Zosano Pharma Reports First Quarter 2021 Financial Results

FREMONT, Calif., May 12, 2021 (GLOBE NEWSWIRE) — Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced financial results for the first quarter ended March 31, 2021, as well as business highlights. “We have gained clarity from the FDA on the resubmission plan for the QtryptaTM NDA, and the full weight of our organization is focused on this endeavor,” said Steven Lo, president and chief executive officer of Zosano. “The pharmacokinetic study required for resubmission of our Qtrypta NDA is expected to begin in June with data available in the third quarter. Pending receipt of positive data from this healthy volunteer study, we anticipate resubmitting the NDA for Qtrypta by the end of this year. If approved, we believe that Qtrypta would represent a significant advancement in the acute treatment of migraine, a disease that impacts one in four U.S. households.” Select Business Highlights Received feedback from the U.S. Food and Drug Administration on the protocol for the pharmacokinetic (“PK”) study required to support the resubmission of the Qtrypta™ (zolmitriptan transdermal microneedle system) 505(b)(2) New Drug Application (“NDA”)Established an agreement with Worldwide Clinical Trials to conduct the Qtrypta PK study, which is expected to involve 48 healthy volunteers to generate comparative pharmacokinetic and safety dataPresented a post-hoc retrospective analysis of data from the ZOTRIP trial at the January 2021 Annual Headache Cooperative of the Pacific 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 Financial Results for the First Quarter Ended March 31, 2021The company reported a net loss for the first quarter of 2021 of $8.1 million, or $0.08 per share on a basic and diluted basis, compared with a net loss of $8.7 million, or $0.24 per share on a basic and diluted basis, for the same quarter in 2020. In the first quarter of 2021, we recognized service revenue and cost of service revenue on agreements with three pharmaceutical companies in which we provide research and development services to determine the feasibility of using our transdermal microneedle system technology in connection with their pharmaceutical agents. Research and development expenses for the first quarter of 2021 were $5.3 million, compared with $5.5 million for the same quarter in 2020. The decrease of $0.2 million was primarily due to lower employee and temporary employee expenses and lower clinical trial costs partially offset by higher production and manufacturing costs due to the scale up and technology transfer to our commercial manufacturing organizations and additional depreciation expense. General and administrative expenses for the first quarter of 2021 were $2.8 million, compared with $3.1 million for the same quarter in 2020. The decrease of $0.3 million was primarily due to lower professional service fees. As of March 31, 2021, cash and cash equivalents were $26.9 million, compared with $35.3 million as of December 31, 2020. About Zosano PharmaZosano 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 Qtrypta™ (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 StatementsThis 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 for and the anticipated timing with respect to the commencement of the PK study and the availability of data from the study, the expected timing of the resubmission of the company’s Qtrypta NDA to the FDA, the potential benefits and availability 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:Christine MatthewsChief Financial Officer510-745-1200 Zosano PR:Sylvia Wheeler or Alexandra [email protected] or [email protected] ZOSANO PHARMA CORPORATIONBALANCE SHEETS(in thousands, except par value and share amounts)  March 31,2021 December 31,2020 (unaudited)  ASSETSCurrent assets:   Cash and cash equivalents$26,882  $35,263 Prepaid expenses and other current assets1,591  453 Total current assets28,473  35,716 Restricted cash455  455 Property and equipment, net32,128  30,909 Operating lease right-of-use assets4,651  4,928 Other long-term assets3  3 Total assets$65,710  $72,011 LIABILITIES AND STOCKHOLDERS’ EQUITYCurrent liabilities:   Accounts payable$2,661  $1,884 Accrued compensation2,703  2,294 Build-to-suit obligation, current portion, net of debt issuance costs and discount4,697  4,779 Operating lease liabilities, current portion1,434  1,378 Paycheck Protection Program loan, current portion1,422  809 Other accrued liabilities1,491  3,367 Total current liabilities14,408  14,511 Build-to-suit obligation, long-term portion, net of debt issuance costs and discount3,426  4,359 Operating lease liabilities, long-term portion4,304  4,687 Paycheck Protection Program loan, long-term portion204  812 Other long-term liabilities217  127 Total liabilities22,559  24,496     Stockholders’ equity:   Preferred stock, $0.0001 par value; 5,000,000 shares authorized; none issued and outstanding as of March 31, 2021 and December 31, 2020, respectively—  — Common stock, $0.0001 par value; 250,000,000 shares authorized as of March 31, 2021 and December 31, 2020, respectively; 106,372,820 and 102,066,218 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively11  10 Additional paid-in capital383,472  379,695 Accumulated deficit(340,332) (332,190)Total stockholders’ equity43,151  47,515 Total liabilities and stockholders’ equity$65,710  $72,011          ZOSANO PHARMA CORPORATIONSTATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(in thousands, except per share amounts)(unaudited)  Three Months Ended March 31, 2021 2020    Service revenue$258  $— Operating expenses:   Cost of service revenue162  — Research and development5,330  5,514 General and administrative2,814  3,082 Total operating expenses8,306  8,596 Loss from operations(8,048) (8,596)Other income (expense):   Interest income1  10 Interest expense(97) (206)Other income (expense), net2  103 Loss before provision for income taxes(8,142) (8,689)Provision for income taxes—  — Net loss and comprehensive loss$(8,142) $(8,689)    Net loss per common share – basic and diluted$(0.08) $(0.24)Weighted-average common shares used in computing net loss per common share – basic and diluted104,356  36,266