FREMONT, Calif., March 01, 2017 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), an emerging central nervous system company focused on providing symptom relief to patients using the Company's proprietary intracutaneous delivery system, today announced financial results for the fourth quarter and year ended December 31, 2016.
"The past year was an important period of progress for the Company as we initiated and in the fourth quarter completed ZOTRIP, our pivotal efficacy trial in migraine," commented Konstantinos Alataris, PhD, President and Chief Executive Officer of Zosano Pharma. "Subsequent to the fiscal year end, we announced positive results from the ZOTRIP trial, which not only advances our lead migraine program towards FDA approval but also further validates the effectiveness of our technology platform. If approved, M207 could be an important new therapeutic option for migraine patients."
The ZOTRIP trial was designed to be a registration-enabling, pivotal efficacy trial of M207 as an acute treatment for migraine. The study was a multicenter, double-blind, randomized, placebo-controlled, dose-ranging trial comparing three doses (1.0mg, 1.9mg and 3.8mg) of M207, a novel transdermal therapeutic, for a single migraine attack. A total of 589 subjects were enrolled at 36 sites across the United States. Dosing of ZOTRIP's first subject was announced in July of 2016. This past November, the Company announced the completion of ZOTRIP's enrollment.
Recent Highlights and Key Upcoming Milestones
Migraine is the leading cause of disability among neurological disorders in the United States according to the American Migraine Foundation. An estimated 30 million men, women and children in the United States suffer from migraine. Migraine can be extremely disabling and costly, accounting for more than an estimated $20 billion in direct (e.g., doctor visits, medications) and indirect (e.g., missed work, lost productivity) expenses each year in the United States.
M207 is our proprietary formulation of zolmitriptan coated onto our patented intracutaneous microneedle patch, which is then applied with our proprietary applicator to ensure uniform and consistent application. In a Phase 1 trial, M207 demonstrated markedly faster absorption kinetics compared to oral zolmitriptan. The Company presented these results at the 2016 annual meeting of the American Headache Society.
Financial Results for the Year Ended December 31, 2016
About Zosano Pharma
Zosano Pharma Corporation is an emerging CNS company focusing on providing rapid symptom relief to patients using known therapeutics and altering their delivery profile using the Company's proprietary intracutaneous delivery system. The Company's goal is to make intracutaneous drug delivery a standard of care for delivering drugs requiring fast onset of action. Zosano Pharma has developed its proprietary intracutaneous delivery system to administer proprietary formulations of existing drugs through the skin for the treatment of a variety of indications. The Company believes that its intracutaneous delivery system offers rapid and consistent drug delivery combined with ease of use. The Company is focused on developing products that deliver established molecules with known safety and efficacy profiles for markets where patients remain underserved by existing therapies. Zosano Pharma 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.
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 PHARMA CORPORATION AND SUBSIDIARIES|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(unaudited; in thousands, except per share amounts) |
|Three Months Ended December 31,||Year Ended December 31,|
|Research and development||5,413||5,665||20,457||20,366|
|General and administrative||2,039||1,518||8,176||6,315|
|Total operating expenses||7,452||7,183||28,633||26,681|
|Loss from operations||(7,452||)||(7,183||)||(28,633||)||(26,368||)|
|Other income (expenses):|
|Interest expense, net||(241||)||(317||)||(1,192||)||(1,564||)|
|Other expense, net||(56||)||(146||)||(7||)||(97||)|
|Warrant revaluation income||-||-||-||48|
|Loss on debt extinguishment||-||-||-||(446||)|
|Net loss per common share ̶ basic and diluted||$||(0.46||)||$||(0.64||)||$||(2.17||)||$||(2.49||)|
|Weighted-average shares used in computing net loss per common share ̶ basic and diluted||16,816||11,967||13,773||11,414|
|ZOSANO PHARMA CORPORATION AND SUBSIDIARIES|
|SELECTED CONSOLIDATED BALANCE SHEETS DATA|
|December 31,||December 31,|
|Cash, cash equivalents and marketable securities||$||15,003||$||36,933|
|Total current assets||15,276||37,271|
|Secured promissory note||12,542||15,270|
Zosano Contact: Georgia Erbez Chief Business Officer and Interim Chief Financial Officer 510-745-1200 Investor Contact: Jamien Jones Blueprint Life Science Group 415-375-3340 x 5 firstname.lastname@example.org