ZSAN
$0.53
Zosano Pharma
($.05)
(8.47%)
Earnings Details
3rd Quarter September 2021
Wednesday, November 10, 2021 4:10:00 PM
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Summary

Zosano Pharma (ZSAN) Recent Earnings

Zosano Pharma (ZSAN) reported a 3rd Quarter September 2021 loss of $0.07 per share on revenue of $0.3 million. The consensus estimate was a loss of $0.07 per share on revenue of $1.1 million.

Zosano Pharma Corp is a clinical stage specialty pharmaceutical company. It develops a proprietary transdermal microneedle patch system to deliver its proprietary formulations of existing drugs through the skin for the treatment of various indications.

Results
Reported Earnings
($0.07)
Earnings Whisper
-
Consensus Estimate
($0.07)
Reported Revenue
$0.3 Mil
Revenue Estimate
$1.1 Mil
Growth
Earnings Growth
Revenue Growth
Power Rating
Grade
Earnings Release

Zosano Pharma Reports Third Quarter 2021 Financial Results

FREMONT, Calif., Nov. 10, 2021 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced financial results for the third quarter ended September 30, 2021, as well as business highlights.

“This quarter we made significant progress towards the resubmission of the NDA for M207 with receipt of top-line data from our pharmacokinetic study,” said Steven Lo, president and chief executive officer of Zosano. “We expect to receive written feedback from the FDA through a Type C meeting by mid-December and expect that their feedback will enable us to further refine our regulatory strategy and to provide an update on our resubmission plans for the NDA. We believe there is a significant need for new acute treatment options for migraine as it is estimated that more than 70% of migraine patients experience an inadequate treatment response, and our goal is to help these patients.”

Select Business Highlights

  • Reported top-line results from a pharmacokinetic study, which evaluated the safety and pharmacokinetics of drug exposure levels of two lots of M207 compared to an intranasal control formulation of two 5 mg doses of zolmitriptan in 48 healthy volunteers
  • Granted a Type C (written response only) meeting with the U.S. Food and Drug Administration (“FDA”) to obtain feedback on the resubmission strategy for the M207 (zolmitriptan transdermal microneedle system) 505(b)(2) New Drug Application (“NDA”)
  • Issued U.S. patent for a method of rapidly achieving therapeutic levels with M207 for the acute treatment of migraine
  • Dismissal of Securities Class Action and Delaware Derivative Action

Financial Results for the Third Quarter Ended September 30, 2021
Zosano reported a net loss for the third quarter of 2021 of $8.7 million, or $0.07 per share on a basic and diluted basis, compared with a net loss of $8.7 million, or $0.11 per share on a basic and diluted basis, for the same quarter in 2020.

Research and development expenses for the third quarter of 2021 were $6.0 million, compared with $5.8 million for the same quarter in 2020. The increase was primarily due to the conduct of a pharmacokinetic study to support the resubmission of the NDA for M207, partially offset by lower employee and consulting costs.

General and administrative expenses for the third quarter of 2021 were $2.5 million compared with $2.7 million for the same quarter in 2020. The decrease of $0.2 million was primarily due to lower consulting and professional services costs.

As of September 30, 2021, cash and cash equivalents were $17.1 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. Learn more at www.zosanopharma.com.

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 expected timing with respect to the written feedback from the FDA, the company’s expectation that the FDA’s written feedback will enable the company to further refine its regulatory strategy and to provide an update on its resubmission plans for the NDA, the potential benefits and availability of M207 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,” “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.

Zosano Contacts:
Christine Matthews
Chief Financial Officer
510-745-1200

Zosano PR:
Sylvia Wheeler or Alexandra Santos
swheeler@wheelhouselsa.com or asantos@wheelhouselsa.com

ZOSANO PHARMA CORPORATION
BALANCE SHEETS
(in thousands, except par value and share amounts)

 September 30,
2021
 December 31,
2020
 (unaudited)  
ASSETS
Current assets:   
Cash and cash equivalents$17,147   $35,263  
Prepaid expenses and other current assets983   453  
Total current assets18,130   35,716  
Restricted cash455   455  
Property and equipment, net32,337   30,909  
Operating lease right-of-use assets4,073   4,928  
Other long-term assets   3  
Total assets$54,995   $72,011  
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:   
Accounts payable$1,551   $1,884  
Accrued compensation1,916   2,294  
Build-to-suit obligation, current portion, net of debt issuance costs and discount4,528   4,779  
Operating lease liabilities, current portion1,552   1,378  
Paycheck Protection Program loan, current portion   809  
Other accrued liabilities2,092   3,367  
Total current liabilities11,639   14,511  
Build-to-suit obligation, long-term portion, net of debt issuance costs and discount1,424   4,359  
Operating lease liabilities, long-term portion3,502   4,687  
Paycheck Protection Program loan, long-term portion   812  
Other long-term liabilities226   127  
Total liabilities16,791   24,496  
    
Stockholders’ equity:   
Preferred stock, $0.0001 par value; 5,000,000 shares authorized; none issued and outstanding as of September 30, 2021 and December 31, 2020, respectively     
Common stock, $0.0001 par value; 250,000,000 shares authorized as of September 30, 2021 and December 31, 2020, respectively; 118,114,793 and 102,066,218 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively12   10  
Additional paid-in capital393,336   379,695  
Accumulated deficit(355,144)  (332,190) 
Total stockholders’ equity38,204   47,515  
Total liabilities and stockholders’ equity$54,995   $72,011  

ZOSANO PHARMA CORPORATION
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except per share amounts)
(unaudited)

 Three Months Ended September 30, Nine Months Ended September 30,
 2021 2020 2021 2020
        
Service revenue$252   $   $698   $  
Operating expenses:       
Cost of service revenue340      704     
Research and development5,985   5,824   16,315   16,270  
General and administrative2,522   2,704   8,294   8,552  
Total operating expenses8,847   8,528   25,313   24,822  
Loss from operations(8,595)  (8,528)  (24,615)  (24,822) 
Other income (expense):       
Interest income1   2   2   17  
Interest expense(17)  (165)  (136)  (561) 
Other income (expense), net(57)  4   1,795   95  
Loss before provision for income taxes(8,668)  (8,687)  (22,954)  (25,271) 
Provision for income taxes           
Net loss and comprehensive loss$(8,668)  $(8,687)  $(22,954)  $(25,271) 
        
Net loss per common share – basic and diluted$(0.07)  $(0.11)  $(0.21)  $(0.45) 
Weighted-average common shares used in computing net loss per common share – basic and diluted115,765   77,883   109,730   56,437  

 


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Source: Zosano Pharma Corporation