On February 22, 2019 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported that Sheila Gujrathi, M.D., Chief Executive Officer and Co-Founder, will present at the following upcoming investor conferences (Press release, Gossamer Bio, FEB 22, 2019, View Source [SID1234533589]):

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8th Annual SVB Leerink Healthcare Conference on Wednesday, February 27 at 11:00 a.m. ET.
Barclays Global Healthcare Conference on Wednesday, March 13 at 3:50 p.m. ET.

On February 22, 2019 Trillium Therapeutics Inc. ("Trillium" or the "Company") (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported that it has priced its previously announced underwritten public offering of 6,550,000 common share units (the "Common Share Units") of the Company and 12,200,000 Series II Non-Voting Convertible First Preferred Share units (the "Series II First Preferred Share Units") of the Company (the "Offering") (Press release, Trillium Therapeutics, FEB 22, 2019, View Source [SID1234533588]). The Series II First Preferred Share Units are being offered to investors whose purchase of Common Share Units in the Offering may result in such investor, together with its affiliates and certain related parties, beneficially owning more than 4.99% of the Company’s outstanding common shares following the consummation of the Offering.

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The Common Share Units are being sold at a public offering price of US$0.80 per Common Share Unit. Each Common Share Unit will be comprised of one common share of the Company (each a, "Common Share") and one Common Share purchase warrant (each a "Common Share Warrant"). Each Common Share Warrant will be exercisable for one Common Share at a price of US$0.96 per Common Share Warrant, subject to adjustment, at any time until 5:00 p.m. (Toronto time) on the date that is sixty (60) months following the closing of the Offering, subject to certain terms and conditions.

The Series II First Preferred Share Units are being sold at a public offering price of US$0.80 per Series II First Preferred Share Unit. Each Series II First Preferred Share Unit will be comprised of one Series II Non-Voting Convertible First Preferred Share (each a "Series II First Preferred Share") and one Series II First Preferred Share purchase warrant (each a "Series II First Preferred Share Warrant"). Each Series II First Preferred Share Warrant will be exercisable for one Series II First Preferred Share at a price of US$0.96 per Series II First Preferred Share Warrant, subject to adjustment, at any time until 5:00 p.m. (Toronto time) on the date that is sixty (60) months following the closing of the Offering, subject to certain terms and conditions.

The gross proceeds to the Company from the Offering are expected to be approximately US$15 million, before deducting underwriting discounts and commissions and other estimated offering expenses. The Offering is expected to close on or around February 27, 2019, subject to the satisfaction of customary closing conditions.

The Company intends to use the net proceeds of the Offering for: (i) ongoing research and development activities of its SIRPαFc program; and (ii) working capital and general corporate purposes.

Cowen and Company, LLC is acting as the sole book-running manager for the Offering.

The Offering is subject to customary closing conditions, including NASDAQ Capital Market ("NASDAQ") and Toronto Stock Exchange ("TSX") approvals. For the purposes of TSX approval, the Company intends to rely on the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible inter-listed issuers on a recognized exchange, such as NASDAQ.

The Offering is being made to purchasers outside of Canada pursuant to a U.S. registration statement on Form F-10, declared effective by the United States Securities and Exchange Commission (the "SEC") on January 8, 2018 (the "Registration Statement"), and the Company’s existing Canadian short form base shelf prospectus (the "Base Shelf Prospectus") dated January 5, 2018. A preliminary prospectus supplement relating to the Offering has been filed with the securities commissions in the provinces of British Columbia, Alberta, Manitoba, Ontario and Nova Scotia in Canada, and with the SEC in the United States (the "Preliminary Prospectus"), and a final prospectus supplement relating to the Offering (together with the Preliminary Prospectus, Base Shelf Prospectus and the Registration Statement, the "Offering Documents") will be filed with the securities commissions in the provinces of British Columbia, Alberta, Manitoba, Ontario and Nova Scotia in Canada, and with the SEC in the United States. The Offering Documents will contain important detailed information about the securities being offered. Before you invest, you should read the Offering Documents and the other documents the Company has filed for more complete information about the Company and the Offering. Copies of the Offering Documents will be available for free by visiting the Company’s profiles on the SEDAR website maintained by the Canadian Securities Administrators at www.sedar.com or the SEC’s website at www.sec.gov, as applicable. Alternatively, copies of the prospectus supplement will be available upon request by contacting Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attn: Prospectus Department, or by emailing [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, nor will there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On February 22, 2019 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported financial results for the three and twelve months ended December 31, 2018 and highlighted recent corporate progress (Press release, Heron Therapeutics, FEB 22, 2019, View Source [SID1234533587]).

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Recent Corporate Progress

Pain Management Franchise

Acceptance of HTX-011 NDA for Postoperative Pain Management with Priority Review Designation; PDUFA Date of April 30, 2019: The U.S. Food and Drug Administration (FDA) recently accepted the new drug application (NDA) for Heron’s investigational agent, HTX-011, and has granted it a Priority Review designation. The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of April 30, 2019 and indicated that it is not currently planning an advisory committee meeting to discuss this application.

90% of Patients Treated with HTX-011 Opioid-Free 72 Hours Post-Surgery in New Multi-center Clinical Study: In this study, 63 patients undergoing hernia repair surgery received HTX-011 together with a regimen of generic, over-the-counter, oral analgesics (acetaminophen and ibuprofen). Ninety percent (90%) of patients were opioid-free 72 hours post-surgery, and 81% were still opioid-free 28 days post-surgery.

Formal Development Initiated on HTX-034, Our Next-Generation Product Candidate for Postoperative Pain Management: Based on the positive results of preclinical studies in which HTX-034 demonstrated significant pain reduction for 7 days, Heron has initiated formal development of this next-generation postoperative pain management product candidate.
CINV Franchise

2018 Net Sales: Fourth-quarter 2018 net sales for the chemotherapy-induced nausea and vomiting (CINV) franchise were $28.8 million, up 187% year-over-year and up 46% from the third quarter of 2018. This included net sales of $23.4 million for CINVANTI (aprepitant) injectable emulsion and $5.4 million for SUSTOL (granisetron) extended-release injection. Full-year 2018 net sales for the CINV franchise were $77.5 million, up 152% year-over-year. This included net sales of $56.2 million for CINVANTI and $21.3 million for SUSTOL.

2019 Net Sales Guidance: Heron expects 2019 net sales for the CINV franchise of $115 million to $120 million.
"2018 was a year of significant growth for our CINV franchise, and we look forward to continued strong performance this year," said Barry Quart, Pharm.D., President and Chief Executive Officer of Heron. "In pain management, Heron remains committed to making a significant impact on the opioid epidemic through the development and commercialization of innovative non-opioid pain management products. With a PDUFA goal date of April 30, 2019, we look forward to launching HTX-011 in the U.S. later this year, if approved."

Financial Results

Net product sales for the three and twelve months ended December 31, 2018 were $28.8 million and $77.5 million, respectively, compared to $10.1 million and $30.8 million for the same periods in 2017, respectively.

Heron’s net loss for the three and twelve months ended December 31, 2018 was $49.6 million and $178.8 million, or $0.63 per share and $2.44 per share, respectively, compared to $62.5 million and $197.5 million, or $1.09 per share and $3.65 per share, for the same periods in 2017, respectively. Net loss for the three and twelve months ended December 31, 2018 included non-cash, stock-based compensation expense of $9.8 million and $33.4 million, respectively, compared to $6.9 million and $30.5 million, for the same periods in 2017, respectively.

As of December 31, 2018, Heron had cash, cash equivalents and short-term investments of $332.4 million, compared to $172.4 million as of December 31, 2017. Net cash used for operating activities for the three and twelve months ended December 31, 2018 was $33.5 million and $191.8 million, respectively, compared to $47.1 million and $170.3 million for the same periods in 2017, respectively.

About HTX-011 for Postoperative Pain

HTX-011, which utilizes Heron’s proprietary Biochronomer drug delivery technology, is an investigational, long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for postoperative pain management. By delivering sustained levels of both a potent anesthetic and a local anti-inflammatory agent directly to the site of tissue injury, HTX-011 was designed to deliver superior pain relief while reducing the need for systemically administered pain medications such as opioids, which carry the risk of harmful side effects, abuse and addiction. HTX-011 has been shown to reduce pain significantly better than placebo or bupivacaine solution in five diverse surgical models: hernia repair, abdominoplasty, bunionectomy, total knee arthroplasty and breast augmentation. HTX-011 was granted Fast Track designation from the FDA in the fourth quarter of 2017 and Breakthrough Therapy designation in the second quarter of 2018. Heron submitted an NDA to the FDA for HTX-011 in October of 2018 and received Priority Review designation in December of 2018. The FDA set a PDUFA goal date of April 30, 2019.

About CINVANTI (aprepitant) injectable emulsion

CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin and nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). CINVANTI is an intravenous formulation of aprepitant, a substance P/neurokinin-1 (NK1) receptor antagonist. CINVANTI is the first intravenous (IV) formulation to directly deliver aprepitant, the active ingredient in EMEND capsules. Aprepitant (including its prodrug, fosaprepitant) is the only single-agent NK1 receptor antagonist to significantly reduce nausea and vomiting in both the acute phase (0 – 24 hours after chemotherapy) and the delayed phase (24 – 120 hours after chemotherapy). CINVANTI is the only IV formulation of an NK1 receptor antagonist indicated for the prevention of acute and delayed nausea and vomiting associated with HEC and nausea and vomiting associated with MEC that is free of polysorbate 80 or any other synthetic surfactant. Pharmaceutical formulations containing polysorbate 80 have been linked to hypersensitivity reactions, including anaphylaxis and irritation of blood vessels resulting in infusion-site pain. FDA-approved dosing administration included in the United States prescribing information for CINVANTI is a 30-minute infusion.

Please see full prescribing information at www.CINVANTI.com.

About SUSTOL (granisetron) extended-release injection

SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-HT3 receptor antagonist that utilizes Heron’s Biochronomer drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL’s efficacy and safety in more than 2,000 patients with cancer. SUSTOL’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0 – 24 hours after chemotherapy) and delayed phase (24 – 120 hours after chemotherapy).

On February 22, 2019 Odonate Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, reported financial results for the three and twelve months ended December 31, 2018 (Press release, Odonate Therapeutics, FEB 22, 2019, View Source [SID1234533586]).

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As of December 31, 2018, Odonate had $139.1 million in cash, compared to $198.1 million as of December 31, 2017. This decrease in cash resulted primarily from net cash used in operating and investing activities of $67.1 million and $1.9 million, respectively, less net cash provided by financing activities of $10.2 million, which includes $9.8 million from the exercise of the underwriters’ option to purchase additional shares of common stock in our initial public offering. Odonate’s net loss for the three and twelve months ended December 31, 2018 was $28.8 million and $89.0 million, or $1.17 per share and $3.64 per share, respectively, compared to $15.7 million and $32.7 million, or $0.81 per share and $2.31 per share, for the same periods in 2017, respectively.

"We remain committed to developing novel therapies that improve the lives of patients with cancer," said Kevin Tang, Chief Executive Officer of Odonate. "Tesetaxel, our investigational, orally administered taxane, has been shown to have significant, single-agent antitumor activity in two multicenter, Phase 2 studies and may provide significant quality-of-life advantages over other chemotherapy options. We expect to complete enrollment in CONTESSA, our ongoing multinational, multicenter, randomized, Phase 3 study of tesetaxel in patients with metastatic breast cancer, in the second half of 2019 and report top-line results in 2020."

About Tesetaxel

Tesetaxel is an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Tesetaxel has several pharmacologic properties that make it unique among taxanes, including: oral administration with a low pill burden; a long (~8-day) terminal plasma half-life in humans, enabling the maintenance of adequate drug levels with relatively infrequent dosing; no history of hypersensitivity (allergic) reactions; and significant activity against chemotherapy-resistant tumors. In patients with metastatic breast cancer, tesetaxel was shown to have significant, single-agent antitumor activity in two multicenter, Phase 2 studies.

About CONTESSA

CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel, an investigational, orally administered taxane, in patients with locally advanced or metastatic breast cancer (LA/MBC). CONTESSA is comparing tesetaxel dosed orally at 27 mg/m2 on the first day of a 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally on days 1-14 of a 21-day cycle) to the approved dose of capecitabine alone (2,500 mg/m2/day dosed orally on days 1-14 of a 21-day cycle) in approximately 600 patients randomized 1:1 with HER2 negative, hormone receptor (HR) positive LA/MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in LA/MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. The primary endpoint is progression-free survival (PFS) assessed by an Independent Radiologic Review Committee (IRC). CONTESSA’s secondary efficacy endpoints are overall survival, objective response rate (ORR) assessed by IRC and disease control rate assessed by IRC. To learn more, please visit www.contessastudy.com.

On February 22, 2019 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that Scott Wolchko, President and Chief Executive Officer, will present at the 8th Annual SVB Leerink Global Healthcare Conference in New York City on Friday, March 1, 2019 at 10:30 a.m. ET (Press release, Fate Therapeutics, FEB 22, 2019, View Source [SID1234533585]).

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A live webcast of the presentation will be available through the investor relations section of the Company’s website at www.fatetherapeutics.com. Following the live webcast, an archived replay will be available on the Company’s website.