Company appoints new VPs of Clinical Science, Manufacturing, and Finance and hires new Senior Director of Marketing
New hires support Acer’s progression from development to potential commercialization of EDSIVOTM
NEWTON, MA – Feb. 5, 2018 – Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and ultrarare diseases with critical unmet medical need, today announced it has appointed Terrie Kellmeyer, Ph.D., as Vice President, Clinical Science; John Klopp as Vice President, Manufacturing; and Jason Kneeland, CPA, as Vice President Finance, Controller. Also, the Company hired Kim Tharaldsen, MBA, as Senior Director, Marketing.
“I am very pleased to welcome Terrie, John, Jason and Kim to the management team. As we continue to successfully and rapidly advance our lead product candidate, EDSIVO™, a potential life-saving therapy for patients with vascular Ehlers-Danlos syndrome (vEDS), their experience and knowledge will be invaluable as we prepare for our NDA filing with the U.S. Food and Drug Administration and conduct precommercial activities,” said Chris Schelling, CEO and Founder of Acer. “Terrie provides us with critical expertise in the clinical/regulatory area and will drive the clinical content of our NDA submission of EDSIVO™, and will report to our CMO. John brings extensive knowledge in manufacturing from the pharmaceutical industry and will drive all our development and commercial manufacturing activities, and will report to me.”
“Jason is a seasoned corporate finance executive and brings nearly 20 years of experience at public revenue-generating companies. He will drive SEC reporting and accounting, and will report to our CFO,” continued Mr. Schelling. “Kim will lead our global marketing plans and will help us drive Acer’s precommercial activities. She will report to me. We plan to make additional senior-level commercial and medical affairs hires this year, as well as continue to build out the commercial team and add other core personnel later this year.”
About Terrie Kellmeyer, Ph.D.
Dr. Kellmeyer joined Acer as Vice President, Clinical Science in December 2017. She brings to Acer over 17 years of experience in the pharmaceutical industry spanning the areas of Clinical Development, Regulatory Affairs, Medical Writing and Medical Affairs. Over her career, Dr. Kellmeyer filed three NDAs, worked on a Brand Team preparing for product launch, and led clinical development programs. Prior to joining Acer, she served as Executive Director of Medical Writing and Scientific Communications at Intercept Pharmaceuticals where she was instrumental in leading scientific content and optimizing timelines for an NDA submission, served as a key member of the team for a positive Advisory Committee meeting, and oversaw all externally and internally facing scientific communications. Previously, Dr. Kellmeyer held positions of increasing responsibility in Clinical Development and Regulatory Affairs at Amylin Pharmaceuticals and Gen-Probe, Inc. She received a B.S. degree in Biotechnology from Rochester Institute of Technology and a Ph.D. degree in Cellular and Molecular Biology from SUNY Health Science Center at Syracuse.
About John Klopp
Mr. Klopp joined Acer as Vice President, Manufacturing in January 2018. He brings 15 years of experience in the biopharmaceutical industry developing small molecule drug candidates in positions ranging from research to process development to contract manufacturing management. Mr. Klopp has spent the last 11 years working on the development and commercialization of orphan drugs at BioMarin Pharmaceutical and later Ultragenyx Pharmaceutical. His expertise includes selecting and managing contract manufacturing sites producing drug substance and various oral dosage forms including associated sponsor clinical and commercial CMC regulatory strategy. Mr. Klopp received a B.S. degree in Chemistry from Pennsylvania State University and a M.S. degree in Chemistry from University of California at Berkeley.
About Jason Kneeland, CPA
Mr. Kneeland joined Acer as Vice President Finance, Controller in November 2017. He brings nearly 20 years of progressive experience in the corporate finance leadership of technology and related companies. Prior to joining Acer, Mr. Kneeland was VP Finance at TechTarget, Inc., a public company with 700 employees and $100M of annual revenue, where he led a team responsible for the day-to-day finance and accounting operations, as well as several key initiatives around revenue recognition and systems implementations. Prior to TechTarget, Mr. Kneeland was a Senior Manager at CFGI, where he assisted domestic and international bio-tech and technology clients with public offerings, mergers and acquisitions and other complex accounting, reporting and internal-control matters. Prior to that, Mr. Kneeland was Director of Technical Accounting of a multi-billion-dollar publicly traded retail pharmacy and pharmacy benefit management company. He has fulfilled various accounting and reporting roles with publicly traded companies in the technology industry since beginning his career in the audit practice of KPMG LLP. Mr. Kneeland is a Certified Public Accountant in the state of Massachusetts and holds a Bachelor of Science in Accounting from Johnson & Wales University.
About Kim Tharaldsen, MBA
Ms. Tharaldsen joined Acer as Senior Director, Marketing in January 2018. She brings to Acer over 16 years of experience managing teams and brands for companies in the pharmaceutical, diagnostic, and device markets. From product launch to end of life planning and execution, Ms. Tharaldsen has managed brands through all phases of the product lifecycle across a number of therapeutic markets including Oncology, Genetics, Neurology and Gastrointestinal disorders. In addition to a deep clinical understanding of various conditions and solutions, she brings to Acer a diverse marketing skill set that has been cultivated by experience with products that range from small niche market entrants to blockbuster, multibillion dollar drugs. Ms. Tharaldsen has contributed to the success of such companies as Eisai, Myriad Genetics, Prometheus and Hologic. She has a BS in Biology, and a MBA in Innovation and Entrepreneurship from Felician University.
About Acer Therapeutics
Acer, headquartered in Newton, MA, is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for patients with serious rare and ultra-rare diseases with critical unmet medical need. Acer’s late-stage clinical pipeline includes two candidates for severe genetic disorders for which there are few or no FDA-approved treatments: EDSIVO™ (celiprolol) for vascular Ehlers-Danlos syndrome (vEDS), and ACER-001 (a fully taste-masked, immediate release formulation of sodium phenylbutyrate) for urea cycle disorders (UCD) and Maple Syrup Urine Disease (MSUD). There are no FDA-approved drugs for vEDS and MSUD and limited options for UCD, which collectively impact more than 4,000 patients in the United States. Acer’s product candidates have clinical proof-of-concept and mechanistic differentiation, and Acer intends to seek approval for them in the U.S. by using the regulatory pathway established under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, or FFDCA, that allows an applicant to rely for approval at least in part on third-party data, which is expected to expedite the preparation, submission, and potential approval of a marketing application.
For more information, visit www.acertx.com.
Forward-Looking Statements
This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the potential for EDSIVO™ (celiprolol) and ACER-001 to safely and effectively target diseases; our ability to successfully complete regulatory submissions; and the development, expected timeline and commercial potential of any product candidates of the company. Acer may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, risks and uncertainties associated with market conditions, unexpected cash requirements, changes in Acer’s business plan, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, and the process of developing, obtaining regulatory approval for and commercializing drug candidates that are safe and effective for use as human therapeutics. Acer disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. You should review additional disclosures we make in our filings with the Securities and Exchange Commission, including our Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.
Investor Contact:
Hans Vitzthum
LifeSci Advisors
Ph: 617-535-7743
hans@lifesciadvisors.com