On November 10, 2016 Bio-Path Holdings, Inc. (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported its financial results for the third quarter ended September 30, 2016 and also provided an update on recent corporate developments (Filing, Q3, Bio-Path Holdings, 2016, NOV 10, 2016, View Source [SID1234516508]).

"Throughout the third quarter and in recent weeks, we have made meaningful progress across our clinical and corporate development programs. Earlier this month, we were pleased to announce the enrollment and dosing of the first patient in the efficacy portion of our Phase 2 clinical study of BP1001 for the treatment of acute myeloid leukemia," said Peter Nielsen, President and CEO of Bio-Path Holdings. "Recently, the European Medicines Agency granted orphan drug designation to BP1001 for the treatment of AML, which recognizes the potential of our DNAbilize technology, underscores the significant unmet medical need in this debilitating disease, and provides regulatory provisions that can accelerate the review process and expand our market exclusivity."

Recent Corporate Highlights

· Announced First Patient Dosed in Phase 2 Trial Evaluating BP1001 in Acute Myeloid Leukemia. In November, the Company announced the enrollment and dosing of the first patient in the efficacy portion of its Phase 2 clinical study of BP1001, a liposomal Grb2 antisense for the treatment of acute myeloid leukemia (AML). The primary endpoint of the study is the number of patients who achieve Complete Remission (CR), including CR with incomplete hematologic recovery (CRi) and CR with incomplete platelet recovery (CRip). Secondary endpoints assessing the safety and efficacy of BP1001 include overall survival, time to response, duration of response, and adverse events as evaluated by physical examination findings, vital signs and clinical laboratory tests.

· Granted Orphan Drug Designation in the European Union for BP1001 for the Treatment of AML. In November, the Company announced that the European Medicines Agency (EMA) granted orphan drug designation to BP1001 for the treatment of AML. To receive orphan drug designation from the EMA, a therapy must be intended for the treatment of a life-threatening or chronically debilitating rare condition with a prevalence of less than five in 10,000 in the European Union. Orphan drug designation provides incentives designed to facilitate development including fee reductions for protocol assistance, scientific advice and importantly, may provide up to ten years of market exclusivity in the EU following product approval.

Financial Results for the Third Quarter Ended September 30, 2016

The Company reported a net loss of $1.6 million, or $0.02 per share, for the three months ended September 30, 2016, compared to a net loss of $1.5 million, or $0.02 per share, for the same period last year. The increase was primarily due to the release of drug material for our Phase 2 clinical trial for BP1001 in AML and associated clinical trial costs.

Research and development expenses for the three months ended September 30, 2016 increased to $2.3 million, compared to $1.0 million for the same period in 2015. General and administrative expenses for the three months ended September 30, 2016 increased to $0.7 million, compared to $0.5 million for the three months ended September 30, 2015.

As of September 30, 2016, the Company had cash of $11.3 million, compared to $8.9 million at December 31, 2015. Net cash used in operating activities for the nine months ended June 30, 2016 was $6.5 million compared to $4.0 million for the comparable period in 2015.

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On November 10, 2016 Mirna Therapeutics, Inc. (Nasdaq: MIRN), a biopharmaceutical company focused on microRNA-based oncology therapeutics, reported financial results for the third quarter of 2016 and provided an update on recent developments (Press release, Mirna Therapeutics, NOV 10, 2016, View Source [SID1234516571]).

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MRX34 CLINICAL PROGRAM

In September 2016, the Company voluntarily halted the ongoing Phase 1 trial of its first product candidate, MRX34, following multiple immune-related serious adverse events (SAEs) observed in patients dosed with MRX34 over the course of the trial. Three of these immune-related events resulted in the patient’s death. Subsequently, the U.S. Food and Drug Administration (FDA) notified the Company that the Investigational New Drug (IND) Application for MRX34 has been placed on full clinical hold. Among other comments, the FDA requested a final clinical study report be submitted and noted that a risk-benefit summary with sufficient justification for the continued development of MRX34 would be necessary if the Company requested removal of the clinical hold.

"We were disappointed with the outcome of our Phase 1 study, however, our first priority in developing innovative therapeutics is the safety of patients," said President and CEO Paul Lammers, M.D., M.Sc. "Based on our assessment of both potential therapeutic benefit and risk, we have decided to discontinue development of MRX34 and suspend our pipeline R&D programs."

The Company has initiated a plan to reduce personnel and expenses in order to preserve capital and streamline operations, and it plans to focus on meeting regulatory requirements related to closure of the Phase 1 trial as well as other operating activities consistent with the decision to discontinue development of MRX34. The Company also expects to explore and evaluate strategic alternatives with the goal of enhancing stockholder value.

THIRD QUARTER 2016 FINANCIAL RESULTS

• Cash Position and Guidance: Cash, cash equivalents, and marketable securities totaled $66.7 million as of September 30, 2016, compared to $89.7 million as of December 31, 2015. The Company has no debt.

Beginning in the first quarter of 2017, after giving effect to the personnel and expense reductions, the Company expects its quarterly cash burn rate will range from $2.1 million to $2.3 million. This 2017 quarterly guidance includes contractual commitments and obligations, but excludes any one-time charges related to a strategic transaction should one be concluded.

• Research and development expenses: Research and development expenses were $3.4 million and $11.6 million for the three and nine months ended September 30, 2016, respectively, compared to $4.7 million and $12.6 million during the comparable periods in 2015. The decrease for the three and nine months ended September 30, 2016 compared to the same period in 2015 was primarily attributable to higher costs incurred in 2015 associated with our Phase 1 clinical trial for MRX34, specifically adding additional sites and upfront drug manufacturing costs. The decrease in 2016 was partially offset by an increase in employee compensation, benefits and stock compensation.

• General and Administrative Expenses: General and administrative expenses were $2.0 million and $6.1 million for the three and nine months ended September 30, 2016, respectively, compared to $1.6 million and $3.6 million during the comparable periods in 2015. The increase in general and administrative expenses was primarily attributable to increased employee compensation expense due to a higher headcount and higher outside professional and consulting costs, the majority of which were costs to comply with public company operating and reporting requirements.

• Net Loss: Net loss was approximately $5.4 million and $17.6 million for the three and nine months ended September 30, 2016, compared to a net loss of $6.2 million and $16.2 million for the comparable periods in 2015. The results included non-cash, stock-based related compensation charges of $513,000 and $1,202,000 for the three and nine months ended September 30, 2016, respectively, and $210,000 and $561,000 for the comparable periods in 2015.

On November 10, 2016 Celsion Corporation (NASDAQ:CLSN), an oncology drug development company, reported financial results for the quarter and nine month period ended September 30, 2016 and provided an update on its development programs for ThermoDox, the Company’s proprietary heat-activated liposomal encapsulation of doxorubicin and GEN-1, an IL-12 DNA-based immunotherapy (Press release, Celsion, NOV 10, 2016, View Source [SID1234516538]).

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"Over the last nine months, we have realized meaningful progress with respect to our two lead programs, ThermoDox and GEN-1. Importantly, we are well positioned to sustain this momentum through the balance of 2016 and beyond," said Michael H. Tardugno, Celsion’s chairman, president and CEO. "The initial data from our GEN-1 program provides highly valuable insights into its favorable clinical and safety profile indicating a great deal of potential in both first and second-line ovarian cancer, and we look forward to reporting additional data from our ongoing OVATION study before year-end."

Mr. Tardugno continued, "Our ongoing global, pivotal Phase III OPTIMA Study of ThermoDox in primary liver cancer remains on track with clinical sites currently enrolling patients in 13 countries worldwide. Investigators continue to recognize the value of findings from the HEAT Study and their continued interest reinforces substantial and mounting support for the OPTIMA Study.

The recent independent analysis conducted by the National Institutes of Health provides further confirmatory support indicating that the use of radiofrequency ablation (RFA) for more than 45 minutes in patients treated with ThermoDox can have a correlative impact on reductions in tumor size and overall survival in patients with primary liver cancer."

Recent Developments
Immunotherapy – GEN-1

Announced Positive Data from the First Two Cohorts of the OVATION Study. In July 2016, the Company announced data from the second cohort of patients in its Phase Ib dose escalating clinical trial (the OVATION Study) combining GEN-1 with the standard of care for the treatment of newly-diagnosed patients with advanced ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debulking surgery. In the first six patients dosed, GEN-1 plus standard chemotherapy produced impressive results, with no dose limiting toxicities and highly promising efficacy signals in this difficult-to-treat cancer. The efficacy data included highly encouraging tumor response rates, successful surgical resections of the eligible patients’ tumors, impressive pathological responses and dramatic, clinically meaningful drops in CA-125 protein levels.

Positive DSMB Review of OVATION Study in Ovarian Cancer. In September 2016, the independent Data Safety Monitoring Board (DSMB) completed its safety review of data from the first three patient cohorts in the ongoing Phase Ib OVATION Study. Based on the DSMB’s recommendation, the study will continue as planned and the Company will proceed with dosing in its fourth and final patient cohort at an escalated dose. Celsion expects the fourth cohort to be fully enrolled this year.

Established a Manufacturing and Commercial Supply Agreement with Hisun for GEN-1. In August 2016, Celsion signed a long term technology transfer, manufacturing and commercial supply agreement with Zhejiang Hisun Pharmaceutical Co. Ltd. The agreement relates to both the clinical and commercial manufacture and supply of GEN-1 for the greater China territory, with the option to expand into other countries in the rest of the world after all necessary regulatory approvals are in effect. With highly cost effective pricing, the agreement will support economically advantaged supply for ongoing and planned clinical studies in the United States and potential future studies of GEN-1 in China as well as Europe.

Chemotherapy – ThermoDox
Announced the Final Overall Survival Data from HEAT Study of ThermoDox in Primary Liver Cancer. In August 2016, the Company announced updated results from its final retrospective analysis of the 701-patient HEAT Study. The overall survival analysis demonstrated that in a large, well bounded, subgroup of 285 patients (41% of the HEAT Study patients), treatment with a combination of ThermoDox and optimized RFA provided an average 54% risk improvement in overall survival compared to optimized RFA alone. The Hazard Ratio (HR) at this analysis is 0.65 (95% CI 0.45 – 0.94) with a p-value of 0.02. Importantly, after 3.5 years of follow up, the median overall survival for the ThermoDox group has yet to be reached and is showing over 80 months survival benefit compared to less than 60 months projection for the optimized RFA only group, which translates into a two year survival benefit.

Announced the Independent NIH Analysis Showing Treatment with ThermoDox Plus RFA may Significantly Improve Overall Survival of Patients with Primary Liver Cancer. In September 2016, the Company announced that the National Institutes of Health (NIH) has conducted an independent retrospective analysis of data from the Company’s HEAT Study. The NIH analysis, which sought to evaluate the correlation between RFA burn time per tumor volume (min/ml) and clinical outcome in patients treated with ThermoDox, concluded that increased RFA burn time per tumor volume substantially improved survival in patients with solitary lesions treated with RFA + ThermoDox compared to patients treated with RFA alone. These findings are consistent with Celsion’s analysis of the HEAT Study data showing that in patients treated with RFA for more than 45 minutes, standardized RFA plus ThermoDox resulted in a statistically significant improvement in overall survival of over two years when compared to standardized RFA alone.

Detailed findings from the NIH study will be presented during oral sessions on Monday, November 28, 2016 at 1:50 pm CT during the 102nd Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA) to be held on November 26 – December 2, 2016 in Chicago, IL.

Announced Presentations Highlighting Phase III OPTIMA Study at Two Asia-Pacific Primary Liver Cancer Expert Meetings.
In July 2016, the Company announced that its ongoing Phase III OPTIMA trial evaluating ThermoDox in primary liver cancer was featured during an oral presentation at the 7th Asia-Pacific Primary Liver Cancer Expert (APPLE) Meeting in Hong Kong, China. The presentation highlighted the potential of ThermoDox plus optimized RFA to significantly improve overall survival of newly diagnosed patients.

In October 2016, the Company announced the presentation of data from the Company’s HEAT Study, highlighting the curative potential for ThermoDox plus optimized RFA in intermediate primary liver cancer at the 3rd Asian Conference on Tumor Ablation (ACTA) in Seoul, Korea.

Announced Collaboration with the Children’s Research Institute to Evaluate the Use of ThermoDox and High Intensity Focused Ultrasound in the Treatment of Solid Tumors in Children and Young Adults. In October 2016, the Company announced a collaboration with the Children’s Research Institute to conduct a clinical study of ThermoDox in combination with magnetic resonance-guided high intensity focused ultrasound to treat relapsed or refractory solid tumors in children and young adults. This investigator-sponsored Phase I clinical study is being partially funded by the National Institutes of Health and is expected to commence in the fourth quarter of 2016.

Financial Results
For the quarter ended September 30, 2016, Celsion reported a net loss of $6.4 million, or $(0.23) per share, compared to a net loss of $4.3 million, or $(0.19) per share, in the same period of 2015. Operating expenses were $5.7 million in the third quarter of 2016 compared to $4.4 million in the same period of 2015. For the nine month period ended September 30, 2016, the Company reported a net loss of $16.7 million, or $(0.66) per share, compared to $16.9 million, or $(0.79) per share, in the same nine month period of 2015. Operating expenses were $15.9 million in the first nine months of 2016 compared to $16.3 million in the same period of 2015. Net cash used in operations was $13.7 million in the first nine months of 2016 compared to $16.9 million in the same period last year. The Company ended the third quarter of 2016 with $8.7 million of total cash, investments and accrued interest on these investments, which included the proceeds of a $6 million registered direct offering completed during the second quarter.

Research and development costs were $4.2 million in the third quarter of 2016 compared to $2.9 million in the same period last year. Research and development costs were $11.0 million in the first nine months of 2016 and 2015. R&D costs in 2016 reflect lower clinical supply costs for the ThermoDox and GEN-1 clinical studies offset by increased costs associated with the enrollment in the OPTIMA and the OVATION studies when compared to 2015. General and administrative expenses were $1.5 million in the third quarter of 2016 and 2015. General and administrative expenses were $4.9 million in the first nine months of 2016, down 8 percent when compared to the same period of 2015. This decrease was primarily the result of lower personnel related costs and professional fees.

On November 10, 2016 Cellectar Biosciences, Inc. (Nasdaq: CLRB) (the "company"), an oncology-focused, clinical stage biotechnology company, reported key accomplishments and its financial results for the third quarter of 2016, which ended September 30, 2016 (Filing, Q3, Cellectar Biosciences, 2016, NOV 10, 2016, View Source [SID1234516513]).

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Corporate highlights for the quarter include:

· Announcement that an 18.75 mCi/m2 single-dose infusion of CLR 131 achieved efficacy data that was equivalent or superior to drugs recently approved for relapsed/refractory (R/R) multiple myeloma (MM) from Cohort 2 of our Phase I study of CLR 131 for relapsed/refractory multiple myeloma

· Completion of Cohort 2 and announcement of a positive adverse event (AE) profile; no observed neuropathies, cardiotoxicities, deep vein thrombosis or gastrointestinal AEs to date

· Advancement and initiation of Cohort 3 in Phase I study of CLR 131 in R/R MM at 25mCi/m2 single-dose infusion

· Awarded non-dilutive NCI – Fast Track SBIR Grant of $2M to support Phase II study of CLR 131 in multiple myeloma and other selected orphan-designated hematologic malignancies

· Selection of CLR 131 for non-dilutive research & development to be studied in combination with external beam radiation for head and neck cancers as part of a $12M NCI SPORE Grant awarded to the University of Wisconsin

· USPTO granted Patent Allowance for CLR 1603 covering method of use in key solid tumors: breast, prostrate, lung, pancreatic and colorectal

· Appointment of Jarrod Longcor as senior vice president, Corporate Development and Operations

"We continue to effectively operate the company and achieve significant clinical development progress with CLR 131 as demonstrated by impressive Cohort 2 data and advancement to the third cohort of our Phase I clinical trial for multiple myeloma. In addition, we plan to initiate our NCI supported Phase II clinical trial in multiple myeloma and selected hematologic malignancies in the first quarter of 2017," said Jim Caruso, president and CEO of Cellectar Biosciences. "We remain focused on closing 2016 strong and communicating near-term, meaningful milestones that further demonstrate the clinical and financial value of our patented PDC delivery platform."

Financial Results for 3Q 2016

The company incurred research and development expenses of $1.3 million during the third quarter of 2016, which was $0.1 million higher than the third quarter of 2015. The primary driver was increased investment to support our upcoming Phase II Study of CLR 131 in Multiple Myeloma and other orphan-designated hematologic malignancies.

Cellectar’s general and administrative expenses for third quarter 2016 totaled $1.2 million, an increase of $0.3 million from the same period in the prior year. This increase was a result of increased costs for consulting services related to financial reporting, investor outreach and executive recruitment. Loss from operations was $2.5 million, an increase of $0.4 million from the third quarter of 2015.

The Company ended the third quarter with $5.6 million in cash and cash equivalents, compared to $3.9 million in cash and cash equivalents on December 31, 2015. The company continues to estimate that its available cash and cash equivalents will fund its planned operations into the first quarter of 2017. The company expects that additional capital will be required to complete its planned clinical and preclinical development.

Cellectar will be holding a conference call at 8:30 AM ET on Friday, November 11, 2016 to review the company’s performance, as well as these financial results. The call can be accessed by calling (888) 646-8293 (US domestic) or (973) 453-3065 (international) or investors may participate via webcast at View Source Replays will be available via the Investor Relations section of the company’s website: View Source

About CLR 131
CLR 131 is an investigational compound under development for a range of hematologic malignancies. It is currently being evaluated in a Phase I clinical trial in patients with relapsed or refractory multiple myeloma. The company plans to initiate a Phase II clinical study to assess efficacy in a range of B-cell malignancies in the first quarter of 2017. Based upon preclinical and interim Phase I study data, treatment with CLR 131 provides a novel approach to treating hematological diseases and may provide patients with therapeutic benefits, including overall response rate (ORR), an improvement in progression-free survival (PFS) and overall quality of life. CLR 131 utilizes the company’s patented PDC tumor targeting delivery platform to deliver a cytotoxic radioisotope, iodine-131 directly to tumor cells. The FDA has granted Cellectar an orphan drug designation for CLR 131 in the treatment of multiple myeloma.

About Phospholipid Drug Conjugates (PDCs)
Cellectar’s product candidates are built upon its patented cancer cell-targeting delivery and retention platform of optimized phospholipid ether-drug conjugates (PDCs). The company deliberately designed its phospholipid ether (PLE) carrier platform to be coupled with a variety of payloads to facilitate both therapeutic and diagnostic applications. The basis for selective tumor targeting of our PDC compounds lies in the differences between the plasma membranes of cancer cells compared to those of normal cells. Cancer cell membranes are highly enriched in lipid rafts, which are glycolipoprotein microdomains of the plasma membrane of cells that contain high concentrations of cholesterol and sphingolipids, and serve to organize cell surface and intracellular signaling molecules. PDCs have been tested in over 70 different xenograft models of cancer.

About Relapsed or Refractory Multiple Myeloma
Multiple myeloma is the second most common blood or hematologic cancer with approximately 30,000 new cases in the United States every year. It affects a specific type of blood cells known as plasma cells. Plasma cells are white blood cells that produce antibodies to help fight infections. While treatable for a time, multiple myeloma is incurable and almost all patients will relapse or the cancer will become resistant/refractory to current therapies.

On November 10, 2016 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, reported a new myeloid gene expression collaboration to expand the company’s immuno-oncology portfolio (Press release, NanoString Technologies, NOV 10, 2016, View Source [SID1234516482]). The Company, in conjunction with Lisa Coussens, Ph.D., Professor & Chair, Developmental & Cancer Biology Department, OHSU Knight Cancer Institute, Portland, Oregon, is developing two new myeloid focused research panels for the study of the innate immune response to cancer. An early version of the Myeloid Innate Immunity Panel will be made available to Dr. Coussens and her collaborators, as well as the Stand Up To Cancer – Lustgarten Foundation Pancreatic Dream Team members in an exclusive, advance offering during the month of November in conjunction with Pancreatic Cancer Awareness Month, after which the panels will be available to all researchers.

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"I am thrilled to be partnering with NanoString to create these novel myeloid-focused panels," said Coussens. "We anticipate that through these efforts, we will enable a more complete understanding of the local interplay between myeloid immune components and neoplastic cells in tumors."

Myeloid cells play a key role in modulating activities fundamental to cancer development and are known to have both tumor promoting and anti-tumor functions. As myeloid cells are affected by and can have an impact on many types of cancer therapy, they are broadly applicable within immuno-oncology research. A heightened awareness of the importance of the mechanisms of immunotherapy resistance has brought the myeloid immune response into focus as a key modulator of the adaptive immune response. NanoString is currently working with Coussens on her efforts in understanding recruitment of myeloid cells into neoplastic tissue, and the subsequent regulation exerted by those myeloid cells on neoplastic cells and other cells within dynamic tumor microenvironments.

The Myeloid Innate Immunity panel includes approximately 700 genes representing all major categories of myeloid cells, enabling quantitative evaluation of heterogeneous myeloid cell populations based on recruitment, differentiation, maturation status, and functional activities. The panels are optimized to work across a range of sample types including fresh frozen tissues, formalin-fixed paraffin-embedded (FFPE) samples, peripheral blood mononuclear cells and cell lysates.

"It has been a pleasure to collaborate with Dr. Coussens and we are excited to share this work with the broader community of cancer researchers. The Myeloid panel is a collection of genes that encompass the many characteristics of the innate immune response that will help advance cancer research with obvious applications in infectious disease as well," said Joseph Beecham, Ph.D., senior vice president of R&D at NanoString. "These myeloid panels are highly complementary to NanoString’s 770 gene PanCancer Immune Profiling Panel, layering a unique dimension of gene expression information that will provide insights into the modulation activities of the innate immune response."

Dr. Coussens is chair of the Department of Cell, Developmental & Cancer Biology at OHSU. Her research is focused on revealing the role that immune cells play in regulating solid tumor development. Coussens is a principal investigator on the Stand Up To Cancer – Lustgarten Foundation Pancreatic Cancer Convergence Dream Team in which her work is focused on clinical evaluation of immune-based therapies in pancreatic cancer. She has received numerous awards, including: the V Foundation Scholar Award, the AACR (Free AACR Whitepaper)-Women in Cancer Research Charlotte Friend Memorial Lectureship, and the 2015 recipient of the 13th Rosalind E. Franklin Award from the National Cancer Institute.

This is the latest in a series of research partnerships NanoString has with global leaders in immuno-oncology. NanoString and Coussens will be presenting independently at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) conference taking place Wednesday, November 9 through Sunday, November 13 at the Gaylord National Hotel & Convention Center in National Harbor, Maryland.

Results from NanoString’s previously announced collaborations with Merck and MD Anderson Cancer Center will also be presented this week at AMP and SITC (Free SITC Whitepaper).

– Title: Beyond PD-L1 IHC: A Gene Expression Based Test in development for anti-PD-1 response on the nCounter Dx Analysis System
– Speaker: Dr. Matthew Marton, Director of Genomics and Companion Diagnostics, Merck
– Date/time: Wednesday, November 9th, 8 AM – 9 AM.

– Title: The increasing clinical relevance of predictive biomarkers in cancer immunotherapy: can we afford to move forward without them?
– Speakers: Alessandra Cesano, Alex Rueben (MDACC) & Jared Lunceford (Merck).
– Date/time: Saturday, November 12th, 12:00 PM – 1:00 PM.