On March 10, 2016 Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, reported financial results and a corporate update for the fourth quarter and full year ended December 31, 2015 (Press release, Immune Design, MAR 10, 2016, View Source [SID:1234509478]).

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Corporate Update and Recent Highlights

New positive data support continued development of Immune Design’s wholly-owned immuno-oncology product candidates.

LV305, the novel vector component of CMB305 that delivers NY-ESO-1 RNA specifically to dendritic cells in vivo, has achieved full patient enrollment in the Phase 1 study as a single agent. Updated data reveal:

A consistently favorable safety profile;

A consistent T cell immune response rate; and

An improved clinical benefit profile using progression-free survival (PFS) as an endpoint.

CMB305, a first-in-class prime-boost immunotherapy combining LV305 and G305, has completed a first-in-human dose-escalation study and is currently undergoing an expansion study as a single agent in patients with cancers expressing the NY-ESO-1 tumor antigen. Initial data indicate:

A favorable safety profile;

A large subset of patients generate or increase CD4 and CD8 T cells responses against NY-ESO-1; a boost effect is observed following G305 administration; and the T cell response appears more robust than that seen in the LV305 Phase 1 trial; and

Preliminary clinical benefit in the form of progression-free rate (PFR) in patients with soft tissue sarcoma.

Immune Design has received notification of orphan drug designation for soft tissue sarcoma for both components of CMB305 (LV305 and G305) in the United States and European Union.

G100, an intratumoral immune activation product candidate comprised of the TLR4 agonist, GLA, completed a Phase 1 study of patients with Merkel cell carcinoma. Building upon data previously reported in a subset of patients, the full data set from the completed trial reveal:

A consistently favorable safety profile;

Evidence of changes in the tumor microenvironment causing inflammation and transforming tumors to a "hot" state in G100-responding patients; and

Clinical benefit remained constant with the full patient set.

This, in addition to the positive preclinical data presented at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting through a collaboration with Dr. Ron Levy’s lab using the A20 NHL model, support the recently initiated Ph1/2 randomized trial testing G100 with or without KeytrudaTM in patients with NHL.

Abstracts for each of these three studies have been submitted for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (June 3-7, 2016).

New data continue to build on the potential of the GLAASTM platform outside of oncology.

In addition to the ongoing Phase 2 study of MEDI7510, MedImmune’s investigational agent for the prevention of Respiratory Syncytial Virus (RSV) that leverages the GLAAS platform, Immune Design presented data at the 2016 American Academy of Allergy, Asthma & Immunology (AAAI) Annual Meeting in March highlighting the ability of GLA to modify the abnormal allergic immune response observed in peripheral blood from patients with pollen allergies. These data build upon additional data showing the potential of the GLAAS platform to treat food allergies, as supported by the licensing agreement with Sanofi to develop therapeutic agents to treat peanut food allergy.
Financial Results

Full Year 2015

Immune Design ended the fourth quarter of 2015 with $112.9 million in cash and cash equivalents, compared to $75.4 million as of December 31, 2014. Net cash used in operations for the year ended December 31, 2015 was $37.8 million.

Net loss and net loss per share for the year ended December 31, 2015 were $39.4 million and $2.06, respectively, compared to $34.2 million and $4.56, respectively, for the same period in 2014.

Revenue for the year ended December 31, 2015 was $9.5 million and was attributable primarily to $4.2 million in collaboration revenue associated with the Sanofi Pasteur G103 collaboration established in the fourth quarter of 2014, $3.5 million in license revenue associated with the company’s collaborations with MedImmune and Sanofi Aventis, and $1.9 million in product sales. Revenue for the same period in 2014 was $6.4 million and was primarily attributable to $4.5 million in license revenue associated with Immune Design’s collaborations with MedImmune and Sanofi Aventis, $1.1 million in collaboration revenue associated with the Sanofi G103 collaboration established in the fourth quarter of 2014, and $0.8 million in product sales.

Research and development expenses for the year ended December 31, 2015 were $33.1 million, compared to $22.7 million for the same period in 2014. The $10.3 million increase was primarily attributable to continuing advancement of our ongoing research and development programs and Phase 1 and Phase 2 clinical trials. Research and development stock-based compensation (a non-cash expense), was $2.2 million for the year ended December 31, 2015.

General and administrative expenses for the year ended December 31, 2015 were $15.1 million, compared to $12.9 million for the same period in 2014. The increase of $2.2 million is primarily attributable to an increase in professional services fees, personnel and facility related expenses to support operations as a public company. General and administrative stock-based compensation (a non-cash expense), was $4.1 million for the year ended December 31, 2015.

Fourth Quarter

Net loss and net loss per share for the fourth quarter of 2015 were $12.1 million and $0.60, respectively, compared to $13.1 million and $0.78, respectively, for the fourth quarter of 2014.

Revenue for the fourth quarter of 2015 was $1.1 million and was attributable primarily to $0.9 million in product sales, and $0.2 million in collaboration revenue associated with the Sanofi Pasteur G103 collaboration established in the fourth quarter of 2014. Revenue for the fourth quarter of 2014 was $1.8 million and was attributable primarily to $0.7 million in product sales, and $1.1 million in collaboration revenue associated with Sanofi Pasteur G103 collaboration established in the fourth quarter of 2014.

Research and development expenses for the fourth quarter of 2015 were $8.9 million, compared to $8.8 million for the fourth quarter of 2014.

General and administrative expenses for the fourth quarter of 2015 were $4.0 million, compared to $5.5 million for the fourth quarter of 2014. The decrease of $1.5 million is primarily attributable to a decrease in legal and litigation costs.

On March 10, 2016 Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported a corporate update and reported financial results for the fourth quarter and full year ending December 31, 2015 (Press release, Five Prime Therapeutics, MAR 10, 2016, View Source [SID:1234509475]).

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"2015 was a transformational year for Five Prime," said Lewis T. "Rusty" Williams, M.D., Ph.D., president and chief executive officer of Five Prime. "Of note, our license and collaboration agreement with Bristol-Myers Squibb (BMS) maximizes the clinical and commercial potential of FPA008 and the exceptional terms have strengthened our financial position. In addition, we are encouraged by the early safety and efficacy data from FPA144 in patients with gastric cancer, and we look forward to assessing its potential in other indications. Beyond our clinical programs, we also made progress in our internal immuno-oncology research programs, and continue to be on track to file an IND application in 2017."

2015 Business Highlights and Recent Developments

Clinical Development:

FPA008: an investigational antibody that inhibits CSF1R and has been shown in preclinical models to block the activation and survival of monocytes and macrophages.

Established Exclusive Worldwide License and Collaboration Agreement with BMS for FPA008. In October 2015, Five Prime and BMS entered into an exclusive worldwide license and collaboration agreement for the development and commercialization of FPA008. Five Prime received a $350 million upfront payment during the fourth quarter and is eligible to receive up to $1.4 billion in development and regulatory milestone payments as well as royalty percentages ranging from the high teens to the low twenties on future worldwide net sales of FPA008. Five Prime also has an option to co-promote FPA008 in the United States.

Initiated Phase 1a/1b FPA008/OPDIVO Combination Trial. In September 2015, Five Prime initiated patient dosing in the Phase 1a/1b clinical trial evaluating the safety, tolerability and preliminary efficacy of the immunotherapy combination of FPA008 with OPDIVO (nivolumab), BMS’s PD-1 immune checkpoint inhibitor. Five Prime expects to expand into Phase 1b in multiple tumor settings in the second half of 2016.

Initiated Phase 1/2 Clinical Trial of FPA008 in Pigmented Villonodular Synovitis (PVNS). In the third quarter of 2015, Five Prime initiated patient dosing in its Phase 1/2 clinical trial in PVNS, a CSF1R-driven tumor and an orphan indication. The company expects to begin Phase 2 expansion, which will evaluate tumor response rate and duration as well as measures of pain and joint function, in mid-2016. The company submitted an epidemiology study focusing on the incidence and prevalence of this rare disease for presentation at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

FPA144: an anti-FGF receptor 2b (FGFR2b) Monoclonal Antibody Engineered to Recruit NK Cells into the Tumor Microenvironment. During the fourth quarter of 2015, Five Prime completed dose escalation in the ongoing Phase 1 trial of single-agent FPA144 and began dose expansion at a selected dose in new cohorts of gastric cancer patients whose tumors overexpress FGFR2b. In January 2016, Five Prime presented preliminary data from the dose escalation portion of the trial at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium, which showed:

Two partial responses in six gastric cancer patients with IHC 3+ FGFR2b-positive gastric cancer;

A partial response in a patient whose bladder cancer overexpressed FGFR2b; and

FPA144 was well tolerated and differentiated from small molecule kinase inhibitors targeting the pathway, which often cause hyperphosphatemia and other dose-limiting toxicities.

Based on results to date, Five Prime continues to evaluate FPA144 as a monotherapy in refractory gastric cancer, as a combination therapy for gastric cancer, and as a potential treatment for other types of cancer. The company submitted an abstract for presentation at the ASCO (Free ASCO Whitepaper) 2016 Annual Meeting in June and will present preclinical data regarding FPA144’s ability to reprogram immune cells in the tumor microenvironment at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2016.

FP-1039/GSK3052230, an FGF Ligand Trap. GlaxoSmithKline (GSK) presented data from the ongoing open-label Phase 1b trial in patients with squamous non-small cell lung cancer (sqNSCLC) and mesothelioma at the World Conference on Lung Cancer in September 2015. In January 2016, GSK and Five Prime agreed to stop enrollment in the sqNSCLC patient cohorts given the change in treatment paradigms following approvals of immuno-oncology agents and the increasingly competitive landscape in sqNSCLC. In addition, the companies agreed that GSK would continue to enroll mesothelioma patients based on encouraging preliminary data from the mesothelioma arm of the trial.

On March 9, 2016, GSK notified Five Prime that it was providing 180-day notice of termination of the FP-1039 license and collaboration agreement for convenience. Five Prime plans to work with GSK to ensure completion of enrollment in the ongoing mesothelioma arm of the Phase 1b study and to transfer the asset and program back to Five Prime. Five Prime continues to be encouraged by the progress of this Phase 1b trial. Mesothelioma could represent a potentially attractive market opportunity for a company like Five Prime. Five Prime will base decisions on future development of FP-1039 on whether the quality and durability of responses in this population is maintained in this trial. GSK has submitted mesothelioma data for presentation at the ASCO (Free ASCO Whitepaper) 2016 Annual Meeting.

Preclinical Research and Development:

Progressed Internal Immuno-Oncology Research Programs. During 2015, Five Prime continued to expand its immuno-oncology research efforts and advanced multiple candidates into preclinical development. The company continues to be on track to file an IND application in 2017.

Established New GITR Agonist Program. Five Prime in-licensed novel, potentially best-in-class, multivalent glucocorticoid-induced tumor necrosis factor receptor (GITR) antibodies from Inhibrx during the third quarter of 2015. Their unique multivalent format facilitates clustering of GITR on T cells, which should result in superior T cell activation compared to conventional antibodies.

Enhanced the Company’s Ability to Generate Therapeutic Antibodies and Move Them More Rapidly Toward IND Applications. In October 2015, Five Prime secured a license from Open Monoclonal Technology (OMT) to access mono- and bi-specific antibody platforms and antibody repertoire sequencing technology for the generation of novel therapeutic candidates. In December 2015, Five Prime obtained a license from Xoma Ltd. to one of Xoma’s proprietary phage display libraries for antibody discovery.

Other Licenses and Collaborations:

Entered into License Agreement with bluebird bio for Antibodies to Develop CAR T Cell Therapy. In May 2015, Five Prime granted an exclusive license to bluebird bio to research, develop and commercialize chimeric antigen receptor (CAR) T cell therapies using Five Prime’s proprietary human antibodies to an undisclosed target for hematologic malignancies and solid tumors. The agreement included a $1.5 million upfront payment and subsequent milestone payments to Five Prime, which together could total over $130 million per licensed product if certain development, regulatory, and commercial milestones are achieved. Five Prime is also eligible to receive tiered royalties on product sales.

GSK Exercised Options to Reserve Multiple Protein Targets Discovered by Five Prime for Respiratory Disease. GSK paid Five Prime $600,000 in target reservation fees.

Finance:

Completed Public Offering of Common Stock. In January 2015, Five Prime completed an underwritten public offering of common stock, raising net proceeds of $78.7 million.

Summary of Financial Results and Guidance:

Cash Position. Cash, cash equivalents and marketable securities totaled $517.5 million on December 31, 2015 compared to $149.1 million on December 31, 2014. The increase in year-end 2015 cash was primarily attributable to the $350 million upfront payment received in December 2015 from BMS for the FPA008 license and collaboration agreement.

Revenue. Collaboration revenue for the fourth quarter of 2015 increased by $358.7 million to $363.3 million from $4.6 million in the fourth quarter of 2014, primarily due to revenue recognized under the FPA008 license and collaboration agreement with BMS. Collaboration revenue for the full year 2015 increased by $360.6 million to $379.8 million in 2015 from $19.2 million in 2014 primarily due to revenue recognized under the collaborations with BMS, UCB and GSK.

R&D Expenses. Research and development expenses for the fourth quarter of 2015 increased by $8.4 million, or 67%, to $21.0 million from $12.6 million in the fourth quarter of 2014. Full year 2015 research and development expenses increased by $27.0 million, or 63%, to $70.2 million in 2015 from $43.2 million in 2014. This increase was primarily related to advancing the FPA008 program in immuno-oncology and PVNS, and advancing internal immuno-oncology research and preclinical activities, including expenses related to in-licensing GITR antibodies.

G&A Expenses. General and administrative expenses for the fourth quarter of 2015 increased by $4.6 million, or 115%, to $8.6 million from $4.0 million in the fourth quarter of 2014. Full year 2015 general and administrative expenses were $22.6 million, an increase of $9.0 million, or 66%, from $13.6 million in 2014. This increase was primarily due to increases in personnel related expenses, including stock-based compensation, facility costs and recruiting related to expansion of operations.

Net Income (Loss). Net income for the fourth quarter of 2015 was $296.1 million, or $11.37 per basic share and $10.63 per diluted share, compared to a net loss of $11.8 million, or $0.55 per basic and diluted share, for the fourth quarter of 2014. Full year 2015 net income was $249.6 million, or $9.73 per basic share and $9.23 per diluted share, compared to a net loss of $37.4 million, or $1.79 per basic and diluted share in 2014. These increases in net income were primarily related to the revenue recognized under the FPA008 license and collaboration agreement with BMS.

Cash Guidance. Five Prime expects full-year 2016 net cash used in operating activities to be less than $120 million, comprising less than $90 million used in operations and less than $30 million used for tax payments. The company estimates ending 2016 with approximately $400 million in cash, cash equivalents and marketable securities.

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.