Enzyvant Therapeutics GmbH

CELEBRATION, Fla., Jan. 23, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra or the Company), a rare disease therapeutics company, today announced the appointment of Alvin Shih, MD, MBA, to the Company’s Board of Directors (Board) effective as of January 20, 2024. Dr. Shih has extensive experience in biotechnology leadership and rare disease therapeutics development and currently serves as President and CEO of Catamaran Bio, a biotechnology company developing cell therapies for multiple oncologic indications. “We are honored to welcome Dr. Shih to our Board as we advance our therapeutic portfolio of product candidates in multiple rare disease indications,” said Tamara A. Favorito, Chair of Zevra’s Board of Directors. “Dr. Shih brings a wealth of leadership expertise across multiple types of rare diseases. His unique skills as an experienced drug developer and physician position him to be an invaluable asset to the Board and for shareholders.” “I am pleased to have the opportunity to serve on the Zevra Board of Directors at a time when the Company is poised to have a profound impact on addressing unmet clinical needs within the rare disease community,” said Dr. Shih. “My long-time focus in therapeutics development and biotechnology leadership fits well with Zevra’s mission to bring life-changing therapies to people living with rare diseases. I look forward to working together with the Board and management team to guide an advancing portfolio and growth capabilities with the potential to make a difference for those we serve.” Dr. Shih has broad experience in drug development, spanning multiple therapeutic areas and with a focus on rare diseases, including as the former Chief Operating Officer and a founding member of Pfizer’s Rare Disease Research Unit. Prior to his current role as President and CEO of Catamaran Therapeutics, he was CEO at Disarm Therapeutics, a biotechnology company that developed therapeutics for both rare and prevalent neurodegenerative diseases until its acquisition by Eli Lilly in 2020. Before that, Dr. Shih was CEO at Enzyvant Therapeutics, where he led the company’s cell/tissue-based therapy development for treating a rare immunologic disease. He also was the Executive Vice President and Head of Research and Development at Retrophin, Inc., where he worked on therapies for multiple rare disease indications. Dr. Shih previously worked in management consulting at McKinsey & Company and L.E.K. Consulting, LLC. He earned his medical degree from the University of Alabama School of Medicine and completed his residency training at Massachusetts General Hospital. Dr. Shih received his MBA degree from the Kellogg School of Management at Northwestern University, and his BA degree from Vanderbilt University. About Zevra Therapeutics: Zevra Therapeutics is a rare disease company melding 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. Expanded access programs are made available by Zevra Therapeutics and its affiliates and are subject to the Company's Expanded Access Program (EAP) policy as published on its website at . Participation in these programs is subject to the laws and regulations of each jurisdiction under which each respective program is operated. Eligibility for participation in any such program is at the treating physician's discretion. 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, and which can be identified by the use of words such as "may," "will," "expect," "project," "estimate," "anticipate," "plan," "believe," "potential," "should," "continue," "could," "intend," "target," "predict," or the negative versions of those words or other comparable words or expressions, although not all forward-looking statements contain these identifying words or expressions. Forward-looking statements are not guarantees of future actions or performance. These forward-looking statements include without limitation statements regarding Zevra’s strategic and product development objectives, including with respect to becoming a leading rare disease company and addressing unmet clinical needs, and Zevra’s plans, goals and expectations concerning market position, future operations and other financial and operating information. Forward-looking statements are based on information currently available to Zevra and its current plans or expectations, and are subject to several known and unknown uncertainties, risks, and other important factors that may cause 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, 2022, as updated in Zevra’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, and Zevra’s other filings with the Securities and Exchange Commission. While Zevra may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, except as required by law, even if subsequent events cause their respective views to change. Although Zevra believes the expectations reflected in such forward-looking statements are reasonable, it cannot assure that such expectations will prove correct. These forward-looking statements should not be relied upon as representing Zevra’s 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: David Schull +1 (858) 717-2310 david.schull@russopartnersllc.com Ignacio Guerrero-Ros, Ph.D. +1 (646) 942-5604 ignacio.guerrero-ros@russopartnersllc.com

None  Welcome to this week's Chutes & Ladders, our roundup of hirings, firings and retirings throughout the industry. Please send the good word—or the bad—from your shop to Max Bayer or Gabrielle Masson, and we will feature it here at the end of each week.  Gene editing biotech Metagenomi adds CSO, CFO Metagenomi Metagenomi is bolstering its senior leadership ranks with a couple of new hires, naming Luis Borges, Ph.D., as chief scientific officer and Pamela Wapnick as chief financial officer.  Borges joins from Century Therapeutics where he held the same role, guiding that biotech’s off-the-shelf, stem-cell-based natural killer and cell therapies. He was also the chief scientific officer of Cell Medica and SVP of research at Five Prime Therapeutics. He joins at a time when Metagenomi is rapidly nearing the clinic, with nine assets in the pipeline and two nearing IND-enabling studies. Wapnick’s appointment is arguably more pertinent as the biotech reportedly considers going public. She’s a serial top biotech financier with previous stints at Diality, Capsida Biotherapeutics and Graybug Vision. In its announcement, Metagenomi notes that while at True North Therapeutics, Wapnick “completed preparations for an initial public offering before the company’s acquisition by Bioverativ.” Release Ex-McKinsey leader André Andonian to lead new Flagship hub in Singapore Flagship Pioneering Flagship Pioneering is planting its—don’t boo us—flag in the Asia-Pacific region with a new hub based in Singapore. The outpost will be led by former senior McKinsey consultant André Andonian. The launch of the new office comes shortly after Flagship began to flap its wings across international waters, opening a London office earlier this year. Flagship founder Noubar Afeyan, Ph.D., said the APEC location will help Flagship’s teams “broaden their impact on human health and the health of our planet through strategic partnerships across industry, academia, and healthcare systems in the region.” Andonian is a well-established regional consultant, working across countries while at McKinsey. He’s served as senior partner and chairman of Japan and managing partner of Korea. Over the course of his career, he’s held top leadership posts across Asia, Europe and Japan. In his new role with Flagship, Andonian will advise on “broader global strategy, regional investor engagement, and institutional development.” Release Assembly appoints Gilead vet to CMO role after $100M deal with pharma Assembly Bio On the heels of a new Gilead Sciences deal, Assembly Bio is tapping Gilead vet Anuj Gaggar, M.D., Ph.D., to serve as chief medical officer. Gaggar joins the antiviral-therapeutics-focused company from Arrive Bio, an early-stage biotech he co-founded in 2019 and helmed as CEO. Before Arrive, the leader worked for nearly 10 years as a senior member for Gilead's clinical research team, most recently serving as VP of clinical research.    While with the Big Pharma, Gaggar contributed to the registrational studies for antiviral Vemlidy, hepatitis C med Sovaldi and antiviral injection Veklury (remdesivir). Just last month, Gilead paid out $100 million upfront for first dibs on all Assembly’s current and future programs. Release (PDF) > Daiichi Sankyo Europe GmbH, the company’s European headquarters, has appointed Masahiro Kato to serve as managing director and Oliver Appelhans to be head of the European specialty business unit. Both Kato and Appelhans take over as Europe GmbH CEO Jan Van Ruymbeke prepares to retire in March after 11 years at the helm. Release > Century Therapeutics has chosen Brent Pfeiffenberger to lead the immuno-oncology company starting Dec. 4, when interim CEO Greg Russotti, Ph.D.,will transition to the role of chief technology and manufacturing officer—an expanded title from his previous position as CTO. As for the new incoming CEO, Pfeiffenberger most recently served as chief operating officer at AstraZeneca’s Neogene Therapeutics. Release > Centivax has chosen Jerald Sadoff, M.D., as chief medical officer, per a company spokesperson. Sadoff has more than 50 years of experience in vaccine development and most recently served as senior adviser of vaccine development for Johnson & Johnson’s Janssen infectious diseases and vaccines division, where he held several leadership roles for more than a decade. > Teva Pharmaceutical has tapped R. Ananthanarayanan (Ananth), Ph.D., to serve as CEO of Teva Active Pharmaceutical Ingredients (api), effective Nov. 27. The role marks a return for Ananth, who led the former Teva api and biologics operations organization from 2014 to 2018 before leaving to pursue other opportunities. Release > Arbutus Biopharma President and CEO William Collier will be retiring at the end of this year. Michael McElhaugh, Arbutus co-founder and chief operating officer, will take on the top title on an interim basis starting Jan. 1, 2024. Release > T-knife Therapeutics has tapped Simone Silva Steiner, Ph.D., to the role of chief technical operations officer. Steiner was most recently Tigen Pharma’s head of technical development and manufacturing and held manufacturing and quality roles at Novartis before that. Release > Avalyn Pharma is shaking up its leadership team, announcing four new change-ups, including Craig Conoscenti, M.D., from Boehringer Ingelheim to serve as Avalyn’s SVP of clinical development. Jim Bishop has also departed Enzyvant Therapeutics to serve as Avalyn’s SVP of business operations, while Allison Trucillo, M.D., comes from Renalytix to serve as VP of medical affairs and Rebecca Boone steps in as VP of clinical operations after leading her own consulting company. Release > Acelyrin has appointed Patricia Turney as its chief technical officer. Turney joins from Arcutis Biotherapeutics, where she served as SVP of operations, and held roles of increasing responsibility at Amgen before that. Release > Spero Therapeutics has selected Esther Rajavelu to serve as chief financial officer and chief business officer. Rajavelu, who most recently served as Fulcrum Therapeutics’ CFO, is taking the place of interim CFO Stephen DiPalma. Release (PDF)  > Texas-based OncoNano Medicine has promoted Kartik Krishnan, M.D., Ph.D., to the new role of president and head of R&D. Before joining OncoNano as chief medical officer in 2022, Krishnan was CMO at Arcus Biosciences. Release > Poolbeg Pharma has poached three former Amryt Pharma executives as the company prepares to be acquired by Chiesi Farmaceutici. David Allmond will join Poolbeg as chief business officer, while John McEvoy will become SVP and chief legal officer, and Laura Maher will step on as VP of clinical operations. Poolbeg Chair Cathal Friel is the co-founder of both Poolbeg and Amryt. Release

Bolstered clinical operations and medical affairs teams as Avalyn prepares to advance its inhaled candidates for pulmonary fibrosis into later stage clinical trialsSEATTLE, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of targeted inhalation therapies for life-threatening pulmonary diseases, today announced four leadership appointments across the organization, including lung disease drug development expert Craig Conoscenti, M.D., FCCP, ATSF, who will serve as senior vice president, clinical development. Dr. Conoscenti brings expertise in both clinical academic practice and pharmaceutical clinical development in the pulmonary field, joining Avalyn from Boehringer Ingelheim where he most recently served as executive director and therapeutic area head, interstitial lung disease clinical development and medical affairs. Avalyn also announced today the appointments of Jim Bishop to senior vice president, business operations; Allison Trucillo, M.D., to vice president, medical affairs; and Rebecca Boone to vice president, clinical operations. “We are thrilled to expand our leadership team with these key appointments as we continue to strategically scale our organization and prepare for advanced clinical development of our lead programs, AP01 and AP02, for pulmonary fibrosis,” said Lyn Baranowski, CEO of Avalyn. “Craig adds to Avalyn’s clinical development capabilities with a strong track record in the development and launch of multiple products and indications in the respiratory and ILD space, as we work to bring forward new treatments for life-threatening pulmonary diseases. We are also delighted to welcome Jim, Allison and Rebecca to Avalyn, who each bring with them crucial expertise in respiratory drug development to steer our business operations, medical affairs and clinical operations functions as we prepare for key clinical and business milestones this year and beyond.” Prior to Avalyn, Dr. Conoscenti served for 21 years at Boehringer Ingelheim, holding roles of increasing responsibility within interstitial lung disease (ILD) clinical research. He was a key contributor to the development and launch of oral nintedanib for idiopathic pulmonary fibrosis (IPF), scleroderma associated ILD and the other progressive fibrosing ILDs. Prior to that, Dr. Conoscenti held various titles including senior pulmonary and critical care medicine consultant for over 17 years at Norwalk Hospital in Norwalk, CT. Dr. Conoscenti earned a Doctor of Medicine from St. George’s University and a Bachelor of Science in Physiology from Fordham University. He completed his residency at Hackensack University Medical Center where he additionally served one year as Chief Medical Resident. Following this, he completed his Pulmonary Critical Care Fellowship at Norwalk Hospital/Yale University School of Medicine. Dr. Conoscenti is a Fellow of the American Thoracic Society, the American College of Chest Physicians and the European Respiratory Society. He received the Norman S. Brady Fellowship where he served sabbatical time at the Brompton Chest Hospital in London. “I felt compelled to join the Avalyn team to develop new and important treatments on behalf of people living with pulmonary fibrosis, many of whom I have had the honor of treating in clinical practice or serving throughout my time working in clinical development in rare ILDs,” said Dr. Conoscenti. “Avalyn’s approach to delivering proven treatments directly to the lungs has shown clinical evidence of efficacy and improved tolerability, and I am dedicated to moving these programs forward with the rest of the experienced team. As I join Avalyn the same week as the Pulmonary Fibrosis Foundation Summit, where the company will be presenting data from its clinical programs in pulmonary fibrosis, I look forward to connecting with the PF community.” Jim Bishop joined Avalyn in October 2023 as senior vice president, business operations, and he is responsible for corporate strategy and overseeing multiple functions across the organization. Prior to joining Avalyn, Mr. Bishop served as senior vice president, business operations at Enzyvant Therapeutics, a commercial-stage biopharmaceutical company. Before the company’s merger with Enzyvant, Mr. Bishop held various roles with increasing responsibility at Altavant Sciences, including senior vice president, business operations; vice president, strategic development and business operations; and chief of staff. Earlier, Mr. Bishop served in business development, operations and project management roles at multiple biotechnology and pharmaceutical companies, including Roivant Sciences, Teva Pharmaceuticals, Cabernet Pharmaceuticals and Oxygen Biotherapeutics. He began his career as a scientist at GlaxoSmithKline. Mr. Bishop earned an MBA from Meredith College and a Bachelor of Science in Biochemistry from Pennsylvania State University. Allison Trucillo, M.D., joined Avalyn in October 2023 as vice president, medical affairs, and she is responsible for developing and executing the company’s medical affairs strategy. Dr. Trucillo has spent the past two decades in the biopharmaceutical industry across big pharma, biotech, medical devices and diagnostics, including time spent in the respiratory therapeutic area at Insmed. Dr. Trucillo earned a Doctor of Medicine from Baylor College of Medicine and a Bachelor of Science in Zoology from the University of Texas at Austin. Rebecca Boone joined Avalyn in October 2023 as vice president, clinical operations, and she is responsible for overseeing the company’s planned clinical studies. Prior to joining Avalyn, Ms. Boone led her own consulting company where she provided clinical operations and contract services to a range of companies. Previously, she worked at several biopharmaceutical companies in clinical operations leadership roles, including in the respiratory therapeutic area working on Serevent, Flovent, Advair and, most recently, Breo for COPD. She obtained a Master of Arts in Liberal Studies from Duke University and a Bachelor of Science in Psychology from Virginia Polytechnic Institute and State University. About Avalyn PharmaAvalyn is a biopharmaceutical company developing targeted therapeutics for the treatment of rare respiratory diseases including pulmonary fibrosis and other interstitial lung diseases (ILD). Pulmonary fibrosis is characterized by scarring, decline in lung function, reduced exercise capacity and quality of life, and is associated with increased mortality. Currently approved therapeutic options slow pulmonary fibrosis progression but are associated with significant toxicities that restrict their use and dosing. Avalyn is developing a pipeline of new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication to the site of disease. Avalyn’s pipeline is led by AP01, an optimized inhaled formulation of pirfenidone, which has been assessed in 150 individuals with different forms of pulmonary fibrosis and demonstrated clinical proof-of-concept with improved efficacy and safety over existing therapies. For more information, please visit avalynpharma.com. Contacts:Alex StrausTHRUST Strategic Communicationsalex@thrustsc.com Cara MayfieldTHRUST Strategic Communicationscara@thrustsc.com