Zosano Pharma Reports Fourth Quarter and Fiscal Year 2020 Financial Results
“Over this past year, we made important progress in advancing QtryptaTM towards the market,” said
Select Business Highlights
- Completed a Type A meeting with the
U.S. Food and Drug Administration (“FDA")Division of Neurology II (the “Division”) onJanuary 29, 2021 regarding the requirements for resubmission of the Qtrypta (zolmitriptan transdermal microneedle system) 505(b)(2) New Drug Application (“NDA”) following the Complete Response Letter received onOctober 20, 2020 - Company plans to conduct an additional pharmacokinetic study that incorporates a patient skin assessment for inclusion in an NDA resubmission package, pending review of the study protocol by the FDA
- Presented a post-hoc retrospective analysis of data from the ZOTRIP trial at the
January 2021 AnnualHeadache Cooperative of thePacific Winter Conference that suggested that Qtrypta™ conferred therapeutic benefit at 30 minutes consistent with recently published criteria for early onset of action, and that those patients who were pain free at 30 minutes were still pain free at 2 hours - Entered into three feasibility study agreements including one with
Mitsubishi Tanabe Pharma Corporation . Under these agreements, Zosano plans to evaluate the feasibility of formulating each partner’s pharmaceutical agent for administration with its proprietary transdermal microneedle system technology - Partnered with EVERSANA, a leading provider of commercial services to the life science industry, to commercialize and distribute Qtrypta™, if approved, in
the United States
Financial Results for the Fourth Quarter Ended
Zosano reported a net loss for the fourth quarter of 2020 of
Research and development expenses for the fourth quarter of 2020 were
General and administrative expenses for the fourth quarter of 2020 were
As of
Financial Results for the Fiscal Year Ended
Zosano reported a net loss for the full year 2020 of
Research and development expenses for the full year 2020 were
General and administrative expenses for the full year 2020 were
About
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 company’s plans to conduct an additional pharmacokinetic study that incorporates a patient skin assessment for inclusion in an NDA resubmission package, the timing with respect to the FDA’s feedback on the pharmacokinetic study protocol, plans for resubmission of the company’s Qtrypta NDA to the FDA, plans to evaluate and explore additional potential therapeutic applications of the company’s transdermal microneedle system technology under feasibility study agreements, 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," "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:
Chief Financial Officer
510-745-1200
Zosano PR:
Sylvia Wheeler or Alexandra Santos
swheeler@wheelhouselsa.com or asantos@wheelhouselsa.com
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
Three Months Ended |
Year Ended |
||||||||||||||||||
2020 | 2019 | 2020 | 2019 | ||||||||||||||||
(unaudited) |
(unaudited) |
||||||||||||||||||
Service revenue | $ | 224 | $ | — | $ | 224 | $ | — | |||||||||||
Operating expenses: | |||||||||||||||||||
Cost of service revenue | 171 | — | 171 | — | |||||||||||||||
Research and development | 5,352 | 5,643 | 21,622 | 25,385 | |||||||||||||||
General and administrative | 2,637 | 3,103 | 11,189 | 11,812 | |||||||||||||||
Total operating expenses | 8,160 | 8,746 | 32,982 | 37,197 | |||||||||||||||
Loss from operations | (7,936 | ) | (8,746 | ) | (32,758 | ) | (37,197 | ) | |||||||||||
Other income (expense): | |||||||||||||||||||
Interest income | 1 | 4 | 18 | 207 | |||||||||||||||
Interest expense | (158 | ) | (166 | ) | (719 | ) | (523 | ) | |||||||||||
Other income (expense), net | (5 | ) | (32 | ) | 90 | (76 | ) | ||||||||||||
Loss before provision for income taxes | (8,098 | ) | (8,940 | ) | (33,369 | ) | (37,589 | ) | |||||||||||
Provision for income taxes | — | — | — | — | |||||||||||||||
Net loss | $ | (8,098 | ) | $ | (8,940 | ) | $ | (33,369 | ) | $ | (37,589 | ) | |||||||
Net loss per common share – basic and diluted | $ | (0.08 | ) | $ | (0.46 | ) | $ | (0.49 | ) | $ | (2.29 | ) | |||||||
Weighted-average shares used in computing net loss per common share – basic and diluted | 102,066 | 19,409 | 67,907 | 16,384 |
CONDENSED BALANCE SHEETS
(in thousands, except par value and share amounts)
2020 |
2019 |
||||||||
ASSETS | |||||||||
Current assets: | |||||||||
Cash and cash equivalents | $ | 35,263 | $ | 6,316 | |||||
Prepaid expenses and other current assets | 453 | 497 | |||||||
Total current assets | 35,716 | 6,813 | |||||||
Restricted cash | 455 | 455 | |||||||
Property and equipment, net | 30,909 | 24,636 | |||||||
Operating lease right-of-use assets | 4,928 | 5,763 | |||||||
Other long-term assets | 3 | 3 | |||||||
Total assets | $ | 72,011 | $ | 37,670 | |||||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|||||||||
Current liabilities: | |||||||||
Accounts payable | $ | 1,884 | $ | 4,356 | |||||
Accrued compensation | 2,294 | 2,015 | |||||||
Build-to-suit obligation, current portion | 4,779 | 4,554 | |||||||
Operating lease liabilities, current portion | 1,378 | 1,140 | |||||||
Paycheck Protection Program loan, current portion | 809 | — | |||||||
Other accrued liabilities | 3,367 | 4,172 | |||||||
Total current liabilities | 14,511 | 16,237 | |||||||
Build-to-suit obligation, long-term portion, net of debt issuance costs and discount | 4,359 | 6,095 | |||||||
Operating lease liabilities | 4,687 | 5,931 | |||||||
Paycheck Protection Program loan, long-term portion | 812 | — | |||||||
Other liabilities | 127 | 15 | |||||||
Total liabilities | 24,496 | 28,278 | |||||||
Stockholders’ equity: | |||||||||
Preferred stock, |
— | — | |||||||
Common stock, |
10 | 2 | |||||||
Additional paid-in capital | 379,695 | 308,211 | |||||||
Accumulated deficit | (332,190 | ) | (298,821 | ) | |||||
Total stockholders’ equity | 47,515 | 9,392 | |||||||
Total liabilities and stockholders’ equity | $ | 72,011 | $ | 37,670 |
Source: Zosano Pharma Corporation