ARS Pharmaceuticals Announces the Appointment of Two New Board Members

June 18, 2019 Off By BusinessWire

Expansion of Board of Directors Adds Commercialization and Financial
Expertise, Further Augments Clinical and Scientific Acumen of Medical
and Scientific Advisory Board

SAN DIEGO–(BUSINESS WIRE)–ARS Pharmaceuticals, Inc., a pharmaceutical company dedicated to
empowering at-risk patients and caregivers to better protect themselves
from severe allergic reactions potentially leading to anaphylaxis, today
announced the appointment of two new members to its Board of Directors –
Michael Kelly, former president of U.S. operations for Adapt Pharma, and
Phillip Schneider, board member and chairman of the audit committee for
Pfenex Inc. and former chief financial officer and senior vice president
of IDEC Pharmaceuticals Corporation.

“Mr. Kelly and Mr. Schneider will bring important perspectives to the
company as we prepare for the commercialization of ARS-1. Both have deep
experience in the life sciences sector and share our commitment to
improve the treatment of anaphylaxis for at-risk patients and
caregivers,” said Richard Lowenthal, Founder, Chief Executive Officer
and President of ARS Pharmaceuticals. “Mr. Kelly was instrumental in the
launch and successful market introduction of NARCAN Nasal Spray, and
will bring invaluable experience in the commercialization of
pharmaceutical products, including nasal drug delivery systems for use
in emergency situations. Mr. Schneider brings decades of financial
expertise and a deep understanding of Wall Street to our Company to help
us prepare the company for future fund raising events.”

About Michael Kelly

Mr. Kelly brings more than 25 years of pharmaceutical industry
expertise. He recently served as president of U.S. operations for Adapt
Pharma, which developed and commercialized NARCAN® (naloxone
HCl) Nasal Spray, the first and only needle-free formulation of naloxone
approved by the U.S. Food and Drug Administration (FDA) and Health
Canada. Under Mr. Kelly’s leadership, NARCAN rapidly gained market share
in the U.S. from needle-based delivery of naloxone, with sales estimated
to reach $200 million to $220 million in 2019, at the time of the
acquisition of Adapt Pharma by Emergent Biosolutions in October 2018 for
$735 million.

Prior to Adapt, he served as chief executive officer and board member
for Covis Pharmaceuticals, Inc. Mr. Kelly was also a member of the
founding management team of Azur Pharma and later, following a strategic
merger, served as senior vice president of sales and marketing for Jazz
Pharmaceuticals plc. Prior to his tenure at Azur, he served as vice
president of commercial operations at Guilford Pharmaceuticals, vice
president of sales and marketing at ViroPharma Incorporated, and held
various commercial and medical roles at TAP Pharmaceuticals. He holds a
Bachelor of Science in business administration from The College of New
Jersey and a Master of Business Administration from Rider University.

“I am pleased to have the opportunity to join ARS’ Board of Directors
and work with the company’s accomplished and talented life science board
members. I was drawn to ARS based on the company’s unique approach to
developing a simple to use intranasal epinephrine spray that has the
potential to help a broad population,” said Mr. Kelly. “I believe ARS
has the potential to bring a first-of-its-kind treatment to at-risk
patients and caregivers to help better protect them from severe allergic
reactions potentially leading to anaphylaxis.”

About Phillip Schneider

Mr. Schneider brings decades of financial expertise to help us prepare
the company to successfully manage our growth and success. He currently
serves as board member and chairman of the audit committee for Pfenex
Inc. Most notably, Mr. Schneider was chief financial officer and senior
vice president for IDEC Pharmaceuticals Corporation. During his tenure,
he helped to raise more than $1 billion in financing as the company went
from a start-up through its initial public offering, to a company valued
in excess of $7 billion. Prior to IDEC, Mr. Schneider held various
management positions at Syntex Pharmaceuticals Corporation and KPMG,
LLC, where he earned his certified public accountant license. Mr.
Schneider has previously served as audit committee chairman and director
for Arena Pharmaceuticals and was board member and chairman of the audit
committee for Auspex Pharmaceuticals and Gen Probe Inc. until their
respective sales. He holds a Master of Business Administration from the
University of Southern California and a Bachelor of Science in
biochemistry from the University of California, Davis.

“I am excited about joining the ARS Board,” stated Mr. Schneider. “I
look forward to working alongside my fellow Board members and company
management to advance a truly innovative drug product which can be a
potential life-saving benefit to children and adults.”

Medical and Scientific Advisory Board

The expansion of ARS Pharmaceuticals’ Board of Directors adds additional
commercialization and financial expertise to the company to further
augment the strong Medical and Scientific Advisory Board, which is
comprised of the following leaders in the treatment of anaphylaxis:

  • F. Estelle R. Simons, M.D., FRCPC, FAAP, FACAAI, FAAAAI, FCAHS, FRSC,
    professor emerita at the University of Manitoba, who served as founder
    and head of the division of allergy and clinical immunology in the
    department of pediatrics and later as training program director in
    allergy and clinical immunology at the university
  • Michael Kaliner, M.D., founder of the Institute for Asthma and Allergy
    and former director of the Allergic Diseases Section of the National
    Institute of Allergy and Infectious Diseases at the National
    Institutes of Health
  • Richard F. Lockey, M.D., division chief at the college of medicine
    internal medicine, director of allergy and immunology and leader of
    the clinical research unit at USF Health
  • Phillip Lieberman, M.D., clinical professor of medicine and pediatrics
    in the departments of internal medicine and pediatrics (divisions of
    allergy and immunology) at the University of Tennessee College of
    Medicine in Memphis, Tenn.
  • Motohiro Ebisawa, M.D., Ph.D., vice-director of clinical research
    center for allergy and rheumatology, Sagamihara National Hospital and
    the visiting professor of the Jikei University School of Medicine. He
    is a leading expert in food allergies in Japan and currently serves as
    the president-elect of World Allergy Organization (WAO), where he has
    served in different leadership roles since
  • Guy Ludbrook Ph.D., M.B.B.S., F.A.N.Z.C.A., G.A.I.C.D., professor at
    the University of Adelaide and director of PARC clinical research at
    the Royal Adelaide hospital and critical care expert

About ARS Pharmaceuticals, Inc.

ARS Pharmaceuticals is dedicated to empowering at-risk patients and
caregivers to better protect themselves from severe allergic reactions
that could lead to anaphylaxis. The Company is developing ARS-1, an
investigational intranasal epinephrine spray with a unique absorption
technology that could be easy-to-use, needle-free, convenient and more
reliable for patients and loved ones at-risk of severe allergic
reactions to food, medications and insect bites that could lead to
life-threatening anaphylaxis. For more, visit www.ars-pharma.com.

About ARS-1

ARS-1 is an aqueous formulation of epinephrine nasal spray uniquely
developed with Intravail®, a novel nasal absorption enhancing
technology. ARS-1 has demonstrated comparable pharmacokinetics to an
intramuscular injection of epinephrine in clinical studies using a low
and safe intranasal dose (1.0 mg epinephrine administered). As a result,
the Company believes that the ARS-1 formulation may enable people to
easily deliver epinephrine in emergency situations more rapidly, and
with less hesitation, at the onset of an allergic reaction, as compared
to currently available epinephrine auto-injectors. The intranasal
epinephrine spray is also designed to be user-friendly, needle-free and
easily portable to carry in a pocket or purse anytime, anywhere.

ARS-1 was granted Fast Track Designation by the U.S. Food and Drug
Administration (FDA) in February 2019. Fast track is a process designed
to facilitate the development and expedite the review of drugs to treat
serious conditions and fill an unmet medical need by providing a therapy
where none exist or by providing a therapy which may be potentially
better than available therapy. Its purpose is to get important new drugs
to patients earlier.

Anaphylaxis is a severe, life-threatening allergic reaction with a
sudden onset that can occur very quickly — as fast as within a couple of
minutes — and could be fatal if not treated immediately. According to
published literature up to 5.3 million people in the United States are
at risk of having an anaphylaxis reaction that may warrant immediate
emergency medical treatment, with more than 200,000 emergency room
visits due to severe reactions from food allergies reported annually.

About Intravail®

The sprayer is uniquely formulated with Intravail®, an absorption
enhancing technology. Intravail® enables the non-invasive delivery of a
broad range of protein, peptide and non-peptide drugs (up to 30,000
daltons in size) that can currently only be administered by injection.

Contacts

Sheryl Seapy
W2O pure
213-262-9390
[email protected]