Zosano Pharma Corp (NASDAQ:ZSAN) reported financial results for the first quarter ended March 31, 2017. In addition, John P. Walker, Chairman of the company’s Board of Directors, has been named Interim Chief Executive Officer to replace Konstantinos Alataris who has resigned as CEO and director of the company. Georgia Erbez, our Chief Business Officer and Interim Chief Financial Officer, has assumed full responsibility for both functions.
“The first quarter saw our lead product candidate meet both co-primary endpoints in ZOTRIP, our pivotal efficacy study of M207 as an acute treatment for migraine. In addition, the company completed a follow-on offering that resulted in $29.3 million in gross proceeds earmarked for advancing M207 towards FDA approval. These two important accomplishments are a result of the commitment and capabilities of Zosano’s management team and gives me great confidence in our ability to continue to meet the strategic milestones established by the company.”
“The pivotal study results importantly validate our technology platform, and, if approved by the FDA, point to M207’s positioning as an acute treatment for migraine sufferers that is differentiated from what is currently available. I look forward to working with the team at Zosano and to bringing this exciting new drug to market,” commented John P. Walker, Interim Chief Executive Officer.
“On behalf of the Board of Directors, I want to thank Konstantinos Alataris for his efforts and commitment to the company over the past two years. We wish him well in his future endeavors,” added Walker.
Pivotal Study Results / Status
In February, the Company announced statistically significant results from the ZOTRIP trial, 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. The 3.8mg dose achieved a p value of <0.05 in the secondary endpoints of pain freedom at 45 minutes and 1 hour, and showed durability of effect on pain freedom to 24 and 48 hours. These results demonstrated that M207 not only provided fast onset but also a durability of effect, up to 2 days and hence freedom from recurrence of migraine. Additionally, M207 demonstrated a similar safety profile as other triptans and no Serious Adverse Events (SAEs) were reported in the trial.
The FDA has indicated that a single, positive, pivotal efficacy study, in addition to a safety study of M207, will be sufficient to file for approval under a 505(b)(2) pathway. The Company plans to initiate the safety study in the second half of 2017.
Financial Results for the First Quarter Ended March 31, 2017
- Zosano reported a net loss for the first quarter of 2017 of $7.0 million, or $0.34 per share on a basic and diluted basis, compared with a net loss of $8.1 million, or $0.68 per share on a basic and diluted basis, for the same quarter in 2016.
- Research and development (R&D) expenses for the first quarter of 2017 were $4.6 million, compared with $5.6 million for the same quarter in 2016. The decrease was primarily driven by decreased costs for the M207 efficacy study upon completion of the pivotal efficacy trial and by the workforce reduction costs associated with our strategic realignment in the first quarter of 2016.
- General and administrative (G&A) expenses for the first quarter of 2017 were $2.1 million, compared with $2.2 million for the same quarter in 2016. G&A expenses were essentially consistent and were primarily composed of personnel, consulting costs, and stock compensation expense.
- As of March 31, 2017, we had cash and cash equivalents of $37.3 million, and debt of $11.2 million. As of March 31, 2017, we had approximately 39.2 million common shares outstanding. In March, Zosano announced the completion of a public offering of common stock that generated aggregate gross proceeds of approximately $29.3 million. The financing provides funding for the continued advancement of M207 towards an NDA submission.
Shares of Zosano Pharma are falling nearly 10% to $1.30 in after-hours trading. ZSAN has a 1-year high of $3.54 and a 1-year low of $0.45. The stock’s 50-day moving average is $1.64 and its 200-day moving average is $1.33.
Zosano Pharma Corp. is a clinical stage pharmaceutical company that develops proprietary intracutaneous delivery system. It offers rapid absorption of drug, consistent drug delivery, improved ease of use and room-temperature stability, benefits that differentiate its delivery platform from other non-oral formulations or injections.