Sophiris Bio Announces Completion of $4.0 Million Registered Direct Offering

On August 30, 2019 Sophiris Bio Inc. (Nasdaq: SPHS) (the "Company" or "Sophiris"), a biopharmaceutical company studying topsalysin (PRX302), a first-in-class, pore-forming protein, in late-stage clinical trials for the treatment of patients with urological diseases, reported the completion of its previously announced registered direct offering of 5,333,334 common shares (or pre-funded warrants to purchase common shares) for an effective price of $0.75 per share with a single healthcare-focused institutional investor (Press release, Sophiris Bio, AUG 30, 2019, View Source [SID1234539157]). In addition to the common shares (or pre-funded warrants to purchase common shares), in a concurrent private placement, Sophiris issued the investor warrants to purchase up to 5,333,334 common shares (the "purchase warrants"), which represent 100% of the number of common shares (or pre-funded warrants to purchase common shares) issued in the registered direct offering, with an exercise price of $0.95 per share and a five-year exercise period commencing six (6) months following the issuance date of such purchase warrants.

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H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The gross proceeds to Sophiris from the offering, before deducting the placement agent’s fees and other estimated offering expenses payable by Sophiris, are approximately $4.0 million.

The common shares (or pre-funded warrants to purchase common shares) (but not the purchase warrants or the common shares underlying such purchase warrants) were sold in the registered direct offering by Sophiris pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-219887), including a base prospectus, previously filed with and declared effective by the Securities and Exchange Commission (the "SEC") on August 30, 2017. A final prospectus supplement and the accompanying base prospectus relating to the registered direct offering has been filed with the SEC and is available on the SEC’s website located at View Source Electronic copies of the prospectus supplement and accompanying base prospectus may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at 646-975-6996 or e-mail at [email protected].

The purchase warrants were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the common shares underlying the purchase warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the purchase warrants and underlying common shares may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities 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 the registration or qualification under the securities laws of any such state or jurisdiction.

Sophiris Bio to Present at the H.C. Wainwright 21st Annual Global Investment Conference

On August 30, 2019 Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris"), a biopharmaceutical company studying topsalysin (PRX302), a first-in-class, pore-forming protein, in late-stage clinical trials for the treatment of patients with urological diseases, reported that Randall E. Woods, president and chief executive officer, will present a corporate overview at the H.C. Wainwright 21st Annual Global Investment Conference on Monday, September 9, 2019 at 3:00 p.m. EDT in New York, NY (Press release, Sophiris Bio, AUG 30, 2019, https://www.prnewswire.com/news-releases/sophiris-bio-to-present-at-the-hc-wainwright-21st-annual-global-investment-conference-300909439.html [SID1234539156]).

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The presentation will be webcast live and can be accessed through the Investor Relations page at www.sophirisbio.com. A replay of the presentation will be available on the Company’s website for 90 days.

Amyris to Present at H.C. Wainwright 21st Annual Global Investment Conference on September 9, 2019

On August 30, 2019 Amyris, Inc. (Nasdaq:AMRS), a leader in the development and production of sustainable ingredients for the Health & Wellness, Clean Beauty and Flavors & Fragrances markets, reported that management will be presenting at the H.C. Wainwright 21st Annual Global Investment Conference to be held September 8-10, 2019, at the Lotte New York Palace Hotel in New York City (Press release, Amyris Biotechnologies, AUG 30, 2019, https://www.prnewswire.com/news-releases/amyris-to-present-at-hc-wainwright-21st-annual-global-investment-conference-on-september-9-2019-300909518.html [SID1234539155]).

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Amyris will provide an update on the progress and performance of its business during the presentation, which is scheduled for Monday, September 9, at 9:10 a.m. ET. A live webcast of the presentation including slides and a replay will be available on the investor relations section of the company’s website at View Source

Exact Sciences to participate in September investor conference

On August 30, 2019 Exact Sciences Corp. (Nasdaq: EXAS) reported that company management will be presenting at the following investor conference and invited investors to participate by webcast (Press release, Exact Sciences, AUG 30, 2019, View Source [SID1234539154]).

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Baird Healthcare Conference, New York
Fireside Chat on September 4, 2019, at 12:50 p.m. EDT
The webcast can be accessed in the investor relations section of Exact Sciences’ website at www.exactsciences.com.

CARsgen Therapeutics Receives US FDA Orphan Drug Designation For Fully Human Anti-BCMA (B Cell Maturation Antigen) Autologous Chimeric Antigen Receptor (CAR) T Cells For The Treatment Of Multiple Myeloma

On August 30, 2019 CARsgen Therapeutics Inc., a clinical-stage biopharmaceutical company reported the United States Food and Drug Administration (FDA) has granted orphan drug designation to its investigational CAR-T cell therapy fully human anti-BCMA (B Cell Maturation Antigen) autologous chimeric antigen receptor (CAR) T Cells (ct053) for the treatment of multiple myeloma (Press release, Carsgen Therapeutics, AUG 30, 2019, View Source [SID1234539153]).

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"FDA orphan designation is an important regulatory milestone in the continued development and commercialization of CT053 anti-BCMA CAR-T cells," said Dr. Zonghai Li, Founder, CEO and CSO of CARsgen. "CT053 has demonstrated outstanding potency in an exploratory phase 1 clinical study in China. A total of 19 of 24 patients with relapsed and refractory multiple myeloma showed complete response. And importantly, no event of grade 3 or higher cytokine release syndrome (CRS) was observed." The CT053 anti-BCMA CAR-T program has received Investigational New Drug (IND) clearance from the US FDA.

Orphan drug designation is granted by the FDA Office of Orphan Products Development to pharmaceutical products which are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. Under the Orphan Drug Act, the CT053 anti-BCMA product would be eligible for certain benefits including seven years of market exclusivity in the United States following marketing approval by the FDA.