SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of report (Date of earliest event reported): November 10, 2021
ZOSANO PHARMA CORPORATION
(Exact name of registrant as specified in its charter)
|Delaware|| ||001-36570|| ||45-4488360|
|(State or other jurisdiction|
| ||(I.R.S. Employer|
34790 Ardentech Court
Fremont, CA 94555
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including area code
(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 class||Trading Symbol(s)||Name of each exchange on which registered|
|Common Stock, $0.0001 par value||ZSAN||The 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 2.02 Results of Operations and Financial Condition.
On November 10, 2021, Zosano Pharma Corporation issued a press release titled “Zosano Pharma Reports Third Quarter 2021 Financial Results.” The press release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference into this Item 2.02.
The information in Item 2.02 of this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
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 10, 2021|| ||By:|| ||/s/ Christine Matthews|
| || ||Name: Christine Matthews|
| || ||Title: Chief Financial Officer|
Zosano Pharma Reports Third Quarter 2021 Financial Results
FREMONT, Calif., November 10, 2021 -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced financial results for the third quarter ended September 30, 2021, as well as business highlights.
“This quarter we made significant progress towards the resubmission of the NDA for M207 with receipt of top-line data from our pharmacokinetic study,” said Steven Lo, president and chief executive officer of Zosano. “We expect to receive written feedback from the FDA through a Type C meeting by mid-December and expect that their feedback will enable us to further refine our regulatory strategy and to provide an update on our resubmission plans for the NDA. We believe there is a significant need for new acute treatment options for migraine as it is estimated that more than 70% of migraine patients experience an inadequate treatment response, and our goal is to help these patients.”
Select Business Highlights
•Reported top-line results from a pharmacokinetic study, which evaluated the safety and pharmacokinetics of drug exposure levels of two lots of M207 compared to an intranasal control formulation of two 5 mg doses of zolmitriptan in 48 healthy volunteers
•Granted a Type C (written response only) meeting with the U.S. Food and Drug Administration (“FDA”) to obtain feedback on the resubmission strategy for the M207 (zolmitriptan transdermal microneedle system) 505(b)(2) New Drug Application (“NDA”)
•Issued U.S. patent for a method of rapidly achieving therapeutic levels with M207 for the acute treatment of migraine
•Dismissal of Securities Class Action and Delaware Derivative Action
Financial Results for the Third Quarter Ended September 30, 2021
Zosano reported a net loss for the third quarter of 2021 of $8.7 million, or $0.07 per share on a basic and diluted basis, compared with a net loss of $8.7 million, or $0.11 per share on a basic and diluted basis, for the same quarter in 2020.
Research and development expenses for the third quarter of 2021 were $6.0 million, compared with $5.8 million for the same quarter in 2020. The increase was primarily due to the conduct of a pharmacokinetic study to support the resubmission of the NDA for M207, partially offset by lower employee and consulting costs.
General and administrative expenses for the third quarter of 2021 were $2.5 million compared with $2.7 million for the same quarter in 2020. The decrease of $0.2 million was primarily due to lower consulting and professional services costs.
As of September 30, 2021, cash and cash equivalents were $17.1 million, compared with $35.3 million as of December 31, 2020.
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.
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 expected timing with respect to the written feedback from the FDA, the company’s expectation that the FDA’s written feedback will enable the company to further refine its regulatory strategy and to provide an update on its resubmission plans for the NDA, the potential benefits and availability of M207 for patients 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.
Chief Financial Officer
Sylvia Wheeler or Alexandra Santos
email@example.com or firstname.lastname@example.org
ZOSANO PHARMA CORPORATION
(in thousands, except par value and share amounts)
September 30, 2021
December 31, 2020
Cash and cash equivalents
Prepaid expenses and other current assets
Total current assets
Property and equipment, net
Operating lease right-of-use assets
Other long-term assets
LIABILITIES AND STOCKHOLDERS’ EQUITY
Build-to-suit obligation, current portion, net of debt issuance costs and discount
Operating lease liabilities, current portion
Paycheck Protection Program loan, current portion
Other accrued liabilities
Total current liabilities
Build-to-suit obligation, long-term portion, net of debt issuance costs and discount
Operating lease liabilities, long-term portion
Paycheck Protection Program loan, long-term portion
Other long-term liabilities
Preferred stock, $0.0001 par value; 5,000,000 shares authorized; none issued and outstanding as of September 30, 2021 and December 31, 2020, respectively
Common stock, $0.0001 par value; 250,000,000 shares authorized as of September 30, 2021 and December 31, 2020, respectively; 118,114,793 and 102,066,218 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively
Additional paid-in capital
Total stockholders’ equity
Total liabilities and stockholders’ equity
ZOSANO PHARMA CORPORATION
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except per share amounts)
Three Months Ended September 30,
Nine Months Ended September 30,
Cost of service revenue
|340 ||— ||704 ||— |
Research and development
|5,985 ||5,824 ||16,315 ||16,270 |
General and administrative
|2,522 ||2,704 ||8,294 ||8,552 |
Total operating expenses
|8,847 ||8,528 ||25,313 ||24,822 |
Loss from operations
Other income (expense):
|1 ||2 ||2 ||17 |
Other income (expense), net
Loss before provision for income taxes
Provision for income taxes
Net loss and comprehensive loss
Net loss per common share – basic and diluted
Weighted-average common shares used in computing net loss per common share – basic and diluted