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CTI BioPharma Announces Data Presentations at the 57th American Society of Hematology Annual Meeting

On November 6, 2015 CTI BioPharma Corp. (CTI) (NASDAQ and MTA: CTIC) reported that data highlighting two compounds (pacritinib and tosedostat) from the company’s investigational pipeline will be presented at the upcoming 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, being held December 5-8 in Orlando, FL – including three oral presentations (Press release, CTI BioPharma, NOV 5, 2015, View Source;p=RssLanding&cat=news&id=2107857 [SID:1234508044]).

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The presentations will include data analyses from the Phase 3 PERSIST-1 trial of pacritinib, an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R that is currently under investigation for the treatment of patients with myelofibrosis and acute myeloid leukemia (AML) as well as findings from a Phase 2 study of tosedostat, an investigational oral selective inhibitor of aminopeptidases that has demonstrated anti-tumor responses in blood-related cancers and solid tumors in Phase 1-2 clinical trials.

"We look forward to the presentation of data for both pacritinib and tosedostat at this year’s ASH (Free ASH Whitepaper) annual meeting," said James A. Bianco, M.D., President and CEO of CTI BioPharma. "With six abstracts accepted, the data involving two of our investigational compounds is a further example of our focused commitment on advancing the development of our pipeline candidates."

A summary of the oral and poster presentations are below, and full abstracts can be accessed on the ASH (Free ASH Whitepaper) website at www.hematology.org.

Oral Presentations

Analysis of Outcomes by Patient Subgroups in Patients with Myelofibrosis Treated with Pacritinib vs Best Available Therapy (BAT) in the Phase III PERSIST-1 Trial
First Author: Alessandro M Vannucchi, M.D., Associate Professor of Hematology, University of Florence, Italy
Date/Time: Saturday, December 5 at 10:15 a.m. ET
Location: W224, Level 2
Oral Session: 634. Myeloproliferative Syndromes: Clinical: Early and Late Stage Trials in MPN
Abstract #58

Pacritinib, a Dual FLT3/JAK2 Inhibitor, Reduces IRAK-1 Signaling in Acute Myeloid Leukemia
First Author: Megan M Cleary, B.S., B.A, Knight Cancer Institute, Division of Hematology and Medical Oncology, Oregon Health & Science University, Portland, OR
Date/Time: Monday, December 7 at 11:45 a.m. ET
Location: Room W109
Oral Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Novel Targeting Approaches
Abstract #570

Tosedostat Plus Low Dose Cytarabine Induces a High Rate of Responses That Can be Predicted By Genetic Profiling in Elderly AML
First Author: Giuseppe Visani, M.D., Director of Hematology and Stem Cell Transplant Center at AORMN, Pesaro, Italy
Date/Time: Sunday, December 6 at 5:30 p.m. ET
Location: Room W109
Oral Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: New Drugs
Abstract #329

Poster Presentations

Relationship Between Patient-Reported Outcomes (PROs) and Health-Related Quality of Life (HRQoL) and Efficacy in Patients with Myelofibrosis in the Phase III PERSIST-1 Trial of Pacritinib Vs. Best Available Therapy (BAT)
First Author: Ruben Mesa, M.D., Chair, Hematology and Medical Oncology Division Mayo Clinic, Scottsdale, AZ
Date/Time: Saturday, December 5 at 5:30-7:30 p.m. ET
Location: Hall A, Level 2
Poster Session: 634. Myeloproliferative Syndromes: Clinical: Poster I
Abstract #1609

Targeting JAK2 by Gene Knockout or Pacritinib Treatment Reduces GVHD and Xenograft Rejection by Promoting Induced Treg Differentiation
First Author: Brian C. Betts, M.D., Medical Oncologist and Assistant Member of the Department of Blood and Marrow Transplant, Moffitt Cancer Center, Tampa, FL
Date/Time: Saturday, December 5 at 5:30-7:30 p.m. ET
Location: Hall A, Level 2
Poster Session: 702. Experimental Transplantation: Immune Function, GVHD and Graft-versus-Tumor Effects
Abstract #1874

Pacritinib (PAC) Synergistically Potentiates Azacitidine (5AZA) Cytotoxicity in Chronic Myelomonocytic Leukemia (CMML)
First Author: Yan Ma, M.D., H. Lee Moffitt Cancer Center, Tampa, FL
Date/Time: Saturday, December 5 at 5:30-7:30 p.m. ET
Location: Hall A, Level 2
Poster Session: 636. Myelodysplastic Syndromes – Basic and Translational Studies: Poster I
Abstract #1658

About Pacritinib

Pacritinib is an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R. In August 2014, pacritinib was granted Fast Track designation by the FDA for the treatment of intermediate and high risk myelofibrosis, including but not limited to patients with disease-related thrombocytopenia, patients experiencing treatment-emergent thrombocytopenia on other JAK2 inhibitor therapy, or patients who are intolerant of, or whose symptoms are sub-optimally managed on other JAK2 inhibitor therapy. The FDA’s Fast Track process is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Pacritinib does not have regulatory approval and is not commercially available.

CTI BioPharma and Baxalta (NYSE:BXLT) are parties to a worldwide license agreement to develop and commercialize pacritinib. CTI BioPharma and Baxalta will jointly commercialize pacritinib in the U.S. while Baxalta has exclusive commercialization rights for all indications outside the U.S.

About Tosedostat

Tosedostat is an investigational oral aminopeptidase inhibitor that has demonstrated anti-tumor responses in blood-related cancers and solid tumors in Phase 1-2 clinical trials. Tosedostat is currently being evaluated in multiple Phase 2 clinical trials for the treatment of patients with AML or high-risk MDS. Tosedostat is not approved or commercially available.

11/05/2015 Corcept Therapeutics Announces Third Quarter 2015 Results and Provides Corporate Update

On November 5, 2015 Corcept Therapeutics Incorporated (NASDAQ: CORT), a pharmaceutical company engaged in the discovery, development and commercialization of drugs that treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, reported its financial results for the quarter ended September 30, 2015 and provided a corporate update (Press release, Corcept Therapeutics, NOV 5, 2015, http://www.corcept.com/news_events/view/pr_1446758532 [SID:1234508043]).

Corcept recorded net revenue of $13.3 million in the third quarter of 2015, compared to $7.3 million for the same period in 2014, an increase of 82 percent. The company reiterated its 2015 revenue guidance of $49 – $53 million.

Corcept reported a net loss on a GAAP basis of $0.6 million for the third quarter of 2015, compared to a GAAP net loss of $6.0 million for the same period in 2014. Excluding non-cash expenses, Corcept generated non-GAAP net income in the third quarter of $1.6 million, compared to a non-GAAP net loss of $3.9 million in the third quarter of 2014. A reconciliation of GAAP to non-GAAP net operating results is set forth below.

At September 30, 2015, Corcept held cash and cash equivalents of $36.5 million, compared to $37.0 million at the end of the prior quarter. This change in cash reflects the repayment of $1.8 million in principal due under the company’s capped royalty financing agreement (Royalty Financing). The company entered into the Royalty Financing in 2012 to fund the commercialization of Korlym and expects to make its final payment in 2017.

Based on its current plans, the company expects to reach cash flow breakeven, including payments of principal due under the Royalty Financing, without needing to raise additional funds.

"Our Cushing’s syndrome franchise continues to grow as more physicians appreciate that using Korlym to modulate the effect of excess cortisol can greatly improve their patients’ health," said Joseph K. Belanoff, M.D., Corcept’s Chief Executive Officer. "As we have said before, our efficient cost structure and the revenue growth in our Cushing’s syndrome business allows us to build our clinical infrastructure, further develop Korlym and advance our next-generation compounds."

Korlym for the Treatment of Triple-Negative Breast Cancer (TNBC)

In December 2015, at the San Antonio Breast Cancer Symposium, Corcept will present preliminary efficacy results of its Phase 1/2 open-label trial of Korlym in combination with eribulin (Halaven) to treat patients with metastatic TNBC.

CORT125134 Phase 2 Trials

CORT125134 is the lead compound in Corcept’s portfolio of proprietary next-generation cortisol modulators. It was well-tolerated in its Phase 1 trial and showed that it shares Korlym’s ability to potently modulate activity at the glucocorticoid receptor (GR), the essential quality in treating Cushing’s syndrome. In addition, when administered with a chemotherapeutic agent, CORT125134 slows tumor growth significantly in mouse models of TNBC and castration-resistant prostate cancer. In vitro, it similarly slows the growth of ovarian cancer tumor cells; in vivo testing in mouse models of ovarian cancer is in progress.

In the first quarter of 2016, the company plans to begin two Phase 2 clinical trials with CORT125134. One trial will be for the treatment of patients with Cushing’s syndrome. The other will administer CORT125134 with a companion chemotherapeutic or hormonal agent to treat patients with a solid tumor cancer.

"It’s an exciting time to join Corcept," said Robert S. Fishman, M.D., Corcept’s Chief Medical Officer. "We are exploring extending Korlym’s label to cover oncologic indications, our lead next-generation cortisol modulator, CORT125134, is about to enter multiple Phase 2 trials and we’re advancing additional selective cortisol modulating compounds toward the clinic."

Financial Discussion

Corcept recorded a GAAP net loss of $0.6 million in the third quarter of 2015, compared to $6.0 million in the third quarter of 2014, including non-cash stock-based compensation and accreted interest expense generated from the Royalty Financing of $2.2 million and $2.1 million in the third quarter of 2015 and 2014, respectively. Excluding these non-cash items, Corcept generated net income on a non-GAAP basis of $1.6 million in the third quarter of 2015, compared to a non-GAAP net loss of $3.9 million in the third quarter of 2014.

Operating expenses for the third quarter were $13.2 million, compared to $12.4 million for the third quarter of 2014. The increase was primarily due to increased staffing costs and additional spending on the Phase 1/2 trial of Korlym for the treatment of TNBC and the development of next-generation cortisol modulators.

In the third quarter of 2015, Corcept made a payment of $2.5 million under the Royalty Financing, of which $0.7 million represented accreted interest and $1.8 million reduced outstanding principal. In the same period of 2014, Corcept paid $1.3 million, of which $0.9 million represented accreted interest and $0.4 million reduced outstanding principal. Corcept expects to make its final payment under the Royalty Financing in 2017.

Corcept’s cash balance at September 30, 2015 was $36.5 million, compared to $37.0 million at June 30, 2015 and $24.2 million at December 31, 2014.

Cellectis to Present Data on its Allogeneic CAR T-Cell Immunotherapy Product Candidates during the Upcoming ASH Annual Meeting

On November 5, 2015 Cellectis (Alternext: ALCLS – Nasdaq: CLLS) reported that data on its engineered allogeneic CAR T-Cell product candidates, UCARTCS1 and UCART123, will be presented during the 2015 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, Cellectis, NOV 5, 2015, View Source [SID:1234508042]). A poster and an oral presentation will be presented during this event.

Bypassing the Constraint for Chimeric Antigen Receptor (CAR) Development in T-Cells Expressing the Targeted Antigen: Improvement of Anti-CS1 CAR Activity in Allogenic TCRa/CS1 Double Knockout T-Cells for the Treatment of Multiple Myeloma (MM)
Oral presentation

Session Name: Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Novel Immunotherapeutics and the Impact of the Microenvironment

Presentation Time: Saturday, December 5, 2015 at 2:15 PM

TCRab Deficient CAR T-Cells Targeting CD123: An Allogeneic Approach of Adoptive Immunotherapy for the Treatment of Acute Myeloid Leukemia (AML)
Poster presentation

Session Name: Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster II

Presentation Time: Sunday, December 6, 2015 from 6:00 PM to 8:00 PM

Oncothyreon Reports Third Quarter 2015 Financial Results

On November 05, 2015 Oncothyreon Inc. (NASDAQ:ONTY) reported financial results for the third quarter ended September 30, 2015 (Press release, Oncothyreon, NOV 5, 2015, View Source [SID:1234508037]).

Net loss for the three months ended September 30, 2015 was $4.6 million, or $0.05 per basic and diluted share, compared with a net loss of $6.7 million, or $0.09 per basic and diluted share, for the comparable period in 2014. The $2.1 million decrease in net loss was attributable to the difference in the change in the fair value of warrant liability of $1.3 million. The decrease in net loss was also due to decreases in research and development expenses of $0.5 million and decreases in general and administrative expenses of $0.3 million.

Net loss for the nine months ended September 30, 2015 was $23.5 million, or $0.24 per basic and diluted share, compared with a net loss of $22.4 million, or $0.31 per basic and diluted share, for the comparable period in 2014. The $1.1 million increase in net loss was attributable to the difference in the change in the fair value of warrant liability of $0.4 million and increases in research and development expenses of $0.7 million.

Oncothyreon’s cash, cash equivalents and investments totaled $63.7 million as of both September 30, 2015 and December 31, 2014.

Financial Guidance

Oncothyreon believes the following financial guidance to be correct as of the date provided. Oncothyreon is providing this guidance as a convenience to investors and assumes no obligation to update it.

Oncothyreon currently expects operating expenses in 2015 to be lower than in 2014, which included the upfront payment to Array BioPharma Inc. for the exclusive license to ONT-380. Oncothyreon currently expects cash used in operations in 2015 to be approximately $30.0 – $32.0 million.

Nektar Therapeutics Reports Financial Results for the Third Quarter of 2015

On November 5, 2015 Nektar Therapeutics (Nasdaq: NKTR) reported its financial results for the third quarter ended September 30, 2015 (Press release, Nektar Therapeutics, NOV 5, 2015, View Source [SID:1234508036]).

Cash and investments in marketable securities at September 30, 2015 were $267.8 million as compared to $279.7 million at June 30, 2015. Cash and investments at September 30, 2015 include a $40.0 million milestone payment received from AstraZeneca in Q3 2015 for the first commercial sale of MOVENTIG (naloxegol) in Germany. Cash and investments at September 30, 2015 do not include the proceeds from the $250 million direct private placement of 7.75% Senior Secured Notes due in 2020, which was closed on October 5, 2015. A portion of the proceeds from these new $250 million Senior Notes were used to redeem fully $125.0 million of 12% Senior Secured Notes due in 2017.

"We have made great progress in advancing our pipeline this year," said Howard W. Robin, President and Chief Executive Officer of Nektar. "MOVANTIK is performing very well with positive feedback from physicians and patients, ADYNOVATE is poised for approval, the NKTR-181 Phase 3 SUMMIT-07 efficacy study is enrolling ahead of schedule and we are exceptionally pleased to report that the FDA cleared the NKTR-214 IND earlier than anticipated. NKTR-214 has the potential to bring a new mechanism – direct and selective stimulation of a patient’s cancer-fighting T-cells — to the next generation of cancer immunotherapies. We expect to dose our first patients shortly at MD Anderson Cancer Center and Yale Cancer Center."

Year-to-date revenue for 2015 was $191.4 million as compared to $181.2 million in the first nine months of 2014. The increase in revenue in the first nine months of 2015 as compared to the same period in 2014 includes the recognition of $90.0 million of the $100.0 million milestone payment from AstraZeneca following the first commercial sale of MOVANTIK in the U.S. and the recognition of the $40.0 million milestone payment from AstraZeneca following the first commercial sale of MOVANTIK in a major European country. In addition, product sales and royalty revenue increased by $9.3 million in the first nine months of 2015 as compared to the same period in 2014. Revenue in the third quarter of 2015 was $60.0 million as compared to $132.9 million in the third quarter of 2014 due to the recognition of a one-time $105 million approval milestone for MOVANTIK in the third quarter of 2014.

Total operating costs and expenses in the third quarter of 2015 were $59.5 million as compared to $52.6 million in the third quarter of 2014. Year-to-date total operating costs and expenses in 2015 were $191.4 million as compared to $160.2 million for the same period in 2014. Total operating costs and expenses increased primarily as a result of increased research and development (R&D) expense.

Research and development expense in the third quarter of 2015 was $43.2 million as compared to $34.2 million in the third quarter of 2014. Year-to-date R&D expense for 2015 was $135.7 million as compared to $109.2 million for the same period in 2014. R&D expense was higher in the third quarter and first nine months of 2015 as compared to the same periods in 2014 primarily due to the initiation of the Phase 3 efficacy trial of NKTR-181 in chronic low back pain and the long-term safety study for NKTR-181. R&D expense for the first nine months of 2015 also increased as a result of IND-enabling and clinical study start-up activities for NKTR-214.

General and administrative expense was $9.5 million in the third quarter of 2015 as compared to $9.1 million in the third quarter of 2014. G&A expense in the first nine months of 2015 was $30.0 million as compared to $28.7 million for the same period in 2014.

Net loss in the third quarter of 2015 was $8.2 million or $0.06 net loss per diluted share as compared to net income of $70.6 million or $0.53 net income per diluted share in the third quarter of 2014. Net loss in the first nine months of 2015 was $27.0 million or $0.21 net loss per diluted share as compared to net loss of $8.2 million or $0.07 net loss per diluted share in the first nine months of 2014.

The company also announced upcoming presentations at the following scientific congresses during the fourth quarter of 2015:

Society for Immunotherapy in Cancer (SITC) (Free SITC Whitepaper) 30th Anniversary Annual Meeting, National Harbor, MD:

Abstract Title: "Synergistic antitumor activity of the CD122-biased immunostimulatory cytokine NKTR-214 when combined with anti-PD-1 in murine tumor models", Hoch, U., et al.
Date: November 6, 2015, 12:45 p.m. — 2:00 p.m. Eastern Time

2015 San Antonio Breast Cancer Symposium, San Antonio, TX:

Poster P1-13-02: "Early change in topoisomerase 1 (Top1) positive circulating tumor cells (CTCs) is associated with overall survival (OS) in patients with advanced breast cancer after treatment with etirinotecan pegol", Rugo, H., et al.
Poster Session: Advanced Chemotherapy
Date: December 9, 2015, 5:00 p.m. – 7:00 p.m. Central Time

Poster P4-11-08: "Impact of treatment on quality of life (QOL) in the BEACON study, a randomized phase III trial of etirinotecan pegol (EP) versus Treatment of Physician’s Choice (TPC) in patients (pts) with advanced breast cancer (aBC) whose disease has progressed following treatment with an Anthracycline, a Taxane and Capecitabine", Cortes, J., et al.
Poster Session: "Psychosocial, Quality of Life, and Educational Aspects: Psychosocial, QOL, and Educational Aspects — Other"
Date: December 11, 2015, 7:30 a.m. — 9:00 a.m. Central Time