On JUNE 9, 2015 Cellectis reported in order to comply with NASDAQ financial practices, is publishing for the first time its 1st quarter results (Filing, 6-K, Cellectis, JUN 9, 2015, View Source [SID:1234505385]).

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Cellectis previously published consolidated financial statements for the first six months of 2014 and for the full year 2014. The Company did not publish financial statements for first half-year and full year 2014. Cellectis did not have consolidated financial statements for the 1st and 3rd quarters 2014. Therefore, no comparative 2014 figures will be presented for 1st and 3rd quarters in 2015. Cellectis will publish full quarterly comparative figures starting 2016.

Consolidated financial statements have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board ("GAAP").

First Quarter 2015 Financial Results

Revenues and Other Income: Total revenues and other income were of €9.2 million for the first quarter 2015 (€26.5 million for FY2014) and mainly comprised €7.9 million of collaboration revenues (€11.9 million for FY2014) and €0.4 million of license revenues (€7.3 million for FY2014).

Total Operating Expenses and Other Operating Income: Total operating expenses and other operating income for the first quarter of 2015 were of €12.8 million (€31.7 million for FY2014).
R&D Expenses: Research and development expenses for the first quarter of 2015 were of €5.6 million (€14.4 million for FY2014). These expenses mainly consisted of personnel expenses (€3.5 million), external purchases and other expenses (€2.1 million).

Research and development expenses for the first quarter also reflect the impact of social charges related to stock-options and free shares granted during the first quarter (€1.9 million).

SG&A Expenses: Selling, general and administrative expenses were of €7.2 million for the first quarter 2015 (€13.1 million for FY2014). These expenses mainly related to personnel expenses (€4.9 million), and to external purchases and other expenses (€2.3 million). Selling, general and administrative expenses for the first quarter also reflect the impact of social charges related to stock-options and free shares granted during the first quarter (€3.3 million). For the first three months 2015, the non–recurring IPO expenses amounted to €0.5 million.

Financial Gain: Financial gain was of €9.9 million for the first quarter 2015 (€7.1 million for FY2014), which is mainly attributable to a favorable Euro-Dollar exchange rate applied to U.S. dollar-denominated cash and cash equivalents during the first quarter of 2015.

Net Income (Loss): Net income was of €6.3 million, or €0.23 per share, for the first quarter of 2015 (net loss of €1.0 million, or €0.00 per share, for FY2014). Adjusted net income for the first quarter of 2015 was €7.1 million, or €0.23 per share. Adjusted net income for the first quarter of 2015 excludes a non-cash stock-based compensation expense of €0.8 million. Please see "Note Regarding Use of Non-GAAP Financial Measures" for a reconciliation of GAAP net income to adjusted net income.

Cash Position: Cash and cash equivalents include cash, bank accounts, money market funds and fixed bank deposits that meet the definition of a cash equivalent. As of March 31, 2015, Cellectis had €118.4 million in cash and cash equivalents compared to €112.3 million as of December 31, 2014. Our initial public offering closed on March 30, 2015 and as of March 31, 2015, the €196.8 million of net proceeds from the initial public offering are classified under Other Current Assets. We believe that our cash and cash equivalents, together with the net proceeds from our initial public offering and our cash flow from operations (including payments we expect to receive pursuant to our collaboration agreements) and government funding of research programs will be sufficient to fund our operations through at least 2017. However, we may require additional capital for the further development of our existing product candidates and may also need to raise additional funds sooner to pursue other development activities related to additional product candidates.

On June 9, 2015 Varian Medical Systems reported RapidArc Radiosurgery, a term for volumetric modulated arc radiosurgery delivered using a medical linear accelerator (linac) from Varian Medical Systems (NYSE: VAR), enables the precise and simultaneous treatment of multiple metastases in the brain, spine, head & neck, or lung, according to four notable clinical experts who spoke yesterday at a Varian-sponsored symposium at the 12th International Stereotactic Radiosurgery Society (ISRS) Congress taking place here this week (Press release, InfiMed, JUN 9, 2015, View Source [SID:1234505381]).

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Clark C. Chen, MD, PhD, co-director of neurological oncology and chief of stereotactic radiosurgery at the University of California, San Diego, offered a neurosurgeon’s perspective on the clinical use of surface imaging to guide RapidArc Radiosurgery for the treatment of brain metastases. He favors this more targeted approach over whole-brain radiotherapy for patients with a limited number of brain metastases to avoid the neurocognitive decline that is associated with the latter.

"The Varian TrueBeam is a powerful linear accelerator that allows precise and efficient delivery of high dose radiation to multiple brain metastases in a remarkably efficient manner," Chen said. His team also uses an optical surface image tracking device during treatment to help ensure accurate radiation delivery. "The combination of surface image tracking and RapidArc Radiosurgery allows us to treat patients with a level of efficiency that we could not achieve previously," he said.

Evan Thomas, MD, PhD, postdoctoral research fellow in the Department of Radiation Oncology at the University of Alabama at Birmingham (UAB), talked about the UAB approach to RapidArc Radiosurgery planning, which makes use of key features of Varian’s Edge and TrueBeam STx platforms for image-guided stereotactic radiosurgery (SRS), including Varian’s HD120 high-definition multileaf collimator for fine beam shaping and the High Intensity Mode for delivering high doses quickly.1 "Multiple refinements and iterations in the UAB technique have enabled us to reliably duplicate Gamma Knife plan quality on TrueBeam STx," Thomas said.2

At the Henry Ford Health System (HFHS) in Detroit, SRS treatments are delivered using Varian’s Edge radiosurgery system. Ian Lee, MD, neurosurgeon with the Hermelin Brain Tumor Center at HFHS, raised the question of how to determine whether surgery, radiosurgery, or both are indicated in cases of metastatic brain cancer. The HFHS uses a multidisciplinary tumor board to make those determinations as a team. He presented a broad range of metastatic brain cancer cases that were treated with stereotactic radiosurgery. "SRS is usually the treatment of choice for oligometastatic disease," he said, referring to patients with multiple brain metastases.

Farzan Siddiqui MD, PhD, director of head and neck radiation oncology at HFHS, described soon-to-be-published data on the precision and accuracy of the Edge system for radiosurgery, showing his institution’s findings of sub-millimeter accuracy for each of the system’s component parts.3 In addition to several metastatic brain tumor cases, Siddiqui presented about cases where the Edge system was used to deliver RapidArc stereotactic body radiotherapy (SBRT) –a medical term for radiosurgery of non-cranial targets—to simultaneously treat multiple metastatic lesions in the spine, lung or head & neck. "The Edge radiosurgery system has been shown to possess high accuracy localization and meets requirements for precisely treating patients with tumors in the various sites using SRS/SBRT-based techniques," he reported.

On June 8, 2015 Navidea Biopharmaceuticals reported that results from an investigator-initiated, comparative study of Lymphoseek (technetium Tc 99m tilmanocept) injection versus filtered Tc-99m Sulfur Colloid (fTcSC) measuring injection site pain in patients with breast cancer undergoing lymphoscintigraphy were presented at the 2015 Society of Nuclear Medicine and Molecular Imaging (SNMMI) conference (Press release, Navidea Biopharmaceuticals, JUN 8, 2015, View Source;p=RssLanding&cat=news&id=2057359 [SID:1234505430]). The results of the randomized, double-blinded trial, led by Anne Wallace, M.D., professor of surgery at University of California, San Diego School of Medicine, highlighted that fTcSC caused statistically significant greater levels of pain after injection compared to Lymphoseek.

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In preparation for Sentinel Lymph Node Biopsy in breast cancer and other cancers, lymphatic pathways are mapped using a procedure called lymphoscintigraphy. "Patients often fear this procedure given the evidence of injection pain from some radiotracers," said Dr. Wallace, who is also director of the Comprehensive Breast Health Center at UC San Diego Moores Cancer Center. "This study of tilmanocept demonstrated, with patient-reported data, a significantly reduced level of post-injection associated pain compared with use of an fTcSC tracer. Along with its other desirable performance characteristics, surgeons now have a reliable tool that can potentially play an important role in improved patient comfort and management."

"This investigator-initiated study is of particular importance as it continues to reinforce the clinical value of Lymphoseek," said Michael Tomblyn, M.D., Navidea’s Executive Medical Director. "While previous studies have reported on Lymphoseek efficacy and ongoing safety, these results further illustrate both the clinical utility and clear benefits to both surgical oncologists and patients."

The poster presentation entitled, "A Randomized Double-Blinded Comparison of Injection Site Pain of Tc-99m Tilmanocept versus Filtered Tc-99m Sulfur Colloid in Patients Undergoing Lymph Node Mapping for Breast Cancer" showed results of the randomized, double-blind clinical trial comparing post-injection site pain using fTcSC versus Lymphoseek in 52 [(27) fTcSC and (25) Lymphoseek] breast cancer patients undergoing lymphoscintigraphy. Pain was evaluated with a visual analogue scale and short form McGill Pain Questionnaire at 1, 2, 3, 4, 5, 15 and 30 minutes post-injection. Analysis of the data indicates baseline pain scores were similar between groups. At one minute post-injection, patients receiving fTcSC experienced a mean change in pain of 16.8mm (standard deviation (SD) 19.5) compared to 0.2mm (SD 7.3) in the Lymphoseek group (p =0.0002). Overall, patients receiving Lymphoseek experienced statistically significant less change in pain scores compared to patients receiving fTcSC at 1-3 minutes post-injection.

About Lymphoseek

Lymphoseek (technetium Tc 99m tilmanocept) injection is the first and only FDA-approved receptor-targeted lymphatic mapping agent. It is a novel, receptor-targeted, small-molecule radiopharmaceutical used in the evaluation of lymphatic basins that may have cancer involvement in patients. Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Lymphoseek is approved by the U.S. Food and Drug Administration (FDA) for use in solid tumor cancers where lymphatic mapping is a component of surgical management and for guiding sentinel lymph node biopsy in patients with clinically node negative breast cancer, melanoma or squamous cell carcinoma of the oral cavity. Lymphoseek has also received European approval in imaging and intraoperative detection of sentinel lymph nodes in patients with melanoma, breast cancer or localized squamous cell carcinoma of the oral cavity.

Accurate diagnostic evaluation of cancer is critical, as it guides therapy decisions and determines patient prognosis and risk of recurrence. Overall in the U.S., solid tumor cancers may represent up to 1.2 million cases per year. The sentinel node label in the U.S. and Europe may address approximately 235,000 new cases of breast cancer, 76,000 new cases of melanoma and 45,000 new cases of head and neck/oral cancer in the U.S., and approximately 367,000 new cases of breast cancer, 83,000 new cases of melanoma and 55,000 new cases of head and neck/oral cancer diagnosed in Europe annually.

Lymphoseek Indication and Important Safety Information

Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:

Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management.
Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.
Important Safety Information

In clinical trials with Lymphoseek, no serious hypersensitivity reactions were reported, however Lymphoseek may pose a risk of such reactions due to its chemical similarity to dextran. Serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (such as iron dextran drugs).

Prior to the administration of Lymphoseek, patients should be asked about previous hypersensitivity reactions to drugs, in particular dextran and modified forms of dextran. Resuscitation equipment and trained personnel should be available at the time of Lymphoseek administration, and patients observed for signs or symptoms of hypersensitivity following injection.

Any radiation-emitting product may increase the risk for cancer. Adhere to dose recommendations and ensure safe handling to minimize the risk for excessive radiation exposure to patients or health care workers.

In clinical trials, no patients experienced serious adverse reactions and the most common adverse reactions were injection site irritation and/or pain (<1%).

On June 8, 2015 Oncolytics Biotech reported an update on its planned registration program for REOLYSIN, its proprietary formulation of the human reovirus, at its Annual General Meeting of Shareholders (Press release, Oncolytics Biotech, JUN 8, 2015, View Source [SID:1234505378]). The presentation highlights that:

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The Company will initially focus on pursuing registration for REOLYSIN in two indications: the neoadjuvant treatment of muscle-invasive bladder cancer and the treatment of glioblastoma; and
The Company will determine further indications and treatment types in which to pursue registration subject to its receipt of data from ongoing single-arm and randomized studies with REOLYSIN.
"In determining our registration program, we have selected indications and study designs that rely on previous results from our existing preclinical and clinical program and will allow us to move into registration studies immediately after the completion of confirmatory run-in clinical trials," said Dr. Brad Thompson, President and CEO of Oncolytics.

Planned Registration Program for Muscle-Invasive Bladder Cancer

The Company has filed an Investigational New Drug Application ("IND") to conduct a small run-in study in patients with muscle-invasive bladder cancer. Pre-operative patients will be treated with a combination of gemcitabine, cisplatin and REOLYSIN and assessed for histopathological response and safety. Subject to confirmation of histopathological responses attributable to REOLYSIN, the Company intends to conduct a larger registration study in this indication.

Planned Registration Program for Gliomas

The Company recently announced that the IND containing the protocol titled "MC1472: Phase 1 Study of Replication Competent Reovirus (REOLYSIN) in Combination with GM-CSF in Pediatric Patients with Relapsed or Refractory Brain Tumors" was active. The Company intends to conduct a separate small run-in study combining the standard of care (surgery followed by radiotherapy and temozolomide) with REOLYSIN in adult patients. Subject to confirmation of responses, the Company intends to conduct a larger registration study using the better therapeutic regime.