NEWARK, Calif., June 17, 2014 (GLOBE NEWSWIRE) -- StemCells, Inc. (Nasdaq: STEM ) announced today one promotion and three new appointments to the Company's executive team. Stephen Huhn, M.D., F.A.C.S., F.A.A.P. has been promoted to the newly created position of vice president, CNS clinical research and chief medical officer. Joel Naor, M.D., M.B.A., M.Sc., has joined StemCells, Inc. as vice president, clinical development, ophthalmology, and will report to Dr. Stephen Huhn; Naymisha Patel has joined StemCells, Inc. as vice president, quality systems; and Mohammad A. El-Kalay, Ph.D. has joined StemCells, Inc. as vice president, process development. Dr. Huhn, Ms. Patel and Dr. El-Kalay will report to Martin McGlynn president and chief executive officer of StemCells, Inc.
"We are pleased to welcome Dr. Naor, Ms. Patel and Dr. El-Kalay to StemCells, Inc., and Dr. Huhn to his new position, at this critical point in the Company's evolution," said Martin McGlynn. "We plan to initiate our first controlled Phase II studies in spinal cord injury and dry age related macular degeneration (AMD) this year. Dr. Huhn's combined background in neurosurgery and academic research, together with his demonstrated leadership of our clinical activities, have prepared him well to assume his new role as our chief medical officer. Dr. Naor's 14 years of clinical experience, with a focus on eye related disorders, will be instrumental for the success of our dry AMD program. Ms. Patel's experience in building and leading quality organizations and Dr. El-Kalay's operational management and process development experience will be invaluable as we look beyond the planned Phase II studies towards additional pivotal studies and the commercialization phase."
As chief medical officer, Dr. Huhn will continue to oversee all aspects of the Company's clinical activities. Dr. Huhn joined StemCells, Inc. in January 2007 to direct the Company's preclinical and clinical development programs for CNS indications. Prior to joining the company, he was associate professor of neurosurgery at Stanford University and chief of pediatric neurosurgery at the Lucile Salter Packard Children's Hospital. Dr. Huhn earned his M.D. at the University of Arizona in 1987 and completed a residency in neurosurgery at the University of Maryland in 1993. He completed a fellowship in neuro-oncology at UCSF Medical Center in San Francisco and pediatric neurosurgery at Northwestern University's Children's Memorial Hospital in Chicago. Dr. Huhn is certified by the American Board of Neurological Surgery and the American Board of Pediatric Neurological Surgery and is a fellow in the American College of Surgeons and the American Academy of Pediatrics. Dr. Huhn maintains an unpaid consulting associate professor appointment with the department of neurosurgery at Stanford University.
Dr. Naor brings more than 14 years of experience drug development for retinal conditions, and will be responsible for the development of cell-based products for retinal diseases, initially from the Company's proprietary HuCNS-SC ® platform technology. To that end, he will oversee the Company's planned Phase II trial in dry AMD. Most recently Dr. Naor served as the vice president and head of global medical affairs at Santen Inc. Dr. Naor was previously vice president of drug development and new ventures at Ora Inc., chief medical officer of Macusight, senior director at Allergan, and a director at QLT. He also had key roles in the development of a Sirolimus formulation for intravitreal and subconjunctival administration, Ozurdex®, Trivaris™, and Visudyne®. Dr. Naor earned his M.D. from the Technion - Israel Institute of Technology and following a residency in ophthalmology, he underwent cornea and external disease training at the University of Toronto where he also obtained an M.Sc. in epidemiology. Dr. Naor holds a M.B.A. from Simon Fraser University in Vancouver, Canada.
Naymisha Patel will be responsible for driving the corporate quality agenda and implementing Quality Management Systems appropriate for our planned clinical and manufacturing growth. Ms. Patel has over 18 years of experience in the field and was most recently executive director of quality assurance at Geron Corporation, where she was responsible for quality and regulatory affairs compliance strategy and implementation. She previously held roles of increasing responsibility at Nektar Therapeutics and Aerogen, Inc. Ms. Patel earned a B.S. in zoology from Maharaja Sayajirao University in India, a B.A. in chemistry from California State University, Hayward, and an M.B.A. in Management from Northcentral University, Arizona. Ms. Patel is a certified quality auditor by the American Society of Quality and holds a regulatory affairs certification from Regulatory Affairs Professional Society.
Mohammad A. El-Kalay, Ph.D., will be responsible for developing scalable and efficient manufacturing processes and assays to meet the increasing clinical and development demand for products. Mohammad has over 25 years of operational and management leadership and was most recently co-founder, president and CEO of EyeCyte, Inc. an early stage company developing therapies to treat acquired and inherited retinal diseases. Dr. El-Kalay previously held roles of increasing responsibility in research, product and process development at MicroIslet, Telos Pharmaceuticals, MorphoGen Pharmaceuticals, Osiris Therapeutics, Pfizer, SyStemix and Applied ImmuneSciences. He has also served as consultant and scientific advisory board member for several companies. He earned his B.Sc. in chemical engineering and his M.Sc. and Ph.D. in biomedical engineering at Strathclyde University, Glasgow.
In connection with their hire, the Company has granted Ms. Patel, Dr. Naor and Dr. El-Kalay an aggregate total of 510,000 restricted stock units (RSUs). Each grant was made pursuant to the Company's 2012 Commencement Incentive Plan and in accordance with Nasdaq Listing Rule 5635(c)(4) concerning inducement grants to new employees. Each RSU gives the holder the right to receive upon vesting, without cash payment, a share of StemCells common stock. All of these granted RSUs have four-year vesting schedules so that they vest in four equal parts on each of their first four service anniversaries, starting in 2015 and ending in 2018.
About StemCells, Inc.
StemCells, Inc. is engaged in the research, development, and commercialization of cell-based therapeutics and tools for use in stem cell-based research and drug discovery. The Company's lead therapeutic product candidate, HuCNS-SC® cells (purified human neural stem cells), is currently in development as a potential treatment for a broad range of central nervous system disorders. In a Phase I clinical trial in Pelizaeus-Merzbacher disease (PMD), a fatal myelination disorder in children, the Company has shown preliminary evidence of progressive and durable donor-derived myelination in all four patients transplanted with HuCNS-SC cells. The Company conducted a Phase I/II clinical trial in chronic spinal cord injury in Switzerland, Canada and the United States, and has reported positive interim data for the first eight patients. The Company is also conducting a Phase I/II clinical trial in dry age-related macular degeneration (AMD) in the United States. In addition, the Company is pursuing preclinical studies in Alzheimer's disease, with support from the California Institute for Regenerative Medicine (CIRM). StemCells also markets stem cell research products, including media and reagents, under the SC Proven® brand. Further information about StemCells is available at http://www.stemcellsinc.com .
Apart from statements of historical fact, the text of this press release constitutes forward-looking statements within the meaning of the U.S. securities laws, and is subject to the safe harbors created therein. These statements include, but are not limited to, statements regarding the prospect for initiating Phase II clinical studies in cervical spinal cord injury and dry AMD and the future business operations of the Company, including its ability to conduct clinical trials as well as its other research and product development efforts. These forward-looking statements speak only as of the date of this news release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Such statements reflect management's current views and are based on certain assumptions that may or may not ultimately prove valid. The Company's actual results may vary materially from those contemplated in such forward-looking statements due to risks and uncertainties to which the Company is subject, including the fact that additional trials will be required to demonstrate the safety and efficacy of the Company's HuCNS-SC cells for the treatment of any disease or disorder; uncertainty as to whether the FDA or other applicable regulatory agencies will permit the Company to continue clinical testing in spinal cord injury or in future clinical trials of proposed therapies for other diseases or conditions; uncertainties regarding the Company's ability to obtain the increased capital resources needed to continue its current and planned research and development operations; and other factors that are described under the heading "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2013, and in its subsequent reports on Form 10-Q and Form 8-K.
Greg Schiffman StemCells, Inc. Chief Financial Officer (510) 456-4128 Andrea Flynn Russo Partners (646) 942-5631
