On March 10, 2016 Verastem, Inc. (NASDAQ:VSTM), focused on discovering and developing drugs to treat cancer, reported the presentation of preclinical data and participation in an expert panel at the Keystone Symposium on Stem Cells and Cancer being held March 6 – 10, 2016 in Breckenridge, CO (Press release, Verastem, MAR 10, 2016, View Source;p=RssLanding&cat=news&id=2147460 [SID:1234509470]).

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"The scientific consensus on the importance of targeting cancer stem cells to enable a durable clinical response continues to build," said Dr. Jonathan Pachter, Verastem Head of Research. "Our presentation at the Keystone Symposium describes our current understanding of the role of PI3K/mTOR and FAK in the survival and tumor-initiating capability of cancer stem cells."

"Of particular interest, we have also found that FAK inhibition increases influx of cytotoxic T cells into tumors while reducing immuno-suppressive and stromal density barriers to anti-tumor immune attack," continued Dr. Pachter. "New data from preclinical models presented today demonstrate that FAK inhibition enhances the anti-tumor effect of adoptive T cell transfer. These data suggest that the benefit of FAK inhibitor combination is likely to extend to various approaches that enhance cytotoxic T cell function, including combination with antibodies against PD-1 and PD-L1. We are now clinically testing this with the combination of VS-6063 and pembrolizumab at Washington University in Saint Louis in patients with advanced pancreatic cancer. We also recently announced a clinical collaboration with Pfizer and Merck KGaA to combine VS-6063 and avelumab for the treatment of patients with ovarian cancer."

Details for the presentation at the Keystone Symposium on Stem Cells and Cancer are as follows:
Oral Presentation and Panel
Title: Targeting Cancer Stem Cells with Selective Inhibitors of FAK and PI3K/mTOR
Session: Targeting Cancer Stem Cells: Trials and Translation
Date and time: Thursday, March 10, 2016, 8:00 – 11:00 am PT
A copy of the oral presentation will be available following the presentation at http://bit.ly/R3M6wc.
About Focal Adhesion Kinase
Focal Adhesion Kinase (FAK) is a non-receptor tyrosine kinase encoded by the PTK-2 gene that is involved in cellular adhesion and, in cancer, metastatic capability. VS-6063 (defactinib) and VS-4718 are orally available compounds that are potent inhibitors of FAK. VS-6063 and VS-4718 utilize a multi-faceted approach to treat cancer by reducing cancer stem cells, enhancing anti-tumor immunity, and modulating the local tumor microenvironment. VS-6063 and VS-4718 are currently being studied in multiple clinical trials for patients with cancer.
About VS-5584
VS-5584 is an orally available compound that has demonstrated potent and highly selective activity against class 1 PI3K enzymes and dual inhibitory actions against mTORC1 and mTORC2. In preclinical studies, VS-5584 has been shown to reduce the percentage of cancer stem cells and induce tumor regression in chemotherapy-resistant models. Verastem is currently conducting a dose escalation trial of VS-5584 in patients with advanced solid tumors.

On March 10, 2016 Tokai Pharmaceuticals Inc. (NASDAQ: TKAI), a biopharmaceutical company focused on developing and commercializing innovative therapies for prostate cancer and other hormonally driven diseases, reported company highlights and financial results for the year ended December 31, 2015 (Press release, Tokai Pharmaceuticals, MAR 10, 2016, View Source;p=RssLanding&cat=news&id=2147507 [SID:1234509466]).

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"We have made substantial progress in the last several months, executing on our Phase 3 ARMOR3-SV trial globally and expanding our galeterone development program to include additional underserved patient populations with prostate cancer," said Jodie Morrison, President and Chief Executive Officer of Tokai. "In ARMOR3-SV, we are gaining momentum in patient screening and enrollment throughout the world. In addition, the data unlocking galeterone’s distinct androgen receptor degradation mechanism presented at the ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium provide further support for the differentiated profile of galeterone. We look forward to a number of important milestones throughout 2016 and into 2017 that we expect to elucidate the broad potential of galeterone in prostate cancer."

Recent business highlights include:

Progress in ARMOR3-SV, a Phase 3 registration clinical trial of galeterone in AR-V7+ mCRPC. Over 100 clinical sites in the United States, Canada, Australia and Western Europe are open and actively screening patients in ARMOR3-SV, Tokai’s pivotal Phase 3 clinical trial evaluating whether administration of galeterone results in a statistically significant increase in radiographic progression free survival as compared to Xtandi (enzalutamide) in treatment-naïve metastatic castration-resistant prostate cancer (mCRPC) patients whose prostate tumor cells express the AR-V7 splice variant. AR-V7 is a truncated form of the androgen receptor that has been associated with poor responsiveness to commonly used oral therapies for mCRPC. Screening experience in ARMOR3-SV to date indicates that the prevalence of AR-V7 continues to be in line with the company’s expectations and consistent with the published literature. Enrollment in ARMOR3-SV is expected to be completed during the second half of 2016, and top-line results from the trial are anticipated by mid-2017.

Expansion of galeterone clinical development into additional mCRPC populations. Tokai is expanding galeterone clinical development into additional mCRPC populations through the planned initiation of two additional studies in the first half of 2016 in patients who have shown resistance following treatment with either abiraterone or enzalutamide, including:
An open-label Phase 2 clinical trial that will evaluate galeterone in men whose mCRPC rapidly progressed following treatment with either abiraterone or enzalutamide.

An expansion of the ongoing Phase 2 clinical trial of galeterone (ARMOR2) in mCRPC patients who have developed acquired resistance to enzalutamide. This expansion follows results observed in a patient who, following an initial response to enzalutamide, experienced a PSA drop of over 90 percent when treated with galeterone. This patient’s PSA response has remained at less than 0.1µg/L for over a year.

Presentation of galeterone’s novel mechanism of action. At the ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium held in January 2016, Tokai presented new data describing the novel mechanism by which galeterone degrades the androgen receptor (AR). These data demonstrate that galeterone selectively inhibits two deubiquitinating enzymes (DUBs) that are not inhibited by either Xtandi or Zytiga (abiraterone acetate), resulting in degradation of the AR via the proteasome, regardless of the presence or absence of a ligand binding domain.
Financial Results

Cash and investments at December 31, 2015 were $64.0 million, as compared to $105.3 million at December 31, 2014.
Research and development expense for the year ended December 31, 2015 was $32.6 million as compared to $14.6 million for the year ended December 31, 2014. The increase in research and development expense was primarily attributable to the initiation of the ARMOR3-SV clinical trial and the development of the AR-V7 clinical trial assay during 2015, and costs associated with other clinical trials to support the submission of a new drug application for galeterone.

General and administrative expense for the year ended December 31, 2015 was $12.6 million, as compared to $8.9 million for the year ended December 31, 2014. The increase in general and administrative expense was primarily attributable to increased headcount, other expenses necessary to operate as a public company, increased patent costs and costs associated with pre-commercialization activities.

Net loss was $45.1 million for the year ended December 31, 2015, or $2.01 per share, as compared to $23.3 million for the year ended December 31, 2014, or $3.60 per share.

On March 10, 2016 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported financial results for the fourth quarter and year ended December 31, 2015 (Press release, Sunesis, MAR 10, 2016, View Source;p=RssLanding&cat=news&id=2147475 [SID:1234509464]). Loss from operations for the three months and year ended December 31, 2015 was $11.3 million and $39.3 million, respectively. As of December 31, 2015, cash, cash equivalents and marketable securities totaled $46.4 million.

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"In the fourth quarter, we achieved a top 2015 corporate milestone with the submission and validation of our Marketing Authorization Application in Europe for vosaroxin to treat relapsed/refractory AML," said Daniel Swisher, Chief Executive Officer of Sunesis. "We are committed to bringing this important new therapy to a patient population with so few options. We will be providing updates later this year on the progress in Europe and in other major regions, including North America."

Mr. Swisher added: "Another key milestone for Sunesis is the progress of our pipeline of kinase inhibitors representing targeted new approaches to the treatment of cancer. Soon, we expect to initiate clinical development of SNS-062, our differentiated non-covalent BTK inhibitor with a European Phase 1A clinical trial in healthy volunteers, followed by a Phase 1B/2 in B-cell malignancy patients later this year. We also look forward to seeing data from the ongoing multi-arm combination study for the Takeda-partnered pan-RAF inhibitor, TAK-580, and to advancing our PDK-1 inhibitor, SNS-229, through IND-enabling toxicology studies to an IND."

Fourth Quarter 2015 and Recent Highlights

Submission of Marketing Authorization Application for Vosaroxin for the Treatment of Acute Myeloid Leukemia (AML) in Europe. In December 2015, Sunesis submitted a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for Vosaroxin for the treatment of relapsed/refractory AML in patients aged 60 years and older. The application was validated by the EMA on December 31, 2015, confirming that the submission was complete and initiating the Centralized Review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The MAA, if authorized, provides a marketing license valid in all 28 EU member states.

Presentation of Results from MD Anderson Sponsored Trial in AML and Washington University Sponsored Phase 1/2 Trial of Vosaroxin in MDS at ASH (Free ASH Whitepaper) Annual Meeting. In December 2015, Sunesis presented results from an ongoing Phase 1B/2 University of Texas MD Anderson Cancer Center-sponsored trial of vosaroxin in combination with decitabine in older patients with previously untreated acute myeloid leukemia (AML) and high-risk myelodyplastic syndrome (MDS), as well as results from a Washington University-sponsored Phase 1 trial of vosaroxin plus azacitidine in patients with myelodysplastic syndrome, at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Orlando, Florida. The oral presentation, titled "Phase I/II Study of Vosaroxin and Decitabine in Newly Diagnosed Older Patients (pts) with Acute Myeloid Leukemia (AML) and High Risk Myelodyplastic Syndrome (MDS)" and the poster "A Phase I Study of Vosaroxin plus Azacitidine for Patients with Myelodysplastic Syndrome," are available on the Sunesis website at www.sunesis.com.

Partnership with Clinigen Group to Initiate Compassionate Use Program for Patients with AML. In December 2015, Sunesis initiated a global Compassionate Use Program for vosaroxin. The program is available to eligible patients diagnosed with relapsed or refractory acute myeloid leukemia (AML) and is being managed by Clinigen Group’s Idis Managed Access division.

First Patient Treated in Indiana University Study of Vosaroxin and Cytarabine in Adults Age 60 Years and Older With Previously Untreated AML. In December 2015, the first patient was treated in an investigator-sponsored study of vosaroxin and cytarabine in adult patients age 60 years and older with previously untreated acute myeloid leukemia (AML). The trial is being conducted at the Melvin and Bren Simon Cancer Center at Indiana University under the direction of Seyed Hamid Sayar, M.D., Assistant Professor of Clinical Medicine.

European Patent Covering Vosaroxin Combination Use in AML and Other Hematological Malignancies. In November 2015, the European Patent Office (EPO) granted European Patent No. 2 049 109 B1, claiming certain combined uses of vosaroxin and cytarabine, at doses of 10-120 mg/m2 and 5-1500 mg/m2, respectively, for the treatment of acute myelogenous leukemia and acute myeloblastic leukemia. The patent further provides for combinations of vosaroxin and cytarabine with other therapies, such as radiation, or other chemotherapeutics, including anti-cancer agents, in hematologic disorders, whether administered simultaneously or sequentially. Sunesis is proceeding to validate this patent in multiple EPO member states. The resulting national patents would expire in the third quarter of 2027, but could be eligible for supplementary patent term in EPO member states beyond this date. Related patent applications are pending in several countries, including the United States and Japan.

Poster Presentation of VALOR Responder Survival Analysis at the Chemotherapy Foundation Symposium. In November, Sunesis presented results from a responder survival analysis of the VALOR trial at the 2015 Chemotherapy Foundation Symposium (CFS) in New York City. The analysis examined the impact of complete remission status on overall survival. Results showed that CR status was the strongest independent predictor of overall survival in patients enrolled in the study, regardless of study arm, with median survival for patients in CR lasting more than 12 months longer than patients without a CR. Furthermore, the addition of vosaroxin to cytarabine demonstrated a two-fold increase in CR rate by day 60. The poster presentation, titled "Impact of Complete Remission on Overall Survival in Patients with Refractory/Relapsed Acute Myeloid Leukemia Treated with Vosaroxin Plus Cytarabine or Placebo Plus Cytarabine: Responder Analysis for the Phase 3 VALOR Trial," is available at www.sunesis.com.

Presentations at the 2015 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). In November 2015, two poster presentations from the company’s proprietary kinase inhibitor programs were presented at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). The presentations included preclinical data from the company’s selective PDK1 inhibitors SNS-229 and SNS-510, as well as the company’s potent noncovalent second-generation BTK inhibitor, SNS-062.
Financial Highlights

Cash, cash equivalents and marketable securities totaled $46.4 million as of December 31, 2015, as compared to $43.0 million as of December 31, 2014. The increase of $3.4 million was primarily due to net proceeds of $43.8 million from the sale of common and preferred shares and from the exercise of warrants, stock options and stock purchase rights, partially offset by $38.7 million of net cash used in operating activities and $1.7 million of principal payments against notes payable. This capital is expected to be sufficient to fund operations through the first quarter of 2017.

Revenues for the three months and year ended December 31, 2015 were $0.7 million and $3.1 million, as compared to $0.9 million and $5.7 million for the same periods in 2014. Revenue in each period was primarily due to deferred revenue recognized related to the royalty agreement with Royalty Pharma.

Research and development expenses were $7.6 million and $23.7 million for the three months and year ended December 31, 2015, from $6.0 million and $27.7 million for the same periods in 2014, primarily relating to the vosaroxin development program in each year. The decrease of $4.0 million in 2015 was primarily due to a decrease of $5.4 million in clinical trial expenses, partially offset by increases of $0.9 million in personnel costs (including an increase of $0.5 million in stock-based compensation expense), and $0.5 million in other outside services and consulting costs.

General and administrative expenses for the three months and year ended December 31, 2015 were $4.4 million and $18.7 million, as compared to $6.1 million and $23.1 million in 2014. The decrease of $4.5 million in 2015 was due to a decrease of $4.5 million in professional services and personnel costs.

Interest expense was $0.2 million and $0.9 million for the three months and year ended December 31, 2015 as compared to $0.3 million and $1.7 million for the same periods in 2014. The decreases in 2015 were due to the reduced principal balance outstanding on notes payable to the Lenders under the Loan Agreement.

Net other income was nil and $3.6 million for the three months and year ended December 31, 2015, as compared to $10.1 million and $3.8 million for the same periods in 2014. The 2014 and 2015 amounts were primarily comprised of non-cash credits for the revaluation of warrants issued in an underwritten offering in 2010.

Cash used in operations was $38.7 million for the year ended December 31, 2015, as compared to $43.2 million for the same period in 2014.

Sunesis reported loss from operations of $11.3 million and $39.3 million for the three months and year ended December 31, 2015, as compared to $11.2 million and $45.0 million for the same periods in 2014. Net loss was $11.6 million and $36.7 million for the three months and year ended December 31, 2015, as compared to $1.3 million and $43.0 million for the same periods in 2014.

About QINPREZO (vosaroxin)

QINPREZO (vosaroxin) is an anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Preclinical data demonstrate that vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (FDA) and European Commission have granted orphan drug designation to vosaroxin for the treatment of AML. Additionally, vosaroxin has been granted fast track designation by the FDA for the potential treatment of relapsed or refractory AML in combination with cytarabine. Vosaroxin is an investigational drug that has not been approved for use in any jurisdiction.

The trademark name QINPREZO is conditionally accepted by the FDA and the EMA as the proprietary name for the vosaroxin drug product candidate.

On March 10, 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 fourth quarter and year ended December 31, 2015 (Press release, Idera Pharmaceuticals, MAR 10, 2016, View Source;p=RssLanding&cat=news&id=2147485 [SID:1234509461]).

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During the fourth quarter of 2015 we:

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);

Initiated a Phase 2 clinical trial of IMO-8400 in patients with dermatomyositis;

Entered into a collaboration and license agreement with GSK to identify, develop and commercialize 3rd Generation Antisense (3GA) molecules for treatment of renal diseases;

Announced first two gene targets for internal development from 3GA platform;

Initiated a Phase 1/2 clinical trial of intra-tumoral IMO-2125 in combination with ipilimumab in patients with metastatic melanoma;

Presented additional pre-clinical IMO-2125 data at AACR (Free AACR Whitepaper)-NCI-EORTC International Conference; and

Announced several key leadership appointments, including new Chief Medical Officer, Dr. Joanna Horobin.

"2015 represented a foundational and momentum-building period for Idera," stated Vincent Milano, Idera’s Chief Executive Officer.
"As a company we made meaningful progress in 2015, particularly in the fourth quarter as we presented the first positive clinical data from our IMO-8400 study in Waldenstrom’s Macroglobulinemia, which strengthens our belief that 8400 has the potential to ultimately become a real-world solution for physicians treating patients suffering from B-cell malignancies. We also further built upon our clinical pipeline by advancing IMO-8400 into clinical development for the treatment of dermatomyositis and initiated the first clinical study of intra-tumoral IMO-2125 in combination with a check point inhibitor, which represents the first step in our immuno-oncology strategy. Finally, our research team continued the advancement of our 3GA platform, and also conducted numerous in-house preclinical studies to guide and support all of our various clinical development programs."

Continued Milano, "Overall, I am pleased with the progress made to date on many levels within the Idera organization, and also cognizant of the fact that we have much more work ahead of us. I am confident that if we continue to focus on the overall goal of delivering solutions to patients suffering severe unmet medical needs, we will achieve success and ultimately deliver the value our shareholders deserve."

Research and Development Program Updates
IMO-8400 and IMO-2125 are our lead clinical development drug candidates. IMO-8400 is an oligonucleotide-based antagonist of Toll-like receptors (TLRs) 7, 8, and 9. IMO-2125 is an oligonucleotide-based agonist of TLR9. The company also announced during the fourth quarter, 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).

Toll-like Receptor (TLR) Agonism

Immuno-Oncology Program
Idera’s development program in immuno-oncology is based on pre-clinical studies that demonstrated through the mechanism of intra-tumoral injections of the TLR9 agonist, IMO-2125, the tumor microenvironment could be impacted in a manner which positively increases the efficacy of check-point inhibition. These studies have lead Idera into a strategic research alliance with the University of Texas MD Anderson Cancer Center to clinically explore the combination of 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 in patients with relapsed or refractory Metastatic Melanoma being conducted at the University of Texas MD Anderson Cancer Center. Additionally, the company will present new preclinical data demonstrating the combination of IMO-2125 and indoleamine-pyrolle 2,3-dioxygenase (IDO) in cancer models at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting on Tuesday, April 19th in New Orleans, LA.

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, in certain B-cell lymphomas that the presence of the MYD88 L265P oncogenic mutation led to over-activation of TLR7 and TLR9 signaling and that blocking these TLRs with our antagonists promoted 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. Subsequently, the company also announced plans to continue further dose escalation of IMO-8400 in both the ongoing trials in Waldenstrom’s Macroglobulinemia and Diffuse Large B-cell Lymphoma to further explore the full potential of IMO-8400 based on the safety profile and efficacy signals seen to date.

Idera previously announced that the U.S. Food and Drug Administration (FDA) granted us 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. The company is also announcing that due to the resources required to fully commit to a Duchenne muscular dystrophy (DMD) clinical development endeavor, the company has reached the decision to suspend internal efforts at this time to advance IMO-8400 into clinical development for DMD.

Third Generation Antisense Platform
Throughout 2015, the company undertook an analysis and prioritization of oncology and rare disease indications for potential development of drug candidates derived from our 3GA technology platform. The key considerations in identifying disease indications from our third generation antisense program included: strong evidence that the disease is caused by a specific protein; clear criteria to identify a target patient population; biomarkers for early assessment of clinical proof-of-concept; a targeted therapeutic mechanism for action; and unmet medical need to allow for a well-defined development path to approval and commercial opportunity. As a result of this analysis, in the fourth quarter of 2015 Idera announced the selection 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 include, but are not limited to interstitial cystitis, uveitis and facioscapulohumeral muscular dystrophy (FSHD), respectively. The company is currently conducting clinical and regulatory pathway and commercial analysis activities in advance of conducting full IND-enabling studies throughout the remainder of 2016, with the plan to enter the clinic in 2017 for the first disease indication.

Also during the fourth quarter of 2015, Idera announced the first licensing agreement from the 3GA platform. The company entered into a worldwide collaboration and licensing agreement with GSK to research, develop and commercialize selected molecules from the platform for the treatment of selected undisclosed targets in renal disease. Under the terms of the agreement, Idera is eligible to receive approximately up to $100 million in development and regulatory milestone payments, including a $2.5 million upfront payment. Additionally, Idera is eligible to receive royalties on all sales upon commercialization at varying rates up to five percent on annual net sales in excess of $500 million.

Recent Corporate Highlights

During the fourth quarter of 2015, Idera announced the following additions to company leadership:

Joanna Horobin, M.B. Ch.B. as Senior Vice President, Chief Medical Officer
Mark J. Cornfeld, M.D., M.P.H. as Vice President and Medical Lead, Oncology
Tanya Lewis, as Vice President, Regulatory Affairs and Quality
John Kirby, as Vice President, Corporate Accounting
Kirsten Gruis, M.D., M.S. as Senior Medical Director, Rare Diseases
Financial Results

Fourth Quarter Results

Net loss applicable to common stockholders for the three months ended December 31, 2015 was $12.0 million, or $0.10 per basic and diluted share, compared to a net loss applicable to common stockholders of $12.0 million, or $0.14 per basic and diluted share, for the same period in 2014. There was nominal revenue recognized in each of the fourth quarters of 2015 and 2014. Research and development expenses for the three months ended December 31, 2015 totaled $8.6 million compared to $8.2 million for the same period in 2014. General and administrative expense for the three months ended December 31, 2015 and December 31, 2014 totaled $3.7 million, respectively.

Full Year Results

Net loss applicable to common stockholders for the year ended December 31, 2015 was $48.6 million or $0.42 per diluted share, compared to net loss applicable to common stockholders of $39.2 million, or $0.47 per diluted share, for the same period in 2014. There was nominal revenue recognized during the years ended December 31, 2015 and 2014. Research and development expenses for the year ended December 31, 2015 totaled $33.7 million compared to $27.5 million for the same period in 2014. General and administrative expenses for the year ended December 31, 2015 totaled $15.4 million compared to $11.3 million for the same period in 2014.

As of December 31, 2015, our cash, cash equivalents and investments totaled $87.2 million compared to $48.6 million as of December 31, 2014. We currently anticipate our cash position is capable of funding our operations into the third quarter of 2017.

On March 10, 2016 Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), reported a publication in Nuclear Medicine and Biology, the official journal of the Society of Radiopharmaceutical Sciences, which describes the clinical linkage between immunodiagnostic and immunotherapeutic agents (Press release, Navidea Biopharmaceuticals, MAR 10, 2016, View Source;p=RssLanding&cat=news&id=2147463 [SID:1234509457]). This process is exemplified by the self-transforming nature of Navidea’s Manocept immunotargeting platform which provides high specificity against receptor-bearing targets and is a promising approach to immunotherapy.

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The first product of the Manocept platform, Lymphoseek (technetium Tc 99m tilmanocept) injection was launched as a novel immunodiagnostic agent approved by the FDA and used in breast, melanoma and oral cavity cancer sentinel lymph node biopsy (SLNB) procedures. Lymphoseek has demonstrated its effectiveness through many evidence-based studies in SLNB, due to its unique structure and targeting of CD206 found on macrophages in tumor-draining lymph nodes. Its Manocept backbone, enabled by the ability to interchange radionuclides for biological modifier molecules, has the potential to target macrophage-mediated diseases and deliver an effective, specifically targeted drug for purposes of disease treatment and reducing or eliminating side effects.

"Past therapeutic strategies attempting to harness the power of the immune system to manage, treat or kill macrophages in disease states like cancer and inflammatory conditions have had limited to no success," said Michael S. McGrath, M.D., Ph.D., Professor, Departments of Laboratory Medicine, Pathology, and Medicine at the University of California, San Francisco (UCSF). "The Manocept platform possesses a unique potential to not only target aberrant macrophages for detection or treatment but also shields non-affected cells, which could profoundly address broad unmet needs for patients both diagnostically and therapeutically."

"These newly published results highlight the remarkable specificity and sensitivity of the Manocept platform, and its plasticity which allow it to exploit the natural history of macrophage-mediated diseases," said Frederick O. Cope, Ph.D., M.S., FACN, Navidea’s Chief Scientific Officer. "It is rare to find a platform that selectively targets activated macrophages, which are central to the immune system. These results provide further validation of the Manocept platform, as we continue to build a pipeline of additional immunodiagnostic and immunotherapeutic products across oncology, inflammatory and infectious diseases."

Summary of Results

A series of studies supported by patient exposure to immunodiagnostic imaging drug, targeting studies, patient explant studies, and in vivo and ex vivo animal data examined Manocept agents including 99mTc-tilmanocept, Cy3-tilmanocept, and Manocept-doxorubicin. These studies validated the self-transforming nature of the Manocept platform from immunodiagnostic imaging to effective Manocept therapeutic targeting. Data from studies in several macrophage-mediated diseases including Kaposi’s sarcoma, rheumatoid arthritis, and cardiovascular disease show that Manocept platform compounds bind almost exclusively to human macrophages and that the mannose receptor (CD206) is the major receptor for its recognition. For complete details of the studies, findings and results, "The Inextricable Axis of Targeted Diagnostic Imaging And Therapy: An Immunological Natural History Approach" appears in the March 2016 print journal Nuclear Medicine and Biology. 2016 Nuclear Medicine and Biology. Volume 43, Issue 3, Pages 215–225. [doi: 10.1016/j.nucmedbio.2015.11.007].

About Lymphoseek

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

Accurate diagnostic evaluation of cancer is critical, as results guide therapy decisions and determine patient prognosis and risk of recurrence. Overall in the U.S., solid tumor cancers may represent up to 1.2 million cases per year. The sentinel node label in the U.S. and Europe may address approximately 600,000 new cases of breast cancer, 160,000 new cases of melanoma and 100,000 new cases of head and neck/oral cancer diagnosed annually.

Lymphoseek Indication and Important Safety Information

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

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

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

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

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

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

FULL LYMPHOSEEK PRESCRIBING INFORMATION CAN BE FOUND AT: WWW.LYMPHOSEEK.COM