8-K 1 acer-8k_20190628.htm 8-K acer-8k_20190628.htm

 

 

 

 

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): June 28, 2019

 

ACER THERAPEUTICS INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware

 

001-33004

 

32-0426967

(State or other jurisdiction of
incorporation)

 

(Commission File Number)

 

(IRS Employer Identification No.)

 

One Gateway Center, Suite 351
300 Washington Street

Newton, Massachusetts

 

02458

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code:  (844) 902-6100

N/A

(Former name or former address, if changed since last report)

 

 

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)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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, $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 2.05.Costs Associated with Exit or Disposal Activities.

On July 5, 2019, Acer Therapeutics Inc. (the “Company”) announced a corporate restructuring initiative which includes a reduction of approximately 60% of its full-time workforce of 48 employees and a halt of pre-commercial activities for EDSIVO™ in light of the Complete Response Letter (“CRL”) received from the U.S. Food and Drug Administration regarding its New Drug Application for EDSIVO™ for the treatment of vascular Ehlers-Danlos syndrome (vEDS) previously disclosed on June 25, 2019.  In order to reduce operating expenses and conserve cash resources following receipt of the CRL, on June 28, 2019, the Company’s Board of Directors approved these actions, which are effective immediately.  The Company estimates that it will record a one-time severance-related charge of approximately $1.5 million associated with the workforce reduction in the second quarter of 2019.  

Item 8.01.Other Events.

The Company issued a press release on July 5, 2019 announcing the restructuring initiative and providing an update on its pipeline programs, a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01.Financial Statements and Exhibits.

(d)  Exhibits

 

 

Cautionary Statement Relating to Forward-Looking Information for the Purpose of “Safe Harbor” Provisions of the Private Securities Litigation Reform Act of 1995

This report contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this report regarding strategy, future operations, future financial position, future revenues, projected expenses, regulatory actions or approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to expectations regarding our capital resources; the potential for EDSIVO™ (celiprolol), ACER-001 and osanetant to safely and effectively treat diseases and to be approved for marketing; the commercial or market opportunity of any of our product candidates in any target indication; the adequacy of our capital to support our future operations and our ability to successfully initiate and complete clinical trials and regulatory submissions; our progress toward possible approval for EDSIVO™; the ability to protect our intellectual property rights; our  strategy and business focus;  and the development, expected timeline and commercial potential of any of our product candidates. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to meet our business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by our intellectual property, risks related to the drug development and the regulatory approval process, including the timing of regulatory actions, and the impact of competitive products and technological changes. We disclaim any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. You should review additional disclosures we make in our filings with the Securities and Exchange Commission, including our Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.


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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.

 

 

Dated: July 5, 2019

ACER THERAPEUTICS INC.

 

 

 

 

 

 

By:

/s/ Harry S. Palmin 

 

 

 

Harry S. Palmin

 

 

 

Chief Operating Officer and Chief Financial Officer

 

 

 

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