The company has not filed an annual or quarterly report since its Q3 FY2019 10-Q, filed Nov 8, 2019. Its latest SEC filing is a SEC STAFF ACTION from Sep 1, 2022.
10-Q for Q3 FY2019, filed Nov 8, 2019
The sections below describe the company as of the FY2018 annual report.
Develops an injectable drug candidate for localized prostate cancer and urinary symptoms caused by an enlarged prostate, for patients with prostate conditions.
10-K for FY2018, filed Mar 13, 2019
No revenue was reported.
10-K for FY2018, filed Mar 13, 2019
Kissei is a customer under an agreement granting it rights to develop and commercialize topsalysin in Japan. If approved, Sophiris planned to reach U.S. customers through its own or a contract urology sales force or a partner, and customers outside the U.S. through partners.
10-K for FY2018, filed Mar 13, 2019We are a clinical-stage biopharmaceutical company focused on developing innovative products for the treatment of urological diseases. We…View ↗
The Company has reviewed its agreement with Kissei and determined that Kissei met the definition of a customer as defined in Topic 606. In…View ↗
We do not currently have a sales, marketing or distribution organization. We intend to commercialize topsalysin by establishing, either…View ↗
10-Q for Q3 FY2019, filed Nov 8, 2019
−$959KView ↗
8-K, filed Mar 31, 2020
On March 30, 2020, Sophiris Bio Inc. (“the Company”) dismissed PricewaterhouseCoopers LLP (“PwC”) as the independent registered public…View ↗
8-K, filed Mar 11, 2020
On March 10, 2020 Sophiris Bio Inc. (the “Company”) announced that the Nasdaq Office of General Counsel notified the Company that the…View ↗
Development priority
The older report discussed development for both BPH and prostate cancer, with a further BPH trial still under consideration and a follow-on prostate cancer study planned. The latest report makes prostate cancer the development priority and leaves further BPH trials contingent on added funding or a partner.
10-K for FY2015, filed Mar 29, 2016 10-K for FY2018, filed Mar 13, 2019We are currently evaluating options to further advance the clinical development of topsalysin for the treatment of BPH. We will require…View ↗
In May 2015 we initiated a single-center, open-label Phase 2a proof of concept clinical trial of topsalysin for the treatment of localized…View ↗
Subject to obtaining additional funding and completing the ongoing proof of concept trial, we plan to conduct a second Phase 2 clinical…View ↗
Our operations have consumed substantial amounts of cash since inception. Since inception, we have raised approximately $146 million from…View ↗
Competes with Nymox Pharmaceuticals, Astellas Pharma, Sanofi, Pfizer, Watson Pharmaceuticals, GlaxoSmithKline, Merck &, Eli Lilly and, NxThera, Procept BioRobotics, and Light Sciences Oncology
10-K for FY2018, filed Mar 13, 2019In 2017, padeliporfin was approved by the EMA for the treatment of low risk prostate cancer which is defined as prostate cancer with a…View ↗
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