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NanoString Technologies Releases Financial Results for Third Quarter of 2015

On November 2, 2015 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, reported financial results for the third quarter ended September 30, 2015 (Press release, NanoString Technologies, NOV 2, 2015, View Source [SID:1234507888]).

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Third Quarter Financial Highlights

Total revenue of $15.7 million, 27% year-over-year growth
Total product and service revenue of $13.9 million, 23% year-over-year growth
Consumables revenue of $9.0 million, including $0.7 million of Prosigna IVD kits, 44% year-over-year growth
Instrument revenue of $4.3 million, 6% year-over-year decline
"Positive third quarter results reflect increasing momentum as we continue to strengthen our leadership position in the field of precision oncology," said President and Chief Executive Officer, Brad Gray. "We are continuing to expand our target markets through new product innovation, such as the recent introductions of our nCounter SPRINT Profiler and our first 3D Biology product, which enables immuno-oncology researchers to make new biological observations while maximizing the data generated from valuable samples."

Recent Business Highlights

Grew installed base to over 320 nCounter Analysis Systems at September 30, 2015
Launched nCounter SPRINT Profiler, a more affordable system designed to meet the needs of the individual researcher
Launched nCounter RNA:Protein PanCancer Immune Profiling Panel, the company’s first 3D Biology application, which expands the company’s immuno-oncology portfolio and provides a powerful tool for researchers
Expanded collaboration with Celgene to include additional countries, such as China and Russia
Received favorable final local coverage determination by Palmetto GBA’s MolDx program for Prosigna, which became effective on Oct 1, 2015
Inclusion of Prosigna in the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) clinical practice guidelines, which recognized Prosigna’s value in determining the potential benefit from chemotherapy in breast cancer patients

Third Quarter Financial Results

Revenue for the three months ended September 30, 2015 rose 27% to $15.7 million, from $12.3 million for the third quarter of 2014. Instrument revenue was $4.3 million, down 6% from the prior year period, reflecting lower sales volumes in the Asia Pacific region. Consumables revenue, excluding Prosigna, was $8.4 million for the third quarter of 2015, 40% higher than in the comparable 2014 quarter. Prosigna revenue was $662,000 for the quarter, and collaboration revenue totaled $1.8 million. Gross margin on product and service revenue was 55% for the third quarter of 2015, up from 53% in the third quarter of 2014.

Research and development expense was $5.8 million for the third quarter of 2015, roughly flat versus $6.0 million for the third quarter of 2014. Selling, general and administrative expense was $12.0 million for the third quarter of 2015 compared to $12.5 million for the prior year period, reflecting efficiencies gained through streamlining the sales and marketing organization.

Net loss for the three months ended September 30, 2015 was $9.5 million, or a loss of $0.49 per diluted share, compared with $12.1 million, or a loss of $0.67 per diluted share, for the third quarter of 2014.

Outlook for 2015

The company’s financial outlook for 2015 includes:

Total revenue in the range of $60 million to $63 million, unchanged
Gross margin of approximately 53%, previously 53% to 55%
Operating expenses in the range of $76 million to $78 million, previously $77 million to $81 million
Operating loss in the range of $40 million to $44 million, previously $41 million to $47 million

8-K – Current report

On November 2, 2015 DARA BioSciences, Inc. (NASDAQ: DARA), an oncology supportive care pharmaceutical company dedicated to providing health care professionals a synergistic portfolio of medicines to help cancer patients adhere to their therapy and manage side effects arising from their cancer treatment,reported its third quarter 2015 results (Filing, 8-K, Dara Biosciences, NOV 2, 2015, View Source [SID:1234507887]).

Third Quarter 2015 Financial Snapshot

DARA reported net revenues of $1.181 million for the third quarter ended September 30, 2015 based on gross product sales in excess of $1.5 million, as compared to net revenues of $597.8 thousand for the third quarter ended September 30, 2014, a year over year increase of 98%. The increase in revenues was primarily attributable to the expanded commercial sales organization and ongoing success in generating interest and prescriptions across DARA’s oncology supportive care product portfolio.

DARA reported a loss attributable to controlling interest of approximately $2.7 million or ($0.14) per share for the third quarter ended September 30, 2015 as compared to a loss attributable to controlling interest of approximately $2.1 million, or ($0.11) per share for the third quarter ended September 30, 2014. Sales and marketing costs for the quarter increased $463.8 thousand over the same period last year, primarily as a result of increased personnel costs, including an increase in incentive based field sales compensation driven by higher sales achievement. An increase in general and administrative expenses of $559.2 thousand was primarily driven by increased professional services costs related to DARA’s proposed merger with Midatech Pharma PLC. Research and development expenses decreased by $46.2 thousand, primarily as a result of reduced personnel costs. As of September 30, 2015, cash and cash equivalents totaled approximately $4.7 million.

"Our third quarter results illustrate continued growth from our commercial portfolio as our products continue to be accepted and utilized to support oncology patients and oncology health care providers nationwide," stated Christopher G. Clement, President and CEO of DARA BioSciences. Our continued momentum in the business and prescription increases for our key products Gelclair and Soltamox on a year to date basis support our full year estimates of net revenues for these two products to reach $3.7 million for 2015, excluding any net revenue contribution from our recent national launch of Oravig .

Clement continued, "We are excited regarding the continued strong performance of our commercial business and look forward to sustained success as we finalize our merger agreement with Midatech Pharma PLC. As of today the timelines for the close of the transaction with Midatech remain on track and we believe that this will take place prior to the end of 2015. Midatech has received clearance from the SEC on their Form F-4 registration statement and from Nasdaq on the listing of American Depositary Receipts representing Midatech Ordinary Shares. A DARA shareholder meeting to approve the merger has been set for December 2, 2015. "

DARA believes that its currently available funds, together with projected sales of Gelclair, an FDA-approved bioadherent oral rinse gel for treating the painful symptoms of oral mucositis (OM), Soltamox, (tamoxifen citrate oral liquid solution), Oravig, the first and only orally-dissolving buccal tablet approved for oral thrush, and the Mission Pharmacal products Ferralet 90 (for anemia) and Aquoral (for cancer-related dry mouth), will enable DARA to fund its current operations and to meet its obligations into the first quarter of 2016.

Third Quarter 2015 Operational Highlights and Recent Key Events

DARA made significant progress during the third quarter of 2015 in executing its strategy as well as expanding the commercial opportunity for its flagship oncology and oncology supportive care products, as follows:

· Quarterly net revenues increased 98% from Q3 FY’14 to $1.181 million, based on continued increases in prescriptions for our oncology supportive care portfolio.

· The merger agreement with Midatech Pharma PLC, a UK based specialty pharmaceutical company, is expected to close during the fourth quarter of 2015.

· Launched Oravig into both the oncology and the primary care markets.

· Oravig has been stocked and is available for both retail and institutional customers throughout the national wholesale distribution network

· Oravig is being supported by DARA’s retail prescription savings program available at over 40,000 pharmacies nationwide

· Gelclair continues to be the leading gel barrier prescribed in the U.S. retail market, per Symphony Prescription data, leading the nearest competitor by a 3 to 1 margin of prescriptions written in September and continues to outperform the overall gel barrier retail prescription market with consistent quarter over quarter prescription growth

· Q3 showed continued strong growth of over 200% in Gelclair prescriptions through DARA’s HUB pharmacy vs Q2 of this year.

· DARA has provided Gelclair to over 800 uninsured or underinsured patients, through DARA’s HUB program, providing health care providers a dependable option for prescribing Gelclair to all of their appropriate patients.

· Soltamox continues to show sequential quarterly sales growth

· DARA initiated a full service specialty pharmacy patient support program for Aquoral through its HUB program

· DARA’s telesales program has and continues to make calls on the top 300 high volume prescribing practitioners in "white space" areas

· The FDA provided formal agreement with DARA’s proposed development plan for KRN as well as proposed bridging studies for the new formulation.

· The US Patent and Trademark Office granted a significant extension of patent protection for DARA’s KRN 5500 developmental asset through a recently issued formulation patent, which DARA believes is strengthening potential opportunities to partner KRN 5500 and bringing newly-interested parties into discussions.

Based on our current trends and continued growth DARA continues to support our previous guidance of $3.7 million for Gelclair and Soltamox net sales for the full year 2015, excluding any net revenue contribution from the launch of Oravig later in the year.

Data Supporting Delcath’s CHEMOSAT System Presented At The European Association Of Dermato Oncology Annual Congress

On November 2, 2015 Delcath Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, reported that data from three studies supporting treatment for liver metastases with the Delcath Hepatic CHEMOSAT Delivery System (CHEMOSAT) were presented at the European Association of Dermato Oncology (EADO) annual congress, which was held in Marseille, France, October 28-31, 2015 (Press release, Delcath Systems, NOV 2, 2015, View Source;p=RssLanding&cat=news&id=2105157 [SID:1234507883]).

Details of the presentations are as follows:

Liver Directed Treatment Of Metastatic Uveal Melanoma By Chemosaturation Via Percutaneous Hepatic Perfusion – A Single Centre Experience, Southampton University (United Kingdom), presented by lead author Dr. Ioannis Karydis. Researchers conducted a retrospective evaluation of 20 patients treated with CHEMOSAT over 3 years, analyzing survival, tumor response, time to progression and treatment related adverse events. Eighteen patients were able to receive treatment, and 17 of these were evaluable for study purposes. Results showed that ten patients remained alive after median 256 days, with one complete response (6%), four partial responses (24%), and eleven (65%) patients with stable disease for greater than 90 days. Progression free survival for patients who had progressed was 181 days at the time of data cut off, and six patients were alive for greater than one year following their first treatment. Eight deaths from disease progression occurred at a median of 241 days following first treatment, and there were no treatment related deaths. Treatment overall was well tolerated, and non-hematological adverse events were rare (3). Most common adverse events were transient, mild

Treating Unresectable Liver Metastases Of Uveal Melanoma With Percutaneous Hepatic Perfusion With Melphalan, Leiden University Medical Center, Erasmus Cancer Institute (the Netherlands) presented by Dr. Mark Burgmans (Leiden). This is an active two-center Investigator Initiated Phase 2 study that aims to evaluate 20 patients with uveal, or ocular melanoma treated with PHP (CHEMOSAT). Data from the first 11 patients with a maximum follow up period of 16 months were presented. Primary endpoints for the study are response rate (as measured by RECIST criteria) following two treatments at 6-week intervals and the percentage of patients with stable disease. Secondary endpoints are safety, overall survival, hepatic progression free survival, and quality of life. Eighteen treatments have been performed on eleven patients and the maximum follow up is currently sixteen months. Current results are that ten patients remain in follow up, and four are without progression of disease. Four patients experienced grade 3 or 4 toxicities that were managed with blood or platelet transfusions. The researchers concluded that PHP with CHEMOSAT "appears to be an effective and safe procedure in selected patients with unresectable liver metastases of uveal melanoma and can be repeated."

Chemosaturation with Percutaneous Hepatic Perfusion of Melphalan for Hepatic Metastases from Uveal Melanoma: Multiinstitutional Evaluation. This study was presented as a poster by lead author Prof. Thomas Vogl, Frankfurt University Hospital and was a retrospective evaluation of non-resectable hepatic metastases from uveal melanoma in 14 patients treated with CHEMOSAT between 2012 and 2014. Eleven patients who received one to three treatments were evaluated by RECIST criteria; survival time analysis was conducted and complications were recorded. Results showed 4 patients (36%) with a partial response, five (46%) with stable disease, and two (18%) with progressive disease. Survival time ranged between 1.5 months to 23 months, with median overall survival of 6.5 months. Time to progression for the two patients who had progressed was 6.2 months for one patient and 1.6 months for a patient who died after evaluation. Treatment was well tolerated by all 14 patients, with seven experiencing leukopenia, six had thrombocytopenia, and two had neutropenia. Researchers concluded that PHP with CHEMOSAT "has been manifested as a potential treatment for patients with non-resectable hepatic metastases of uveal melanoma."

"These studies complement others presented at major medical conferences this fall in examining the potential for treatment with CHEMOSAT for unresectable liver metastases," said Dr. Jennifer K. Simpson, President & CEO of Delcath Systems. "We are pleased with the quality and pace of research being presented and published recently, and look forward to building on this momentum to further advance the commercial and clinical adoption of CHEMOSAT in Europe."

CEL-SCI REPORTS RECORD MONTHLY PATIENT ENROLLMENT IN OCTOBER FOR ITS PHASE 3 HEAD AND NECK CANCER TRIAL

On November 2, 2015 CEL-SCI Corporation (NYSE MKT: CVM) ("CEL SCI" or the "Company") reported that in the month of October it has enrolled 38 patients in the ongoing Phase 3 trial of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in patients with advanced primary head and neck cancer (Press release, Cel-Sci, NOV 2, 2015, View Source [SID:1234507880]). This number represents a new monthly record. Total patient enrollment is now 608 as of October 31, 2015 in the world’s largest Phase 3 study in head and neck cancer.

"We are very pleased with the hard work and dedication of the clinical research organizations (CRO) currently overseeing the Phase 3 study. We are also encouraged by the recent additional financial commitment by one of the CROs, Ergomed, which increased its co-development investment in our Phase 3 trial from $10 million to $12 million. Ergomed’s commitment to efficiently administering our head and neck cancer trial is clear through both its investment and the continued robust enrollment numbers," stated CEL-SCI CEO Geert Kersten.

The current study goal is to enroll 880 patients through approximately 100 clinical centers in over 20 countries.

About the Multikine Phase 3 Study

The Multikine Phase 3 study is enrolling patients with advanced primary squamous cell carcinoma of the head and neck. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus standard of care ("SOC") vs. subjects who are treated with SOC only.

About Multikine

Multikine (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase 3 clinical trial as a potential first-line treatment for advanced primary squamous cell carcinoma of the head and neck. Multikine is designed to be a different type of therapy in the fight against cancer: one that appears to have the potential to work with the body’s natural immune system in the fight against tumors.

Multikine is also being tested in a Phase 1 study under a Cooperative Research and Development Agreement ("CRADA") with the U.S. Naval Medical Center, San Diego, and at University of California, San Francisco (UCSF), as a potential treatment for peri-anal warts in HIV/HPV co-infected men and women. Dr. Joel Palefsky, a world renowned scientist and Key Opinion Leader (KOL) in human papilloma virus (HPV) research and the prevention of anal cancer, is the Principal Investigator at UCSF, which was added to the study in July 2015.

CEL-SCI has also entered into two additional co-development agreements for up to $3 million each with Ergomed Clinical Research Limited to further the development of Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV.

8-K – Current report

On November 2, 2015 Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) reported financial results for the third quarter 2015 (Filing, 8-K, Threshold Pharmaceuticals, NOV 2, 2015, View Source [SID:1234507877]). Revenue for the third quarter ended September 30, 2015 was $3.7 million. The operating loss for the third quarter ended September 30, 2015 was $6.8 million. The net loss for the third quarter ended September 30, 2015 was $6.4 million, which included the operating loss of $6.8 million and non-cash income of $0.3 million related to the changes in fair value of the Company’s outstanding warrants and was classified as other income (expense). As of September 30, 2015, Threshold had $56.4 million in cash, cash equivalents and marketable securities, with no debt outstanding.

"This is an exciting time for Threshold as we anticipate announcing top-line results from the two pivotal Phase 3 clinical trials of evofosfamide in patients with advanced soft tissue sarcoma (TH-CR-406) and in patients with advanced pancreatic cancer (MAESTRO) around the end of this year," said Barry Selick, Ph.D., Chief Executive Officer at Threshold. "In the third quarter, we also made significant progress with tarloxotinib, our exclusively-licensed hypoxia-activated EGFR tyrosine kinase inhibitor, with the initiation of two proof-of-concept Phase 2 clinical trials. We expect to have preliminary data from those trials in the first half of 2016."

Third Quarter 2015 Financial and Operational Results

Revenue of $3.7 million was recognized for both the third quarter of 2015 and 2014. Revenue is related to the amortization of the aggregate of $110 million in upfront and milestone payments earned in 2013 and 2012 from Threshold’s collaboration with Merck KGaA, Darmstadt, Germany, for evofosfamide (previously known as TH-302). The revenue from the upfront and milestone payments earned under the agreement is being amortized over the relevant performance period, rather than being immediately recognized when the upfront and milestone payments are earned or received.

The net loss for the third quarter of 2015 was $6.4 million compared to a net loss of $7.7 million for the third quarter of 2014. Included in the net loss for the third quarter of 2015 was an operating loss of $6.8 million and non-cash income of $0.3 million compared to an operating loss of $7.6 million and non-cash expense of $0.3 million included in the net loss for the third quarter of 2014. The non-cash income or expense is related to the change in fair value of the Company’s outstanding warrants and was classified as other income (expense).

Research and development expenses were $8.1 million for the third quarter of 2015 compared to $8.9 million for the third quarter of 2014. The decrease in research and development expenses was due primarily to a $1.1 million net decrease in clinical development expenses, net of reimbursement from Merck KGaA, Darmstadt, Germany related to their 70% share of total development expenses for evofosfamide. The decrease in clinical development expenses was due to a decrease in clinical development expenses for evofosfamide, partially offset by an increase in clinical development expenses for tarloxotinib.

General and administrative expenses were $2.4 million for both the third quarter of 2015 and 2014.

Non-cash stock-based compensation expense included in total operating expenses was $1.5 million for the third quarter of 2015 versus $1.2 million for the third quarter of 2014. The increase in stock-based compensation expense was due to the amortization of a greater number of options with higher fair values.

As of September 30, 2015 and June 30, 2015, Threshold had $56.4 million and $67.0 million in cash, cash equivalents and marketable securities, respectively. The net decrease of $10.6 million in cash, cash equivalents and marketable securities during the third quarter of 2015 was primarily due to the Company’s operating cash requirements for the third quarter of 2015.

Corporate Highlights

Announced the appointment of Mark Hopkins, J.D., Ph.D., as Vice President of Intellectual Property and Assistant General Counsel. In this newly created position, Dr. Hopkins oversees worldwide intellectual property strategy and activities related to further advancement of Threshold’s intellectual property portfolio for its investigational anti-cancer therapeutics, evofosfamide and tarloxotinib, and hypoxia-activated prodrug technology. Dr. Hopkins is also responsible for oversight of corporate legal matters at Threshold.

Threshold- and Merck KGaA, Darmstadt, Germany-Sponsored Trials of Evofosfamide: Clinical Development Highlights and Outlook

Announce top-line data from the two pivotal Phase 3 clinical trials. The companies are focused on efficient execution of the two Phase 3 clinical trials of evofosfamide: one in patients with advanced soft tissue sarcoma (TH-CR-406) and the other in patients with advanced pancreatic cancer ("MAESTRO"). The current expectations are that top-line data will be announced around the end of 2015 for both trials and that the companies will prepare for potential submission of marketing applications, assuming the data from the trials are supportive.

Continue enrollment in the Phase 2 non-squamous non-small cell lung cancer clinical trial. Threshold is conducting a 440-patient, randomized, double-blind, placebo-controlled trial of evofosfamide in combination with pemetrexed in patients with second-line advanced non-squamous non-small cell lung cancer. This international Phase 2 clinical trial is designed to support registration and will compare the combination of evofosfamide plus pemetrexed versus pemetrexed plus placebo as second-line therapy in this patient population. Overall survival is the primary endpoint. Enrollment in the trial is ongoing.

Commence enrollment in final cohort of the Phase 1/2 multiple myeloma clinical trial. Threshold plans to initiate dosing with the combination of evofosfamide, dexamethasone, and Pomalyst (pomalidomide, an immunomodulatory drug) in up to 38 patients with relapsed/refractory multiple myeloma in the final cohort of its ongoing Phase 1/2 trial. A total of 62 patients have been enrolled in the trial in which the safety and efficacy of evofosfamide plus dexamethasone with or without Velcade (bortezomib, a proteasome inhibitor) was assessed.

Threshold-Sponsored Trials of Tarloxotinib Bromide*: Clinical Development Highlights and Outlook

Initiated patient dosing in Phase 2 non-small cell lung cancer clinical trial. In August, Threshold announced that the Company, in collaboration with the Academic Thoracic Oncology Medical Investigators Consortium (ATOMIC), initiated the first Phase 2 clinical trial of tarloxotinib for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer who have been previously treated with an EGFR tyrosine kinase inhibitor and are progressing on treatment, but have not acquired the T790M resistance mutation. The trial is expected to enroll up to 37 patients; preliminary data are expected to be available in the first half of 2016.

Initiated patient dosing in Phase 2 squamous cell carcinomas clinical trial. In August, Threshold announced initiation of dosing in a Phase 2 clinical trial of tarloxotinib for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck or skin. The trial is expected to enroll up to 69 patients; preliminary data are expected to be available in the first half of 2016.

About Evofosfamide

Evofosfamide (previously known as TH-302) is an investigational hypoxia-activated prodrug that is thought to be activated under severe hypoxic tumor conditions, a feature of many solid tumors. Areas of low oxygen levels (hypoxia) in solid tumors are due to insufficient blood vessel supply. Similarly, the bone marrow of patients with hematological malignancies has also been shown, in some cases, to be severely hypoxic.

Evofosfamide is currently in two Phase 3 trials, both of which are fully recruited: one in combination with doxorubicin versus doxorubicin alone in patients with locally advanced unresectable or metastatic soft tissue sarcomas (STS) (the TH-CR-406 trial), and the other in combination with gemcitabine versus gemcitabine and placebo in patients with locally advanced unresectable or metastatic pancreatic cancer (the MAESTRO trial). Both Phase 3 trials are being conducted under Special Protocol Assessment (SPA) agreements with the FDA. The FDA and the European Commission have granted evofosfamide Orphan Drug designation for the treatment of STS and pancreatic cancer. The FDA has also granted Fast Track designation for evofosfamide for both STS and pancreatic cancer. Evofosfamide is also being investigated in a Phase 2 trial designed to support registration for the treatment of non-squamous non-small cell lung cancer, and in earlier-stage clinical trials of other solid tumors and hematological malignancies.

Threshold has a global license and co-development agreement for evofosfamide with Merck KGaA, Darmstadt, Germany, which includes an option for Threshold to co-commercialize in the U.S.

About Tarloxotinib Bromide

Tarloxotinib bromide, or "tarloxotinib", is a prodrug designed to selectively release a covalent (irreversible) EGFR tyrosine kinase inhibitor under severe hypoxia, a feature of many solid tumors. Accordingly, tarloxotinib has the potential to effectively shut down aberrant EGFR signaling in a tumor-selective manner, thus potentially avoiding or reducing the systemic side effects associated with currently available EGFR tyrosine kinase inhibitors. Tarloxotinib is currently being evaluated in two Phase 2 proof-of-concept trials: one for the treatment of patients with mutant EGFR-positive, T790M-negative advanced non-small cell lung cancer progressing on an EGFR tyrosine kinase inhibitor, and the other for patients with recurrent or metastatic squamous cell carcinomas of the head and neck or skin. Threshold licensed exclusive worldwide rights to tarloxotinib from the University of Auckland, New Zealand, in September 2014.