zsan-20211117
FALSE000158722100015872212021-11-172021-11-17

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): November 17, 2021
ZOSANO PHARMA CORPORATION
(Exact name of registrant as specified in its charter) 
 
Delaware 001-36570 45-4488360
(State or other jurisdiction
of incorporation)
 (Commission
File Number)
 (I.R.S. Employer
Identification No.)

34790 Ardentech Court
Fremont, CA 94555
(Address of principal executive offices) (Zip Code)
(510) 745-1200
Registrant’s telephone number, including area code
Not applicable
(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 Exchange Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, $0.0001 par valueZSANThe Nasdaq Stock Market
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 8.01    Other Events.
On November 17, 2021, Zosano Pharma Corporation issued a press release announcing the successful formulation of a COVID-19 vaccine candidate on its microneedle patch system. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.
 
Item 9.01    Financial Statements and Exhibits.
 
(d)Exhibits.
Exhibit  Description
99.1   
104.1 Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURE
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.
 
 ZOSANO PHARMA CORPORATION
Date: November 17, 2021 By: /s/ Christine Matthews
  Name: Christine Matthews
  Title: Chief Financial Officer


Document



Zosano Pharma Announces the Successful Formulation of a COVID-19
Vaccine Candidate on its Microneedle Patch System


FREMONT, Calif., November XX, 2021 -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced the successful formulation of a COVID-19 vaccine candidate, obtained from a vaccine developer, utilizing Zosano’s microneedle patch system. Zosano’s patch consists of an array of approximately two thousand drug-coated titanium microneedles mounted on an adhesive patch that is administered to the skin using a reusable applicator.

“We are pleased to have successfully formulated a COVID-19 vaccine candidate onto our microneedle patch system, which provides additional support for the potential of our microneedle patch technology,” said Mahmoud Ameri, Ph.D., vice president of research and development at Zosano. “We believe a COVID-19 vaccine candidate using our patch technology, if successfully developed and approved, may provide an alternative to traditional intramuscular injections. The formulated patches are also designed to be stable at room temperature, which we believe may enable easier and broader distribution without the burden of cold-chain storage.”

“This successful development milestone along with previously published data on the formulation and coating of an influenza vaccine on our transdermal patch is encouraging for the broader applicability of Zosano’s technology,” said Steve Lo, chief executive officer of Zosano. “While we continue to be focused on the potential resubmission of our M207 New Drug Application, we also continue to pursue non-dilutive and partnership opportunities to expand the potential use of our technology.”

About Zosano Pharma
Zosano Pharma Corporation is a clinical-stage biopharmaceutical company focused on developing products where rapid administration of approved molecules with established safety and efficacy profiles may provide substantial benefit to patients, in markets where patients remain underserved by existing therapies. The company’s transdermal microneedle system technology consists of titanium microneedles coated with drug that are designed to enable rapid systemic administration of therapeutics to patients. Zosano’s lead product candidate is M207, which is a proprietary formulation of zolmitriptan designed to be delivered via its transdermal microneedle system technology, as an acute treatment for migraine. Learn more at www.zosanopharma.com.


Forward-Looking Statements
This press release 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 benefits and potential uses of the company’s microneedle patch technology, the potential benefits and availability of a Covid-19 vaccine candidate, the potential resubmission of the M207 New Drug Application, the potential benefits and availability of M207 for patients, the pursuit of non-dilutive and partnership opportunities to expand the potential use of our technology and other future events and expectations described in this press release. 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.

Zosano Contacts:
Christine Matthews
Chief Financial Officer
510-745-1200

Zosano PR:
Sylvia Wheeler or Alexandra Santos
swheeler@wheelhouselsa.com or asantos@wheelhouselsa.com