On August 10, 2015 Inovio Pharmaceuticals (Nasdaq:INO) reported that it has entered into a license agreement and collaboration with MedImmune, the global biologics research and development arm of AstraZeneca (Press release, Inovio, AUG 10, 2015, View Source [SID:1234507147]).

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Under the agreement, MedImmune will acquire exclusive rights to Inovio’s INO-3112 immunotherapy, which targets cancers caused by human papillomavirus (HPV) types 16 and 18. INO-3112, which is in phase I/II clinical trials for cervical and head and neck cancers, works by generating killer T-cell responses that are able to destroy HPV 16- and 18-driven tumors. These HPV types are responsible for more than 70 percent of cervical pre-cancers and cancers.

MedImmune intends to study INO-3112 in combination with selected immunotherapy molecules within its pipeline in HPV-driven cancers. Emerging evidence suggests that the benefits from immuno-oncology molecules, such as those in MedImmune’s portfolio, can be enhanced when they are used in combination with cancer vaccines that generate tumor-specific T-cells.

Under the terms of the agreement, MedImmune will make an upfront payment of $27.5 million to Inovio as well as potential future payments upon reaching development and commercial milestones totaling up to $700 million. MedImmune will fund all development costs. Inovio is entitled to receive up to double-digit tiered royalties on INO-3112 product sales.

Within the broader collaboration, MedImmune and Inovio will develop up to two additional DNA-based cancer vaccine products not included in Inovio’s current product pipeline, which MedImmune will have the exclusive rights to develop and commercialize. Inovio will receive development, regulatory and commercialization milestone payments and will be eligible to receive royalties on worldwide net sales for these additional cancer vaccine products.

Dr. David Berman, Senior Vice President and Head of the Oncology Innovative Medicines unit, MedImmune, said: "Today’s collaboration with Inovio leverages our deep internal expertise in the use of vaccines to drive antigen-specific T-cell responses. The unique combination of our broad immuno-oncology portfolio with Inovio’s T-cell-activating INO-3112, which enhances cancer specific killer T-cells, has the potential to deliver real clinical benefits for patients."

Dr. J. Joseph Kim, President and CEO, Inovio, said: "Our licensing partnership with MedImmune represents an important step in executing our immuno-oncology combination strategy and advancing Inovio’s cancer vaccine R&D pipeline with a leading cancer immunotherapy company. INO-3112 is progressing, with positive interim data generated in an Inovio-initiated phase I study. We appreciate MedImmune’s recognition of our ability to activate best-in-class killer T-cells in vivo and look forward to working with them on this collaboration."

Today’s agreement builds on the existing partnership between Inovio and MedImmune on two research and development collaborations in the infectious disease area. Both efforts are funded by the Defense Advanced Research Projects Agency (DARPA) and support R&D focused on Ebola, influenza, and bacterial infections. MedImmune has a strong heritage in infectious disease and vaccine innovation, having developed the first monoclonal antibody approved by the US Food & Drug Administration for the prevention of an infectious disease and the technology that led to the creation of an HPV vaccine.

About INO-3112

Inovio’s SynCon DNA-based immunotherapies help the immune system activate disease-specific killer T cells to fight a targeted disease. HPV, the most pervasive sexually transmitted virus, causes numerous pre-cancers and cancers. Inovio’s HPV immunotherapy called INO-3112 targets disease associated with the high-risk HPV types 16 and 18, which are responsible for over 70% of cervical pre-cancers and cancers. INO-3112 combines Inovio’s VGX-3100, its immunotherapy targeting HPV-caused diseases, with its DNA-based immune activator encoded for IL-12. INO-3112 is in three clinical studies for cervical and head and neck cancers.

Earlier this year, Inovio reported preliminary data showing that INO-3112 generated significant antigen-specific CD8+ T cell responses in 3 of 4 patients with head and neck cancer associated with human papillomavirus (HPV) types 16 and 18. These positive results represent the first study and first report of antigen-specific T cell immune responses generated in cancer patients after treatment with a DNA immunotherapy.

Previously in a phase II efficacy trial, treatment with VGX-3100 resulted in histopathological regression of late-stage cervical dysplasia to early stage or no disease, meeting the study’s primary endpoint. In addition, the trial demonstrated clearance of the HPV virus in conjunction with regression of cervical lesions, meeting the secondary endpoint. Robust T-cell activity was observed in subjects who received VGX-3100 compared to those who received placebo.

On August 10, 2015 Ignyta, Inc. (Nasdaq: RXDX), a precision oncology biotechnology company, reported company highlights and financial results for the second quarter ended June 30, 2015 (Press release, Ignyta, AUG 10, 2015, View Source [SID:1234507143]).

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"Since the beginning of the second quarter of 2015, we have continued to make important strides toward our goal of becoming a leading precision oncology biotechnology company that can provide compelling treatment options to cancer patients with unmet needs," said Jonathan Lim, M.D., Chairman and CEO of Ignyta. "We made strong progress on our lead product candidate, entrectinib, announcing promising data at ASCO (Free ASCO Whitepaper) from our two Phase I clinical trials, releasing our proprietary next-generation sequencing assay to support our potentially registration-enabling STARTRK-2 Phase 2 clinical trial, and kicking off a collaboration with UCSF to study entrectinib in melanoma. We are also starting to gain good momentum in advancing the former Teva assets we acquired only a quarter earlier, as exemplified by the FDA’s clearance of our IND for RXDX-107, for which we are preparing to initiate a Phase 1/1b clinical trial. We also strengthened our balance sheet by raising gross proceeds of approximately $75 million in an underwritten public offering of our common stock, and we continued to expand our team with incredibly talented people."

Company Highlights

Presentation of Entrectinib Clinical Data at ASCO (Free ASCO Whitepaper)

In June 2015, Ignyta announced that interim results from the company’s two Phase 1 clinical trials of entrectinib were presented at the 2015 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago, Illinois.

The clinical trials included the ALKA-372-001 study and the STARTRK-1 study, which is the first of the "Studies of Tumor Alterations Responsive to Targeting Receptor Kinases." Both trials were designed to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D), as well as preliminary anti-cancer activity, of single agent entrectinib in patients with solid tumors with the relevant molecular alterations: NTRK1 (encoding TrkA), ROS1 or ALK for ALKA-372-001 and NTRK1/2/3 (encoding TrkA/TrkB/TrkC), ROS1 or ALK for STARTRK-1.

As of the May 1, 2015, data cut-off for the presentation, the findings showed:

A total of 67 patients with a range of solid tumors had been dosed across both clinical trials;
Entrectinib was well tolerated to date, with no treatment-related serious adverse events. Other safety findings included:
In the ALKA-372-001 study, two Grade 3 treatment-related adverse events were observed: fatigue and muscle weakness, each of which subsided with dose reduction. The most frequent adverse events were paresthesia, nausea, myalgia, asthenia, dysgeusia, and vomiting;

In the STARTRK-1 study, three Grade 3 treatment-related adverse events were observed: neutropenia, which resolved with dose reduction, and two dose-limiting toxicities of reversible cognitive impairment and fatigue, both of which resolved upon study drug interruption. The most frequent adverse events were fatigue, dysgeusia, constipation, nausea, and paresthesia;

Pharmacokinetic measurements showed dose-proportional increases across the daily dosing regimens evaluated, with a half-life compatible with once-daily dosing;

The body surface area (BSA)-based recommended Phase 2 dose was determined to be 400 mg/m2 once per day (QD); both studies are continuing in order to determine a fixed daily dose regimen;

11 patients across both clinical trials met the company’s expected Phase 2 eligibility criteria, which include:
Presence of NTRK1/2/3, ROS1 or ALK fusions, as opposed to other types of molecular alterations (e.g., SNPs, amplifications, deletions);

ALK inhibitor and/or ROS1 inhibitor naïve; and

Treatment at or above the recommended Phase 2 dose of 400 mg/m2;

The response rate in the 11 patients that met these criteria across both studies was 91% (10 of 11 responses as assessed by the clinical sites), with 9 patients remaining on study treatment with durable responses of up to 16 treatment cycles. The responses included:

3 of 3 responses in patients with NTRK1/2/3 fusions, including patients with non-small cell lung cancer (NSCLC), colorectal cancer and acinic cell cancer;

5 of 6 responses, including one complete response, in patients with ROS1 fusions, all of which were in NSCLC; and
2 of 2 responses in patients with ALK fusions, including one NSCLC patient and one patient with another solid tumor.

Release for Clinical Use of Proprietary NGS Clinical Trial Assay

In June 2015, the company announced the release for clinical use of its first clinical trial assay to support patient identification and enrollment into its STARTRK clinical development program for entrectinib. The proprietary assay was co-developed with ArcherDx and validated within Ignyta’s own CLIA-registered, QSR-compliant diagnostic lab in San Diego. This lab will utilize this assay in acting as the central testing lab for patient screening for the STARTRK-2 Phase 2 clinical study of entrectinib.

Entrectinib Collaboration with UCSF

In July 2015, the company announced a clinical collaboration with the University of California, San Francisco (UCSF), under which UCSF will study entrectinib in a proof-of-concept clinical trial in cancer patients with metastatic melanoma that is positive for activating alterations to NTRK1/2/3 (encoding TrkA/TrkB/TrkC) or ROS1.

The study is a multicenter, open label umbrella trial designed by UCSF to obtain proof-of-concept data in patients with metastatic melanoma that is positive for molecular alterations in specific tyrosine kinase receptors. UCSF will exclusively use entrectinib for patients enrolled in the clinical trial having activating molecular alterations to NTRK1/2/3 or ROS1.

Clearance of Investigational New Drug (IND) Application for RXDX-107

In July 2015, Ignyta announced that the U.S. Food and Drug Administration (FDA) cleared the IND for Ignyta’s new chemical entity RXDX-107, a next-generation alkyl ester of bendamustine encapsulated in human serum albumin (HSA) to form nanoparticles.

Under this IND, the company intends to initiate a new Phase 1/1b, multicenter, open-label clinical trial of RXDX-107 in adult patients. This dose-escalation study is designed to determine the MTD, RP2D, tolerability, pharmacokinetics and preliminary clinical activity of RXDX-107 in patients with locally advanced or metastatic solid tumors.

Financing

In June 2015, the company issued an aggregate of 4,285,714 shares of its common stock in an underwritten public offering at a purchase price of $17.50 per share, which resulted in aggregate gross proceeds of approximately $75 million.

Enhancement of Leadership Capacity

In July 2015, Ignyta announced that Bernard Parker joined the company as its Chief Commercial Officer, bringing to the company broad commercial oncology experience from a variety of senior roles spanning sales, marketing, reimbursement, global brand management and regional business unit leadership at several leading pharmaceutical companies. Mr. Parker’s previous experience includes serving as Head of the EMEA Pharmaceuticals Franchise for the Alcon division of Novartis; as Global Brand Director, Biopharmaceuticals Portfolio for the Sandoz division of Novartis; as a management consultant at Bain & Company; and in various marketing and sales roles at Amgen, Pfizer and Parke-Davis.

Second Quarter 2015 Financial Results

For the second quarter of 2015, net loss was $13.1 million, or $0.51 per share, compared with $5.4 million, or $0.28 per share, for the second quarter of 2014.

Ignyta did not record any revenue for the three months ended June 30, 2015. Ignyta recorded revenue of $150,000 for the three months ended June 30, 2014, which consisted of a one-time service fee for research services conducted in the second quarter of 2014.

Research and development expenses for the second quarter of 2015 were $8.8 million, compared with $3.6 million for the second quarter of 2014. The increase was primarily due to an increase in activities relating to development of entrectinib and the company’s other product candidates, including the assets acquired from Teva Pharmaceutical Industries Ltd. in March 2015. The increase between periods was also due to personnel expenses related to hiring and engaging additional employees and consultants to help advance the company’s product candidates, facilities related expenses as a result of the expansion of the company’s leased facilities space and expenses incurred in connection with the Teva asset acquisition.

General and administrative expenses were $3.9 million for second quarter of 2015, compared with $2.0 million for second quarter of 2014. The increase was primarily caused by increases in personnel costs and investor relations, audit, legal and intellectual property costs.

At June 30, 2015, the company had cash, cash equivalents and available-for-sale securities totaling $166.4 million and current and long-term debt of approximately $21.0 million. At December 31, 2014, the company had cash, cash equivalents and available-for-sale securities totaling $76.6 million and current and long-term debt of approximately $21.0 million.

On August 10, 2015 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported financial results for the second quarter ended June 30, 2015 (Press release, Halozyme, AUG 10, 2015, View Source [SID:1234507141]). Financial highlights include revenues of $43.4 million and net income of $3.0 million, or $0.02 per share, compared to revenues of $18.4 million and a net loss of $16.3 million, or $0.13 per share, for the second quarter of 2014.

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"Our performance in the quarter continued to demonstrate the strength of our two-pillar strategy," said Dr. Helen Torley, president and CEO. "In the ENHANZE pillar, we signed our largest licensing agreement in company history with AbbVie, which has the potential to generate new royalty revenue and approximately $130 million for each of up to nine targets.

"In our oncology pillar, we continued to make good progress toward the planned initiation of our phase 3 trial in metastatic pancreatic cancer patients, and expanded our efforts to explore and demonstrate the pan-tumor potential of our investigational new drug, PEGPH20, through our first oncology clinical collaboration agreement. This agreement with Eisai will broaden the PEGPH20 development plan into breast cancer, building on our ongoing work in pancreatic and non-small cell lung cancer, exploring combinations with chemotherapies and immunotherapies."

Second Quarter 2015 Highlights and Subsequent Events

Global clinical collaboration with Eisai Co., Ltd. to investigate HALAVEN (eribulin) and PEGPH20 in metastatic breast cancer: Halozyme entered into a worldwide clinical collaboration with Eisai Co. Ltd. to evaluate HALAVEN in combination with PEGPH20 in first line HER2-negative metastatic breast cancer patients. The companies will co-fund a phase 1b/2 clinical trial to explore whether HALAVEN in combination with PEGPH20 can improve overall response rate, as compared with HALAVEN alone.

Received feedback from the European Medicines Agency (EMA) on the Phase 3 Study 301 design. During the quarter, the company received scientific advice from the EMA for its planned Phase 3 registration study in metastatic pancreatic cancer patients with high-HA tumors. Based on feedback received to date from the U.S. Food and Drug Administration (FDA) and the EMA, the company plans to proceed with the trial design previously discussed with the FDA and continues to target the end of first quarter 2016 to initiate the study.

Global collaboration with AbbVie to develop and commercialize products using ENHANZE technology: Halozyme entered into a worldwide collaboration and license agreement with AbbVie for the purpose of developing and commercializing products combining proprietary AbbVie compounds with Halozyme’s ENHANZE technology. Halozyme received an initial payment of $23 million in June 2015. The agreement provides for milestone payments totaling approximately $130 million for each of up to nine collaboration targets, in addition to tiered royalty payments based on net sales of products using ENHANZE technology.

Interim results from Study 202 evaluating PEGPH20 with gemcitabine and ABRAXANE (nab-paclitaxel) in metastatic pancreatic cancer patients were presented at the annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper): In a retrospectively defined sub-population of patients, the data showed a doubling in median progression free survival in metastatic pancreatic cancer patients with high levels of hyaluronan (HA) who were treated with PEGPH20 combined with ABRAXANE and gemcitabine (9.2 months vs. 4.3 months in patients treated with ABRAXANE and gemcitabine alone). Additional reported results included:
A more than doubling of overall response rate of 52 percent versus 24 percent (p-value of 0.038) and a duration of response of 8.1 months compared to 3.7 months in high HA patients treated with PEGPH20 combined with ABRAXANE and gemcitabine (PAG) versus ABRAXANE and gemcitabine (AG);

A trend toward improvement in median overall survival of 12 months compared to 9 months in high HA patients treated with PAG versus AG (hazard ratio of 0.62) despite discontinuation of PEGPH20 in more than half of the PAG-treated patients at the time of the clinical hold in April 2014.

A thromboembolic event (TE) event rate of 13 percent in 38 patients treated with PAG versus 18 percent in 17 patients receiving AG.

Global agreement with Ventana Medical Systems to collaboratively develop a companion diagnostic for cancer treatment: Entered into a global agreement with Ventana to develop and commercialize a companion diagnostic assay for use with PEGPH20. Under the agreement, Ventana will develop the in vitro diagnostic, with the intent of submitting it for regulatory approval in the United States, Europe and other countries.

Second Quarter 2015 Financial Highlights

Revenues for the second quarter of 2015 were $43.4 million, compared to $18.4 million for the second quarter of 2014, driven by a $23 million payment for initiation of a global collaboration agreement with AbbVie. Revenues in the second quarter included $6.4 million in royalty revenue from sales of products under collaboration agreements, $7.7 million in product sales of bulk rHuPH20 for use in manufacturing collaboration products for Roche and Baxalta, $4.2 million in Hylenex recombinant (hyaluronidase human injection) product sales, and $24.7 million in collaboration revenues, which includes the $23 million payment from AbbVie. Royalty revenues represent January to March 2015 partnered product sales as a result of the one quarter lag in royalty reports.

Research and development expenses for the second quarter of 2015 were $21.2 million, compared to $18.6 million for the second quarter of 2014. The increase was primarily due to an increase in expenses related to preclinical and clinical activities for PEGPH20, off-set by a planned decrease in expenses associated with discontinued development programs.

Selling, general and administrative expenses for the second quarter of 2015 were $9.8 million, compared to $8.8 million for the second quarter of 2014. The increase was primarily due to an increase in personnel expenses, including stock compensation, for the period.

Net income for the second quarter of 2015 was $3.0 million, or $0.02 per share, compared to a net loss for the second quarter of 2014 of $16.3 million, or $0.13 per share.

Cash, cash equivalents and marketable securities were $140.7 million at June 30, 2015, compared to $128.5 million at March 31, 2015. Net cash increase in the second quarter of 2015 was approximately $12.2 million.

Financial Outlook for 2015

For the full year 2015, the company revised its previously disclosed guidance to the following:

Net revenues to be in the range of $110 million to $115 million, from a prior range of $85 million to $95 million.
Operating expenses to be in the range of $160 million to $170 million, from a prior range of $145 million to $155 million.
Net cash burn to be between $20 million to $30 million, from a prior range of $35 to $45 million, with year-end cash balance expected to be $105 million to $115 million.

The company raised its revenue projection due to payment received from the AbbVie agreement. Operating expenses are expected to increase primarily due to acceleration of a bulk PH20 manufacturing campaign to fulfill current and future orders, and the building of capabilities related to an expansion of the PEGPH20 clinical program from 2 to 5 trials, including assuring readiness for the global phase 3 study at the end of Q1 2016. Cash burn is expected to decrease due to the inflow of new revenue, partially offset by the increase in planned expenses.

On August 10, 2015 GenSpera, Inc. (OTCQB: GNSZ) on August 6, 2015, the company reported its financial results for the three and six months ended June 31, 2015, and has provided the following corporate update to its shareholders in order to highlight the Company’s extensive organizational advances and clinical progress during the second quarter of 2015 (Filing, 8-K, GenSpera, AUG 10, 2015, View Source [SID:1234507140]). GenSpera continues to unlock conventional thinking to conceive, design, and develop novel cancer therapies. GenSpera’s unique technology platform combines a powerful, plant-derived cytotoxin (thapsigargin) with a patented prodrug delivery system that provides targeted release of drug candidates within tumors.

"The second quarter of 2015 has been incredibly busy and very significant for GenSpera’s future," said Craig Dionne, Ph.D., chief executive officer at GenSpera. "With impressive final Phase II clinical data for hepatocellular carcinoma (HCC), plus meeting and exceeding clinical milestones for our ongoing Phase II glioblastoma trials which resulted in expanded patient enrollment, I believe the value of mipsagargin is being telegraphed strong. It is an exciting time for GenSpera and management looks forward to ongoing communications with all our primary audiences."

Second Quarter Clinical and Business Highlights

· On July 16, 2015, the U.S. Court of Appeals for the Federal Circuit entered judgment in GenSpera, Inc. v. Annastasiah Mudiwa Mhaka in favor of GenSpera. In a per curiam order without an opinion, the Federal Circuit affirmed the decision of the U.S. District Court for the District of Maryland granting summary judgment in GenSpera’s favor in two consolidated cases relating to the inventorship of two patents owned by GenSpera. The district court had issued a declaratory judgment that Dr. Annastasiah Mhaka should not be added as an inventor to the two patents at issue, and had also granted summary judgment with respect to state law tort claims brought by Dr. Mhaka against the company and two of its founders, Dr. John Isaacs and Dr. Sam Denmeade. The U.S. Court of Appeals for the Fourth Circuit previously dismissed another appeal brought by Dr. Mhaka from the same district court judgments.

· GenSpera’s strategic partner, Phyton Biotech, has had its international patent application WO 2015/0892978 A1 "PRODUCTION OF THAPSIGARGINS BY THAPSIA CELL SUSPENSION CULTURE," published by the World Intellectual Property Organization (WIPO). The invention described in the patent application provides, for the first time, a suspension cell culture suitable for mass production of thapsigargin and offers a potentially alternative route to commercial scale production of this starting material for synthesis of mipsagargin.

· We issued final data from our Phase II liver cancer trial in which a total of twenty-five patients were treated with mipsagargin. Study participants experienced a median time to progression of 4.5 months, more than double the time demonstrated in prior studies with placebo or ineffective agents. Sixty-three percent of patients experienced stable disease at two months. Additionally, mipsagargin was shown to dramatically decrease blood flow in liver tumors. 

· Santosh Kesari, MD, PhD, Principal Investigator of GenSpera’s glioblastoma clinical trial, received a $1.6 million RO-1 grant from the Food and Drug Administration for preclinical work and biomarker development in support of the ongoing mipsagargin clinical trial studies in humans. The clinical trial is being conducted at UC San Diego Moores Cancer Center in La Jolla, CA. Sufficiently encouraging data were observed in the first stage of the ongoing Phase II study of mipsagargin in glioblastoma (brain cancer) patients to warrant continuation of enrollment for an expansion phase of the trial. We have now treated fifteen patients in our Phase II glioblastoma clinical trial.

· GenSpera continued partnering, licensing, and research collaboration discussions with multinational and regional pharmaceutical companies.

· GenSpera harvests and plants next generation crop of thapsigargin in Spain.

· In July 2015, we completed a private placement of approximately $2.5 million of the Company’s securities. 

Second Quarter Corporate Communications Highlights

· GenSpera was featured upon Los Angeles KTLA "Health Smart" television news program. The show effectively conveyed the potential of the Company’s broad technology platform.

· Craig Dionne begins writing monthly Chairman’s blog designed to inform, educate, and provide perspective to shareholders about GenSpera’s drug development and business progress.

· PCG Advisory Group (PCG), GenSpera’s Investor Relations agency of record, orchestrated a series of non-deal roadshows and investor outreach programs. Since engagement, GenSpera has been introduced to a new level of institutional funds and individuals that could be strategic long term investors for the Company both nationally and internationally.

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On August 10, 2015 Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, reported financial results for the quarter ended June 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 is currently under development for the localized treatment of ovarian and brain cancers (Press release, Celsion, AUG 10, 2015, View Source [SID:1234507134]).

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"Over the past few months, we reported positive data highlighting the multiple development opportunities for our portfolio, launched our European Early Access Program for ThermoDox in recurrent chest wall breast cancer and strengthened our balance sheet, providing a strong foundation as we advance our pipeline," said Michael H. Tardugno, Celsion’s chairman, president and CEO. "We remain on track to initiate key clinical studies this year, including the Euro-DIGNITY study evaluating ThermoDox in breast cancer, a Phase 1b trial for GEN-1 in first-line ovarian cancer, and a trial evaluating GEN-1 with Avastin in platinum-resistant ovarian cancer patients. In parallel, we continue enroll patients from North America, Europe and Asia Pacific in our global Phase III OPTIMA Study evaluating ThermoDox in primary liver cancer. Finally, we continue to evaluate ways to leverage our TheraSilence technology platform to advance the development of RNAi therapeutics that can be delivered directly to the lung."

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, notably 5 complete responses, 4 partial responses and 4 patients with stable disease.

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

As of July 15, 2015, the latest Overall Survival (OS) analysis demonstrated that in a large, well bounded, subgroup of patients (n=285, 41% of the study patients), 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). These data continue to support the protocol for the Phase III OPTIMA Study, which is evaluating ThermoDox in combination with optimized RFA, which will be standardized to a minimum of 45 minutes across all investigators and clinical sites for treating lesions 3 to 7 centimeters, versus standardized RFA alone. The study is expected to enroll up to 550 patients globally in up to 75 clinical sites in the United States, Europe, China and Asia Pacific.

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

The Company and myTomorrows launched the ThermoDox Early Access Program in the second quarter, making ThermoDox available for sales to physicians who are treating patients with limited therapeutic options. 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

Presented Phase Ib Data for GEN-1 in Platinum-Resistant Ovarian Cancer at ASCO (Free ASCO Whitepaper).

In May 2015, Celsion presented clinical results from the Phase Ib trial for GEN-1in combination with pegylated doxorubicin in 16 patients with platinum-resistant ovarian cancer in a poster session at the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting in Chicago. The clinical findings demonstrated an overall clinical benefit of 57% for all treatment arms, with a partial response (PR) rate of 21% and a stable disease (SD) rate of 36%. The overall clinical benefit observed at the highest dose cohort in this difficult-to-treat patient population was 100% (PR=33% and SD=67%) in all six evaluable patients. GEN-1 was well tolerated, with no dose limiting toxicities and no overlapping toxicities between GEN-1 and pegylated doxorubicin.

TheraSilence

Demonstrated Potent, Durable Preclinical Lung Expression Data for Its TheraSilence.

In May 2015, Celsion reported data from a preclinical study confirming that its TheraSilence technology platform can safely and effectively deliver RNA to the lungs in non-human primates, enabling the development of RNA therapeutics for lung diseases. In the study, TheraSilence-formulated signaling RNA resulted in preferential expression in the lungs, with expression in the liver at less than 15% of expression levels observed in the lungs, and expression levels in tissues other than the lung, spleen and liver at very low or background levels. A liver-directed delivery system, used as a positive control for the study, yielded preferential expression in liver and spleen, with only background expression levels observed in the lung.

Published Preclinical Data Demonstrating Lung Specific Delivery of microRNA-145 Inhibitor Using the TheraSilence Platform.

In May 2015, an abstract published in the Journal of Controlled Release summarized findings from a preclinical study confirming effective delivery of RNA to lung cells. In the study, the Company’s TheraSilence technology platform safely and effectively delivered an inhibitor of microRNA-145 (miR-145) in a well-established model of severe occlusive pulmonary arterial hypertension (PAH). Treatment was associated with significant delivery of miR-145 inhibitor in the lung, inhibition of miR-145 levels and reversal of the pulmonary hypertension associated with the advanced stages of the disease leading to a normalization of cardiovascular function.

Corporate Developments

Raised $8 Million Through Registered Direct Equity Offering priced "at the market".

During the second quarter of 2015, the Company completed an $8 million at-the-market registered direct equity offering and a concurrent private placement of warrants to purchase common stock with two institutional healthcare investors.

Financial Results

For the quarter ended June 30, 2015, Celsion reported a net loss of $5.7 million, or $(0.27) per share, compared to a net loss of $6.7 million, or $(0.38) per share, in the same period of 2014. Operating expenses were $5.4 million in the second quarter of 2015 compared to $6.5 million in the same period of 2014. For the six month period ended June 30, 2015, the Company reported a net loss of $12.7 million, or $(0.62) per share, compared to $12.1 million, or $(0.71) per share, in the same period of 2014. Operating expenses were $11.9 million in the first half of 2015 compared to $11.9 million in the same period of 2014. Net loss and operating expenses for the three-month and six-month periods ended June 30, 2014 included $1.1 million of one-time costs associated with the acquisition of EGEN, Inc. Net cash used in operations was $11.6 million in the first half of 2015 compared to $9.0 million in the same period last year. The Company ended the second quarter of 2015 with $30.8 million of total cash, investments and accrued interest on these investments, which included the proceeds of an $8 million registered direct offering that was completed during the quarter.

Research and development costs were $3.6 million in the second quarter of 2015 compared to $3.2 million the same period last year. Research and development costs were $8.1 million in the first half of 2015 compared to $6.1 million the same period last year. The increases in 2015 is primarily due to costs associated with the operations of EGEN, Inc., which the Company acquired in June 2014, and the costs associated with the initiation of the Phase III OPTIMA Study in 2014 and the production of clinical supplies in the first half of 2015 for the three GEN-1 Phase I studies. General and administrative expenses were $1.8 million in the second quarter of 2015 compared to $2.3 million the same period of 2014. General and administrative expenses were $3.8 million in the first half of 2015 compared to $4.7 million the same period of 2014. These decreases were primarily the result of lower insurance premiums and lower personnel costs.