extremely grateful that he is joining the AIM team.”

For more information about AIM’s ongoing work with COVID-19-related conditions, see the recent announcement: AIM ImmunoTech Reports Positive Topline Results from Phase 2 Study Evaluating Ampligen^® for the Treatment of Post-COVID Conditions.

About AIM ImmunoTech Inc.

AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19. The Company’s lead product is a first-in-class investigational drug called Ampligen^® (rintatolimod), a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials for globally important cancers, viral diseases and disorders of the immune system.

For more information, please visit aimimmuno.com and connect with the Company on X, LinkedIn, and Facebook.

Investor Contact:

JTC Team, LLC
Jenene Thomas
(833) 475-8247
AIM@jtcir.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/635c0bae-2a83-41c3-a149-9169f978f583

TAMPA, Fla., March 26, 2024 /PRNewswire/ -- Psilera, a leading biotechnology company developing groundbreaking therapies for hard-to-treat neurological disorders, is pleased to announce the appointment of Magali Haas, M.D., Ph.D., to its esteemed Board of Directors. Dr. Haas brings a wealth of experience from multiple leadership roles at Janssen and Johnson & Johnson, as well as biotechnology, and mission-driven nonprofits.

"We are thrilled to welcome Magali as an independent member of our Board of Directors," said Dr. Chris Witowski, CEO of Psilera. "Her extensive background in neuroscience and experience translating early-stage research and clinical development align perfectly with our mission at Psilera."

Dr. Haas currently serves as Founder and Chair of Cohen Veterans Bioscience, a non-profit organization dedicated to improving the detection and treatment of post-traumatic stress (PTS) and traumatic brain injuries (TBI) through cutting-edge research, where she served as CEO & President for ten years. Her dedication to optimizing brain health across a patient's lifespan led her to establish the Brain Health Nexus, a global initiative focused on operationalizing brain health through the development, validation and adoption of a global brain health index.

"Joining the board of Psilera provides a thrilling opportunity to be at the forefront of brain health research," said Dr. Haas. "I'm deeply impressed by their unique capabilities melding artificial intelligence and machine learning, a proprietary compound library, and a patient-centric ethos. I look forward to working with the leadership team and my board colleagues on transformative advancements for patients."

Dr. Haas's appointment to Psilera's Board of Directors further solidifies the company's commitment to advancing brain health and underscores its dedication to attracting top talent in the field. With her invaluable contributions, Psilera is poised to make significant strides in its pursuit of improving the lives of individuals affected by brain-related conditions.

About Psilera

Psilera is a biopharmaceutical company focused on developing innovative patient-centric therapies for neurological disorders. They are the first company to target neurodegenerative diseases with their first-in-class, next-generation psychedelic derivative, PSIL-006, delivering results without hallucinogenic effects. With a deep commitment to scientific excellence and patient centricity, Psilera aims to transform the lives of individuals affected by devastating neurodegenerative diseases. For more information visit www.psilera.com.

Media Contact:

Katie DeMarsh

Katie@Psilera.com 

 View original content to download multimedia:https://www.prnewswire.com/news-releases/psilera-welcomes-biopharma-executive-dr-magali-haas-to-its-board-of-directors-302099546.html

SOURCE Psilera

March 18, 2024 07:00 AM Eastern Daylight Time

SARASOTA, Fla.--(BUSINESS WIRE)--Oragenics, Inc. (NYSE American: OGEN), a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders, today announced it has appointed Dr. James “Jim” Kelly, Neurologist, as its Chief Medical Officer, to oversee its upcoming Phase II clinical trial. Oragenics’ lead drug candidate, ONP-002 is combined with its intranasal device intended for the treatment of mild Traumatic Brain Injury (TBI), aka concussion. ONP-002 is a new chemical entity (NCE) designed to target the brain through delivery into the nasal cavity and onward to the brain. A 40-patient Phase I study was completed and showed the drug to be safe and well-tolerated.

In the recent past, Dr. Kelly served as the Executive Director of the Marcus Institute for Brain Health (MIBH) and Professor of Neurology at the University of Colorado Anschutz Medical Campus in Aurora, Colorado. The MIBH specialized treatment program is funded by the Marcus Foundation to care for US military veterans with persistent symptoms of TBI. Dr. Kelly was also National Director of the Avalon Action Alliance TBI Programs for which the MIBH serves as the clinical coordinating center.

“I am excited to join Oragenics as its Chief Medical Officer at such an important and pivotal time in the drug development process. I have been involved with the drug for many years now and look forward to testing the drug and showing it can improve patient outcomes in our upcoming Phase II clinical trials,” said Dr. Kelly.

Prior to these recent positions, Dr. Kelly was the Director of the National Intrepid Center of Excellence (NICoE) at Walter Reed National Military Medical Center in Bethesda, MD. As its founding Director, he led the creation of an innovative interdisciplinary team of healthcare professionals who blended high-tech diagnosis and treatment with complementary and alternative medical interventions in a holistic, integrative approach to the care of US military personnel with the complex combination of TBI and psychological conditions, such as post-traumatic stress, depression, and anxiety. In this role, Dr. Kelly was frequently called upon by leaders of the Military Health System at the Pentagon, the US Congress, the Department of Veterans Affairs, and numerous military facilities in the continental US and abroad. Dr. Kelly has interacted with the FDA and clinical trials for brain injury throughout his esteemed career. He is a strong advocate for treatments in the acute phase of brain injury and understands the value of protecting the brain early on from inflammation, swelling and oxidative stress to gain better clinical outcomes.

“We are fortunate to have such an esteemed neurologist as Dr. Kelly join our team in this important role at Oragenics. Dr. Kelly is recognized as a leading expert in concussion and other brain injuries and we are fortunate to have him lead our drug trials going forward. We are currently completing the drug manufacturing and formulation at GMP facilities to ensure the integrity of the drug before and during the trials, and we look forward to completing this work in the short-term and getting the Phase II trial underway,” stated Michael Redmond, President of Oragenics.

In preclinical animal models, the drug has been shown to acutely improve molecular and behavioral outcomes following brain injury. In addition, intranasal delivery of the drug as a nanoparticle has been shown to enhance brain exposure and metabolism in animals. “Our Phase I human study has shown ONP-002 to be well tolerated in humans. Our mission now is to show that the ONP-002 brain protective mechanisms in animals translates to humans. Our Phase II study is designed to establish time to first dose, relationships between drug application and blood biomarkers, and the evaluation of clinical endpoints to determine improved in patient outcomes, ” said Dr. Kelly.

Concussion is an unmet medical need. There is an estimated 69 million concussions annually reported worldwide. Common causes of concussion include falls, motor vehicle accidents, and contact sports. Other neurological disorders including Alzheimer’s Disease, Parkinson’s Disease and Chronic Traumatic Encephalopathy (CTE) have been linked to concussion. Post concussion syndrome is linked to long term disability and occurs in as high as 20% of concussed patients.

Forward-Looking Statements

This communication contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the ability of the Company to timely and successfully undertake the Phase II clinical trial using its novel drug - device combination for the treatment of mild Traumatic Brain Injury. These forward-looking statements are based on management’s beliefs and assumptions and information currently available. The words "believe," "expect," "anticipate," "intend," "estimate," "project" and similar expressions that do not relate solely to historical matters identify forward-looking statements. Investors should be cautious in relying on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. These factors include, but are not limited to: the Company’s ability to advance the development of its product candidates, including the neurology assets, under the timelines and in accord with the milestones it projects; the Company’s ability to retain its key employees and independent contractors necessary to continue to develop its product candidates and in particular ONP-002 and the availability of those key employees and independent contractors; the Company’s ability to raise capital and obtain funding, non-dilutive or otherwise, for the development of its product candidates; the Company’s expectations as to the outcome of the Phase II clinical trial and the potential benefits, activity, effectiveness and safety of its product candidates including as to administration, transmission, manufacturing, storage and distribution; and general economic and market conditions and risks, as well as other uncertainties described in our filings with the U.S. Securities and Exchange Commission. All information set forth is as of the date hereof unless otherwise indicated. You should consider these factors in evaluating the forward-looking statements included and not place undue reliance on such statements. We do not assume any obligation to publicly provide revisions or updates to any forward-looking statements, whether as a result of new information, future developments or otherwise, should circumstances change, except as otherwise required by law.

Released March 18, 2024

Contacts

Oragenics, Inc.
Janet Huffman, Chief Financial Officer
813-286-7900
jhuffman@oragenics.com

LHA Investor Relations
Tirth T. Patel
212-201-6614
tpatel@lhai.com

ORAGENICS, INC.

March 18, 2024 08:30 ET| Source: Safety Shot, Inc.Follow

The results-driven CEO will guide the development and marketing of the world’s very first rapid alcohol detox drink.

• Long has led Orangetheory Fitness through countless pivotal achievements including the launch of two apps, the creation of a proprietary heart monitor with strategically chosen partners, and the signing of celebrity brand ambassadors.
• He helped expand the European Wax Center concept from 4 to over 550 locations in less than nine years.
• He spearheaded the boom of the therapeutic massage and skincare chain Massage Envy from 25 locations to 800.

JUPITER, FL, March 18, 2024 (GLOBE NEWSWIRE) -- Safety Shot, Inc. (Nasdaq: SHOT) (the “Company), a pioneer in innovative well-being solutions, is excited to announce that David J. Long, the CEO and co-founder of Orangetheory Fitness, has joined the company’s Board of Directors.

Long has over 20 years of experience in the fitness and wellness industries, leading and increasing growth for companies. He has been instrumental in the early stages of several successful franchise brands including Massage Envy, European Wax Center and launching his wildly successful fitness concept: Orangetheory Fitness.

In the years since co-founding and leading Orangetheory, the brand has opened some 1,500-plus studios throughout 27 countries and has attracted one million-plus members. The brand has also crossed the threshold to surpass $1 billionin systemwide sales, accruing more than US$1.4 billion in annual revenue.

The Orangetheory CEO regularly appears on television to reach large audiences and is a University of Florida alum who has achieved a lifelong goal of being named #1 on the Gator100 list of fastest-growing, Gator-owned businesses in the world.

“Safety Shot is set to change the paradigm of wellness by helping people to more rapidly hydrate and process alcohol consumption. I’m pleased to join the Safety Shot team and am thrilled to support the launch of this exceptional product,” stated Long.

“We welcome David to our Board of Directors. We are so proud and excited to bring an amazing asset like this to the Safety Shot team. We are also excited for shareholders as David has built multiple billion-dollar brands. I am confident that Safety Shot could become the next one,” stated Safety Shot Chairman of the Board John Gulyas.

About Safety Shot

Safety Shot, Inc., has developed a first-of-its-kind beverage that makes you feel better faster from the effects of alcohol by reducing blood alcohol content and increasing mental clarity. Safety Shot leverages scientifically proven ingredients to enhance metabolic pathways responsible for breaking down blood alcohol levels. The formulation includes a tailored selection of all-natural vitamins, minerals, and nootropics, promoting faster alcohol breakdown and aiding in recovery and rehydration. Safety Shot has been available for retail purchase since the first week of December 2023 at www.DrinkSafetyShot.com and www.Amazon.com. In addition, the Company plans to introduce business-to-business sales to distributors, retailers, restaurants, and bars in 2024.

Forward Looking Statements

This communication contains forward-looking statements regarding Safety Shot, including, the anticipated timing of studies and the results and benefits thereof. You can generally identify forward-looking statements by the use of forward-looking terminology such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “explore,” “evaluate,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” or “will,” or the negative thereof or other variations thereon or comparable terminology. These forward-looking statements are based on each of the Company’s current plans, objectives, estimates, expectations, and intentions and inherently involve significant risks and uncertainties, many of which are beyond Safety Shot’s control. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties and other risks and uncertainties affecting Safety Shot and, including those described from time to time under the caption “Risk Factors” and elsewhere in Safety Shot’s Securities and Exchange Commission (SEC) filings and reports, including Safety Shot’s Annual Report on Form 10-K for the year ended December 31, 2023 and future filings and reports by Safety Shot. Moreover, other risks and uncertainties of which the combined company is not currently aware may also affect each of the companies’ forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. Investors are cautioned that forward-looking statements are not guarantees of future performance. The forward-looking statements made in this communication are made only as of the date hereof or as of the dates indicated in the forward-looking statements and reflect the views stated therein with respect to future events at such dates, even if they are subsequently made available by Safety Shot on its website or otherwise. Safety Shot undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made.

Media Contact:
Phone: 904-477-2306
Email: emily@pantelidespr.com

Investor Contact:
Phone: 561-244-7100
Email: investors@drinksafetyshot.com

March 12, 2024 08:00 ET| Source: Veru Inc.Follow

MIAMI, March 12, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle for high quality weight loss, oncology, and viral induced acute respiratory distress syndrome (ARDS), today announced the appointment of Louis Aronne, MD, as Chief Medical Advisor and a member of the Scientific Advisory Board to support the advancement of enobosarm, an oral novel selective androgen receptor modulator (SARM), to avoid muscle loss and augment fat loss when combined with a Glucagon-like peptide-1 receptor agonist (GLP-1 RA) drug for potentially higher quality weight loss.

Dr. Louis Aronne is a leading authority on obesity and its treatment. He is the Sanford I. Weill Professor of Metabolic Research and the director of the Comprehensive Weight Control Center, a state-of-the-art, multidisciplinary obesity research, education, and treatment center in the division of Endocrinology, Diabetes & Metabolism at Weill Cornell Medicine. A graduate of Johns Hopkins University School of Medicine, Dr. Aronne is a founder and past chairman of the American Board of Obesity Medicine and a past president of The Obesity Society. He is founder and Chief Scientific Advisor of Intellihealth a cloud-based weight management system which delivers obesity treatment online as flyte.

He completed his internship and residency at Albert Einstein College of Medicine and Jacobi Medical Center, followed by a Henry J. Kaiser Family Foundation Fellowship in General Internal Medicine at New York-Presbyterian/Weill Cornell Medical Center.

Dr. Aronne has been an investigator on more than 65 trials of obesity treatment modalities including medications, devices, and diets. He has authored more than 150 papers and book chapters on obesity and edited the National Institutes of Health’s Practical Guide to Obesity Treatment. He served as a consultant to the VA Weight Management/Physical Activity Executive Council in the development of the MOVE! Program, the nation’s largest medically based weight control program. Dr. Aronne has won many awards, including the 2015 Atkinson-Stern Award for Distinguished Public Service and 2021 Clinician of the Year from The Obesity Society, and several for medical teaching, including the Davidoff Prize from Albert Einstein College of Medicine and the Elliot Hochstein Award from Weill Cornell Medical College. Since 2001, he has appeared annually in Castle-Connolly’s Top Doctors directory as a specialist in obesity and internal medicine.

Dr Aronne has served as a consultant/advisor to many companies developing treatments for obesity including Boehringer Ingelheim Pharmaceuticals, Inc. (USA), Mediflix Inc. Pfizer, Inc., Altimmune, Inc., Amgen, Inc., Eli Lilly and Company, Janssen Pharmaceutical Company, Novo Nordisk Pharmaceuticals, Inc., Senda Biosciences, and Versanis Bio.*

“The weight loss and health benefits of the new generation of anti-obesity medications, the GLP-1 receptor agonists, are clear. Weight loss through any modality produces muscle loss, and there is an unmet need to minimize that in certain groups of patients in order to produce better quality weight loss. In conjunction with a GLP-1 drug, enobosarm has the potential to deliver better quality weight loss while utilizing lower doses of the GLP-1 drug. This should not only produce fewer side effects and better functioning, but potentially lead to longer term maintenance of weight loss.”

“We are pleased that Dr. Aronne, a world-renowned obesity expert, will be our Chief Medical Advisor to help us develop enobosarm as a treatment for chronic weight management,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru Inc. “Enobosarm is a drug candidate that may provide higher quality weight loss for obese or overweight patients by preferentially increasing fat loss while preserving muscle. We are fortunate that Dr. Aronne and the other senior expert members of our Scientific Advisory Board will help guide the enobosarm development program.”

About Sarcopenic Obesity

According to the CDC, 41.5% of older adults have obesity in the United States and could benefit from a weight loss medication. Up to 34.4% of these obese patients over the age of 60 have sarcopenic obesity. This large subpopulation of sarcopenic obese patients is especially at risk for taking GLP-1 drugs for weight loss as they already have critically low amount of muscle due to age-related muscle loss. Further loss of muscle mass when taking a GLP-1 RA medication may lead to muscle weakness leading to poor balance, decreased gait speed, mobility disability, loss of independence, falls, bone fractures and increased mortality which is a condition like age-related frailty. Because of the magnitude and speed of muscle loss while on GLP-1 RA therapy for weight loss, GLP-1 RA drugs may accelerate frailty in older obese or overweight elderly patients.

About Enobosarm

Enobosarm (aka ostarine, MK-2866, GTx-024, and VERU-024), a novel daily oral selective androgen receptor modulator (SARM), has been previously studied in 5 clinical studies involving 968 older normal men and postmenopausal women as well as older patients who have muscle wasting because of advanced cancer. Advanced cancer simulates a “starvation state” where there is significant unintentional loss of both muscle and fat mass like that seen with GLP-1 RA treatment. The totality of the clinical data from these five clinical trials demonstrates that enobosarm treatment leads to preservation of muscle mass with improvements in physical function as well as significant reductions in fat mass.

Enobosarm has a large safety database, which includes 27 clinical trials involving 1581 men and women dosed with duration of treatment in some patients for up to 3 years. In this large safety database, enobosarm was generally well tolerated with no increase in gastrointestinal side effects. This is important as there are already significant and frequent gastrointestinal side effects with a GLP-1 RA treatment alone.

The efficacy and safety clinical data that were generated from five enobosarm clinical trials in both elderly patients and in patients with a cancer induced starvation-like state provide strong clinical rationale for enobosarm. The expectation is that enobosarm in combination with a GLP-1 RA would potentially augment the fat reduction with higher quality total weight loss while preserving muscle and physical function.

Planned Phase 2b enobosarm clinical trial design for potentially high quality weight loss

The Phase 2b, multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial is designed to evaluate the safety and efficacy of enobosarm 3mg, enobosarm 6mg, or placebo as a treatment to preserve muscle and augment fat loss in 90 sarcopenic obese or overweight elderly (>60 years of age) patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness. The primary endpoint is lean body mass (muscle), and the key secondary endpoints are total body fat mass and physical function at 16 weeks. The IND has received FDA clearance, and the clinical study is expected to begin in April 2024 with the topline clinical results from the trial expected calendar year-end 2024.

After completing the efficacy dose-finding portion of the Phase 2b clinical trial, participants will then continue into a Phase 2b extension clinical trial where all patients will stop receiving a GLP-1 RA, but will continue taking placebo, enobosarm 3mg, or enobosarm 6mg for an additional 12 weeks. The Phase 2b extension clinical trial will evaluate whether enobosarm can maintain muscle and prevent the fat and weight rebound that occurs after stopping a GLP-1 RA drug. The topline results of the separate Phase 2b extension clinical study is expected in calendar Q2 2025.

About Veru Inc.
Veru is a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of metabolic diseases, oncology, and ARDS. The Company’s drug development program includes two late-stage novel small molecules, enobosarm and sabizabulin.

Enobosarm, a selective androgen receptor modulator (SARM), is being developed for two indications: (i) Phase 2b clinical study of enobosarm as a treatment to augment fat loss and to prevent muscle loss in sarcopenic obese or overweight elderly patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness and (ii) subject to the availability of sufficient funding, Phase 3 ENABLAR-2 clinical trial of enobosarm for the treatment of androgen receptor positive (AR+), estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer in the 2nd line setting.

Sabizabulin, a microtubule disruptor, is being developed as a Phase 3 clinical trial for the treatment of hospitalized patients with viral-induced ARDS. The Company does not intend to undertake further development of sabizabulin for the treatment of viral-induced ARDS until we obtain funding from government grants, pharmaceutical company partnerships, or other similar third-party external sources.

The Company also has an FDA-approved commercial product, the FC2 Female Condom® (Internal Condom), for the dual protection against unplanned pregnancy and sexually transmitted infections.

*Dr. Aronne, like other members of the Company’s Scientific Advisory Board, receives certain compensation from the Company for his services.
        
Forward-Looking Statements
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, express or implied statements related to whether and when the planned phase 2b trial of enobosarm discussed above will commence or produce topline data or patients will progress into the extension study, the planned design, timing, endpoints, patient population and patient size of such trial and whether such trial will successfully meet any of its endpoints, whether enobosarm will enhance weight loss or preserve muscle in, or meet any unmet need for, obesity patients and whether it will enhance weight loss, whether the Scientific Advisory Board will make valuable contributions to the Company’s metabolic development program, and whether the Company will be successful in its transformation into a late stage biopharmaceutical company focused on obesity and oncology. The words "anticipate," "believe," "could," "expect," "intend," "may," "opportunity," "plan," "predict," "potential," "estimate," "should," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based upon current plans and strategies of Veru Inc. (the Company) and reflect the Company's current assessment of the risks and uncertainties related to its business and are made as of the date of this press release. The Company assumes no obligation to update any forward- looking statements contained in this press release because of new information or future events, developments or circumstances. Such forward-looking statements are subject to known and unknown risks, uncertainties and assumptions, and if any such risks or uncertainties materialize or if any of the assumptions prove incorrect, our actual results could differ materially from those expressed or implied by such statements. Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to, uncertainties related to market conditions and the satisfaction of customary closing conditions related to the proposed public offering and the Company’s expectations regarding the completion, timing and size of the proposed public offering and the use of proceeds therefrom. This list is not exhaustive and other risks are detailed in the Company’s periodic reports filed with the SEC, including the Company's Form 10-K for the year ended September 30, 2023.

Investor and Media Contact:

Samuel Fisch
Executive Director, Investor Relations and Corporate Communications
Email: veruinvestor@verupharma.com

February 28, 2024 08:46 ET| Source: Safety Shot, Inc.Follow

• Boon was one of the original thought leaders and investors in LifeLock, which was subsequently acquired for $2.3 billion.
• He was the Co-Founder and CEO of GBB Drink Lab, which developed Safety Shot.
• Boon will lead the launch and growth of the Safety Shot business.

JUPITER, FL, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Safety Shot, Inc. (Nasdaq: SHOT) (the “Company), a pioneer in innovative well-being solutions, announced today that Brian John is stepping down as Chief Executive of the Company. In this transition, Jarrett Boon will be appointed as the new Chief Executive Officer.

Jarrett Boon has over 30 years of experience building successful businesses from creation to exit. He was one of the original thought leaders and investors in LifeLock, a leading identity protection provider. At LifeLock Boon applied his expertise in sales, marketing, and strategic business development to grow the company to $500 million in revenue. LifeLock went public in 2012 and was subsequently acquired by Symantec in 2016 for $2.3 billion. Prior to LifeLock, Boon founded SW Promotions, a marketing and advertising company. SW Promotions and its 400 employees were acquired by one of its publicly traded partners.

Brian John is leaving the Company to work with Elite Health Partners Inc., a leading provider of world-class, innovative products and services that fulfill a broad range of consumer health and beauty needs globally. Safety Shot had recently signed an agreement to license and sell its legacy Jupiter Wellness assets to Elite on February 22, 2024.

The Company’s Jupiter Wellness assets include a portfolio of over-the-counter commercialized products as well as product candidates in development for indications including skin care, hair growth, and women’s health. Safety Shot is spinning off its legacy assets from its Jupiter Wellness business to unlock value for shareholders.

"Safety Shot is an incredible product that is catching fire on social media and the internet.,” stated John. It is time to transition the Company to make room for experts in the Beverage space. I have had the pleasure working along Side Jarrett for the past 8 months and I am 100% confident he is the right person to take Safety Shot to the next level.” Additionally, I look forward to making the legacy Jupiter Wellnesses products another asset and dividend for Shot Shareholders.”

“I thank Brian for the passion and commitment he has brought to Safety Shot and wish him well as he moves on to his next chapter with Elite Health Partners," commented Boon. "I am excited to take the business forward and even more excited about the tremendous potential that Safety Shot has to improve the health and well-being of millions of consumers in the growing $1.56 billion market. This is an amazing opportunity and I will be dedicated to accelerating the growth of Safety Shot into a leading wellness beverage while increasing shareholder value,” he added.

About Safety Shot

Safety Shot Inc., founded in 2018, is the first patented beverage that makes you feel better fast by reducing blood alcohol content and increasing mental clarity. Valued at $1.56 billion in 2020 and projected to grow at a CAGR of 14.6% through 2028, Safety Shot leverages scientifically proven ingredients to enhance metabolic pathways responsible for breaking down blood alcohol levels. The drink is purported to form a protective layer around the stomach, preventing residual alcohol absorption into the body. The formulation includes a tailored selection of all-natural vitamins, minerals, and nootropics, promoting faster alcohol breakdown and aiding in recovery and rehydration Safety Shot has been available for retail purchase since the first week of December 2023 at www.DrinkSafetyShot.com and www.Amazon.com. Additionally, the company plans to introduce business-to-business sales to distributors, retailers, restaurants, and bars in 2024.

Forward Looking Statements

This communication contains forward-looking statements regarding Safety Shot, including, the anticipated timing of studies and the results and benefits thereof. You can generally identify forward-looking statements by the use of forward-looking terminology such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “explore,” “evaluate,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” or “will,” or the negative thereof or other variations thereon or comparable terminology. These forward-looking statements are based on each of the Company’s current plans, objectives, estimates, expectations, and intentions and inherently involve significant risks and uncertainties, many of which are beyond Safety Shot’s control. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties and other risks and uncertainties affecting Safety Shot and, including those described from time to time under the caption “Risk Factors” and elsewhere in Safety Shot’s Securities and Exchange Commission (SEC) filings and reports, including Safety Shot’s Annual Report on Form 10-K for the year ended December 31, 2023 and future filings and reports by Safety Shot. Moreover, other risks and uncertainties of which the combined company is not currently aware may also affect each of the companies’ forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. Investors are cautioned that forward-looking statements are not guarantees of future performance. The forward-looking statements made in this communication are made only as of the date hereof or as of the dates indicated in the forward-looking statements and reflect the views stated therein with respect to future events at such dates, even if they are subsequently made available by Safety Shot on its website or otherwise. Safety Shot undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made.

Investor Contact:
Phone: 561-244-7100
Email: investors@drinksafetyshot.com

MIAMI, Feb. 20, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle for higher quality weight loss, oncology, and viral induced acute respiratory distress syndrome (ARDS), today announced the formation of a new Scientific Advisory Board to support the advancement of enobosarm, an oral novel selective androgen receptor modulator (SARM), to avoid muscle loss and augment fat loss when combined with a Glucagon-like peptide-1 receptor agonist (GLP-1 RA) drugs for potentially higher quality weight loss. The Scientific Advisory Board brings deep and complementary knowledge in metabolic diseases, obesity, weight management, muscle preservation and physical function in addition to significant experience in clinical research and in drug development.

“We are pleased to announce the addition of such an esteemed group of experts to our new Scientific Advisory Board,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru Inc. “All of these experts in obesity and muscle share our vision and goal to develop enobosarm as a drug candidate that may potentially enhance quality weight loss for obese or overweight patients by preferentially increasing fat loss while preserving muscle. We know that all of them will make valuable contributions to guide the enobosarm development program.”

The members of Veru’s new Scientific Advisory Board are:

Dr. Caroline M. Apovian
Caroline M. Apovian, MD, FACP, FTOS, DABOM is Co-Director of the Center for Weight Management and Wellness (CWMW) in the Division of Endocrinology, Diabetes, and Hypertension at Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical School. For over thirty years, Dr. Apovian has held a position at the forefront of the obesity and nutrition fields. One of the world’s premier weight management experts, she has distinguished herself as a leading researcher, healthcare provider, teacher, and New York Times bestselling author. In collaboration with the Divisions of Gastroenterology and Metabolic Surgery, the CWMW will offer comprehensive, multidisciplinary care for patients seeking weight loss. Under Dr. Apovian’s direction, the Endocrinology arm of the Center will specialize in the assessment and treatment of obesity and its comorbidities. Nationally, she is one of the founding creators of the American Board of Obesity Medicine which provides certification and recognition for physicians who have specialized knowledge and training in the practice of obesity medicine. Her current research interests are weight change and its effects on adipose tissue metabolism and inflammation, obesity and cardiovascular disease, resolution of type 2 diabetes and cardiovascular disease in the bariatric surgery population, disparities in the treatment of obesity in underserved populations, and novel pharmacotherapeutic agents for the treatment of obesity. She is also an expert in sampling subcutaneous adipose tissue and muscle tissue in humans and has been studying the relationship between adipose tissue inflammation and obesity for over 15 years. Dr. Apovian has published over ten books and over 200 peer-reviewed original research and review articles on obesity and nutrition. Dr. Apovian was a member of the expert panel for updating the 2013 AHA/ACC/TOS Clinical Guidelines for the Management of Overweight and Obesity in Adults, published in the Circulation and Obesity journals and was the Chair of the Endocrine Society Guidelines for Medical Treatment of Obesity published in the Journal of Endocrinology and Metabolism in 2015. She is a former Nutrition Consultant for the National Aeronautics and Space Administration (NASA). Dr. Apovian has given over 200 invited lectures nationally and internationally and served as President of The Obesity Society in 2017-2018. She is also a past Co-Director for the NIH-funded Boston Nutrition and Obesity Research Center.

Dr. Shalender Bhasin
Shalender Bhasin, M.D., B.S., is a Professor of Medicine at the Harvard Medical School, and Director of the Research Program for Men’s Health and Aging at the Brigham and Women’s Hospital in Boston, Mass. He is the co-Director of the Brigham Center for Transgender Health. He is also the Director of the Boston Claude D. Pepper Aging Research Center at the Harvard Medical School. Dr. Bhasin is one of the foremost experts in men’s health and aging. He has published more than 400 original research papers in top tier journals and has conducted some of the most important randomized trials of testosterone in men and women. His lab has characterized the mechanisms of testosterone's action and the role of steroid 5-alpha reductase in adults. He led the Endocrine Society's expert panel that developed the guidelines for testosterone treatment of hypogonadal men since 2005. His lab has investigated the mechanisms of muscle loss with aging. He chaired an expert panel that developed the evidence-based definition of sarcopenia and has conducted many randomized trials of function promoting therapies. He has been investigating the role of Nicotinamide Adenine Dinucleotide (NAD) in aging biology and the potential applications of NAD augmentation to treat age-related diseases. Dr. Bhasin has been the recipient of numerous research, teaching, and mentorship awards throughout his career. He received the Endocrine Society's Outstanding Clinical Investigator Award, and the American College of Endocrinology's Frontiers in Science Award. Shalender Bhasin is the recipient of research grants from AbbVie, MIB and FPT. He is also a consultant with Novartis.

Dr. Adrian Dobs
Adrian Sandra Dobs, MD, MHS, is Professor of Medicine and Oncology and Director of the Johns Hopkins Clinical Research Network of the Johns Hopkins Institute for Clinical and Translational Research (JHCRN). The JHCRN is a multi-institutional collaboration linking academic and community hospitals in the mid-Atlantic United States. Dr Dobs received her undergraduate degree from Cornell University, a medical degree from Albany Medical College, in New York, and completed an internship in internal medicine at Montefiore Hospital, Albert Einstein College of Medicine, in the Bronx, New York. She held a fellowship in endocrinology from Johns Hopkins University School of Medicine and earned a master’s in health sciences degree in cardiovascular epidemiology at the Johns Hopkins University Bloomberg School of Public Health. Dr Dobs is an active clinician seeing patients with general endocrine problems, with a subspecialty in sex hormone disorders. She has been an investigator on several NIH-funded studies evaluating the relationship of sex hormones and cardiovascular risk. She lectures in the United States and internationally in these areas, as well as aging and testosterone therapy and testosterone and cardiovascular disease. With book chapters, monographs, and journal articles, as well as television and Web contributions, Dr Dobs has published extensively on topics that include sex hormones and its relationship to metabolic disorders. Journals publishing her research include the New England Journal of Medicine, Journal of Clinical Endocrinology and Metabolism, JAIDS, and Journal of Andrology. She has sat on multiple NIH grant review committees and data safety monitoring boards. Dr Dobs is very active in mentoring medical students and postdoctoral fellows and was honored by the Johns Hopkins University School of Medicine with the David M. Levine Excellence in Mentoring Award.

Dr. William J. Evans
William J. Evans, PhD is an Adjunct Professor of Medicine in the Division of Geriatrics at the Duke University Medical Center and Human Nutrition in the Department of Nutritional Sciences at the University of California, Berkeley. He previously was Vice President and head of the Muscle Metabolism Discovery Unit at GSK. He has served as laboratory director at the Reynolds Institute on Aging at the University of Arkansas for Medical Sciences, the Noll Physiological Research Center at Penn State and as the Chief of the Human Physiology Laboratory at the Human Nutrition Research Center on Aging at Tufts University. With an H-index of 124 and more than 78,000 citations he is the author or co-author of more than 350 publications in scientific journals and was the first to describe sarcopenia. He is the co-inventor of the D3Creatine dilution method, a non-invasive and accurate measurement of muscle mass which is strongly related to health outcomes in older people. His work has been featured in the PBS series, NOVA, Good Morning America, 20/20, CBS evening news, CNN, and the New York Times. Dr. Evans has been invited to testify before the US Senate Select Committee on Aging on strategies to save Medicare. He is a founding member of the Society for Sarcopenia, Cachexia, and Wasting Disorders and recently received the Lifetime Achievement Award from the International Conference on Frailty and Sarcopenia Research.

About Sarcopenic Obesity

According to the CDC, 41.5% of older adults have obesity in the United States and could benefit from a weight loss medication. Up to 34.4% of these obese patients over the age of 60 have sarcopenic obesity. This large subpopulation of sarcopenic obese patients is especially at risk for taking GLP-1 drugs for weight loss as they already have critically low amount of muscle due to age-related muscle loss. Further loss of muscle mass when taking a GLP-1 RA medication may lead to muscle weakness leading to poor balance, decreased gait speed, mobility disability, loss of independence, falls, bone fractures and increased mortality which is a condition like age-related frailty. Because of the magnitude and speed of muscle loss while on GLP-1 RA therapy for weight loss, GLP-1 RA drugs may accelerate frailty in older obese or overweight elderly patients.

About Enobosarm

Enobosarm (aka ostarine, MK-2866, GTx-024, and VERU-024), a novel oral daily selective androgen receptor modulator (SARM), has been previously studied in 5 clinical studies involving 968 older normal men and postmenopausal women as well as older patients who have muscle wasting because of advanced cancer. Advanced cancer simulates a “starvation state” where there is significant unintentional loss or wasting of both muscle and fat mass similar to what is observed with GLP-1 RA treatment. The totality of the clinical data from these five clinical trials demonstrates that enobosarm treatment leads to dose-dependent increases in muscle mass with improvements in physical function as well as significant dose-dependent reductions in fat mass. The patient data that were generated from these five enobosarm clinical trials in both elderly patients and in patients with a cancer induced starvation-like state provide strong clinical rationale for enobosarm. The expectation is that enobosarm in combination with a GLP-1 RA would potentially augment the fat reduction and total weight loss while avoiding muscle loss.

In addition, enobosarm has a large safety database, which includes 27 clinical trials involving 1581 men and women dosed with duration of treatment in some patients for up to 3 years. In this large safety database, enobosarm was generally well tolerated with no increase in gastrointestinal side effects. This is important as there are already significant and frequent gastrointestinal side effects with a GLP-1 RA treatment alone.

Planned Phase 2b enobosarm clinical trial design for potentially higher quality weight loss

The Phase 2b, multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial is designed to evaluate the safety and efficacy of enobosarm 3mg, enobosarm 6mg, or placebo as a treatment to augment fat loss and to prevent muscle loss in 90 sarcopenic obese or overweight elderly patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness. The primary endpoint is lean body mass (muscle), and the key secondary endpoint is total body fat mass at 16 weeks. The IND has received FDA clearance, and the clinical study is expected to begin in April 2024 with the topline clinical results from the trial expected in the end of the fourth calendar quarter of 2024.

After completing the efficacy dose-finding portion of the Phase 2b clinical trial, participants will then continue into a Phase 2b extension clinical trial where all patients will stop receiving a GLP-1 RA, but will continue taking placebo, enobosarm 3mg, or enobosarm 6mg for an additional 12 weeks. The Phase 2b extension clinical trial will evaluate whether enobosarm can maintain muscle and prevent the fat and weight rebound that occurs after stopping a GLP-1 RA drug. The results of the separate Phase 2b extension clinical study is expected in calendar Q2 2025.

About Veru Inc.
Veru is a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of metabolic diseases, oncology, and ARDS. The Company’s drug development program includes two late-stage novel small molecules, enobosarm and sabizabulin.

Enobosarm, a selective androgen receptor modulator (SARM), is being developed for two indications: (i) Phase 2b clinical study of enobosarm as a treatment to augment fat loss and to prevent muscle loss in sarcopenic obese or overweight elderly patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness and (ii) subject to the availability of sufficient funding, Phase 3 clinical trial of enobosarm for the treatment of androgen receptor positive (AR+), estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer in the 2nd line setting.

Sabizabulin, a microtubule disruptor, is being developed as a Phase 3 clinical trial for the treatment of hospitalized patients with viral-induced ARDS. The Company does not intend to undertake further development of sabizabulin for the treatment of viral-induced ARDS until we obtain funding from government grants, pharmaceutical company partnerships, or other similar third-party external sources.

The Company also has an FDA-approved commercial product, the FC2 Female Condom® (Internal Condom), for the dual protection against unplanned pregnancy and sexually transmitted infections.
        
Forward-Looking Statements
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, express or implied statements related to whether and when the planned phase 2b trial of enobosarm discussed above will commence or produce topline data or patients will progress into the extension study, the planned design, timing, endpoints, patient population and patient size of such trial and whether such trial will successfully meet any of its endpoints, whether enobosarm will enhance weight loss or preserve muscle in, or meet any unmet need for, obesity patients and whether it will enhance weight loss, whether the Scientific Advisory Board will make valuable contributions to the Company’s metabolic development program, and whether the Company will be successful in its transformation into a late stage biopharmaceutical company focused on obesity and oncology. The words "anticipate," "believe," "could," "expect," "intend," "may," "opportunity," "plan," "predict," "potential," "estimate," "should," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based upon current plans and strategies of Veru Inc. (the Company) and reflect the Company's current assessment of the risks and uncertainties related to its business and are made as of the date of this press release. The Company assumes no obligation to update any forward- looking statements contained in this press release because of new information or future events, developments or circumstances. Such forward-looking statements are subject to known and unknown risks, uncertainties and assumptions, and if any such risks or uncertainties materialize or if any of the assumptions prove incorrect, our actual results could differ materially from those expressed or implied by such statements. Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to, uncertainties related to market conditions and the satisfaction of customary closing conditions related to the proposed public offering and the Company’s expectations regarding the completion, timing and size of the proposed public offering and the use of proceeds therefrom. This list is not exhaustive and other risks are detailed in the Company’s periodic reports filed with the SEC, including the Company's Form 10-K for the year ended September 30, 2023.

Investor and Media Contact:
Samuel Fisch
Executive Director, Investor Relations and Corporate Communications
Email: veruinvestor@verupharma.com

JACKSONVILLE, Fla., Feb. 15, 2024 /PRNewswire/ -- The Alfred I. duPont Charitable Trust, which for almost 90 years has supported and advanced its charitable beneficiary, The Nemours Foundation, today announced the election of three new Directors to The Nemours Foundation Board. The Nemours Foundation is the governing body that oversees Nemours Children's Health. Joining the Board are Cindy Bertrando, Chief Financial Officer of the National MS Society, Delaware County, Pa.; Ed Karlovich, Former Executive Vice President and Chief Financial Officer of the University of Pennsylvania Medical Center (UPMC), Pittsburgh, Pa.; and Judy Titera, Former Chief Privacy Officer USAA, Venice, Fla.

"These exemplary professionals bring a broad base of business, academic medicine, and risk management expertise to the Nemours Board that complements the knowledge and skills of our existing Board of Directors," said Hugh M. Durden, Chairman of Alfred I. duPont Charitable Trust. "I am excited about the contributions that Cindy, Ed, and Judy will make to the continued growth of Nemours Children's Health and its vision for creating the healthiest generations of children."

Cindy Bertrando is a senior finance leader with extensive experience in audit, financing deals, mergers and acquisitions, financial transformation, and business development. She is steeped in strategy and execution and currently serves as CFO of the National MS Society, responsible for ensuring the financial stability of this $150M national organization. Cindy also leads the annual budget process and manages the Finance, Investment, and Audit Committees of the National Board of Directors.

Ed Karlovich recently retired as Executive Vice President and Chief Financial Officer of UPMC, a $28B healthcare provider and insurance enterprise, supporting innovative care delivery models, physician partnerships, affiliation strategies, and organization redesign. His financial leadership responsibilities at UPMC included oversight of UPMC's free-standing, 315-bed Children's Hospital, rated as a Top 10 children's hospital by US News & World Report.

Judy Titera is an experienced board director and risk professional, currently serving on the Board and Audit Committee for Mitsui Sumitomo Transverse Insurance and serves on the Advisory Board for private equity-held RadarFirst, a SaaS-based incident response management platform. Most recently, Judy held the position of Chief Privacy Officer at USAA, where she was responsible for all risk and compliance activities associated with the design, development, and operations of the enterprise information privacy program and operational excellence, along with ensuring close alignment with cybersecurity teams and requirements.

Completing his term on The Nemours Foundation Board of Directors is Rick Walsh, Chairman and CEO of the Knob Hill Companies. "Nemours is extremely grateful to Rick for his more than 12 years of service to Nemours Children's as a member of our inaugural Nemours Children's Hospital, Florida, Florida Board of Managers and more recently, The Nemours Foundation Board," said Durden. "We are deeply grateful for his many contributions."

About Alfred I. duPont Charitable Trust 

The Alfred I. duPont Charitable Trust is a non-profit organization created by philanthropist Alfred Irénée duPont in 1935. The duPont Trust is devoted to supporting the trust's sole charitable beneficiary, The Nemours Foundation for the benefit of Nemours Children's Health and the Nemours Estate. The Trust is one of America's most generous supporters of pediatric healthcare. Since 1935, the Trust has provided funding to its primary beneficiary, The Nemours Foundation, for the care and treatment of children primarily in Delaware and Florida and has helped hundreds of thousands of sick children find health and new hope for the future, regardless of ability to pay. Learn more at https://alfrediduponttrust.org/.

About Nemours Children's Health      

Nemours Children's Health is one of the nation's largest multistate pediatric health systems, which includes two free-standing children's hospitals and a network of more than 70 primary and specialty care practices. Nemours Children's seeks to transform the health of children by adopting a holistic health model that utilizes innovative, safe, and high-quality care while also caring for the health of the whole child beyond medicine. Nemours Children's also powers the world's most-visited website for information on the health of children and teens, Nemours KidsHealth.org.

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SOURCE The Nemours Foundation

February 12, 2024 04:41 PM Eastern Standard Time

SARASOTA, Fla.--(BUSINESS WIRE)--Oragenics, Inc. (NYSE American: OGEN) (the “Company”), a company focused on developing unique, intranasal nanoparticle pharmaceuticals for the treatment of neurological disorders, today announced that, on February 12, 2024, the Company and Kimberly Murphy, the Company’s Chief Executive Officer, entered into a mutually agreeable Separation Agreement (the “Separation Agreement”), pursuant to which Ms. Murphy’s employment with the Company terminated effective February 12, 2024. Ms. Murphy will, however, continue to serve the Company as a member of the Company’s board of directors (the “Board”). The Separation Agreement provides Ms. Murphy with the benefits under her employment agreement with the Company for a separation without cause. Ms. Murphy’s resignation as an officer was not due to any disagreement with the Company on any matter related to its operations, policies or practices.

The Board will provide direction to the Company during this transition in management, with Charlie Pope, the Company’s Chairman of the Board, serving, on an interim basis, as Executive Chairman, effective immediately. In addition, effective February 12, 2024, the Board appointed Michael Redmond, the Company’s President, as the Company’s Interim Principal Executive Officer.

“We appreciate Ms. Murphy’s strategic leadership on the shift in the Company’s focus to its recently acquired neurology assets and look forward to her continued positive impact on and support of the Company as a director,” said Charles Pope, Executive Chairman of the Board.

About Oragenics

Oragenics, Inc. is a development-stage company focused on nasal delivery of pharmaceutical medications in neurology and fighting infectious diseases including coronaviruses and multidrug-resistant organisms. Its ONP-002 product candidate is a fully synthetic neurosteroid being developed to treat Mild Traumatic Brain Injury (mTBI). Its NT-CoV2-1 product candidate is an intranasal vaccine candidate to prevent COVID-19 and variants of the SARS-CoV-2 virus. The NT-CoV2-1 program leverages coronavirus spike protein research licensed from the National Institutes of Health (NIH) and the National Research Council of Canada (NRC) with a focus on reducing viral transmission and offering a more patient-friendly intranasal administration. For more information, please visit www.oragenics.com.

Forward-Looking Statements

This communication contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the ability of the Company to timely and successfully undertake Phase II clinical trial using its novel drug - device combination for the treatment of mild Traumatic Brain Injury. These forward-looking statements are based on management’s beliefs and assumptions and information currently available. The words “believe,” “expect,” “anticipate,” “intend,” “estimate,” “project” and similar expressions that do not relate solely to historical matters identify forward-looking statements. Investors should be cautious in relying on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. These factors include, but are not limited to: the Company’s ability to advance the development of its product candidates, including the neurology assets, under the timelines and in accord with the milestones it projects; the Company’s ability to raise capital and obtain funding, non-dilutive or otherwise, for the development of its product candidates; the regulatory application process, research and development stages, and future clinical data and analysis relating to its product candidates, including any meetings, decisions by regulatory authorities, such as the FDA and investigational review boards, whether favorable or unfavorable; the Company’s ability to obtain, maintain and enforce necessary patent and other intellectual property protection; the nature of competition and development relating to concussion treatments; the Company’s expectations as to the outcome of preclinical studies and clinical trials and the potential benefits, activity, effectiveness and safety of its product candidates including as to administration, transmission, manufacturing, storage and distribution; and general economic and market conditions and risks, as well as other uncertainties described in our filings with the U.S. Securities and Exchange Commission. All information set forth is as of the date hereof unless otherwise indicated. You should consider these factors in evaluating the forward-looking statements included and not place undue reliance on such statements. We do not assume any obligation to publicly provide revisions or updates to any forward-looking statements, whether as a result of new information, future developments or otherwise, should circumstances change, except as otherwise required by law.

Contacts

Oragenics, Inc.
Janet Huffman, Chief Financial Officer
813-286-7900
jhuffman@oragenics.com

LHA Investor Relations
Tirth T. Patel
212-201-6614
tpatel@lhai.com

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: www.cadrenal.com.  

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

press@cadrenal.com 

Investors:

Lytham Partners, LLC

Robert Blum, Managing Partner

602-889-9700

CVKD@lythampartners.com 

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SOURCE Cadrenal Therapeutics, Inc.

Dr. Kuro-o to speak at Second Annual Entrepreneurship, Longevity and Biotech Conference Held in Boca Raton, Florida

February 05, 2024 09:41 ET| Source: Advantage Therapeutics Inc.Follow

BOCA RATON, Fla. and VIENNA, Austria, Feb. 05, 2024 (GLOBE NEWSWIRE) -- ADvantage Therapeutics, a pioneer in developing therapies for neurodegenerative conditions by addressing the biology of aging, today announced the appointment to its Scientific Advisory Board of Professor Makoto Kuro-o, a pioneer in the science of aging and longevity and the first to identify the klotho gene. In addition, ADvantage’s CEO, Jeffrey Madden, will provide updates on the development of ADvantage’s lead compound, AD04™, now in phase 2 clinical trials in Alzheimer’s Disease patients, and on the company’s work on the klotho protein, which aims to reduce the effects of aging.

Kuro-o and Madden will speak at the invite-only Entrepreneurship, Longevity, and Biotech Conference in Boca Raton on February 9 and 10. The conference assembles biotech and longevity scientists and entrepreneurs to share research and exchange ideas for improving the biotech and longevity industries.  Last year, Moderna co-founder Professor Robert Langer gave the keynote address.

“The biology of aging is growing in prominence as scientists discover how damage accumulates throughout the body and how some factors, such as the klotho protein, rejuvenate and protect multiple systems,” said Madden. “ADvantage is working to reduce the burden of aging in Alzheimer’s specifically and other age-related conditions more generally, and Dr. Kuro-o will be a tremendous addition in that effort. His discovery of the klotho gene opened a new field that we will work together to advance.

Makoto Kuro-o, M.D., Ph.D. is a professor at the Center of Molecular Medicine, Jichi Medical University, Japan. He has more than 30 years of research and clinical experience in endocrinology, endocrine fibroblast growth factors, molecular biology of aging, nephrology, and mineral metabolism. He discovered and named the klotho gene in 1997, and since then has written and published extensively on the topic. His pioneering research has opened new and promising paths toward understanding longevity as well as preventing and treating disease. Dr. Kuro-o received his degrees from the University of Tokyo, Japan.

Other speakers at this year’s conference include Dr. Carmela Abraham, Chief Science Officer, ADvantage Therapeutics, Dr. Rudy Tanzi, Professor of Neurology, Harvard Medical School and Director of the Genetics and Aging Research Unit, MGH, Dr. Leona Krohle CEO and Founder, Bluezone Longevity Sphere, Nathan Cheng, General Partner, Healthspan Capital, Lisa Fabiny-Kiser, CEO, SENS Research Foundation, Agustin Fernandez III, CEO, Rational Vaccines, Iosif Gershteyn, CEO, ImmuVia, Bryan Johnson, Founder and CEO, Blueprint, Jeff Madden, CEO, ADvantage Therapeutics, Fiona Miller, Managing Partner, QuadraScope, Jim O'Neill, Co-founder, the Thiel Fellowship, Former HHS Official, Dr. Achim Schneeberger, Chief Medical Officer, ADvantage Therapeutics, Yuri Deigin, Co-Founder, YouthBio Therapeutics, Petr Sramek, CEO, healthylongevity.clinic, Managing Partner, Longevitytech.fund, Dr. Jean Hebert, Professor, Albert Einstein College of Medicine, Daniel Gropper, Dean, FAU College of Business, Dr. Siri Terjesen, Phil Smith Professor, Associate Dean of Research & External Relations, Executive Director, Madden Center for Value Creation at Florida Atlantic University, Leonardo Ferreira, Professor at Medical University of South Carolina. Jonathan Gootenberg, McGovern Fellow at MIT, Omar Abudayyeh, McGovern Institute Fellow at MIT, Andre Watson, Chairman and CEO, Ligandal, and other biotech visionaries.

Sponsored by the Madden Center for Value Creation at FAU’s College of Business and in collaboration with FAU Health, the conference is being held February 9^th and 10^th on the FAU campus in Boca Raton, Florida.

About AD04™
ADvantage Therapeutics is developing AD04™ as a novel immunotherapy for mild Alzheimer’s Disease. The compound has been used extensively as an adjuvant in human and animal vaccination programs. In a previous trial, AD04™ serving as a control against another compound appeared to demonstrate statistically significant slower decline in cognitive and quality of life clinical measures compared to other treatment groups. AD04™ also showed slower decline in hippocampal volume as a biomarker.

The Company believes that rather than being limited to a specific aspect of AD pathology, such as amyloid beta or tau, AD04™ may address inflammatory mechanisms in the brain, functioning as an immunomodulator, stimulating and/or regulating the immune system to reduce AD pathology.

About Alzheimer’s Disease
About fifty million people worldwide suffer from Alzheimer’s Disease, which is the sixth leading cause of death in industrialized countries. In 2019, the World Health Organization estimated the total worldwide cost of dementia at $1.3 trillion and expects this cost to rise to $2 trillion by 2030. The socio-economic burden of Alzheimer’s Disease is enormous. AD devastates the lives of patients and their families. AD victims lose their memory and independence. Alzheimer’s Disease is a high unmet medical need as there are currently no disease-modifying drugs approved worldwide. The availability of a safe, effective, affordable drug would transform the life of an AD patient from accepting a debilitating disease to the retention of personality, independence, and dignity.

About ADvantage Therapeutics, Inc.
Headquartered in the Wynwood neighborhood in Miami, ADvantage Therapeutics is developing therapies to treat neurodegenerative conditions with a central focus on Alzheimer’s Disease. The Company’s lead compound AD04™ is a subcutaneous injectable therapy that entered, in November 2023, confirmatory Phase 2b clinical trials in Europe, to evaluate its safety and efficacy in early AD patients. The Company believes that AD04™ may function as an immunomodulator, stimulating and regulating the immune system to reduce AD pathology, rather than limiting therapy to attack the misfolded proteins, beta amyloid and tau. The Company is exploring additional approaches to mitigating neurodegenerative disease, among them increasing the levels of Klotho, a life and health extending protein which will have an overall impact on longevity.

About ADvantage Therapeutics GmbH
ADvantage Therapeutics GmbH, founded in 2021, is the Vienna BioCenter-based subsidiary of ADvantage Therapeutics, Inc., where the Company conducts early research and drug development.

Safe Harbor-Forward-Looking Statements
This press release may contain forward-looking statements, including statements of potential mode of action, potential clinical effect, potential safety, and ADvantage’s potential clinical development program and pipeline program. ADvantage is in the early stages of developing and testing its AD04™ compound and may not receive future regulatory approvals needed for marketing it as a drug. The described clinical effect of our lead compound AD04™ is primarily based on results of a Phase 2 study designed to evaluate a different compound. The described results need to be confirmed for proof of concept, might not be representative of larger scale clinical trials, and do not guarantee future clinical success. Any preclinical results presented here are interim. The mechanism of action of AD04™, as potentially determined in our future investigations, particularly in future clinical trials with patients with Alzheimer’s Disease, might differ from the one presented.

Contacts:
For ADvantage Therapeutics
195 NW 40th Street
Miami, FL 33127

Jeffrey Madden CEO
jeff@advantagetherapeutics.com
(305) 846-9027

David Buchsbaum CFO
david@advantagetherapeutics.com
(305) 846-9027