Mr. David Dvorak, previously the President and CEO of Zimmer Biomet, brings a 25+ year proven track record of executive leadership, operating experience, and board memberships
Dr. Gregory Berk joins with 30+ years of medical experience with oncology expertise in clinical trials, drug development, and regulatory strategy in both industry and academia
GARDEN CITY, N.Y., Feb. 03, 2022 — Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and, through its affiliate Beyond Cancer, ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, today announced the appointments of Mr. David Dvorak and Dr. Gregory Berk to Beyond Cancer’s Board of Directors. Following these appointments, the Beyond Cancer Board of Directors will be comprised of six members with no further additions planned.
Dr. Selena Chaisson, CEO of Beyond Cancer, commented, “I am excited to announce the addition of two highly-talented and successful industry veterans to broaden Beyond Cancer’s skill set and complete our Board. I have no doubt that the decades of experience brought by Mr. Dvorak and Dr. Berk as healthcare leaders will enhance our ability to successfully meet our timelines and execute on our strategic objectives as we continue to invest in UNO therapy for the treatment of solid tumors. We remain on track to enter first in human studies in the first half of this calendar year and will continue providing updates on our progress.”
Mr. David Dvorak is a highly successful, recognized healthcare executive with over 25 years of operating experience building globally leading medical device companies. From 2001 to 2007, he served at Zimmer Biomet Holdings, Inc. in positions with increasing responsibility, culminating in him being named the President and Chief Executive Officer from 2007 to 2017. Under his leadership Zimmer Biomet grew into a Fortune 500 Company with operations in more than 25 countries and products sold in more than 100 countries. During his tenure, revenues increased from $1.2 billion to $7.7 billion and enterprise value from $6.6 billion to $36.0 billion, while Zimmer Biomet embraced an innovative, patient-centric approach delivering value to healthcare providers and patients. Mr. Dvorak has successfully consummated and integrated 30 strategic acquisitions with aggregate consideration of $20 billion and over $800 million in operating synergies, notably championing the $13.4 billion acquisition and integration of Biomet in 2014. Prior to Zimmer Biomet, Mr. Dvorak served as an executive officer with STERIS Corporation, and has been on the Board of Directors of St. Jude Medical, Inc., the Advanced Medical Technology Association, and the Orthopaedic Research and Education Foundation.
Mr. Dvorak is currently the CEO and Chairman of the Board at DeepThink Health, Inc., Executive Chairman of the Board of Directors of THINK Surgical, Inc., and Managing Director at Black Lake Expeditions, LLC. He received a BS in Finance from Miami University in Oxford, Ohio in 1985, and earned a J.D., magna cum laude, from Case Western Reserve University School of Law in 1991, where he was elected to the Order of the Coif.
Dr. Gregory Berk joins Beyond Cancer’s Board of Directors with over three decades of medical experience specifically focusing on the oncology pipeline for biotechnology companies, executing operationally across clinical trials, drug development and regulatory strategy. Dr. Berk currently serves as the President of Research & Development and Chief Medical Officer of GT Biopharma, a clinical stage immuno-oncology company, while also leading the company as interim Chief Executive Officer. Prior to GT Biopharma, Dr. Berk served as the Chief Medical Officer of Celularity, where he led the company’s oncology, infectious and degenerative disease programs. Dr. Berk also held executive roles at Verastem, Sideris Pharmaceuticals, BIND Therapeutics, Abraxis BioScience, and Intellikine, the latter of which was acquired in 2011 by Takeda Pharmaceuticals and Millennium for as much as $310 million ($190 million cash upfront and $120 million in milestone payments) for its oncology pipeline. Dr. Berk also served on the integration leadership team during the Celgene, $3.7 Billion acquisition of Abraxis in 2010.
Dr. Berk received his BS in Biochemistry from Tulane University, graduating summa cum laude, and earned his medical degree from Case Western Reserve University in 1984. He completed his internship and residency in internal medicine, and fellowship in hematology-oncology at the Weill Medical College of Cornell University and New York Presbyterian Hospital, where he also served as a faculty member from 1989-2004. During this time, Dr. Berk served as an investigator on several industry-sponsored and cooperative group oncology clinical trials, including the pivotal trials for Gleevec® and Avastin®.
About Beyond Air, Inc.
Beyond Air, Inc. is a clinical-stage medical device and biopharmaceutical company developing a revolutionary NO Generator and Delivery System, LungFit®, that uses NO generated from ambient air to deliver precise amounts of NO to the lungs for the potential treatment of a variety of pulmonary diseases. The LungFit® can generate up to 400 ppm of NO, for delivery either continuously or for a fixed amount of time and has the ability to either titrate dose on demand or maintain a constant dose. The Company is currently applying its therapeutic expertise to develop treatments for pulmonary hypertension in various settings, in addition to treatments for respiratory tract infections that are not effectively addressed with current standards of care. Beyond Air is currently advancing its revolutionary LungFit® for clinical trials for the treatment of severe lung infections such as acute viral pneumonia (including COVID-19) and nontuberculous mycobacteria (NTM). Additionally, Beyond Air, through its affiliate, Beyond Cancer, is using ultra-high concentrations of NO with a proprietary delivery system to target certain solid tumors in the pre-clinical setting. For more information, visit www.beyondair.net.
About Nitric Oxide (NO)
Nitric Oxide (NO) is a powerful molecule, naturally synthesized in the human body, proven to play a critical role in a broad array of biological functions. In the airways, NO targets the vascular smooth muscle cells that surround the small resistance arteries in the lungs. Currently, exogenous inhaled NO is used in adult respiratory distress syndrome, post certain cardiac surgeries and persistent pulmonary hypertension of the newborn to treat hypoxemia. Additionally, NO is believed to play a key role in the innate immune system and in vitro studies suggest that NO possesses anti-microbial activity not only against common bacteria, including both gram-positive and gram-negative, but also against other diverse pathogens, including mycobacteria, viruses, fungi, yeast and parasites, and has the potential to eliminate multi-drug resistant strains.
About Beyond Cancer: UNO Therapy for Solid Tumors
Cancer is the second leading cause of death globally, with tumor metastases responsible for approximately 90% of all cancer-related deaths. Current cancer treatment modalities generally include chemotherapy, immunotherapy, radiation, and/or surgery. Nitric oxide at ultra-high concentrations has been reported to show anticancer properties and to serve as a potential chemosensitizer and radiotherapy enhancer. Based on its current findings, Beyond Cancer is developing treatment protocols using ultra-high nitric oxide concentrations to ablate primary tumors and treat metastatic disease. For more information, visit www.beyondcancer.com.
Forward Looking Statements
This press release contains “forward-looking statements” concerning inhaled nitric-oxide and the Company’s LungFit® product, including statements with regard to potential regulatory developments, the potential impact on patients and anticipated benefits associated with its use. Forward-looking statements include statements about our expectations, beliefs, or intentions regarding our product offerings, business, financial condition, results of operations, strategies or prospects. You can identify such forward-looking statements by the words “anticipates,” “expects,” “intends,” “impacts,” “plans,” “projects,” “believes,” “estimates,” “likely,” “goal,” “assumes,” “targets” and similar expressions and/or the use of future tense or conditional constructions (such as “will,” “may,” “could,” “should” and the like) and by the fact that these statements do not relate strictly to historical or current matters. Rather, forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. These forward-looking statements are only predictions and reflect our views as of the date they are made with respect to future events and financial performance. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including risks related to: our approach to discover and develop novel drugs, which is unproven and may never lead to efficacious or marketable products; our ability to fund and the results of further pre-clinical and clinical trials; obtaining, maintaining and protecting intellectual property utilized by our products; our ability to enforce our patents against infringers and to defend our patent portfolio against challenges from third parties; our ability to obtain additional funding to support our business activities; our dependence on third parties for development, manufacture, marketing, sales, and distribution of products; the successful development of our product candidates, all of which are in early stages of development; obtaining regulatory approval for products; competition from others using technology similar to ours and others developing products for similar uses; our dependence on collaborators; our short operating history and other risks identified and described in more detail in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on our website. We undertake no obligation to update, and we do not have a policy of updating or revising, these forward-looking statements, except as required by applicable law.
CONTACTS:
Maria Yonkoski, Head of Investor Relations
Beyond Air, Inc.
Myonkoski@beyondair.net
Corey Davis, Ph.D.
LifeSci Advisors, LLC
Cdavis@lifesciadvisors.com
(212) 915-2577
