On August 3, 2016 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, reported financial results for the second quarter ended June 30, 2016(Press release, NanoString Technologies, AUG 3, 2016, View Source [SID:1234514216]).

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Second Quarter Financial Highlights

Total revenue of $22.6 million, 73% year-over-year growth
Total product and service revenue of $17.5 million, 40% year-over-year growth
Consumables revenue of $10.3 million, including $1.2 million of Prosigna IVD kits, 39% year-over-year growth
Instrument revenue of $6.4 million, 46% year-over-year growth
Collaboration revenue of $5.1 million

"We had a successful second quarter characterized by strong commercial execution and rapid progress in delivering against diagnostic milestones in our biopharma collaborations," said president and chief executive officer Brad Gray. "Demand for our nCounter platform was robust across all products and geographies. Our nCounter SPRINT Profiler accounted for approximately half of units sold, driving 46% year-on-year growth in instrument revenue and underscoring the value of SPRINT in reaching new customers and expanding our installed base."

Recent Business Highlights

Grew installed base to over 410 nCounter Analysis Systems at June 30, 2016
Achieved milestones in the Merck and Medivation & Astellas collaborations valued at $13.5 million, of which $5.0 million was received in the second quarter and $8.5 million was received in the third quarter
Over 30 abstracts presented at the June 2016 annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) demonstrating the value of the nCounter platform, including several highlighting investigational assays for immuno-oncology and lymphoma
Received positive Medical Coverage Policy decisions from Aetna and Cigna for the Prosigna Breast Cancer Gene Signature Assay
Presented first proof-of-concept data for digital immunohistochemistry (IHC), a novel technology to simultaneously count multiple protein targets in the spatial context of tumor tissue biopsies, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) conference

Second Quarter Financial Results

Revenue for the three months ended June 30, 2016 increased by 73% to $22.6 million, as compared to $13.1 million for the second quarter of 2015. Instrument revenue was $6.4 million, up 46% versus the prior year period, resulting from strong demand for all products in all regions. Consumables revenue, excluding Prosigna, was $9.1 million for the second quarter of 2016, 32% higher than in the comparable 2015 quarter. Prosigna IVD kit revenue was $1.2 million for the quarter, an increase of 110% over the second quarter of 2015. Collaboration revenue totaled $5.1 million, benefiting from the achievement of multiple milestones in diagnostic development collaborations. Gross margin on product and service revenue was 55% for the second quarter of 2016, up from 53% for the second quarter of 2015.

Research and development expense increased by 52% to $8.8 million for the second quarter of 2016 versus $5.8 million for the second quarter of 2015, reflecting increased costs associated with biopharma collaborations announced earlier this year and new products and technologies under development for the life science research market. Selling, general and administrative expense was $15.5 million for the second quarter of 2016 compared to $12.8 million for the prior year period.

Net loss for the three months ended June 30, 2016 declined to $10.8 million, or a loss of $0.55 per diluted share, compared with $12.4 million, or a loss of $0.66 per diluted share, for the second quarter of 2015.

Outlook for 2016

The company raised its financial outlook for 2016 as follows:

Total revenue was increased to the range of $89 million to $93 million, as compared to the previous range of $86 million to $90 million
Gross margin on product and service revenues in the range of 54% to 55%, unchanged
Operating expenses in the range of $94 million to $99 million, unchanged
Operating loss guidance was reduced to the range of $37 million to $40 million, as compared to the previous range of $40 million to $43 million
Net loss per share range was reduced to $2.15 to $2.30, as compared to the previous range of $2.30 to $2.45
Cash from collaborations in 2016 in the range of $40 million to $45 million, unchanged

On August 3, 2016 NantHealth, Inc. (Nasdaq: NH), a leading next-generation, evidence-based, personalized healthcare company, reported that Sanford Health, one of the largest health systems in the nation, has entered into a commercial license agreement for the use of its eviti, the evidence-based treatment intelligence and web-based oncology decision support platform, which was recently named #1 Clinical Decision Support solution for 2016 by Black Book Market Research (Press release, NantHealth, AUG 3, 2016, View Source [SID:1234514219]).

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Under terms of the agreement, Sanford Health’s network of oncologists will have access to NantHealth’s eviti Connect decision support solution, providing them with evidence-based regimens, condition-specific clinical trial options and the potential for more efficient preauthorization and expedited reimbursement. Further, the eviti service holds the promise of delivering OMICS data for bio-specific therapy. Sanford Health, based in the Dakotas, joins over 75 percent of U.S. oncology practices who have used the eviti platform to make better clinical decisions earlier in the treatment process.

eviti Connect will be deployed to streamline system-wide processes for the prescribing of high-quality, cost-effective treatments while improving the flow of information between Sanford Health and its providers. All of the participants in the cancer care process benefit from eviti’s collaborative, real-time approach to improving care and lowering risks and costs.

In order for oncologists to serve as many cancer patients as possible, select treatment plans with the best possible outcome, and with the most responsible economic profile, the technology solution must have the rapid-learning and data compilation capabilities of true super-computing. eviti’s clinical decision support is easy to use while computing massive amounts of complex data to quickly present appropriate treatment options, including the latest peer-reviewed and proprietary immunotherapy clinical trials. eviti applications go beyond the capabilities of most traditional electronic medical records systems to present treatment options personalized for each patient’s need.

"Sanford Health Plan is committed to offering oncologists in our networks the support they need to provide the best, most advanced patient care possible," said Kirk Zimmer, Executive Vice President, Sanford Health Plan. "eviti gives physicians real-time access to the widest range of evidenced-based treatment options available, and further, to ensure that the care they provide meets the clinical requirements for reimbursement. This comprehensive approach stands to improve clinical outcomes, while reducing claims denials and potentially costs."

The eviti platform provides physicians real-time access to its comprehensive, unbiased Evidence-Based Medical Library, which encompasses over 2,700 of the most appropriate, evidence-based treatment regimens covering all cancers and cancer subtypes and all modalities. Each regimen incorporates level of evidence, expected clinical outcomes, treatment costs, toxicities and any supporting literature. This evidence-based medical library is meticulously compiled from peer-reviewed literature, oncology associations, and government agencies. The library is maintained by a full-time team of oncologists and oncology nurses, clinical informatics professionals, and an advisory board of nationally recognized oncology experts.

"We are pleased to enter into this partnership with Sanford Health and look forward to working with the organization to enable their oncologists to more quickly see and evaluate the spectrum of appropriate treatment options in order to make even better, and more informed treatment decisions," said Patrick Soon-Shiong, M.D., CEO of NantHealth. "Today, independent studies show that nearly 32 percent of oncology treatment plans deviate from evidence-based standards without medical justification. While this is understandable given the rapidly growing number of treatment options available to patients and their caregivers, we must do better. Our goal is to provide a single, reliable source of the most current information available to physicians, enabling them to provide the right care at the right time—and to immediately know whether that care will be covered."

On August 3, 2016 Geron Corporation (Nasdaq:GERN) reported financial results for the three and six months ended June 30, 2016 and recent events (Press release, Geron, AUG 3, 2016, View Source;p=RssLanding&cat=news&id=2192600 [SID:1234514242]).

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For the second quarter of 2016, the company reported a net loss of $8.6 million, or $0.05 per share, compared to $9.4 million, or $0.06 per share, for the comparable 2015 period. Net loss for the first six months of 2016 was $17.5 million, or $0.11 per share, compared to $18.7 million, or $0.12 per share, for the comparable 2015 period. The company ended the second quarter of 2016 with $136.4 million in cash and investments and has not incurred any impairment charges on its marketable securities portfolio.

Revenues for the three and six months ended June 30, 2016 were $211,000 and $960,000, respectively, compared to $251,000 and $788,000 for the comparable 2015 periods. Revenues for the three and six month periods ending June 30, 2016 and 2015 included royalty and license fee revenues under various non-imetelstat license agreements.

Total operating expenses for the three and six months ended June 30, 2016 were $9.1 million and $18.9 million, respectively, compared to $9.7 million and $19.7 million for the comparable 2015 periods. Research and development expenses for the three and six months ended June 30, 2016 were $4.6 million and $9.6 million, respectively, compared to $4.8 million and $9.8 million for the comparable 2015 periods. General and administrative expenses for the three and six months ended June 30, 2016 were $4.5 million and $9.3 million, respectively, compared to $4.0 million and $8.6 million for the comparable 2015 periods. Operating expenses for the three and six months ended June 30, 2015 also included restructuring charges of $941,000 and $1.3 million, respectively, in connection with the company’s organizational resizing announced in March 2015.

The decrease in research and development expenses for the three and six month periods ending June 30, 2016, compared to the same periods in 2015, primarily reflects the net result of reduced personnel-related costs resulting from the March 2015 organizational resizing and lower costs for the manufacturing of imetelstat drug product, partially offset by higher costs for the company’s proportionate share of clinical development expenses under the imetelstat collaboration with Janssen Biotech, Inc. (Janssen). The company expects research and development expenses to increase during the remainder of the year as the clinical development of imetelstat continues in collaboration with Janssen. The increase in general and administrative expenses for the three and six month periods ending June 30, 2016, compared to the same periods in 2015, primarily reflects higher non-cash stock-based compensation expense and increased allocation of facilities and other overhead costs to general and administrative activities.

Interest and other income for the three and six months ended June 30, 2016 was $293,000 and $549,000, respectively, compared to $145,000 and $294,000 for the comparable 2015 periods. The increase in interest and other income for the three and six month periods ending June 30, 2016, compared to the same periods in 2015, primarily reflects higher yields on the company’s marketable securities portfolio.

Recent Company Events

In July 2016, three U.S. patents related to imetelstat were issued by the U.S. Patent and Trademark Office. U.S. 9,375,485 has claims covering the use of telomerase inhibitor compounds, including imetelstat, for alleviating at least one symptom of myelofibrosis or myelodysplastic syndromes, including chronic myelomonocytic leukemia, and is expected to remain in force until at least March 2033. U.S. 9,388,415 and U.S. 9,388,416 have claims covering methods for using imetelstat to inhibit the activity of telomerase and using imetelstat to inhibit cancer cell proliferation, as well as methods for using imetelstat to treat cancer, and are expected to remain in force until at least September 2024. These patents are related to Geron’s existing imetelstat composition of matter patent U.S. 7,494,982, which issued in 2009 and is expected to remain in force until at least December 2025. Further extension of patent terms may be available for regulatory review periods.

Geron’s portfolio of patents related to imetelstat and related products whose mechanism of action is telomerase inhibition have been licensed to Janssen under an exclusive worldwide license and collaboration agreement for all human disorders or medical conditions.

On August 03, 2016 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy for treatment of cancer, reported that it has received notice from the U.S. Food and Drug administration that a partial clinical hold has been placed on its planned pivotal study of NY-ESO SPEAR T-cell therapy in myxoid round cell liposarcoma (MRCLS) (Press release, Adaptimmune, AUG 3, 2016, View Source;p=RssLanding&cat=news&id=2192667 [SID:1234514215]). This trial is not yet active at any investigational sites, and has not recruited any patients. This notification of partial clinical hold does not apply to any other Adaptimmune study.

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The FDA notification is not based on safety concerns. In its correspondence, the FDA requested additional CMC information and answers to certain trial design questions prior to the trial start. Adaptimmune intends to provide a full response to the FDA shortly.

"Adaptimmune is running a number of different studies with its NY-ESO program and continues to enroll patients in synovial sarcoma, ovarian, and lung cancer trials in the U.S.," said James Noble, Adaptimmune CEO. "We have been in dialogue with the FDA since achieving breakthrough status earlier this year and this partial clinical hold requires a number of questions to be answered before we can start a new MRCLS trial intended to be used for registration purposes. We will be providing a full response to the FDA shortly and will update the markets when we have further news to report."

The company will discuss this notice of partial clinical hold during its conference call to discuss the second quarter ended June 30, 2016, scheduled for 8:00 a.m. Eastern Time (1:00 p.m. BST) on Monday August 8, 2016.

On August 02, 2016 Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel nucleic acid-based therapeutics for oncology and rare diseases, reported its financial and operational results for the second quarter ended June 30, 2016 (Press release, Idera Pharmaceuticals, AUG 2, 2016, View Source;p=RssLanding&cat=news&id=2191763 [SID:1234514185]).

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"The second quarter of this year represented a period of solid execution throughout the organization," stated Vincent Milano, Idera’s Chief Executive Officer. "As a result of the efforts of the team to continue driving our programs forward, we are rapidly approaching critical data readouts for Idera. During the second half of this year, we expect to be in position to share important data from our melanoma trial with IMO-2125, as well as the next steps in the program. We also expect to be in a position to select a recommended Phase 2 dose for our B-cell lymphoma program with IMO-8400. Lastly, we plan to begin elucidating the path forward for the 3GA (third generation antisense) platform, which we believe represents a pillar in the foundation of the company we are building."

Continued Milano, "I’m very proud of the team’s focus and determination as they continued to advance our research and development programs. We certainly have much more work ahead of us to arrive at our ultimate goal of delivering solutions to patients; however, we are energized knowing that we will soon be in possession of critical information to further understand the potential of these opportunities."

Research and Development Program Updates
IMO-2125 and IMO-8400 are the Company’s lead clinical development drug candidates. IMO-2125 is an oligonucleotide-based agonist of Toll-like receptor (TLR) 9. IMO-8400 is an oligonucleotide-based antagonist of TLRs 7, 8, and 9. The Company also announced during the fourth quarter of 2015, the first two development targets from its proprietary 3GA Technology platform: NLRP3 (NOD-like receptor family, pyrin domain containing protein 3) and DUX4 (Double Homeobox 4). The Company continues to evaluate these and other potential targets for clinical proof of concept. The Company plans to take the first 3GA candidate into human proof of concept studies in 2017.

Toll-like Receptor (TLR) Agonism

Immuno-Oncology Program
Idera’s development program in immuno-oncology is based on the rationale that intra-tumoral injections of IMO-2125, a TLR9 agonist, will activate dendritic cells and modulate the tumor microenvironment to potentiate the anti-tumor activity of checkpoint inhibitors. This rationale is supported by pre-clinical data in multiple tumor types. These studies have led Idera into a strategic alliance with the University of Texas MD Anderson Cancer Center to evaluate the combination of intra-tumoral IMO-2125 with checkpoint inhibitors.

In December 2015, Idera announced the initiation of a Phase 1/2 clinical trial of intra-tumoral IMO-2125 in combination with ipilimumab, a CTLA4 antibody being conducted at the University of Texas MD Anderson Cancer Center. This study is in patients with relapsed or refractory Metastatic Melanoma who have failed prior PD-1 therapy. The trial continues to accrue patients according to plan and the Company intends to present the first clinical immune response translational data from this trial, addressing the mechanism of action, during the second half of 2016 at a select immuno-oncology conference, with clinical results expected in 2017.

The study has recently been amended to include the exploration of the combination of IMO-2125 with pembrolizumab, an anti-PD1 antibody.

Toll-like Receptor (TLR) Antagonism

Genetically Defined Forms of B-cell Lymphoma
Idera’s program in genetically defined forms of B-cell lymphoma is based on pre-clinical studies that have demonstrated that, in certain B-cell lymphomas driven by the oncogenic MYD88-L265P mutation, blocking TLR7 and 9 signaling can promote tumor cell death.

In December 2015, Idera presented positive clinical data from the ongoing Phase 1/2 trial of IMO-8400 in patients with Waldenstrom’s Macroglobulinemia at the 57th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in Orlando, FL. The Company is continuing dose escalation of IMO-8400 in the ongoing trials in Waldenstrom’s Macroglobulinemia and Diffuse Large B-cell Lymphoma to explore the full potential of IMO-8400 based on the safety profile and efficacy signals seen to date. The Company plans to be in position to select a recommended Phase 2 dose by year end 2016.

Idera previously announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation for IMO-8400 for the treatment of Waldenstrom’s macroglobulinemia and DLBCL.

Rare Diseases
In November 2015, Idera announced the initiation of a Phase 2 clinical trial of IMO-8400 in patients with Dermatomyositis, a rare auto-immune condition, which negatively affects skin and may result in debilitating muscle weakness. TLRs have been reported to play a role in the pathogenesis of the disease. This randomized, double-blind, placebo controlled Phase 2 trial is expected to enroll 36 patients and is being conducted at approximately 20 clinical sites worldwide. The Company plans to complete enrollment of this trial by the end of 2017.

Third Generation Antisense Platform (3GA)
Idera’s proprietary third-generation antisense (3GA) platform technology is focused on silencing the mRNA associated with disease causing genes. Idera has designed 3GA oligonucleotides to overcome specific challenges associated with earlier generation antisense technologies and RNAi technologies.

In late 2015, Idera announced the identification of NLRP3 (NOD-like receptor family, pyrin domain containing protein 3) and DUX4 (Double Homeobox 4) as initial gene targets to advance into IND-enabling activities, which will occur throughout 2016. Potential disease indications related to these targets include, but are not limited to, interstitial cystitis, lupus nephritis, uveitis and facioscapulohumeral muscular dystrophy (FSHD). The Company is currently conducting clinical, regulatory and commercial analysis activities and conducting IND-enabling studies with the plan to enter the clinic in 2017 for the first clinical development program. In addition to these activities, over the first half of 2016, Idera generated 3GA compounds for a series of additional gene targets. These will enable the Company to continue to expand its future pipeline opportunities for both internal development as well as partnerships in areas outside of Idera’s focus. Idera plans to present pre-clinical data at several conferences in the second half of 2016.

In late 2015, Idera entered into a collaboration and license agreement with GSK to research, develop and commercialize compounds from its 3GA technology for the treatment of undisclosed, selected renal targets. As per the terms of the agreement, Idera received an upfront payment of $2.5 million and is eligible to receive up to approximately $100 million in milestone payments in addition to royalties.

Financial Results

Second Quarter 2016 Results

Net loss for the three months ended June 30, 2016 was $13.5 million, or $0.11 per basic and diluted share, compared to a net loss of $12.7 million, or $0.11 per basic and diluted share, for the same period in 2015. Revenue totaled $0.3 million and $0.6 million during the three and six months ended June 30, 2016, respectively. There was nominal revenue recognized during the corresponding 2015 periods. For the six month period ended June 30, 2016, the Company’s net loss was $26.3 million, or $0.22 per basic and diluted share, compared to a net loss of $25.2 million, or $0.23 per diluted share, for the same period in 2015.

Research and development expenses for the three months ended June 30, 2016 totaled $10.1 million compared to $9.0 million for the same period in 2015. For the six month period ended June 30, 2016, research and development expenses totaled $19.4 million compared to $17.7 million for the same period in 2015.

General and administrative expense for the three months ended June 30, 2016 and June 30, 2015 totaled $3.8 million, respectively. For the six month period ended June 30, 2016 and June 30, 2015, general and administrative expenses totaled $7.7 million, respectively.

As of June 30, 2016, Idera’s cash, cash equivalents and investments totaled $64.1 million compared to $87.2 million as of December 31, 2015. The company expects the current cash position and investments to fund its operations into the third quarter of 2017.