Athersys, Inc. (Nasdaq: ATHX), an international, late-stage, regenerative medicine company, announced today the appointment of Daniel A. Camardo as the Company's Chief Executive Officer, effective February 14, 2022. Mr. Camardo is a senior pharmaceutical and biotech executive with more than 25 years of commercial leadership experience. As Chief Executive Officer, he will lead Athersys forward to complete the development, approval, launch, and commercialization of the Company's MultiStem® (invimestrocel) cell therapy for the treatment of serious conditions, including ischemic stroke. Mr. Camardo will also join the Athersys Board of Directors. Mr. William (B.J.) Lehmann, who has served most recently as interim CEO, will continue to serve as the Company's President and Chief Operating Officer, the position he held prior to his interim appointment.
"It's with great excitement today that the Board announces Daniel Camardo as the new CEO of Athersys," commented Dr. Ismail Kola, Chairman of the Board. "We are confident that Dan is the right person to lead Athersys as the Company moves forward towards the commercialization of Multistem. He brings a wealth of knowledge and a proven track record of product development, commercialization, and overall business strategy. Dan's extensive industry experience includes transforming single product start-ups into high-functioning multi-franchise organizations, business development and alliance management. His breadth of skills and experience combined with his respected leadership and team-building style will be invaluable to Athersys as the Company enters the next exciting phase of its evolution," concluded Dr. Kola.
Mr. Camardo currently serves as Executive Vice President and Head of the Rare Disease and Inflammation Business Units and President, U.S. at Horizon Therapeutics (Horizon), where he has led a broad commercial transformation and built out new capabilities to support a portfolio of products in the rare disease and specialty medicines space. Prior to this, he led commercial operations for Horizon and helped transform the small specialty products company into a global biotechnology company focused on rare, autoimmune, and severe inflammatory diseases. He has worked in commercial leadership roles for other biotechnology and pharmaceutical companies, including Astellas, where he helped build a commercial business from U.S. market entry to more than $3.5 billion in annual net sales driven by a portfolio of specialty and rare disease medicines. Mr. Camardo has been involved in more than 10 medicine launches across various therapeutic areas, including small molecules and biologics. Mr. Camardo is recognized for creating innovative solutions to overcome marketplace challenges and fostering cross-functional collaboration to drive results. Mr. Camardo holds a Bachelor of Arts degree in Economics and Mathematics from the University of Rochester and a Master of Business Administration from Northwestern University's Kellogg School of Management.
"I am thrilled to be joining Athersys at this pivotal time," commented Daniel Camardo, new Chief Executive Officer of Athersys. "The Company and its MultiStem product have tremendous potential to help patients in a number of serious diseases with significant unmet need. I look forward to working closely with the Board, executive leadership and Athersys employees to commercialize MultiStem and build the Company into a global leader in cell therapy and regenerative medicine," said Mr. Camardo.
"We are very happy to have Dan joining us to lead the Company as we move to complete development and prepare for commercialization," stated Mr. William (B.J.) Lehmann, President and Chief Operating Officer of Athersys. "He brings proven leadership in the preparation, launch and marketing of high impact therapies and cross-functional leadership, and is well-suited to lead the important efforts ahead of us. I look forward to working with him."
Athersys is a biotechnology company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. The Company is developing its MultiStem® cell therapy product, a patented, adult-derived "off-the-shelf" stem cell product, initially for disease indications in the neurological, inflammatory and immune, cardiovascular and other critical care indications and has several ongoing clinical trials evaluating this potential regenerative medicine product. Athersys has forged strategic partnerships and a broad network of collaborations to further advance the MultiStem cell therapy toward commercialization. More information is available at www.athersys.com. Follow Athersys on Twitter at www.twitter.com/athersys.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. These forward-looking statements relate to, among other things, the expected timetable for development of our product candidates, our growth strategy, and our future financial performance, including our operations, economic performance, financial condition, prospects, and other future events. We have attempted to identify forward-looking statements by using such words as "anticipates," "believes," "can," "continue," "could," "estimates," "expects," "intends," "may," "plans," "potential," "should," "suggest," "will," or other similar expressions. These forward-looking statements are only predictions and are largely based on our current expectations. A number of known and unknown risks, uncertainties, and other factors could affect the accuracy of these statements. Some of the more significant known risks that we face are the risks and uncertainties inherent in the process of discovering, developing, and commercializing products that are safe and effective for use as therapeutics, including the uncertainty regarding market acceptance of our product candidates and our ability to generate revenues. The following risks and uncertainties may cause our actual results, levels of activity, performance, or achievements to differ materially from any future results, levels of activity, performance, or achievements expressed or implied by these forward-looking statements: our ability to raise capital to fund our operations, including but not limited to, the timing and nature of results from MultiStem clinical trials, including the MASTERS-2 Phase 3 clinical trial evaluating the administration of MultiStem for the treatment of ischemic stroke, and the Healios TREASURE and ONE-BRIDGE clinical trials in Japan evaluating the treatment in stroke and ARDS patients, respectively, including the timing of the release of data by Healios from its clinical trials, which could be delayed by, among other things, the regulatory process with the PMDA; the success of our MACOVIA clinical trial evaluating the administration of MultiStem for the treatment of COVID-19 induced ARDS, and the MATRICS-1 clinical trial being conducted with The University of Texas Health Science Center at Houston evaluating the treatment of patients with serious traumatic injuries; the impact of the COVID-19 pandemic on our ability to complete planned or ongoing clinical trials; the possibility that the COVID-19 pandemic could delay clinical site initiation, clinical trial enrollment, regulatory review and the potential receipt of regulatory approvals, payment of milestones under our license agreements and commercialization of one or more of our product candidates, if approved; the availability of product sufficient to meet commercial demand shortly following any approval, such as in the case of accelerated approval for the treatment of COVID-19 induced ARDS; the impact on our business, results of operations and financial condition from the ongoing and global COVID-19 pandemic, or any other pandemic, epidemic or outbreak of infectious disease in the United States; the possibility of delays in, adverse results of, and excessive costs of the development process; our ability to successfully initiate and complete clinical trials of our product candidates; the impact of the COVID-19 pandemic on the production capabilities of our contract manufacturing partners and our MultiStem trial supply chain; the possibility of delays, work stoppages or interruptions in manufacturing by third parties or us, such as due to material supply constraints, contamination, operational restrictions due to COVID-19 or other public health emergencies, labor constraints, regulatory issues or other factors which could negatively impact our trials and the trials of our collaborators; uncertainty regarding market acceptance of our product candidates and our ability to generate revenues, including MultiStem cell therapy for neurological, inflammatory and immune, cardiovascular and other critical care indications; changes in external market factors; changes in our industry's overall performance; changes in our business strategy; our ability to protect and defend our intellectual property and related business operations, including the successful prosecution of our patent applications and enforcement of our patent rights, and operate our business in an environment of rapid technology and intellectual property development; our possible inability to realize commercially valuable discoveries in our collaborations with pharmaceutical and other biotechnology companies; our ability to meet milestones and earn royalties under our collaboration agreements, including the success of our collaboration with Healios; our collaborators' ability to continue to fulfill their obligations under the terms of our collaboration agreements and generate sales related to our technologies; the success of our efforts to enter into new strategic partnerships and advance our programs, including, without limitation, in North America, Europe and Japan; our possible inability to execute our strategy due to changes in our industry or the economy generally; changes in productivity and reliability of suppliers; the success of our competitors and the emergence of new competitors; and the risks mentioned elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2020 under Item 1A, "Risk Factors" and our other filings with the SEC. You should not place undue reliance on forward-looking statements contained on our website and/or on our accounts on Twitter, Facebook, LinkedIn or other social media platforms, and we undertake no obligation to publicly update forward-looking statements, whether as a result of new information, future events or otherwise.
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