ZSAN Zosano Pharma Corporation

0.82
-0.03  -4%
Previous Close 0.86
Open 0.86
52 Week Low 0.405
52 Week High 3.54
Market Cap $44,652,647
Shares 54,361,635
Float 51,522,268
Enterprise Value $44,523,634
Volume 1,306,239
Av. Daily Volume 1,591,780
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Upcoming Catalysts

Drug Stage Catalyst Date
Qtrypta (M207)
Migraine
PDUFA
PDUFA
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Drug Pipeline

Drug Stage Notes
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., June 13, 2020 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced that new post-hoc efficacy analyses of QtryptaTM, Zosano's lead investigational product candidate for the acute treatment of migraine, will be presented as a virtual oral presentation on the 2020 American Headache Society's Virtual Annual Scientific Meeting Platform.

    Six different measurements of pain reduction from the exploratory efficacy results in the long-term safety study ("LTSS") were examined and compared to the positive clinical results observed in the Phase 2/3 Zotrip study.  Across all six efficacy measurements, which included pain freedom and pain relief at 2 hours, clinical activity…

    FREMONT, Calif., June 13, 2020 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced that new post-hoc efficacy analyses of QtryptaTM, Zosano's lead investigational product candidate for the acute treatment of migraine, will be presented as a virtual oral presentation on the 2020 American Headache Society's Virtual Annual Scientific Meeting Platform.

    Six different measurements of pain reduction from the exploratory efficacy results in the long-term safety study ("LTSS") were examined and compared to the positive clinical results observed in the Phase 2/3 Zotrip study.  Across all six efficacy measurements, which included pain freedom and pain relief at 2 hours, clinical activity observed in the LTSS during the one-year trial period treating approximately 6,000 attacks was consistent with the positive pivotal study results.

    ParameterZOTRIP (Single Dose)Open-Label
    Long-Term
    Placebo M207 3.8 mg M207 3.8 mg
    (n = 77)(n = 82)(5,617 migraine attacks*)
    Pain Freedom at 2 hours14%42%44%
    Pain Relief at 2 hours57%81%81%
    Sustained Pain Freedom 2-24 hour10%32%38%
    Sustained Pain Freedom 2-48 hour9%27%35%
    Sustained Pain Relief 2-24 hour38%68%70%
    Sustained Pain Relief 2-48 hour33%63%65%
    * For sustained endpoints, data from all timepoints 2-24 (48) hours had to be present

    Similar to the pivotal study, the most common adverse events observed in the LTSS were redness and swelling at the application site, of which more than 95% were classified as mild. 80% of these site reactions were generally resolved within 48 hours. Patients treated with Qtrypta reported less triptan-like neurological side effects than are typically found with the class, with less than 2% of patients in the LTSS reporting effects such as dizziness and paresthesia.

    "Migraine is a painful and debilitating neurologic disease impacting over 34 million people in the US. The post-hoc analyses suggest that Qtrypta's efficacy results across approximately 6000 attacks treated in the LTSS were consistent with the positive results seen in the pivotal Zotrip study," said Egilius Spierings, MD, Founder, Medical Director, and Principal Investigator Medvadis Research Director, Boston Headache Institute at Boston PainCare. "I believe that Qtrypta, if approved, has the potential to be a promising and innovative option for migraine patients."

    "As we continue to learn about the profile of our unique investigational product being developed as a potential treatment for headache disorders, we remain committed to sharing this information with the scientific community," said Dr. Don Kellerman, Vice President of Clinical Development and Medical Affairs at Zosano.

    About Qtrypta™ (M207)

    Qtrypta is Zosano's proprietary formulation of zolmitriptan delivered utilizing its proprietary intracutaneous microneedle system (the "System") in development for the acute treatment of migraine.   The System consists of titanium microneedles coated with drug, and in the case of Qtrypta™, the formulation is zolmitriptan. The drug-coated microneedles are designed to penetrate the stratum corneum, where the investigational drug dissolves and easily enters into the bloodstream. In February 2017, the Company announced statistically significant results from the ZOTRIP pivotal study, in which the 3.8 mg dose of Qtrypta™ met both co-primary endpoints, achieving pain freedom and most bothersome symptom freedom at 2 hours.

    About Migraine

    Migraine is a highly prevalent neurological disease impacting 12% of the US population and 1 in 4 households. Patients impacted by migraine experience significant disability, with 90% unable to function normally.  Migraine attacks are estimated to lead to lost productivity costs as high as $36 billion annually in the United States, including both direct and indirect costs. There is a significant need for new acute treatment options since 74% of migraine patients experience inadequate treatment response.

    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 intracutaneous 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 intracutaneous 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.

    Forward-Looking Statements

    This press release contains forward-looking statements regarding the presentation of post-hoc analyses of Qtrypta's (M207) clinical trial data on the 2020 American Headache Society's Virtual Annual Scientific Meeting Platform, the potential benefits 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," "unaudited," "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 for the remainder of 2020, 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 Contact:

    Christine Matthews

    Chief Financial Officer

    (510) 745-1200

    PR Contacts:

    Sylvia Wheeler or Alexandra Santos

    or

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  2. FREMONT, Calif., June 11, 2020 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN) (the "Company" or "Zosano"), a clinical-stage biopharmaceutical company, today announced a change in the format of its Annual Meeting of Stockholders ("Annual Meeting") from in-person to virtual-only. Due to the public health impact of the coronavirus (COVID-19) pandemic and to support the health and well-being of our stockholders, employees and their families, the Company will hold its Annual Meeting in a virtual meeting format only, via webcast. As previously announced, the Annual Meeting will be held on Thursday, June 25, 2020 at 8:30 a.m. Pacific time.

    As described in the Company's proxy materials previously distributed for the Annual Meeting, stockholders…

    FREMONT, Calif., June 11, 2020 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN) (the "Company" or "Zosano"), a clinical-stage biopharmaceutical company, today announced a change in the format of its Annual Meeting of Stockholders ("Annual Meeting") from in-person to virtual-only. Due to the public health impact of the coronavirus (COVID-19) pandemic and to support the health and well-being of our stockholders, employees and their families, the Company will hold its Annual Meeting in a virtual meeting format only, via webcast. As previously announced, the Annual Meeting will be held on Thursday, June 25, 2020 at 8:30 a.m. Pacific time.

    As described in the Company's proxy materials previously distributed for the Annual Meeting, stockholders at the close of business on May 11, 2020, the record date, are entitled to attend and participate in the Annual Meeting. To attend, participate in and/or vote at the virtual Annual Meeting at www.virtualshareholdermeeting.com/ZSAN2020, stockholders must enter the 16-digit control number found on their proxy card or voting instruction form previously distributed.         

    For additional information regarding how stockholders may attend, participate in and/or vote at the virtual Annual Meeting, please refer to the Company's supplemental proxy materials filed today with the Securities and Exchange Commission.

    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 intracutaneous 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 intracutaneous microneedle system technology, as a potential 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.

    Zosano Contact:

    Christine Matthews

    Chief Financial Officer

    (510) 745-1200

    PR Contact:

    Sylvia Wheeler and Alexandra Santos

    /

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  3. FREMONT, Calif., May 14, 2020 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced financial results for the first quarter ended March 31, 2020, as well as recent business highlights.

    "This quarter was marked by a momentous milestone for the company with the FDA acceptance for filing of our New Drug Application (NDA) for Qtrypta™, a potential new treatment for patients with migraine utilizing our microneedle patch technology," said Steven Lo, president and CEO of Zosano. "In preparation for our upcoming Prescription Drug User Fee Act (PDUFA) goal date of October 20 of this year, we have been scaling up our pre-commercial activities, including key components such as targeting…

    FREMONT, Calif., May 14, 2020 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced financial results for the first quarter ended March 31, 2020, as well as recent business highlights.

    "This quarter was marked by a momentous milestone for the company with the FDA acceptance for filing of our New Drug Application (NDA) for Qtrypta™, a potential new treatment for patients with migraine utilizing our microneedle patch technology," said Steven Lo, president and CEO of Zosano. "In preparation for our upcoming Prescription Drug User Fee Act (PDUFA) goal date of October 20 of this year, we have been scaling up our pre-commercial activities, including key components such as targeting and market access. We believe Qtrypta, if approved, will provide patients an attractive option for their migraine treatment, given its potential to provide rapid and sustained headache relief, in addition to the favorable safety results demonstrated in clinical studies. We are looking forward to the opportunity to help patients with this debilitating disease."

    Recent Business Highlights

    • Received U.S. Food and Drug Administration (FDA) filing acceptance of the 505(b)(2) NDA filing for Qtrypta™ for the acute treatment of migraine
    • Appointed Christine Matthews, previously the company's interim chief financial officer, to the position of chief financial officer
    • Completed a blinded market research study conducted with high-volume physicians and payors, including 100 physician specialists and five national payors representing over 100 million covered lives, which found that:
      -  79% of the physicians strongly agree that there remains an unmet need in the treatment of migraine in the acute setting even in patients that respond to preventive therapy
      -  70% of the physicians would offer a non-oral triptan that has fast and complete pain relief that is sustained and well-tolerated

    Financial Results for the First Quarter Ended March 31, 2020
    Zosano reported a net loss for the first quarter of 2020 of $8.7 million, or $0.24 per share on a basic and diluted basis, compared with a net loss of $9.4 million, or $0.79 per share on a basic and diluted basis, for the same quarter in 2019.

    Research and development expenses for the first quarter of 2020 were $5.5 million, compared with $6.6 million for the same quarter in 2019. The $1.1 million decrease was primarily attributable to lower clinical trial costs due to the completion of the Qtrypta long-term safety study in 2019.

    General and administrative expenses for the first quarter of 2020 were $3.1 million, compared with $2.9 million for the same quarter in 2019. The increase of $0.2 million was mainly due to costs related to intellectual property matters.

    As of March 31, 2020, cash and cash equivalents were $18.6 million, 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 intracutaneous 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 intracutaneous microneedle system technology, as a potential 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 would streamline clinical development and accelerate the path towards commercialization. Learn more at www.zosanopharma.com.

    Forward-Looking Statements
    This press release contains forward-looking statements regarding the preparation for potential approval and launch of Qtrypta, the potential benefits 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," "unaudited," "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 for the remainder of 2020, 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 Contact:
    Christine Matthews
    Chief Financial Officer
    (510) 745-1200

    PR Contacts:
    Sylvia Wheeler or Alexandra Santos
    or

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

      March 31,
    2020
      December 31,
    2019
      (unaudited)    
    ASSETS
    Current assets:      
    Cash and cash equivalents $ 18,557     $ 6,316  
    Prepaid expenses and other current assets 623     497  
    Total current assets 19,180     6,813  
    Restricted cash 455     455  
    Property and equipment, net 30,164     24,636  
    Operating lease right-of-use assets 5,533     5,763  
    Other long-term assets 3     3  
    Total assets $ 55,335     $ 37,670  
    LIABILITIES AND STOCKHOLDERS' EQUITY
    Current liabilities:      
    Accounts payable $ 3,263     $ 4,356  
    Accrued compensation 2,553     2,015  
    Build-to-suit obligation, current portion 4,665     4,554  
    Operating lease liabilities, current portion 1,184     1,140  
    Other accrued liabilities 8,943     4,172  
    Total current liabilities 20,608     16,237  
    Build-to-suit obligation, long-term portion, net of debt issuance costs and discount 5,129     6,095  
    Operating lease liabilities, long-term portion 5,618     5,931  
    Other liabilities 10     15  
    Total liabilities 31,365     28,278  
    Stockholders' equity:      
    Preferred stock, $0.0001 par value; 5,000,000 shares authorized; none issued and outstanding as of March 31, 2020 and December 31, 2019      
    Common stock, $0.0001 par value; 250,000,000 shares authorized; 54,361,635 and 23,503,214 shares issued and outstanding as of March 31, 2020 and December 31, 2019, respectively 5     2  
    Additional paid-in capital 331,475     308,211  
    Accumulated deficit (307,510 )   (298,821 )
    Total stockholders' equity 23,970     9,392  
    Total liabilities and stockholders' equity
    $ 55,335     $ 37,670  




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

      Three Months Ended March 31,
      2020   2019
           
    Revenue $     $  
    Operating expenses:      
    Research and development 5,514     6,616  
    General and administrative 3,082     2,871  
    Total operating expenses 8,596     9,487  
    Loss from operations (8,596 )   (9,487 )
    Other income (expense):      
    Interest income 10     80  
    Interest expense (206 )   (41 )
    Other income, net 103     22  
    Loss before provision for income taxes (8,689 )   (9,426 )
    Provision for income taxes      
    Net loss $ (8,689 )   $ (9,426 )
    Unrealized gain on marketable securities, net of tax     6  
    Comprehensive loss $ (8,689 )   $ (9,420 )
           
    Net loss per common share – basic and diluted $ (0.24 )   $ (0.79 )
    Weighted-average shares used in computing net loss per common share – basic and diluted 36,266,018     11,973,039  

     

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  4. FREMONT, Calif., May 01, 2020 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced the appointment of Christine Matthews as the company's chief financial officer (CFO). Ms. Matthews, who previously served as interim CFO, will be responsible for leading the finance and accounting departments.

    "We are pleased to appoint Christine to the position of chief financial officer," said Steven Lo, president and chief executive officer of Zosano. "Christine has demonstrated strong leadership during her tenure at Zosano and has a proven track record of diligent financial planning and execution. I am confident that her continued contributions will be key in our future success as we head

    FREMONT, Calif., May 01, 2020 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced the appointment of Christine Matthews as the company's chief financial officer (CFO). Ms. Matthews, who previously served as interim CFO, will be responsible for leading the finance and accounting departments.

    "We are pleased to appoint Christine to the position of chief financial officer," said Steven Lo, president and chief executive officer of Zosano. "Christine has demonstrated strong leadership during her tenure at Zosano and has a proven track record of diligent financial planning and execution. I am confident that her continued contributions will be key in our future success as we head towards possible commercialization."

    "It is an exciting time to be at Zosano as we enter this next phase of growth," said Christine Matthews, chief financial officer of Zosano. "I look forward to continuing my work with the Zosano management team as we prepare for the potential approval of Qtrypta."

    Ms. Matthews has over 20 years of broad leadership experience in finance and accounting. She was most recently the interim CFO at Zosano, a position she was appointed to after having served as the company's vice president and corporate controller. Previously, Ms. Matthews was as an accounting and financial consultant with RGP, a professional services company. Her past positions include senior director of financial planning & analysis at Cepheid, a leading molecular diagnostic company (acquired by Danaher), supporting North America commercial operations, as well as group director of finance at Cadence Design Systems. Ms. Matthews began her career with Arthur Andersen, LLP. She holds a B.S. in business administration with an emphasis in accounting from the University of Colorado at Boulder.

    About Zosano
    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 intracutaneous 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 intracutaneous 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 would streamline clinical development and accelerate the path towards commercialization.

    Forward-Looking Statements
    This press release contains forward-looking statements regarding the potential approval and commercialization of Qtrypta. 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," "unaudited," "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 for the remainder of 2020, 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 Contact:
    Christine Matthews
    Chief Financial Officer
    (510) 745-1200

    PR Contacts:
    Sylvia Wheeler

    Alexandra Santos

     

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  5. FREMONT, Calif., March 13, 2020 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced financial results for the fourth quarter and year ended December 31, 2019, as well as recent business highlights.

    "2019 was a transformational year for Zosano on multiple fronts," said Steven Lo, president and chief executive officer of Zosano. "We completed clinical development for Qtrypta™ for the acute treatment of migraine, which supported our submission of a New Drug Application seeking approval of our first product formulated with our microneedle delivery technology. This year will be focused on preparing for potential approval and launch of Qtrypta as a new and differentiated treatment…

    FREMONT, Calif., March 13, 2020 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced financial results for the fourth quarter and year ended December 31, 2019, as well as recent business highlights.

    "2019 was a transformational year for Zosano on multiple fronts," said Steven Lo, president and chief executive officer of Zosano. "We completed clinical development for Qtrypta™ for the acute treatment of migraine, which supported our submission of a New Drug Application seeking approval of our first product formulated with our microneedle delivery technology. This year will be focused on preparing for potential approval and launch of Qtrypta as a new and differentiated treatment option for patients suffering from acute migraines."

    2019 and Recent Accomplishments

    • Submission and subsequent acceptance for filing of the company's first 505(b)(2) New Drug Application (NDA) for Qtrypta™ with the U.S. Food and Drug Administration for the acute treatment of migraine
    • Appointed Steven Lo, an industry veteran with over 25 years of large pharmaceutical and small biotech executive and commercial experience, as president and chief executive officer
    • Initiated the C213 Phase 2/3 trial for the acute treatment of cluster headache
    • Published Qtrypta™ data in Headache, describing its performance in providing pain freedom and freedom from most bothersome symptoms (MBS) at 2 hours
    • Presented Migraine-ACT Scores for Qtrypta™ at the American Headache Society (AHS) Annual Scientific Meeting showcasing patient-reported effectiveness of Qtrypta™ in treating their migraines
    • Presented keynote address titled, "A Novel Intracutaneous Microneedle Delivery System for the Acute Treatment of Migraine" at the Pharmaceutics & Advanced Delivery Systems Conference
    • Presented positive results from the long-term safety study of Qtrypta™ at the Congress of the International Headache Society
    • Appointed Dushyant Pathak, Ph.D., who has a proven track record of executing value-generating strategic alliances, as senior vice president of business development

    Expected Upcoming Events

    • Zosano to host conference call at 4:30 pm ET on March 26, 2020 to provide a corporate update and share plans for commercialization readiness for Qtrypta™
    • FDA decision on the NDA for Qtrypta™ for the acute treatment of migraine

    Financial Results for the Fourth Quarter Ended December 31, 2019

    Zosano reported a net loss for the fourth quarter of 2019 of $8.9 million, or $0.46 per share on a basic and diluted basis, compared with a net loss of $10.1 million, or $0.85 per share on a basic and diluted basis, for the same quarter in 2018.

    Research and development expenses for the fourth quarter were $5.6 million, compared with $7.3 million for the same quarter in 2018. The decrease of $1.7 million was primarily due to a decrease in clinical trial costs related to our long-term safety study.

    General administrative expenses for the fourth quarter of 2019 were $3.1 million compared with $2.5 million in 2018. The increase of $0.6 million was primarily due to an increase in professional service fees and employee expenses.

    As of December 31, 2019, cash, cash equivalents and marketable securities were $6.3 million, compared with $23.0 million as of December 31, 2018.

    Financial Results for the Fiscal Year Ended December 31, 2019

    Zosano reported a net loss for the full year 2019 of $37.6 million, or $2.29 per share on a basic and diluted basis, compared with a net loss of $35.4 million, or $3.74 per share on a basic and diluted basis, for the full year 2018.

    Research and development expenses for the full year 2019 were $25.4 million, compared with $25.5 million in 2018. The decrease of $0.1 million was primarily due to a decrease in pre-clinical and clinical trial costs, related to the completion of the Qtrypta™ long-term safety study, offset by an increase in costs associated with the scale up and technology transfer to our commercial manufacturing organizations and increased employee expenses.

    General administrative expenses for the full year 2019 were $11.8 million, compared with $9.4 million in 2018. The increase of $2.4 million was primarily due to costs spent on strategic development and pre-commercialization activities and an increase in employee expenses and professional service fees.

    Conference Call on March 26, 2020

    The Company will host a conference call with the investment community Thursday, March 26, 2020 at 1:30 Pacific Time / 4:30 Eastern Time. The dial-in numbers for the conference call are (844) 379-5311 (U.S.) or (209) 905-5963 (international). The conference ID number is 4536336. To access the live webcast, please visit the Investor Relations page of the Zosano Pharma website at http://ir.zosanopharma.com/events.cfm.

    For interested individuals unable to join the live call, an archived webcast will be available on the Company's website at http://ir.zosanopharma.com/events.cfm approximately three hours after the call.

    About Zosano

    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 intracutaneous 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 intracutaneous 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 would streamline clinical development and accelerate the path towards commercialization.

    Forward-Looking Statements

    This press release contains forward-looking statements regarding the preparation for potential approval and launch of Qtrypta, the expected FDA decision on the NDA for Qtrypta and other future events and expectations described under "Expected Upcoming Milestones" and elsewhere 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," "unaudited," "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 for the remainder of 2020, 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, we 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 Contact:
    Christine Matthews
    Interim Chief Financial Officer
    (510) 745-1200

    PR Contacts:
    Sylvia Wheeler

    Alexandra Santos


    ZOSANO PHARMA CORPORATION
    STATEMENTS OF OPERATIONS
    (in thousands, except share and per share amounts)

        Three Months Ended December 31,   Year Ended December 31,
        2019   2018   2019   2018
        (unaudited)   (unaudited)        
    Revenue   $     $     $     $  
    Operating expenses:                
    Research and development   5,643     7,270     25,385     25,508  
    General and administrative   3,103     2,470     11,812     9,357  
    Impairment loss       511         511  
    Total operating expenses   8,746     10,251     37,197     35,376  
    Loss from operations   (8,746 )   (10,251 )   (37,197 )   (35,376 )
    Other income (expense):                
    Interest income   4     134     207     381  
    Interest expense   (166 )   (33 )   (523 )   (379 )
    Other income (expense), net   (32 )   3     (76 )   16  
    Net loss   $ (8,940 )   $ (10,147 )   $ (37,589 )   $ (35,358 )
    Net loss per common share – basic and diluted   $ (0.46 )   $ (0.85 )   $ (2.29 )   $ (3.74 )
    Weighted-average common shares used in computing net loss per common share – basic and diluted   19,408,544     11,973,039     16,383,730     9,452,491  


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

        December 31,
    2019
      December 31,
    2018
    ASSETS
    Current assets:        
    Cash and cash equivalents   $ 6,316     $ 9,140  
    Marketable securities at fair value       13,862  
    Prepaid expenses and other current assets   497     358  
    Total current assets   6,813     23,360  
    Restricted cash   455     455  
    Property and equipment, net   24,636     11,916  
    Operating lease right-of-use assets   5,763      
    Other long-term assets   3     49  
    Total assets   $ 37,670     $ 35,780  
     
    LIABILITIES AND STOCKHOLDERS' EQUITY
    Current liabilities:        
    Accounts payable   $ 4,356     $ 4,450  
    Accrued compensation   2,015     2,092  
    Build-to-suit obligation, current portion   4,554     2,326  
    Operating lease liabilities, current portion   1,140      
    Other accrued liabilities   4,154     2,414  
    Finance lease obligation, current portion   18     5  
    Total current liabilities   16,237     11,287  
    Build-to-suit obligation, long-term portion, net of debt issuance costs and discount   6,095     4,478  
    Operating lease liabilities   5,931      
    Finance lease obligation, long-term portion   15     18  
    Deferred rent       1,287  
    Total liabilities   28,278     17,070  
    Stockholders' equity:        
    Preferred stock, $0.0001 par value, 5,000,000 shares authorized; none issued and outstanding as of December 31, 2019 and 2018        
    Common stock, $0.0001 par value; 250,000,000 shares authorized as of December 31, 2019 and 2018, respectively; 23,503,214 and 11,973,039 shares issued and outstanding as of December 31, 2019 and 2018, respectively   2     1  
    Additional paid-in capital   308,211     279,946  
    Accumulated deficit   (298,821 )   (261,232 )
    Accumulated other comprehensive loss       (5 )
    Total stockholders' equity   9,392     18,710  
    Total liabilities and stockholders' equity   $ 37,670     $ 35,780  
                     

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