1stOncology™: Cancer Intelligence Service – Page 15640 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

RedHill Biopharma to Host Third Quarter 2017 Financial Results Conference Call on November 13, 2017

On November 6, 2017 RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary drugs for gastrointestinal and inflammatory diseases and cancer, reported that it will report its third quarter 2017 financial results on Monday, November 13, 2017 (Press release, RedHill Biopharma, NOV 6, 2017, View Source [SID1234521588]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

The Company will host a conference call on Monday, November 13, 2017, at 9:00 am EST to review the financial results and business highlights.

To participate in the conference call, please dial one of the following numbers 15 minutes prior to the start of the call: United States: +1-877-280-2296; International: +1-212-444-0896; and Israel: +972-3-763-0147. The access code for the call is: 2543708.

The conference call will be broadcasted live and available for replay on the Company’s website, View Source, for 30 days. Please access the Company’s website at least 15 minutes ahead of the conference to register, download and install any necessary audio software.

OncoCyte to Report Third Quarter 2017 Financial Results on November 14, 2017

On November 6, 2017 OncoCyte Corporation (NYSE American:OCX), a developer of novel, non-invasive blood based tests for the early detection of cancer, reported 14, 2017, after the close of the U.S. financial markets (Press release, BioTime, NOV 6, 2017, View Source [SID1234521579]). The Company will host a conference call on Tuesday, November 14, 2017, at 4:30 p.m. ET / 1:30 p.m. PT to discuss the results along with recent corporate developments.

The dial-in number in the U.S./Canada is 888-542-1102, for international participants the number is 719-325-2356. For all callers, refer to Conference ID 1817036. To access the live webcast, go to the investor relations section on the company’s website, View Source

A replay of the conference call will be available for seven business days beginning about two hours after the conclusion of the live call, by calling 888-203-1112 toll-free (from U.S./Canada); international callers dial 719-457-0820. Use the Conference ID 1817036. Additionally, the archived webcast will be available View Source

Heat Biologics to Present Data on its ComPACT Technology, at the Society for Immunotherapy of Cancer (SITC) Annual Meeting

On November 6, 2017 Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX), a biopharmaceutical company developing drugs designed to activate a patient’s immune system against cancer, reported that it will deliver pre-clinical data on its Combination Pan-antigen Cytotoxic Therapy (ComPACT) platform on November 11, 2017, at the 32nd annual Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (Press release, Heat Biologics, NOV 6, 2017, View Source [SID1234521582]).

The poster, Gp96-IG/costimulatory Combination Vaccine Improves T-cell Priming and Enhances Immunity, Memory, and Tumor Elimination, will be presented by Louis E. Gonzalez, Ph.D., director of research and principal scientist for Heat. He is available for discussion from 12:30 p.m. – 2 p.m. and 6:30 p.m. – 8 p.m. on Saturday, Nov. 11, 2017.

ComPACT is Heat’s next generation, T-cell Activation Platform (TCAP). It combines T-cell activation and co-stimulation in a single therapy by both delivering the gp96 heat shock protein and a T-cell co-stimulatory fusion protein (OX40L) in a single compound.

Heron Therapeutics Reports Financial Results for the Three and Nine Months Ended September 30, 2017 and Recent Corporate Progress

On November 6, 2017 Heron Therapeutics, Inc. (Nasdaq:HRTX) (the Company or Heron), a commercial-stage biotechnology company focused on developing novel, best-in-class treatments to address some of the most important unmet patient needs, reported financial results for the three and nine months ended September 30, 2017 and highlighted recent corporate progress (Press release, Heron Therapeutics, NOV 6, 2017, View Source [SID1234521583]).

Recent Corporate Progress

Pain Franchise

Initiated Phase 3 Program for HTX-011 in Postoperative Pain. Heron is enrolling patients in two pivotal Phase 3 efficacy studies in bunionectomy and hernia repair. Heron’s Phase 3 program is designed to achieve a broad indication for the reduction in postoperative pain and the need for opioid analgesics for 72 hours following surgery. Heron anticipates completing the pivotal Phase 3 efficacy studies in the first half of 2018 and expects to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in 2018.
Fast Track Designation Granted for HTX-011. The FDA has granted Fast Track designation for HTX-011 for local administration into the surgical site to reduce postoperative pain and the need for opioid analgesics for 72 hours. Fast Track designation is intended to facilitate the development and expedite the review of new therapies to treat serious conditions with unmet medical needs by providing sponsors with the opportunity for frequent interactions with the FDA. HTX-011 is the first opioid alternative for local administration into the surgical site to receive Fast Track designation.
Patent Issued Covering Novel Bupivacaine/Meloxicam Combination. The U.S. Patent and Trademark Office issued to Heron U.S. Patent No. 9,801,945, which covers HTX-011 and all clinically relevant combinations of bupivacaine and meloxicam for the prevention of postoperative pain.
CINV Franchise

SUSTOL Sales. Net product sales of SUSTOL (granisetron) extended-release injection for the three and nine months ended September 30, 2017 were $8.6 million and $20.7 million, respectively. Heron commenced commercial sales of SUSTOL in October 2016. Guidance for full-year 2017 net product sales of SUSTOL remains $25 million to $30 million.
CINVANTI FDA Action Date in Q4 2017. The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of November 12, 2017 for a decision on the Company’s NDA for CINVANTI.
“Heron made good progress in the third quarter of 2017, highlighted by the start of Phase 3 studies for HTX-011, which recently has been granted Fast Track designation, and SUSTOL’s continued commercial success, outperforming all other CINV new drug launches in the last decade,” said Barry D. Quart, Pharm.D., Chief Executive Officer of Heron. “Looking ahead, we are focused on FDA approval of CINVANTI, which, if approved, we expect to launch in January 2018, reporting top-line Phase 3 results for HTX-011 in the first half of next year and filing an NDA for HTX-011 in 2018.”

Financial Results

Net product sales of SUSTOL for the three months ended September 30, 2017 were $8.6 million and totaled $20.7 million for the nine months ended September 30, 2017. Heron commenced commercial sales of SUSTOL in October 2016.

Heron’s net loss for the three and nine months ended September 30, 2017 was $41.9 million and $135.0 million, or $0.77 per share and $2.55 per share, respectively, compared to a net loss of $48.5 million and $125.2 million, or $1.24 per share and $3.34 per share, respectively, for the same periods in 2016. Net loss for the three and nine months ended September 30, 2017, included non-cash, stock-based compensation expense of $7.5 million and $23.6 million, respectively, compared to $7.5 million and $18.7 million, respectively, for the same periods in 2016.

Heron’s cash, cash equivalents and short-term investments were $74.0 million as of September 30, 2017. The Company also had accounts receivable of $28.9 million, the majority of which the Company expects to collect in the fourth quarter of 2017 and the first quarter of 2018. Net cash used for operating activities for the three months ended September 30, 2017 was $40.5 million, compared to $36.1 million for the three months ended September 30, 2016. Net cash used for operating activities for the nine months ended September 30, 2017 was $123.2 million, compared to $95.6 million for the nine months ended September 30, 2016.

Infinity to Host Investor Reception and Webcast at SITC

On November 6, 2017 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that it will host a reception for investors and analysts on Friday, November 10, 2017, from 6:00 a.m. to 8:00 a.m. to discuss the clinical development of IPI-549, including a review of data from the ongoing Phase 1/1b clinical study. The reception will take place in conjunction with the 2017 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting at the Gaylord National Hotel and Convention Center in National Harbor, MD (Press release, Infinity Pharmaceuticals, NOV 6, 2017, View Source;p=RssLanding&cat=news&id=2314510 [SID1234521584]). IPI-549 is an orally administered immuno-oncology development candidate that selectively inhibits phosphoinositide-3-kinase gamma (PI3K-gamma) and is believed to be the only PI3K-gamma inhibitor in clinical development.

Featured speakers at the reception will include:

David Hong, M.D., Deputy Chair, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX
Taha Merghoub, Ph.D., Co-Director, Ludwig Collaborative Laboratory and the Swim Across America Laboratory at Memorial Sloan Kettering
The presentation portion of the reception will be webcast beginning at 6:30 a.m. ET. The webcast and accompanying slides can be accessed in the "investors/media" section of the company’s website, www.infi.com. A replay of the event will also be available.

About the IPI-549 and the Ongoing Phase 1 Study
IPI-549 is an investigational, orally administered immuno-oncology development candidate that selectively inhibits PI3K-gamma. In preclinical studies, IPI-549 reprograms macrophages from a pro-tumor, M2, to an anti-tumor, M1, phenotype and is able to overcome resistance to checkpoint inhibition as well as to enhance the activity of checkpoint inhibitors.1,2 As such, IPI-549 may have the potential to treat a broad range of solid tumors and represents a potentially complementary approach to restoring anti-tumor immunity in combination with other immunotherapies such as checkpoint inhibitors.

A Phase 1 study of IPI-549 in patients with advanced solid tumors is ongoing to evaluate the safety, tolerability, activity, pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy and in combination with Opdivo in approximately 200 patients with advanced solid tumors.3 The four-part study includes monotherapy and combination dose-escalation components, in addition to monotherapy expansion and combination expansion components. Patient enrollment is complete in monotherapy dose-escalation, and monotherapy expansion is ongoing. Combination dose-escalation is also ongoing, and combination expansion is expected to begin in the second half of 2017.

The combination expansion component includes multiple cohorts designed to evaluate IPI-549 in patients with specific types of cancer, including patients with non-small cell lung cancer (NSCLC), melanoma, and head and neck squamous cell carcinoma (HNSCC) whose tumors show initial resistance or subsequently develop resistance to immune checkpoint blockade therapy. This combination expansion will also include a cohort of patients with triple negative breast cancer (TNBC) who have not been previously exposed to immune checkpoint blockade therapy. Although there has been great progress in the treatment of cancer, there remains a need for additional treatment options. NSCLC, melanoma, HNSCC and TNBC account for more than 22 percent of all new cancer cases in the U.S.4,5

IPI-549 is an investigational compound and its safety and efficacy has not been evaluated by the U.S. Food and Drug Administration or any other health authority.