Current Report Filing (8-k)
September 01 2020 - 08:32AM
Edgar (US Regulatory)
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): September 1,
2020
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
incorporation)
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(Commission File Number)
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(IRS Employer Identification No.)
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One Gateway Center, Suite 351
300 Washington Street
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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☐
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Written communications pursuant to Rule 425 under the Securities
Act (17 CFR 230.425)
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☐
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act
(17 CFR 240.14a-12)
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☐
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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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☐
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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
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Trading Symbol
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Name of Each
Exchange on Which Registered
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Common Stock, $0.0001 par value per
share
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ACER
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The Nasdaq Stock Market LLC
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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
7.01.Regulation FD
Disclosure
Acer Therapeutics Inc. (the “Company”) has updated its Corporate
Presentation that will be available on the Investor Relations page
of the Company’s website at https://acertx.com/investor-relations
and will be used at investor and other meetings. A copy of the
updated Corporate Presentation is furnished as Exhibit 99.1 to this
Current Report on Form 8-K and is incorporated herein by reference.
The Company does not undertake to update this presentation.
The information in Item 7.01 of this Current Report on Form 8-K,
including Exhibit 99.1, shall not be deemed to be filed for
purposes of Section 18 of the Securities Exchange Act of 1934 (the
“Exchange Act”), or otherwise subject to the liability of that
section, and shall not be incorporated by reference into any
registration statement or other document filed under the Securities
Act of 1933 or the Exchange Act, except as shall be expressly set
forth by specific reference in such filing.
Item 8.01.Other Events.
The Company recently received feedback from the U.S. Food and Drug
Administration (FDA) about its development program for ACER-001,
the Company’s taste-masked formulation of sodium phenylbutyrate
being developed for treatment of certain inborn errors of
metabolism, including Urea Cycle Disorders (UCDs). As a result of
that feedback, the Company intends to continue its development of
ACER-001, including with the following refinements:
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(i)
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Because BUPHENYL® is labeled for administration with food and a
food effect has been observed with ACER-001, the Company plans to
conduct a bioequivalence (BE) trial in healthy subjects, comparing
the pharmacokinetics of BUPHENYL® and ACER-001, both under fed
conditions. The results of that BE study would be included as a
part of the Company’s planned New Drug Application (NDA) submission
under the Section 505(b)(2) regulatory pathway for ACER-001 in the
treatment of UCDs, where ACER-001 is administered with food. The
Company intends to complete that BE study in the first quarter of
2021, consistent with its intention to submit an NDA for ACER-001
under fed conditions in the second quarter of 2021.
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(ii)
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The Company also plans to evaluate potential development of
ACER-001 for administration under fasted or pre-meal conditions,
which would require additional clinical pharmacokinetic, safety and
efficacy studies, and potentially other clinical and nonclinical
studies, in order to provide the necessary evidence of safety and
efficacy of ACER-001 to be considered for FDA approval for
administration under fasted or pre-meal conditions.
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The planned submission of the Company’s NDA for ACER-001 remains
subject to a successful BE study outcome under fed conditions,
positive stability and non-clinical data, and any further guidance
from FDA, in addition to the availability of necessary capital.
There can be no assurance that the Company will submit an NDA for
any indication, whether for fed or fasted / pre-meal
administration, or that, if submitted, it would be accepted for
filing or ultimately approved by FDA. The information in this Item
8.01 is based on management’s current expectations and involves
risks and uncertainties, including but not limited to further
guidance or requirements from FDA. Actual results and performance
could differ materially. Disclosure regarding those risks and
uncertainties is included in the Company’s SEC filings, including
its most recent Quarterly Report on Form 10-Q and Annual Report on
Form 10-K.
Item 9.01.Financial Statements and
Exhibits.
(d) Exhibits
2
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: September 1, 2020
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ACER THERAPEUTICS INC.
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By:
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/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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