KemPharm, Inc. (NasdaqGS: KMPH) (KemPharm, or the Company), a rare
disease therapeutics company focused on the development of
treatments for rare central nervous system (CNS), neurodegenerative
diseases, lysosomal storage disorders and related treatment areas,
today announced changes to its Board of Directors (Board) and
executive leadership team as part of the Company’s ongoing business
transformation initiatives. Effective immediately, Matthew R.
Plooster, who has been serving as an independent member of the
Board of Directors, has been appointed to serve as Chairman of the
Board of Directors. Richard W. Pascoe, who has been serving as
Executive Chairman, will transition into the role of Chief
Executive Officer (CEO) and remains a member of the Board of
Directors. Travis C. Mickle, Ph.D., who is co-founder and has been
serving as President and CEO, will transition to the role of
President and will also remain a member of the Board of Directors
until the Company’s 2023 Annual Meeting of Stockholders.
Thereafter, Dr. Mickle will continue to support the Company’s
pipeline build and the planned resubmission of the arimoclomol New
Drug Application (NDA) as a scientific advisor. Additionally,
Joshua Schafer has been appointed to the newly created role of
Chief Commercial Officer and Executive Vice President of Business
Development.
The Board believes that these leadership changes
are an important component of our strategic transformation into a
leading rare disease company, build upon the strengths of the
senior leadership team and have the potential to further enable the
team to achieve the Company’s key objectives, which include
securing regulatory approval for its pipeline assets, building
top-tier commercial capabilities, and enhancing the Company’s
development pipeline through targeted business development
transactions.
“With these changes, we are continuing to
execute the strategic plan embarked upon two years ago to become a
commercially-focused rare disease company with multiple
value-creating programs,” said Matthew R. Plooster, Chairman of
KemPharm’s Board of Directors. “With this announcement of our
senior leadership transition plan, we are excited to enter the next
chapter of our corporate evolution. We are confident that Rich and
the senior team are well-positioned to drive KemPharm’s long-term
success as a rare disease therapeutics company.”
“I am pleased to welcome Josh to the KemPharm
team as we seek to realize our strategic vision of becoming a
commercially-focused rare disease company. Josh brings significant
commercial and business development experience to KemPharm, and I
look forward to working closely with him and the entire team to
build value for our stakeholders in 2023 and beyond,” said Richard
W. Pascoe, Chief Executive Officer of KemPharm. “With Travis
focused on the arimoclomol opportunity, my priorities will be to
hire additional senior talent, work with Josh to build a top-tier
commercial organization, strengthen our core corporate functions
and augment our rare disease pipeline with the goal of positioning
KemPharm as a leading rare disease company with multiple commercial
assets addressing life-altering conditions.”
“After these many years at KemPharm, I look
forward to focusing entirely on the science. With the upcoming
arimoclomol NDA resubmission and the advancement of KP1077 into a
Phase 2 trial, the opportunity for me to provide my full support to
KemPharm’s science team will best allow for the Company to achieve
its strategic goal of becoming a rare disease-focused commercial
organization,” said Travis C. Mickle, Ph.D., President of
KemPharm.
“I am excited to join KemPharm at this critical
point in its corporate evolution and I look forward to working
closely with Rich and the executive management team to build a
commercial organization to launch arimoclomol subject to regulatory
approval and to lead the business development effort to strengthen
the Company’s rare disease pipeline,” said Josh Schafer, Chief
Commercial Officer and Executive Vice-President of Business
Development of KemPharm.
Joshua Schafer brings to KemPharm over 25 years
of pharmaceutical commercial, new product development and merger
and acquisition (M&A) experience. Mr. Schafer previously served
as General Manager of the Autoimmune and Rare Disease business at
Mallinckrodt Pharmaceuticals, and prior to that, he served as Chief
Strategy and Business Officer. During his professional career, he
has successfully led over $16 billion in aggregate M&A
transactions. Prior to Mallinckrodt, Mr. Schafer served as Vice
President and Oncology Therapeutic Area Head, Global Marketing and
Strategy at Astellas Pharmaceuticals, where he was responsible for
building the company's global oncology franchise, and also held
senior roles at Takeda Pharmaceuticals, Accenture (formerly
Anderson Consulting), G. D. Searle & Co. (later acquired by
Pfizer) and Cognia Corporation. Mr. Schafer currently serves as a
Board member of Pharnext SA and Shuttle Pharmaceuticals. He
received his B.A. in Biology and German at the University of Notre
Dame, and both an M.S. in Biotechnology and an M.B.A. from
Northwestern University.
In connection with Mr. Schafer’s appointment, on January 6,
2023, the Compensation Committee of the Company’s Board of
Directors approved a grant, effective January 9, 2023, to Mr.
Schafer of an option to purchase 300,000 shares of the Company’s
common stock. The stock option has an exercise price per share
equal to the closing trading price of the Company’s common stock on
January 9, 2023. The option will vest in four equal annual
installments, with the first such installment occurring on January
9, 2024, subject to Mr. Schafer’s continued employment on each
vesting date. The award was granted under the KemPharm 2023
Employment Inducement Award Plan, which was approved by the
Company’s Board of Directors in January 2023 under Rule 5635(c)(4)
of the Nasdaq Listing Rules for equity grants to induce new
employees to enter into employment with the Company.
About
KemPharm:
KemPharm is a rare disease therapeutics company
focused on the discovery, development and commercialization of
novel treatments for rare CNS and neurodegenerative diseases,
lysosomal storage disorders and related treatment areas. KemPharm
has a diverse product portfolio, combining a clinical-stage
development pipeline with NDA-stage and commercial assets. The
pipeline includes arimoclomol, an orally-delivered, first-in-class
investigational product candidate for Niemann-Pick disease type C
(NPC), and KP1077, which the Company is developing as a treatment
for idiopathic hypersomnia (IH), a rare neurological sleep
disorder, and narcolepsy. In addition, the U.S. Food and Drug
Administration (FDA) has approved AZSTARYS®, a once-daily treatment
for ADHD in patients age six years and older containing KemPharm’s
prodrug, serdexmethylphenidate (SDX), which is being commercialized
by Corium, Inc. in the U.S. The FDA has also approved APADAZ®, an
immediate-release combination product containing benzhydrocodone,
KemPharm’s prodrug of hydrocodone, and acetaminophen, which is
being commercialized by KVK-Tech, Inc. in the U.S. For more
information on KemPharm and its pipeline of product candidates,
visit www.kempharm.com or connect with us on Twitter, LinkedIn,
Facebook and YouTube.
Early access programs are made available by
KemPharm, Inc. and its affiliates, and are subject to the Company’s
Early Access Program (EAP) policy as published on its website at
www.kempharm.com. Participation in these programs is subject to the
laws and regulations of each jurisdiction under which each
respective program is operated. Eligibility for participation in
any such program is at the discretion of the treating
physician.
Caution Concerning Forward Looking
Statements:
This press release may contain forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements include all
statements that do not relate solely to historical or current
facts, which can be identified by the use of words such as “may,”
“will,” “expect,” “project,” “estimate,” “anticipate,” “plan,”
“believe,” “potential,” “should,” “continue,” “could,” “intend,”
“target,” “predict,” or the negative versions of those words or
other comparable words or expressions, although not all
forward-looking statements contain these identifying words or
expressions. Forward-looking statements are not guarantees of
future actions or performance. These forward-looking statements
include without limitation statements regarding the Company’s
strategy, including with respect to leadership transitions; its
prospects, key objectives, priorities and goals; the promise and
potential impact of the Company’s preclinical or clinical trial
data, including without limitation the timing and results of any
clinical trials or readouts, the Company's strategic and product
development objectives, and the planned resubmission of the
arimoclomol New Drug Application. These forward-looking statements
are based on information currently available to KemPharm and its
current plans or expectations and are subject to a number of known
and unknown uncertainties, risks and other important factors that
may cause our actual results, performance or achievements to be
materially different from any future results, performance or
achievements expressed or implied by the forward-looking
statements. These and other important factors are described in
detail in the “Risk Factors” section of KemPharm’s Annual Report on
Form 10-K for the year ended December 31, 2021, as updated by
KemPharm’s Quarterly Report on Form 10-Q for the three months ended
September 30, 2022, and KemPharm’s other filings with the
Securities and Exchange Commission. While we may elect to update
such forward-looking statements at some point in the future, except
as required by law, we disclaim any obligation to do so, even if
subsequent events cause our views to change. Although we believe
the expectations reflected in such forward-looking statements are
reasonable, we can give no assurance that such expectations will
prove to be correct. These forward-looking statements should not be
relied upon as representing our views as of any date subsequent to
the date of this press release.
KemPharm Contacts:
Tiberend Strategic Advisors, Inc.Jason
Rando/Daniel Kontoh-Boateng
jrando@tiberend.comdboateng@tiberend.com
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