CLEVELAND, Ohio–(BUSINESS WIRE)–Athersys, Inc. (Nasdaq: ATHX), a regenerative medicine company developing MultiStem® cell therapy, today announced that Dr. Gil Van Bokkelen has stepped down as Chairman and Chief Executive Officer, effective immediately. The Athersys Board has appointed William (B.J.) Lehmann, the Company’s President and Chief Operating Officer, as Interim Chief Executive Officer. Dr. Ismail Kola, Lead Director of the Athersys Board, has been appointed Chairman of the Board.
The Company’s Board is commencing a comprehensive search process to identify a permanent CEO. The Board intends to identify and select a CEO who can guide Athersys in the commercial stage.
“On behalf of the Board and everyone at Athersys, I want to thank Gil for his valuable contributions and years of service since co-founding Athersys in 1995,” said Dr. Ismail Kola, Chairman of the Athersys Board. “During Gil’s tenure, Athersys successfully established a portfolio of therapeutic product development programs to address significant unmet medical needs across several disease areas that represent substantial commercial opportunities. His vision, energy, tenacity and leadership have been critical for building Athersys into the leader in regenerative medicine it is today, and we wish him all the best in his future endeavors.
Dr. Kola continued, “As we advance our late-stage pipeline and lay the groundwork for commercialization of our MultiStem product, Gil and the Board have mutually determined that now is the right time to transition to the next generation of leadership to help drive the Company forward and position Athersys for long-term growth and success. Over the last several years, Athersys has made significant progress across our clinical programs and commercial readiness activities, and we remain excited about the future of Athersys and the potential for MultiStem to improve the lives of millions of patients globally. With two important clinical trials nearing completion in Japan in partnership with Healios, for which results are expected in 2021, and several of our own clinical studies, including our lead ischemic stroke program, we remain focused on preparing for important top-line data readouts and on developing our go-to-market strategy for MultiStem.”
“It’s been a privilege to lead Athersys, and I am proud of all that we have accomplished together,” said Dr. Van Bokkelen. “Athersys has a wealth of talent and some of the best and most knowledgeable employees in the regenerative medicine space, and I am confident that the Company’s future is bright and remains in good hands under experienced leadership as the Board identifies the right person to guide the Company through commercial launch. I look forward to following the Company’s exciting progress.”
Dr. Kola concluded, “We have great confidence in the strong executive management team that will be continuing to lead the company, consisting of B.J.; John Harrington, Executive Vice President and Chief Scientific Officer; and, Ivor Macleod, Chief Financial Officer. All three are seasoned executives with decades of leadership and operational experience. We appreciate that BJ has agreed to step into the role of Interim CEO while we search for a permanent successor. B.J., John and Ivor have made significant contributions to Athersys, and we are confident that it will be a seamless transition as we continue our evolution into a commercial company.”
Mr. Lehmann said, “I am grateful for the opportunity to have worked with Gil over the years and eager as Interim CEO to carry forward with the Company’s mission to develop the leading cell therapy company while addressing substantial unmet needs in large markets. I, John and Ivor look forward to working alongside the Company’s outstanding Board and management team to advance Athersys on our road to commercialization. We have great confidence in the Company’s strategic plan and in the many opportunities we have ahead of us to deliver value for both patients and shareholders.”
In light of today’s news, the Company’s Virtual Investor Day, which was scheduled for today, has been postponed and will be rescheduled at a later date.
About William (B.J.) Lehmann, JD
Mr. Lehmann has worked with Athersys since 2001 and has served as the Company’s President and Chief Operating Officer since June 2006. He has been involved in all aspects of the Company’s operations over the years, including business development, partnership management, finance, clinical development, regulatory, legal and intellectual property management among other things. He has helped develop, negotiate and build most of the Company’s major business relationships, including research & development collaborations and manufacturing among other things. Prior to Athersys, from 1994 to 2001, Mr. Lehmann was with McKinsey & Company, Inc., an international management consulting firm, where he worked extensively with new technology and service-based businesses in the firm’s Business Building practice. Additionally, he was active in the firm’s marketing practice, focusing on both business to business and consumer marketing. Prior to joining McKinsey, he worked at Wilson, Sonsini, Goodrich & Rosati, a Silicon Valley law firm, and, before that, with First Chicago Corporation, a financial institution. Mr. Lehmann received his J.D. from Stanford University, his M.B.A. from the University of Chicago, and his B.A. from the University of Notre Dame.
About Dr. Ismail Kola
Dr. Kola served as Lead Director from August 2020 and a Director since October 2010. He served as Executive Vice President of UCB S.A. in Belgium, a biopharmaceutical company dedicated to the development of innovative medicines focused on the fields of central nervous system and immunology disorders, and President and Chief Scientific Officer of UCB New Medicines, UCB’s discovery research through to proof-of-concept in man organization. Dr. Kola was formerly Senior Vice President, Discovery Research and Early Clinical Research & Experimental Medicine at Schering-Plough Research Institute, the pharmaceutical research arm of Schering-Plough Corporation, a pharmaceutical company, and Chief Scientific Officer at Schering-Plough Corporation, from March 2007 until his appointment at UCB. Prior to Schering-Plough, Dr. Kola held senior positions from January 2003 to March 2007 at Merck, a pharmaceutical company, where he was Senior Vice President and Site Head, Basic Research. From 2000 to 2003, Dr. Kola was Vice President, Research, and Global Head, Genomics Science and Biotechnology, at Pharmacia Corporation, a pharmaceutical company. Prior to his position with Pharmacia, Dr. Kola spent 15 years as Professor of Human Molecular Genetics and was Director of the Centre for Functional Genomics and Human Disease at Monash Medical School in Australia. Dr. Kola received his Ph.D. in Medicine from the University of Cape Town, South Africa, his B.Sc. from the University of South Africa, and his B.Pharm. from Rhodes University, South Africa. He currently serves on the board of directors of Biotie Therapies, Inc. (NASDAQ: BITI) (and previously Synosia who merged with Biotie) since February 2011, where he serves on the compensation committee. Dr. Kola served on the board of directors of Astex Therapeutics (NASDAQ: ASTX) from May 2010 until its sale to Otsuka Pharmaceuticals in October 2013, Ondek Pty Ltd from 2009 to 2011, and Promega Corporation from 2003 to 2007. Dr. Kola has authored 159 technical publications in scientific and medical journals and is the named inventor on at least a dozen patents. Dr. Kola holds Adjunct Professorships of Medicine at Washington University in St. Louis, Missouri, and Monash University Medical School; a Foreign Adjunct Professorship at the Karolinska Institute in Stockholm, Sweden; and was elected William Pitt Fellow at Pembroke College, Cambridge University, UK in 2008. Dr. Kola has also been appointed a Visiting Professor at Oxford University, Nuffield School of Medicine, Oxford UK, since September 2012.
Dr. Kola has led numerous teams that have brought a large number of medicines successfully to the market. Dr. Kola’s experience and leadership in taking numerous drugs from the research stage to market or late-stage development brings a unique and valuable perspective to the Company.
MultiStem® cell therapy is a patented regenerative medicine product candidate in clinical development that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of therapeutic factors in response to signals of inflammation and tissue damage. MultiStem therapy’s potential for multidimensional therapeutic impact may distinguish it from traditional biopharmaceutical therapies focused on a single mechanism of benefit. MultiStem represents a unique “off-the-shelf” stem cell product candidate that can be manufactured in a scalable manner, may be stored for years in frozen form, and is administered without tissue matching or the need for immune suppression. Based upon favorable outcome data, its novel mechanisms of action, and favorable and consistent tolerability data in clinical studies, we believe that MultiStem therapy may provide a meaningful benefit to patients, including those suffering from serious diseases and conditions with unmet medical need.
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, our ability to access our traditional financing sources on the same or reasonably similar terms as were available to us before the COVID-19 pandemic; 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; 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, 2019 under Item 1A, “Risk Factors” and our other filings with the SEC. You should not place undue reliance on forward-looking statements contained in this press release, and we undertake no obligation to publicly update forward-looking statements, whether as a result of new information, future events or otherwise.