Press Release

KemPharm is a clinical stage, specialty pharmaceutical company engaged in the development and discovery of proprietary prodrugs that are designed to be improved versions of widely prescribed and FDA approved products.

23 Oct

KemPharm and twoXAR Announce Technology Collaboration to Develop Prodrug-Based Therapies for Multiple Indications

Drug Development Approach Combines twoXAR’s Artificial-Intelligence-Driven Drug Discovery Technology with KemPharm’s LATTM Prodrug Technology

Coralville, IA and Mountain View, CA – October 23, 2018 –KemPharm, Inc. (NASDAQ: KMPH), a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, and twoXAR, Inc., an artificial-intelligence (AI)-driven biopharmaceutical company, together announced todaythat they have entered into a technology collaboration to develop prodrug-based therapies for multiple therapeutic areas and indications.  This collaboration will combine twoXAR’s AI-based technology to identify and de-risk drug product candidates with KemPharm’s LATTM technology developed to create new prodrugs that are designed to address unmet patient needs, improve the profile of drug product candidates and generate long-lived composition-of-matter patents.

In connection with this collaboration, KemPharm has executed a research and license agreement with Novoxar, Inc. a wholly-owned subsidiary of twoXAR, under which KemPharm will begin research to develop a prodrug that may form the basis of a target drug product candidate of Novoxar in a therapeutic area which has yet to be disclosed. Under this agreement, KemPharm is eligible to receive specified license fees upon successful delivery of the target prodrug, payments upon achievement of certain product development and commercial milestones, and royalties on commercial sales of any product developed under this agreement.

“Today’s announcement of a technology collaboration between twoXAR and KemPharm, and the related research and license agreement with Novoxar, provide KemPharm’s team with another opportunity to apply our prodrug expertise to a potentially under-served therapeutic area, and ultimately bring potential new benefits to patients,” said Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm.  “We believe this collaboration has the potential to create long-term value for our shareholders by potentially extending KemPharm’s reach into new therapeutic areas, creating long-term patent protection and, together with twoXAR, further de-risk and accelerate the product development cycle.”

“KemPharm’s LATTM technology provides a path to creating unique and valuable drug candidates,” said Andrew A. Radin, Co-Founder and CEO of twoXAR. “The KemPharm team’s technology and drug development experience combined with twoXAR’s discovery technology enables a route to greater efficiency in drug development.”

About KemPharm:

KemPharm is a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its proprietary LATTM (Ligand Activated Therapy) technology.  KemPharm utilizes its LAT technology to generate improved prodrug versions of existing FDA-approved drugs as well as to generate prodrug versions of existing compounds that may have applications for new disease indications.  Currently, KemPharm’s product pipeline is focused on the high need areas of ADHD, pain and other central nervous system disorders, and its co-lead clinical development candidates are KP415 and KP484, both based on a prodrug of d-methylphenidate but with differing extended-release/effect profiles, are intended for the treatment of ADHD.  In addition, KemPharm has received FDA approval for APADAZ®, an immediate-release combination product containing benzhydrocodone, a prodrug of hydrocodone, and acetaminophen.  For more information on KemPharm and its pipeline of prodrug product candidates visit www.kempharm.com or connect with us on Twitter, LinkedIn, Facebook and YouTube.

About twoXAR:

twoXAR is an artificial intelligence-driven biopharmaceutical company that leverages its computational platform to identify promising drug candidates, de-risk the opportunities through preclinical studies, and progress drug product candidates into the clinic through industry partnerships. Based in Mountain View, California, the twoXAR team includes experts in drug discovery and development, biomedical informatics, computational biology, data science and software development.  Investors in twoXAR include SoftBank Ventures, the Andreessen Horowitz Bio Fund, OS Fund, CLI Ventures, and the Stanford-StartX Fund. For more information, please visit www.twoXAR.com.

Caution Concerning Forward Looking Statements:

This press release may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.  Forward-looking statements include all statements that do not relate solely to historical or current facts, and can be identified by the use of words such as “may,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,” “continue” or the negative versions of those words or other comparable words. These forward-looking statements include statements regarding the clinical development and expected features and characteristics of KemPharm’s product candidates and the potential benefits of KemPharm’s technology collaboration with twoXAR. Forward-looking statements are not guarantees of future actions or performance. These forward-looking statements are based on information currently available to KemPharm and its current plans or expectations. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including the risks and uncertainties associated with: KemPharm’s financial resources and whether they will be sufficient to meet KemPharm’s business objectives and operational requirements; results of earlier studies and trials may not be predictive of future clinical trial results; the protection and market exclusivity provided by KemPharm’s intellectual property; risks related to the drug discovery and the regulatory approval process; the impact of competitive products and technological changes; and the FDA approval process under the Section 505(b)(2) regulatory pathway, including without limitation any timelines for related approval. Risks concerning KemPharm’s business are described in detail in KemPharm’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, filed with the Securities and Exchange Commission (SEC) on August 10, 2018, and KemPharm’s other Periodic and Current Reports filed with the SEC.  KemPharm is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.

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KemPharm Contacts:           twoXAR Contacts:
Jason Rando / Joshua Drumm, Ph.D.
Tiberend Strategic Advisors
(212) 375-2665 / 2664
jrando@tiberend.com
jdrumm@tiberend.com
Nicole Litchfield
Bioscribe, Inc.
(415) 793-6468
nicole@bioscribe.com