On November 16, 2015 Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris"), a biopharmaceutical company developing PRX302 (topsalysin) for the treatment of urological diseases, reported financial results for the three and nine months ended September 30, 2015 (Press release, Sophiris Bio, NOV 16, 2015, View Source [SID:1234508265]).
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Business Highlights:
On November 10, 2015, the Company announced final positive results from its Phase 3 "PLUS-1" study of PRX302 as a treatment for lower urinary tract symptoms of benign prostatic hyperplasia (BPH, enlarged prostate). PRX302 demonstrated a statistically significant improvement in International Prostate Symptom Score (IPSS) total score from baseline over 12 months compared to the vehicle-only control group (7.60 vs. 6.58 point overall improvement; p = 0.043), the primary endpoint of the study. The clinical relevance of the overall improvement in IPSS was assessed by an additional efficacy endpoint, the patient self-assessment of the impact of treatment on their quality of life, which was assessed using the 0 – 6 point Quality of Life from the IPSS questionnaire. The PRX302 average change from the 4.5 point baseline was a sustained 1.6 to 1.7 points improvement from Weeks 18 through 52, which was statistically significantly superior to patients treated with vehicle for every post-baseline visit beginning at week 18 (reaching p = 0.004). PRX302 treatment was generally well tolerated in the study and continues to demonstrate a favorable safety profile, with no evidence of any treatment related sexual or cardiovascular side effects.
A total of 17 patients with clinically significant, localized low to intermediate risk prostate cancer have been enrolled in the ongoing Phase 2a proof of concept study. The study utilizes previously obtained MRI images mapped to real time 3D ultrasound to target the delivery of PRX302 directly into and around a pre-identified clinically significant tumor. The study is being conducted at a single center well known for the focal treatment of prostate cancer in the UK. Although the primary objective of the study is to assess safety and tolerability, potential efficacy will be assessed by biopsy after six months. The Company expects to have initial data on histological and MRI changes after six months for approximately half the patients in early 2016 and final data on all patients in the second quarter of 2016.
"We have remained focused and diligent at Sophiris as we approach key data milestones, and that steadfast commitment and belief in our topsalysin programs is paying off," stated Randall Woods, president and CEO of Sophiris Bio. "The successful outcome of the Phase 3 PLUS-1 study indicates that patients treated with topsalysin experienced a significant improvement in their BPH symptoms and their quality of life. These data increase our confidence in the targeted mechanism by which topsalysin ablates prostate tissue, thus supporting our rationale for advancing the development of topsalysin as a treatment for localized prostate cancer. We are fast approaching another key data milestone in early 2016, in which we anticipate initial data from a Phase 2a proof of concept trial of topsalysin in patients with localized low to intermediate risk prostate cancer."
Financial Results
At September 30, 2015, we had cash, cash equivalents and securities available-for-sale of $9.9 million and net working capital of $7.6 million. We expect that our cash, cash equivalents and securities available-for-sale as of September 30, 2015 will be sufficient to fund our operations through the end of April 2016 assuming that we do not initiate any additional clinical development of PRX302. We will need to obtain additional capital to fund a second Phase 3 clinical trial of PRX302 for the treatment of the symptoms of BPH and for any future clinical development of PRX302 for the treatment of localized prostate cancer beyond our ongoing Phase 2a proof of concept clinical trial.
For the three months ended September 30, 2015
The Company reported a net loss of $3.7 million ($0.22 per share) for the three months ended September 30, 2015 compared to a net loss of $8.2 million ($0.49 per share) for the three months ended September 30, 2014.
Research and development expenses
Research and development expenses were $2.6 million for the three months ended September 30, 2015 compared to $6.7 million for the three months ended September 30, 2014. The decrease in research and development costs are attributable to a decrease in the costs associated with the Company’s Phase 3 PLUS-1 clinical trial of PRX302 and costs associated with the manufacturing activities for PRX302. This decrease is partially offset by an increase in costs associated with the Company’s Phase 2a proof of concept trial for localized low to intermediate risk prostate cancer.
General and administrative expenses
General and administrative expenses were $0.9 million for the three months ended September 30, 2015 compared to $1.4 million for the three months ended September 30, 2014. The decrease is primarily due to a decrease in non-cash stock-based compensation expense and, to a lesser extent, a decrease in legal, accounting and personnel related costs.
For the nine months ended September 30, 2015
The Company reported a net loss of $11.7 million ($0.69 per share) for the nine months ended September 30, 2015 compared to a net loss of $25.4 million ($1.54 per share) for the nine months ended September 30, 2014.
Research and development expenses
Research and development expenses were $8.2 million for the nine months ended September 30, 2015 compared to $20.6 million for the nine months ended September 30, 2014. The decrease in research and development costs are attributable to a decrease in the costs associated with the Company’s Phase 3 PLUS-1 clinical trial of PRX302 and costs associated with the manufacturing activities for PRX302. This decrease is partially offset by an increase in costs associated with the Company’s Phase 2a proof of concept trial for localized low to intermediate risk prostate cancer.
General and administrative expenses
General and administrative expenses were $3.0 million for the nine months ended September 30, 2015 compared to $4.3 million for the nine months ended September 30, 2014. The decrease is primarily due to a decrease in non-cash stock-based compensation expense and, to a lesser extent, a decrease in legal, consulting and personnel related costs.