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
Financial Results
At
For the three months ended
The Company reported a net loss of
Research and development expenses
Research and development expenses were
General and administrative expenses
General and administrative expenses were
For the nine months ended
The Company reported a net loss of
Research and development expenses
Research and development expenses were
General and administrative expenses
General and administrative expenses were
For complete financial results, please see the Company's website at www.sophiris.com.
About Sophiris
Certain statements included in this press release may be considered forward-looking, including the quote of Sophiris' President and CEO and any expectations relating to the results of Sophiris' Phase 3 clinical trial of BPH and the Phase 2a proof of concept trial for the treatment of localized low to intermediate risk prostate cancer and expectations about efficacy of PRX302, the timing of receipt of data from the proof of concept trial or Sophiris' capital requirements. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. Some of the risks and uncertainties that could cause actual results, performance or achievements to differ include without limitation, risk associated with the process of developing, manufacturing commercial scale drug products, obtaining regulatory approval of and commercializing treatments that are safe and effective, and in the endeavor of building a business around such treatments. All forward-looking statements are based on Sophiris' current beliefs as well as assumptions made by and information currently available to Sophiris and relate to, among other things, anticipated financial performance, business prospects, strategies, regulatory developments, clinical trial results, market acceptance, ability to raise capital and future commitments. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by Sophiris in its public securities filings; actual events may differ materially from current expectations. Sophiris disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Company Contact: | |
Chief Financial Officer | |
(858) 777-1760 | |
Corporate Communications and Investor Relations: | |
NATIONAL Equicom | |
Corporate Communications and IR | Investor Relations |
(619) 849-6005 | 858-886-7813 |
jason@canalecomm.com | mmoore@national.ca |
Condensed Consolidated Balance Sheets (In thousands, except share amounts) (Unaudited) | |||||
2015 | 2014 | ||||
Assets: | |||||
Current assets: | |||||
Cash and cash equivalents | $ | 4,908 | $ | 4,123 | |
Securities available-for-sale | 4,952 | 18,572 | |||
Other receivables | 18 | 16 | |||
Prepaid expenses | 1,506 | 2,825 | |||
Total current assets | 11,384 | 25,536 | |||
Property and equipment, net | 21 | 36 | |||
Other long-term assets | 19 | 19 | |||
Total assets | $ | 11,424 | $ | 25,591 | |
Liabilities and shareholders' equity: | |||||
Current liabilities: | |||||
Accounts payable | $ | 775 | $ | 2,633 | |
Accrued expenses | 1,245 | 2,307 | |||
Current portion of promissory notes | 1,719 | 598 | |||
Total current liabilities | 3,739 | 5,538 | |||
Long-term promissory notes | 4,035 | 5,343 | |||
Stock-based compensation liability | 42 | 22 | |||
Total liabilities | 7,816 | 10,903 | |||
Shareholders' equity: | |||||
Common shares, unlimited authorized shares, no par value; 16,844,736 shares issued and outstanding at | 113,095 | 113,095 | |||
Contributed surplus | 17,670 | 17,053 | |||
Accumulated other comprehensive gain | 100 | 99 | |||
Accumulated deficit | (127,257) | (115,559) | |||
Total shareholders' equity | 3,608 | 14,688 | |||
Total liabilities and shareholders' equity | $ | 11,424 | $ | 25,591 | |
Condensed Consolidated Statements of Operations (In thousands, except per share amounts) (Unaudited) | ||||||||
Three Months Ended | Nine Months Ended | |||||||
2015 | 2014 | 2015 | 2014 | |||||
Operating expenses: | ||||||||
Research and development | $ | 2,555 | $ | 6,710 | $ | 8,192 | $ | 20,629 |
General and administrative | 921 | 1,370 | 2,967 | 4,316 | ||||
Total operating expenses | 3,476 | 8,080 | 11,159 | 24,945 | ||||
Other income (expense): | ||||||||
Interest expense | (174) | (175) | (528) | (551) | ||||
Interest income | 4 | 10 | 18 | 40 | ||||
Gain on revaluation of warrant liability | — | — | — | 49 | ||||
Other income (expense), net | (9) | 21 | (28) | (27) | ||||
Total other expense | (179) | (144) | (538) | (489) | ||||
Net loss | $ | (3,655) | $ | (8,224) | $ | (11,698) | $ | (25,434) |
Basic and diluted loss per share | $ | (0.22) | $ | (0.49) | $ | (0.69) | $ | (1.54) |
Weighted average number of outstanding shares - basic and diluted | 16,845 | 16,845 | 16,845 | 16,499 | ||||
Other comprehensive income (loss): | ||||||||
Unrealized (loss) gain on securities available-for sale | — | (1) | 1 | 3 | ||||
Total other comprehensive loss | $ | (3,655) | $ | (8,225) | $ | (11,697) | $ | (25,431) |
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/sophiris-bio-reports-third-quarter-financial-results-and-business-highlights-300179485.html
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