On November 7, 2016 Portola Pharmaceuticals, Inc. (NASDAQ:PTLA) reported a corporate update and reported its financial results for the third quarter ended September 30, 2016 (Press release, Portola Pharmaceuticals, NOV 7, 2016, View Source;p=RssLanding&cat=news&id=2220288 [SID1234516691]).

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"We continue to focus on obtaining regulatory approval for our two lead programs in the United States and EU. Both programs have the potential to become the standard of care in two growth areas of thrombosis that have a high unmet medical need and limited treatment options. If approved, betrixaban, our oral Factor Xa inhibitor, would be the first anticoagulant indicated for extended VTE prophylaxis in the over 24 million medically ill patients admitted to the hospital annually in the G7. AndexXa, our much anticipated Factor Xa inhibitor antidote, would be the first agent approved to treat the growing number of patients admitted to the hospital with life-threatening anticoagulant-related bleeding. We have made important progress toward bringing both betrixaban and AndexXa to market. We submitted an NDA for betrixaban in the United States and plan to submit an MAA in the EU," said Bill Lis, chief executive officer of Portola. "Also, we continue to engage in positive, productive dialogue with the FDA to resolve outstanding questions regarding the Complete Response Letter for AndexXa, most of which are focused on manufacturing."

Recent Achievements, Upcoming Events and Milestones

Betrixaban – an oral Factor Xa inhibitor anticoagulant in development for the prevention of venous thromboembolism (VTE) in acute medically ill patients; designated Fast Track status by the U.S. Food and Drug Administration (FDA)

Submitted a New Drug Application (NDA) to the FDA seeking approval to market betrixaban for extended-duration prophylaxis of VTE in acutely ill medical patients with risk factors for VTE
Plan to submit a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) by year-end
Three abstracts on results of sub-analyses of the Phase 3 APEX Study conducted by the PERFUSE Study Group were accepted for oral and poster presentations at the upcoming American Heart Association Scientific Sessions 2016
AndexXa (andexanet alfa) – a Factor Xa inhibitor antidote in development for patients treated with a Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening bleeding or when urgent surgery is required; designated a Breakthrough Therapy and an Orphan Drug by the FDA

Submitted an MAA, which completed the validation period and was accepted for review by the EMA
Continued productive dialogue with the FDA regarding the Complete Response Letter; Portola currently plans to resubmit the BLA in the second quarter of 2017
Presented a preliminary analysis of interim data from the ongoing Phase 3b/4 ANNEXA-4 Study in patients with acute major bleeding in a Late-Breaking Science Hot Line session at the European Society of Cardiology 2016 Congress with simultaneous publication online by The New England Journal of Medicine
Plan to present data from the ongoing Phase 2 study of andexanet alfa reversal of betrixaban in an oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting 2016
Cerdulatinib – an oral, dual Syk/JAK inhibitor in development to treat resistant or relapsed hematologic cancer patients

Continued to enroll patients in a Phase 2a study evaluating the safety and efficacy of cerdulatinib in patients with relapsed/refractory B-cell malignancies who have failed multiple therapies
Two abstracts were accepted for presentation at the upcoming ASH (Free ASH Whitepaper) Annual Meeting 2016
Third Quarter 2016 Financial Results
Collaboration revenue earned under Portola’s collaborations with Bristol-Myers Squibb Company and Pfizer, Bayer Pharma and Janssen Pharmaceuticals, and Daiichi Sankyo was $9.3 million for the third quarter of 2016 compared with $2.9 million for the third quarter of 2015. The increase in revenue was primarily due to $2.5 million received upon achievement of a milestone from the Bayer and Janssen Phase 3 agreement, $2.5 million received upon achievement of a milestone from the Daiichi Sankyo Phase 3 agreement, and incremental revenue of $2.0 million from three collaboration and license agreements executed in the first quarter of 2016 to develop and commercialize andexanet alfa in Japan.

Total operating expenses for the third quarter of 2016 were $100.8 million compared with $58.5 million for the same period in 2015. Total operating expenses for the third quarter of 2016 included $7.8 million in stock-based compensation expense compared with $6.1 million for the same period in 2015.

Research and development expenses were $87.2 million for the third quarter of 2016 compared with $48.4 million for the third quarter of 2015. The increase in R&D expenses was primarily due to a $27.3 million impairment charge for AndexXa manufacturing expenses that Portola prepaid to CMC Biologics. These expenses were intended to be credited against future batch manufacturing costs for the Line C, or 6×2,000 liter, manufacturing process. This impairment charge was triggered by the Company’s decision to focus on Line A/B manufacturing at CMC Biologics and Gen 2 manufacturing at Lonza, and suspend Line C manufacturing at CMC Biologics.

Selling, general and administrative expenses for the third quarter of 2016 were $13.6 million compared with $10.1 million for the same period in 2015 as the Company increased headcount to support its growth and increased commercial launch preparation activities for AndexXa in advance of the PDUFA date in August 2016.

For the third quarter of 2016, we reported a net loss of $92.9 million dollars, or a net loss per share of $1.64, compared with a net loss of $55.2 million dollars, or a net loss per share of $1.05, for the same period in 2015. Net loss for the third quarter of 2016 included the $27.3 million impairment charge. Shares used to compute net loss per share attributable to common stockholders were approximately 56.5 million for the third quarter of 2016 compared with approximately 52.6 million for the same period in 2015.

As of September 30, 2016, cash, cash equivalents and investments totaled $274.6 million compared with cash, cash equivalents and investments of $460.2 million as of December 31, 2015.

On November 7, 2016 Verastem, Inc. (NASDAQ:VSTM), focused on discovering and developing drugs to treat cancer, reported financial results for the third quarter ended September 30, 2016, and also provided an overview of certain corporate developments (Press release, Verastem, NOV 7, 2016, View Source;p=RssLanding&cat=news&id=2220267 [SID1234516784]).

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"Last week, we announced the inlicensing of the late-stage oncology product candidate duvelisib from Infinity Pharmaceuticals. This transaction brings a complementary development program on attractive financial terms," said Robert Forrester, President and Chief Executive Officer of Verastem. "Duvelisib has a proven mechanism of action and has clinically demonstrated anti-cancer activity, along with a manageable safety profile, in several lymphoid malignancies. We believe duvelisib has the potential to help patients with lymphoma."

Mr. Forrester continued, "Since the beginning of 2016, we have made significant progress with our immuno-oncology focused clinical development program aimed at advancing our FAK inhibitors in combination with immunotherapies and other current and emerging standard of care treatments. We recently announced a new clinical collaboration with Cancer Research UK and MSD to evaluate defactinib in combination with MSD’s anti-PD-1 immunotherapy pembrolizumab (Keytruda) MSD’s PD-1 immunotherapy in patients with mesothelioma, non-small cell lung and pancreatic cancer. This is our third clinical collaboration to be announced this year and we are delighted to be working with such prestigious organizations to clinically elucidate the potential of defactinib in combination with immunotherapeutics across several different cancer types."

Third Quarter 2016 and Recent Highlights:
Duvelisib
Inlicensed Late-stage, Complementary Oncology Product Candidate Duvelisib – Last week, Verastem and Infinity Pharmaceuticals, Inc. (Infinity) announced the signing of an agreement under which Verastem licensed exclusive worldwide rights to develop and commercialize Infinity’s duvelisib, an investigational product candidate currently in development for hematologic malignancies. In consideration for duvelisib, Verastem will pay to Infinity no upfront payment, and up to $28 million in milestones. Positive data from DUO, a Phase 3, randomized monotherapy study of duvelisib in patients with relapsed or refractory CLL, triggers the first milestone payment. Verastem will also pay royalties on worldwide net sales. Duvelisib is well aligned with Verastem’s strategic focus of developing novel anti-cancer therapeutics that modulate the tumor microenvironment.

Phase 2 DYNAMO Data to be Reported at ASH (Free ASH Whitepaper) 2016 – Phase 2 clinical data for duvelisib will be presented at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which is being held December 3-6, 2016 in San Diego. In an oral presentation, titled "A phase 2 study demonstrating the clinical activity of duvelisib in patients with relapsed refractory indolent non-Hodgkin lymphoma," (Publication ID: 1218) Ian Flinn, MD, PhD, Director, Hematologic Malignancies Program, Sarah Cannon Research Institute, will describe the results from DYNAMO, a Phase 2 study evaluating the efficacy and safety of duvelisib in relapsed/refractory iNHL. The oral presentation will take place on Monday, December 5, 2016, at 7:30 PM PT at the San Diego Convention Center, Ballroom 20BC.

Defactinib (VS-6063)
New Clinical Collaboration with Cancer Research UK and MSD to Evaluate Defactinib in Combination with Immunotherapy in Mesothelioma, Non-small Cell Lung and Pancreatic Cancer – In September 2016, the companies announced a new clinical trial collaboration agreement to evaluate the combination of Verastem’s defactinib and MSD’s PD-1 immunotherapy pembrolizumab (Keytruda). This clinical collaboration is based on discoveries by scientists at the Edinburgh Cancer Research UK Centre at the University of Edinburgh who showed that inhibiting FAK increases the effectiveness of anti-PD-1 agents. The trial is expected to enroll up to 60 patients and will commence in early 2017.

Published Preclinical Research in Nature Medicine – In July 2016, Verastem announced the publication of preclinical research conducted by its scientific collaborator, David G. DeNardo, PhD, Assistant Professor of Medicine, Division of Oncology, Department of Immunology, Washington University School of Medicine in St. Louis. In the published study, Dr. DeNardo demonstrates that FAK inhibition decreases fibrosis and immunosuppressive cell populations in pancreatic ductal adenocarcinoma, rendering previously unresponsive tumors sensitive to chemo- and immunotherapy. These findings provide important support and rationale for the ongoing Phase 1 dose-escalation clinical studies evaluating Verastem’s FAK inhibitors in combination with pembrolizumab and gemcitabine, and, gemcitabine and Abraxane in patients with pancreatic cancer.

Third Quarter 2016 Financial Results
Net loss for the third quarter ended September 30, 2016 (2016 Quarter) was $7.9 million, or $0.21 per share, as compared to a net loss of $15.4 million, or $0.42 per share, for the third quarter ended September 30, 2015 (2015 Quarter). Net loss includes non-cash stock-based compensation expense of $1.3 million and $2.1 million for the 2016 Quarter and 2015 Quarter, respectively.
Research and development expense for the 2016 Quarter was $4.2 million compared to $11.3 million for the 2015 Quarter. The $7.1 million decrease from the 2015 Quarter to the 2016 Quarter was primarily related to a decrease of $5.3 million in contract research organization expense for outsourced biology, chemistry, development and clinical services, which includes our clinical trial costs, a decrease in personnel related costs of approximately $653,000 due to lower headcount as a result of our reduction in force in Q4 2015, a decrease of approximately $491,000 in consulting fees, a decrease in lab supplies of approximately $228,000, and a decrease in stock-based compensation and other expenses of approximately $376,000.

General and administrative expense for the 2016 Quarter was $3.8 million compared to $4.2 million for the 2015 Quarter. The decrease of approximately $387,000 from the 2015 Quarter to the 2016 Quarter primarily resulted from decreases in stock-based compensation expense of approximately $665,000 and personnel costs of approximately $108,000. These decreases were partially offset by increases in professional fees of approximately $235,000 and consulting and other costs of approximately $151,000.
As of September 30, 2016, Verastem had cash, cash equivalents and investments of $86.9 million compared to $110.3 million as of December 31, 2015. Verastem used $6.0 million for operating activities during 2016 Quarter.

The number of outstanding common shares as of September 30, 2016, was 36,992,418.

Financial Guidance
Based on current operating plans, we expect to have sufficient cash, cash equivalents and short-term investments to fund our research and development programs and operations into 2018.

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 patients 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. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.6

About Defactinib
Defactinib (VS-6063) is an investigational inhibitor of Focal Adhesion Kinase (FAK), a non-receptor tyrosine kinase encoded by the PTK-2 gene that mediates oncogenic signaling in response to cellular adhesion and growth factors.7 Based on the multi-faceted roles of FAK, defactinib is used to treat cancer through modulation of the tumor microenvironment, enhancement of anti-tumor immunity, and reduction of cancer stem cells.8,9 Defactinib is currently being evaluated in three separate clinical collaborations in combination with immunotherapeutic agents for the treatment of several different cancer types including pancreatic, ovarian, non-small cell lung cancer, and mesothelioma. These studies are combination clinical trials with pembrolizumab and avelumab from Merck & Co. and Pfizer/Merck KGaA, respectively.10,11,12 Information about these and additional clinical trials evaluating the safety and efficacy of defactinib can be found on www.clinicaltrials.gov.

On November 7, 2016 Cellectis (Alternext: ALCLS; Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene edited CAR T-cells (UCART), reported that abstracts regarding the Company’s allogeneic, off-the-shelf, CAR T programs have been accepted for presentation at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (Press release, Cellectis, NOV 7, 2016, View Source [SID1234516381]). The meeting will be held December 3-6, 2016 in San Diego.
Oral presentations: • 765 Allogeneic Tcrα/β Deficient CAR T-Cells Targeting CD123 Prolong Overall Survival of AML Patient-Derived Xenografts
View Source Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation Program: Oral and Poster Abstracts Type: Oral Session: 616.

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Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Emerging Immune-Based Therapies for AML Monday, December 5, 2016: 11:00 AM San Diego Ballroom AB (Marriott Marquis San Diego Marina)
Monica L. Guzman, PhD1, Mayumi Sugita, MD1*, Hongliang Zong, MD, PhD1*, Nathan EwingCrystal1*, Vicenta Trujillo-Alonso1*, Nuria Mencia-Trinchant, PhD1*, Linda Lam1*, Nicole M. Cruz, MD1, Roman Galetto, PhD2*, Agnès Gouble, PhD2*, Duane C Hassane, PhD1, Julianne Smith, PhD2 and Gail J. Roboz3
1Division of Hematology and Medical Oncology, Department of Medicine, Weill Cornell Medical College, New York, NY
2Cellectis SA, Paris, France
3Weill Cornell Medical College, New York, NY
• 381 Preclinical Evaluation of Allogeneic Anti-Bcma Chimeric Antigen Receptor T Cells with Safety Switch Domains and Lymphodepletion Resistance for the Treatment of Multiple Myeloma
View Source
Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy Program: Oral and Poster Abstracts Type: Oral Session: 652. Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Novel Immune Approaches for Myeloma Therapy Sunday, December 4, 2016: 12:30 PM Grand Hall B (Manchester Grand Hyatt San Diego)
Bijan Boldajipour, PhD1*, Roman Galetto, PhD2*, Cesar Sommer, PhD1*, Thomas Pertel, PhD1*, Julien Valton, PhD3*, Yoon Park, PhD1*, Annabelle Gariboldi2*, Amy Chen1*, Tao Geng1*, Hong H Dong1*, Gregory R Boucher1*, Thomas J Van Blarcom, PhD1*, Javier Chaparro-Riggers, PhD1*, Arvind Rajpal, PhD1*, Julianne Smith, PhD3, Tracy Kuo, PhD1* and Barbra Sasu, PhD1
1Pfizer Inc., South San Francisco, CA
2Cellectis SA, Paris, France
3Cellectis Inc., New York, NY

Poster presentation:
• 4039 Pre-Clinical Studies of Anti-CD123 CAR-T Cells for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
View Source
Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation Program: Oral and Poster Abstracts Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster III
Monday, December 5, 2016, 6:00 PM-8:00 PM Hall GH (San Diego Convention Center)
Tianyu Cai, PhD1*, Roman Galetto, PhD2*, Agnès Gouble, PhD2*, Julianne Smith, PhD2, Antonio Cavazos, MS1*, Sergej Konoplev, MD, PhD3, Andrew A. Lane, MD, PhD4, Monica L. Guzman, PhD5, Hagop M. Kantarjian, MD1, Naveen Pemmaraju, MD1 and Marina Konopleva, MD, PhD1
1Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX
2Cellectis SA, Paris, France
3Department of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, TX 4Dana-Farber Cancer Institute, Boston, MA 5Division of Hematology an

On November 7, 2016 Compugen Ltd. (NASDAQ: CGEN), a leading predictive drug discovery company, reported its quarterly financial results for the third quarter 2016 and nine months ending September 30, 2016 (Filing, Q3, Compugen, 2016, NOV 7, 2016, View Source [SID1234516382]).

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As previously announced, the Company confirms that it has postponed its third quarter conference call to Wednesday, November 16, 2016 at 10:00 am ET, in order to include discussion of new CGEN-15029 program data to be presented this Friday, November 11, 2016, at the 31st Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper).

An abstract of Compugen’s presentation, selected by SITC (Free SITC Whitepaper) as a late breaking presentation, will be available tomorrow, November 8th, beginning at 8:00 am ET, on the SITC (Free SITC Whitepaper) conference website. In addition, the Company plans to issue a press release on November 11, 2016 with respect to the new data to be disclosed at the SITC (Free SITC Whitepaper) conference that day.

Anat Cohen-Dayag, Ph.D., President and Chief Executive Officer of Compugen, stated, "We are extremely pleased with our continuing progress in the pursuit of immuno-oncology programs addressing novel immune checkpoint target candidates identified by us in silico. These efforts have resulted in an exceptional pipeline of multiple novel targets, consisting of both T cell-based and more recently myeloid-based targets, potentially offering multiple first-in-class therapeutics with various mechanisms-of-action."

Dr. Cohen-Dayag continued, "Although advancing such novel target programs to therapeutic development requires longer target validation timelines than required for targets generally pursued by the industry, we believe that the medical and commercial potential presented by these multiple first-in-class programs more than justifies this additional time and effort."

Revenues for the three and nine months ending September 30, 2016 were $0.1 million and $0.7 million respectively, compared with $0.2 million and $1.0 million for the comparable periods in 2015, primarily reflecting changes in the non-cash amortization during each of these periods of the upfront payment related to the August 2013 collaboration and license agreement with Bayer.

R&D expenses for the three and nine months ending September 30, 2016 were $6.0 million and $18.2 million respectively, compared with $5.3 million and $15.4 million in the comparable periods in 2015. These increases primarily reflect expanded activities involving our pipeline program candidates, including initiation of certain pre-clinical activities and the hiring of additional professional employees and manufacturing and regulatory consultants to support these activities.

Net loss for the third quarter of 2016 was $7.8 million, or $0.15 per diluted share, compared with a net loss of $6.7 million, or $0.13 per diluted share, for the comparable period in 2015. Net loss for the nine months ending September 30, 2016 was $23.0 million, or $0.45 per diluted share, compared with a net loss of $19.7 million, or $0.39 per diluted share, for the comparable period in 2015.

As of September 30, 2016, cash and cash related accounts totaled $68.0 million. The Company has no debt.

On November 7, 2016 Dynavax Technologies Corporation (NASDAQ: DVAX) reported financial results for the third quarter and nine months ended September 30, 2016 (Press release, Dynavax Technologies, NOV 7, 2016, View Source [SID1234516383]).

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The Company had $109.6 million in cash, cash equivalents and marketable securities as of September 30, 2016, compared to $196.1 million at December 31, 2015. The net loss for the third quarter of 2016 was $34.7 million, compared to $30.1 million for the third quarter of 2015.

Recent Progress

HEPLISAV-B. In late August, the U.S. Food and Drug Administration (FDA) cancelled its previously scheduled Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review the Biologics License Application (BLA) for HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)]. The FDA indicated that remaining questions on the BLA will be addressed between Dynavax and the FDA review team. The Company has since provided responses to information requests by the FDA related to remaining questions. The FDA also confirmed in August that it will not include in its review of the BLA the immunogenicity data submitted by the Company related to sub-populations, including results in individuals with diabetes. The Company plans to submit these data as a supplemental BLA.

The Prescription Drug User Fee Act (PDUFA) date for the HEPLISAV-B BLA is December 15, 2016.

In late October, we reported sub-group results from HBV-23, demonstrating that HEPLISAV-B, when administered as two doses over one month, induced significantly higher seroprotection rates than the approved hepatitis B vaccine Engerix-B, when administered as three doses over six months. This result was observed in all prespecified groups of study participants, including those with characteristics that are known to have a reduced immune response to currently licensed hepatitis B vaccines, including older age, high body mass index, diabetes mellitus, male gender and persons who smoke. In the total Phase 3 trial population, the rates of adverse events, serious adverse events and deaths were similar between the HEPLISAV-B and Engerix-B groups. The data were presented at the Infectious Diseases Society of America’s (IDSA) annual IDWeek 2016 meeting in New Orleans.

Preparations for launch of HEPLISAV-B are continuing, including pre-commercial activities, manufacturing of launch inventory and continued infrastructure spending related to commercial development and information technology capabilities and related increases in headcount.

Immuno-oncology. In October we announced at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress 2016 the first presentation of findings from an ongoing Phase 1/2 study evaluating SD-101, Dynavax’s intratumoral TLR9 agonist, in combination with Keytruda (pembrolizumab), Merck’s anti-PD-1 treatment. Early results evaluating five patients with metastatic melanoma for efficacy and 16 patients for safety were reported. In patients naïve to anti-PD-1 treatment objective responses were observed in three out of four (75%) including one complete response (CR) and two partial responses (PR’s). One patient with progressive disease while receiving anti-PD-1 therapy was observed to have stable disease (SD). The drug combination was well-tolerated. No dose-limiting toxicities of the combination were observed in any dose cohort, and a maximum tolerated dose (MTD) was not identified. No immune-related adverse events were reported. Additional results from this study will be presented at future scientific meetings.

Financial. In late October we secured a $100 million loan commitment from Deerfield upon FDA approval of HEPLISAV-B and satisfaction of other conditions. We intend to use the net proceeds for general corporate purposes, including the commercialization of HEPLISAV-B.

Financials

Total revenues for the third quarter of 2016 were $0.2 million compared to $1.2 million for the same period in 2015. The $1.0 million decrease was due to the conclusion of our work under the research collaboration and license agreement with AstraZeneca for the clinical development of AZD 1419.

Research and development expenses for the third quarter of 2016 were $23.2 million compared to $24.1 million for the same period in 2015. This $0.9 million decrease was primarily due to reduction in outside services expense associated with the completion of HBV-23 in the fourth quarter of 2015, partially offset by an increase in employee headcount and regulatory and manufacturing activities in preparation for the anticipated commercial launch of HEPLISAV-B.

General and administrative expenses for the third quarter of 2016 were $11.8 million compared to $5.5 million for the same period in 2015. This $6.3 million increase reflects expenses related to preparation for the commercial launch of HEPLISAV-B including additional headcount, information technology systems and infrastructure to support commercial development.

The net loss for the third quarter of 2016 was $34.7 million, or $0.90 per basic and diluted share, compared to $30.1 million, or $0.82 per basic and diluted share, for the same period in 2015.