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.

On November 3, 2016 BioTime, Inc. (NYSE MKT and TASE: BTX), a clinical stage biotechnology company with a focus on pluripotent cell-based technologies, reported financial results for the third quarter ended September 30, 2016, and recent therapeutic program progress (Press release, BioTime, NOV 3, 2016, View Source;p=RssLanding&cat=news&id=2219412 [SID1234516220]).

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"Through the quarter, we continued to execute on our plan with great progress across all our programs within the BioTime family of companies. We are particularly encouraged by the early data reported on Renevia and OpRegen. Both Asterias and OncoCyte also reported promising data from their clinical trials," said Adi Mohanty, Co-Chief Executive Officer. "For the remainder of the year and into 2017, we expect to achieve a substantial number of value-enhancing milestones, including additional efficacy and safety data from the second and third patient cohorts in the OpRegen clinical trial, and pivotal data and potential CE mark approval for Renevia in Europe."

Third Quarter and Recent Accomplishments

Clinical Progress

OpRegen (retinal pigment epithelial cells)

The ongoing Phase I/IIa clinical trial is evaluating the safety of three different dosage regimens of OpRegen in the advanced form of dry age-related macular degeneration (Dry-AMD). Dry-AMD is a condition for which there is currently no FDA-approved therapy. Preliminary data from the first cohort of patients treated in this trial of OpRegen resulted in no serious adverse events. Imaging data from the first patient who completed one-year of post-treatment clinical assessment may indicate that the graft can survive for at least 12 months. These and other data will be presented at the International Symposium on Ocular Pharmacology and Therapeutics (ISOPT), on December 2, in Rome, Italy.
Enrollment in the second cohort, in which patients are receiving a higher and more clinically meaningful 200,000 cell dose, is expected to be complete by year end 2016, and data are expected early in 2017.
Additional data, from the third cohort, which is expected to commence before year end, is anticipated by the end of 2017.
US clinical trial sites are expected to be announced in early 2017.
Renevia (adipose cells + cell delivery matrix)

The Renevia pivotal clinical trial for HIV-related facial lipoatrophy continues to enroll new patients and is on track to complete patient enrollment by the end of 2016. The objective of the trial is to assess the safety and efficacy of Renevia in restoring normal skin contours in patients whose subcutaneous fat has been lost due to antiviral drug treatment for HIV. BioTime expects top-line efficacy data in the first half of 2017. If the data are positive, the company plans to submit an application for CE mark approval in Europe shortly thereafter.
Positive data from the pivotal trial could provide support for future studies of Renevia in certain broader applications of fat tissue deficits. These include various medical aesthetics applications, such as age-related and trauma-related facial fat loss.
AST-OPC1 (oligodendrocyte progenitor cells)

In September, BioTime’s affiliate Asterias Biotherapeutics, Inc. (NYSE MKT: AST), announced positive data from the AST-OPC1 SCiSTAR Phase 1/2a clinical study in patients with complete cervical spinal cord injuries. All patients in the initial cohort who received 10 million AST-OPC1 cells showed at least one motor level of improvement (regaining some function in their arms), while two of five patients achieved two motor levels of improvement (regaining some function in their arms, hands and fingers) on at least one side of their body. The data were presented at the Annual Scientific Meeting of the International Spinal Cord Society (ISCoS) in Vienna, Austria.
Six-month efficacy data on this first cohort are expected to be announced in January 2017. Enrollment is also ongoing in a new cohort in which patients are receiving a higher dose of 20 million cells.
OncoCyte (non-invasive cancer diagnostics)

In August, BioTime’s subsidiary OncoCyte Corporation (NYSE MKT: OCX) closed a financing with both new and existing investors, providing OncoCyte with gross proceeds of $10.55 million, before deducting placement agent fees and offering expenses.
Data was presented related to OncoCyte’s lead product, a confirmatory diagnostic for lung cancer screening. OncoCyte expects to complete the study by year end and, if successful, could launch the product by mid-year 2017.
Research and Development

In August, BioTime strengthened its regenerative medicine intellectual property portfolio with the issuance of 31 new patents. This included nine in the U.S. and 22 in Australia, Canada, China, India, Israel, and Japan. The new patents supplement the existing portfolio of more than 700 patents and patent applications owned or licensed by the BioTime family of companies worldwide.
Management Team

In October, BioTime strengthened its senior management team with the appointment of Jim Knight as Senior Vice President, Head of Corporate Development. Mr. Knight is a highly accomplished professional with an extensive skill set and knowledge that is applicable immediately, as the company has started reporting encouraging early clinical data on its key programs.
Third Quarter Financial Results

Cash Position and Equity Values: Cash and cash equivalents totaled $30.5 million as of September 30, 2016, compared to $42.2 million as of December 31, 2015, which included Asterias’ cash and cash equivalents of $11.2 million. Based on the September 30, 2016, closing prices of Asterias and OncoCyte common stock on the NYSE MKT, the shares of Asterias and OncoCyte owned by BioTime had an estimated market value of $92.2 million and $74.0 million, respectively, or an aggregate market value of approximately $166.0 million on that date.

Revenues: Total revenues were $1.5 million for the third quarter, compared to $2.3 million in the third quarter of 2015. Asterias’ total revenues included in the third quarter of 2015 were $1.4 million as shown in the table below (in thousands). BioTime’s operating revenues are currently generated primarily from research grants, licensing fees and advertising from the marketing of online database products.

Three months ended September 30, 2016 Three months ended September 30, 2015
Consolidated
Results of

Operations

Asterias Consolidated
Results less

Asterias

Consolidated
Results of

Operations

Asterias

Consolidated
Results less

Asterias

REVENUES:
Total revenues 1,499 - 1,499 2,306 1,423 883

R&D Expenses: Research and development expenses were $6.4 million for the third quarter, compared to $11.4 million for the comparable period in 2015. The 2015 expenses included $4.6 million attributable to Asterias’ research and development. The decrease year over year was primarily due to the deconsolidation of Asterias for financial reporting purposes commencing May 13, 2016.

G&A Expenses: General and administrative expenses were $4.6 million for the third quarter, compared to $7.5 million for the third quarter of 2015. The decrease was primarily due to the deconsolidation of Asterias financial results and reduced expenses incurred by OncoCyte.

Operating Loss: Loss from operations was $9.6 million in the third quarter compared with a loss of $17.1 million in the third quarter of 2015. The decrease was primarily due to the lower operating expenses as a result of the deconsolidation of Asterias operating results and reduced expenses incurred by OncoCyte.

Net Income (loss) attributable to BioTime: Net income attributable to BioTime was $31.2 million, or $0.30 per basic and diluted share for the three months ended September 30, 2016, due primarily to the gain on our interest in Asterias at fair value using the equity method of accounting. There was no deferred income tax provision or benefit recorded in the three months ended September 30, 2016. For the third quarter of 2015, net loss attributable to BioTime was $14.0 million, or ($0.18) per share. Net income (loss) attributable to BioTime includes losses from BioTime’s majority owned and consolidated subsidiaries based upon BioTime’s percentage ownership of those subsidiaries.

On November 3, 2016 Incyte Corporation (Nasdaq: INCY) reported that more than 20 abstracts including data from its ongoing clinical development program for Jakafi (ruxolitinib) and its small molecule development programs targeting JAK1, LSD1 and PI3Kδ will be presented at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting 2016 in San Diego, California from December 3-6, 2016 (Press release, Incyte, NOV 3, 2016, View Source;p=RssLanding&cat=news&id=2219274 [SID1234516279]).

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"We are pleased to have an array of data highlighting the potential of our portfolio accepted for presentation at this year’s ASH (Free ASH Whitepaper) meeting, including the pooled overall survival analysis of five-year data from our COMFORT-I and COMFORT-II trials, which reinforces the long-term clinical profile of Jakafi; data from INCB39110, our selective JAK1 inhibitor, in acute graft-versus-host disease; and emerging data from our LSD1 and PI3Kδ inhibitor programs in other hematologic diseases," said Steven Stein, M.D., Incyte’s Chief Medical Officer.

Key abstract presentations and publications, inclusive of studies sponsored by Incyte, Novartis and independent investigator studies, include:

Myelofibrosis
Effects of Long-Term Ruxolitinib (RUX) on Bone Marrow (BM) Morphology in Patients (pts) with Myelofibrosis (MF) Enrolled in the COMFORT-I Study (Abstract #1949)

• Saturday, December 3, 2016, 5:30-7:30 PM PST, Hall GH, Poster Session: 634

Ruxolitinib (RUX) plus Pomalidomide in Myelofibrosis (MF): Updated Results from the MPNSG-0212 Trial (NCT01644110) (Abstract #1939)
• Saturday, December 3, 2016, 5:30-7:30 PM PST, Hall GH, Poster Session: 634

Clinical Outcomes with Ruxolitinib (RUX) in Patients (pts) with Myelofibrosis (MF) Stratified by Transfusion Status: A Pooled Analysis of the COMFORT-I and -II Trials (Abstract #3118)
• Sunday, December 4, 2016, 6:00-8:00 PM PST, Hall GH, Poster Session: 634

A Pooled Overall Survival Analysis of 5-Year Data from the COMFORT-I and COMFORT-II Trials of Ruxolitinib (RUX) for the Treatment of Myelofibrosis (MF) (Abstract #3110)
• Sunday, December 4, 2016, 6:00-8:00 PM PST, Hall GH, Poster Session: 634

Safety and Efficacy of Ruxolitinib (RUX) for the Final Enrollment of JUMP: An Open-Label, Multicenter, Single-Arm, Expanded-Access Study in Patients (pts) with Myelofibrosis (MF) (N = 2233) (Abstract #3107)
• Sunday, December 4, 2016, 6:00-8:00 PM PST, Hall GH, Poster Session: 634

Ruxolitinib (RUX) in Combination with 5-Azacytidine (AZA) as Therapy for Patients (pts) with Myelofibrosis (MF) (Abstract #1127)
• Monday, December 5, 2016, 4:30-6:00 PM PST, Ballroom Salons 15-17, Oral Presentation: 634

Exploring the potential of JAK1/2 inhibitor Ruxolitinib (RUX) with reduced intensity hematopoietic cell transplantation (HCT) for Myelofibrosis (MF): Stage I results of a prospective trial conducted through the Myeloproliferative Disorders – Research Consortium (MPD-RC) (Abstract #1126)
• Monday, December 5, 2016, 4:30-6:00 PM PST, Pacific Ballroom Salons 15-17, Oral Presentation: 634

Polycythemia Vera
Examining the Clinical Features and Underlying Cardiovascular Risk Among Patients with Polycythemia Vera in the REVEAL Study (Abstract #1934)
• Saturday, December 3, 2016, 5:30-7:30 PM PST, Hall GH, Poster Session: 634

Essential Thrombocythemia
Correlation between Treatment Outcomes, Baseline Characteristics and Molecular Responses in the MAJIC Study which compared Ruxolitinib (RUX) to Best Available Therapy in Essential Thrombocythemia (ET) (Abstract #1929)
• Saturday, December 3, 2016, 5:30-7:30 PM PST, Hall GH, Poster Session: 634

Myeloproliferative Neoplasms
Impact of Myeloproliferative Neoplasms on Patients’ Employment Status and Work Productivity in the United States: Results from the Living with MPN Patient Survey (Abstract #4265)
• Monday, December 5, 2016, 6:00-8:00 PM PST, Hall GH, Poster Session: 634

The impact of Myeloproliferative Neoplasms (MPNs) on patients’ quality of life and productivity: Results from the international MPN LANDMARK survey (Abstract #4267)
• Monday, December 5, 2016, 6:00-8:00 PM PST, Hall GH, Poster Session: 634

Other Hematologic Malignancies
A Phase I Study of Ruxolitinib (RUX) Plus Nilotinib in Chronic Phase CML Patients with Molecular Evidence of Disease (Abstract #1892)
• Saturday, December 3, 2016, 5:30-7:30 PM PST, Hall GH, Poster Session: 632

A Phase 1 Trial of Janus Kinase (JAK) Inhibition with INCB039110 in Acute Graft-Versus-Host Disease (aGVHD) (Abstract #390)
• Sunday, December 4, 2016, 12:00-1:30 PM PST, Grand Hall C, Oral Presentation: 722

LSD1 Inhibition Induces Fetal Hemoglobin Expression and Provides a Novel Therapeutic Approach to Sickle Cell Disease (Abstract #2472)
• Sunday, December 4, 2016, 6:00-8:00 PM PST, Hall GH, Poster Session: 113

Effects of INCB052793, a Selective JAK1 Inhibitor, in Combination with Anti Myeloma Agents on Human Multiple Myeloma (MM) In Vitro and In Vivo (Abstract #3297)
• Sunday, December 4, 2016, 6:00-8:00 PM PST, Hall GH, Poster Session: 652

Safety and efficacy of combined Ruxolitinib (RUX) and Decitabine in patients with blast-phase MPN and post-MPN AML: Results of a Phase I study (Myeloproliferative Diseases Research Consortium 109 trial) (Abstract #1124)
• Monday, December 5, 2016, 4:30-6:00 PM PST, Pacific Ballroom Salons 15-17, Oral Presentation: 634

An ongoing open-label phase 1/2 study of INCB050465, a selective PI3Kδ inhibitor, in patients with previously treated B-cell malignancies (Abstract #4195)
• Monday, December 5, 2016, 6:00-8:00 PM PST, Hall GH, Poster Session: 626

Ruxolitinib (RUX) in Combination with Azacytidine (AZA) in Patients (pts) with Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPNs) (Abstract #4246)
• Monday, December 5, 2016, 6:00-8:00 PM PST, Hall GH, Poster Session: 634

Phase I Study of Ruxolitinib (RUX) for Patients (pts) with Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) Who Failed at Least One Line of Therapy (Abstract #4318)
• Monday, December 5, 2016, 6:00-8:00 PM PST, Hall GH, Poster Session: 637

Phase I/II study of Ruxolitinib (RUX) with decitabine (DAC) in patients with post-myelofibrosis neoplasm acute myeloid leukemia (post-MPN AML): Phase I results (Abstract #4262)
• Monday, December 5, 2016, 6:00-8:00 PM PST, Hall GH, Poster Session: 634

A LYSA phase II study of oral JAK1/2 inhibitor Ruxolitinib in advanced relapsed/refractory (R/R) Hodgkin lymphoma (HL) (Abstract #4160)
• Monday, December 5, 2016, 6:00-8:00 PM PST, Hall GH, Poster Session: 624

Full sessions details and data presentation listing for ASH (Free ASH Whitepaper) 2016 can be found at: View Source
About Jakafi (ruxolitinib)
Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. Food and Drug Administration, for treatment of people with intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF, and post–essential thrombocythemia MF.
Jakafi is also indicated for treatment of people with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea.
Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi (ruxolitinib) outside the United States. Jakafi is a registered trademark of Incyte Corporation. Jakavi is a registered trademark of Novartis AG in countries outside the United States.
Important Safety Information
Jakafi can cause serious side effects, including:
Low blood counts: Jakafi (ruxolitinib) may cause your platelet, red blood cell, or white blood cell counts to be lowered. If you develop bleeding, stop taking Jakafi and call your healthcare provider. Your healthcare provider will perform blood tests to check your blood counts before you start Jakafi and regularly during your treatment. Your healthcare provider may change your dose of Jakafi or stop your treatment based on the results of your blood tests. Tell your healthcare provider right away if you develop or have worsening symptoms such as unusual bleeding, bruising, tiredness, shortness of breath, or a fever.
Infection: You may be at risk for developing a serious infection during treatment with Jakafi. Tell your healthcare provider if you develop any of the following symptoms of infection: chills, nausea, vomiting, aches, weakness, fever, painful skin rash or blisters.
Skin cancers: Some people who take Jakafi have developed certain types of non-melanoma skin cancers. Tell your healthcare provider if you develop any new or changing skin lesions.
Increases in Cholesterol: You may have changes in your blood cholesterol levels. Your healthcare provider will do blood tests to check your cholesterol levels during your treatment with Jakafi.
The most common side effects of Jakafi include: low platelet count, low red blood cell counts, bruising, dizziness, headache.
These are not all the possible side effects of Jakafi. Ask your pharmacist or healthcare provider for more information. Tell your healthcare provider about any side effect that bothers you or that does not go away.
Before taking Jakafi, tell your healthcare provider about: all the medications, vitamins, and herbal supplements you are taking and all your medical conditions, including if you have an infection, have or had tuberculosis (TB), or have been in close contact with someone who has TB, have or had hepatitis B, have or had liver or kidney problems, are on dialysis, had skin cancer or have any other medical condition. Take Jakafi exactly as your healthcare provider tells you. Do not change or stop taking Jakafi without first talking to your healthcare provider. Do not drink grapefruit juice while on Jakafi.
Women should not take Jakafi while pregnant or planning to become pregnant, or if breast-feeding.
Full Prescribing Information, which includes a more complete discussion of the risks associated with Jakafi, is available at www.jakafi.com.

On November 3, 2016 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a biopharmaceutical company developing investigational Probody therapeutics for the treatment of cancer, reported third quarter 2016 financial results (Press release, CytomX Therapeutics, NOV 3, 2016, View Source;p=RssLanding&cat=news&id=2219490 [SID1234516221]).

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"This quarter was marked by a number of significant milestones in our Probody pipeline, most notably the filing of our Investigational New Drug (IND) application for CX-072, our PD-L1-targeting Probody therapeutic for the treatment of cancer patients," said Sean McCarthy, D.Phil., president and chief executive officer of CytomX Therapeutics. "We have also made strong technical progress in our alliance with Bristol Myers Squibb on anti-CTLA-4 Probody therapeutics and look forward to presentations of preclinical proof-of-concept data at the European Society for Medical Oncology Symposium on Immuno-Oncology and the Society for Immunotherapy in Cancer 31st Annual Meeting & Associated Programs."

As of September 30, 2016, CytomX had cash and cash equivalents and investments of $180.5 million. The Company continues to expect full year net cash utilization of $20.0 to $25.0 million in 2016. Based upon its current operating plan, the Company expects its existing capital resources will be sufficient to fund operations through 2018.

Business Highlights and Recent Developments

PROCLAIM-072 (PD-L1 Probody) Program

IND application filed with the U.S. FDA for PROCLAIM-072 clinical study of CX-072, a PD-L1-targeting Probody therapeutic for the treatment of cancer patients.
Pending ongoing discussions with the FDA regarding clinical protocol finalization, initial clinical sites are expected to be open by year end to support first patient enrollment.
Clinical data is expected to begin to emerge in the second half of 2017, and throughout 2018.
CX-2009 (CD166 Probody Drug Conjugate) Program

The IND for CX-2009, a first-in-class Probody drug conjugate targeting the highly expressed tumor antigen CD166, remains on track to be filed during the first half of 2017.
Clinical data is expected to begin to emerge in the second half of 2017, and throughout 2018.
Other Pipeline Updates

Pursuant to CytomX’s partnership with AbbVie, AbbVie exercised a licensing option with Seattle Genetics for the clinically and commercially validated payload, MMAE, for conjugation to the CD71 Probody Drug Conjugate that is being advanced in preclinical studies.
Upcoming Presentations
CytomX and partner Bristol-Myers Squibb will present updates on their respective Probody programs at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Symposium on Immuno-Oncology, held November 4-5, 2016, in Lausanne, Switzerland, and the Society for Immunotherapy in Cancer (SITC) (Free SITC Whitepaper) 31st Annual Meeting & Associated Programs, held November 9-13, 2016, in National Harbor, MD.

ESMO

Title: Next Generation Anti-CTLA-4 Antibodies
Presenter: Alan J. Korman, Ph.D., vice president, immuno-oncology, Bristol-Myers Squibb Company
Date: Saturday, November 5, 2016
Time: 8:00-8:20 a.m. CET
Session: Beyond PD-1/PD-L1 Axis Blockade: Combinations or New Molecules
SITC

Title: CD3-EGFR Probody T Cell-Engaging Bispecific Induces Tumor Regressions and Substantially Increases Safety Window in Preclinical Studies
Presenter: Bryan A. Irving, Ph.D., vice president, immunology, CytomX Therapeutics
Date: Wednesday, November 9, 2016
Time: 11:45-11:50 a.m. EST
Sub-Session II: Pre-Clinical New Agents in Development

Title: Probody Therapeutic Targeting PD-1 Provides Preclinical Anti-tumor Efficacy While Minimizing Induction of Autoimmunity as a Single Agent and in Combination with CTLA-4 Blockade
Presenter: Kimberly A. Tipton, senior scientist, CytomX Therapeutics
Date: Friday, November 11, 2016
Time: 12:15-1:30 p.m. and 6:15-7:30 p.m. EST
Session: Poster

Title: Next Generation Anti-CTLA-4 Antibodies
Presenter: Alan J. Korman, Ph.D., vice president, immuno-oncology, Bristol-Myers Squibb Company
Date: Saturday, November 12, 2016
Time: 9:10-9:35 a.m. EST
Session: Beyond Single-Agents: The Future of Combination Immunotherapy
Third Quarter Financial Results
Cash, cash equivalents and investments totaled $180.5 million as of September 30, 2016, compared to $186.7 million as of December 31, 2015. The decrease reflects cash used in operations, partially offset by a $30.0 million upfront payment received from AbbVie in connection with the collaboration agreements entered in April 2016, and a $10.0 million milestone payment received from Bristol-Myers Squibb in connection with its third target selection in January 2016.

Research and development expenses were $13.3 million for the third quarter of 2016, compared to $9.2 million for the third quarter of 2015. The increase was primarily attributable to $1.7 million in manufacturing costs for the CX-072 and CX-2009 programs, $1.2 million to advance CX-072 into Phase 1 clinical development, $0.9 million in personnel-related expenses due to an increase in headcount and $0.7 million in non-cash stock-based compensation due to higher stock valuation.

General and administrative expenses were $5.0 million for the third quarter of 2016, compared to $4.1 million for the third quarter of 2015. The increase was predominantly due to $0.6 million in non-cash stock based compensation due to higher stock valuation, $0.2 million in personnel-related expenses due to an increase in headcount and $0.2 million in additional consulting and professional service expenses associated with operating as a public company.

About PROCLAIM
CytomX is launching the PROCLAIM (Probody Clinical Assessment In Man), a first-of its-kind clinical trial program that enables clinical study sites and physicians to access CytomX’s wholly-owned Probody therapeutics under one international umbrella. The first module within the PROCLAIM program is an open-label, dose-finding Phase 1/2 study evaluating CX-072 as monotherapy and in combination with Yervoy (ipilimumab) or Zelboraf (vemurafenib) in anti-PD-(L)1 inhibitor naïve patients with certain cancers. CX-072 is a PD-L1-targeting Probody therapeutic for the treatment of cancer patients. CytomX aims to achieve three goals as part of the PROCLAIM-072 clinical trial:

Safety: Demonstrate that CX-072 is well tolerated in patients, and potentially improves safety, particularly in the combination setting.
Anti-cancer activity: Demonstrate initial evidence of CX-072’s anti-cancer activity as monotherapy and in combination.
Translational program and Probody platform proof-of-concept: Explore mechanistic aspects of Probody activity in patients as observed in preclinical studies.
Clinical data is expected to begin to emerge in the second half of 2017, and throughout 2018. The IND application for CX-072 is currently under review with FDA.