ZSAN Zosano Pharma Corporation

0.61
-0.02  -3%
Previous Close 0.63
Open 0.64
52 Week Low 0.3275
52 Week High 1.96
Market Cap $62,597,211
Shares 102,066,218
Float 99,226,851
Enterprise Value $36,984,137
Volume 1,813,731
Av. Daily Volume 5,988,547
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Drug Pipeline

Drug Stage Notes
Qtrypta (M207)
Migraine
CRL
CRL
CRL announced October 21, 2020.
C213
Cluster headache
Phase 2/3
Phase 2/3
Phase 2/3 trial initiation announced October 24, 2019.
M207
Migraine
Phase 3
Phase 3
Phase 3 trial data due released February 13, 2017 - primary endpoints met.

Latest News

  1. FREMONT, Calif., Nov. 16, 2020 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced that the Compensation Committee of the Board of Directors granted a stock option to purchase 100,000 shares of Zosano's common stock to a new employee as an inducement award.

    The stock option has an exercise price of $0.4777 per share, which is equal to the closing price of Zosano's common stock on November 16, 2020. 25% of the shares underlying the option will vest on November 16, 2021, and 1/48th of the total shares will vest monthly thereafter, subject to continued service.

    The award was approved in accordance with Nasdaq Listing Rule 5635(c)(4).

    About Zosano Pharma

    Zosano Pharma Corporation…

    FREMONT, Calif., Nov. 16, 2020 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced that the Compensation Committee of the Board of Directors granted a stock option to purchase 100,000 shares of Zosano's common stock to a new employee as an inducement award.

    The stock option has an exercise price of $0.4777 per share, which is equal to the closing price of Zosano's common stock on November 16, 2020. 25% of the shares underlying the option will vest on November 16, 2021, and 1/48th of the total shares will vest monthly thereafter, subject to continued service.

    The award was approved in accordance with Nasdaq Listing Rule 5635(c)(4).

    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 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

    Zosano Contacts:

    Christine Matthews

    Chief Financial Officer

    510-745-1200

    Zosano PR:

    Sylvia Wheeler or Alexandra Santos

     or 



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  2. FREMONT, Calif., Nov. 13, 2020 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced financial results for the third quarter ended September 30, 2020, as well as recent business updates.

    "Our priority focus is obtaining resolution regarding the NDA for Qtrypta™," said Steven Lo, President and CEO of Zosano. "We plan on having a Type A meeting with the FDA as soon as possible and look forward to clarification on next steps and the possibility of resubmitting our NDA. We continue to believe in the promise that Qtrypta holds as an attractive alternative for patients suffering from migraine. Separately during the quarter, we executed a feasibility study agreement with Mitsubishi…

    FREMONT, Calif., Nov. 13, 2020 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced financial results for the third quarter ended September 30, 2020, as well as recent business updates.

    "Our priority focus is obtaining resolution regarding the NDA for Qtrypta™," said Steven Lo, President and CEO of Zosano. "We plan on having a Type A meeting with the FDA as soon as possible and look forward to clarification on next steps and the possibility of resubmitting our NDA. We continue to believe in the promise that Qtrypta holds as an attractive alternative for patients suffering from migraine. Separately during the quarter, we executed a feasibility study agreement with Mitsubishi Tanabe Pharma Corporation that reinforces the potential of our transdermal microneedle system technology."

    Recent Business Updates

    • Entered into a feasibility study agreement with Mitsubishi Tanabe Pharma Corporation. Under the agreement, Zosano plans to evaluate the feasibility of formulating a pharmaceutical agent being developed by Mitsubishi Tanabe Pharma Corporation 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
    • Received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) in connection with the Qtrypta™ (zolmitriptan transdermal microneedle system) 505(b)(2) New Drug Application (NDA)
    • To conserve resources, decided to end enrollment of new subjects into the placebo-controlled Phase 2/3 clinical trial evaluating the potential of C213 as an acute treatment for cluster headache as of December 31, 2020; subjects enrolled prior to that time will continue to be evaluated

    Financial Results for the Third Quarter Ended September 30, 2020

    Zosano reported a net loss for the third quarter of 2020 of $8.7 million, or $0.11 per share on a basic and diluted basis, compared with a net loss of $9.9 million, or $0.55 per share on a basic and diluted basis, for the same quarter in 2019.

    Research and development expenses for the third quarter of 2020 were $5.8 million, compared with $6.5 million for the same quarter in 2019. The decrease of $0.7 million was primarily attributable to lower clinical trial costs of $0.8 million due to the completion of Zosano's long-term safety study in 2019, a decrease of $0.2 million in compensation costs due to reduced headcount and a $0.3 million decrease in travel and general business expenses due to COVID-19. These decreases were partially offset by an increase of $0.3 million associated with the scale up and technology transfer to Zosano's contract manufacturers and an increase in depreciation expense of $0.3 million related to assets placed into service at its contract manufacturers.

    General and administrative expenses for the third quarter of 2020 were $2.7 million, compared with $3.1 million in 2019. The decrease of $0.4 million was primarily attributable to a $0.4 million decrease in professional services costs related to strategic and pre-commercial activities and a $0.2 million decrease in compensation costs related to lower headcount. These decreases were partially offset by a $0.2 million increase in legal and professional services costs related to corporate and intellectual property matters and audit fees.

    As of September 30, 2020, cash and cash equivalents were $43.6 million as compared with $6.3 million as of December 31, 2019.

    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 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 or connect through LinkedIn at https://www.linkedin.com/company/zosano-pharma, Twitter at https://twitter.com/ZosanoPharma and Instagram at https://www.instagram.com/zosanopharma/.

    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, the company's plan to have a Type A meeting with the FDA and the company's expectations with respect to the meeting with the FDA, the company's plan to evaluate the feasibility of formulating a pharmaceutical agent being developed by Mitsubishi Tanabe Pharma Corporation for administration, with the company's proprietary transdermal microneedle system technology and the company's plan with respect to the placebo-controlled Phase 2/3 clinical trial evaluating the potential of C213 as an acute treatment for cluster headache. Such forward-looking statements involve known and unknown risks, uncertainties, and other important factors that may cause the company's actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the company's business in general, see the most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. The company does not plan to publicly update or revise any forward-looking statements contained in this press release, whether as a result of any new information, future events, changed circumstances or otherwise, except as required by law.

    Zosano Contacts:

    Christine Matthews

    Chief Financial Officer

    510-745-1200

    Zosano PR:

    Sylvia Wheeler or Alexandra Santos

     or 



    ZOSANO PHARMA CORPORATION

    CONDENSED BALANCE SHEETS

    (in thousands, except par value and share amounts)

      September 30,

    2020
     December 31,

    2019
      (unaudited)  
    ASSETS
    Current assets:    
    Cash and cash equivalents $43,554  $6,316 
    Prepaid expenses and other current assets 615  497 
    Total current assets 44,169  6,813 
    Restricted cash 455  455 
    Property and equipment, net 30,621  24,636 
    Operating lease right-of-use assets 5,204  5,763 
    Other long-term assets 3  3 
    Total assets $80,452  $37,670 
    LIABILITIES AND STOCKHOLDERS' EQUITY
    Current liabilities:    
    Accounts payable $1,972  $4,356 
    Accrued compensation 1,982  2,015 
    Build-to-suit obligation, current portion 4,293  4,554 
    Operating lease liabilities, current portion 1,332  1,140 
    Paycheck Protection Program loan, current portion 201   
    Other accrued liabilities 3,394  4,172 
    Total current liabilities 13,174  16,237 
    Build-to-suit obligation, long-term portion, net of debt issuance costs and discount 5,447  6,095 
    Operating lease liabilities, long-term portion 5,058  5,931 
    Paycheck Protection Program loan, long-term portion 1,416   
    Other liabilities 113  15 
    Total liabilities 25,208  28,278 
         
    Stockholders' equity:    
    Preferred stock, $0.0001 par value; 5,000,000 shares authorized; none issued and outstanding as of September 30, 2020 and December 31, 2019    
    Common stock, $0.0001 par value; 250,000,000 shares authorized; 102,066,218 and 23,503,214 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively 10  2 
    Additional paid-in capital 379,326  308,211 
    Accumulated deficit (324,092) (298,821)
    Total stockholders' equity 55,244  9,392 
    Total liabilities and stockholders' equity $80,452  $37,670 



    ZOSANO PHARMA CORPORATION

    CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (in thousands, except share and per share amounts)

    (unaudited)

      Three Months Ended September 30, Nine Months Ended September 30,
      2020 2019 2020 2019
             
    Revenue $  $  $  $ 
    Operating expenses:        
    Research and development 5,824  6,486  16,270  19,742 
    General and administrative 2,704  3,071  8,552  8,709 
    Total operating expenses 8,528  9,557  24,822  28,451 
    Loss from operations (8,528) (9,557) (24,822) (28,451)
    Other income (expense):        
    Interest income 2  41  17  203 
    Interest expense (165) (281) (561) (357)
    Other income (expense), net 4  (66) 95  (44)
    Loss before provision for income taxes (8,687) (9,863) (25,271) (28,649)
    Provision for income taxes        
    Net loss $(8,687) $(9,863) $(25,271) $(28,649)
    Unrealized gain on marketable securities, net of tax       5 
    Comprehensive loss $(8,687) $(9,863) $(25,271) $(28,644)
             
    Net loss per common share – basic and diluted $(0.11) $(0.55) $(0.45) $(1.84)
    Weighted-average shares used in computing net loss per common share – basic and diluted 77,883,158  17,832,092  56,437,417  15,579,387 


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  3. --FDA feedback consistent with FDA's preliminary communication in September--

    --Company requesting meeting with FDA to discuss next steps required to resubmit the NDA--

    FREMONT, Calif., Oct. 21, 2020 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, announced today that it has received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) in connection with the Qtrypta™ (zolmitriptan transdermal microneedle system) 505(b)(2) New Drug Application (NDA).

    The CRL cited inconsistent zolmitriptan exposure levels observed across clinical pharmacology studies, which had been previously identified in the FDA's discipline review letter in September. Specifically, the…

    --FDA feedback consistent with FDA's preliminary communication in September--



    --Company requesting meeting with FDA to discuss next steps required to resubmit the NDA--

    FREMONT, Calif., Oct. 21, 2020 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, announced today that it has received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) in connection with the Qtrypta™ (zolmitriptan transdermal microneedle system) 505(b)(2) New Drug Application (NDA).

    The CRL cited inconsistent zolmitriptan exposure levels observed across clinical pharmacology studies, which had been previously identified in the FDA's discipline review letter in September. Specifically, the CRL noted differences in zolmitriptan exposures observed between subjects receiving different lots of Qtrypta in the company's trials and inadequate pharmacokinetic bridging between the lots that made interpretation of some safety data unclear. The CRL referenced unexpected high plasma concentrations of zolmitriptan observed in five study subjects enrolled in the company's pharmacokinetic studies. The FDA recommended that the company conduct a repeat bioequivalence study between three of the lots used during development. The NDA included data on a total of 774 subjects across 5 trials who were administered or dosed with Qtrypta.

    The CRL noted that additional product quality validation data, which were planned to be submitted following approval, if received, were required to be submitted with the application. In addition, the CRL mentioned that due to U.S. Government and/or Agency-wide restrictions on travel, inspections of Zosano's contract manufacturing facilities were not able to be conducted but would be required before the application may be approved.

    Zosano will request a Type A meeting with the FDA to discuss strategies to address the FDA's comments.

    "We are working diligently to address the deficiencies identified by the FDA and look forward to the possibility of resubmitting our NDA," said Steven Lo, president and chief executive of Zosano. "We expect that the Type A meeting with the FDA will provide clarity on the next steps for the program, which we will communicate once solidified. There are thousands of people suffering from migraine attacks that are not adequately addressed with available drugs, and we continue to believe that Qtrypta, if approved, could offer a much-needed new therapy for these patients."

    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 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 or connect through LinkedIn and Twitter.

    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, the company's plan to request a Type A meeting with the FDA to discuss strategies to address the FDA's comments in the CRL and the company's expectations with respect to the meeting with the FDA. Such forward-looking statements involve known and unknown risks, uncertainties, and other important factors that may cause the company's actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the company's business in general, see the most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. The company does not plan to publicly update or revise any forward-looking statements contained in this press release, whether as a result of any new information, future events, changed circumstances or otherwise, except as required by law.

    Zosano Contacts:

    Christine Matthews

    Chief Financial Officer

    510-745-1200

    Zosano PR:

    Sylvia Wheeler or Alexandra Santos

    or  

    Primary Logo

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  4. FREMONT, Calif., Sept. 30, 2020 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company today announced that it has received a discipline review letter (DRL) from the U.S. Food and Drug Administration (FDA) in connection with the Qtrypta™ (zolmitriptan transdermal microneedle system) 505(b)(2) New Drug Application (NDA). A DRL is used by the FDA to convey preliminary comments on deficiencies identified during the NDA review with respect to a particular review discipline.

    The DRL described two concerns with respect to the clinical pharmacology section of the NDA. First, the FDA raised questions regarding unexpected high plasma concentrations of zolmitriptan observed in five study subjects from…

    FREMONT, Calif., Sept. 30, 2020 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company today announced that it has received a discipline review letter (DRL) from the U.S. Food and Drug Administration (FDA) in connection with the Qtrypta™ (zolmitriptan transdermal microneedle system) 505(b)(2) New Drug Application (NDA). A DRL is used by the FDA to convey preliminary comments on deficiencies identified during the NDA review with respect to a particular review discipline.

    The DRL described two concerns with respect to the clinical pharmacology section of the NDA. First, the FDA raised questions regarding unexpected high plasma concentrations of zolmitriptan observed in five study subjects from two pharmacokinetic studies and how the data from these subjects affect the overall clinical pharmacology section of the application. Second, the FDA raised questions regarding differences in zolmitriptan exposures observed between subjects receiving different lots of Qtrypta in the company's clinical trials.

    Although a DRL reflects preliminary comments that are subject to change, and does not reflect the FDA's final decision on the NDA, approval of Qtrypta by the Prescription Drug User Fee Act goal date of October 20, 2020 is not expected given the letter.

    "We are disappointed in this notification and are in the process of evaluating and addressing FDA's comments," said Steven Lo, president and chief executive of Zosano. "We believe Qtrypta represents an attractive therapeutic alternative for patients suffering from migraines and look forward to working with FDA through the NDA review process."

    As of September 29, 2020, the Company had approximately $43.4 million in cash and cash equivalents. This cash and cash equivalents information is preliminary and subject to completion, including the completion of customary financial statement closing and review procedures for the quarter ending September 30, 2020. As a result, the preliminary information set forth above reflects the Company's preliminary estimate with respect to such information, based on information currently available to management, and may vary from the Company's actual cash and cash equivalents as of September 29, 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 Qtrypta™ (M207), which is a proprietary formulation of zolmitriptan delivered via its transdermal microneedle system technology, as an acute treatment for migraine. The company anticipates that many of its current and future development programs may enable the company to utilize a regulatory pathway that has the potential to streamline clinical development and accelerate the path towards commercialization. Learn more at www.zosanopharma.com or connect through LinkedIn and Twitter.

    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 cash and cash equivalents as of September 29, 2020 and the Company's expectations with respect to approval of Qtrypta by the Prescription Drug User Fee Act goal date. Such forward-looking statements involve known and unknown risks, uncertainties, and other important factors that may cause the Company's actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the Company's business in general, see the most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. The Company does not plan to publicly update or revise any forward-looking statements contained in this press release, whether as a result of any new information, future events, changed circumstances or otherwise, except as required by law.

    Zosano Contacts:

    Christine Matthews

    Chief Financial Officer

    510-745-1200

    Zosano PR:

    Sylvia Wheeler or Alexandra Santos

     or

     

    Primary Logo

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  5. FREMONT, Calif., Sept. 09, 2020 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced that its president and chief executive officer, Steven Lo, will present a company overview at the Cantor Virtual Global Healthcare Conference on Tuesday, September 15, 2020 at 10:40 am ET.

    A live webcast of the event will be available on the company's website at http://ir.zosanopharma.com/events-presentations. The archived webcast will remain available for 30 days following the date of the presentation.

    About Zosano Pharma
    Zosano Pharma Corporation is a clinical-stage biopharmaceutical company focused on developing products where rapid administration of approved molecules with established…

    FREMONT, Calif., Sept. 09, 2020 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced that its president and chief executive officer, Steven Lo, will present a company overview at the Cantor Virtual Global Healthcare Conference on Tuesday, September 15, 2020 at 10:40 am ET.

    A live webcast of the event will be available on the company's website at http://ir.zosanopharma.com/events-presentations. The archived webcast will remain available for 30 days following the date of the presentation.

    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 Qtrypta™ (M207), which is a proprietary formulation of zolmitriptan delivered via its transdermal microneedle system technology, as an acute treatment for migraine. The company anticipates that many of its current and future development programs may enable the company to utilize a regulatory pathway that has the potential to streamline clinical development and accelerate the path towards commercialization. Learn more at www.zosanopharma.com.

    Zosano Contact:

    Christine Matthews

    Chief Financial Officer

    510-745-1200

    PR Contacts:

    Sylvia Wheeler or Alexandra Santos

    or

    Primary Logo

    View Full Article Hide Full Article
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