On November 6, 2017 Trillium Therapeutics Inc. (Nasdaq/TSX: TRIL) a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported that the company is scheduled to present an update on the company’s programs and progress at several upcoming scientific conferences (Press release, Trillium Therapeutics, NOV 6, 2017, View Source [SID1234521590]).

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Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 32nd Annual Meeting
Presenter: Lisa Johnson, Ph.D., Trillium Research Scientist
Title: The checkpoint inhibitor TTI-621 (SIRPaFc) stimulates innate and adaptive immune responses in patients with hematologic and solid tumor malignancies (P42)
Date and Time: Nov. 11, 2017 at 12:30 p.m. – 2:00 p.m. and 6:30 p.m. – 8:00 p.m. ET
Location: Gaylord National Hotel and Convention Center, National Harbor Maryland

Presenter: Lei Cui, Ph.D., Trillium Postdoctoral Research Fellow
Title: The anti-tumor effect of radiation therapy is enhanced with the addition of TTI-621 (SIRPaFc), an immune checkpoint inhibitor blocking the CD47 "do not eat" signal (P272)
Date and Time: Nov. 11, 2017 at 12:30 p.m. – 2:00 p.m. and 6:30 p.m. – 8:00 p.m. ET
Location: Gaylord National Hotel and Convention Center, National Harbor Maryland

Society for Neuro Oncology 22nd Annual Meeting
Presenter: Zezhou Wang, Ph.D., Trillium Research Scientist

Title: TTI-2341: A novel, orally bioavailable, brain-penetrant, covalent epidermal growth factor receptor (EGFR) inhibitor for treatment of glioblastoma multiforme (GBM) and brain metastases of non-small cell lung cancer (NSCLC)
Date and Time: Nov. 18, 2017 at 5:00 p.m. – 7:00 p.m. PT,
Location: Marriott Marquis, San Francisco, California

American Society of Hematology 59th Annual Meeting
Presenter: Stephen Ansell, M.D., Ph.D., Division of Hematology, Mayo Clinic
Title: TTI-621 (SIRPaFc), an Immune Checkpoint Inhibitor Blocking the CD47 "Do Not Eat" Signal, Induces Objective Responses in Patients with Advanced, Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Date and Time: Dec. 11, 2017 at 6:00 p.m. – 8:00 p.m. ET
Location: Building A, Level 1, Hall A2, Georgia World Congress Center, Atlanta, Georgia

Presenter: Christiane Querfeld, M.D., Ph.D., City of Hope National Medical Center
Title: A Single Direct Intratumoral Injection of TTI-621 (SIRPaFc) Induces Antitumor Activity in Patients with Relapsed/Refractory Mycosis Fungoides and Sézary Syndrome: Preliminary Findings Employing an Immune Checkpoint Inhibitor Blocking the CD47 "Do Not Eat" Signal
Date and Time: Dec. 11, 2017 6:00 p.m. – 8:00 p.m. ET,
Location: Building A, Level 1, Hall A2, Georgia World Congress Center, Atlanta, Georgia

On November 6, 2017 Diplomat Pharmacy, Inc. (NYSE: DPLO), the nation’s largest independent provider of specialty pharmacy services, reported financial results for the quarter ended September 30, 2017 (Press release, Diplomat Speciality Pharmacy, NOV 6, 2017, View Source [SID1234521604]). All comparisons, unless otherwise noted, are to the quarter ended September 30, 2016.

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Diplomat Specialty Pharmacy (PRNewsFoto/Diplomat Pharmacy, Inc.)

Third Quarter 2017 Highlights include:

Revenue of $1,125 million, compared to $1,181 million
Total prescriptions dispensed of 222,000, compared to 266,000
Gross margin of 7.6% versus 6.6%
Gross profit per prescription dispensed of $360, compared to $289
Net income attributable to Diplomat of $1.0 million, compared to $5.4 million
Adjusted EBITDA of $23.2 million, compared to $22.6 million
Adjusted EBITDA margin of 2.1% versus 1.9%
EPS of $0.01 per diluted common share versus $0.08
Adjusted EPS of $0.25 versus $0.21
Phil Hagerman, CEO and Chairman of Diplomat, commented “Diplomat’s third quarter results were solid as we achieved financial results in-line with our expectations, experienced continued growth in our oncology and infusion businesses and expansion in our access to limited distribution drugs, as well as encouraging trends within the specialty pharmacy industry. I am pleased to announce we have resolved our arbitration with CVS and have transitioned from a PSAO contract to a direct contract with CVS, one of the nation’s largest health care companies. 2017 is a transition year for Diplomat, and we continue to make significant strides, including broadening our services through our acquisitions of NPS and 8th Day Software and enhancing our senior management team to execute on our strategy to become a broader-based health care company.”

Third Quarter Financial Summary:

Revenue for the third quarter of 2017 was $1,125 million, compared to $1,181 million in the third quarter of 2016. The decrease was driven by a loss of approximately $118 million due to contracts that were not renewed in 2017 and approximately $89 million due to a decrease in the demand for hepatitis C drugs versus the prior year period. These decreases were partially offset by approximately $64 million from the impact of manufacturer price increases, approximately $47 million from increased volume and mix with existing payor contracts, approximately $25 million of revenue from our recent acquisitions, and approximately $15 million from drugs that were new in the past year. Our revenue increase year over year excluding the impact of the contract losses was approximately 6%.

Gross profit in the third quarter of 2017 was $85.3 million and generated a 7.6% gross margin, compared to $78.5 million and 6.6% in the third quarter of 2016. The gross margin increase in the quarter was primarily due to the continued growth of our specialty infusion therapeutic category, the impact of our WRB Communications acquisition, each having higher margins, the receipt and recognition of approximately $1 million of insurance proceeds, and the non-repeat of an approximately $4 million direct and indirect remuneration (“DIR”) fee true-up that occurred in the year ago period.

Selling, general, and administrative expenses (“SG&A”) for the third quarter of 2017 were $83.0 million, an increase of $5.9 million, compared to $77.1 million in the third quarter of 2016. Of this change, $4.9 million related to employee cost, of which $5.2 million was employee cost for our recently acquired entities partially offset by operational efficiencies. Also contributing to the SG&A increase was a $2.4 million increase in amortization expense from definite-lived intangible assets, and a $1.9 million increase in the fair value of contingent consideration, both of which are associated with our acquired entities. We also experienced increases in other SG&A; including professional fees, workers’ compensation insurance, and other miscellaneous expenses. These increases were partially offset by the non-repeat of a $4.8 million impairment expense to fully impair certain definite-lived intangible assets in the prior year period. As a percentage of revenue, SG&A excluding change in fair value of contingent consideration and the prior year period impairment was 7.2% for the three months ended September 30, 2017, compared to 6.1% in the prior year period. This increase is primarily attributable to acquisition related amortization, professional fees, and the increased operating complexity associated with both our acquisitions and new drugs.

Net income attributable to Diplomat for the third quarter of 2017 was $1.0 million compared to $5.4 million in the third quarter of 2016. This decrease was primarily driven by the revenue, gross profit, and SG&A explanations above, as well as a $2.6 million change in income taxes. Adjusted EBITDA for the third quarter of 2017 was $23.2 million compared to $22.6 million in the third quarter of 2016.

Earnings per share for the third quarter of 2017 was $0.01 per basic/diluted common share, compared to $0.08 per basic/diluted common share for the third quarter of 2016. Diluted non-GAAP adjusted earnings per share (“Adjusted EPS”) was $0.25 in the third quarter of this year compared to $0.21 in the third quarter of 2016.

2017 Financial Outlook

For the full-year 2017, we are updating our previous financial guidance:

Revenue between $4.4 and $4.6 billion, versus the previous range of $4.3 and $4.6 billion
Net income attributable to Diplomat between $10 and $14 million, versus the previous range of $10 and $16 million
Adjusted EBITDA between $99 and $102 million, versus the previous range of $97 and $103 million
Diluted EPS between $0.15 and $0.20, versus the previous range of $0.15 and $0.23
Adjusted EPS between $0.82 and $0.87, versus the previous range of $0.71 and $0.79
Our EPS and Adjusted EPS expectations assume approximately 68,600,000 weighted average common shares outstanding on a diluted basis and a tax rate of 19%, versus the previous tax rate of 26%, for the full year 2017, which could differ materially.

Earnings Conference Call Information

As previously announced, the Company will hold a conference call to discuss its third quarter performance this evening, November 6, 2017, at 5:00 p.m. Eastern Time. Shareholders and interested participants may listen to a live broadcast of the conference call by dialing 833-286-5805 (or 647-689-4450 for international callers) and referencing participant code 95696083 approximately 15 minutes prior to the call. A webcast and audio file of the conference call will be available on the investor relations section of the Company’s website for approximately 90 days at ir.diplomat.is.

On November 6, 2017 AVEO Oncology (NASDAQ:AVEO) and EUSA Pharma reported the presentation of promising results from the ongoing Phase 1 portion of the TiNivo study, a Phase 1/2 multicenter trial of tivozanib (FOTIVDA) in combination with Bristol-Myers Squibb’s nivolumab (OPDIVO), an immune checkpoint, or PD-1, inhibitor, for the treatment of advanced renal cell carcinoma (RCC) (Press release, AVEO, NOV 6, 2017, View Source;p=RssLanding&cat=news&id=2314412 [SID1234521570]). The results were presented on Friday, November 3, at the 16th International Kidney Cancer Symposium in Miami, in an oral presentation titled "TiNivo: A Phase Ib Dose Escalation Trial of Tivozanib and Nivolumab in Renal Cell Carcinoma" by Laurence Albiges, M.D., Ph.D., Head, Genitourinary Unit, Institute Gustave Roussy, and a lead investigator of the study. A copy of the presentation is available at www.aveooncology.com or further information can be obtained via EUSA Pharma Medical Information.

The Phase 1 portion of the trial enrolled six patients, three with previously untreated metastatic RCC and three who had received first-line treatment. RCC tumor histology included five clear cell (one with sarcomatoid features) and one papillary. Tivozanib was administered to patients in two escalating dose cohorts (1.0 mg/QD and 1.5 mg/QD) in combination with nivolumab at a constant 240 mg every 2 weeks. The combination was well tolerated to the full dose and schedule of single agent tivozanib, with no dose limiting toxicities. The most common adverse events (any grade) were hypertension, asthenia and decreased appetite. No grade 4 adverse events were reported. Two grade 3 events were reported beyond cycle 1 (stomatitis and increased ALT), which did not lead to study discontinuation and were managed concurrently. Unconfirmed best response to date includes a 67% (4/6) partial response (PR) rate and a 100% disease control rate (PR + stable disease). Enrollment of approximately 20 patients in the Phase 2 portion of the trial is ongoing.

"Combining VEGF TKIs and PD-1s holds the potential for synergistic activity against renal cell carcinoma, yet most such combinations demonstrate a high rate of toxicity in the clinic," said Dr. Albiges. "Tivozanib has several distinguishing properties that may enhance its ability to combine with checkpoint inhibitors, including a highest in-class selectivity for the VEGF-Receptor (types 1, 2 and 3), and therefore fewer off-target effects, and the ability to significantly reduce regulatory T cells, thereby enhancing immune activity against the tumor. Tivozanib’s favorable tolerability profile has been demonstrated against sorafenib in the pivotal TIVO-1 study, and early results from the TiNivo study show a tolerable combination and evidence of promising activity."

"We are encouraged by the preliminary tolerability and activity results from the TiNivo study, as we believe they begin to underscore the unique potential of tivozanib-immunotherapy combinations," said Michael Needle, M.D., chief medical officer of AVEO. "With immunotherapy combinations continuing to demonstrate improved outcomes in patients with RCC, it will become increasingly important to leverage the best-in-class VEGF therapies and immunotherapies to optimize efficacy and tolerability in defined populations within this disease. We believe tivozanib is well-positioned within this evolving landscape, and we look forward to presenting the Phase 2 portion of TiNivo in the first half of next year. We also anticipate moving into additional combination studies in the coming quarters."

Lee Morley, EUSA Pharma’s Chief Executive Officer said, "Following the recent European approval of tivozanib (FOTIVDA) for the first-line treatment of patients with advanced RCC, emerging data from the TiNivo study indicates the potential for tivozanib in the setting of combination treatment with immunotherapies. The initial results of the TiNivo study are promising and, in partnership with AVEO, we look forward to developing new and innovative options based on the unique profile of tivozanib which will be important for the future management of patients."

About Tivozanib (FOTIVDA)

Tivozanib (FOTIVDA) is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) discovered by Kyowa Hakko Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma in the European Union plus Norway and Iceland. It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.1,2 Tivozanib has been investigated in several tumors types, including renal cell, colorectal and breast cancers.

CombiMatrix has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, CombiMatrix, 2017, NOV 6, 2017, View Source [SID1234521619]).

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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

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On October 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.

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.