Zosano Pharma Corporation (ZSAN)

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Zosano Pharma Completes Manufacture of M207 Registration Batches

FREMONT, Calif., Sept. 19, 2018 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (ZSAN) (“Zosano” or the “Company”), a clinical-stage biopharmaceutical company focused on providing rapid systemic administration of therapeutics to patients using its proprietary Adhesive Dermally-Applied Microneedle (“ADAM™”) technology, today announced the release of three registration batches of M207, the Company’s lead development candidate.

The registration batches will be used to support Zosano’s New Drug Application (NDA) filing with the U.S. Food and Drug Administration (FDA). Twelve months of room temperature stability for a product candidate are typically required in order for the FDA to assess manufacturability and stability of a drug product. Zosano’s batches have been placed on stability per regulatory requirements and will complete the 12-month timepoint in September of 2019.

“This is a significant milestone for Zosano in the development of our lead product candidate, M207,” said Hayley Lewis, senior vice president, operations at Zosano Pharma. “Our process development and manufacturing teams have successfully established a robust process to scale up for commercial manufacturing of M207. We can now confidently say we have completed an important requirement in anticipation of our filing in Q4 2019, which is a monumental and very encouraging accomplishment.”

About M207

M207 is our proprietary formulation of zolmitriptan delivered utilizing Zosano's proprietary ADAM technology. Zosano's ADAM technology consists of titanium microprojections (microneedles) coated with drug, and in the case of M207, our formulation of zolmitriptan. The drug-coated microneedles penetrate into the epidermis and dermis, where the drug is dissolved and enters into the bloodstream. In February 2017, the Company announced statistically significant results from the ZOTRIP pivotal study, which demonstrated that the 3.8mg dose of M207 met both co-primary endpoints, achieving pain freedom and most bothersome symptom freedom at 2 hours. In November 2017, the Company announced the initiation of its long-term safety study evaluating M207 and expects to file an NDA for M207 in the fourth quarter of 2019.

Forward-Looking Statements

This press release contains forward-looking statements regarding the timing of expected clinical development milestones, sufficiency of our capital resources and need for future funding and other future events and expectations. 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 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. Although we believe 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:
John Walker
Chief Executive Officer and Chairman of the Board
510-745-1200

Media Contact:
Sara Zelkovic
LifeSci Public Relations
[email protected]
(646) 876-4933

Shareholders Should Check If Insiders Own Shares In Zosano Pharma Corporation (NASDAQ:ZSAN)

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Every investor in Zosano Pharma Corporation (NASDAQ:ZSAN) should be aware of the most powerful shareholder groups. Institutions often own shares in more established companies, while it’s not unusual to see insiders own a fair bit of smaller companies. We also tend to see lower insider ownership in companies that were previously publicly owned.

Zosano Pharma is a smaller company with a market capitalization of US$49.0m, so it may still be flying under the radar of many institutional investors. Taking a look at the our data on the ownership groups (below), it’s seems that institutional investors have bought into the company. Let’s take a closer look to see what the different types of shareholder can tell us about ZSAN.

See our latest analysis for Zosano Pharma

NasdaqCM:ZSAN Ownership Summary September 14th 18

What Does The Institutional Ownership Tell Us About Zosano Pharma?

Many institutions measure their performance against an index that approximates the local market. So they usually pay more attention to companies that are included in major indices.

As you can see, institutional investors own 36.8% of Zosano Pharma. This can indicate that the company has a certain degree of credibility in the investment community. However, it is best to be wary of relying on the supposed validation that comes with institutional investors. They too, get it wrong sometimes. It is not uncommon to see a big share price drop if two large institutional investors try to sell out of a stock at the same time. So it is worth checking the past earnings trajectory of Zosano Pharma, (below). Of course, keep in mind that there are other factors to consider, too.

NasdaqCM:ZSAN Income Statement Export September 14th 18

It would appear that 8.4% of Zosano Pharma shares are controlled by hedge funds. That’s interesting, because hedge funds can be quite active and activist. Many look for medium term catalysts that will drive the share price higher. While there is some analyst coverage, the company is probably not widely covered. So it could gain more attention, down the track.

Insider Ownership Of Zosano Pharma

While the precise definition of an insider can be subjective, almost everyone considers board members to be insiders. Management ultimately answers to the board. However, it is not uncommon for managers to be executive board members, especially if they are a founder or the CEO.

I generally consider insider ownership to be a good thing. However, on some occasions it makes it more difficult for other shareholders to hold the board accountable for decisions.

Our information suggests that Zosano Pharma Corporation insiders own under 1% of the company. It has a market capitalization of just US$49.0m, and the board has only US$161.9k worth of shares in their own names. Many investors in smaller companies prefer to see the board more heavily invested. You can click here to see if those insiders have been buying or selling.

General Public Ownership

The general public, with a 33.9% stake in the company, will not easily be ignored. While this size of ownership may not be enough to sway a policy decision in their favour, they can still make a collective impact on company policies.

Private Equity Ownership

Private equity firms hold a 20.0% stake in ZSAN. This suggests they can be influential in key policy decisions. Sometimes we see private equity stick around for the long term, but generally speaking they have a shorter investment horizon and — as the name suggests — don’t invest in public companies much. After some time they may look to sell and redeploy capital elsewhere.

Next Steps:

I find it very interesting to look at who exactly owns a company. But to truly gain insight, we need to consider other information, too.

I like to dive deeper into how a company has performed in the past. You can find historic revenue and earnings in this detailed graph.

If you would prefer discover what analysts are predicting in terms of future growth, do not miss this free report on analyst forecasts.

NB: Figures in this article are calculated using data from the last twelve months, which refer to the 12-month period ending on the last date of the month the financial statement is dated. This may not be consistent with full year annual report figures.

To help readers see past the short term volatility of the financial market, we aim to bring you a long-term focused research analysis purely driven by fundamental data. Note that our analysis does not factor in the latest price-sensitive company announcements.

The author is an independent contributor and at the time of publication had no position in the stocks mentioned. For errors that warrant correction please contact the editor at [email protected].

Zosano Pharma to Present Phase 3 Safety Study Update for ADAM™ Technology in the Delivery of Zolmitriptan at the 5th Annual Transdermal & Intradermal Drug Delivery Systems Conference

FREMONT, Calif., Sept. 06, 2018 (GLOBE NEWSWIRE) --

Zosano Pharma Corporation (ZSAN) (“Zosano” or the “Company”), a clinical-stage biopharmaceutical company, developing and commercializing therapies that deliver rapid systemic absorption by leveraging its novel and proprietary technology called Adhesive Dermally-Applied Microarray (“ADAM™”), is scheduled to present an update on its ongoing Phase 3 long-term safety trial utilizing its proprietary ADAM technology for the delivery of zolmitriptan at the 5th Annual Transdermal & Intradermal Drug Delivery Systems Conference being held on September 6-7, 2018 in Philadelphia, PA.

“Our ADAM technology continues to perform well in clinical studies, which supports the potential to develop ADAM with new drugs for additional indications. One of the major potential advantages of our ADAM technology is the ability to effectively deliver a drug through the skin, as some drugs have poor oral bioavailability and slow intestinal absorption," said Dr. Donald Kellerman, vice president of clinical development and medical affairs at Zosano. "We are pleased with these promising results and believe that this presentation highlights the potential of our technology for the delivery of zolmitriptan for the treatment of migraine.”

Oral Presentation:          Update on a Long-Term Safety Trial Using a Microneedle System
Presenter:                       Donald Kellerman, vice president of clinical development and medical affairs
Date:                                September 7th, 2018
Time:                               10:15 AM EDT
Location:                         The Racquet Club of Philadelphia

About M207
M207 is our proprietary formulation of zolmitriptan delivered utilizing Zosano's proprietary ADAM technology. Zosano's ADAM technology consists of titanium microprojections (microneedles) coated with drug, and in the case of M207, our formulation of zolmitriptan. The drug-coated microneedles  penetrate into the epidermis and dermis, where the drug is dissolved and enters into the bloodstream. In February 2017, the Company announced statistically significant results from the ZOTRIP pivotal study, which demonstrated that the 3.8mg dose of M207 met both co-primary endpoints, achieving pain freedom and most bothersome symptom freedom at 2 hours.  In November 2017, the Company announced the initiation of its long-term safety study evaluating M207 and expects to file an NDA for M207 in the fourth quarter of 2019.

Forward-Looking Statements
This press release contains forward-looking statements regarding the timing of expected clinical development milestones, sufficiency of our capital resources and need for future funding and other future events and expectations. 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 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. Although we believe 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:
John Walker
Chief Executive Officer and Chairman of the Board
510-745-1200

Media Contact:
Sara Zelkovic
LifeSci Public Relations
[email protected]
(646) 876-4933

Zosano Pharma and Collaborators to Present Efficacy Data for M207 in the Treatment of Migraine at the 17th Biennial Migraine Trust International Symposium (MTIS)

FREMONT, Calif., Sept. 05, 2018 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (ZSAN) (“Zosano” or the “Company”), a clinical-stage biopharmaceutical company focused on providing rapid systemic administration of therapeutics to patients using its proprietary Adhesive Dermally-Applied Microarray (“ADAM™”) technology, today announced additional efficacy data will be presented in a digital poster during the 17th Biennial Migraine Trust International Symposium (MTIS) to be held from September 6-9, 2018 in London, United Kingdom.

“The selection of our abstract for oral presentation demonstrates the significant need for new and effective therapies for patients with difficult to treat migraine,” said lead author Stewart Tepper M.D., Professor of Neurology, Geisel School of Medicine at Dartmouth and Director of the Dartmouth Headache Clinic in Lebanon, New Hampshire. “To date, M207 has shown great potential in the treatment of traditionally difficult to treat migraine. We are pleased to have the opportunity to present our data with M207 before the world’s leading experts on migraine and headache.”

Title:  Efficacy of M207 (Intracutaneous Zolmitriptan) for the Acute Treatment of Difficult to Treat Migraine
Presenter:  Dr. Stewart Tepper
Abstract #:  MTIS2018-063
Date:  Friday, September 7, 2018
Time:  3:20-3:25 PM BST
Location:  Hilton London Metropole, Exhibition Hall (Monarch Suite), Digital Poster Booth 2

Further details can be found on the MTIS website at http://mtis2018.org/.

About M207

M207 is our proprietary formulation of zolmitriptan delivered utilizing Zosano's proprietary ADAM technology. Zosano's ADAM technology consists of titanium microprojections (microneedles) coated with drug, and in the case of M207, our formulation of zolmitriptan. The drug-coated microneedles  penetrate into the epidermis and dermis, where the drug is dissolved and enters into the bloodstream. In February 2017, the Company announced statistically significant results from the ZOTRIP pivotal study, which demonstrated that the 3.8mg dose of M207 met both co-primary endpoints, achieving pain freedom and most bothersome symptom freedom at 2 hours.  In November 2017, the Company announced the initiation of its long-term safety study evaluating M207 and expects to file an NDA for M207 in the fourth quarter of 2019.

Forward-Looking Statements

This press release contains forward-looking statements regarding the timing of expected clinical development milestones, sufficiency of our capital resources and need for future funding and other future events and expectations. 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 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. Although we believe 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:
John Walker
Chief Executive Officer and Chairman of the Board
510-745-1200

Media Contact:
Sara Zelkovic
LifeSci Public Relations
[email protected]
(646) 876-4933


Zosano Pharma Reports Second Quarter 2018 Financial Results and Operational Update

  • Completed enrollment for our M207-ADAM study with 344 subjects
  • Presented additional analyses from the ZOTRIP pivotal study on pain relief and recurrence at the 2018 American Headache Society (AHS) meeting
  • Published M207 nonclinical data in multiple leading scientific journals

FREMONT, Calif., Aug. 09, 2018 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (ZSAN), a clinical-stage biopharmaceutical company, developing and commercializing therapies that deliver rapid systemic absorption by leveraging its novel and proprietary technology called Adhesive Dermally-Applied Microarray (“ADAM™”), today announced financial results for the second quarter ended June 30, 2018.

“In the second quarter, enrollment was completed for the M207-ADAM study, a long-term safety study for the acute treatment of migraine. Since study initiation in November 2017, a total of 344 subjects have been enrolled in the study and received M207. The open-label study, designed in consultation with the FDA will evaluate at least 150 subjects for six months and at least 50 subjects for a year,” commented John Walker, Chairman and Chief Executive Officer. “We are pleased with the observed data from the study thus far, which illustrates that the ADAM patch is reported to be well-tolerated by subjects after multiple applications for their migraines. Additionally, there have been no drug related serious adverse events reported to date. Importantly, efficacy based on the secondary measures of observed pain freedom at two hours and pain relief at two hours remain consistent with earlier clinical studies at 42% response rate and 84% response rate, respectively.”

“In the second quarter, we continued to grow our body of evidence supporting the development and potential commercialization of M207. Analyses from the M207 Phase 2/3 clinical study on pain relief by time and recurrence of migraine in subjects with pain relief at two hours were presented at the American Headache Society (AHS) meeting in June. The data showed M207 demonstrated both early and durable responses in the treatment of migraine,” Mr. Walker continued. “During AHS, there was also a poster and oral presentation on key findings for receptor binding kinetics of zolmitriptan and sumatriptan. These findings showed differences between the two compounds, with zolmitriptan having a longer duration of receptor occupancy, providing a potential mechanistic rationale for the durability of effect seen in the ZOTRIP Study.”

Recent Business Highlights and Clinical Update

  • In May 2018, Zosano completed enrollment for M207-ADAM long-term safety study, with 344 subjects enrolled in the study.
  • In May 2018, Zosano announced the publication of most bothersome symptom (MBS) data from the ZOTRIP pivotal study in Headache: the Journal of Head and Face Pain. MBS freedom at two hours was observed in 68% of M207 3.8 mg subjects as compared to 43% of placebo subjects (P < .0009).
  • In May 2018, Zosano announced the appointment of Steven A. Elms to the Board of Directors. Mr. Elms is a seasoned investment executive with extensive experience in M&A, financings, investment banking and capital market transactions.
  • In May 2018, the company entered into a new employment agreement with John Walker, Chairman and CEO, reflecting his full-time status and commitment to Zosano Pharma.
  • In June 2018, Zosano’s Board of Directors appointed Kenneth Greathouse as lead independent director.
  • In June 2018, Zosano presented at the 2018 American Headache Society (AHS) meeting additional analyses from the ZOTRIP pivotal study on pain relief and recurrence, demonstrating both early onset and durability of effect.
  • In June 2018, the Journal of Pharmaceutics published positive data from a nonclinical study evaluating pharmacokinetics and skin tolerability for ADAM™ technology for the delivery of zolmitriptan.
  • In July 2018, the Journal of Pharmaceutical Science published skin tolerability and bioavailability data using ADAM’s intracutaneous zolmitriptan delivery. The pharmacokinetic studies showed that the ADAM 1.9-mg zolmitriptan was delivered with high efficiency (85%) and high absolute bioavailability (77%).

Financial Results for the Second Quarter Ended June 30, 2018

  • Zosano reported a net loss of $8.8 million, or $0.75 per share on a basic and diluted basis, and $17.0 million, or $2.47 per share on a basic and diluted basis, for the three and six months ended June 30, 2018, respectively, compared to a net loss of $6.7 million, or $3.44 per share on a basic and diluted basis, and $13.7 million, or $9.22 per share on a basic and diluted basis, for the same periods in 2017.

  • Research and development expenses were $6.5 million and $12.3 million for the three and six months ended June 30, 2018, respectively, compared to $4.4 million and $9.0 million for the same periods in 2017. The increase in research and development expenses was primarily attributable to an increase in clinical trial costs related to the M207-ADAM study and to support production of the registration batches.

  • General and administrative (G&A) expenses were $2.3 million and $4.5 million for the three and six months ended June 30, 2018, respectively, compared to $2.2 million and $4.3 million for the same period in 2017. The increase in general and administrative expenses was due to the increased rent, franchise taxes, and other general corporate activities.

  • As of June 30, 2018, we had cash, cash equivalents and marketable securities of $37.6 million, debt of $3.6 million and approximately 12 million common shares outstanding. In April 2018, Zosano announced the closing of a public offering of 10 million shares of its common stock at a price of five dollars per share. The net proceeds to Zosano from this offering were $45.6 million after deducting underwriting discounts and commissions.

Conference Call

The Company will host a conference call with the investment community today, August 9th, at 4:30 p.m. 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 2469348. To access the live webcast, please visit the Investor Relations page of the Zosano Pharma website at http://ir.zosanopharma.com/events.cfm. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.

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 and available through September 9, 2018.

About M207

M207 is our proprietary formulation of zolmitriptan delivered utilizing Zosano's proprietary ADAM technology. Zosano's ADAM technology consists of titanium microprojections coated with drug, and in the case of M207, our formulation of zolmitriptan. The drug-coated microneedles physically break through the stratum corneum and penetrate into the epidermis and dermis, where the dry drug coating is dissolved by the surrounding skin interstitial fluid. In February 2017, the Company announced statistically significant results from the ZOTRIP pivotal study, which demonstrated that the 3.8mg dose of M207 met both co-primary endpoints, achieving pain freedom and most bothersome symptom freedom at 2 hours. In November 2017, the Company announced the initiation of its long-term safety study evaluating M207 and anticipates filing an NDA for M207 in the fourth quarter of 2019.

Forward-Looking Statements

This press release contains forward-looking statements regarding the timing of expected clinical development milestones, sufficiency of our capital resources and need for future funding and other future events and expectations. 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 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. Although we believe 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:
John Walker
Chief Executive Officer and Chairman of the Board
510-745-1200

Media Contact:
Sara Zelkovic
LifeSci Public Relations
[email protected]
646-876-4933


ZOSANO PHARMA CORPORATION
CONDENSED STATEMENTS OF OPERATIONS
(unaudited; in thousands, except per share amounts)
                 
    Three Months Ended June 30,   Six Months Ended June 30,
      2018       2017       2018       2017  
                 
Revenue:   $ -     $ -     $ -     $ -  
Operating expenses:                
Research and development     6,533       4,363       12,339       8,989  
General and administrative     2,272       2,188       4,532       4,310  
Total operating expenses     8,805       6,551       16,871       13,299  
Loss from operations     (8,805 )     (6,551 )     (16,871 )     (13,299 )
Other income (expenses):                
Interest expense, net     (33 )     (207 )     (174 )     (454 )
Other income, net     2       12       3       10  
Net loss   $ (8,836 )   $ (6,746 )   $ (17,042 )   $ (13,743 )
                 
Net loss per common share  ̶  basic and diluted   $ (0.75 )   $ (3.44 )   $ (2.47 )   $ (9.22 )
                 
Weighted-average shares used in computing net loss per common share  ̶  basic and diluted     11,753       1,960       6,890       1,491  


ZOSANO PHARMA CORPORATION
SELECTED CONDENSED BALANCE SHEETS DATA
(in thousands)
         
    June 30,   December 31,
    2018   2017
    (unaudited)      
Cash, cash equivalents and marketable securities   $ 37,638   $ 11,651
Total current assets     38,507     13,393
Total assets     45,226     18,000
Secured promissory note     3,600     6,687
Total liabilities     9,146     10,952
Stockholders’ equity     36,080     7,048


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