On November 10, 2016 ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) reported financial results for the third quarter of 2016 and provided an update on its research and development activities (Press release, ImmunoCellular Therapeutics, NOV 10, 2016, View Source [SID1234516541]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Andrew Gengos, ImmunoCellular’s Chief Executive Officer, commented: "During the third quarter and year to date, we continued to implement our ICT-107 registration trial in patients with newly diagnosed glioblastoma, and conduct our phase 1 trial of ICT-121 in patients with recurrent glioblastoma. Today, in our ICT-107 phase 3 trial, about 225 patients have been screened, 11 have been randomized, and clinical site activation is continuing, with a total of 66 sites activated to date. We have determined that the number of patients who complete screening and then proceed to randomization, post-chemoradiation, is lower than expected, and thus the rate of randomization is slower than we would like. To address this challenge, we are implementing a protocol amendment for the ICT-107 trial that will modify some elements of how patients qualify for the trial, which is designed to accelerate the pace and efficiency of randomization. We also anticipate increasing the target number of randomized patients, which would extend the timeline to trial completion. We are continuing to screen and randomize patients, and anticipate completing the amendment process in the first quarter of 2017."

Continued Mr. Gengos: "The phase 1 open-label trial of ICT-121 being conducted at six sites in the U.S. completed enrollment of 20 patients in the third quarter. The preliminary results thus far are encouraging, showing a current median survival of 13.8 months as of October 31st, seven patients who are alive beyond 18 months, and four patients who are alive at the two-year mark. We are continuing to monitor outcomes, with the goal of having preliminary data by mid-2017, potentially in time for the ASCO (Free ASCO Whitepaper) 2017 meeting. We are grateful for the continued support of the medical and scientific cancer community for our clinical programs, and the confidence placed in our company by our collaborators."

Achievements, Upcoming Goals and Milestones:

ICT-107:
Continue to bring U.S., Canadian and European clinical sites online. A total of 75 site initiation visits have been completed, and 66 sites have been activated to date.
A protocol amendment is underway, which will modify some elements of how patients qualify for the trial, raise the target number of randomized patients from 414 to at least 500 and result in a potential 12 to 18 month extension to complete the trial. We now anticipate randomization of all patients to be completed by the first half of 2019, and an additional 2-3 years from then to achieve the number of required events.
Plan to conduct a futility interim analysis at 30% of events, or at about the time of full randomization, and an efficacy interim analysis at 67% of events, about six months later.
Present updated immune monitoring data from the ICT-107 phase 2 trial and updated long-term survival data from the phase 1 trial at the 2016 Society for NeuroOncology annual scientific meeting, being held in Scottsdale, AZ in two oral presentations.
Friday, November 18, 4:35 pm MT, Adult Clinical Trials – Immunological (ATIM-19) "Categorizing immune responders with fusion metrics and simulation for association to survival and progression-free survival with immune response in HLA-A2+ patients with GBM from a phase 2 trial of dendritic cell (DC) immunotherapy (ICT-107)," presented by Steven J. Swanson, PhD, ImmunoCellular Therapeutics, Ltd, Calabasas, CA.
Friday, November 18, 4:40 pm, MT, Adult Clinical Trials – Immunological (ATIM-25): "Ten-year follow up with long term remission in patients with newly diagnosed glioblastoma (GBM) treated with ICT-107 vaccine (phase 1)," presented by Surasak Phuphanich, MD, Neuro-Oncology Program, Department of Neurosurgery & Neurology, Cedars-Sinai Medical Center, Los Angeles, CA
ICT-121:
Continuing to monitor patients, with data expected around mid-2017.
Research:
Anticipate having one or more T cell receptors identified for a Stem-to-T-cell clinical candidate or candidates by year-end 2016.
Initial attempt to package a T cell receptor DNA sequence in the lentivirus/gene therapy construct by year-end 2016.
Continued progress in collaboration with University of Maryland on projects that have application to existing dendritic cell immunotherapy and Stem-to-T-cell technology platforms.
Third Quarter 2016 Financial Results

For the quarter ended September 30, 2016, ImmunoCellular incurred a net loss of $4.8 million, or $0.04 per basic and diluted share, compared to a net loss of $3.4 million, or $0.04 per basic and diluted share, for the quarter ended September 30, 2015.

During the third quarter 2016, ImmunoCellular incurred $4.6 million of research and development expenses compared to $2.7 million in the prior year quarter, while general and administrative expenses decreased to $908,000 compared to $1.1 million in the prior year. The $1.9 million increase in research and development expenses primarily reflects the additional expenses associated with the phase 3 trial of ICT-107. The decrease in general and administrative expenses reflects lower professional fees in the current quarter.

The loss for the current quarter was partially offset by a $1.1 million credit to other income to reflect a reduction in the valuation of the Company’s warrant derivative liabilities. In the same quarter of the prior year, the Company recorded a corresponding credit of $339,000.

For the nine months ended September 30, 2016, ImmunoCellular incurred a net loss of $15.8 million, or $0.15 per basic and diluted share, compared to a net loss of $8.0 million, or $0.09 per basic and diluted share. During the nine months ended September 30, 2016, ImmunoCellular incurred $13.7 million in research and development expenses compared to $7.0 million in the prior year.

ImmunoCellular also reported that cash used in operations during the nine months ended September 30, 2016 was $16.1 million compared to $13.2 million in the prior year. The increase primarily reflects the additional research and development expenditures in the current year. As of September 30, 2016, ImmunoCellular had $15.3 million in cash.

In August 2016, the Company entered into an underwriting agreement with Maxim Group LLC, pursuant to which the Company received net proceeds of approximately $6.6 million (after deducting the underwriting discount and offering expenses) from the initial sale of 34.6 million shares of the Company’s common stock, base warrants to purchase 35,250,000 shares of common stock at an exercise price of $0.1921 per share, and pre-funded warrants to purchase 12,450,000 shares of common stock at an exercise price of $0.01 per share. The underwriters partially exercised their option to purchase additional shares and base warrants and purchased an additional 1,500,000 million shares of the Company’s common stock at a price of $0.15 per share and base warrants to purchase 4,478,625 shares. The pre-funded warrants were substantially paid for at the time of the offering and have an exercise price of $0.01 per share. As of September 30, 2016, the Company had 137,795,802 shares of common stock issued and outstanding.

Additionally, the terms of the California Institute of Regenerative Medicine (CIRM) award were modified such that ImmunoCellular received an additional $1.5 million in August 2016 as part of the initial award received from CIRM. The total amount of the award and other award conditions remain unchanged.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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 Heat Biologics, Inc. ("Heat") (Nasdaq:HTBX), an immuno-oncology company developing novel therapies that activate a patient’s immune system against cancer, reported its financial results and provided a general business update for the third quarter and nine months ended September 30, 2016 (Press release, Heat Biologics, NOV 10, 2016, View Source [SID1234516526]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We look forward to reporting top-line data in both our bladder and lung cancer trials within the next few weeks," commented Jeff Wolf, Heat’s Founder and CEO. "Our results come on the heels of encouraging interim study findings from our Phase 1b trial evaluating HS-110 in combination with the Bristol-Myers Squibb anti-PD-1 checkpoint inhibitor, nivolumab. Our data in lung cancer suggest HS-110 may improve response rates for patients with ‘cold tumors’ who typically have lower response rates to checkpoint inhibitor monotherapy. We are also encouraged by our early data in bladder cancer that suggest we are activating a robust antigen-specific immune response.

"Moreover, we are pleased to announce the expansion of our gp96 platform into the infectious disease arena. We recently formed a new subsidiary, Zolovax, which will focus exclusively on developing gp96-based vaccines for Zika and other infectious diseases, such as HIV, West Nile, dengue and yellow fever. Preclinical studies suggest that our gp96 platform may have a role as a broad-based infectious disease vaccine. Importantly, in the case of Zika, the robust mucosal immune response generated by gp96 in ongoing oncology studies may suggest that a gp96 vaccine could also stimulate a Zika-specific immune response in the placenta, thus protecting the fetus from virus transmission.

"During the third quarter, we strengthened our balance sheet and benefitted from the exercise of warrants and substantial pay down of our existing debt. I am pleased to report we ended the quarter with approximately $8.5 million of cash on hand. This year through November 10, 2016, we have generated over $3.1 million in cash from the exercise of our March 23, 2016 warrants. Meanwhile, we continue to carefully manage our expenses as we await important top-line data this quarter."

Recent Developments & Third Quarter 2016 Corporate Highlights

In late October, Heat announced that it entered into an agreement with the University of Miami for the license and development of a portfolio of patents leveraging its gp96 platform to target the Zika virus and other infectious diseases including HIV, West Nile, dengue and yellow fever.
In October, Heat announced that it has advanced its biomarker discovery collaboration with Adaptive Biotechnologies. Adaptive will use its patented immune profiling assay, immunoSEQ, to enable an in-depth characterization of the immune response to Heat’s ImPACT and ComPACT-based immunotherapies, including HS-410, Heat’s Phase 2 product candidate for non-muscle invasive bladder cancer.
In September, Heat announced that it had resumed enrollment in its Phase 1b trial evaluating HS-110 in combination with nivolumab (Opdivo), a Bristol-Myers Squibb anti-PD-1 checkpoint inhibitor, for the treatment of non-small cell lung cancer (NSCLC). The decision to resume trial enrollment was based on the encouraging data reported in June, including two clinical responses in "cold tumor" patients. There are currently 15 patients enrolled and the Company expects to report topline 6-month data on the first eight of these patients before year end.
In July, Heat announced that preclinical findings from its ComPACT platform technology were published online in the journal "Cancer Immunology Research." Heat demonstrated that its ComPACT technology secreting the co-stimulator OX40L enhanced tumor rejection in two cancer tumor types compared to OX40 agonist antibody treatment. Heat also reported that ComPACT-enhanced antigen-specific T cell infiltration into tumors improved memory T cell responses and demonstrated greater specificity than OX40 agonist antibody treatments.
Third Quarter 2016 Financial Highlights

Research and development (R&D) expenses decreased to approximately $0.6 million in the third quarter of 2016 compared to approximately $0.7 million in the third quarter of 2015, a decrease of approximately $0.1 million. The decrease is primarily attributable to reductions in consultant fees and a decrease in compensation costs attributable to deferral of salary as part of our cost-savings plan.
Clinical and regulatory expenses decreased to approximately $1.1 million in the third quarter of 2016 compared to approximately $3.7 million in the third quarter of 2015, a decrease of approximately $2.6 million. The decrease is primarily attributable to reductions in clinical trial execution costs.
General and administrative (G&A) expenses decreased to approximately $0.8 million in the third quarter of 2016 compared to approximately $0.9 million in the third quarter of 2015, a decrease of $0.1 million. The decrease is attributable to a reduction in compensation costs and work force reductions as part of the cost-savings plan.
Net loss for the third quarter of 2016 was $1.7 million compared to a net loss of $5.4 million for the third quarter of 2015.
Nine Months Ended September 30, 2016 Financial Highlights

R&D expenses decreased to approximately $1.5 million for the nine months ended September 30, 2016 compared to approximately $1.8 million for the nine months ended September 30, 2015, a decrease of approximately $0.3 million. The decrease is attributable to reductions in patent, license and other professional fees, as well as a decrease in consultant expense and a decrease in compensation costs attributable to deferral in salary as part of our cost-savings initiatives.
Clinical and regulatory expenses decreased to approximately $5.6 million for the nine months ended September 30, 2016 compared to approximately $9.2 million for the nine months ended September 30, 2015, a decrease of approximately $3.6 million. The decrease is primarily attributable to reductions in clinical trial execution expenses.
G&A expenses decreased to approximately $2.9 million for the nine months ended September 30, 2016 compared to approximately $3.1 million for the nine months ended September 30, 2015, a decrease of approximately $0.2 million. The decrease is primarily attributable to a decrease in compensation costs attributable to deferral of salary and work force reductions as part of our cost-savings plan.
Net loss for the nine months ended September 30, 2016 was $9.4 million compared to a net loss of $14.4 million for the nine months ended September 30, 2015.
Cash and cash equivalents totaled approximately $8.5 million at September 30, 2016 compared to cash, cash equivalents and short-term investments which totaled approximately $11.6 million at December 31, 2015.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!