VLON Vallon Pharmaceuticals Inc.

5.11
-0.27  -5%
Previous Close 5.38
Open 5.37
52 Week Low 3.61
52 Week High 10.36
Market Cap $34,813,592
Shares 6,812,836
Float 4,194,758
Enterprise Value $24,254,699
Volume 76,702
Av. Daily Volume 237,337
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Latest News

  1. - Lead program, ADAIR, advancing toward completion of patient enrollment and treatment in ongoing SEAL study

    - Selection of final formulation completed for second development program, ADMIR

    - Company's two lead programs targeting the large and growing ~$9 billion US ADHD market

    - New data from a survey of nearly 500 prescription stimulant abusers support the clinical unmet need for abuse deterrent stimulants

    PHILADELPHIA, PA, Oct. 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 central nervous system (CNS) disorders, today…

    - Lead program, ADAIR, advancing toward completion of patient enrollment and treatment in ongoing SEAL study

    - Selection of final formulation completed for second development program, ADMIR

    - Company's two lead programs targeting the large and growing ~$9 billion US ADHD market

    - New data from a survey of nearly 500 prescription stimulant abusers support the clinical unmet need for abuse deterrent stimulants

    PHILADELPHIA, PA, Oct. 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 central nervous system (CNS) disorders, today provided an update on the progress of 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.

    "Over the past few months, we have made considerable progress on multiple fronts. While the COVID-19 pandemic has presented some inevitable challenges in patient recruitment for the SEAL study, we are pleased to have achieved approximately 75% of target subject completion. We have implemented additional recruiting initiatives which have bolstered our enrollment efforts. Our team continues to advance toward the completion of enrollment and treatment of all subjects, now targeted for the first quarter of 2022, with topline results expected shortly thereafter," commented David Baker, President & Chief Executive Officer of Vallon.

    "Additionally, we have made important advancements in our second development program, ADMIR, by finalizing the selection of a very promising abuse-deterrent formulation of methylphenidate (Ritalin®). We have signed a manufacturing agreement with Catalent, a development and manufacturing partner and are moving towards filing an IND which will allow the commencement of human clinical trials. In addition, we've strengthened our corporate expertise and leadership with the formation of a scientific advisory board. We believe their knowledge and expertise will be a significant asset and validates our approach to the advancement our CNS-focused, novel abuse-deterrent platform. With this exciting progress, I believe we are well-positioned to successfully bring our first program, ADAIR, across the finish line and continue to progress additional opportunities in the development of much-needed treatments for CNS disorders," added Mr. Baker.

    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, the SEAL study. The SEAL study is expected to be the final clinical trial prior to NDA filing. If approved, ADAIR has the potential to address the growing Adderall® segment of the ~$9 billion US ADHD market.

    The 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. Safety will be assessed via adverse events, vital signs, ECGs, clinical laboratory tests and other standard measures.

    Patient enrollment is ongoing with approximately 75% of the target number of subjects completing the study. The final patient visit and completion of treatment is expected in the first quarter of 2022 with topline results expected shortly thereafter.

    ADAIR is also currently being developed in Europe and the UK through a license and collaboration agreement with MEDICE Arzneimittel Pütter GmbH, a leader in the European ADHD market. The Company is in ongoing partnering discussions for additional regional license opportunities for ADAIR.

    Vallon received its first EU patent for ADAIR in July 2021. The Company has filed additional patents in other major territories that are important ADHD markets in order to bolster its IP protection.

    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.

    Vallon has completed its formulation development work and selected a final formulation for ADMIR. This formulation has demonstrated excellent dissolution and abuse-deterrent characteristics in the laboratory setting that the Company believes is compelling for advanced development. Preparations are underway to submit an IND with plans to commence the first human clinical trial in 2022.

    Additionally, the Company recently entered into an agreement with Catalent to support the development and manufacturing of ADMIR. Catalent is a leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply.

    Real World Stimulant Abuse Insights and the Need for Abuse-Deterrent Formulations

    In addition to advancing its clinical programs, the Company recently sponsored a large survey on stimulant abuse patterns in adults. The survey was led by researchers at the University of Kentucky and included nearly 500 people who misuse or abuse prescription stimulants. Results of the survey provided important insights into patterns of abuse and confirmed the clinical unmet need for products with abuse deterrent characteristics like ADAIR. Results from the survey have been accepted for presentation at the upcoming American Academy of Child and Adolescent Psychiatry Annual Meeting being held virtually October 18-30, 2021.

    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


    1 ADAIR is not approved by the FDA



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  2. - 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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  3. 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…

    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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  4. - 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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  5. - 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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