Zosano Pharma Reports Second Quarter 2021 Financial Results
08/10/2021 - 04:05 PM
FREMONT, Calif., Aug. 10, 2021 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced financial results for the second quarter ended June 30, 2021, as well as business highlights.
“We are pleased to have initiated the healthy volunteer pharmacokinetic study that was requested by the FDA for the resubmission of the New Drug Application (NDA) for M207,” said Steven Lo, president and chief executive officer of Zosano. “The study is evaluating pharmacokinetics and safety in approximately 48 healthy volunteers. We are diligently working to complete this study in the third quarter. Pending receipt of positive data, we plan to resubmit the NDA for M207 by year-end. Additionally, this quarter we strengthened our patent portfolio with the issuance of a U.S. patent covering method of use of M207.”
Select Business Highlights
Initiated the pharmacokinetic study required to support the resubmission of the M207 (zolmitriptan transdermal microneedle system) 505(b)(2) NDA Announced publication of an article titled, “Long Term Safety, Tolerability, and Efficacy of Intracutaneous Zolmitriptan (M207) in the Acute Treatment of Migraine” in The Journal of Headache and Pain highlighting the positive safety and efficacy results from this long-term study Received notification of a newly issued U.S. patent for method of rapidly achieving therapeutic levels with M207 for the acute treatment of migraine Appointed Kathy McGee, an accomplished biopharmaceutical executive currently serving as the chief operating officer of AVITA MEDICAL, to the board of directors Financial Results for the Second Quarter Ended June 30, 2021 $6.1 million , or $0.06 per share on a basic and diluted basis, compared with a net loss of $7.9 million , or $0.14 per share on a basic and diluted basis, for the same quarter in 2020. The net loss for the second quarter of 2021 included a $1.6 million gain on the forgiveness of our Paycheck Protection Loan.
Research and development expenses for the second quarter of 2021 were $5.0 million , compared with $4.9 million for the same quarter in 2020. The increase was primarily due to an increase of $0.2 million in manufacturing costs related to the scale up and technology transfer to our commercial manufacturing organizations and $0.2 million in increased spending for clinical trials. These increases were partially offset by a decrease of $0.3 million in employee and consulting costs.
General and administrative expenses for the second quarter of 2021 were $3.0 million compared with $2.8 million for the same quarter in 2020. The increase of $0.2 million was primarily due to higher employee related costs.
As of June 30, 2021, cash and cash equivalents were $22.1 million , compared with $35.3 million as of December 31, 2020.
About Zosano Pharma
Forward-Looking Statements
Zosano Contacts:
Zosano PR: swheeler@wheelhouselsa.com or asantos@wheelhouselsa.com
ZOSANO PHARMA CORPORATION BALANCE SHEETS (in thousands, except par value and share amounts)
June 30, 2021 December 31, 2020 (unaudited) ASSETS Current assets: Cash and cash equivalents $ 22,058 $ 35,263 Prepaid expenses and other current assets 1,787 453 Total current assets 23,845 35,716 Restricted cash 455 455 Property and equipment, net 32,184 30,909 Operating lease right-of-use assets 4,366 4,928 Other long-term assets — 3 Total assets $ 60,850 $ 72,011 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $ 1,677 $ 1,884 Accrued compensation 1,801 2,294 Build-to-suit obligation, current portion, net of debt issuance costs and discount 4,825 4,779 Operating lease liabilities, current portion 1,492 1,378 Paycheck Protection Program loan, current portion — 809 Other accrued liabilities 1,620 3,367 Total current liabilities 11,415 14,511 Build-to-suit obligation, long-term portion, net of debt issuance costs and discount 2,237 4,359 Operating lease liabilities, long-term portion 3,911 4,687 Paycheck Protection Program loan, long-term portion — 812 Other long-term liabilities 221 127 Total liabilities 17,784 24,496 Stockholders’ equity: Preferred stock, $0.0001 par value; 5,000,000 shares authorized; none issued and outstanding as of June 30, 2021 and December 31, 2020, respectively — — Common stock, $0.0001 par value; 250,000,000 shares authorized as of June 30, 2021 and December 31, 2020, respectively; 113,329,291 and 102,066,218 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively 11 10 Additional paid-in capital 389,531 379,695 Accumulated deficit (346,476 ) (332,190 ) Total stockholders’ equity 43,066 47,515 Total liabilities and stockholders’ equity $ 60,850 $ 72,011
ZOSANO PHARMA CORPORATION STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except per share amounts) (unaudited)
Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Service revenue $ 188 $ — $ 446 $ — Operating expenses: Cost of service revenue 202 — 364 — Research and development 5,000 4,932 10,330 10,446 General and administrative 2,958 2,766 5,772 5,848 Total operating expenses 8,160 7,698 16,466 16,294 Loss from operations (7,972 ) (7,698 ) (16,020 ) (16,294 ) Other income (expense): Interest income — 5 1 15 Interest expense (22 ) (190 ) (119 ) (396 ) Other income (expense), net 1,850 (12 ) 1,852 91 Loss before provision for income taxes (6,144 ) (7,895 ) (14,286 ) (16,584 ) Provision for income taxes — — — — Net loss and comprehensive loss $ (6,144 ) $ (7,895 ) $ (14,286 ) $ (16,584 ) Net loss per common share – basic and diluted $ (0.06 ) $ (0.14 ) $ (0.13 ) $ (0.36 ) Weighted-average common shares used in computing net loss per common share – basic and diluted 108,943 54,927 106,662 45,597
