– Pivotal data from lead program, ADAIR, expected in second half 2021
– Potential NDA filing for ADAIR in Q2 2022; targeting a ~$9 billion U.S. ADHD market1
– Novel abuse-deterrent platform technology enables pipeline expansion opportunities across multiple drugs and indications
PHILADELPHIA, PA,, March 29, 2021 — 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.
- 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.
- 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.
- 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.
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 , 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.
JTC Team, LLC
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