On November 3, 2016 Verastem, Inc. (NASDAQ:VSTM), focused on discovering and developing drugs to treat cancer, reported that new data for duvelisib, an investigational, oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2016 Annual Meeting, being held December 3-6, 2016 in San Diego (Press release, Verastem, NOV 3, 2016, View Source;p=RssLanding&cat=news&id=2219237 [SID1234516338]).
Data from DYNAMO, a Phase 2 monotherapy study evaluating the efficacy and safety of duvelisib in relapsed/refractory iNHL, will be presented in an oral session. Updated data from CONTEMPO, a Phase 1b/2 study evaluating duvelisib in combination with rituximab or obinutuzmab in treatment-naïve follicular lymphoma patients, and preclinical research on the role of Focal Adhesion Kinase (FAK) inhibition in AML, will be presented in a poster session.
Details for the presentations at ASH (Free ASH Whitepaper) are below:
Oral Presentation
Title: DYNAMO: A phase 2 study demonstrating the clinical activity of duvelisib in patients with relapsed refractory indolent non-Hodgkin lymphoma
Lead Author: Ian Flinn, M.D., Ph.D., Director, Hematologic Malignancies Program, Sarah Cannon Research Institute
Abstract Number: 1218
Location: San Diego Convention Center, Ballroom 20BC
Date and Time: Monday, December 5, 2016, 7:30 – 7:45 pm PT
The full abstract can be viewed here.
Poster Presentations
Title: Preliminary results in first-line treatment of follicular lymphoma with the oral dual PI3K-delta,gamma inhibitor, duvelisib, in combination with rituximab or obinutuzumab
Lead Author: Carla Casulo, M.D., Assistant Professor, Wilmot Cancer Institute, University of Rochester
Abstract Number: 2979
Location: San Diego Convention Center, Hall GH
Date and Time: Sunday, December 4, 2016, 6:00 – 8:00 pm PT
The full abstract can be viewed here.
Title: Inhibition of FAK Exerts Anti-Leukemic Activity and Potentiates ABT-199-Induced Apoptosis in AML
Lead Author: Bing Carter, Ph.D.., Associate Professor, Department of Leukemia – Research, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center
Abstract Number: 1574
Location: San Diego Convention Center, Hall GH
Date and Time: Saturday, December 3, 2016, 5:30 – 7:30 pm PT
The full abstract can be viewed here.
About the Tumor Microenvironment
The tumor microenvironment encompasses various cellular populations and extracellular matrices within the tumor or cancer niche that support cancer cell survival. This includes immunosuppressive cell populations such as regulatory T cells, myeloid-derived suppressor cells, M2 tumor-associated macrophages, as well as tumor-associated fibroblasts and extracellular matrix proteins which can hamper the entry and therapeutic benefit of cytotoxic immune cells and anti-cancer drugs. In addition to targeting the proliferative and survival signaling of cancer cells, Verastem’s compounds duvelisib, defactinib, VS-4718 and VS-5584 also target the tumor microenvironment as a mechanism of action to potentially improve a patient’s response to therapy.
About Duvelisib
Duvelisib is an investigational, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes that are known to help support the growth and survival of malignant B cells and T cells. PI3K signaling may lead to the proliferation of malignant B cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3 Duvelisib is currently being evaluated in late- and mid-stage clinical trials, including DUO, a randomized, Phase 3 monotherapy study in patients with relapsed/refractory chronic lymphocytic leukemia (CLL)4, and DYNAMO, a single-arm, Phase 2 monotherapy study in patients with refractory indolent non-Hodgkin lymphoma (iNHL) that achieved its primary endpoint of overall response rate upon topline analysis of efficacy data5. Duvelisib is also being evaluated for the treatment of hematologic malignancies through investigator-sponsored studies, including T cell lymphoma.6 Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

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On November 3, 2016 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported its revenues and cash position for the first nine months of 2016 (Press release, Innate Pharma, NOV 3, 2016, View Source [SID1234516195]).

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Cash, cash equivalents and financial instruments of the Company amounted to €239.6 million at September 30, 2016, including current and non-current financial assets (€243.6 million at June 30, 2016). At the same date, its financial liabilities amounted to €5.6 million (€4.1 million at June 30, 2016).

The consumption of cash, cash equivalents and financial instruments amounted to €4.0 million for the third quarter of 2016. This includes the collection during the period of the research tax credit relating to the year 2015 (€7.0 million) and of €2.0 million relating to finance-leases.

This revenue mainly results from:

€27.2 million resulting from the co-development and commercialization agreement with AstraZeneca, corresponding to the recognition over the period of the initial payment received in April 2015 (€5.9 million for the same period in 2015);
€0.7 million from the collaboration and licensing agreement with Bristol-Myers Squibb corresponding to the recognition of the upfront payment received in July 2011 (€4.4 million from a milestone payment for the same period in 2015).
As a reminder, within the frame of the collaboration and licensing agreement signed with Bristol-Myers Squibb in July 2011, the upfront payment received (€24.9 million, $35.3 million) was recognized in revenue during the expected period of duration of the clinical program in progress at the date of the contract. This upfront payment was entirely recognized as of June 30, 2016.

Regarding the co-development and commercialization agreement with AstraZeneca, the Company recognizes the initial payment of $250 million over the period during which the Company is committed to complete the studies and based on actual expenses incurred. The measurement of progress has been based on actual expenses incurred compared to the total estimated amount of expenses to be incurred for these studies.

Hervé Brailly, Chief Executive Officer of Innate Pharma, commented: "Innate Pharma is pleased to report another period of significant progress, as our core programs continue to advance in the clinic and we are maintaining a solid cash position. Preliminary safety and clinical activity results for IPH4102 have been presented at the world congress of cutaneous lymphomas. These results are encouraging for this wholly-owned program. Recently, our partner Bristol-Myers Squibb reported safety data for lirilumab and we now look forward to the release of efficacy data at the SITC (Free SITC Whitepaper) annual meeting in a few days. Beyond our clinical programs, we have continued to invest in our proprietary preclinical pipeline as we seek to build the Company’s wholly-owned portfolio of programs and improve cancer treatment and clinical outcomes for patients."

On November 3, 2016 Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS), a clinical-stage company developing new therapeutics and molecular diagnostics that target the underlying mechanisms of cancer, reported that new preclinical data for its lead investigational anticancer therapeutic APTO-253 will be presented at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition being held December 3-6, 2016, in San Diego, CA (Press release, Aptose Biosciences, NOV 3, 2016, View Source;p=RssLanding&cat=news&id=2219559 [SID1234516219]).

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Poster Presentation Details:
Inhibition of c-Myc By Apto-253 As an Innovative Therapeutic Approach to Induce Cell Cycle Arrest and Apoptosis in Acute Myeloid Leukemia
Date & Time: Saturday, December 3, 2016, 5:30-7:30 p.m.
Session Title: 617. Acute Myeloid Leukemia: Biology, Cytogenetics, and Molecular Markers in Diagnosis and Prognosis: Poster I
Abstract Number: 1716
Location: San Diego Convention Center, Hall GH
The abstract can be viewed on the ASH (Free ASH Whitepaper) conference website at the following link:
View Source

On November 3, 2016 Nektar Therapeutics (Nasdaq: NKTR) reported its financial results for the third quarter ended September 30, 2016 (Press release, Nektar Therapeutics, NOV 3, 2016, View Source [SID1234516305]).

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Cash and investments in marketable securities at September 30, 2016 were $253.5 million as compared to $308.9 million at December 31, 2015. Our cash and investments in marketable securities at September 30, 2016 do not include net proceeds of approximately $189.1 million from the recent sale and issuance of our common stock on October 24, 2016.

"Our pipeline is rapidly advancing with several important data catalysts and potential approvals expected over the next several quarters," said Howard W. Robin, President and Chief Executive Officer of Nektar. "With the positive clinical results from our ongoing Phase 1 study of NKTR-214, we have now demonstrated that NKTR-214 is the first investigational medicine in immuno-oncology that selectively stimulates the in vivo proliferation of endogenous tumor-killing lymphocytes within the tumor micro-environment. In Q3, these data led to a broad clinical collaboration with Bristol-Myers Squibb to evaluate combination regimens with their anti-PD-1 agent in five different tumor types and at least seven indications. Within the next two quarters, we will have Phase 3 data for four programs: two Bayer anti-infective programs, Ophthotech’s Fovista in wet AMD, and our own proprietary pain program, NKTR-181, in chronic low back pain. We are also expecting a decision from the European CHMP on conditional approval of ONZEALD by the end of Q1 2017."

Year-to-date revenue for 2016 was $128.0 million as compared to $191.4 million in the first nine months of 2015. Revenue in 2016 included recognition of $31.0 million from AstraZeneca as a result of its sublicense of MOVENTIG (naloxegol) to ProStrakan (Kyowa Kirin) in Europe. In addition, product sales, royalty revenue, and non-cash royalty revenue increased in the first nine months of 2016 compared to the first nine months of 2015. Revenue in 2015 included 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. in Q1 2015 and the $40.0 million milestone payment from AstraZeneca following the first commercial sale of MOVENTIG in the EU in Q3 2015. Revenue in the third quarter of 2016 was $36.3 million as compared to $60.0 million in the third quarter of 2015.

Revenue included non-cash royalty revenue, related to our 2012 royalty monetization, of $7.7 million and $22.3 million in the third quarter and first nine months of 2016, respectively, and $6.1 million and $14.8 million in the third quarter and first nine months of 2015, respectively. This non-cash royalty revenue is offset by non-cash interest expense also incurred in connection with the 2012 royalty monetization of $4.9 million and $14.9 million in the third quarter and first nine months of 2016, respectively and $5.2 million and $15.4 million in the third quarter and first nine months of 2015, respectively.

Total operating costs and expenses in the third quarter of 2016 were $69.2 million as compared to $59.5 million in the third quarter of 2015. Year-to-date total operating costs and expenses in 2016 were $208.7 million as compared to $191.4 million for the same period in 2015. 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 2016 was $52.0 million as compared to $43.2 million in the third quarter of 2015. Year-to-date R&D expense for 2016 was $153.6 million as compared to $135.7 million for the same period in 2015. R&D expense was higher in the third quarter and first nine months of 2016 as compared to the same periods in 2015 primarily due to expenses for the NKTR-181 Phase 3 studies and the initiation of the Phase 1/2 study of NKTR-214.

General and administrative expense was $10.3 million in the third quarter of 2016 as compared to $9.5 million in the third quarter of 2015. G&A expense in the first nine months of 2016 was $31.5 million as compared to $30.0 million for the same period in 2015.

Net loss in the third quarter of 2016 was $43.2 million or $0.32 loss per share as compared to $8.2 million or $0.06 loss per share in the third quarter of 2015. Net loss in the first nine months of 2016 was $111.3 million or $0.82 loss per share as compared to $27.0 million or $0.21 loss per share in the first nine months of 2015.

The company also announced upcoming presentations at the following scientific congresses during the fourth quarter of 2016:

Society for Immunotherapy in Cancer (SITC) (Free SITC Whitepaper) 31st Anniversary Annual Meeting, National Harbor, MD:

Oral Presentation: "A CD122-biased agonist increases CD8+T Cells and natural killer cells in the tumor microenvironment; making cold tumors hot with NKTR-214"
Presenter: Dr. Adi Diab, Assistant Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas
Session: New Cancer Immunotherapy Agents in Development
Date: Wednesday, November 9, 2016, 11:10 a.m. – 12:20 p.m. Eastern Time
Poster 387: "A CD122-biased agonist increases CD8+T Cells and natural killer cells in the tumor microenvironment; making cold tumors hot with NKTR-214"
Session: Tumor Microenvironment
Date: Friday, November 11, 2016, 12:15 – 1:30 p.m. and 6:15 – 7:30 p.m. Eastern Time
Poster 343: "Anti-tumor activity of NKTR-214; a CD122-biased agonist that promotes immune cell activation in the tumor microenvironment and lymphoid tissues"
Session: Promoting and Measuring Anti-Tumor Activity
Date: Friday, November 11, 2016, 12:15 – 1:30 p.m. and 6:15 – 7:30 p.m. Eastern Time
Poster 359: "NKTR-214, an engineered cytokine, synergizes and improves efficacy of anti-cancer vaccination in the treatment of established murine melanoma tumors"
Session: Therapeutic Cancer Vaccines
Date: Friday, November 11, 2016, 12:15 – 1:30 p.m. and 6:15 – 7:30 p.m. Eastern Time
Poster 342: "NKTR-255: an IL-15-based therapeutic with optimized biological activity and anti-tumor efficacy"
Session: Promoting and Measuring Anti-Tumor Activity
Date: Saturday, November 12, 2016, 11:45 a.m. – 1:00 p.m. and 6:45 – 8:00 p.m. Eastern Time
EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium, Munich, Germany:

Poster: "Intra-tumoral immune cell mobilization and anti-tumor activity after treatment with the engineered cytokine NKTR-214 in multiple preclinical mouse tumor models", Charych, D., et al.
Poster Session: Immunotherapy
Date: November 30, 2016, 8:30 a.m. Central European Time
2016 San Antonio Breast Cancer Symposium, San Antonio, TX:

Poster OT1-04-08: "Phase 3 study of etirinotecan pegol versus treatment of physician’s choice in patients with metastatic breast cancer who have stable brain metastases previously treated with an anthracycline, a taxane, and capecitabine", Tripathy, D. et al.
Poster Session: Ongoing Trials – Metastases
Date: December 7, 2016, 5:00 p.m. – 7:00 p.m. Central Time

On November 3, 2016 Insys Therapeutics, Inc. (NASDAQ:INSY) ("Insys" or "the Company") reported financial results for the three-month period ended September 30, 2016 (Press release, Insys Therapeutics, NOV 3, 2016, View Source;p=RssLanding&cat=news&id=2219054 [SID1234516196]).

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Highlights of and subsequent to the third quarter of 2016 include:

Total net revenue was $55.2 million, compared to $91.3 million for the third quarter of 2015;
Net income totaled $190,000, or $0.00 per basic and $0.00 per diluted share, compared to net income of $26.1 million, or $0.36 per basic and $0.34 per diluted share, for the third quarter of 2015;
Cash, cash equivalents and investments were $217.2 million as of September 30, 2016; and
Insys received FDA approval for the marketing of SyndrosTM (dronabinol oral solution), a proprietary, orally administered liquid formulation of dronabinol.
"Although Subsys volumes declined in the quarter, we are pleased to have maintained a mid-40% market share and believe the product will continue to provide a solid financial foundation for growth and to support our R&D efforts," said Dr. John N. Kapoor, Chairman, President and Chief Executive Officer of Insys Therapeutics. "We are currently awaiting DEA scheduling of Syndros, our recently FDA approved product for cancer induced nausea and vomiting and anorexia associated with weight loss in AIDS patients. We look forward to launching Syndros, our second commercial product, which we believe has distinct advantages over the current formulation of dronabinol in soft gel capsule. We remain excited about our pipeline and believe that both our spray and cannabinoid platform products will provide opportunities for future growth," he concluded.

Third Quarter 2016 Financial Results

Net revenue for the third quarter of 2016 was $55.2 million compared to $91.3 million for the third quarter of 2015, a decrease of 39.5%. The results reflect a decline in Subsys prescription volumes due to softness in overall demand in the TIRF category, including Subsys, and continued pressure from third-party payers.

Gross margin was 92% for the third quarter of 2016 compared with 92% for the comparable quarter of 2015.

Sales and marketing expense was $16.7 million during the third quarter of 2016, or 30% of net revenue, compared to $19.2 million, or 21% of net revenue, for the third quarter of 2015.

Research and development expense increased to $16.5 million for the third quarter of 2016, compared to $12.3 million for the third quarter of 2015, as we continue to advance the multistage products in our pipeline.

General and administrative expense increased to $17.7 million for the third quarter of 2016, up from $13.7 million for the third quarter of 2015, and included a non-cash equity compensation charge of approximately $4 million in connection with the departure of a former executive.

Net income for the third quarter of 2016 was $190,000, or $0.00 per basic and $0.00 per diluted share, compared to net income of $26.1 million, or $0.36 per basic and $0.34 per diluted share, for the third quarter of 2015. Non-GAAP adjusted net income for the third quarter of 2016 was $5.0 million, or $0.07 per diluted share, compared to non-GAAP adjusted net income of $38.0 million, or $0.50 per diluted share, in the prior-year quarter. The reconciliation of net income to non-GAAP adjusted net income is included at the end of this press release.

Liquidity

The Company had $217.2 million in cash, cash equivalents, and short-term and long-term investments, no debt, and $269 million in stockholders’ equity as of September 30, 2016.