On May 15, 2017 Sophiris Bio Inc. (NASDAQ: SPHS) (the “Company” or “Sophiris”), a late stage clinical biopharmaceutical company developing topsalysin (PRX302) for the treatment of patients with urological diseases, today reported first quarter financial results and key corporate highlights (Press release, Sophiris Bio, MAY 15, 2017, View Source [SID1234519162]).

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Key Corporate Highlights:

Update on Phase 2b Localized Prostate Cancer Study. In March 2017, the Company initiated its Phase 2b open-label localized prostate cancer study with investigational sites in both the UK and US. Five clinical trial sites have been initiated and additional sites are in the process of being initiated.

The Company is currently awaiting final regulatory clearance for the diluent (the medium in which topsalysin is diluted prior to dosing), which is anticipated this month, at which point the investigational sites will begin dosing patients.

The Company expects to receive the six-month biopsy data for all patients in the first quarter of 2018 assuming enrollment is completed as expected. The Company expects to have complete data on all patients who receive a second dose by the fourth quarter of 2018.

Presented Proof-of-Concept and Phase 2a Data at Global Urological Meetings. The Company presented positive data from its Phase 2a clinical trial of topsalysin for the focal treatment of localized prostate cancer at the 112th American Urological Association Annual Meeting and at the 32nd European Association of Urology Congress. Copies of the posters are available on the Company’s website at www.sophirisbio.com.

“We now have five clinical trial sites fully trained with additional sites coming onboard,” said Randall E. Woods, president and CEO of Sophiris. “The regulatory approval of the diluent is the last remaining box to check in the administrative work that enables the dosing of patients which we anticipate being able to do in the very near future.”

Financial Results:

At March 31, 2017, the Company had cash, cash equivalents and securities available-for-sale of $25.7 million and working capital of $25.6 million. The Company expects that its cash and cash equivalents will be sufficient to fund its operations through the end of 2018. The Company is currently not planning on pursuing a second Phase 3 trial in BPH, unless the Company can secure a development partner to fund a new clinical trial or the Company obtains other financing.

The Company reported a net loss of $2.6 million ($0.09 per share) for the three months ended March 31, 2017 compared to a net loss of $2.2 million ($0.13 per share) for the three months ended March 31, 2016.

Research and development expenses were $1.2 million for the three months ended March 31, 2017, compared to $0.9 million for the three months ended March 31, 2016. The increase in research and development expenses was primarily attributable to an increase in the costs associated with the Company’s on-going Phase 2b clinical trial for the focal treatment of localized prostate cancer which was initiated in March 2017 and, to a lesser extent, an increase in costs associated with manufacturing activities for topsalysin. These increases were partially offset by a decrease in costs associated with our completed Phase 2a proof of concept clinical trial for low to intermediate risk prostate cancer.

General and administrative expenses were $1.4 million for the three months ended March 31, 2017 compared to $1.2 million for the three months ended March 31, 2016. The increase in general and administrative expenses was primarily due to an increase in non-cash stock-based compensation expense which was offset by a reduction in legal and professional services.