Item 8.01. Other Events.
On March 29, 2019, Pfenex Inc. (the “Company”) received notice from the Department of Health and Human Services
(“HHS”), Biomedical Advanced Research and Development Authority (“BARDA”), advising the Company of its decision not to exercise development options for cGMP manufacturing and potential Phase 1/2b study readiness for the
Company’s novel anthrax vaccine candidates Px563L and RPA563 (collectively, the “anthrax programs”). In the notice BARDA stated: “While technical risks were noted, this decision was more of a reflection of the programmatic
strategy around [BARDA’s] vaccine portfolio as a whole, and a lack of products for other urgent threats.”
Following the receipt
of the notice from BARDA and pursuant to ongoing discussions with BARDA, the Company is assessing the priority of this program in its portfolio.
Reference is made to the Company’s Annual Report on Form
10-K
for the year ended
December 31, 2018, and the relevant exhibits thereto, for a description of the Company’s Cost-Plus Fixed Fee Agreement, dated July 30, 2010, as amended, between the Company and the United States Department of Health and Human
Services.
Forward-Looking Statements
This
Current Report on
Form 8-K contains
forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events
or Pfenex’s future financial or operating performance. In some cases, you can identify forward-looking statements because they contain words such as “may,” “will,” “should,” “expects,” “plans,”
“anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or
the negative of these words or other similar terms or expressions that concern Pfenex’s future expectations, strategy, plans or intentions. Forward-looking statements in this Current Report on
Form 8-K include,
but are not limited to, statements regarding Pfenex’s expectation to continue discussions with BARDA regarding the further development of its anthrax programs. Pfenex’s
expectations and beliefs regarding these matters may not materialize, and actual results in future periods are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Information on these and
additional risks, uncertainties, and other information affecting Pfenex’s business and operating results is contained in Pfenex’s Annual Report
on Form 10-K for
the year ended
December 31, 2018 and in its other filings with the Securities and Exchange Commission. The forward-looking statements in this Current Report
on Form 8-K are
based on information available
to Pfenex as of the date hereof, and Pfenex disclaims any obligation to update any forward-looking statements, except as required by law.