On November 6, 2017 CTI BioPharma Corp. (NASDAQ and MTA:CTIC) reported financial results for the third quarter ended September 30, 2017 (Press release, CTI BioPharma, NOV 6, 2017, View Source;p=RssLanding&cat=news&id=2314662 [SID1234521603]).

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Recent Highlights

Clinical / Regulatory

In July 2017, the first patient was enrolled in PAC203, a Phase 2 clinical trial of pacritinib in patients with primary myelofibrosis who have failed prior ruxolitinib therapy. PAC203 is designed to evaluate the dose response relationship for safety and efficacy (spleen volume reduction at 12 and 24 weeks) of three dose regimens: 100 mg once-daily, 100 mg twice-daily (BID) and 200 mg BID. The 200 mg BID dose regimen was used in the Phase 3 PERSIST-2 trial of pacritinib in patients with myelofibrosis. The trial is expected to enroll up to approximately 105 patients.
In July 2017, the European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) for pacritinib for the treatment of patients with myelofibrosis who have thrombocytopenia (platelet counts less than 100,000 per microliter). Validation confirms that the submission is complete and initiates the centralized review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP).
Board of Directors and Management

In September 2017, Laurent Fischer, M.D. was appointed Chairman of the Board of Directors. Dr. Fischer has more than 20 years of experience in developing and commercializing novel medicines in the biopharmaceutical industry and currently serves as liver therapeutic area head at Allergan following its acquisition of Tobira Therapeutics in 2016.
In September 2017, David H. Kirske was promoted to Chief Financial Officer and Bruce J. Seeley to Chief Operating Officer of the company.
"In the third quarter, we solidified our board and senior management leadership and continue to make significant progress in reducing expenses to operate as a leaner organization as we approach important milestones," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI BioPharma. "We believe there remains a significant unmet need for myelofibrosis patients with low platelets and continue activating sites in the PAC203 trial of pacritinib. We also look forward to continuing to work with the EMA over the next nine months during their review of the MAA for pacritinib."

Third Quarter Financial Results

Total revenues for the third quarter and nine months ended September 30, 2017, were $1.7 million and $24.7 million, respectively, compared to $4.4 million and $48.3 million for the respective periods in 2016. The decrease in total revenues for the nine months of 2017 is primarily due to recognition of $32 million in milestone revenue related to pacritinib in the first quarter of 2016. Net product sales of PIXUVRI for the third quarter and nine months ended September 30, 2017, were zero and $0.9 million, respectively, compared to $0.9 million and $3.1 million for the respective periods in 2016. The decrease in net product sales for the periods in 2017 compared to 2016, is primarily related to the April 2017 expansion of the PXUVRI agreement with Servier under which they have rights in all markets except the U.S.

GAAP operating loss for the third quarter and nine months ended September 30, 2017, was $11.8 million and $25.8 million, respectively, compared to GAAP operating loss of $28.7 million and $43.6 million for the respective periods in 2016. Non-GAAP operating loss, which excludes non-cash share-based compensation expense, for the third quarter and nine months ended September 30, 2017 was $10.4 million and $21.5 million, respectively, compared to non-GAAP operating loss of $23.6 million and $32.4 million for the respective periods in 2016. Non-cash share-based compensation expense for the third quarter and nine months ended September 30, 2017, was $1.4 million and $4.3 million, respectively, compared to $5.1 million and $11.2 million for the respective periods in 2016. The decrease in operating loss for the third quarter and nine months of 2017 was due to a significant decrease in research and development and selling, general and administrative expenses primarily related to a decrease in pacritinib development costs as a result of the completion of the Phase 3 clinical studies in 2017 and a decrease in expenses for the manufacture of pacritinib and personnel costs. For information on CTI BioPharma’s use of non-GAAP operating loss and a reconciliation of such measure to GAAP operating loss, see the section below entitled "Non-GAAP Financial Measures."

Net loss for the third quarter of 2017 was $12.0 million, or ($0.28) per share, compared to a net loss of $29.2 million, or ($1.04) per share, for the same period in 2016. Net loss for the nine months ended September 30, 2017, was $30.8 million, or ($0.90) per share, compared to a net loss of $45.6 million, or ($1.63) per share, for the same period in 2016.

As of September 30, 2017, cash and cash equivalents totaled $52.8 million, compared to $44.0 million at December 31, 2016.

Conference Call Information

CTI BioPharma management will host a conference call to review its third quarter 2017 financial results and provide an update on business activities. The event will be held today at 1:30 p.m. PT / 4:30 p.m. ET / 10:30 p.m. CET. Participants can access the call at 1-888-461-2021 (domestic) or +1 719-325-2359 (international). To access the live audio webcast or the subsequent archived recording, visit www.ctibiopharma.com. Webcast and telephone replays of the conference call will be available approximately two hours after completion of the call. Callers can access the replay by dialing 1-888-203-1112 (domestic) or +1 719-457-0820 (international). The access code for the replay is 1048572. The telephone replay will be available until November 13, 2017.

On November 6, 2017 TG Therapeutics, Inc. (NASDAQ:TGTX), reported that a conference call will be held on Wednesday, November 8, 2017 at 8:30am ET to discuss results for the third quarter of 2017 and provide a business outlook for the remainder of the year (Press release, TG Therapeutics, NOV 6, 2017, View Source [SID1234521589]). Michael S. Weiss, Executive Chairman and Chief Executive Officer, will host the call.

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To participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics Third Quarter 2017 Earnings Call. A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at www.tgtherapeutics.com. An audio recording of the conference call will also be available for replay at www.tgtherapeutics.com, for a period of 30 days after the call.

TG Therapeutics will announce its financial results for this period in a press release to be issued prior to the call.

On November 6, 2017 ERYTECH Pharma (Paris:ERYP) (ADR:EYRYY) (Euronext Paris: ERYP) (ADR: EYRYY), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells (“ERYTECH” or the “Company”), reported a business update and its financial results for the quarter ended September 30, 2017

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Business Highlights

In September 2017, ERYTECH presented full results from its open-label, multi-center, randomized Phase 2b trial of eryaspase in combination with chemotherapy for the treatment of second-line metastatic pancreatic cancer at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress in Madrid. In October 2017, the Company met with the FDA to discuss further development of eryaspase for the pancreatic cancer indication and intends to meet with the EMA to also discuss the design of a Phase 3 clinical trial that the Company hopes to initiate during the third quarter of 2018. The Company expects that the Phase 3 clinical trial will be designed to study the safety and efficacy of eryaspase combined with chemotherapy in patients with second-line metastatic pancreatic cancer. The trial is expected to enroll approximately 400 to 600 patients across clinical sites in the United States and Europe. The Company expects the primary endpoint of the trial to measure overall survival, and the main secondary endpoints will include progression-free survival, objective response rate, disease control rate, quality of life and safety. ERYTECH is also considering proof-of-concept studies in first-line pancreatic cancer and other settings and has initiated further preclinical work to assess the combinability of eryaspase with other compounds used in the treatment of first-line pancreatic cancer patients.

In October 2017, the Company resubmitted its MAA for eryaspase (GRASPA) for the treatment of patients with R/R ALL to the EMA. The validation of the MAA by the EMA is ongoing, after which the EMA will begin its formal assessment.

In September 2017, the Company announced the determination of the recommended Phase 2 dose in its U.S. Phase 1 dose escalation trial of eryaspase (GRASPA) as a first-line treatment of adult ALL patients at the level of 100 U/kg. This dose had been previously recommended following ERYTECH’s Phase 2 trial in elderly ALL patients. It is also the dose level used in the Company’s Phase 2b trial in second-line, metastatic pancreatic cancer and in its ongoing Phase 2b trial in AML, from which top-line results are expected by the end of 2017.

Preclinical development activities of other product candidates are progressing:
In September, ERYTECH presented preclinical data on its eryminase and erymethionase programs at the 13th International Congress of Inborn Errors of Metabolism (ICIEM). Both programs underscore ERYTECH’s opportunities with companies active in the field of metabolic diseases and enzyme replacement therapies. Further proof of concept data are expected during the course of 2018.

ERYTECH continues to explore the use of its proprietary ERYCAPS platform to encapsulate tumor antigens within red blood cells as an innovative approach to cancer immunotherapy. The Company expects to complete preclinical proof-of-concept studies of ERYMMUNE during the course of 2018.
Financial Highlights

Net loss for the nine-month period ended September 30, 2017 was €20.8 million, compared to €16.1 million for the same period in the prior year. The €4.7 million increase reflected increased activity to advance the Company’s ongoing preclinical and clinical development programs and was primarily related to the clinical and regulatory progress of product development projects, and higher personnel costs incurred due to the previously announced staffing of key positions in the Company’s preclinical, clinical and pharmaceutical operations, to address the Company’s activity expansion and prepare the Company for the next stages of its development strategy.

As of September 30, 2017, ERYTECH had cash and cash equivalents totaling €80.3 million, compared with €88.6 million as of June 30, 2017 and €37.6 million as of December 31, 2016. Total net cash utilization was €8.3 million in the third quarter of 2017 and €22.8 million for the nine-month period ended September 30, 2017, excluding the €65.2 million net proceeds from the Company’s April 2017 capital raise.

The financial results for the three and nine months ended September 30, 2017 were in line with ERYTECH’s established strategy for 2017 and reflected the strengthening of the Company’s operations, which focuses on preparing the Company for its next stage of development, including its expected launch in 2018 of a Phase 3 clinical trial in second line metastatic pancreatic cancer in Europe and the United States. Management believes that its cash and cash equivalents available at September 30, 2017 are sufficient to fund our clinical trials that have already commenced, on the basis of its current cost structure and its ongoing programs, to ensure its viable going concern through the 2020 horizon.

Key newsflow and milestones expected over the next 12 months

Expect to report results from EU Phase 2b AML study in Europe
Meeting with CHMP on PDAC development plan
Meeting with FDA on ALL development plan
Potential initiation of Phase 3 trial in second-line PDAC in Europe and the U.S.
Potential initiation of clinical studies in first-line PDAC and other solid tumors
Potential launch of Phase 3 trial in first-line adult ALL
Potential launch of Phase 3 trial in AML
Expected initiation of erymethionase Phase 1 study

Next financial updates:

Financial highlights for the 4th quarter and full-year 2017: March 12, 2018 (after market close), followed by a conference call and webcast on March 13, 2018 (1:30pm CET/8:30am EDT)
Upcoming participations at investor conferences:

Jefferies Global Healthcare Conference, November 15-16, 2017, London
Actionaria, November 23-24, 2017, Paris
Geneva European Midcap Event, November 28-29, Geneva
Biomed Invest Securities, December 19, Paris
Investor access event at the J.P. Morgan Healthcare Conference, January 8-11, 2018, San Francisco
ODDO BHF Forum, January 11-12, 2018, Lyon

Gilead Sciences has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Gilead Sciences, 2017, NOV 6, 2017, View Source [SID1234521655]).

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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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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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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