On October 30, 2015 Heat Biologics, Inc. ("Heat") (Nasdaq:HTBX), an immuno-oncology company developing novel therapies to activate a patient’s immune system against cancer, rreported its financial results for the third quarter ended September 30, 2015 (Filing, 8-K, Heat Biologics, OCT 30, 2015, View Source [SID:1234507855]).

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"During the third quarter, we continued to advance our programs while demonstrating our ability to quickly shift to accommodate the rapidly evolving immunotherapy space," said Jeff Wolf, Founder and CEO of Heat Biologics. "We treated the first patient in a new trial in non-small cell lung cancer combining our HS-110 with Opdivo, a Bristol Myers-Squibb PD-1 checkpoint inhibitor.i This trial represents the first checkpoint inhibitor/vaccine combination in non-small cell lung cancer, as well as an important paradigm for future checkpoint combinations, since published data indicates our vaccines may be synergistic with checkpoint inhibitors. Additionally, we recently completed enrollment in the randomized portion of our Phase 2 trial with our HS-410 therapy in non-muscle invasive bladder cancer and we expect to announce Phase 1 results this quarter."

Third Quarter 2015 Corporate Highlights & Recent Developments

· In October, Heat completed enrollment of the 75 patients in the company’s blinded, randomized, placebo-controlled arms of its Phase 2 clinical trial of HS-410 (vesigenurtacel-L) for the treatment of high-risk, non-muscle invasive bladder cancer (NMIBC). In these three arms, Heat is evaluating the ability of HS-410 in combination with standard of care, Bacillus Calmette-Guérin (BCG), to prevent cancer recurrence. Heat continues to enroll an additional 25 patients to evaluate HS-410 as a monotherapy in an unblinded, open-label arm. The company expects to report topline efficacy, immune-response and safety data in the fourth quarter of 2016.

· In September, Heat reported further findings from its preclinical research conducted with ComPACT in a poster at the CRI-CIMT-EATI-AACR Inaugural International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper). Heat’s next generation combination immunotherapy platform, ComPACT, combines a pan-antigen T cell priming vaccine and T cell co-stimulator in a single product, producing the first potential dual-acting immunotherapy. Heat expects to announce its selection of the first product candidate based on the ComPACT platform in the first quarter of 2016.

· In September, Heat announced the dosing of its first patient in a Phase 1b clinical trial investigating the combination of HS-110 (viagenpumatucel-L) and a PD-1 checkpoint inhibitor in patients with non-small cell lung cancer (NSCLC). Primary and second endpoints include safety and tolerability, immune response, overall response rate and progression-free survival. Topline data is expected in the fourth quarter of 2016.

Third Quarter 2015 Financial Highlights

· Research and development expenses totaled $0.7 million for the third quarter of 2015 compared to $1.0 million for the third quarter of 2014, a decrease of $0.3 million. The decrease is attributable to a reduction in pre-manufacturing costs associated with preparing to produce HS-410 and HS-110 for use in our clinical trials, offset by increases in compensation costs, lab supplies and other fees.

· Clinical and regulatory expenses totaled $3.7 million for the third quarter of 2015 compared to $1.3 million for the third quarter of 2014, an increase of $2.4 million. The increase is attributable to increases in clinical trial execution costs, investigator payments and expenses related to the production of HS-410 and HS-110 for our clinical trials.

· General and administrative expenses totaled $0.9 million for the third quarter of 2015 compared to $0.8 million for the third quarter of 2014, an increase of $0.1 million. The increase is attributable to increased employee and professional service fees.

· Net loss was $5.4 million for the third quarter of 2015, compared to $3.1 million for the third quarter of 2014.

· Cash, cash equivalents and short-term investments totaled approximately $15.0 million at September 30, 2015, compared to $14.4 million at December 31, 2014.

Year to Date 2015 Financial Highlights

· Research and development expenses totaled $1.8 million for the nine months ended September 30, 2015 compared to $2.4 million for the nine months ended September 30, 2014, a decrease of $0.6 million. The decrease is attributable to a reduction in pre-manufacturing costs associated with preparing to produce HS-410 and HS-110 for use in our clinical trials, offset by increases in compensation costs, lab supplies and other fees.

· Clinical and regulatory expenses totaled $9.3 million for the nine months ended September 30, 2015 compared to $3.2 million for the nine months ended September 30, 2014, an increase of $6.1 million. The increase is attributable to increases in clinical trial execution costs, investigator payments and expenses related to the production of HS-410 and HS-110 for our clinical trials.

· General and administrative expenses totaled $3.2 million for the nine months ended September 30, 2015 compared to $2.8 million for the nine months ended September 30, 2014, an increase of $0.4 million. The increase is attributable to increased employee and professional service fees.

· Net loss was $14.4 million for the nine months ended September 30, 2015, compared to $8.5 million for the nine months ended September 30, 2014.

(Filing, 10-Q, Seattle Genetics, OCT 30, 2015, View Source [SID:1234507860])

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On October 30, 2015 Adaptimmune Therapeutics plc (Nasdaq: ADAP), a clinical stage biopharmaceutical company focused on the use of T-cell therapy to treat cancer, reported that it will present new data from trials of its NY-ESO affinity enhanced T-cell therapy in patients with synovial sarcoma and myeloma, as well as data from preclinical safety assessments of its affinity enhanced T-cell therapy directed at MAGE A-10, at the 2015 Annual Meeting of the Society of Immunotherapy for Cancer (SITC) (Free SITC Whitepaper) (Press release, Adaptimmune, OCT 30, 2015, View Source [SID:1234507856]). SITC (Free SITC Whitepaper) is the world’s leading member-driven organization specifically dedicated to professionals working in the field of cancer immunology and immunotherapy. The meeting will take place at the McCormick Place exhibition center in National Harbor, MD on November 4 through 8, 2015.

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Adaptimmune’s poster presentations will take place on November 6, 2015 in the Prince George’s Exhibition Hall from 12:45 to 2:00 pm and are as follows:

Friday November 6, 2015
Poster Presentations
Presentation Time: 12:45-2:00 pm
Location: Prince George’s Exhibition Hall

Track Name: Clinical Trials in Progress

Abstract number: 112286
Title: "Optimizing engineered TCR T-cell therapy for synovial sarcoma"
Sandra D’Angelo, M.D., Assistant Attending, Sarcoma Medical Oncology / Immunotherapeutics Core at Memorial Sloan-Kettering Cancer Center will provide additional data from the Company’s NY-ESO-1 synovial sarcoma study. Updates will include data on the expanded study group, longer follow-up and time-to-event, as well as updated correlative and safety data, and characterization of the product pre and post infusion.

Track Name: Mechanisms and Responses to Immune Therapy

Abstract number: 112346
Title: "Deep phenotypic characterization of NY-ESO TCR engineered T cells and tumor in patients with advanced myeloma"
Presenter: Eduardo Davila, Ph.D., Associate Professor of Microbiology and Immunology at the University of Maryland School of Medicine, Program Leader for Tumor Immunology and Immunotherapy Research Program at the Greenebaum Cancer Center at the University of Maryland will present follow-up data from the recently published Nature Medicine paper, including details on NY-ESO-1 T-cell phenotyping and functional data, as well as clinical and basic correlative data in myeloma patients.

Track Name: Adoptive Immunotherapy

Abstract number: 112244
Title: "Preclinical safety testing of an affinity-optimized MAGE-A10 T cell receptor for adoptive T cell therapy"
Presenter: Andrew Gerry, Ph.D., Director of Preclinical Research, Adaptimmune Therapeutics will provide a summary of the preclinical safety testing of the Company’s next affinity optimized TCR entering clinical studies in 2015, an affinity-enhanced T-cell therapy targeting MAGE-A10 in patients with non-small cell lung cancer.

Adaptimmune’s affinity enhanced T-cell candidates are novel cancer immunotherapies that have been engineered to target and destroy cancer cells by strengthening a patient’s natural T-cell response. T-cells are a type of white blood cell that play a central role in a person’s immune response. Adaptimmune’s goal is to harness the power of the T-cell and, through its multiple therapeutic candidate, significantly impact cancer treatment and clinical outcomes of patients with multiple solid and hematologic cancers.

(Filing, 10-Q, Telik, OCT 30, 2015, View Source [SID:1234507861])

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On October 29, 2015 Baxalta Incorporated (NYSE:BXLT) reported strong third quarter financial results, exceeding its previously-issued sales and earnings guidance (Press release, Baxalta, OCT 29, 2015, View Source [SID:1234507835]). The company also raised its outlook for the second half of 2015 and provided preliminary 2016 guidance.

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"We are already delivering on our promise to patients and shareholders in the short time that we have been an independent, standalone company," said Ludwig Hantson, chief executive officer and president. "Baxalta’s strong financial performance, increasing depth and breadth across the portfolio and meaningful pipeline achievements all validate our company’s compelling growth prospects, vision and commitment to driving shareholder value."

Results for the Third Quarter 2015

In the third quarter, Baxalta generated net income on a GAAP (Generally Accepted Accounting Principles) basis of $309 million and earnings of $0.45 per diluted share. These results include net after-tax special items totaling $76 million, or $0.11 per diluted share, primarily for intangible asset amortization, expenses associated with the company’s separation, certain business development and collaboration-related items, and a gain from the sale of the company’s vaccines business which is classified as a discontinued operation.

On an adjusted pro forma basis, excluding special items, Baxalta reported third quarter net income of $385 million and earnings of $0.56 per diluted share, which exceeded the company’s previously-issued guidance of $0.48 to $0.50 per diluted share. These financial results reflect positive sales momentum from across the portfolio, including meaningful sales contributions, value from new product launches, and strong operational performance.

Positive Sales Momentum Across Market-Leading Portfolio

In the third quarter, Baxalta’s worldwide revenues on a GAAP basis of $1.6 billion advanced 7 percent from the prior-year period. Excluding the impact of foreign currency, sales advanced 16 percent.

On a pro forma basis, worldwide revenues grew 4 percent. Excluding the impact of foreign currency, sales advanced 13 percent, exceeding the company’s previously-issued guidance of growth in the 8 to 10 percent range. Within the United States, sales of $841 million rose 14 percent, and international sales of $754 million declined 5 percent. Excluding foreign currency, international sales increased 12 percent.

Baxalta’s leading hematology and immunology businesses generated double-digit sales growth (excluding the impact of foreign currency) in the quarter. Hematology revenues of $935 million increased 10 percent (excluding the impact of foreign currency) as the company continues to focus on enhancing access and elevating standards of care worldwide. Key drivers of growth include heightened demand for ADVATE [Antihemophilic Factor (Recombinant)], a treatment for hemophilia A, and FEIBA [Anti-Inhibitor Coagulant Complex], an inhibitor treatment. A benefit from newly launched products, such as RIXUBIS [Coagulation Factor IX (Recombinant)] for the treatment of hemophilia B, and OBIZUR [Antihemophilic Factor (Recombinant), Porcine Sequence], for the treatment of acquired hemophilia A, also contributed to performance.

Immunology sales of $626 million advanced 13 percent (excluding the impact of foreign currency) on a pro forma basis. The company continues to capitalize on its broad and differentiated portfolio of immunoglobulin therapies, including HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase], and is driving strong sales of specialty biotherapeutics. Baxalta’s new oncology business, which leverages the company’s heritage and expertise in orphan diseases, recorded sales of $34 million in the quarter. This reflects the recent acquisition of ONCASPAR (pegaspargase), a marketed biologic treatment for acute lymphocytic leukemia (ALL).

Nine-Month Sales Results

For the nine-month period, Baxalta reported worldwide revenues on a GAAP basis of $4.4 billion, which increased 3 percent from the prior-year period. Excluding the impact of foreign currency, sales advanced 11 percent.

On a pro forma basis, worldwide revenues for the nine-month period grew 2 percent, and excluding the impact of foreign currency, sales advanced 10 percent. Within the United States, sales of $2.4 billion rose 9 percent, and international sales of $2.1 billion declined 5 percent. Excluding the impact of foreign currency, international sales increased 10 percent.

Advancing Pipeline with Key Milestone Achievements

Baxalta is building a solid track record with an array of meaningful milestone achievements toward its objective of launching 20 new products by 2020.

"We continue to make progress toward our goal of achieving 20 new product launches by 2020 with a rich pipeline of promising late-stage assets, novel mechanisms of action and disruptive technologies," added Hantson. "Successful commercial launches of these products are projected to result in approximately $2.8 billion in risk-adjusted revenues by 2020, and approximately $7 billion on a risk-adjusted basis by 2025, creating enhanced value for patients, customers and shareholders."

Recent highlights include:

Approval in Canada of OBIZUR [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in patients with acquired hemophilia A, a very rare and life-threatening acute bleeding disorder. OBIZUR is the first recombinant porcine sequence FVIII treatment specifically designed to enable physicians to monitor treatment response by measuring FVIII activity levels in addition to clinical assessments. The company has also received a positive opinion on OBIZUR from the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), and expects marketing authorization from the European Commission later this year.
Publication of pivotal phase III data for BAX 111 (to be marketed in the U.S. as VONVENDI) in Blood, the journal of the American Society of Hematology (ASH) (Free ASH Whitepaper). The data showed 100 percent of patients treated with this highly purified recombinant von Willebrand factor (rVWF) candidate achieved success in the management of bleeding episodes.1 VONVENDI is currently under review by the FDA and, if approved, would become the first recombinant replacement treatment for managing bleeding episodes for von Willebrand patients.2
FDA submission for approval of an investigational 20% concentration subcutaneous immune globulin (IGSC) treatment for primary immunodeficiencies. As Baxalta expands its immunoglobulin portfolio to address patient needs, the higher potency IG treatment is intended to offer faster infusions with less volume. The product is also under regulatory review in Europe.
Initiation of a pivotal phase III clinical trial in collaboration with Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA) in patients with chronic plaque psoriasis for M923, a biosimilar version of HUMIRA (adalimumab). The trial will compare the safety, efficacy and immunogenicity of M923 with HUMIRA, and the companies are targeting first regulatory submission in 2017 and first commercial launch in 2018.
Announcement of plans to submit a new drug application (NDA) to the FDA with partner CTI BioPharma Corp. (NASDAQ: CTIC) for pacritinib, an investigational oral kinase inhibitor with specificity for JAK2 and FLT3 for the treatment of patients with myelofibrosis, in the fourth quarter of 2015. The companies plan to request priority review for the treatment of patients with intermediate and high-risk myelofibrosis with low platelet counts of less than 50,000 per microliter (<50,000/uL) for whom there are no approved treatments.
Completion of the ONCASPAR leukemia portfolio acquisition from Sigma-Tau Finanziaria S.p.A. The acquisition includes ONCASPAR, a marketed biologic treatment for acute lymphocytic leukemia (ALL), the investigational biologic calaspargase pegol, and an established oncology infrastructure with clinical and sales resources.
Financial Outlook for Fourth Quarter and Second Half 2015

For the fourth quarter of 2015, Baxalta expects pro forma sales growth, excluding the impact of foreign currency, of 3 to 5 percent. Including the impact of foreign currency, the company expects pro forma sales to decline 1 to 3 percent. Baxalta also expects fourth quarter 2015 adjusted earnings, before special items, of $0.55 to $0.57 per diluted share.

This guidance translates into an improved outlook for the second half of 2015, which now includes adjusted earnings, before special items, of $1.11 to $1.13 per diluted share. This is an increase from the previously communicated earnings guidance range of $1.02 to $1.04 per diluted share. Also for the second half of 2015, Baxalta now expects pro forma sales growth, excluding the impact of foreign currency, of approximately 8 to 9 percent, compared to its prior guidance of growth in the 5 to 6 percent range. Including the impact of foreign currency, pro forma sales growth is expected to be flat to up 1 percent.

For the full-year 2015, Baxalta projects pro forma sales growth, excluding the impact of foreign currency, of approximately 8 percent, compared to its prior guidance of growth in the 6 to 7 percent range. Including the impact of foreign currency, the company now expects pro forma sales in 2015 to be comparable to 2014.

Preliminary Full-Year 2016 Guidance

Baxalta is also providing preliminary guidance for full-year 2016, which includes pro forma sales growth, excluding the impact of foreign currency, of 8 to 9 percent. Including the impact of foreign currency, the company expects pro forma sales growth of approximately 7 to 8 percent. Based on strong sales momentum and operating performance, Baxalta expects adjusted earnings, before special items, of $2.15 to $2.25 per diluted share for full-year 2016.

"Baxalta has a competitive and compelling financial profile with an outlook that balances accelerating growth with attractive returns," said Robert J. Hombach, chief financial officer and chief operations officer. "We firmly believe that our focus on orphan diseases and underserved conditions combined with numerous new product opportunities uniquely positions us to drive enhanced and sustainable value for our shareholders."

Reconciliation of GAAP and Non-GAAP Results

The company’s guidance for earnings in the fourth quarter of 2015 excludes approximately $0.02 per diluted share of projected intangible asset amortization expense. The company’s adjusted earnings guidance for the second half excludes $0.13 per diluted share of special items comprising $0.11 per diluted share of special items recorded during the third quarter and $0.02 of projected intangible asset amortization expense for the fourth quarter. Reconciling for the inclusion of these items results in expected GAAP earnings of $0.53 to $0.55 per diluted share for the fourth quarter of 2015, and earnings of $0.98 to $1.00 per diluted share for the second half of 2015.

The company’s guidance for full-year 2016 excludes approximately $0.08 per diluted share of projected intangible asset amortization expense. Reconciling for the inclusion of this item results in expected GAAP earnings of $2.07 to $2.17 per diluted share.