Zosano Pharma Reports Third Quarter 2018 Financial Results and Operational Update
- Selected a contract manufacturer for commercial launch of M207
- Completed first required data set in long-term safety study of M207
Greg Kitcheneras Chief Financial Officer
“The Company has continued to execute upon our stated milestones throughout 2018. We recently completed our registration batches; reached an important milestone in our long-term safety study as 150 patients completed 6 months of therapy; secured a capital equipment lease line and contracted with a leading organization to manufacture M207. This manufacturing arrangement provides production capacity for the commercial launch of M207 and frees up our in house manufacturing capacity for research and the production of clinical trial material as we seek to expand our portfolio of proprietary programs,” stated
Recent Business Highlights and Clinical Update
September 2018, Dr. Stewart Tepperpresented M207 data, when used for the treatment of difficult to treat migraines at the 17th Biennial Migraine Trust International Symposium (MTIS).
September 2018, Zosano presented a phase 3 safety study update for ADAM technology for the delivery of zolmitriptan at the 5th Annual Transdermal and Intradermal Drug Delivery Systems Conference.
September 2018, Zosano announced completion and release of registration batches of M207.
September 2018, Zosano entered into a financing partnership with Trinity Capitalinvestments that provides a capital equipment leasing line of up to $14.0 million.
October 2018, Zosano entered into a long-term manufacturing and supply agreement with Patheon, a leading global contract development and manufacturing organization.
October 2018, Zosano appointed Greg Kitcheneras Chief Financial Officer.
October 2018, Zosano hosted a key opinion leader meeting on new treatments for Migraine. A replay is accessible via the link here.
October 2018, Zosano announced more than 150 evaluable subjects have completed their six month visit in the M207-ADAM study and more than 4,000 migraines treated since study initiation.
Financial Results for the Third Quarter Ended
- Zosano reported a net loss of
$8.2 million, or $0.68per share on a basic and diluted basis, and $25.2 million, or $2.93per share on a basic and diluted basis, for the three and nine months ended September 30, 2018, respectively, compared to a net loss of $7.9 million, or $0.20per share on a basic and diluted basis, and $21.6 million, or $0.66per share on a basic and diluted basis, for the same periods in 2017.
- Research and development expenses were
$5.9 millionand $18.2 millionfor the three and nine months ended September 30, 2018, respectively, compared to $5.7 millionand $14.7 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 completion of the registration batches.
- General and administrative (G&A) expenses were
$2.4 millionand $6.9 millionfor the three and nine months ended September 30, 2018, respectively, compared to $2.0 millionand $6.3 millionfor the same periods in 2017. The increase in general and administrative expenses was due to an increase in software implementation costs as well as an increase in payroll and stock compensation costs.
- As of
September 30, 2018, Zosano had cash, cash equivalents and marketable securities of $29.5 million, debt of $4.6 millionand approximately 12 million shares of common stock outstanding.
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 Zosano’s proprietary formulation of zolmitriptan delivered utilizing its proprietary ADAM technology. Zosano's ADAM technology consists of titanium microprojections (microneedles) coated with drug, and in the case of M207, its formulation of zolmitriptan. The drug-coated microneedles penetrate into the epidermis and dermis, where the drug is dissolved and enters into the bloodstream. In
This press release contains forward-looking statements. All statements other than statements of historical facts contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the expected timing of a New Drug Application for M207, the expected timing of the final data set in the Company’s long-term safety study, and the expected timing of stability testing for GMP manufacturing lots. 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," "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, without limitation, risks and uncertainties associated with the process of discovering, developing and commercializing products that are safe and effective for use as human therapeutics, risks and uncertainties relating to the Company’s depence on third parties for the development and commercialization of M207, risks and uncertainties of the regulatory approval process, risks and uncertainties 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 filed with the
Chief Financial Officer
LifeSci Public Relations
|ZOSANO PHARMA CORPORATION|
|CONDENSED STATEMENTS OF OPERATIONS|
|(unaudited; in thousands, except per share amounts)|
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Research and development||5,899||5,683||18,238||14,672|
|General and administrative||2,353||2,036||6,887||6,346|
|Total operating expenses||8,252||7,719||25,125||21,018|
|Loss from operations||(8,252||)||(7,719||)||(25,125||)||(21,018||)|
|Other income (expenses):|
|Interest income (expense), net||74||(154||)||(99||)||(608||)|
|Other income, net||9||-||13||10|
|Net loss per common share ̶ basic and diluted||$||(0.68||)||$||(0.20||)||$||(2.93||)||$||(0.66||)|
|Weighted-average shares used in computing net loss per common share ̶ basic and diluted||11,973||39,228||8,603||32,991|
|ZOSANO PHARMA CORPORATION|
|SELECTED CONDENSED BALANCE SHEETS DATA|
|(unaudited; in thousands)|
|September 30,||December 31,|
|Cash, cash equivalents and marketable securities||$||29,476||$||11,651|
|Total current assets||30,545||13,393|
|Secured promissory note||-||6,687|
|Equipment line of credit||4,601||-|
Source: Zosano Pharma Corporation