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): August 14, 2019
ZOSANO PHARMA CORPORATION
(Exact name of registrant as specified in its charter)
(State or other jurisdiction
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 (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 Act:
Title of each class
Name of each exchange on which registered
Common Stock, 0.0001 par value
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 August 14, 2019, we issued a press release titled “Zosano Pharma Reports Second Quarter 2019 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.
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
Dated: August 14, 2019
/s/ Gregory Kitchener
Name: Gregory Kitchener
Title: Chief Financial Officer
Zosano Pharma Reports Second Quarter 2019 Financial Results and Provides Corporate Update
Conference call scheduled for 1:30 pm PT today
FREMONT, Calif., August 14, 2019 -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced financial results for the second quarter ended June 30, 2019, as well as recent business highlights.
"We have concentrated our efforts on QtryptaTM and are on track for the planned submission of a New Drug Application (NDA) with the FDA in the fourth quarter of this year,” said John Walker, chairman and CEO of Zosano. “We recently presented Migraine-ACT scores that demonstrated Qtrypta’s ability to effectively manage patients’ acute migraines over a period of up to a year. Additionally, we completed an important manufacturing qualification milestone, confirming that we have a robust and reliable manufacturing process in preparation for a potential commercial launch. We are increasingly enthusiastic about offering a new therapy to the millions of migraineurs still searching for a better and consistent treatment for their acute migraine attacks. If approved by the FDA, Qtrypta has the potential
to offer faster, more complete and longer lasting clinical benefit to these patients.”
Recent Business Highlights
Filed an IND to initiate a Phase 2/3 clinical study in Cluster Headache
Pre-Clinical and Clinical pre-NDA meeting scheduled for September 2019 for Qtrypta
Completed site qualification batches at a contract manufacturing organization for Qtrypta
Presented Migraine-ACT Scores for Qtrypta at the American Headache Society (AHS) Annual Scientific Meeting highlighting the effectiveness of Qtrypta in treating migraines
Featured in a keynote speech entitled, “A Novel Intracutaneous Microneedle Delivery System for the Acute Treatment of Migraine” at the Pharmaceutics & Advanced Delivery Systems Conference in Paris
Financial Results for the Second Quarter Ended June 30, 2019
Zosano reported a net loss for the second quarter of 2019 of $9.4 million, or $0.55 per share on a basic and diluted basis, compared with a net loss of $8.8 million, or $0.75 per share on a basic and diluted basis, for the same quarter in 2018.
Research and development expenses for the second quarter of 2019 were $6.6 million, compared with $6.5 million for the same quarter in 2018. The minor increase in R&D of $0.1 million was mainly due to the scale up and technology transfer to our contract manufacturers, which was offset by lower clinical trial costs.
General and administrative expenses for the second quarter of 2019 were $2.8 million, compared with $2.3 million in 2018. The increase of $0.5 million was mainly due to consulting and costs in preparation for commercialization.
As of June 30, 2019, cash, cash equivalents and marketable securities were $17.7 million, compared with $23.0 million as of December 31, 2018. The second quarter cash position includes $18.5 million in net cash proceeds from a public offering completed in May 2019.
Conference Call Information
Zosano will host a conference call and live audio webcast this afternoon at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time to discuss second quarter 2019 financial results and provide a corporate update.
The live call may be accessed by dialing (844) 379-5311 for domestic callers or (209) 905-5963 for international callers. A live webcast of the call can be accessed online from the investor relations section of the Zosano website at http://ir.zosanopharma.com/events.cfm and will be archived there for 30 days.
About Zosano Pharma
Zosano Pharma Corporation is a clinical stage biopharmaceutical company focused on developing products where rapid administration of established molecules with established safety and efficacy profiles may provide an increased benefit to patients, for markets where patients remain underserved by existing therapies. The company’s Adhesive Dermally-Applied Microarray (ADAM) technology consists of titanium microneedles coated with drug that is designed to enable rapid systemic administration of therapeutics to patients. Zosano’s lead product candidate is QtryptaTM (M207), which is an investigational, proprietary formulation of zolmitriptan delivered via ADAM technology, currently in development for the acute treatment of migraine. In February 2017, the company announced positive clinical and statistically significant results from the ZOTRIP pivotal study and in February 2019, the company announced the completion of the final milestone in its long-term safety study. The company is preparing to submit a New Drug Application to the Food and Drug Administration for Qtrypta (M207). Learn more at www.zosanopharma.com.
This press release contains forward-looking statements regarding the expected timing of a New Drug Application for Qtrypta (M207), manufacturing plans and other future events and expectations. 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 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 quarterly report on Form 10-Q. Although Zosano believes that the expectations reflected in these forward-looking statements are reasonable, we 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
firstname.lastname@example.org or email@example.com
ZOSANO PHARMA CORPORATION
CONDENSED BALANCE SHEETS
(in thousands, except par value and share amounts)
Cash and cash equivalents
Marketable securities at fair value
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
Operating lease liabilities, 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
Preferred stock, $0.0001 par value; 5,000,000 shares authorized; none issued and outstanding as of June 30, 2019 and December 31, 2018
Common stock, $0.0001 par value; 250,000,000 shares authorized; 17,723,039 and 11,973,039 shares issued and outstanding as of June 30, 2019 and December 31, 2018, respectively
Additional paid-in capital
Accumulated other comprehensive loss
Total stockholders’ equity
Total liabilities and stockholders’ equity
ZOSANO PHARMA CORPORATION
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share amounts)
Three Months Ended June 30,
Research and development
General and administrative
Total operating expenses
Loss from operations
Other income (expense):
Other income, net
Loss before provision for income taxes
Provision for income taxes
Unrealized gain (loss) on marketable securities, net of tax
Net loss per common share – basic and diluted
Weighted-average shares used in computing net loss per common share – basic and diluted