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Tag: Zosano Pharma Corp.

  • Zosano Pharma Corp. (ZSAN) stock Continues its Uptrend After Hours. Here’s why?

    On March 16, Zosano Pharma Corp. (ZSAN) rebounded during the regular session after a continuous downfall. The stock continued its uptrend in the after-hours as well. There is no official announcement or SEC filing from the company behind the stock’s comeback.

    During the regular session, the stock rallies by a huge 19.09% after fluctuating between $0.1551 and $0.1900. ZSAN closed the session at a price of $0.1840 per share while 15.48 million shares exchanged hands. The tock continued its uptrend into the following after-hours session to add a further 8.42%. Thus, ZSAN was trading at a value of $0.1995 per share at an after-hours volume of 1.64 million shares on Wednesday.

    The clinical-stage biopharmaceutical company, Zosano Pharma Corp. has a market capitalization of $26.49 million. Currently, the company has 171.46 million shares outstanding in the market.

    What is Happening with ZSAN?

    ZSAN stock had been in a downtrend for the past few days. After a persistent but mild downward spiral for a few days, the stock rebounded on Wednesday. Since there is no recent news or SEC filing, the stock seems to be moving due to external factors. It seems social media chatter, stock sentiment combined with the downtrend were the cause of the recovery. Investors seem to be buying the dip as it provided a good investment opportunity.

    ZSAN stock stands at a year-to-date loss of 60.85% while it lost 20.83% last month. Moreover, the stock subtracted a huge value of 87.48% in the past year.

    Upcoming Special Meeting

    Source: Corpbiz

    According to the SEC filing of February 25, the company will hold a special meeting of stockholders on April 8, 2022, at 8:30 am, ET. The purpose of the meeting is a Reverse Stock Split Proposal in the range of 1-for-5 to 1-for-50 for regaining compliance with Nasdaq’s minimum bid requirement.

    Furthermore, the meeting will take place virtually on the internet via a webcast.

    FDA’s Response Letter to ZSAN

    As per the company’s SEC filing of February 18, ZSAN received a response letter from FDA on February 17 regarding its NDA resubmission. The company had resubmitted its NDA for M207, zolmitriptan microneedle system on January 18. According to the letter, the resubmission failed to fulfill the previously identified deficiencies in the resubmission. Thus, FDA informed to not commence a substantive review of the application.

    Additionally, the company started to analyze and work over its best course of action regarding the NDA.

  • Zosano Pharma Corp. (ZSAN) stock Rolls Down After Hours on FDA Complete Response Letter

    On February 18, Zosano Pharma Corp. (ZSAN) filed a current report on Form 8-K with the SEC. According to the filing, the company has received a complete response letter regarding the recent resubmission of the New Drug Application for M207. Thus, the company’s resubmitted NDA was also deemed incomplete and unacceptable by the FDA. Consequently, the stock took a harsh hit in the after-hours on Friday.

    The stock was already trading in the red during the regular session at a volume of 9.24 million shares. ZSAN closed the session at $0.2159 with a loss of 3.49% after it reached a value of $0.2249. Following the SEC filing, the stock suffered a loss of 28.67% at 4.24 million shares. Hence, ZSAN stock was trading at a value of $0.1540 per share in the after-hours on Friday.

    The clinical-stage biopharmaceutical company, Zosano Pharma Corp. has a market capitalization of $37.02 million. Currently, the company has 171.46 million shares outstanding in the market.

    Recent Complete Response Letter

    Previously, the company had received a complete response letter from the FDA on October 19, 2020, regarding the NDA submission of M207. M207 is the companies investigational zolmitriptan transdermal microneedle system. The CRL highlighted the deficiencies in the NDA submission and suggested further studies and data provision. Therefore, the company conducted a Phase 1 PK study which was recently completed.

    On January 18, 2022, ZSAN resubmitted the 505(b)(2) New Drug Application for M207 with the FDA. As per February 18’s filing, the company received a response letter to the resubmission of February 17. According to the response letter, the company has failed to complete all the deficiencies highlighted in the previous CRL. So, the FDA will not be commencing a substantive review of the application unless a complete response is received.

    While the company is assessing its best course of action, there is no certainty as to whether it would be able to further pursue the NDA submission of M207. After the financial and strategic evaluation and planning, the company will decide upon a path.

    ZSAN’s Q3 Highlights

    In the third quarter of 2021, the company had a net loss of $8.7 million ($0.07/share), against $8.7 million ($0.11/share) in the year-ago quarter.

    ZSAN ended the quarter with cash and cash equivalents of $17.1 million on September 30, 2021. Comparatively, the company had $35.3 million on December 31, 2020.

  • The Zosano Pharma Corp. (NASDAQ: ZSAN) stock rises by 12.78% in afterhours. Here’s to know why:

    The Zosano Pharma Corp. (NASDAQ: ZSAN) stock rises by 12.78% in afterhours. Here’s to know why:

    Zosano Pharma Corp. (NASDAQ: ZSAN) stock showed a downswing by 5.00% in the last trading close whereas the stock rises in after-hours by 12.78%. There is no recent news or press release available, to be the exact reason behind this change in ZSAN stock price. On 11 March, ZSAN has announced its fourth quarter and fiscal year 2020 financial results which could might be the reason behind this up and down in Zosano Pharma stock price. Zosano Pharma Corp is a biopharmaceutical company that focuses on developing products with rapid administration of approved molecules and established safety and efficacy profiles to provide benefit to the patient whereas in the market people do not get the treatment that they need.

    Financial Results

    • ZSAN has reported a net loss of $8.1 million in the fourth quarter of 2020 as compared to $8.9 million in the fourth quarter of 2019. For full-year 2020, ZSAN stock has experienced a net loss of $33.4 million compared to $37.6 million for the full year 2019.
    • ZSAN has calculated its Research and Development expenses as $5.4 million in the fourth quarter of 2020 compared with $5.6 million for the same quarter of 2019. The decrease of $0.2 was mainly due to $0.4 million of lower employee and consulting expenses. For full-year 2020, the R&D expenses were $21.6 million compared with $25.4 million in full-year 2019.
    • General and administrative expense in the fourth quarter of ZSAN financial year was $2.6 million, while for the fourth quarter of 2019 it was $3.1million. For the full year 2020, the G&A expense was $11.2 million while it was $11.8 million for the full year 2019. The decrease of $0.5 million and $0.6 million is due to lower employee-related expenses.
    • Lastly, ZSAN recorded its cash and cash equivalents as $35.3 million which was previously calculated as $6.3 million as of December 31, 2019.

    Conclusion

    If we look closely at the financial results, ZSAN has made better progress as compared to the previous year despite the pandemic situation going on in the world. This could be a solid reason for investors to show their interest in ZSAN stock that has caused the rise in stock. Furthermore, ZSAN has signed few important agreements, one of which is with Mitsubishi Tanabe Pharma Corporation and partnerships with EVERSANA which is a promising sign for the future of Zosano Pharma Corp.