UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (date of earliest event reported): October 6, 2021
ACER THERAPEUTICS INC.
(Exact name of registrant as specified in its charter)
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Delaware |
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001-33004 |
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32-0426967 |
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(State or other jurisdiction of
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(Commission File Number) |
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(IRS Employer Identification No.) |
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One Gateway Center, Suite 351
Newton, Massachusetts |
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02458 |
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(Address of principal executive offices) |
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(Zip Code) |
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Registrant’s telephone number, including area code: (844) 902-6100 |
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N/A |
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(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:
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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: |
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Title of Each Class |
Trading Symbol |
Name of Each Exchange on Which Registered |
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Common Stock, $0.0001 par value per share |
ACER |
The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☐
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 1.01.Entry into a Material Definitive Agreement.
On October 6, 2021, Acer Therapeutics Inc. (the “Company”) and Relief Therapeutics Holding AG (“Relief”) entered into a Waiver and Agreement (the “Waiver”) with respect to timing of a portion of the Second Development Payment due from Relief to the Company under the terms of that certain Collaboration and License Agreement, dated March 19, 2021, between the parties (the “Collaboration Agreement”). The Collaboration Agreement provides for the development and commercialization of ACER-001 (sodium phenylbutyrate) for the treatment of various inborn errors of metabolism, including for the treatment of urea cycle disorders (“UCDs”) and Maple Syrup Urine Disease (“MSUD”). Pursuant to the Collaboration Agreement, Relief is obligated to pay the Company a Second Development Payment of $10.0 million within 15 business days after the New Drug Application (“NDA”) for ACER-001 for a UCD has been accepted for review by the U.S. Food and Drug Administration (“FDA”). Relief requested and the Company agreed to waive the original payment terms and amend the timing for payment of a portion of the Second Development Payment. Pursuant to the Waiver, $5.0 million of the $10.0 million Second Development Payment due from Relief will be payable to the Company on or before January 14, 2022, unless the Company in its sole and absolute discretion requests earlier payment upon 15 business days’ written notice.
The foregoing description of the Waiver does not purport to be complete and is qualified in its entirety by reference to the full text of the Waiver, a copy of which is attached to this Current Report on Form 8-K as Exhibit 10.1 and is incorporated herein by reference.
Item 9.01.Financial Statements and Exhibits.
(d) Exhibits
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Exhibit No. |
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Description |
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10.1 |
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104 |
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Cover page interactive data file (embedded within the inline XBRL document). |
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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, thereunto duly authorized.
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Dated: October 8, 2021 |
ACER THERAPEUTICS INC. |
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By: |
/s/ Harry S. Palmin |
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Harry S. Palmin |
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Chief Operating Officer and Chief Financial Officer |
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Exhibit 10.1
WAIVER AND AGREEMENT
This WAIVER AND AGREEMENT dated as of October 6, 2021 is made between ACER THERAPEUTICS INC., a Delaware corporation (“Acer”), and RELIEF THERAPEUTICS HOLDING AG, a company organized and existing under the laws of Switzerland (“Relief”), with respect to that certain Collaboration and License Agreement, dated March 19, 2021, between the Parties (the “Agreement”). Capitalized terms used herein but not defined shall have the meaning assigned to them in the Agreement.
RECITALS:
WHEREAS, pursuant to Section 5.2(d) of the Agreement, Relief is obligated to pay Acer Ten Million Dollars ($10,000,000) within fifteen (15) Business Days after the NDA for the Acer Product for a UCD has been accepted for review by the FDA (the “Second Development Payment”).
WHEREAS, Relief has requested and Acer has agreed to waive the original payment terms and amend the timing for payment of a portion of the Second Development Payment to tranche the amount in two payments.
NOW, THEREFORE, in consideration of the premises and mutual agreements herein, the Parties agree as follows:
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1. |
Upon the FDA accepting for review the NDA for the Acer Product for a UCD, the Second Development Payment will be payable by Relief to Acer as follows: |
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Relief will pay Acer Five Million Dollars ($5,000,000) within fifteen (15) Business Days; and |
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b. |
Relief will pay Acer Five Million Dollars ($5,000,000) on or before January 14, 2022; provided, however, if requested by Acer in its sole and absolute discretion, Relief will pay Acer the remaining Five Million Dollars ($5,000,000) upon fifteen (15) Business Days’ written notice from Acer to Relief. |
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Except as stated herein, all other terms and conditions of the Agreement remain in full force and effect. |
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3. |
Governing Law. This Waiver and Agreement and all disputes arising out of or related hereto or any breach hereof will be governed by and construed under the laws of the State of New York, U.S., without giving effect to any choice of law principles that would require the application of the laws of a different jurisdiction and excluding the United Nations Convention on Contracts for the International Sales of Goods. |
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Counterparts. This Waiver and Agreement may be executed in two (2) or more counterparts, each of which will be deemed an original, but all of which together will constitute one and the same instrument. Facsimile and other electronically scanned signatures shall have the same effect as their originals. |
IN WITNESS WHEREOF, the Parties have caused their duly authorized representatives to execute this Waiver and Agreement as of the date first written above.
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ACER THERAPEUTICS INC. |
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RELIEF THERAPEUTICS HOLDING AG |
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By: |
/s/ Chris Schelling |
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By: |
/s/ Jeremy Meinen |
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Printed Name: |
Chris Schelling |
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Printed name: |
Jeremy Meinen |
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Title: |
CEO / Founder |
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Title: |
VP Finance |
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