On November 9, 2016 Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris"), a biopharmaceutical company developing topsalysin (PRX302) for the treatment of urological diseases, reported financial results for the three and nine months ended September 30, 2016 (Press release, Sophiris Bio, NOV 9, 2016, View Source [SID1234516726]).
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Business Highlights:
On August 26, 2016, the Company announced the closing of a public offering in which the Company raised net proceeds of $27.4 million. The Company plans to use the proceeds from this offering to fund a Phase 2b clinical trial for the treatment of localized prostate cancer and working capital and general corporate purposes, which may include research and development expenses, general and administrative expenses and manufacturing expenses.
During the third quarter of 2016, the Company received proceeds of $1.7 million from the exercise of warrants and stock options.
In September 2016, the Company repaid the outstanding principal balance of the loan with Oxford Finance LLC with a total payment of $4.2 million.
On October 12, 2016 the Board of Directors of Sophiris Bio Inc. approved the appointment of Allison Hulme, Ph.D., the Company’s chief operating officer and head of research and development, as a director of the Company.
"Sophiris has been successful in building on a series of positive clinical milestones that we believe will enable us to further the development of topsalysin," said Randall Woods, president and CEO of Sophiris Bio. "In the wake of announcing positive data from our Phase 2a proof-of-concept study in localized prostate cancer as well as from our Phase 3 trial in BPH that met its primary endpoint, the Company was able to raise additional funds in the public market in the third quarter to strengthen our balance sheet and enable us to fund an additional clinical trial. Over the past quarter, we have made significant progress in preparing to initiate a Phase 2b clinical trial of topsalysin for the treatment of localized prostate cancer, which is expected to report initial results by the end of 2017."
Financial Results:
At September 30, 2016, we had cash, cash equivalents and securities available-for-sale of $31.3 million and net working capital of $29.8 million. We expect that our cash and cash equivalents will be sufficient to fund our operations into the second quarter of 2018. At this point in time we do not plan on pursuing a second Phase 3 trial in BPH unless we obtain additional financing.
For the three months ended September 30, 2016
The Company reported a net loss of $4.3 million ($0.17 per share) for the three months ended September 30, 2016 compared to a net loss of $3.7 million ($0.22 per share) for the three months ended September 30, 2015.
Research and development expenses
Research and development expenses were $0.6 million for the three months ended September 30, 2016, compared to $2.6 million for the three months ended September 30, 2015. The decrease in research and development costs are primarily attributable to a decrease in the costs associated with the Company’s Phase 3 PLUS-1 clinical trial and our Phase 2a proof of concept clinical trial for localized prostate cancer both of which were completed prior to the third quarter.
General and administrative expenses
General and administrative expenses were $3.0 million for the three months ended September 30, 2016 compared to $0.9 million for the three months ended September 30, 2015. The increase is primarily due to the inclusion of $1.4 million in offering expenses which were allocated to the fair value of the warrants issued in our public offering in August 2016. The balance of the offering expenses were recorded as a reduction to equity. The increase was also related to an increase in personnel related costs and professional services.
Loss on revaluation of warrant liability.
Loss on revaluation of the warrant liability was $0.3 million for the three months ended September 30, 2016. The non-cash loss is associated with the change in the fair value of our warrant liability.
For the nine months ended September 30, 2016
The Company reported a net loss of $10.6 million ($0.51 per share) for the nine months ended September 30, 2016 compared to a net loss of $11.7 million ($0.69 per share) for the nine months ended September 30, 2015.
Research and development expenses
Research and development expenses were $2.5 million for the nine months ended September 30, 2016 compared to $8.2 million for the nine months ended September 30, 2015. The decrease in research and development costs are primarily attributable to a decrease of $5.2 million in the costs associated with the Company’s completed Phase 3 PLUS-1 clinical trial of topsalysin for the treatment of BPH and to a lesser extent a decrease in costs associated with our Phase 2a proof of concept clinical trial for localized prostate cancer and manufacturing activities for topsalysin.
General and administrative expenses
General and administrative expenses were $5.6 million for the nine months ended September 30, 2016 compared to $3.0 million for the nine months ended September 30, 2015. The increase is primarily due to the inclusion of $1.6 million in offering costs which were allocated to the warrants issued in connection with our offerings which closed in May and August of 2016. The increase, to a lesser extent, is due to an increase in personnel, legal, accounting, consulting and professional services. These increases were partially offset by a decrease in non-cash stock-based compensation expense.
Loss on revaluation of warrant liability.
Loss on revaluation of the warrant liability was $2.0 million for the nine months ended September 30, 2016. The non-cash loss is associated with the change in the fair value of our warrant liability.