Vallon Pharmaceuticals Inc. (NASDAQ: VLON), (“Vallon” or the
“Company”), a clinical-stage biopharmaceutical company primarily
focused on the development of novel drugs that are designed to
deter abuse in the treatment of CNS disorders, today reported its
financial results for the full year 2020.
Additionally, the Company provided an update on
its development programs, ADAIR and ADMIR, which leverage the
Company’s proprietary technology that is designed to resist
manipulation for snorting and provide barriers to injection.
Recent Highlights
- Successfully completed an $18.0 million initial public offering
and began trading on the Nasdaq Capital Market under the ticker
“VLON”;
- Appointed Marella Thorell, an accomplished executive leader
with more than 30 years of experience in finance and operations, to
Board of Directors;
- Presented positive data from two studies at the 2021 American
Professional Society of ADHD and Related Disorders (APSARD) Annual
Meeting, evaluating ADAIR which demonstrated bioequivalence to
immediate release (IR) dextroamphetamine when administered orally
and appears to be less desirable to recreational drug abusers when
snorted compared to currently available IR dextroamphetamine;
and
- Presented positive data from proof-of-concept intranasal human
abuse study at the 2020 American Academy of Child & Adolescent
Psychiatry (AACAP) Annual Meeting, which demonstrated ADAIR to have
less abuse potential than standard IR dextroamphetamine when
manipulated and misused intranasally, while at the same time
maintaining a similar Pk profile to standard IR dextroamphetamine
when taken orally as prescribed.
“The last few months have been truly
transformational for the Company with the closing of our IPO and
listing on Nasdaq. We are now well funded and committed to driving
awareness, advancing an important abuse deterrent formulation for
patients and building shareholder value in the near and long-term,”
commented David Baker, President & Chief Executive Officer of
Vallon. “We continue to drive our lead program, ADAIR, towards
approval and expect topline results from the SEAL study, our
ongoing pivotal intranasal abuse study in the second half of this
year, which will support our planned NDA filing in the second
quarter of 2022. There is a large and growing concern about
prescription stimulant abuse. With the data we have generated to
date, and pivotal data expected later this year, we believe we are
well-positioned to offer the first immediate-release
abuse-deterrent formulation of an ADHD stimulant and access a
significant market opportunity.”
Clinical Program Update
ADAIR2: Abuse-Deterrent Formulation of Dextroamphetamine
According to reports from the U.S. Department of
Health and Human Services, more than 5 million Americans misuse or
abuse prescription stimulants annually3, most commonly teenagers
and young adults. Separate studies indicate that approximately 40%
of people who misuse prescription stimulants report snorting
them.
ADAIR is the Company’s proprietary
abuse-deterrent formulation of immediate-release dextroamphetamine
currently in development for the treatment of attention deficit
hyperactivity disorder (ADHD) and narcolepsy. Dextroamphetamine has
been used clinically for more than fifty years and is the same
active ingredient used in FDA-approved products, such as Adderall®,
Dexedrine®, and Vyvanse®.
ADAIR is being developed leveraging the
de-risked 505(b)(2) regulatory pathway. The Company is currently
conducting the pivotal intranasal abuse study expected to be the
final clinical trial prior to NDA filing. The ongoing SEAL study
(Study to Evaluate the
Abuse Liability,
Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent
d-Amphetamine Sulfate Immediate Release Formulation), is a pivotal
randomized, double-blind, double dummy, placebo and
active-controlled 4 period, 4 way crossover assessing the abuse
potential of ADAIR compared to dextroamphetamine administered
intranasally in recreational drug abusers with past history of
snorting stimulants.
ADAIR is also being developed for Europe and the
UK through a license and collaboration agreement with MEDICE
Arzneimittel Pütter GmbH, a leader in the European ADHD market.
Upcoming Milestones
- Report pivotal data from the SEAL study targeted for the second
half of 2021.
- NDA submission targeted for Q2 2022.
ADMIR: Abuse-Deterrent Formulation of
Methylphenidate (Ritalin®) The Company’s second program in
development is ADMIR, a novel abuse-deterrent formulation of
immediate-release methylphenidate (Ritalin). Ritalin is another
commonly prescribed stimulant for treating ADHD that is frequently
misused and abused.
Upcoming Milestones
- Complete formulation development work.
- Upon completion of formulation development, Vallon will submit
an IND to allow for the initiation of human clinical trials.
Summary of Financial Results for Fiscal
Year 2020 Net loss for the year ended December 31, 2020
was approximately $4.8 million. Research and development expenses
increased by approximately $1.8 million to $3.7 million from the
year ended December 31, 2019 to the year ended December 31, 2020.
The increase in research and development expenses was primarily due
to increases of $1.2 million related to the registration
development program of ADAIR. General and administrative expenses
decreased by approximately $91,000 to $1.2 million from the year
ended December 31, 2019 to the year ended December 31, 2020.
On December 31, 2020, the Company had cash and
cash equivalents totaling approximately $109,000. On January 11,
2021, the Company entered into a Convertible Promissory Note
Purchase Agreement with certain existing shareholders for cash
proceeds of $350,000. On February 12, 2021, the Company completed
its initial public offering for total gross proceeds of $18.0
million, resulting in net proceeds of approximately $15.5 million
after deducting the underwriting commission and all expenses in
connection with the offering.
Management estimates that the net $15.9 million
raised pursuant to the IPO and the 2021 Convertible Notes provides
funding for the Company’s ongoing business activities into the
third quarter of 2022.
About Vallon Pharmaceuticals
Inc.
Vallon Pharmaceuticals Inc. is a clinical-stage
biopharmaceutical company, headquartered in Philadelphia, PA. The
Company is focused on the development of new medications to help
patients with central nervous system (CNS) disorders. The Company’s
lead investigational product candidate, ADAIR, is a novel abuse
deterrent formulation of amphetamine immediate release being
developed for the treatment of ADHD and narcolepsy. For more
information about the company, please visit www.vallon-pharma.com
or connect with us on LinkedIn or Twitter. Forward Looking
Statements
This press release contains “forward-looking
statements” that are based on Vallon’s current expectations and
subject to inherent uncertainties, risks and assumptions that are
difficult to predict, including, without limitation, Vallon’s
ability to execute its business plan, continue its growth and fund
its ongoing business activities as planned, Vallon’s ability to
develop and commercialize its product candidates, expectations
related to results of clinical trials and studies, Vallon’s
expectations with respect to the important advantages it believes
its abuse-deterrent formulation of drugs have over similar drugs in
the market, and the growing need for abuse-deterrent formulations
of drugs, Vallon’s ability to utilize the 505(b)(2) regulatory
pathway, and Vallon’s ability to obtain FDA approval of ADAIR and
its other product candidates. Forward-looking statements may be
identified by the use of words such as “anticipate,” “believe,”
“contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,”
“may,” “might,” “plan,” “potential,” “predict,” “project,”
“target,” “aim,” “should,” "will,” “would,” or the negative of
these words or other similar expressions. Further, certain
forward-looking statements are based on assumptions as to future
events that may not prove to be accurate. These and other risks and
uncertainties are described more fully in the section titled “Item
1A. Risk Factors” in our Annual Report on Form 10-K, filed with the
U.S. Securities and Exchange Commission on March [25], 2021.
Forward-looking statements contained in this announcement are made
as of this date, and the Company undertakes no duty to update such
information except as required under applicable law.
Investor Contact:JTC Team, LLCJenene
Thomas(833) 475-8247vallon@jtcir.com
1 IQVIA, NSP, 2019
2 ADAIR is not approved by the FDA
3 SAMHSA, Center for Behavioral Health Statistics and Quality,
National Survey on Drug Use and Health, 2017
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