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.

On August 10, 2015 Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, reported that it has expanded its Early Access Program (EAP) for lyso-thermosensitive liposomal doxorubicin (LTLD), referred to by Celsion as ThermoDox, with myTomorrows to include patients with primary liver cancer, also known as hepatocellular carcinoma (HCC) and liver cancer metastases, in all countries of the European Union (EU) territory, Switzerland, Turkey and Israel (Press release, Celsion, AUG 10, 2015, View Source [SID:1234507133]). The Company’s original European EAP with myTomorrows, formed in January 2015, provides eligible patients with access to LTLD for the treatment of recurrent chest wall (RCW) breast cancer. The EAP for LTLD was launched in the second quarter. LTLD is Celsion’s proprietary heat-activated liposomal encapsulation of doxorubicin, known as ThermoDox.

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The expanded EAP is based, in part, on data from Celsion’s Phase III HEAT study of ThermoDox in HCC. 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 HEAT 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).

"The survival data from the large subgroup of patients in our HEAT study provides strong support for the expansion of the LTLD EAP into this patient population that has limited treatment options," stated Dr. Nicolas Borys, Celsion’s senior vice president and chief medical officer. "We will be working closely with myTomorrows to set up the EAP in this indication."

EAPs allow biopharmaceutical companies to provide eligible patients with ethical access to investigational medicines for unmet medical needs within the scope of the existing early access legislation. Access is provided in response to physician requests in a fully compliant manner, where no alternative treatment options are available to these patients. Celsion will provide LTLD in the EU, Switzerland, Turkey and Israel through myTomorrows. The Company expects to have LTLD available for HCC in the second half of 2015.

"This expansion of our EAP in liver cancer reflects our commitment to provide access to patients in desperate need of new treatment options," said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "We have been pleased with establishing our Early Access Program in RCW breast cancer, and look forward to being able to provide expanding access to patients with HCC and liver metastases consistent with our goal of providing effective therapies which may significantly prolong and improve the quality of life. In parallel with this EAP, we are also continuing to focus on enrolling patients in our global Phase III OPTIMA study in HCC designed to support registration in key markets worldwide. We have expanded our HCC clinical development footprint with the addition of 17 clinical sites in Spain, Germany and Italy."

About LTLD

Lyso-Thermosensitive Liposomal Doxorubicin (LTLD) is a proprietary heat-activated liposomal encapsulation of doxorubicin, an approved and frequently used oncology drug for the treatment of a wide range of cancers. LTLD is being evaluated in a Phase III clinical trial for primary liver cancer and a Phase II clinical trial for recurrent chest wall breast cancer. Localized mild hyperthermia (39.5 – 42 degrees Celsius) releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.

About myTomorrows

myTomorrows is an online patient platform that is creating freedom of choice for patients with unmet medical needs by offering earlier access to medicines that show promising results during clinical trials, but are not officially registered yet. With the support of their doctors, patients who suffer from cancer, a neurological disorder, a rare disease or a severe depression, can have earlier access to such medicines. For more information about myTomorrows, please visit the website www.mytomorrows.com.

On August 10, 2015 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported business and financial highlights for the second quarter ended June 30, 2015 (Press release, Celldex Therapeutics, AUG 10, 2015, View Source [SID:1234507132]).

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"Celldex is acutely aware of the significant unmet need for patients with glioblastoma, and we continue to focus considerable efforts on advancing the RINTEGA program," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "At ASCO (Free ASCO Whitepaper) in June, we presented data from the Phase 2 ReACT study, which achieved the primary endpoint of progression-free survival at six months and, most importantly, demonstrated a survival benefit for patients on the RINTEGA arm. We continue to follow these patients and look forward to presenting data on the emerging long-term survival benefit later this year. The Phase 3 ACT IV study continues to progress as planned, and we look forward to the second interim analysis in late 2015/early 2016."

"Our momentum is further supported by ongoing progress in our pipeline. Varlilumab is now in four combination studies, and we anticipate that a fifth study with Roche’s anti-PDL1 antibody will start later this year. We look forward to presenting data from a number of these studies in 2016 and believe these data will define an important role for varlilumab in cancer immunotherapy treatment. Glembatumumab vedotin also continues to actively enroll patients in two trials—the METRIC study in triple negative breast cancer and a study in metastatic melanoma. We are completing preparations that support the opening of METRIC study sites in the EU early next year and remain on track to complete enrollment in 2016. As we continue to advance Celldex towards becoming a fully integrated, commercial-stage biotechnology company, we were pleased to announce the promotion of Dr. Rick Wright to the position of Chief Commercial Officer. In this role, Rick will be responsible for developing a global business strategy and building the infrastructure required to support commercialization of RINTEGA and our cancer immunotherapy pipeline," concluded Marucci.

Program Updates:

RINTEGA ("rindopepimut"; "rindo"; CDX-110), an EGFRvIII(v3)-specific therapeutic vaccine for glioblastoma (GBM)

In June, the independent Data Safety and Monitoring Board (DSMB) recommended continuation of the Phase 3 ACT IV study of RINTEGA (rindopepimut) in patients with newly diagnosed glioblastoma as a result of a prespecified interim analysis assessing safety, futility and efficacy at 50% of events (deaths). The ACT IV study is a randomized, double-blind, placebo controlled study of RINTEGA plus GM-CSF added to standard of care temozolomide in patients with newly diagnosed, surgically resected, EGFRvIII-positive glioblastoma. 745 patients were enrolled into ACT IV to reach the required 374 patients with minimal residual disease (assessed by central review) needed for analysis of the primary overall survival endpoint. All patients, including those with disease that exceed this threshold, will be included in a secondary analysis of overall survival as well as analyses of progression-free survival, safety and tolerability, and quality of life. The second interim analysis is expected to occur in late 2015/early 2016.
Data from the Phase 2 ReACT study in patients with recurrent glioblastoma were presented in an oral session at the 2015 ASCO (Free ASCO Whitepaper) Annual Meeting by David A. Reardon, M.D., Clinical Director, Center for Neuro-Oncology, Dana-Farber Cancer Institute and Associate Professor of Medicine, Harvard Medical School, and the lead investigator of the ReACT study. Patients on the RINTEGA arm experienced a statistically significant overall survival (OS) benefit, and an impressive long-term survival benefit is emerging. The primary endpoint of the study, progression-free survival at six months (PFS6), was met, and a clear advantage was demonstrated across multiple, clinically important endpoints including long-term progression-free survival, objective response rate (ORR) and need for steroids. The Company anticipates that mature overall survival and long-term survival will be presented by year-end at an upcoming medical meeting.

Based on discussions to date with the regulatory authorities about the Phase 2 REACT data, the Company continues to believe the most likely scenario for potential RINTEGA approval filings will be upon receiving data from the ACT IV study, at which time the Company expects that it would file for full approval in both the front-line and recurrent setting. Under the RINTEGA program’s recently awarded Breakthrough Therapy Designation, the Company is actively engaged with the Center for Biologics Evaluation and Research (CBER) to complete all of the required activities associated with the ability to apply for licensure and considerable progress is being made, particularly in the areas of chemistry manufacturing and controls (CMC) and companion diagnostics readiness. The Company will continue to take all the necessary steps to prepare for filing so this process can be completed as expeditiously as possible when ACT IV data become available.

Glembatumumab vedotin ("glemba"; CDX-011), an antibody-drug conjugate targeting gpNMB in multiple cancers

Patient enrollment has accelerated in the Company’s Phase 2b randomized study (METRIC) of glembatumumab vedotin in patients with metastatic triple negative breast cancers that overexpress gpNMB, a molecule associated with poor outcomes for triple negative breast cancer patients and the target of glembatumumab vedotin. Approximately 100 sites are open to enrollment across the United States, Canada and Australia. Trial expansion into the European Union (EU) is underway, and the Company plans to open enrollment in up to 50 sites in the EU in early 2016. Based on current projections, enrollment will be completed in the second half of 2016.

Patient enrollment continues in the Phase 2 study of glembatumumab vedotin in metastatic melanoma. To date, 10 sites are open to enrollment in the United States.

Celldex continues to advance plans to expand the study of glembatumumab vedotin in other cancers in which gpNMB is expressed.
Study design is being finalized for a Phase 2 study in squamous cell lung cancer, and the study is expected to commence in 2H 2015.

Celldex and the National Cancer Institute have entered into a Cooperative Research and Development Agreement (CRADA) under which the NCI will sponsor two studies of glembatumumab vedotin—one in uveal melanoma and one in pediatric osteosarcoma. Protocols for the study are currently being developed.

Varlilumab ("varli"; CDX-1127), a fully human monoclonal agonist antibody that binds and activates CD27, a critical co-stimulatory molecule in the immune activation cascade

The Phase 1/2 study of varlilumab and nivolumab (Opdivo) in adult patients with advanced non-small cell lung cancer, metastatic melanoma, colorectal cancer, ovarian cancer, and head and neck squamous cell carcinoma is actively enrolling patients. This study is being conducted by Celldex under a clinical trial collaboration with Bristol-Myers Squibb Company. The companies are sharing development costs.

In April 2015, Celldex announced that it had entered into a clinical trial collaboration with Roche to evaluate the combination of varlilumab and atezolizumab (anti-PDL1) in a Phase 1/2 study in renal cell carcinoma. Under the terms of this agreement, Roche will provide study drug, and Celldex will be responsible for conducting and funding the study, which is expected to open to enrollment in 2H 2015.

In the second quarter, the Company announced the initiation of two combination studies of varlilumab, both of which are now enrolling patients. Efforts are underway for additional Phase 2 studies of varlilumab, and the Company will provide updates on these studies as they are initiated. Newly initiated studies in the second quarter include:

A Phase 1/2 safety and tolerability study examining the combination of varlilumab and sunitinib (Sutent) in patients with metastatic clear cell renal cell carcinoma (CC-RCC); and,

A Phase 1/2 safety and tolerability study examining the combination of varlilumab and ipilimumab (Yervoy) in patients with Stage III or IV metastatic melanoma. In the Phase 2 portion of the study, patients with tumors that express NY-ESO-1 will also receive Celldex’s CDX-1401.

Celldex presented preclinical data that support varlilumab’s expansion into combination studies with PD-1 inhibitors in a poster session at the 2015 AACR (Free AACR Whitepaper) Annual Meeting in April. Data demonstrated that the combination of varlilumab and anti-PDL1 induces a potent immune-mediated effect that results in important changes in the tumor microenvironment. Most notably, the combination strategy improved the ratio of effector T cells to regulatory T cells, which was accompanied by a reduction in the expression of PD-1 on both effector and regulatory T cells.

The Phase 1b study of varlilumab and ONT-10, Oncothyreon’s therapeutic vaccine targeting the tumor-associated antigen MUC1, continues to actively enroll patients with advanced breast or ovarian cancer. Celldex is providing study drug, and Oncothyreon is conducting the study.

CDX-1401, an antibody-based NY-ESO-1-specific therapeutic vaccine for multiple solid tumors

In the second quarter, Celldex announced the initiation of a Phase 1/2 study examining the combination of varlilumab and ipilimumab (Yervoy) in patients with Stage III or IV metastatic melanoma. This study is currently open to enrollment. In the Phase 2 portion of the study, patients with tumors that express NY-ESO-1 will also receive CDX-1401, an off-the-shelf antibody-based dendritic cell targeted vaccine.

Celldex continues to support several external collaborations, including a National Cancer Institute sponsored Phase 2 study of CDX-1401 and CDX-301 for patients with metastatic melanoma, which is open to enrollment.

CDX-301 (recombinant human Flt3L), a potent hematopoietic cytokine that uniquely expands dendritic cells and hematopoietic stem cells

CDX-301 is being developed as a combination product with other immuno-oncology agents in a number of investigator-sponsored studies.

A pilot study of CDX-301 alone and in combination with Mozobil in hematopoietic stem cell transplantation was initiated in September 2014 and is currently enrolling patients and sibling-matched donors.

Second Quarter and First Six Months 2015 Financial Highlights and 2015 Guidance

Cash position: Cash, cash equivalents and marketable securities as of June 30, 2015 were $334.0 million compared to $359.8 million as of March 31, 2015. The decrease was primarily driven by our second quarter net cash burn of $25.8 million. As of June 30, 2015 Celldex had 98.5 million shares outstanding.

Revenues: Total revenue was $2.2 million in the second quarter of 2015 and $2.7 million for the six months ended June 30, 2015, compared to $0.6 million and $1.0 million for the comparable periods in 2014. The increase in the second quarter of 2015 and the six months ended June 30, 2015 was primarily due to our clinical trial collaboration with Bristol-Myers Squibb and our research and development agreement with Rockefeller University.

R&D Expenses: Research and development (R&D) expenses were $26.5 million in the second quarter of 2015 and $51.6 million for the six months ended June 30, 2015, compared to $24.1 million and $51.2 million for the comparable periods in 2014.

G&A Expenses: General and administrative (G&A) expenses were $8.2 million in the second quarter of 2015 and $14.3 million for the six months ended June 30, 2015, compared to $4.8 million and $9.4 million for the comparable periods in 2014. The increase in G&A expenses was primarily attributable to higher commercial personnel-related expenses as we prepare for potential product launch and a $2.2 million increase year to date in RINTEGA and glembatumumab vedotin commercial planning costs over the $1.9 million spent in the comparable period in 2014.

Net loss: Net loss was $32.4 million, or ($0.33) per share, for the second quarter of 2015 and $62.5 million, or ($0.65) per share, for the six months ended June 30, 2015, compared to a net loss of $28.3 million, or ($0.32) per share and $58.2 million, or ($0.65) per share for the comparable periods in 2014.

Financial guidance: Celldex expects that its cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements through 2017; however, this could be impacted by our clinical data results from the RINTEGA program and their potential impact on our pace of commercial manufacturing and the rate of expansion of our commercial operations.

RINTEGA is a registered trademark of Celldex Therapeutics. Opdivo and Yervoy are registered trademarks of Bristol-Myers Squibb. Sutent is a registered trademark of Pfizer. Mozobil is a registered trademark of sanofi-aventis U.S. LLC.