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): May 14, 2020
 
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 (see General Instruction A.2. below): 

[ ]
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  x

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.   x





Item 2.02    Results of Operations and Financial Conditions.
On May 14, 2020, Zosano Pharma Corporation issued a press release titled “Zosano Pharma Reports First Quarter 2020 Financial Results and Provides Corporate Update.” 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 (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 or the Exchange Act, except as expressly set forth by specific reference in such filing.
 
Item 9.01    Financial Statements and Exhibits.
 
(d)
Exhibits.
Exhibit
  
Description
 
 
99.1

  

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: May 14, 2020
 
 
By:
 
/s/ Christine Matthews
 
 
 
 
 
Name: Christine Matthews
 
 
 
 
 
Title:   Chief Financial Officer



Exhibit


Exhibit 99.1

Zosano Pharma Reports First Quarter 2020 Financial Results and Provides Corporate Update

FREMONT, Calif., May 14, 2020 -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced financial results for the first quarter ended March 31, 2020, as well as recent business highlights.

"This quarter was marked by a momentous milestone for the company with the FDA acceptance for filing of our New Drug Application (NDA) for Qtrypta™, a potential new treatment for patients with migraine utilizing our microneedle patch technology,” said Steven Lo, president and CEO of Zosano. “In preparation for our upcoming Prescription Drug User Fee Act (PDUFA) goal date of October 20 of this year, we have been scaling up our pre-commercial activities, including key components such as targeting and market access. We believe Qtrypta, if approved, will provide patients an attractive option for their migraine treatment, given its potential to provide rapid and sustained headache relief, in addition to the favorable safety results demonstrated in clinical studies. We are looking forward to the opportunity to help patients with this debilitating disease.”

Recent Business Highlights
•
Received U.S. Food and Drug Administration (FDA) filing acceptance of the 505(b)(2) NDA filing for Qtrypta™ for the acute treatment of migraine
•
Appointed Christine Matthews, previously the company’s interim chief financial officer, to the position of chief financial officer
•
Completed a blinded market research study conducted with high-volume physicians and payors, including 100 physician specialists and five national payors representing over 100 million covered lives, which found that:
◦
79% of the physicians strongly agree that there remains an unmet need in the treatment of migraine in the acute setting even in patients that respond to preventive therapy
◦
70% of the physicians would offer a non-oral triptan that has fast and complete pain relief that is sustained and well-tolerated

Financial Results for the First Quarter Ended March 31, 2020
Zosano reported a net loss for the first quarter of 2020 of $8.7 million, or $0.24 per share on a basic and diluted basis, compared with a net loss of $9.4 million, or $0.79 per share on a basic and diluted basis, for the same quarter in 2019.

Research and development expenses for the first quarter of 2020 were $5.5 million, compared with $6.6 million for the same quarter in 2019. The $1.1 million decrease was primarily attributable to lower clinical trial costs due to the completion of the Qtrypta long-term safety study in 2019.

General and administrative expenses for the first quarter of 2020 were $3.1 million, compared with $2.9 million for the same quarter in 2019. The increase of $0.2 million was mainly due to costs related to intellectual property matters.

As of March 31, 2020, cash and cash equivalents were $18.6 million, compared with $6.3 million as of December 31, 2019.

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 intracutaneous 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 Qtrypta™ (M207), which is a proprietary formulation of zolmitriptan delivered via its intracutaneous microneedle system technology, as a potential acute treatment for migraine. The company anticipates that many of its current and future development programs may enable the company to utilize a regulatory pathway that would streamline clinical development and accelerate the path towards commercialization. Learn more at www.zosanopharma.com.





Forward-Looking Statements
This press release contains forward-looking statements regarding the preparation for potential approval and launch of Qtrypta, the potential benefits of Qtrypta 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," "goal," "unaudited," "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 for the remainder of 2020, 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 Contact:
Christine Matthews
Chief Financial Officer
(510) 745-1200

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





ZOSANO PHARMA CORPORATION
CONDENSED BALANCE SHEETS
(in thousands, except par value and share amounts)
 
March 31,
2020
 
December 31,
2019
 
(unaudited)
 
 
ASSETS
Current assets:
 
 
 
Cash and cash equivalents
$
18,557

 
$
6,316

Prepaid expenses and other current assets
623

 
497

Total current assets
19,180

 
6,813

Restricted cash
455

 
455

Property and equipment, net
30,164

 
24,636

Operating lease right-of-use assets
5,533

 
5,763

Other long-term assets
3

 
3

Total assets
$
55,335

 
$
37,670

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
 
 
 
Accounts payable
$
3,263

 
$
4,356

Accrued compensation
2,553

 
2,015

Build-to-suit obligation, current portion
4,665

 
4,554

Operating lease liabilities, current portion
1,184

 
1,140

Other accrued liabilities
8,943

 
4,172

Total current liabilities
20,608

 
16,237

Build-to-suit obligation, long-term portion, net of debt issuance costs and discount
5,129

 
6,095

Operating lease liabilities, long-term portion
5,618

 
5,931

Other liabilities
10

 
15

Total liabilities
31,365

 
28,278

Stockholders’ equity:
 
 
 
Preferred stock, $0.0001 par value; 5,000,000 shares authorized; none issued and outstanding as of March 31, 2020 and December 31, 2019
—

 
—

Common stock, $0.0001 par value; 250,000,000 shares authorized; 54,361,635 and 23,503,214 shares issued and outstanding as of March 31, 2020 and December 31, 2019, respectively
5

 
2

Additional paid-in capital
331,475

 
308,211

Accumulated deficit
(307,510
)
 
(298,821
)
Total stockholders’ equity
23,970

 
9,392

Total liabilities and stockholders’ equity
$
55,335

 
$
37,670






ZOSANO PHARMA CORPORATION
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share amounts)
(unaudited)
 
Three Months Ended March 31,
 
2020
 
2019
 
 
 
 
Revenue
$
—

 
$
—

Operating expenses:
 
 
 
Research and development
5,514

 
6,616

General and administrative
3,082

 
2,871

Total operating expenses
8,596

 
9,487

Loss from operations
(8,596
)
 
(9,487
)
Other income (expense):
 
 
 
Interest income
10

 
80

Interest expense
(206
)
 
(41
)
Other income, net
103

 
22

Loss before provision for income taxes
(8,689
)
 
(9,426
)
Provision for income taxes
—

 
—

Net loss
$
(8,689
)
 
$
(9,426
)
Unrealized gain on marketable securities, net of tax
—

 
6

Comprehensive loss
$
(8,689
)
 
$
(9,420
)
 
 
 
 
Net loss per common share – basic and diluted
$
(0.24
)
 
$
(0.79
)
Weighted-average shares used in computing net loss per common share – basic and diluted
36,266,018

 
11,973,039