Item 8.01  Other Events.
On January 18, 2022, Zosano Pharma Corporation ("Zosano" or the "Company")
resubmitted its M207 (zolmitriptan transdermal microneedle system) 505(b)(2) New
Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA")
following the Complete Response Letter received on October 20, 2020.
In line with the Company's previously disclosed resubmission strategy, the NDA
has been resubmitted under Section 505(b)(2) of the Food, Drug, and Cosmetic Act
and relies on the FDA's findings of safety and efficacy of ZOMIG® nasal spray
(NDA 21-450) ("Listed Drug"). The resubmitted NDA relies primarily on data from
the recently completed Phase 1 pharmacokinetic ("PK") study (CP 2021-001), along
with previous PK studies evaluating M207 (CP-2018-002 and CP-2019-002), to
establish a PK bridge to the Listed Drug, with the goal of establishing
comparative bioavailability to the Listed Drug. Prior to the resubmission, the
FDA provided Zosano with written feedback which, among other things, noted
concerns regarding the Company's approach for establishing a PK bridge to the
Listed Drug through comparisons across multiple PK studies of M207, particularly
Study CP-2019-002, which included PK outliers.
Zosano believes that the data provided in its resubmitted NDA demonstrates an
adequate bridge to the Listed Drug. With this resubmission that includes
additional PK data from our CP 2021-001 study, the FDA can evaluate and
determine the adequacy of the data package to potentially support M207 approval.
Forward Looking Statements
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 resubmission strategy of the M207 NDA and other future events and
expectations described in this report. 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 possibility that FDA will require additional studies in
support of the M207 NDA resubmission, 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.

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