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
“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
“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
Recent Business Highlights and Clinical Update
May 2018, Zosano completed enrollment for M207-ADAM long-term safety study, with 344 subjects enrolled in the study.
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).
May 2018, Zosano announced the appointment of Steven A. Elmsto the Board of Directors. Mr. Elms is a seasoned investment executive with extensive experience in M&A, financings, investment banking and capital market transactions.
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.
June 2018, Zosano’s Board of Directors appointed Kenneth Greathouseas lead independent director.
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.
June 2018, the Journal of Pharmaceuticspublished positive data from a nonclinical study evaluating pharmacokinetics and skin tolerability for ADAM™ technology for the delivery of zolmitriptan.
July 2018, the Journal of Pharmaceutical Sciencepublished 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
- Zosano reported a net loss of
$8.8 million, or $0.75per share on a basic and diluted basis, and $17.0 million, or $2.47per 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 $3.44per share on a basic and diluted basis, and $13.7 million, or $9.22per share on a basic and diluted basis, for the same periods in 2017.
- Research and development expenses were
$6.5 millionand $12.3 millionfor the three and six months ended June 30, 2018, respectively, compared to $4.4 millionand $9.0 millionfor 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 millionand $4.5 millionfor the three and six months ended June 30, 2018, respectively, compared to $2.2 millionand $4.3 millionfor 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 millionand 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 dollarsper share. The net proceeds to Zosano from this offering were $45.6 millionafter deducting underwriting discounts and commissions.
The Company will host a conference call with the investment community today,
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
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
|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|
Source: Zosano Pharma Corporation