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 10, 2021
ZOSANO PHARMA CORPORATION
(Exact name of registrant as specified in its charter)
|Delaware|| ||001-36570|| ||45-4488360|
|(State or other jurisdiction|
| ||(I.R.S. Employer|
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:
|☐||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 ☐
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. ☐
Item 2.02 Results of Operations and Financial Condition.
On August 10, 2021, Zosano Pharma Corporation issued a press release titled “Zosano Pharma Reports Second Quarter 2021 Financial Results.” 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, as amended (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, as amended, 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|
|Date: August 10, 2021|| ||By:|| ||/s/ Christine Matthews|
| || ||Name: Christine Matthews|
| || ||Title: Chief Financial Officer|
Zosano Pharma Reports Second Quarter 2021 Financial Results
FREMONT, Calif., August 10, 2021 -- 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
Zosano reported a net loss for the second quarter of 2021 of $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
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 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 M207, which is a proprietary formulation of zolmitriptan designed to be delivered via its transdermal microneedle system technology, as an acute treatment for migraine. Previously, M207 was known as Qtrypta, which the company no longer intends to use as the proprietary name of M207. The Company is currently in the process of identifying an alternative proprietary name for M207. Learn more at www.zosanopharma.com.
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 ongoing pharmacokinetic study and the anticipated timing with respect to the study; the expected timing of the potential resubmission of the NDA for M207, the potential benefits and availability of M207 for patients, the expectations for identifying a proprietary name for M207 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," “scheduled,” "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.
Chief Financial Officer
Sylvia Wheeler or Alexandra Santos
firstname.lastname@example.org or email@example.com
ZOSANO PHARMA CORPORATION
(in thousands, except par value and share amounts)
|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 ||$||72,011 |
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accounts payable||$||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 |
|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, $0.0001 par value; 250,000,000 shares authorized as of June 30, 2021 and December 31, 2020, respectively; 113,329,291 and 102,066,218 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively||11 ||10 |
|Additional paid-in capital||389,531 ||379,695 |
Total stockholders’ equity
|43,066 ||47,515 |
|Total liabilities and stockholders’ equity||$||60,850 ||$||72,011 |
ZOSANO PHARMA CORPORATION
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except per share amounts)
| ||Three Months Ended June 30,||Six Months Ended June 30,|
|Service revenue||$||188 ||$||— ||$||446 ||$||— |
|Cost of service revenue||202 ||— ||364 ||— |
|Research and development||5,000 ||4,932 ||10,330 ||10,446 |
|General and administrative||2,958 ||2,766 ||5,772 ||5,848 |
Total operating expenses
|8,160 ||7,698 ||16,466 ||16,294 |
|Loss from operations||(7,972)||(7,698)||(16,020)||(16,294)|
|Other income (expense):|
|Interest income||— ||5 ||1 ||15 |
|Other income (expense), net||1,850 ||(12)||1,852 ||91 |
Loss before provision for income taxes
Provision for income taxes
|— ||— ||— ||— |
|Net loss and comprehensive loss||$||(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 |