1. - Inaugural appointments include globally renowned leaders and experts on attention-deficit/hyperactivity disorder (ADHD) and stimulant abuse


    PHILADELPHIA, PA, Sept. 14, 2021 (GLOBE NEWSWIRE) -- 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 central nervous system (CNS) disorders, today announced the formation of and initial appointments to its Scientific Advisory Board (SAB). The SAB will guide and advise the Company as it advances its novel abuse-deterrent platform technology and its lead development programs ADAIR and ADMIR, which leverage the technology to resist…

    - Inaugural appointments include globally renowned leaders and experts on attention-deficit/hyperactivity disorder (ADHD) and stimulant abuse



    PHILADELPHIA, PA, Sept. 14, 2021 (GLOBE NEWSWIRE) -- 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 central nervous system (CNS) disorders, today announced the formation of and initial appointments to its Scientific Advisory Board (SAB). The SAB will guide and advise the Company as it advances its novel abuse-deterrent platform technology and its lead development programs ADAIR and ADMIR, which leverage the technology to resist manipulation for snorting and provide barriers to injection.

    David Baker, President and Chief Executive Officer of Vallon commented, "We are proud to announce the formation of and the initial appointments to our SAB, which I believe marks a significant milestone for the Company. We are pleased to welcome these accomplished and highly regarded individuals as our inaugural members and look forward to leveraging their knowledge and expertise moving forward. Drs. Faraone, Newcorn and Rostain each bring distinct expertise and invaluable leadership in the psychiatry field as a whole, but more specifically in ADHD, which will be an important asset to the Company. As we work to advance our proprietary abuse-deterrent technology and address the treatment of CNS disorders we are pleased to have their scientific perspectives and guidance to assist Vallon in unlocking its full potential."

    Joining the Company's SAB are the following:

    Stephen V. Faraone, PhD

    Distinguished Professor, Departments of Psychiatry and Neuroscience & Physiology, SUNY Upstate Medical University

    Dr. Faraone is one of the world's leading authorities on the genetics of psychiatric disorders and an expert on ADHD. He has made substantial contributions to research in psychopharmacology and research methodology having authored over 1000 journal articles, editorials, chapters and books, he was the eighth highest producer of High Impact Papers in Psychiatry from 1990 to 1999 as determined by the Institute for Scientific Information. In 2005, ISI determined him to be the second highest cited author for Attention Deficit Hyperactivity Disorder. From 2014 to 2019 he has been listed as a highly cited researcher by Thomson Reuters/Clarivate Analytics. In 2019 and 2020, his citation metrics placed him in the top 0.01% of scientists across all fields. In 2021, expertscape indicated he was the top-rated expert in ADHD, worldwide.

    In 2002, Dr. Faraone was inducted into the CHADD Hall of Fame in recognition of outstanding achievement in medicine and education research on attention disorders. In 2004 and 2008, Faraone was elected Vice President of the International Society of Psychiatric Genetics and in 2019, he received the Paul Hoch Award from the American Psychopathological Association. In 2008, he received the SUNY Upstate President's Award for Excellence and Leadership in Research. In 2019, he was elected President of the World Federation of ADHD.

    Dr. Faraone also currently serves as the Senior Scientific Advisor to the Research Program Pediatric Psychopharmacology at the Massachusetts General Hospital and a lecturer at Harvard Medical School. Over the course of his career, Dr. Faraone has been principal investigator on several National Institutes of Health funded grants studying the nature and causes of mental disorders in childhood. Additionally, Dr. Faraone heads the adult ADHD education initiative at www.adhdinadults.com and is Biostatistical and Methodology Editor for the Journal of Attention Disorders.

    Jeffrey Newcorn, MD

    Professor of Psychiatry and Pediatrics and Director of the Division of ADHD and Learning Disorders; Icahn School of Medicine at Mount Sinai

    Dr. Newcorn is a highly regarded researcher in the areas of ADHD, aggression, descriptive psychopathology of child and adolescent disorders, and child and adolescent psychopharmacology, whose work spans both clinical and translational topics. Over the course of his career, he has published over 350 articles and book chapters on these and related subjects. Dr. Newcorn has received numerous awards for his work, including the Hulse Award for lifetime achievement from the New York Council on Child and Adolescent Psychiatry (2002), and the Elaine Schlosser Lewis Award for Research in Attention Deficit Disorder (2018). He was elected to the CHADD Hall of Fame in 2014

    Dr. Newcorn is the Principal Investigator or Co-Investigator on several NIH-funded grants that examine the clinical, genetic, neuroanatomic and neurophysiologic basis of ADHD its treatment, as well as the neurobiological basis of substance abuse risk. He also directs an active clinical trials program, and has studied many of the recent medication treatments for ADHD. Dr. Newcorn is an internationally recognized educator and mentor, and is an editorial board member of several leading child psychiatry/psychology and psychopharmacology journals. He was a member of the steering committee of the NIMH-funded multicenter study "Multimodal Treatment of Children with ADHD (MTA)" and the DSM-IV advisory committees on child and adolescent disorders and disruptive behavior disorders. He was a founding member of the board of directors of the American Professional Society for ADHD and Related Disorders (APSARD), and has served as President since 2020.

    Anthony Rostain, MD

    Chief of Psychiatry and Behavioral Health at Cooper University Healthcare, Chair and Professor of Psychiatry and Pediatrics at Cooper Medical School of Rowan University and is Emeritus Professor of Psychiatry and Pediatrics at the University of Pennsylvania Perelman School of Medicine

    Dr. Rostain is a well-established leader in neurodevelopmental psychiatry, ADHD and related disorders, and college student mental health. His clinical focus is lifespan neurodevelopmental psychiatry, which includes caring for patients with ADHD, Autism Spectrum Disorders, Tourette Syndrome, Learning Disabilities (verbal and nonverbal), Neurogenetic Disorders (e.g., Fragile X, Rett) and related social-emotional learning disorders. Dr. Rostain served as Vice Chair of Education for the Department of Psychiatry at Perelman School of Medicine from 1998-2017 and was Co-Chair of the University of Pennsylvania's Task Force on Student Psychological Health and Welfare from 2014-2016. Dr. Rostain was President of APSARD from 2011-2016 and Co-Chair of its Education Committee from 2016-2020. He currently serves on the Medical Advisory Board of the Tourette Association of America. Dr. Rostain is a member of American Academy of Child and Adolescent Psychiatry's Transitional Age Youth and College Student Mental Health Committee and is one of AACAP's representatives to the Higher Education Mental Health Alliance (HEMHA).

    Dr. Rostain's research is focused on improving clinical outcomes for patients with neurodevelopmental disorders across the lifespan, and on creating effective service systems for these patients and their families. He has co-authored two books on adult ADHD (with J. Russell Ramsay, Ph.D.) entitled The Adult ADHD Tool Kit: Using CBT to Facilitate Coping Inside and Out, and Cognitive-Behavioral Therapy for Adult ADHD: An Integrative Psychosocial and Medical Approach (Routledge, 2015). He is also co-author (with B. Janet Hibbs, Ph.D.) of The Stressed Years of Their Lives: Helping Your Kid Survive and Thrive During Their College Years (St. Martin's Press, 2019).

    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 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.

    References and links to websites have been provided for convenience, and the information contained on any such website is not a part of, or incorporated by reference into, this press release. Vallon is not responsible for the contents of third-party websites.

    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, Vallon's ability to obtain FDA approval of ADAIR and its other product candidates, and Vallon's expectations with respect to its cash runway. 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 "Risk Factors" in Vallon's Quarterly and Annual Reports filed with the U.S. Securities and Exchange Commission. 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, LLC

    Jenene Thomas

    (833) 475-8247

    vallon@jtcir.com



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  2. Live video webcast with David Baker, President and CEO of Vallon, on Wednesday, August 18th12:30 PM ET

    PHILADELPHIA, PA, Aug. 11, 2021 (GLOBE NEWSWIRE) -- 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 central nervous system (CNS) disorders, announced today that David Baker, President & Chief Executive Officer of Vallon will present at the Q3 Virtual Investor Summit on Wednesday, August 18, 2021 at 12:30 PM ET.

    In addition to the presentation, management will be available to participate in virtual one-on-one meetings with qualified members of the investor community…

    Live video webcast with David Baker, President and CEO of Vallon, on Wednesday, August 18th 12:30 PM ET

    PHILADELPHIA, PA, Aug. 11, 2021 (GLOBE NEWSWIRE) -- 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 central nervous system (CNS) disorders, announced today that David Baker, President & Chief Executive Officer of Vallon will present at the Q3 Virtual Investor Summit on Wednesday, August 18, 2021 at 12:30 PM ET.

    In addition to the presentation, management will be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information about the conference, please visit the conference website.

    A live video webcast of the presentation will be accessible on the Events page in the Investors section of the Company's website (www.vallon-pharma.com) and will be archived for 90 days following the event.

    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.

    References and links to websites have been provided for convenience, and the information contained on any such website is not a part of, or incorporated by reference into, this press release. Vallon is not responsible for the contents of third-party websites.

    Investor Contact:

    JTC Team, LLC

    Jenene Thomas

    (833) 475-8247

    vallon@jtcir.com



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  3. - Company continues to drive enrollment in pivotal intranasal abuse study evaluating ADAIR toward completion before year-end 2021

    - ADAIR targeting the large and growing Adderall® segment of the ~$9 billion US ADHD market

    PHILADELPHIA, PA, Aug. 10, 2021 (GLOBE NEWSWIRE) -- 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 central nervous system (CNS) disorders, today reported its financial results for the quarter ended June 30, 2021.

    The Company also provided an update on its development programs, ADAIR and ADMIR, which leverage the Company's proprietary technology…

    - Company continues to drive enrollment in pivotal intranasal abuse study evaluating ADAIR toward completion before year-end 2021

    - ADAIR targeting the large and growing Adderall® segment of the ~$9 billion US ADHD market

    PHILADELPHIA, PA, Aug. 10, 2021 (GLOBE NEWSWIRE) -- 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 central nervous system (CNS) disorders, today reported its financial results for the quarter ended June 30, 2021.

    The Company also 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

    • Bolstered senior leadership team with appointment of Leanne Kelly, an accomplished financial executive with over 20 years of experience leading private and publicly traded companies, as its Chief Financial Officer;
    • Announced the issuance of a new European Patent covering method of use and composition of matter for ADAIR, with a base patent term extending until 2038; and
    • Continued to progress enrollment in the ongoing Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent d-Amphetamine Sulfate Immediate Release Formulation (SEAL Study), a pivotal intranasal abuse study.

    David Baker, President & Chief Executive Officer of Vallon commented, "As the first half of the year comes to a close, our team is laser-focused on the completion of the SEAL Study, our pivotal intranasal abuse study of our lead program, ADAIR, and advancing toward our planned NDA submission targeted for the second quarter of 2022. Even during the COVID pandemic, the use of immediate release stimulants such as Adderall, which have the highest reported rates of abuse, has continued to grow, highlighting the need for novel investigational treatments like ADAIR. Looking to the future, we are planning for success and significant value-driving milestones in the months ahead."

    Clinical Program Update

    ADAIR1: Abuse-Deterrent Formulation of Dextroamphetamine

    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 is the main active ingredient in Adderall. In the U.S. ADAIR is being developed leveraging the de-risked 505(b)(2) regulatory pathway and is currently being evaluated in a pivotal intranasal abuse study, the SEAL Study. 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.

    The ongoing SEAL Study is a pivotal randomized, double-blind, double dummy, placebo and active-controlled 4 period, 4-way crossover assessing the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability of manipulated ADAIR 30 mg when compared to crushed d-amphetamine sulfate and placebo. In the study, subjects are given ADAIR to snort after it has been optimally manipulated using a professional laboratory technique. A total of 64 subjects demonstrating a confirmed positive response to stimulants are planned to enter the treatment phase. Safety will be assessed via adverse events, vital signs, ECGs, clinical laboratory tests and other standard measures. The Company remains on track to complete enrollment in the study and report topline data before year-end. The SEAL Study is expected to be the final clinical trial prior to NDA filing.

    Upcoming Milestones

    • Complete enrollment of SEAL Study before year-end 2021.
    • Report topline data before year-end 2021.
    • NDA submission targeted for the second quarter of 2022.

    ADMIR: Abuse-Deterrent Formulation of Methylphenidate (Ritalin®)

    The Company's second development program 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.
    • Submission of an IND to allow for the initiation of human clinical trials upon completion of formulation development.

    Pipeline Expansion Opportunities

    The Company's proprietary platform technology can be applied to other prescription drugs with abuse potential enabling the development of novel abuse-deterrent medications for CNS disorders. Vallon is evaluating pipeline expansion opportunities across multiple drugs and indications.

    Summary of Financial Results for Second Quarter 2021

    Net loss for the quarter ended June 30, 2021 was $2.3 million. Research and development expenses were $1.2 million and $0.8 million for the three months ended June 30, 2021, and 2020, respectively. General and administrative expenses were $1.1 million and $0.3 million for the three months ended June 30, 2021, and 2020, respectively.

    As of June 30, 2021, the Company had cash and cash equivalents totaling approximately $10.5 million, which the Company expects will provide funding for its 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.

    References and links to websites have been provided for convenience, and the information contained on any such website is not a part of, or incorporated by reference into, this press release. Vallon is not responsible for the contents of third-party websites.

    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, Vallon's ability to obtain FDA approval of ADAIR and its other product candidates, and Vallon's expectations with respect to its cash runway. 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 "Risk Factors" in Vallon's Quarterly and Annual Reports filed with the U.S. Securities and Exchange Commission. 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, LLC

    Jenene Thomas

    (833) 475-8247

    vallon@jtcir.com


    1 ADAIR is not approved by the FDA



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  4. - Patent bolsters intellectual property protection as Company's partner, MEDICE, works to develop and potentially commercialize ADAIR in Europe and the UK

    PHILADELPHIA, PA, July 13, 2021 (GLOBE NEWSWIRE) -- 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 central nervous system (CNS) disorders, today announced that the European Patent Office has issued patent number EP3576719B1 covering ADAIR1, the Company's proprietary abuse-deterrent formulation of immediate-release dextroamphetamine.

    ADAIR is being developed for Europe and the UK through a license and collaboration…

    - Patent bolsters intellectual property protection as Company's partner, MEDICE, works to develop and potentially commercialize ADAIR in Europe and the UK

    PHILADELPHIA, PA, July 13, 2021 (GLOBE NEWSWIRE) -- 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 central nervous system (CNS) disorders, today announced that the European Patent Office has issued patent number EP3576719B1 covering ADAIR1, the Company's proprietary abuse-deterrent formulation of immediate-release dextroamphetamine.

    ADAIR is 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. Under the terms of the agreement, Vallon will receive development and sales milestone payments and double-digit sales-based royalty payments. The issuance of this Composition of Matter and Method of Use patent provides additional protection as MEDICE works towards the potential commercialization of ADAIR in the European Union and United Kingdom. In the US, the Company continues to develop ADAIR, leveraging the 505(b)(2) regulatory pathway. The Company is currently conducting a pivotal intranasal abuse study, the SEAL Study, in recreational drug abusers.

    David Baker, President & Chief Executive Officer of Vallon commented, "There is a clear and growing unmet need for products that can treat ADHD effectively while attending to the significant problem of stimulant misuse. We continue to be encouraged by the potential of our novel platform technology, which we believe can also be applied to other prescription drugs that have abuse potential. We are pleased to successfully expand our intellectual property portfolio with the issuance of this new European patent."

    The new European patent covers composition of matter and method of use for ADAIR, with a base patent term extending until 2038. The design and development of an abuse-deterrent formulation involves the balance of limiting the potential for manipulation and abuse while maintaining acceptable dissolution rates and bioavailability. ADAIR was previously granted two patents in the United States with a base patent term extending until 2037, excluding patent term extensions.

    About ADAIR

    ADAIR (Abuse Deterrent Amphetamine Immediate Release) is an investigational new drug; a novel, patented formulation of dextroamphetamine designed to deter attempts to crush and snort it or take it by other non-oral routes that can produce a greater "high." Dextroamphetamine has been used clinically for more than 50 years. It is the same active ingredient used in FDA-approved products, such as Adderall®, Dexedrine®, and Vyvanse®. ADAIR is not approved by the FDA.

    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.

    References and links to websites have been provided for convenience, and the information contained on any such website is not a part of, or incorporated by reference into, this press release. Vallon is not responsible for the contents of third-party websites.

    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, Vallon's ability to obtain FDA approval of ADAIR and its other product candidates, and Vallon's expectations with respect to its cash runway. 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 "Risk Factors" in Vallon's Quarterly and Annual Reports filed with the U.S. Securities and Exchange Commission. 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, LLC

    Jenene Thomas

    (833) 475-8247

    vallon@jtcir.com


    1 ADAIR is not approved by the FDA



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  5. - Company remains on track to report pivotal data from lead program, ADAIR, in second half 2021

    - Novel abuse-deterrent platform technology enables pipeline expansion opportunities across multiple drugs and indications


    PHILADELPHIA, PA, May 13, 2021 (GLOBE NEWSWIRE) -- 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 central nervous system (CNS) disorders, today reported its financial results for the quarter ended March 31, 2021.

    Additionally, the Company provided an update on its development programs, ADAIR and ADMIR, which leverage the Company's proprietary technology…

    - Company remains on track to report pivotal data from lead program, ADAIR, in second half 2021

    - Novel abuse-deterrent platform technology enables pipeline expansion opportunities across multiple drugs and indications



    PHILADELPHIA, PA, May 13, 2021 (GLOBE NEWSWIRE) -- 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 central nervous system (CNS) disorders, today reported its financial results for the quarter ended March 31, 2021.

    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 of its common stock (the IPO) and began trading on the Nasdaq Capital Market under the ticker symbol "VLON";
    • Appointed Leanne Kelly, an accomplished financial executive with over 20 years of experience leading private and publicly traded companies, as its Chief Financial Officer;
    • Appointed Marella Thorell, a proven executive leader with more than 30 years of experience in finance and operations, to Board of Directors;
    • Continued to progress enrollment for the ongoing Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent d-Amphetamine Sulfate Immediate Release Formulation (SEAL Study), a pivotal intranasal abuse study. Enrollment in the study remains on track to support topline study results in 2H21; and
    • 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.

    David Baker, President & Chief Executive Officer of Vallon commented, "The first quarter was marked by our successful IPO and continued execution on the clinical and operational fronts. The SEAL Study, our pivotal intranasal abuse study of our lead program, ADAIR, continues to progress well through enrollment and we remain on track to report data in the second half of this year, with an NDA submission targeted for the second quarter of 2022. We also made key appointments to our Board and executive leadership team in the first quarter that provide additional expertise and leadership as we advance our novel platform technology and development pipeline. Our team is committed to bringing this important program across the finish line and potentially bringing to market a new effective, abuse-deterrent treatment for ADHD."

    Clinical Program Update

    ADAIR1: Abuse-Deterrent Formulation of Dextroamphetamine

    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. ADAIR is being developed leveraging the de-risked 505(b)(2) regulatory pathway and is currently being evaluated in a pivotal intranasal abuse study, SEAL Study. The SEAL Study is expected to be the final clinical trial prior to NDA filing.

    The ongoing SEAL Study is a pivotal randomized, double-blind, double dummy, placebo and active-controlled 4 period, 4 way crossover assessing the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability of manipulated ADAIR 30 mg when compared to crushed d-amphetamine sulfate and placebo. A total of 64 subjects demonstrating a confirmed positive response to stimulants are planned to enter the treatment phase. Safety will be assessed via adverse events, vital signs, ECGs, clinical laboratory tests and other standard measures.

    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 the second quarter of 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 First Quarter 2021

    Net loss for the quarter ended March 31, 2021 was $2.6 million. Research and development expenses were $1.8 million and $0.9 million for the three months ended March 31, 2021 and 2020, respectively. The $0.9 million increase in research and development expenses was primarily due to an increase of $1.0 million related to the registration development program of ADAIR. General and administrative expenses were $0.8 million and $0.4 million for the three months ended March 31, 2021 and 2020, respectively. The increase was primarily related to increased costs for directors and officers insurance, non-cash stock compensation and increases in consultant related expenses.

    On January 11, 2021, the Company entered into an agreement with certain existing shareholders for cash proceeds of $350,000 through the issuance of convertible promissory notes (the 2021 Convertible Notes). On February 12, 2021, the Company completed the IPO 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. The 2021 Convertible Notes converted to common stock concurrently with the closing of the IPO, resulting in a net $15.9 million raised pursuant to the IPO and the 2021 Convertible Notes.

    As of March 31, 2021, the Company had cash and cash equivalents totaling approximately $13.0 million, which the Company expects will provide funding for its 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.

    References and links to websites have been provided for convenience, and the information contained on any such website is not a part of, or incorporated by reference into, this press release. Vallon is not responsible for the contents of third-party websites.

    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, Vallon's ability to obtain FDA approval of ADAIR and its other product candidates, and Vallon's expectations with respect to its cash runway. 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 "Risk Factors" in Vallon's Quarterly and Annual Reports filed with the U.S. Securities and Exchange Commission. 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, LLC

    Jenene Thomas

    (833) 475-8247

    vallon@jtcir.com


    1 ADAIR is not approved by the FDA



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  6. - Financial executive bringing over 20 years of experience in accounting, finance and management with a foundation established from big four accounting firm


    PHILADELPHIA, PA, May 11, 2021 (GLOBE NEWSWIRE) -- 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 announced the appointment of Leanne Kelly as its Chief Financial Officer.

    Ms. Kelly is an accomplished financial executive with over 20 years of experience leading private and publicly traded companies across life science, technology and e-Commerce sectors and a foundation in public accounting…

    - Financial executive bringing over 20 years of experience in accounting, finance and management with a foundation established from big four accounting firm



    PHILADELPHIA, PA, May 11, 2021 (GLOBE NEWSWIRE) -- 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 announced the appointment of Leanne Kelly as its Chief Financial Officer.

    Ms. Kelly is an accomplished financial executive with over 20 years of experience leading private and publicly traded companies across life science, technology and e-Commerce sectors and a foundation in public accounting.

    "Following our IPO earlier this year, we have taken thoughtful steps to strengthen our team and ensure we have key people with the right expertise needed to best position the Company for success. Leanne is a great addition to the Vallon executive management team as CFO and her industry experience and professional track record are perfectly aligned with the Company's strategic priorities in the near and long term," commented David Baker, President & Chief Executive Officer of Vallon.

    Prior to joining Vallon, she most recently served as the Controller and Executive Director, Global Financial Reporting at OptiNose, Inc. a $50M revenue specialty pharmaceutical company. Over the course of her career, she has held Senior Vice President of Finance, Controller and Chief Financial Officer positions in private and public companies such as Flower Orthopedics, Iroko Pharmaceuticals, LLC, and Genaera Corporation. Ms. Kelly began her career as an auditor with KPMG LLP. While serving in those roles, Ms. Kelly's work included multi-million dollar financings, M&A diligence and support. She also has experience in financial oversight, internal and external financial reporting, forecasting, and financial analysis, as well as investor and public relations.

    "Vallon truly represents an exciting opportunity for me with the recently completed IPO and its lead clinical development program, ADAIR, on target for pivotal data readout in the second half of this year," added Ms. Kelly. "I look forward to leveraging the knowledge and tools amassed over my career to help propel us to our next phase of growth."

    Ms. Kelly received her Bachelor of Science degree in Business Economics with a concentration in Accounting from Lehigh University, and is a licensed CPA (inactive status) in the state of Pennsylvania.

    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.

    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 29, 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, LLC

    Jenene Thomas

    (833) 475-8247

    vallon@jtcir.com



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  7. Live video webcast with David Baker, President and CEO of Vallon on Tuesday, May 18, 2021 at 4:15 PM ET

    PHILADELPHIA, PA, May 07, 2021 (GLOBE NEWSWIRE) -- 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, announced today that David Baker, President & Chief Executive Officer of Vallon will present at the Q2 Virtual Investor Summit on Tuesday, May 18th at 4:15 PM ET.

    In addition to the presentation, management will be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the…

    Live video webcast with David Baker, President and CEO of Vallon on Tuesday, May 18, 2021 at 4:15 PM ET

    PHILADELPHIA, PA, May 07, 2021 (GLOBE NEWSWIRE) -- 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, announced today that David Baker, President & Chief Executive Officer of Vallon will present at the Q2 Virtual Investor Summit on Tuesday, May 18th at 4:15 PM ET.

    In addition to the presentation, management will be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information about the conference, please visit the conference website.

    A live video webcast of the presentation will be accessible on the Events page in the Investors section of the Company's website (www.vallon-pharma.com) and will be archived for 90 days following the event.

    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.

    References and links to websites have been provided for convenience, and the information contained on any such website is not a part of, or incorporated by reference into, this press release. Vallon is not responsible for the contents of third-party websites.

    Investor Contact:

    JTC Team, LLC

    Jenene Thomas

    (833) 475-8247

    vallon@jtcir.com



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  8. David Baker, President and CEO of Vallon to participate in the virtual Advances in Neuropsychiatry Panel on April 29that 10:30 AM ET

    PHILADELPHIA, PA, April 26, 2021 (GLOBE NEWSWIRE) -- 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, announced today that David Baker, President & Chief Executive Officer of Vallon will participate at the virtual 4th Annual Neuroscience Innovation Forum being held April 28-30, 2021.

    A video webcast of the Company's presentation is now available on-demand in the Showcase section of the conference portal and will be accessible…

    David Baker, President and CEO of Vallon to participate in the virtual Advances in Neuropsychiatry Panel on April 29th at 10:30 AM ET

    PHILADELPHIA, PA, April 26, 2021 (GLOBE NEWSWIRE) -- 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, announced today that David Baker, President & Chief Executive Officer of Vallon will participate at the virtual 4th Annual Neuroscience Innovation Forum being held April 28-30, 2021.

    A video webcast of the Company's presentation is now available on-demand in the Showcase section of the conference portal and will be accessible on the conference platform until May 26, 2021. Following the event, the presentation will be made available on the Company's website.

    Additionally, Mr. Baker will be a panelist on the virtual Advances in Neuropsychiatry Panel, being held on April 29, 2021 at 10:30 AM ET. The live webcast of the panel will be accessible to those registered to attend the conference.

    Management will also be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference. To schedule a meeting, please contact the conference one-on-one desk or reach out through the online platform.

    For more information about the event, please visit the conference website.

    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.

    Investor Contact:

    JTC Team, LLC

    Jenene Thomas

    (833) 475-8247

    vallon@jtcir.com



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  9. - Ongoing ADAIR SEAL study on target for pivotal data readout in second half of 2021
    - Target NDA filing in Q2 2022 for a potential abuse-deterrent alternative to commercially available IR amphetamines in the treatment of ADHD, a ~$9 billion U.S. market1

    PHILADELPHIA, PA, April 13, 2021 (GLOBE NEWSWIRE) -- 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 provided a clinical program update for its lead program, ADAIR, a proprietary abuse-deterrent formulation of immediate-release (IR) dextroamphetamine currently in development for the treatment of attention…

    - Ongoing ADAIR SEAL study on target for pivotal data readout in second half of 2021

    - Target NDA filing in Q2 2022 for a potential abuse-deterrent alternative to commercially available IR amphetamines in the treatment of ADHD, a ~$9 billion U.S. market1

    PHILADELPHIA, PA, April 13, 2021 (GLOBE NEWSWIRE) -- 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 provided a clinical program update for its lead program, ADAIR, a proprietary abuse-deterrent formulation of immediate-release (IR) dextroamphetamine currently in development for the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy.

    "Prescription stimulant abuse is a growing, serious issue with more than five million Americans misusing and abusing ADHD prescriptions stimulants on an annual basis. We believe ADAIR, if approved, has the potential to help address this significant problem by making it difficult for individuals to manipulate the drug. Our proprietary immediate release formulation has been shown in studies to behave as intended when taken orally, but is difficult to prepare for snorting or injecting," commented David Baker, President & Chief Executive Officer of Vallon.

    Vallon is currently conducting its pivotal intranasal human abuse liability study, which is expected to be the final clinical trial prior to NDA filing. This 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.

    "Through the use of the 505(b)(2) regulatory pathway, we expect to leverage much of the existing data for dextroamphetamine, which has been demonstrated to be an effective treatment for ADHD and narcolepsy," added Dr. Timothy Whitaker, Vallon's Chief Medical Officer. "Our ongoing SEAL study is designed to evaluate the safety and abuse liability of ADAIR by recreational drug users. We are pleased with the progress of the study and remain on track with our expectations to report topline results in the second half of this year, which have the potential to support our NDA filing in the second quarter of 2022."

    The SEAL study will assess the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability of manipulated ADAIR 30mg when compared to crushed d-amphetamine sulfate and placebo. The primary PD endpoint is mean maximum (Emax) Drug Liking on a bipolar 100mm visual analog scale, a standard endpoint used in human abuse liability studies.

    To date, two cohorts of subjects have been screened, qualified, and completed the treatment phase of the study. Enrollment in the study remains ongoing. A total of 64 subjects demonstrating a confirmed positive response to stimulants are planned to enter the treatment phase. Safety will be assessed via adverse events, vital signs, ECGs, clinical laboratory tests and Columbia Suicide Severity Rating Scale (C-SSRS).

    For more information about the study, please visit clinicaltrials.gov and reference identifier: NCT04647903.

    About ADAIR

    ADAIR (Abuse Deterrent Amphetamine Immediate Release) is an investigational new drug; a novel, patented formulation of dextroamphetamine designed to deter attempts to crush and snort it or take it by other non-oral routes that can produce a greater "high." Dextroamphetamine has been used clinically for more than 50 years. It is the same active ingredient used in FDA-approved products, such as Adderall®, Dexedrine®, and Vyvanse®. ADAIR is not approved by the FDA.

    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.

    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 29, 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.

    References and links to websites have been provided for convenience, and the information contained on any such website is not a part of, or incorporated by reference into, this press release. Vallon is not responsible for the contents of third-party websites.

    Investor Contact:

    JTC Team, LLC

    Jenene Thomas

    (833) 475-8247

    vallon@jtcir.com


    1 IQVIA, NSP, 2019



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  10. - 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 (GLOBE NEWSWIRE) --
    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…

    - 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 (GLOBE NEWSWIRE) --
    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, LLC

    Jenene Thomas

    (833) 475-8247

    vallon@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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  11. PHILADELPHIA, PA, March 03, 2021 (GLOBE NEWSWIRE) -- 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, announced today that David Baker, President & Chief Executive Officer of Vallon will present at the virtual H.C. Wainwright Global Life Sciences Conference, which is taking place March 9 and 10, 2021.

    In addition to the presentation, management will also be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference.

    The video webcast presentation will be available…

    PHILADELPHIA, PA, March 03, 2021 (GLOBE NEWSWIRE) -- 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, announced today that David Baker, President & Chief Executive Officer of Vallon will present at the virtual H.C. Wainwright Global Life Sciences Conference, which is taking place March 9 and 10, 2021.

    In addition to the presentation, management will also be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference.

    The video webcast presentation will be available for viewing on-demand beginning Tuesday, March 9, 2021, at 7:00 AM ET for those registered for the event and will be accessible on the Events page of the Investors section of the Company's website (www.vallon-pharma.com) and will be archived for 90 days following the event. 

    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.



    Investor Contact:

    JTC Team, LLC

    Jenene Thomas

    (833) 475-8247

    vallon@jtcir.com



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  12. - Accomplished executive leader with more than 30 years of experience in finance and operations

    PHILADELPHIA, PA, Feb. 23, 2021 (GLOBE NEWSWIRE) -- 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 announced the appointment of Marella Thorell to its Board of Directors, effective as of February 12, 2021 in connection with the closing of the Company's initial public offering.

    "We are pleased to have Marella join the Board and look forward to the valuable insight she brings. As we continue to advance the Company, I believe Marella's wealth of…

    - Accomplished executive leader with more than 30 years of experience in finance and operations

    PHILADELPHIA, PA, Feb. 23, 2021 (GLOBE NEWSWIRE) -- 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 announced the appointment of Marella Thorell to its Board of Directors, effective as of February 12, 2021 in connection with the closing of the Company's initial public offering.

    "We are pleased to have Marella join the Board and look forward to the valuable insight she brings. As we continue to advance the Company, I believe Marella's wealth of knowledge and executive leadership experience will be a key asset in the next phase of our growth," commented Ofir Levi, Ph.D., Chairman of Vallon's Board of Directors.

    "Vallon has continued to make great progress, including its recent initial public offering of its common stock. It is an exciting time for the Company, and I am thrilled to add my perspective and industry experience to the Board. I look forward to leveraging my expertise and to working alongside the management team to unlock the full potential of Vallon's technology," commented Ms. Thorell.

    Ms. Thorell has established a successful track record over the course of her more than 30-year career in finance and operations having successfully led multiple M&A, licensing, and fundraising transactions. She recently joined Centessa Pharmaceuticals Limited, a next-generation biopharmaceutical company, formed by Medicxi through the merger of 10 private biotech companies and completion of a $250M Series A, as Head of Finance. Prior to that, Ms. Thorell served as the Chief Financial Officer of Palladio Biosciences, a privately owned, VC-backed, clinical-stage biopharmaceutical company developing medicines for orphan diseases of the kidney, leading the Company's capital strategy and execution.

    Prior to joining Palladio Biosciences, Ms. Thorell served as Chief Financial Officer, Chief Operating Officer and Executive Director of Realm Therapeutics. At Realm, Ms. Thorell was responsible for raising capital to fund the Company's clinical development plans and led M&A and licensing transactions. In 2019 Realm was acquired by ESSA Pharma. Ms. Thorell was appointed to ESSA's Board of Directors. She began her career and earned her CPA at Ernst & Young, LLP. Subsequently, she worked for Campbell Soup Company in finance and operational roles and served as an executive consultant focusing on financial and human capital needs. Ms. Thorell earned a BS in Business from Lehigh University, magna cum laude.

    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 the Company's current expectations and subject to inherent uncertainties, risks and assumptions that are difficult to predict, including, without limitation, Vallon's ability to progress its business and continue its growth. 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 "Risk Factors" in the final prospectus related to Vallon's initial public offering, filed with the U.S. Securities and Exchange Commission on February 11, 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, LLC

    Jenene Thomas

    (833) 475-8247

    vallon@jtcir.com



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  13. PHILADELPHIA, PA, Feb. 12, 2021 (GLOBE NEWSWIRE) -- 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 announced the closing of its initial public offering of 2,250,000 shares of common stock at a public price offering of $8.00 per share. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Vallon, were $18.0 million. In addition, Vallon has granted the underwriters a 45-day option to purchase up to an additional 337,500 shares of Vallon's common stock at the initial public offering…

    PHILADELPHIA, PA, Feb. 12, 2021 (GLOBE NEWSWIRE) -- 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 announced the closing of its initial public offering of 2,250,000 shares of common stock at a public price offering of $8.00 per share. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Vallon, were $18.0 million. In addition, Vallon has granted the underwriters a 45-day option to purchase up to an additional 337,500 shares of Vallon's common stock at the initial public offering price, less underwriting discounts and commissions.

    Vallon's common stock began trading on the Nasdaq Capital Market on February 10, 2021 under the ticker symbol "VLON."

    ThinkEquity, a division of Fordham Financial Management, Inc., acted as sole book-running manager for the offering.

    A registration statement relating to the securities being sold in the offering was declared effective by the Securities and Exchange Commission ("SEC") on February 9, 2021. This offering was made only by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained from ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, NY 10004, by telephone at (877) 436-3673, by email at prospectus@think-equity.com. These documents may also be obtained free of charge, when they are available, by visiting the SEC's website at http://www.sec.gov/



    This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    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.



    Forward Looking Statements

    Statements in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release 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, although not all forward-looking statements contain these words. Forward-looking statements are based on the Company's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. 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 "Risk Factors" in the final prospectus related to the public offering filed with the Securities and Exchange Commission. 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, LLC

    Jenene Thomas

    (833) 475-8247

    vallon@jtcir.com



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