Recent Key Operational Highlights

• Based on feedback from a guidance meeting with the U.S. Food and Drug Administration in February, the Company has finalized the design of its first Phase 3 clinical trial for the treatment of the symptoms of BPH, which the Company plans to initiate in the second quarter of this year, subject to raising additional capital. This clinical trial will be a randomized, double-blind, vehicle-controlled, dose confirmation, multicenter, safety and efficacy study of a single intraprostatic treatment of PRX302 for lower urinary tract symptoms secondary to BPH, which the Company refers to as the PLUS-1 trial.

• In February, the Company announced that it had filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission relating to a proposed initial U.S. public offering of its common shares and listing on The NASDAQ Stock Market LLC. The Company also filed a preliminary short form prospectus with the securities regulatory authorities in British Columbia and Ontario in connection with the proposed offering.

• During the first quarter, the Company recognized revenue of $4.6 million, net of a sub-licensing royalty fee, associated with a non-refundable milestone payment due upon the achievement of certain development activities due in connection with its licensing agreement for PRX302 with Kissei Pharmaceutical Co., Ltd. (“Kissei”). The Company received payment for this milestone in April 2013.

• Topsalysin was approved as the generic name for PRX302 by both the United States Adopted Names Council (USAN) and the World Health Organization and will be published on the USAN web site and in the US Pharmacopeia Dictionary on May 1, 2013.

Financial Results for the First Quarter Ended March 31, 2013

The Company reported a net loss of $0.1 million ($0.001 per share) for the three months ended March 31, 2013, compared to a net loss of $4.5 million ($0.03 per share) for the three months ended March 31, 2012, representing a decrease of $4.4 million. The significant decrease in the Company’s net loss represents the recording of revenue of $4.6 million associated with a non-refundable milestone payment, net of a sub-licensing royalty fee, in connection with the Company’s licensing agreement with Kissei during the three months ended March 31, 2013. This milestone payment relates to the completion of certain development activities as outlined in the Company’s licensing agreement with Kissei.

License Revenue

During the three months ended March 31, 2013 the Company recognized as revenue $4.6 million, net of a sub-licensing royalty fee, associated with a non-refundable milestone payment due upon the achievement of certain development activities in connection with the Company’s licensing agreement for PRX302 with Kissei. The milestone payment was recorded net of a $0.4 million sub-license royalty fee due to UVIC Industry Partnerships Inc. and The Johns Hopkins University.

Research and Development Costs

Research and development expenses were $2.5 million for the three months ended March 31, 2013 compared to $3.1 million for the three months ended March 31, 2012, representing a decrease of $0.6 million. The decrease in research and development costs is primarily attributable to a $0.4 million decrease in the costs associated with the Company‘s non-clinical activities, specifically a repeat dose monkey study and a rat fertility study, both of which were completed in 2012. In addition, the costs associated with the transfer and scale-up of manufacturing activities for PRX302 decreased approximately $0.4 million from the March 31, 2012 to March 31, 2013. Offsetting this decrease is an increase in personnel related costs from the three months ended March 31, 2012 to the three months ended March 31, 2013. The research and development costs included stock-based compensation charges of $0.1 million for the three months ended March 31, 2013, as compared to approximately $48,000 for the three months ended March 31, 2012.

General and Administrative Costs

General and administrative expenses were $1.2 million for the three months ended March 31, 2013, compared to $1.0 million for the three months ended March 31, 2012. This increase is partially related to an increase in accounting and tax professional fees. This increase is also attributable to an increase in stock-based compensation expense, which increased $0.1 million for the three months ended March 31, 2012 to $0.2 million for the three months ended March 31, 2013.

Interest Expense

During the three months ended March 31, 2013, the Company incurred interest expense related to its Oxford Loan of $0.4 million, of which $0.1 million was related to the accretion of the debt discount, as compared to the three months ended March 31, 2012, in which the Company incurred $0.5 million interest expense, of which $0.2 million related to the accretion. Cash paid for interest was $0.3 million for the three months ended March 31, 2013, no change from the same period in 2012.

Foreign Exchange (Loss) Gain

For the three months ended March 31, 2013, the Company recorded a foreign exchange loss of $0.1 million compared to a foreign exchange gain of $0.1 million for the three months ended March 31, 2012.

Income Tax Expense

The milestone payment from Kissei was subject to a 10% Japanese withholding tax. As a result to Company recorded income tax expense of $0.5 million for the three months ended March 31, 2013. The Company will be eligible to utilize the withholding tax to offset future taxes due in Japan. Given the uncertainty around the Company’s ability to generate future taxable income, the Company has expensed the withholding tax during the three months ended March 31, 2013.

For complete financial results, please see the Company’s filings at www.sedar.com.

About Sophiris

Sophiris Bio Inc. is a urology company developing a clinical-stage, targeted treatment for benign prostatic hyperplasia (BPH or enlarged prostate), a market with significant demand. Sophiris’ lead candidate for BPH, PRX302, is designed to be as efficacious as pharmaceuticals, less invasive than the surgical interventions, and without the sexual side effects seen with existing treatments. Sophiris is planning to begin a Phase 3 clinical trial in the second quarter of 2013 subject to raising additional capital. For more information, please visit www.sophirisbio.com.

Certain statements included in this press release may be considered forward-looking. 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. 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, market acceptance 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.

For further information contact:

Lauren Glaser
Investor Relations
The Trout Group
646-378-2972
lglaser@troutgroup.com

James Beesley
Investor Relations
Sequoia Partners
778-389-7715
james@sequoiapartners.ca

Michael Moore
Investor Relations
Equicom Group
619-467-7067
mmore@equicomgroup.com

Jason I. Spark
Canale Communications, Inc.
619-849-6005
jason@canalecomm.com

Download full press release »

Citigroup and Leerink Swann are acting as joint book-running managers for the offering. Stifel and Lazard Capital Markets are acting as co-managers. The offering will be made only by means of a prospectus. When available, copies of the preliminary prospectus relating to and describing the terms of the offering may be obtained from Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, or by email at batprospectusdept@citi.com or by phone at 1-800-831-9146, and Leerink Swann LLC (excluding the Canadian preliminary prospectus), Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 02110, or by email at Syndicate@Leerink.com or by phone at 1-800-808-7525.

A registration statement relating to these securities has been filed with the SEC, but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. This release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Sophiris
Sophiris Bio Inc. is a biopharmaceutical company developing a treatment for benign prostatic hyperplasia (BPH or enlarged prostate), which it believes is an unsatisfied market with significant market potential. PRX302, the Company’s lead candidate for BPH, is designed to be as efficacious as pharmaceuticals, less invasive than the surgical interventions, and without the sexual side effects experienced with existing treatments. Sophiris is planning to begin the first of two pivotal clinical trials of PRX302 before the end of 2013.

Certain statements included in this press release may be considered forward-looking. 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. 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, regulatory approval and marketing of the offering, anticipated financial performance, business prospects, strategies, regulatory developments, market acceptance 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.

For further information contact:

Lauren Glaser
Investor Relations
The Trout Group
646-378-2972
lglaser@troutgroup.com

James Beesley
Investor Relations
Sequoia Partners
778-389-7715
james@sequoiapartners.ca

Michael Moore
Investor Relations
TMX Equicom
619-467-7067
mmore@tmxequicom.com

Jason I. Spark
Media Relations
Canale Communications, Inc.
619-849-6005
jason@canalecomm.com

Download full press release »

Recent Key Operational Highlights for the year-ended 2012

• The 12 month data from the Company’s Phase 2b study (TRIUMPH) of PRX302 has been accepted for publication by the Journal of Urology and is currently available online at:
http://www.jurology.com/article/S0022-5347(12)05468-7/abstract.

• In the 12 month Phase 2b (TRIUMPH) study, patients receiving PRX302 for the treatment of BPH experienced a clinically significant improvement in the subjective symptom score (International Prostate
Symptom Score, or IPSS) and the objective measure of mean peak urinary flow rate (Qmax) sustained over 12 months.

• The Company released data from its transrectal safety study demonstrating that PRX302 was well tolerated through three months following a transrectal injection. The results support the use of a
transrectal ultrasound (TRUS) guided injection for the delivery of PRX302 directly into the prostate. This route of administration will be used in future clinical trials of PRX302 in patients with
BPH.

• The Company announced the appointment of Randall E. Woods as Chief Executive Officer effective August 16, 2012. Mr. Woods brings almost 40 years of relevant industry experience to Sophiris,
including past roles as CEO at NovaCardia Inc. (acquired by Merck & Co in 2007) and Corvas International (acquired by Dendreon in 2003).

• During the first quarter of 2012 the Company closed an additional CND $8.3 million investment from our largest shareholder, Warburg Pincus pursuant to its rights under the terms of the Investment
Agreement dated September 28, 2010.

Financial Results for the Quarter Ended December 31, 2012

The Company reported a net loss of $5.3 million ($0.03 per share, basic and diluted) for the three months ended December 31, 2012, compared to a net loss of $5.7 million ($0.05 per share, basic and diluted) for the three months ended December 31, 2011, representing a decrease of $0.4 million.

Research and Development Expenses

Research and development expenses were $3.3 million for the three months ended December 31, 2012 compared to $4.1 million for the three months ended December 31, 2011 a decrease of $0.8 million. The decrease in research and development expenses is primarily attributable to a $1.5 million decrease in the costs associated with the Company’s CMC program for the manufacture and testing of clinical batches of PRX302 clinical trial material. Offsetting this decrease is an increase of $0.8 million of clinical trial costs during the three months ended December 31, 2012 primarily associated with start-up costs for the Company’s first pivotal study for the treatment of the symptoms of BPH which the Company expects to initiate in the first half of 2013.

General and Administrative Expenses

General and administrative expenses were $1.3 million for the three months ended December 31, 2012 compared to $1.0 million for the three months ended December 31, 2011. This increase primarily relates to an increase in personnel related costs associated with the build-out of the Company’s San Diego headquarters.

Interest Income

The Company earned interest income of approximately $15,000 during the three months ended December 31, 2012 compared to approximately $5,000 for the three months ended December 31, 2011. Interest income earned during a particular period or between periods is a function of interest rates available as well as average cash balances invested in interest bearing securities.

Interest Expense

During the three months ended December 31, 2012, the Company incurred interest expense related to our Oxford loan of $0.4 million of which $0.1 million was related to the accretion of the debt discount, as compared to interest expense of $0.5 million during the three months ended December 31, 2011, of which $0.2 million related to accretion of the debt discount. Cash paid for interest was $0.3 million for the three months ended December 31, 2012 as compared to $0.4 million for the three month period ended December 31, 2011. Interest expense will decline over the term of the loan as the principal is reduced.

Financial Results for the Year-Ended December 31, 2012

The Company reported a net loss of $21.2 million ($0.13 per share, basic and diluted) for the year-ended December 31, 2012, compared to a net loss of $14.2 million ($0.12 per share, basic and diluted) for the year-ended December 31, 2011, representing an increase of $7.0 million.

Research and Development Expenses

Research and development expenses were $13.5 million in the year ended December 31, 2012 and $8.7 million in the year ended December 31, 2011, an increase of $4.8 million. This increase is primarily attributable to an increase of $0.4 million associated with the Company’s ongoing Phase 1/2 transrectal BPH clinical trial, which began enrollment in September 2011, an increase of $2.0 million of start-up costs associated with the Company’s first pivotal study and an increase of $1.8 million in our costs associated with the transfer and scale up of manufacturing activities for PRX302 clinical trial material.

General and Administrative Expenses

General and administrative expenses were $5.7 million for the year ended December 31, 2012 compared to $4.6 million for the year ended December 31, 2011, an increase of $1.1 million. Included in the Company’s general and administrative expenses for the year ended December 31, 2011 is $0.7 million of severance related costs associated with the shut-down of the Company’s Vancouver operations. Excluding these severance related costs, the Company’s general and administrative expenses increased $1.8 million for the year ended December 31, 2012 as compared to the year ended December 31, 2011. This increase primarily relates to an increase of approximately $0.6 million in personnel related costs associated with the build-out of the Company’s San Diego general and administrative group, an increase in professional fees of approximately $0.5 million and an increase of approximately $0.6 million in market research expenses.

Interest Income

The Company earned interest income of $0.1 million during the year ended December 31, 2012 compared to approximately $55,000 for the year ended December 31, 2011. Interest income earned during a particular period or between periods is a function of interest rate available as well as average cash balances invested in interest bearing securities.

Interest Expense

During the year ended December 31, 2012, the Company incurred interest expense related to the Oxford loan of approximately $2.0 million of which $0.6 million was related to the accretion of the debt discount, as compared to interest expense of $0.9 million during the year ended December 31, 2011, of which $0.3 million was related to the accretion of the debt discount. Cash paid for interest was $1.4 million for the year ended December 31, 2012 as compared to $0.5 million for the year ended December 31, 2011. The Oxford loan was originated during July 2011. As such, there was an increase in interest expense related to this loan during the year ended December 31, 2012. In future periods this expense will decline over the term of the loan as the principal is reduced.

Liquidity

As of December 31, 2012, the Company’s cash and cash equivalents totaled $9.7 million compared to $23.4 million as of December 31, 2011. The decrease in cash and cash equivalents is primarily the result of cash utilization to fund operations during the year-ended 2012 offset by the receipt of CND $8.3 million from Warburg Pincus under their Investment Agreement. The Company expects that its current cash and cash equivalents will be sufficient to fund its operations into the third quarter of 2013.

Change in Auditors

The Company also announces that, in connection with the relocation of the head office of the Company to San Diego, California it has changed its auditor from PricewaterhouseCoopers LLP (Canada) (“PwC Canada”) to PricewaterhouseCoopers LLP (U.S.) (“PwC U.S.”). PwC Canada has resigned effective as of January 10, 2013 and PwC U.S. has been appointed as auditor of the Company effective as of the same date. PwC U.S. provided the audit report on the Company’s financial statements for the year ended December 31, 2012. The change in auditor has been approved by the Company’s Audit Committee and Board of Directors.

For complete financial results, please see the Company’s filings at www.sedar.com.

About Sophiris

Sophiris Bio Inc. is a biopharmaceutical company developing a treatment for benign prostatic hyperplasia (BPH or enlarged prostate), which it believes is an unsatisfied market with significant market potential. PRX302, the Company’s lead candidate for BPH, is designed to be as efficacious as pharmaceuticals, less invasive than the surgical interventions, and without the sexual side effects experienced with existing treatments. Sophiris is planning to begin the first of two pivotal clinical trials of PRX302 in the first half of 2013. For more information, please visit www.sophirisbio.com.

Certain statements included in this press release may be considered forward-looking. 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. 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, market acceptance 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.

For further information contact:

Lauren Glaser
Investor Relations
The Trout Group
646-378-2972
lglaser@troutgroup.com

James Beesley
Investor Relations
Sequoia Partners
778-389-7715
james@sequoiapartners.ca

Michael Moore
Investor Relations
Equicom Group
619-467-7067
mmore@equicomgroup.com

Jason I. Spark
Media Relations
Canale Communications, Inc.
619-849-6005
jason@canalecomm.com

Download full press release »

Mr. Knauf focuses on healthcare and life sciences as an investment professional at Warburg Pincus. He currently serves on the Boards of Directors of Constitution Medical Investors, Home Dialysis Plus, International Technidyne Corporation, Keystone Dental, RegionalCare Hospital Partners and Silk Road Medical. Prior to joining Warburg Pincus, Mr. Knauf was an Associate at Parthenon Capital, a private equity firm, and a consultant with Bain & Company, a global consulting firm. He holds an MBA from Stanford University Graduate School of Business where he was an Arjay Miller Scholar, and earned a Bachelor of Science in Business Administration degree (BSBA) from the University of Arizona.
Sophiris Bio would like to thank Jonathan Leff for his service to the board and to the Company.

About Sophiris

Sophiris Bio Inc. is a urology company developing a late-stage, highly targeted treatment for benign prostatic hyperplasia (BPH or enlarged prostate), an unsatisfied market with significant demand. PRX302, the company’s lead candidate for BPH, is designed to be as efficacious as pharmaceuticals, less invasive than the surgical interventions, and without the sexual side effects seen with existing treatments. Sophiris is planning to begin a pivotal trial in the first half of 2013. Sophiris is advised by world-leading urologists, backed by experienced investors, and led by a team that has achieved more than twenty drug approvals. For more information, please visit www.sophirisbio.com.

Certain statements included in this press release may be considered forward-looking. 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. 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, market acceptance 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.

For further information contact:

Lauren Glaser
Investor Relations
The Trout Group
646-378-2972
lglaser@troutgroup.com

James Beesley
Investor Relations
Sequoia Partners
778-389-7715
james@sequoiapartners.ca

Michael Moore
Investor Relations
Equicom Group
619-467-7067
mmore@equicomgroup.com

Jason I. Spark
Canale Communications, Inc.
619-849-6005
jason@canalecomm.com

Download full press release »

Recent Key Operational Highlights

• The 12 month data from the Phase 2b study (TRIUMPH) of PRX302 has been accepted for publication by the Journal of Urology and is currently available online at: http://www.jurology.com/article/S0022-5347(12)05468-7/abstract.

• In the 12 month Phase 2b (TRIUMPH) study, patients receiving PRX302 for the treatment of BPH experienced a clinically significant improvement in the subjective symptom score (International Prostate
Symptom Score, or IPSS) and the objective measure of mean peak urinary flow rate (Qmax) sustained over 12 months.

• The Company released data from its transrectal safety study demonstrating that PRX302 was well tolerated through three months following a transrectal injection. The results support the use of a transrectal
ultrasound (TRUS) guided injection for the delivery of PRX302 directly into the prostate. This route of administration will be used in future clinical trials of PRX302 in patients with BPH.

• The Company announced the appointment of Randall E. Woods as Chief Executive Officer effective August 16, 2012. Mr. Woods brings almost 40 years of relevant industry experience to Sophiris, including past
roles as CEO at NovaCardia Inc. (acquired by Merck & Co in 2007) and Corvas International (acquired by Dendreon in 2003).

Financial Results for the Quarter Ended September 30, 2012

The Company reported a net loss of $5.6 million ($0.03 per share) for the three months ended September 30, 2012, compared to a net loss of $3.0 million ($0.02 per share) for the three months ended September 30, 2011, representing an increase of $2.6 million. The increase in net loss was driven primarily from an increase in total operating expenses over the same period in 2011 as a result of our increased research and development activities of PRX302, principally our on-going transrectal study and clinical material manufacturing expenses.

Research and Development Costs

Research and development costs were $3.4 million for the three months ended September 30, 2012, versus $1.5 million for the three months ended September 30, 2011, an increase of $1.9 million. The increase in research and development expenses is primarily attributable to the PRX302 clinical program, specifically the ongoing transrectal study and clinical material manufacturing expenses.

General and Administrative Costs

General and administrative costs for the three months ended September 30, 2012, were $2.0 million, an increase of $0.9 million from the $1.1 million incurred during the three months ended September 30, 2011. The increase in general and administrative expenses is primarily related to an increase in market research costs and to a lesser extent an increase in personnel related costs associated with the build-out of our San Diego headquarters.

Interest Income

Interest income increased approximately $25,000 in the three months ended September 30, 2012, compared to the three months ended September 30, 2011. The increase in interest income was due to an increase in the average cash balance invested in interest bearing accounts during the three months ended September 30, 2012 compared to the prior period.

Interest Expense

Interest expense for the three months ended September 30, 2012, was $0.5 million, an increase of $0.1 million from the $0.4 million incurred during the three months ended September 30, 2011. The interest expense recorded by the Company is related to the Company’s secured promissory note with Oxford Financial LLC. The secured promissory note was originated during July 2011 and therefore the increase in the interest expense from the three months ended September 30, 2011 to September 30, 2012 is the result of the promissory note being outstanding for the entire three months during 2012.

Financial Results for the Nine Months Ended September 30, 2012

The Company reported a net loss of $15.8 million ($0.10 per share) for the nine months ended September 30, 2012, compared to a net loss of $8.5 million ($0.07 per share) for the nine months ended September 30, 2011, representing an increase of $7.3 million. The increase in net loss was driven primarily from an increase in total operating expenses of $6.4 million over the same period in 2011, as a result of our increased research and development activities of PRX302, principally our on-going transrectal study and clinical material manufacturing expenses.

Research and Development Costs

Research and development costs were $10.2 million for the nine months ended September 30, 2012, versus $4.5 million for the nine months ended September 30, 2011, an increase of $5.7 million. The increase in research and development expenses is primarily attributable to the PRX302 clinical program, specifically the on-going transrectal study and clinical material manufacturing expenses.

General and Administrative Costs

General and administrative costs for the nine months ended September 30, 2012, were $4.3 million, an increase of $0.7 million from the $3.6 million incurred during the nine months ended September 30, 2011. For the nine months ended September 30, 2011, included as a component of our general and administrative expenses is $0.7 million of severance related costs associated with the shut-down of our Vancouver operations. When the severance related costs are excluded from our operating results for the nine months ended September 30, 2011, our general and administrative expenses increased $1.4 million for the nine months ended September 30, 2012 compared to the same period in 2011. This increase primarily relates to an increase in personnel related costs associated with the build-out of our San Diego headquarters, market research costs and costs associated with our recent name change.

Interest Income

Interest income increased approximately $43,000 in the nine months ended September 30, 2012 compared to the nine months ended September 30, 2011. The increase in interest income was due to an increase in the average cash balance invested in interest bearing accounts during the nine months ended September 30, 2012 compared to the prior period.

Interest Expense

Interest expense for the nine months ended September 30, 2012, was $1.5 million, an increase of $1.1 million from the $0.4 million incurred during the nine months ended September 30, 2011. The interest expense recorded by the Company relates to the Company’s secured promissory note with Oxford Financial LLC. The secured promissory note was originated during July 2011 and therefore the increase in the interest expense from the nine months ended September 30, 2011 to September 30, 2012 is the result of the promissory note being outstanding for the entire nine months during 2012.

For complete financial results, please see our filings at www.sedar.com.

About Sophiris

Sophiris Bio Inc. is a urology company developing a late-stage, highly targeted treatment for benign prostatic hyperplasia (BPH or enlarged prostate), an unsatisfied market with significant demand. PRX302, the company’s lead candidate for BPH, is designed to be as efficacious as pharmaceuticals, less invasive than the surgical interventions, and without the sexual side effects seen with existing treatments. Sophiris is planning to begin a pivotal trial in the first half of 2013. Sophiris is advised by world-leading urologists, backed by experienced investors, and led by a team that has achieved more than twenty drug approvals. For more information, please visit www.sophirisbio.com.

Certain statements included in this press release may be considered forward-looking. 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. 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, market acceptance 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.

For further information contact:

Lauren Glaser
Investor Relations
The Trout Group
646-378-2972
lglaser@troutgroup.com

James Beesley
Investor Relations
Sequoia Partners
778-389-7715
james@sequoiapartners.ca

Michael Moore
Investor Relations
Equicom Group
619-467-7067
mmore@equicomgroup.com

Download full press release »

SAN DIEGO, CA and VANCOUVER, BC, November 6, 2012 – Sophiris Bio Inc. (TSX: SHS), a urology company developing a late-stage, highly targeted treatment for benign prostatic hyperplasia (BPH or enlarged prostate), today announced that Randall E. Woods, President and Chief Executive Officer, will present an overview of the Company at the Lazard Capital Markets 9th Annual Healthcare Conference in New York. Mr. Woods’ presentation will take place at 4:00 p.m. EST on Tuesday, November 13, 2012.

A live webcast of the presentation may be accessed via the Sophiris website at www.sophirisbio.com.

About Sophiris

Sophiris Bio Inc. is a urology company developing a late-stage, highly targeted treatment for benign prostatic hyperplasia (BPH or enlarged prostate), an unsatisfied market with blockbuster potential. PRX302, the company’s lead candidate for BPH, is designed to be as efficacious as pharmaceuticals, less invasive than the surgical interventions, and without the sexual side effects seen with existing treatments. Sophiris is planning to begin a pivotal trial by the end of 2012. Sophiris is advised by world-leading urologists, backed by experienced investors, and led by a team that has achieved more than twenty drug approvals including several blockbusters. For more information, please visit www.sophirisbio.com.

Certain statements included in this press release may be considered forward-looking. 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. 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, market acceptance 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.

For Further Information Contact:

Lauren Glaser
Investor Relations
The Trout Group
646-378-2972
lglaser@troutgroup.com

James Beesley
Investor Relations
Sequoia Partners
778-389-7715
james@sequoiapartners.ca

Michael Moore
Investor Relations
Equicom Group
619-467-7067
mmore@equicomgroup.com

Jason I. Spark
Canale Communications, Inc.
619-849-6005
jason@canalecomm.com

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PRX302 treatment resulted in approximately 8 to 9-point average reduction of IPSS that was sustained over 12 months. The IPSS is a patient self-administered questionnaire of lower urinary tract symptoms with a possible range of 0 to 35 points, with 0 being no symptoms and 35 being the high end of severe symptoms. This average improvement in IPSS was a clinically meaningful 2.8 to 4.1 point reduction over and above the IPSS improvement observed in the placebo group. In addition, PRX302 treatment resulted in a ~3 mL/sec average increase in Qmax, which was sustained over 12 months. Both IPSS and Qmax are validated clinical endpoints used for BPH product regulatory approvals.

PRX302 was well tolerated in this study with patients who had moderate to severe lower urinary tract symptoms due to BPH, about half of whom had previously taken oral medication for BPH. The side effect profile was favorable with most of the side effects attributed to the injection procedure itself and not related to drug toxicity.

“PRX302 is demonstrating potential as an alternative treatment to oral medications as well as surgical procedures,” said Randall Woods, President and CEO of Sophiris Bio. “Patients commonly stop oral medications for lack of efficacy or side effects, or are non-compliant with taking daily pills. ‘Minimally invasive’ procedures that aim to remove excess tissue in the prostate require anesthesia and catheterization, which limit access for patients and add to cost. PRX302 has the potential to be safer than surgical procedures, more efficacious than oral medications, and with a sustained treatment effect for 12 months.”

Woods added: “We expect to confirm these results in a pivotal study that closely resembles the design of this Phase 2b study and includes the same proven clinical endpoints used for prior regulatory approvals of drugs for BPH.”

About BPH

Benign prostatic hyperplasia (BPH) is an enlarged prostate gland often resulting in a constricted or partially blocked urethra that can lead to pain, discomfort and other complications with urination. BPH occurs in almost all men as they age, with 50% of men over age 50 and 70% of men over age 70 complaining of symptoms. If untreated, it can lead to urinary problems such as:

• Trouble starting and stopping urination
• Frequent and irregular needs to urinate, particularly in the night while sleeping
• A weak urine stream
• Painful urination or urinary retention, leading to infections, stones or kidney damage

In the US, approximately 11 million men have been diagnosed with BPH. Five million of these patients are bothered enough by symptoms to seek treatment, such as daily pharmaceuticals, but these treatments often lack sustainable efficacy and are associated with undesirable side effects including sexual dysfunction. With current pharmaceutical treatments, symptoms will usually return if medication is discontinued. More aggressive treatment options include invasive surgical procedures that may be successful at treating BPH but may be accompanied by operative complications. Any type of prostate surgery can cause side effects, such as semen flowing backward into the bladder (retrograde ejaculation), loss of bladder control (incontinence) and impotence (erectile dysfunction).

About PRX302

PRX302 is designed to be a once-a-year treatment for the long-term relief of BPH symptoms without causing sexual dysfunction or sacrificing quality of life. PRX302 is precisely targeted to the prostate tissue constricting the urethra without damaging neighboring healthy tissue. It is delivered by a 1-3 minute injection completed during an office visit. PRX302 has been engineered to be activated only by the prostate specific antigen (PSA) enzyme that is produced in large amounts in the prostates of men with BPH. Once activated, PRX302 forms disruptive pores in the membranes of prostate cells, thus creating a highly targeted, localized and more convenient approach to eliminating prostate cells constricting the urethra.

About Sophiris

Sophiris Bio Inc. is a urology company developing a late-stage, highly targeted treatment for benign prostatic hyperplasia (BPH, or enlarged prostate), an unsatisfied market with large potential demand. PRX302, the company’s lead candidate for BPH, is designed to be as efficacious as pharmaceuticals, less invasive than the surgical interventions, and without the sexual side effects seen with existing treatments. Sophiris is advised by world-leading urologists, backed by experienced investors, and led by a team that has achieved more than twenty drug approvals including drugs with annual sales in excess of $1 billion. For more information, please visit www.sophirisbio.com.

Certain statements included in this press release may be considered forward-looking. 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. 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, market acceptance 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.

For Further Information Contact:

Lauren Glaser
Investor Relations
The Trout Group
646-378-2972
lglaser@troutgroup.com

James Beesley
Investor Relations
Sequoia Partners
778-389-7715
james@sequoiapartners.ca

Michael Moore
Investor Relations
Equicom Group
619-467-7067
mmore@equicomgroup.com

Jason I. Spark
Canale Communications, Inc.
619-849-6005
jason@canalecomm.com

Download full press release »

SAN DIEGO, CA and VANCOUVER, October 2, 2012 – Sophiris Bio Inc. (TSX: SHS), a urology company developing a late-stage, highly targeted treatment for benign prostatic hyperplasia (BPH or enlarged prostate), today announced that Randall E. Woods, President and Chief Executive Officer, will present at the 11th Annual BIO Investor Forum in San Francisco. Mr. Woods’ presentation will take place at 4:00 p.m. PDT on Tuesday, October 9, 2012.

A live webcast of the presentation may be accessed via the Sophiris website at www.sophirisbio.com. A replay of the presentation will be available on the company’s website for 90 days.

About Sophiris

Sophiris Bio Inc. is a urology company developing a late-stage, highly targeted treatment for benign prostatic hyperplasia (BPH or enlarged prostate), an unsatisfied market with blockbuster potential. PRX302, the company’s lead candidate for BPH, is designed to be as efficacious as pharmaceuticals, less invasive than the surgical interventions, and without the sexual side effects seen with existing treatments. Sophiris is planning to begin a pivotal trial by the end of 2012. Sophiris is advised by world-leading urologists, backed by experienced investors, and led by a team that has achieved more than twenty drug approvals including several blockbusters. For more information, please visit www.sophirisbio.com.

Certain statements included in this press release may be considered forward-looking. 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. 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, market acceptance 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.

For Further Information Contact:

Lauren Glaser
Investor Relations
The Trout Group
646-378-2972
lglaser@troutgroup.com

James Beesley
Investor Relations
Sequoia Partners
778-389-7715
james@sequoiapartners.ca

Michael Moore
Investor Relations
Equicom Group
619-467-7067
mmore@equicomgroup.com

Jason I. Spark
Canale Communications, Inc.
619-849-6005
jason@canalecomm.com

Download full press release »

Sophiris is currently evaluating the structure of the Company’s finance department and in the interim Peter Slover, Head of Finance and Principal Accounting Officer, will assume Mr. Casdin’s duties. Mr. Slover was the Vice President, Finance and Operations at Anadys Pharmaceuticals, Inc. prior to joining Sophiris in April 2012. Mr. Casdin has made himself available to us should we need his counsel on pending matters.

For additional information and other publicly filed documents relating to Sophiris, please see the Company filings at www.sedar.com.

About Sophiris Bio

Sophiris Bio Inc. is a urology company developing a late-stage, highly targeted treatment for benign prostatic hyperplasia (BPH or enlarged prostate), an unsatisfied market with large potential demand. PRX302, the company’s lead candidate for BPH, is designed to be as efficacious as pharmaceuticals, less invasive than the surgical interventions, and without the sexual side effects seen with existing treatments. Sophiris is planning to begin a pivotal trial by the end of 2012. Sophiris is advised by world-leading urologists, backed by experienced investors, and led by a team that has achieved more than twenty drug approvals including several drugs with annual sales in excess of $1billion. For more information, please visit www.sophirisbio.com.
Certain statements included in this press release may be considered forward-looking, including statements about the potential for PRX302. 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. All forward-looking statements are based on Sophiris Bio’s’ current beliefs as well as assumptions made by and information currently available to Sophiris Bio and relate to, among other things, anticipated financial performance, business prospects, strategies, regulatory developments, market acceptance 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 inherent in late stage drug development and risks relating to obtaining FDA and other regulatory approvals as well as risks identified by Sophiris Bio in its public securities filings; actual events may differ materially from current expectations. Sophiris Bio disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

For Further Information Contact:

Lauren Glaser
Investor Relations
The Trout Group
646-378-2972
lglaser@troutgroup.com

James Beesley
Investor Relations
Sequoia Partners
778-389-7715
james@sequoiapartners.ca

Michael Moore
Investor Relations
TMX Equicom
619-467-7067
mmoore@equicomgroup.com

Jason Spark
Media Relations
Canale Communications
619-849-6005
Jason@canalecomm.com

Download full press release »

The primary objective of this small study was to evaluate the safety and tolerability of delivering PRX302 via a transrectal route of administration using TRUS. The data allow an assessment as to whether the safety profile from the transrectal delivery was similar to that observed with the transperineal route of administration, which had been used in all previous clinical studies with PRX302.

“The decision to move to a transrectal route of delivering PRX302 directly into the prostate as opposed to transperineal was made based on the input of our advisors and leading urologists treating patients with BPH,” said Randall Woods, CEO of Sophiris Bio. “The transrectal route enables PRX302 to be administered by a urologist in an office based setting, in a brief procedure that does not require catheterization. To date 126 patients with BPH have been treated with PRX302 with a similar safety and tolerability profile between the transrectal and transperineal routes of administration.”

This ongoing randomized, placebo controlled, double-blind, multicenter, Phase 1-2 study enrolled 40 patients with moderate to severe BPH. Patients were randomized within one of four ascending dose cohorts, and the decision to move to the next higher dose was guided by an independent data monitoring committee that reviewed the safety data through Day 15. The primary endpoint of the study was to evaluate the 3-month safety and tolerability of escalating doses of PRX302, although patients are to continue to be evaluated through Month 12. The data from all four cohorts through Month 3 indicate that PRX302 continues to be well tolerated with an adverse event profile similar to that seen in previous clinical studies using a transperineal injection. No drug-related sexual function adverse events were observed, and there were no reports of bacteremia or sepsis. Improvement in the International Prostate Symptom Score (IPSS) was observed in all cohorts. Given the small sample size of eight patients on PRX302 and two patients on placebo in each cohort, no statistically significant differences were observed.

About BPH

BPH is a $5 billion market with more than 4 million patients treated each year in the U.S. alone. Despite available medical treatments and surgical options, no single solution provides quick, long-term relief of symptoms without serious unwanted side effects. Pharmaceutical product sales in the U.S. for BPH are $4 billion annually, however they lack sustainable efficacy and are associated with undesirable side effects including sexual dysfunction. More aggressive treatment options include invasive surgical procedures that may be successful at treating BPH but can also result in nerve damage and sexual dysfunction.

About PRX302

PRX302 is designed to be a single treatment for the long-term relief of BPH symptoms, such as restricted urinary flow from enlarged prostate, without causing sexual dysfunction or sacrificing quality of life.
PRX302 is highly targeted to prostate tissue. It is delivered directly to the prostate tissue via localized injection and it is activated selectively by active Prostate Specific Antigen (PSA) found only in prostate tissue. PRX302 has shown meaningful improvements in the International Prostate Symptom Score (IPSS) and urinary flow (Qmax) at 3 and 6 months in a randomized controlled Phase IIb trial (TRIUMPH study). IPSS has been a primary endpoint and Qmax has been a secondary or co-primary endpoint for prior BPH drug approvals. To date 126 patients with BPH have been treated with PRX302, and no drug related sexual adverse events have been reported in the studies completed.

About Sophiris

Sophiris Bio Inc. is a urology company developing a late-stage, highly targeted treatment for benign prostatic hyperplasia (BPH or enlarged prostate), an unsatisfied market with blockbuster potential. PRX302, the company’s lead candidate for BPH, is designed to be as efficacious as pharmaceuticals, less invasive than the surgical interventions, and without the sexual side effects seen with existing treatments. Sophiris is planning to begin a pivotal trial by the end of 2012. Sophiris is advised by world-leading urologists, backed by experienced investors, and led by a team that has achieved more than twenty drug approvals including several blockbusters. For more information, please visit www.sophirisbio.com.

Certain statements included in this press release may be considered forward-looking. 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. 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, market acceptance 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.

For Further Information Contact:

Lauren Glaser
Investor Relations
The Trout Group
646-378-2972
lglaser@troutgroup.com

James Beesley
Investor Relations
Sequoia Partners
778-389-7715
james@sequoiapartners.ca

Michael Moore
Investor Relations
Equicom Group
619-467-7067
mmore@equicomgroup.com

Jason I. Spark
Canale Communications, Inc.
619-849-6005
jason@canalecomm.com

Download full press release »