Company Update (NASDAQ:SPHS): Sophiris Bio Inc Reports Second Quarter 2016 Financial Results and Key Business Highlights


Sophiris Bio Inc (NASDAQ:SPHS), a biopharmaceutical company developing topsalysin (PRX302) for the treatment of urological diseases, today announced financial results for the three and six months ended June 30, 2016.

Business Highlights:

  • On June 9, 2016, the Company announced successful results from its completed Phase 2a study of topsalysin in localized prostate cancer.
  • On May 12, 2016, the Company announced the engagement Oppenheimer & Co. Inc. as its financial advisor to assist with the evaluation of various strategic options for advancing topsalysin development programs.
  • On May 11, 2016, the Company announced the closing of a registered offering in which the Company raised net proceeds of $4.6 million. During June and July, the Company received proceeds of $2.4 million from the exercise of warrants included in this transaction bringing the total proceeds from this offering to $7.0 million.
  • On May 7, 2016, the Company presented positive data from its successful Phase 3 clinical trial of topsalysin as a treatment for the symptoms of benign prostatic hyperplasia (“BPH”) as a late breaking poster at the 111th American Urological Association Annual Meeting.

“2016 is proving to be a transformational year for Sophiris,” stated Randall Woods, president and CEO of Sophiris Bio. “In the past quarter, we completed a Phase 2a proof of concept trial of topsalysin in localized prostate cancer in which topsalysin demonstrated the ability to ablate tumor cells in 50 percent of patients, including two men who experienced complete ablation of their targeted tumor with no evidence of any tumor remaining at 6 months post treatment. We also presented complete results from the Phase 3 BPH study in a late breaking presentation at the AUA 2016 Annual Meeting, demonstrating that topsalysin met the primary endpoint of a reduction in symptom score compared to the vehicle control arm. These two indications represent very large patient populations with very few adequate treatment options, and these clinical results are generating interest from investigators and the medical community. We are currently evaluating our options for moving these programs forward into additional clinical trials.”

Financial Results:

At June 30, 2016, we had cash and cash equivalents of $8.3 million and net working capital of $5.7 million. We expect that our cash and cash equivalents will be sufficient to fund our operations for at least the next twelve months assuming that we do not initiate any new development activities for topsalysin. We do not plan to initiate any new clinical trials, including a second Phase 3 trial in BPH or a second Phase 2 trial in localized prostate cancer unless we obtain additional financing. We are actively evaluating strategic alternatives, including potential partnering arrangements, financings or a strategic transaction. As of June 30, 2016, the outstanding principal balance of our term loan was $4.3 million on which we make principal and interest payments monthly.

For the three months ended June 30, 2016

The Company reported a net loss of $4.1 million ($0.21 per share) for the three months ended June 30, 2016 compared to a net loss of $3.7 million($0.22 per share) for the three months ended June 30, 2015.

Research and development expenses

Research and development expenses were $1.0 million for the three months, ended June 30, 2016, compared to $2.6 million for the three months ended June 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 the low to intermediate risk prostate cancer. These decreases are partially offset by an increase in personnel related costs and a $0.1 million milestone payment payable as the result of the completion of Phase 1 clinical activities of topsalysin for the treatment of prostate cancer.

General and administrative expenses

General and administrative expenses were $1.4 million for the three months ended June 30, 2016 compared to $1.0 million for the three months endedJune 30, 2015. The increase is primarily due to increases in personnel related costs, legal costs and closing costs which were allocated to the warrants issued in our financing completed in May 2016. These increases were partially offset by a decrease in non-cash stock-based compensation expense.

For the six months ended June 30, 2016

The Company reported a net loss of $6.3 million ($0.35 per share) for the six months ended June 30, 2016 compared to a net loss of $8.0 million ($0.48per share) for the six months ended June 30, 2015.

Research and development expenses

Research and development expenses were $1.9 million for the six months ended June 30, 2016 compared to $5.6 million for the six months endedJune 30, 2015. The decrease in research and development costs are primarily attributable to a decrease in the costs associated with the Company’s completed Phase 3 PLUS-1 clinical trial of topsalysin and costs associated with the manufacturing activities for topsalysin. These decreases are partially offset by increases in personnel related costs and a $0.1 million milestone payment payable as the result of the completion of Phase 1 clinical activities of topsalysin for the treatment of prostate cancer.

General and administrative expenses

General and administrative expenses were $2.5 million for the six months ended June 30, 2016 compared to $2.0 million for the six months ended June 30, 2015. The increase is primarily due to an increase in legal, accounting, professional services, personnel related costs and closing costs which were allocated to the warrants issued in our financing completed in May 2016. These increases were partially offset by a decrease in non-cash stock-based compensation expense. (Original Source)

Shares of Sophiris Bio are down 4% to $4.83 in after-hours trading Tuesday. SPHS has a 1-year high of $8.55 and a 1-year low of $0.67. The stock’s 50-day moving average is $3.44 and its 200-day moving average is $2.01.

On the ratings front, Sophiris has been the subject of a number of recent research reports. In a report issued on June 10, Maxim Group analyst Jason Kolbert reiterated a Buy rating on SPHS, with a price target of $4, which reflects a potential downside of -25.1% from last closing price. Separately, on the same day, Echelon Wealth Partners’ Douglas Loe reiterated a Buy rating on the stock and has a price target of $5.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason Kolbert and Douglas Loe have a total average return of -15.3% and 57.2% respectively. Kolbert has a success rate of 28.7% and is ranked #4016 out of 4105 analysts, while Loe has a success rate of 50.0% and is ranked #932.

Sophiris Bio, Inc. is a clinical-stage biopharmaceutical company, which develops products for the treatment of urological diseases. It is currently developing PRX302 as a treatment for the symptoms of benign prostatic hyperplasia which is a non-cancerous enlargement of the prostate gland that causes a restriction in urine flow from the urethra resulting in lower urinary tract symptoms.