On March 11, 2016 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported financial results for the year ended December 31, 2015, and provided an overview of recent accomplishments and upcoming milestones for its research and development programs (Filing, Annual, CytRx, 2015, MAR 10, 2016, View Source [SID:1234509488]).

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"2015 was an important year as CytRx achieved several key milestones, including completing the enrollment of our global, pivotal Phase 3 trial with aldoxorubicin one quarter ahead of schedule," said Steven A. Kriegsman, CytRx’s Chairman and CEO. "We unveiled our LADRTM technology platform and nominated DK049 as the next drug candidate for clinical development. Additionally, as we prepare for aldoxorubicin’s commercial launch, we welcomed Olivia Ware as Chief Commercial Officer and three new members to the Board of Directors: Cheryl Cohen, former Chief Commercial Officer at Medivation who led the launch of Xtandi, Anita Chawla, Ph.D., a health economics, pricing and reimbursement expert formerly at Genentech, and Eric Selter, an investment professional at Morton Capital Management, LLC."

Fourth Quarter 2015 and Recent Highlights

Announced $40 Million Long-Term Debt Facility. In February 2016, CytRx announced that it entered into a long-term loan agreement with Hercules Technology Growth Capital and received an initial amount of $25 million. An additional $15 million can be accessed at CytRx’s option, subject to achieving certain R&D milestones by December 31, 2016.

Appointed Olivia Ware as Chief Commercial Officer. In January 2016, Ms. Ware joined CytRx as Chief Commercial Officer. She brings more than 20 years of biotechnology and pharmaceutical experience including 13 years at Genentech where she was responsible for key aspects of the launches of the oncology drugs Rituxan, Herceptin and Avastin.

Completed Enrollment in Pivotal Global Phase 3 Trial Ahead of Schedule. In December 2015, CytRx announced that the Phase 3 clinical trial with aldoxorubicin for the treatment of second-line soft tissue sarcomas reached the target enrollment of 400 patients. It was originally estimated to be completed in Q1 2016. Top-line results from this trial are expected in Q2 2016.

Nominated DK049 for Clinical Development. In December 2015, CytRx announced that DK049 has been selected for advancement into clinical trials. DK049 incorporates a novel two-stage linker from the LADRTM technology platform and has demonstrated significant anti-tumor activity in animal models of non-small cell lung cancer, ovarian and pancreatic cancers.

Announced the Settlement of Consolidated Securities Class Action Lawsuit. In December 2015, CytRx agreed to settle its class action lawsuits to avoid potentially lengthy and costly litigation. The Company believes the allegations are completely without merit and the settlement contains no admission of liability or wrongdoing. The agreement provides for a payment in cash of $4,000,000 of which CytRx’s insurance carriers will cover at least $3,500,000, and between 1,200,000 and 1,800,000 shares of common stock depending on the prevailing stock price at the time of the court’s final approval of the settlement.

Presented Aldoxorubicin Combination Data at the 2015 CTOS Annual Meeting. In November 2015, Sant Chawla, M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center, presented data from the Phase 1b/2 clinical trial of aldoxorubicin in combination with ifosfamide/Mesna at the 21st Annual Connective Tissue Oncology Society (CTOS) Annual Meeting in Salt Lake City, Utah. At the time of the meeting, eight of 10 patients with soft and non-soft tissue sarcomas treated with the combination demonstrated tumor shrinkage include three partial responses. This trial is ongoing.

Reported Update on Aldoxorubicin Clinical Trial in Glioblastoma. In November 2015, CytRx announced the completion of enrollment in the Phase 2 clinical trial evaluating aldoxorubicin in patients with unresectable glioblastoma (GBM). To date, aldoxorubicin has shown evidence of tumor shrinkage. Patients continue to be followed as overall survival has not yet been reached.

Upcoming Milestones

· Present data on DK049 and the LADRTM technology platform at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual (AACR) (Free AACR Whitepaper) Meeting in April 2016

· Announce top-line data from the global, pivotal Phase 3 clinical trial of aldoxorubicin as second-line treatment in patients with soft tissue sarcomas in the next quarter ending June 30, 2016. Subject to FDA approval, the Company projects aldoxorubicin’s market launch in 2017

· Initiate rolling New Drug Application (NDA) submission by the end of 2016

· Announce overall survival data from the ongoing Phase 2 glioblastoma trial in the second half of 2016

· Complete Phase 1b clinical trial with combination of aldoxorubicin and ifosfamide/mesna as first-line treatment for advanced sarcomas in the second half of 2016

· Complete Phase 1b clinical trial with combination of aldoxorubicin and gemcitabine in metastatic solid tumors in the second half of 2016

· File Investigational New Drug (IND) Application for DK049 by the end of 2016

· Announce top-line results from the Phase 2b clinical trial of aldoxorubicin as second-line treatment in patients with small cell lung cancer

· Nominate next drug candidate using LADRTM technology for clinical development by the end of 2016.

Full Year 2015 Results

CytRx reported cash, cash equivalents and short-term investments of $57.3 million as of December 31, 2015. CytRx then added $25.0 million in February 2016 to its cash through a $40.0 million long-term debt facility.

Net loss for the year ended December 31, 2015, was $58.6 million, or $(0.97) per share, compared with a net loss of $30.1 million, or $(0.55) per share, for the year ended December 31, 2014. In 2015, the Company recognized a non-cash gain of $4.4 million on the fair value adjustment of warrant derivative liability related to warrants issued in August 2011 and July 2009, compared to a non-cash gain of $19.1 million in 2014. The Company reported licensing revenue of $100,000 in 2015, compared to $100,000 in 2014.

Research and development (R&D) expenses were $43.4 million for 2015, and included development expenses of $37 million for aldoxorubicin, approximately $1.7 million for pre-clinical development of new albumin-binding cancer drugs (German lab), and approximately $3.6 million for general operation of our clinical programs. R&D expenses were $36.7 million for 2014.

General and administrative (G&A) expenses were $19.7 million for 2015, compared with $12.8 million for 2014. G&A expenses for 2015 included a non-cash litigation settlement expense of $4.5 million for the eventual issuance of our common shares. They also included non-cash stock-compensation expense of $5.8 million and $4.1 million for 2015 and 2014, respectively.

(Filing, Annual, BioLineRx, 2015, MAR 10, 2016, View Source [SID:1234509467])

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On March 10, 2016 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, reported its financial results for the year ended December 31, 2015 (Press release, BioLineRx, MAR 10, 2016, View Source;p=RssLanding&cat=news&id=2147470 [SID:1234509454]).

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Kinneret Savitsky, Ph.D., CEO of BioLineRx, remarked, "2015 was a year of significant progress for BioLineRx on several fronts, as we advanced our lead therapeutic clinical programs both from a development and regulatory perspective, and entered into an exciting new collaboration in the immuno-oncology space."

"During the past year, we enhanced and expanded the development strategy for our BL-8040 cancer therapy platform, which is currently being investigated for multiple cancer and hematological indications. These include a Phase 2 study for treating relapsed and refractory AML patients, top line results of which are expected by the end of this month. Results from the first part of this trial continue to demonstrate substantial mobilization of leukemic cells from the bone marrow to the peripheral blood and robust induction of cancer cell apoptosis, which, combined with the reported 38% composite remission rate, strongly suggest that BL-8040 has potent anti-leukemic activity. In addition, we are also assessing BL-8040 as an AML consolidation treatment in a large Phase 2b study that is currently up and running at full steam. Successful top-line safety and efficacy results were also reported from a Phase 1 study in stem cell mobilization, supporting BL-8040 as one-day, single-dose collection regimen, which is a significant improvement upon the current standard of care. We now await receipt of regulatory approval in order to begin, by the end of the month, a Phase 2 trial for BL-8040 as a stem cell mobilizer for allogeneic transplantation. Finally, we are advancing an ongoing Phase 1/2 study for BL-8040 as a novel treatment for hMDS and AA, two bone marrow failure conditions."

"We recently entered the exciting field of immuno-oncology through our collaboration with Merck, a pioneer and world leader in cancer immunotherapy. A Phase 2 study is planned to commence by mid-year investigating BL-8040 in combination with KEYTRUDA, Merck’s anti-PD-1 immunotherapy, in patients with metastatic pancreatic cancer. Although there have been significant advances in the immuno-oncology field, many cancer types, such as pancreatic cancer, remain resistant to immunotherapy, and combination treatments appear to offer a better chance to treat these cancers. We are therefore enthusiastic about this opportunity to evaluate the potential of our lead drug candidate as a combination therapy with immune checkpoint inhibitors. We are also planning to commence a Phase 2a trial for BL-8040 in the second half of 2016, for the treatment of AML patients with the FLT3-ITD mutation. With the guidance and insight of our newly established Oncology Scientific Advisory Board, consisting of world-renowned key opinion leaders, we look forward to realizing the potential of this promising oncology platform and to reaching several meaningful development milestones during 2016."

"BL-7010, for the treatment of celiac disease and gluten sensitivity, which was found to be safe and well tolerated in a Phase 1/2 trial in celiac patients, has recently received confirmation for the medical device designation pathway in Europe. Over the past year, we have invested considerable efforts in examining the potential of BL-7010 as a food supplement, in order to address the multi-billion dollar market for gluten sensitivity, which we believe has a significantly shorter time to market than drug or device pathways, especially in the US market. We are currently conducting a number of activities towards the development of BL-7010 as a food supplement, including the development of a suitable product formulation, preparation of the documents necessary for a GRAS designation submission, and preparations for a relatively small clinical trial to support future marketing efforts. We expect to complete these activities by mid-2017, in order to support future expected partnering discussions for the food supplement market in the US and other relevant territories. We also plan to continue to evaluate the pathway in Europe for celiac disease and intend to make a decision about the timing and scope of the next efficacy study for European registration over the next few months."

"Regarding BL-5010, our partner Omega Pharma, now part of Perrigo, is swiftly progressing with its development as an OTC solution for the non-surgical removal of benign skin lesions. Omega Pharma submitted a CE Mark application for BL-5010 during the third quarter of 2015, and has completed the initial manufacturing process automation to support the product’s commercial launch, expected during 2016. We also look forward to the potential expansion of this product to other markets and to non-OTC indications."

"During 2015, we invested significant efforts in our new strategic collaboration with Novartis and have been jointly evaluating promising therapeutic candidates to be developed under the collaboration. In addition, we continue to explore other collaboration possibilities for maximizing the value of our current pipeline assets, including some of our non-core programs."

Dr. Savitsky concluded, "Yesterday, we announced the appointment of Dr. Merril Gersten as our new Chief Scientific Officer. Merril brings with her many years of leadership in both academia and the pharma industry in the US. I am confident that she will bring great value to BioLineRx and I am very excited to begin working with her. Finally, with almost $48 million on our balance sheet, we remain well capitalized to execute on our development programs and achieve significant milestones across our expanded therapeutic pipeline well into 2018."

Financial Results for Year Ended December 31, 2015

Research and development expenses for the year ended December 31, 2015 were $11.5 million, a decrease of $0.4 million, or 3.4%, compared to $11.9 million for the year ended December 31, 2014. The decrease resulted primarily from a decrease in spending on BL-7010 and various other projects, partially offset by increased spending on BL-8040.

Sales and marketing expenses for the year ended December 31, 2015 were $1.0 million, a decrease of $0.6 million, or 37.5%, compared to $1.6 million for the year ended December 31, 2014. The decrease resulted primarily from professional fees related to business development activities carried out in 2014, including professional services related to the strategic collaboration agreement with Novartis and the out-licensing agreement with Omega Pharma regarding BL-5010.

General and administrative expenses for the year ended December 31, 2015 were $3.7 million, a decrease of $0.1 million, or 2.6%, compared to $3.8 million for the year ended December 31, 2014. The decrease primarily resulted from a decrease in salary-related payments, partially offset by a small increase in professional fees.

The Company’s operating loss for the year ended December 31, 2015 amounted to $16.2 million, compared with an operating loss of $17.3 million for the year ended December 31, 2014.

The Company recognized net non-operating income of $1.4 million for the year ended December, 2015, compared to net non-operating income of $3.1 million for the year ended December 31, 2014. Non-operating income for both periods primarily relates to fair-value adjustments of liabilities on account of warrants issued in the private and direct placements conducted in February 2012 and 2013. These fair-value adjustments were highly influenced by the Company’s share price at each period end (i.e., warrant revaluation date).

Net financial income amounted to $0.4 million for the year ended December 31, 2015, compared to net financial income of $3.1 million for the year ended December 31, 2014. Net financial income for 2015 primarily relates to investment income earned on bank deposits, partially offset by banking fees. The 2014 period also includes significant exchange rate differences primarily relating to changes in the USD/NIS exchange rate prior to adoption of the dollar as the Company’s functional and reporting currency, effective as of January 1, 2015.

The Company’s net loss for the year ended December 31, 2015 amounted to $14.4 million, compared with a net loss of $11.1 million for the year ended December 31, 2014.

The Company held $47.7 million in cash, cash equivalents and short-term bank deposits as of December 31, 2015.

Net cash used in operating activities for the year ended December 31, 2015 was $14.2 million, compared to $15.8 million for the year ended December 31, 2014. The decrease in net cash used in operating activities in 2015 was primarily the result of a decrease in the Company’s operating loss.

Net cash used in investing activities for the year ended December 31, 2015 was $15.6 million, compared to $19.7 million for the year ended December 31, 2014. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits and other investments during the respective periods.

Net cash provided by financing activities for the year ended December 31, 2015 was $29.5 million, compared to $32.6 million for the year ended December 31, 2014. The cash flows in 2015 primarily reflect the underwritten public offering of the Company’s ADSs in March 2015. The cash flows in 2014 primarily reflect the underwritten public offering of the Company’s ADSs in March 2014, as well as the investment made by Novartis pursuant to the strategic collaboration agreement with them signed in December 2014.

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 (Filing, Q4/Annual, Five Prime Therapeutics, 2015, MAR 10, 2016, View Source [SID:1234509490]).

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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 income tax payments. The company estimates ending 2016 with approximately $400 million in cash, cash equivalents and marketable securities.

On March 10, 2016 Committed to technologies that assist in the goal of reducing lung cancer morbidity worldwide, Medtronic (NYSE: MDT) reported European enrollment in the NAVIGATE clinical trial (Press release, Medtronic, MAR 10, 2016, View Source;p=RssLanding&cat=news&id=2147494 [SID:1234509456]). This 2,500-patient international study will assess the long-term impact of its superDimension(TM) navigation system as an aid in early detection of lung cancer and subsequent treatment.

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The superDimensionsystem uses LungGPS(TM) technology, the first of its kind to enable Electromagnetic Navigation Bronchoscopy (ENB) procedures. ENB procedures provide a minimally invasive approach to access difficult-to-reach areas of the lung, which can aid in the diagnosis of lung disease, can help patients avoid surgery for benign disease and other invasive procedures like transthoracic needle aspiration, and lead to earlier, personalized treatment – potentially saving lives. The superDimension system has received CE Mark in Europe, 510(k) clearance in the US and has also been approved for use in numerous international markets.

"Early detection, diagnosis and intervention are crucial to the survival of people living with lung cancer," said Mag. Petra Lichtenberger, Assistant to Prof. Dr. Lamprecht at the Department of Pulmonology of Kepler University Clinic Linz, Austria, which enrolled the first ENB patient in Europe. "Technology that allows medical professionals to view areas of the lung that could not be accessed before is a major advance that is changing the landscape of lung cancer diagnosis and helping save patient lives."

Up to 75 centers around the world will enroll patients in the single-arm, multi-center post-market observational study designed to evaluate the impact of ENB procedures on early diagnosis and treatment. The NAVIGATE study will also determine the success rate of physicians using the technology to obtain biopsy samples from the surrounding lymph nodes. In addition, the study will assess the effectiveness of physicians’ placement of fiducial markers or dyes to guide subsequent procedures to treat or remove lung tumors.

More than 22 sites have been activated to enroll patients since the study first launched in the U.S. in April 2015. Healthcare professionals will follow patients for 24 months.

"The NAVIGATE study represents our commitment to delivering meaningful solutions that support the early detection and treatment of lung cancer to save patient lives," said Vafa Jamali, president, Early Technologies business in the Medtronic Minimally Invasive Therapies Group. "The enrollment of patients in Europe for the NAVIGATE study is a significant milestone and an important step to help establish ENB procedures as the gold standard for detecting lung cancer in the earlier, more curable stages."

According to the World Health Organization, lung cancer is the number one cancer killer in the world, accounting for 1.59 million deaths in 2012.1 In its early stages, lung cancer presents few, if any, symptoms. As a result, diagnosis for the vast majority of lung cancer patients happens in the late stages, and long-term survival rates drastically decline. When diagnosed early, an estimated 85 percent of lung cancer cases appear at a more curable stage.2 Early detection and immediate treatment dramatically increases the typical long-term survival rate from 15 percent at five years3 to 88 percent at 10 years.

To date nearly 100,000 ENB procedures have been performed globally at more than 600 hospitals commercially and as part of prior clinical trials.

Additional information about the NAVIGATE study and enrolling sites can be found at clinicaltrials.gov/ct2/show/NCT02410837.

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