On November 5, 2015 Genmab A/S (OMX: GEN) reported that 14 daratumumab and 5 ofatumumab abstracts have been accepted for presentation at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition December 5-8 in Orlando, Florida (Press release, Genmab, NOV 5, 2015, View Source [SID:1234508008]). The abstracts are available on the ASH (Free ASH Whitepaper) website at www.hematology.org.

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"We are delighted that daratumumab will be featured in three oral presentations at the 2015 ASH (Free ASH Whitepaper) Annual Meeting. We are particularly looking forward to the presentation of the updated data from the Phase I study of daratumumab in combination with pomalidomide and dexamethasone in relapsed or relapsed and refractory multiple myeloma and the poster presentation describing previously unknown immunomodulatory effects of daratumumab," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "Data from the Phase II study of daratumumab in patients with heavily pretreated relapsed or refractory multiple myeloma, the Phase I/II study of daratumumab in combination with lenalidomide and dexamethasone in patients with relapsed and refractory multiple myeloma will also be presented in oral sessions."

Daratumumab

Highlights

Clinical Efficacy of Daratumumab Monotherapy in Patients with Heavily Pretreated Relapsed or Refractory Multiple Myeloma — Oral presentation, Saturday, December 5

Daratumumab in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed or Relapsed and Refractory Multiple Myeloma: Updated Results from a Phase 1/2 Study (GEN503) — Oral presentation, Monday, December 7

Immunomodulatory Effects and Adaptive Immune Response to Daratumumab in Multiple Myeloma — Poster presentation, Sunday, December 6

Open-label, Multicenter Phase 1b Study of Daratumumab in Combination with Pomalidomide and Dexamethasone in Patients with ≥2 Lines of Prior Therapy and Relapsed or Relapsed and Refractory Multiple Myeloma (MM) — Oral presentation, Monday, December 7

Other abstracts

Serum Proteomic Analysis of Multiple Myeloma Subjects Treated with Daratumumab Monotherapy — Poster presentation, Saturday, December 5

Management of Infusion-related Reactions Following Daratumumab Monotherapy in Patients with ≥3 Lines of Prior Therapy or Double Refractory Multiple Myeloma (MM): 54767414MMY2002 (Sirius) — Poster presentation, Saturday, December 5

Outcomes and Management of Red Blood Cell Transfusions in Multiple Myeloma Patients Treated with Daratumumab — Poster presentation, Monday, December 7

Understanding the Dose Regimen for Daratumumab in Patients with Relapsed or Refractory Multiple Myeloma after Prior Proteasome Inhibitors and Immunomodulatory Drugs: A Quantitative Pharmacologic Perspective — Poster presentation, Monday, December 7

Target-mediated Drug Disposition of Daratumumab Following Intravenous Infusion in Relapsed or Refractory Multiple Myeloma after Prior Proteasome Inhibitors and Immunomodulatory Drugs: A Population Pharmacokinetic Analysis — Poster presentation, Monday, December 7

Analyses of Real-World Data on Overall Survival in Multiple Myeloma Patients With ≥3 Prior Lines of Therapy Including a PI and an IMID, or Double Refractory to a PI and an IMID — Poster presentation, Monday, December 7

Treatment of Ex Vivo Expanded NK Cells with Daratumumab F(ab’)2 Fragments Protects Adoptively Transferred NK Cells from Daratumumab-mediated Killing and Augments Daratumumab-induced Antibody Dependent Cellular Toxicity (ADCC) of Myeloma — Poster presentation, Monday, December 7

Generation and characterization of microvesicles after Daratumumab interaction with myeloma cells — Poster presentation, Saturday, December 5

Expression Profile of CD38 And Related Ectoenzymes in Myeloma Bone Niche: A Rational Basis for the Use of Daratumumab to Inhibit Osteoclast Formation and Activity — Poster presentation, Sunday, December 6

International Validation of a Dithiothreitol (DTT)-based Method to Resolve the Daratumumab Interference with Blood Compatibility Testing — Poster presentation, Monday, December 7

Ofatumumab
Risk-adapted Induction and Maintenance with Ofatumumab in Previously Untreated Patients with CLL/SLL — Poster presentation, Saturday, December 5

A Phase II Study of Ofatumumab-High Dose Methyl-prednisolone Followed by Ofatumumab-Alemtuzumab in 17p Deleted or TP53 Mutated CLL — Poster presentation, Monday, December 7

A Phase II Study of Ofatumumab in Combination with a Pan-AKT Inhibitor (Afuresertib) in Previously Treated Patients with CLL —
Poster presentation, Saturday, December 5

A Phase II Study of Alemtuzumab-Ofatumumab (A+O) Combination in Patients with Previously Untreated CLL — An Update —

Poster presentation, Saturday, December 5
Sequential Therapy with Ofatumumab, High Dose Methyl-prednisolone and Lenalidomide Is a Safe and Effective Regimen for the Treatment of Previously Treated and Untreated CLL/SLL: The HiLO Trial — Poster presentation, Sunday, December 6

About daratumumab
Daratumumab is an investigational human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. It induces rapid tumor cell death through multiple immune-mediated mechanisms1, including complement-dependent cytotoxicity1, antibody-dependent cellular phagocytosis2 and antibody-dependent cellular cytotoxicity1, as well as via induction of apoptosis3 . Five Phase III clinical studies with daratumumab in relapsed and frontline settings are currently ongoing. Additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant diseases on which CD38 is expressed, such as smoldering myeloma and non-Hodgkin lymphoma. Daratumumab has been granted Breakthrough Therapy Designation from the US FDA. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

About Ofatumumab (Arzerra)
Ofatumumab is a human monoclonal antibody that is designed to target the CD20 molecule found on the surface of chronic lymphocytic leukemia (CLL) cells and normal B lymphocytes.

In the United States, Arzerra is approved for use in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate. In the European Union, Arzerra is approved for use in combination with chlorambucil or bendamustine for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy. In more than 50 countries worldwide, Arzerra is also indicated as monotherapy for the treatment of patients with CLL who are refractory after prior treatment with fludarabine and alemtuzumab.
Please see full Prescribing Information, including Boxed WARNING for Arzerra (ofatumumab).
Arzerra is marketed under a collaboration agreement between Genmab and Novartis.

On November 5, 2015 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that more than 45 abstracts featuring eight of its approved or investigational medicines will be presented during the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting from December 5-8 in Orlando (Press release, Hoffmann-La Roche , NOV 5, 2015, View Source [SID:1234508007]). The abstracts include more than 15 oral presentations across a broad range of molecular targets and combinations, as well as different clinical endpoints that Roche is exploring in various blood diseases and lines of treatment.

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"Our data at ASH (Free ASH Whitepaper) this year showcase the evolution of our haematology portfolio and represent potential future approaches to helping people with blood cancers and blood disorders," said Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development. "We’re particularly excited about studies evaluating new combinations with Gazyva/Gazyvaro and venetoclax, as well as studies examining the potential clinical significance of minimal residual disease negativity."

Data for Gazyva/Gazyvaro include results from combination studies such as the Phase IIIb GREEN study and the pivotal CLL11 and GADOLIN studies. GREEN results will include data for Gazyva/Gazyvaro in combination with bendamustine in previously untreated chronic lymphocytic leukemia (CLL). Roche will also share updated results from the Phase III CLL11 study, which formed the basis of the Gazyva/Gazyvaro approval in previously untreated CLL in combination with chlorambucil, and further data from the pivotal Phase III GADOLIN study for the investigational use of Gazyva/Gazyvaro in patients with indolent non-Hodgkin’s lymphoma (NHL) that is refractory to MabThera/Rituxan (rituximab)-based treatment, that add to the positive results presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June this year.

Roche will also present findings from multiple studies that suggest a potential role for minimal residual disease (MRD)-negativity in the treatment of certain blood cancers. In collaboration with AbbVie, Roche will share new data for investigational medicine venetoclax as a monotherapy or in combinations across a number of blood cancers, including CLL, non-Hodgkin’s lymphoma (NHL), multiple myeloma (MM) and acute myeloid leukemia (AML). Data will also be shown for investigational medicine ACE910, which was recently granted breakthrough therapy designation by the U.S. Food and Drug Administration (FDA) for the prophylactic treatment of people who are 12 years or older with haemophilia A with factor VIII inhibitors.

The table below contains key abstracts featuring Roche medicines that will be presented. Follow Roche on Twitter via @Roche and keep up to date with ASH (Free ASH Whitepaper) Annual Meeting news and updates by using the hashtag #ASH2015.

Separately, the FDA has accepted for priority review the company’s supplemental Biologics License Application (sBLA) for Gazyva/Gazyvaro in the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to a rituximab-containing regimen, based on GADOLIN study results. Marketing applications for Gazyva/Gazyvaro have also been submitted to other health authorities, including the European Medicines Agency, for approval consideration in the treatment of patients with FL who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen. In addition, AbbVie has submitted a New Drug Application (NDA) for venetoclax to the FDA under breakthrough therapy designation, based in part on results of the pivotal Phase II M13-982 study evaluating venetoclax in people with relapsed/refractory CLL harboring the 17p deletion. Roche and AbbVie announced positive top-line results from this study earlier this year.

On November 5, 2015 Dynavax Technologies Corporation (NASDAQ: DVAX) reported financial results for the third quarter ended September 30, 2015 (Press release, Dynavax Technologies, NOV 5, 2015, View Source [SID:1234508006]).

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The Company had $220.7 million in cash, cash equivalents and marketable securities as of September 30, 2015, compared to $93.4 million at June 30, 2015. The balance at September 30, 2015 includes approximately $164 million of net proceeds from sales of common stock in the third quarter and reflects payment of all principal and accrued interest, prepayment charges and other fees totaling approximately $11 million under a loan agreement.

Operating expenses of $29.6 million for the quarter ended September 30, 2015 increased by $4.8 million compared to the quarter ended June 30, 2015 primarily due to production, clinical trial and commercial preparation costs.

We recently initiated a clinical trial to evaluate the combination of our cancer immunotherapeutic product candidate SD-101 and Merck’s KEYTRUDA (pembrolizumab) in patients with metastatic melanoma. All study visits for HBV-23, the Phase 3 clinical study of HEPLISAV-B, were completed in October 2015. Top line results of this study are expected to be released in early 2016.

The net loss allocable to common stockholders for the quarter ended September 30, 2015 was $30.1 million, or $0.82 per basic and diluted share. The net loss allocable to common stockholders for the quarter ended June 30, 2015 was $23.6 million, or $0.80 per basic and diluted share.

On November 5, 2015 DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported that it will present at the SeeThruEquity Microcap Investor Forum on Thursday, November 12, 2015, at 10:00 a.m. Eastern Time at Convene Grand Central in New York City (Press release, DelMar Pharmaceuticals, NOV 5, 2015, View Source [SID:1234508005]).

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Scott Praill, DelMar’s Chief Financial Officer, will present a corporate overview and provide an update on the ongoing Phase II clinical trial of VAL-083 (dianhydrogalactitol) in patients with recurrent glioblastoma multiforme (GBM). DelMar recently completed enrollment in the Phase II expansion cohort of the study and confirmed 40mg/m2 as the maximum tolerated dose (MTD) for advancement into registration-directed Phase II/III clinical trials in GBM.

Mr. Praill will also discuss the Company’s plans to initiate clinical trials with VAL-083 as a potential treatment for non-small cell lung cancer (NSCLC) and the promising potential of VAL-083 as chemotherapeutic alternative in ovarian cancer, pediatric brain tumors and other solid tumors.

A live audio webcast of the presentation will be available by accessing DelMar’s IR Calendar in the Investors section of the Company’s website (www.DelMarPharma.com). The webcast replay will be available approximately two hours after the presentation and will be accessible for one month.

About VAL-083
VAL-083 is a "first-in-class," small-molecule chemotherapeutic. In more than 40 Phase I and II clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated clinical activity against a range of cancers including lung, brain, cervical, ovarian tumors and leukemia both as a single-agent and in combination with other treatments. VAL-083 is approved in China for the treatment of chronic myelogenous leukemia (CML) and lung cancer, and has received orphan drug designation in Europe and the U.S. for the treatment of malignant gliomas.

DelMar has demonstrated that VAL-083’s anti-tumor activity is unaffected by the expression of MGMT, a DNA repair enzyme that is implicated in chemotherapy resistance and poor outcomes in GBM patients following standard front-line treatment with Temodar (temozolomide).

DelMar recently announced the completion of enrollment in a Phase II clinical trial of VAL-083 in refractory GBM. Patients have been enrolled at five clinical centers in the United States: Mayo Clinic (Rochester, MN); UCSF (San Francisco, CA) and three centers associated with the Sarah Cannon Cancer Research Institute (Nashville, TN, Sarasota, FL and Denver, CO).

In the Phase I dose-escalation portion of the study, VAL-083 was well tolerated at doses up to 40mg/m2 using a regimen of daily x 3 every 21 days. Adverse events were typically mild to moderate; no treatment-related serious adverse events reported at doses up to 40 mg/m2. Dose limiting toxicity (DLT) defined by thrombocytopenia (low platelet counts) was observed in two of six (33%) of patients at 50 mg/m2. Generally, DLT-related symptoms resolved rapidly and spontaneously without concomitant treatment, although one patient who presented with hemorrhoids received a platelet transfusion as a precautionary measure.

Sub-group analysis of data from the Phase I dose-escalation portion of the study suggested a dose-dependent and clinically meaningful survival benefit following treatment with VAL-083 in GBM patients whose tumors had progressed following standard treatment with temozolomide, radiotherapy, bevacizumab and a range of salvage therapies.

Patients in a low dose (≤5mg/m2) sub-group had a median survival of approximately five (5) months versus median survival of approximately nine (9) months for patients in the therapeutic dose (30mg/m2 & 40mg/m2) sub-group following initiation of VAL-083 treatment. DelMar reported increased survival at 6, 9 and 12 months following initiation of treatment with VAL-083 in the therapeutic dose sub-group compared to the low dose sub-group.

On November 5, 2015 Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, reported financial results for the quarter ended September 30, 2015 and provided an update on its development programs, including ThermoDox, its proprietary heat-activated liposomal encapsulation of doxorubicin, and GEN-1, an IL-12 DNA-based immunotherapy encased in a synthetic nanoparticle delivery system, which minimizes toxicity and maximizes the multiple antitumor effects of IL-12 and is currently under development for the localized treatment of ovarian and brain cancers (Press release, Celsion, NOV 5, 2015, View Source [SID:1234508004]).

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"During the past quarter, we reported positive data highlighting the multiple development opportunities for our chemotherapy and immunotherapy products, broadened our European Early Access Program to include primary liver cancer and realigned our current organization structure, which we expect to provide the most efficient path forward for our broad, diversified product pipeline with a focus on generating clinical data from our GEN-1 platform," said Michael H. Tardugno, Celsion’s chairman, president and CEO. "We plan to initiate multiple clinical studies over the next six to twelve months, including the Euro-DIGNITY study evaluating ThermoDox in breast cancer, a Phase 1b trial for GEN-1 in first-line ovarian cancer, and a second trial evaluating GEN-1 in combination with Avastin and Doxil in platinum-resistant ovarian cancer patients. Enrollment of patients in our global Phase III OPTIMA Study evaluating ThermoDox in primary liver cancer is continuing to build momentum. Lastly, we plan to leverage our TheraSilence RNAi lung-directed delivery platform through non-dilutive licensing and co-development collaborations."

Recent Developments

ThermoDox

Reported Positive Interim Data from the Phase II US DIGNITY Study in RCW Breast Cancer.

In July 2015, Celsion announced continuing positive interim data from its Phase II DIGNITY trial of ThermoDox in recurrent chest wall (RCW) breast cancer. Of the 17 patients enrolled and treated in the DIGNITY Study, 13 were eligible for evaluation of efficacy. Based on available data, every patient experienced a clinical benefit of their highly refractory disease with a local response rate of 69% observed in the 13 evaluable patients, including 5 complete responses, 4 partial responses and 4 patients with stable disease. Local tumor control in this population provides clinical benefit sufficient to warrant its designation as a primary endpoint for pivotal studies.

Announced Updated Overall Survival Data from Phase III HEAT Study, Providing Support for the Clinical Protocol for the Phase III OPTIMA Study.

In August 2015, Celsion announced the latest Overall Survival (OS) analysis (as of July 15, 2015) from the Phase III HEAT Study. The findings, which were demonstrated in a large, well bounded, well defined subgroup of patients (n=285, 41% of the study patients), showed that the combination of ThermoDox and optimized RFA provided a 58% improvement in OS compared to optimized RFA alone. The Hazard Ratio at this analysis is 0.63 (95% CI 0.43 – 0.93) with a p-value of 0.0198. Median overall survival for the ThermoDox group has been reached which translates into a 25.4 month (2.1 year) survival benefit over the optimized RFA only group (79 months for the ThermoDox plus optimized RFA group versus 53.6 months for the optimized RFA only group). An overall survival benefit greater than 60 months is widely recognized as curative.

In September 2015, the Company announced presentations by three leading experts in the treatment of primary liver cancer at the 2015 International Liver Cancer Association (ILCA) 9th Annual Conference during a symposium entitled "Intermediate HCC: Cure vs. Palliation." These experts noted that ThermoDox may represent a treatment with curative potential if the subgroup findings from the HEAT Study are confirmed.

Earlier this week, the Company announced several presentations by leading liver cancer experts in Asia highlighting the curative potential for ThermoDox plus optimized RFA at the 2nd Asian Conference on Tumor Ablation. The presentations at both of these meetings support the protocol for the Phase III OPTIMA Study which is expected to enroll up to 550 patients globally in up to 75 clinical sites in the United States, Europe, China and Asia Pacific. The Company noted that the presentations at ACTA now represent the fifth international medical conference and the seventh time that the Overall Survival data from the HEAT Study has been discussed by leading experts in HCC research.

Expanded the ThermoDox Early Access Program (EAP) in Europe.

In August, the Company and myTomorrows expanded the ThermoDox European Early Access Program to include patients with primary liver cancer and liver cancer metastases in all countries in the European Union territory, Switzerland, Turkey and Israel. The Company’s original EAP with myTomorrows, formed in January 2015, provides eligible patients with access to ThermoDox for the treatment of recurrent chest wall breast cancer. The EAP provides physicians with access to products in later stage development demonstrating evidence of clinical benefit, with an acceptable safety profile and a quality manufacturing process in place. Celsion will be allowed to price ThermoDox at commercial rates.

GEN-1 IL-12 DNA-Based Immunotherapy

Enrolled the First Patient in the OVATION Study

In October 2015, Celsion announced the enrollment of the first patient in its Phase Ib dose escalating clinical trial (the OVATION Study) combining GEN-1, the Company’s DNA-based immunotherapy, with standard of care for the treatment of newly diagnosed ovarian cancer patients who will undergo neoadjuvant chemotherapy. Interim results from this open label study will be available with patient evaluability and will continue through the first half of next year at higher doses of GEN-1.

Announced Confirmatory Preclinical Data for its GEN-1 IL-12 Immunotherapy in Combination with Avastin and Doxil for Ovarian Cancer

In October 2015, Celsion announced results from a large, comprehensive, preclinical program of the Company’s GEN-1 IL-12 immunotherapy in combination with Avastin and Doxil for the treatment of platinum resistant ovarian cancer. The preclinical studies provide evidence of a robust and synergistic anti-cancer advantage compared to untreated animals and suggest a statistically significant improvement over the combination of Avastin and Doxil. These studies support an IND filing for a Phase I/II trial evaluating the combination in ovarian cancer later this year.

Corporate Developments

Completed Integration of June 2014 EGEN Acquisition

During the third quarter of 2015, the Company completed the integration of its June 2014 acquisition of EGEN, Inc. with the consolidation of all early stage preclinical assets at its Huntsville, AL facility. All clinical development, commercialization, business development and administrative functions are now located in Lawrenceville, NJ. From this reorganization, the Company expects to realize a 15 to 20 percent reduction in personnel and related annual operational costs.

Financial Results

For the quarter ended September 30, 2015, Celsion reported a net loss of $4.3 million, or $(0.19) per share, compared to a net loss of $6.9 million, or $(0.40) per share, in the same period of 2014. Operating expenses were $4.4 million in the third quarter of 2015 compared to $6.8 million in the same period of 2014. For the nine month period ended September 30, 2015, the Company reported a net loss of $16.9 million, or $(0.79) per share, compared to $19.0 million, or $(1.12) per share, in the same period of 2014. Operating expenses were $16.3 million in the first nine months of 2015 compared to $18.7 million in the same period of 2014. Net loss and operating expenses for the three-month and nine-month periods ended September 30, 2014 included $0.1 million and $1.2 million, respectively of one-time costs associated with the June 2014 acquisition of EGEN, Inc. Net cash used in operations was $16.9 million in the first nine months of 2015 compared to $14.8 million in the same period last year. The Company ended the third quarter of 2015 with $24.4 million of total cash, investments and accrued interest on these investments.

Research and development (R&D) costs were $2.8 million in the third quarter of 2015 compared to $4.6 million the same period last year. Research and development costs were $11.0 million in the first nine months of 2015 compared to $10.7 million the same period last year. The increase in R&D costs in 2015 is primarily due to expenses associated with the operations of EGEN, Inc., the costs associated with the start-up and initiation of the Phase III OPTIMA Study in 2014 and the production of clinical supplies in 2015 for anticipated GEN-1 Phase I studies. General and administrative expenses were $1.5 million in the third quarter of 2015 compared to $2.0 million the same period of 2014. General and administrative expenses were $5.3 million in the first nine months of 2015 compared to $6.8 million the same period of 2014. These decreases were primarily the result of lower insurance premiums and lower personnel costs resulting from the reorganization and staff reductions announced during the third quarter of 2015.

Quarterly Conference Call

The Company is hosting a conference call to provide a business update and discuss the third quarter 2015 financial results at 11:00 a.m. EST on Thursday, November 5, 2015. To participate in the call, interested parties may dial 1-877-419-6594 (Toll-Free/North America) or 1-719-325-4755 (International/Toll) and ask for the Celsion Corporation Third Quarter 2015 Conference Call (Conference Code: 939465) to register ten minutes before the call is scheduled to begin. The call will also be broadcast live on the internet at View Source." target="_blank" title="View Source." rel="nofollow">View Source

The call will be archived for replay on Thursday, November 5, 2015 and will remain available until Thursday, November 19, 2015. The replay can be accessed at 1-888-203-1112 (Toll-Free/North America) or +1 719-457-0820 (International/Toll) using Conference ID: 939465. An audio replay of the call will also be available on the Company’s website, View Source, for 30 days after 2:00 p.m. EST Thursday November 5, 2015.