SECURITIES AND EXCHANGE COMMISSION
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|Item 8.01.|| |
On October 25, 2021, Zosano Pharma Corporation (the “Company”) received full data tables from its pharmacokinetic study, which were consistent with the top-line results previously announced and reported in the Company’s current report on Form 8-K filed with the Securities and Exchange Commission on October 4, 2021.
On October 27, 2021, the Company submitted a briefing package to the U.S. Food and Drug Administration (the “FDA”) in advance of the Type C Written Response Only meeting request, previously granted by the FDA, to obtain feedback on the Company’s strategy for resubmitting the M207 (zolmitriptan transdermal microneedle system) 505(b)(2) New Drug Application, as previously disclosed in the Company’s current report on Form 8-K filed with the Securities and Exchange Commission on October 6, 2021.
This current report on Form 8-K contains forward-looking statements. All statements other than statements of historical facts contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the Company’s strategy for the resubmission of a 505(b)(2) NDA and the data that may be required to support the 505(b)(2) NDA resubmission. Readers are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “might,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “forecast,” “designed,” “scheduled,” “goal,” “approximately” or the negative of those words or other comparable words to be uncertain and forward-looking. These statements are subject to risks and uncertainties that are difficult to predict, and actual outcomes may differ materially. These include risks and uncertainties, without limitation, associated with the Company’s ability to obtain additional cash resources to continue operations, the process of discovering, developing and commercializing products that are safe and effective for use as human therapeutics, risks inherent in the effort to build a business around such products and other risks and uncertainties described under the heading “Risk Factors” in the Company’s most recent annual report on Form 10-K and quarterly reports on Form 10-Q. Although Zosano believes that the expectations reflected in these forward-looking statements are reasonable, Zosano cannot in any way guarantee that the future results, level of activity, performance or events and circumstances reflected in forward-looking statements will be achieved or occur. All forward-looking statements are based on information currently available to Zosano and Zosano assumes no obligation to update any such forward-looking statements.
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: October 29, 2021||ZOSANO PHARMA CORPORATION|
|Chief Financial Officer|