8-K
GRI Bio, Inc. (GRI)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) ofThe Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 10, 2021
| VALLON PHARMACEUTICALS, INC. | ||
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| (Exact name of registrant as specified in its charter) | ||
| Delaware | 001-40034 | 82-4369909 |
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| (State or other jurisdiction<br><br>of incorporation) | (Commission File Number) | (IRS Employer<br><br>Identification No.) |
| 100 N. 18th Street, Suite 300, Philadelphia, PA | 19103 | |
| --- | --- | |
| (Address of principal executive offices) | (Zip Code) | |
| (267) 207-3606 | ||
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| (Registrant’s telephone number, including area code) | ||
| (Former name or former address, if changed since last report) | ||
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common Stock, par value $0.0001 per share | VLON | Nasdaq Capital Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.
Emerging Growth Company x
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
| Item 2.02 | Results of Operations and Financial Condition. |
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On May 13, 2021, Vallon Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 2021, and provided a business update. A copy of this press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference.
The information in this report, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained herein and in the accompanying Exhibit 99.1 shall not be deemed incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof regardless of any general incorporation language in such filing.
| Item 5.02 | Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. |
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On May 10, 2021, Leanne M. Kelly was appointed to serve as the Chief Financial Officer and principal financial and accounting officer of the Company. In connection with Ms. Kelly’s appointment as principal financial and accounting officer, David Baker, who previously served as principal executive, financial and accounting officer, resigned as principal financial and accounting officer, but will continue to serve as the principal executive officer of the Company.
Prior to joining the Company, Ms. Kelly served as the Controller and Executive Director, Global Financial Reporting at OptiNose, Inc. (NASDAQ: OPTN), a $50M revenue specialty pharmaceutical company, from September 2016 to May 2021. From February 2016 to September 2016, she served as a senior manager at Genova Group, a financial advisory and support consulting firm. From September 2013 to January 2016, she served as Senior Vice President of Finance of Flower Orthopedics Corporation, a private medical device company. She has also served as controller of Iroko Pharmaceuticals, LLC, and Senior Vice President, Chief Financial Officer and Secretary of 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.
In connection with Ms. Kelly’s appointment, the Company entered into an employment agreement with Ms. Kelly (the “Kelly Agreement”). The Kelly Agreement provides for an initial base annual salary of $275,000 and a target bonus opportunity equal to 35% of her base salary.
The Kelly Agreement also provides for a stock option grant covering 100,000 common shares of the Company (the “Stock Option”). The Stock Option shall have an exercise price per share equal to the fair market value of a share of the Company’s common stock on the date of grant and shall vest in installments and become exercisable as follows: (i) 70% of the shares underlying the Stock Option shall vest as follows: (x) 17,500 option shares on the first anniversary of her start date, and (y) the remaining 52,500 option shares in equal installments on a quarterly basis for the next three years, in each case subject to continued employment, and (ii) 30% of the shares underlying the Stock Option shall vest as follows: (x) 15,000 option shares on the date the Company submits a New Drug Application (“NDA”) filing for ADAIR with the U.S. Food & Drug Administration, and (y) 15,000 option shares on the date when the U.S. Food & Drug Administration approves the NDA, provided that she is employed by the Company at the time the applicable performance objective is achieved.
The Kelly Agreement provides that if she is terminated by the Company other than for cause, or she resigns for good reason, in either case not in connection with a change in control, she will receive:
| · | continued base salary for a period of 9 months, plus a pro-rated bonus for<br>the year of termination, based on actual performance results for the entire year, and provided she was employed for at least six months<br>during that year; and |
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| · | if she elects to continue receiving group health insurance<br>coverage pursuant to COBRA, subsidized premiums for COBRA continuation coverage for a period of 9 months (or such earlier date that she<br>obtains alternative coverage), such that she will continue to pay the premium cost for active employees who receive the same type of coverage<br>during that period. |
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If she is terminated by the Company other than for cause, or she resigns for good reason, in either case within the one-year period commencing on a change in control, she will receive:
| · | continued base salary for a period of 12 months,<br>plus a lump sum payment equal to 100% of her target bonus, without proration, for the fiscal year of termination; |
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| · | if she elects to continue receiving group health<br>insurance coverage pursuant to COBRA, subsidized premiums for COBRA continuation coverage for a period of 12 months (or such earlier date<br>that she obtains alternative coverage), such that she will continue to pay the premium cost for active employees who receive the same<br>type of coverage during that period; and |
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| · | accelerated vesting of all outstanding stock-based<br>awards held by the executive as of the date of termination, with any performance awards deemed satisfied at the “target” performance<br>level, and any stock options remaining outstanding for their full term. |
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In exchange for the severance benefits described above, Ms. Kelly must comply with certain confidentiality, non-competition and non-solicitation provisions, return all company property, and sign a release of claims in favor of the Company.
The Company expects to include the Kelly Agreement as an exhibit to a future periodic report, to be filed with the U.S. Securities and Exchange Commission. The foregoing description does not constitute a complete summary of the terms of the Kelly Agreement and is qualified in its entirety by reference to the full text of the Kelly Agreement. All capitalized terms used but not defined herein have the meanings set forth in the Kelly Agreement.
On May 11, 2021, the Company issued a press release announcing Ms. Kelly’s appointment as Chief Financial Officer, a copy of which is attached to this Current Report on Form 8-K as Exhibit 99.2.
| Item 9.01 | Financial Statements and Exhibits. |
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| (d) | Exhibits |
| --- | --- |
| Exhibit No. | Description |
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| 99.1 | Press Release, dated May 13, 2021. |
| 99.2 | Press Release, dated May 11, 2021. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: May 13, 2021 | VALLON PHARMACEUTICALS, INC. | |
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| By: | /s/ David Baker | |
| David Baker | ||
| President and Chief Executive Officer |
Exhibit 99.1
Vallon PharmaceuticalsReports First Quarter 2021 Financial Results and Provides Corporate Update
- Company remains ontrack to report pivotal data from lead program, ADAIR, in second half 2021
- Novel abuse-deterrentplatform technology enables pipeline expansion opportunities across multiple drugs and indications
PHILADELPHIA, PA, May 13, 2021 – Vallon Pharmaceuticals Inc. (NASDAQ: VLON), (“Vallon” or the “Company”), a clinical-stage biopharmaceutical company primarily focused on the development of novel drugs that are designed to deter abuse in the treatment of 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<br>public offering of its common stock (the IPO) and began trading on the Nasdaq Capital Market under the ticker symbol “VLON”; |
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| · | Appointed Leanne Kelly, an accomplished financial<br>executive with over 20 years of experience leading private and publicly traded companies, as its Chief Financial Officer; |
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| · | Appointed Marella Thorell, a proven executive<br>leader with more than 30 years of experience in finance and operations, to Board of Directors; |
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| · | Continued to progress enrollment for the ongoing<br>Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent d-Amphetamine<br>Sulfate Immediate Release Formulation (SEAL Study), a pivotal intranasal abuse study. Enrollment in the study remains on track to support<br>topline study results in 2H21; and |
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| · | Presented positive data from two studies at the<br>2021 American Professional Society of ADHD and Related Disorders (APSARD) Annual Meeting, evaluating ADAIR which demonstrated bioequivalence<br>to immediate release (IR) dextroamphetamine when administered orally and appears to be less desirable to recreational drug abusers when<br>snorted compared to currently available IR dextroamphetamine. |
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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
ADAIR^1^: 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<br>for the second half of 2021. |
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| · | NDA submission targeted for the second quarter<br>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. |
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| · | Upon completion of formulation development, Vallon<br>will submit an IND to allow for the initiation of human clinical trials. |
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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.
^1^ ADAIR is not approved by the FDA
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 PharmaceuticalsInc.
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
Exhibit 99.2
Vallon PharmaceuticalsAppoints Leanne Kelly as Chief Financial Officer
May 11, 2021
- Financial executive bringing over 20 yearsof 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