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FREMONT, Calif., Aug. 09, 2018 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ: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
Financial Results for the Second Quarter Ended June 30, 2018
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.
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.
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.
Chief Executive Officer and Chairman of the Board
LifeSci Public Relations
|ZOSANO PHARMA CORPORATION|
|CONDENSED STATEMENTS OF OPERATIONS|
|(unaudited; in thousands, except per share amounts)|
|Three Months Ended June 30,||Six Months Ended June 30,|
|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 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|
|June 30,||December 31,|
|Cash, cash equivalents and marketable securities||$||37,638||$||11,651|
|Total current assets||38,507||13,393|
|Secured promissory note||3,600||6,687|