VLON Vallon Pharmaceuticals Inc.

4.59
0  0%
Previous Close 4.59
Open 4.63
52 Week Low 3.61
52 Week High 9.9
Market Cap $31,270,917
Shares 6,812,836
Float 4,194,758
Enterprise Value $18,531,917
Volume 26,284
Av. Daily Volume 95,297
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Drug Stage Catalyst Date
ADAIR
ADHD / Narcolepsy
Phase 1
Phase 1
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Latest News

  1. - 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


    1 ADAIR is not approved by the FDA



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  2. - 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


    1 ADAIR is not approved by the FDA



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  3. - 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



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  4. 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



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  5. 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



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