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

On March 10, 2016 OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel cancer stem cell (CSC) and immuno-oncology therapeutics, reported financial results for the year and quarter ended December 31, 2015 and provided 2016 guidance (Press release, OncoMed, MAR 10, 2016, View Source [SID:1234509493]). As of December 31, 2015, pro-forma cash and marketable securities totaled $227.3 million, exceeding the company’s 2015 guidance of year-end cash of greater than $120 million. Full-year cash expense was $101.1 million, in line with the 2015 cash expense guidance of $100-$110 million.

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2016 Financial Guidance
For the full year 2016, based on its current plans and expectations, OncoMed anticipates total cash expenses in the range of approximately $110-$120 million. OncoMed projects a 2016 year-end cash balance of more than $100 million, before considering the receipt of any potential collaboration milestones or opt-in payments. Potential milestone and opt-in payments over the course of 2016, 2017, and 2018 total over $270 million. Existing cash is anticipated to fund company operations for at least two years, without taking into account potential future milestones or payments from partners. This is an increase from the 1.5 years of cash guidance announced in January 2016 and is the result of pipeline and budget prioritization and careful fiscal management.

"Having extended our runway to greater than two years cash — without taking into account potential milestones over the course of those two years — OncoMed is well positioned to execute on plan and continue to build value through the advancement and growth of our research and development pipeline," said Paul J. Hastings, Chairman and Chief Executive Officer. "We have a number of things to look forward to in 2016, including the advancement of three randomized Phase 2 trials, data from several earlier-stage clinical programs, and two new immuno-oncology programs moving toward IND filings in late 2016/early 2017."

Key 2016 Milestones and Anticipated Events
Demcizumab (anti-DLL4, OMP-21M18)

Initiate a Phase 1b trial of demcizumab plus anti-PD-1 (pembrolizumab) in solid tumor patients in the first quarter.

Present updated survival data from the demcizumab Phase 1b non-small cell lung cancer (NSCLC) trial mid-year, contingent upon abstract acceptance.

Complete enrollment in the Phase 2 YOSEMITE clinical trial of demcizumab plus Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin bound) plus gemcitabine in patients with first-line pancreatic cancer by year end. Data from this study are expected to be available in the first half of 2017.

Continue enrollment in the Phase 2 DENALI clinical trial of demcizumab plus carboplatin and pemetrexed in patients with first-line non-squamous NSCLC. Data from the Phase 2 DENALI trial are anticipated in late 2017-2018.

Data from YOSEMITE or DENALI trials could trigger a potential Celgene opt-in, leading to an as-yet undisclosed opt-in payment and the Phase 3 co-development and co-commercialization of demcizumab in the U.S.

Tarextumab (anti-Notch2/3, OMP-59R5)

Complete enrollment in the Phase 2 PINNACLE clinical trial of tarextumab plus platinum chemotherapy and etoposide in subjects with first-line extensive-stage small cell lung cancer by year end. Data from this study are expected to be available in early 2017. Data from PINNACLE could support an opt-in decision from GlaxoSmithKline (GSK) for the tarextumab program in the first half of 2017, resulting in a $25 million milestone payment to OncoMed, and the advancement of the program to a fully funded randomized Phase 3 trial funded and conducted by GSK.

Wnt Programs – Vantictumab (anti-Fzd7, OMP-18R5) and Ipafricept (Fzd8-Fc, OMP-54F28)

Present opt-in packages to Bayer for both vantictumab and ipafricept by late 2016/early 2017. Bayer can elect to exercise its option for vantictumab and/or ipafricept at any time through completion of the Phase 1b clinical trials. OncoMed could receive a total of $40 million with the potential opt-in by Bayer of these two programs, and the programs could be advanced to randomized Phase 2 clinical trials by Bayer.

Present clinical Phase 1b data from the vantictumab breast cancer and pancreatic cancer trials in 2016, contingent upon abstract acceptance.

Present clinical Phase 1b data from the ipafricept ovarian cancer and pancreatic cancer trials in 2016, contingent upon abstract acceptance.

Brontictuzumab (anti-Notch1, OMP-52M51)

Initiate Phase 1b clinical trial of brontictuzumab combined with chemotherapy in colorectal cancer patients including an expansion cohort of biomarker-selected patients. GSK and OncoMed have agreed to share out-of-pocket costs for the Phase 1b clinical trial and are currently in discussions to potentially extend GSK’s option through the end of the Phase 1b clinical trial. Currently, GSK may exercise its option for brontictuzumab at the end of Phase 1a or Phase 2 clinical trials.

Anti-DLL4/VEGF Bispecific (OMP-305B83)

Present data from the Phase 1a dose-escalation clinical trials of anti-DLL4/VEGF bispecific in the second half of the year, contingent upon dose-escalation and abstract acceptance.

In coordination with our partner, Celgene, initiate at least one Phase 1b anti-DLL4/VEGF bispecific clinical trial in combination with standard of care.

Completion of Phase 1b could trigger a potential Celgene opt-in, resulting in an as-yet undisclosed opt-in payment from Celgene and the potential co-development and co-commercialization of the program in the U.S.

Anti-RSPO3 (OMP-131R10)

Present data from the Phase 1a/b dose-escalation clinical trial of anti-RSPO3 in the second half of the year, contingent upon dose-escalation and abstract acceptance.

Completion of the Phase 1a/1b trial and delivery of the data could trigger a potential Celgene opt-in, resulting in an as-yet undisclosed opt-in payment from Celgene and the potential co-development and co-commercialization of the program in the U.S.

Immuno-Oncology Programs

Advance the immuno-oncology product candidate that is part of OncoMed’s collaboration with Celgene (IO#2) and OncoMed’s wholly owned GITRL-Fc program toward at least one Investigational New Drug (IND) application filing by the end of 2016. Both programs are currently advancing in IND-enabling preclinical studies.

OncoMed reiterated that over the course of the next three years (2016, 2017 and 2018), the company may be eligible to receive more than $270 million in potential opt-in and milestone payments from its partners: over $168 million from its collaboration with Celgene, $60 million from Bayer and over $43 million from GSK. OncoMed is eligible for more than $5 billion in total potential milestone and option payments from its collaboration agreements with Celgene, Bayer, and GSK. To date, OncoMed has received over $450 million from its existing partners.

Full Year and Fourth Quarter 2015 Financial Results
Pro-forma cash, cash equivalents and short-term investments at the end of 2015 totaled $227.3 million, including a $70.0 million safety milestone related to the demcizumab program from Celgene, compared to $232.0 million as of December 31, 2014. The cash decrease was driven by increased spending related to pipeline development, partially offset by a recaptured tax payment associated with the Celgene collaboration 2013 upfront payment, and the achievement of milestone revenues from collaborative partnerships.

Revenues for the full year 2015 totaled $25.9 million compared to $39.6 million in 2014. OncoMed achieved the $70.0 million safety milestone for demcizumab from Celgene, which was recorded as deferred revenue and will be amortized over the performance period. The year-over-year decrease was primarily due to the recognition of an $11.0 million development milestone in 2014 related to the tarextumab "ALPINE" clinical trial.

Fourth quarter 2015 recognized revenues decreased to $6.8 million compared to $8.5 million for the fourth quarter of 2014. The decrease was due to revisions to the estimated periods of performance, which extended the amortization of upfront payments for the company’s GSK and Bayer collaborations. In the fourth quarter 2015, OncoMed achieved a $2.5 million milestone from Celgene for the candidate designation of a novel undisclosed immuno-oncology program as well as the $70.0 million safety milestone for demcizumab which was recorded as deferred revenue and will be amortized over the performance period. In the fourth quarter 2014, OncoMed received a $2.5 million milestone from Celgene for the candidate designation of anti-RSPO3 (OMP-131R10).

Research and development (R&D) expenses for the full year ended December 31, 2015 were $92.9 million compared with $76.4 million for the year ended December 31, 2014. For the fourth quarter of 2015, R&D expenses were $26.7 million compared to $20.6 million for the fourth quarter of 2014. Increases in R&D expenditures for the full year and fourth quarter were primarily attributable to increased personnel expenses, as well as increased program costs associated with the advancement of OncoMed’s clinical-stage product candidates and preclinical pipeline.

General and administrative (G&A) expenses for the years ended December 31, 2015 and 2014 were $18.6 million and $13.8 million, respectively. For the fourth quarter of 2015 G&A expenses were $5.0 million compared to $3.6 million for the fourth quarter of 2014. Higher full-year and fourth quarter costs for 2015 were primarily attributable to increased personnel expenses, including an increase in headcount and stock-based compensation, higher legal patent expenses, and financial expenses related to the S-3 shelf registration filing in June 2015.

Net loss for the year ended December 31, 2015 was $85.4 million ($2.84 per share), compared to $50.0 million ($1.69 per share) for the year ended December 31, 2014. Non-GAAP net loss for the year ended December 31, 2015 was $21.4 million ($0.71 per share), compared to $78.1 million ($2.63 per share) for the year ended December 31, 2014. Net loss for the fourth quarter of 2015 was $24.8 million ($0.82 per share) compared to $15.1 million ($0.50 per share) for the same period of 2014. Non-GAAP net income was $45.3 million ($1.50 per share) compared to non-GAAP net loss of $18.9 million ($0.63 per share) for the same period of 2014. The change in net loss for the year and fourth quarter were primarily due to increases in operational expenses and lower milestone revenues. Non-GAAP net income was attributable to the Celgene $70.0 million safety milestone.

Recent Highlights
Demcizumab (anti-DLL4, OMP-21M18)

In December 2015, OncoMed received a $70.0 million safety-related milestone from Celgene based on an analysis of the OncoMed Phase 1b and blinded interim Phase 2 clinical trial safety data that were available at that time.
Data from the pancreatic, non-small cell lung and ovarian cancer clinical trials showed no demcizumab-related Grade 3 or higher cardio-pulmonary toxicities among 155 patients treated with truncated dosing. Of those, 68 patients had received at least two cycles of demcizumab at the Phase 2 dose or higher and had been followed for at least 100 days.
In January 2016, OncoMed presented updated Phase 1b survival data for demcizumab in combination with Abraxane plus gemcitabine in previously untreated pancreatic cancer patients at the Gastrointestinal Cancer Symposium (ASCO GI).
In 32 previously untreated patients, the updated Kaplan-Meier estimated median progression-free survival was 7.1 months and median overall survival was 12.7 months for the patients who received the demcizumab-gemcitabine-Abraxane combination.
OncoMed has completed enrollment of the Phase 1b clinical trial in advanced ovarian cancer patients and as part of budget and pipeline prioritization, and will not conduct the Phase 2 portion of that clinical trial at this time.

Tarextumab (anti-Notch2/3, OMP-59R5)

In January 2016, OncoMed discontinued dosing of the ALPINE randomized Phase 2 clinical trial of tarextumab with Abraxane plus gemcitabine in advanced first-line pancreatic cancer.

A pre-planned data safety monitoring board (DSMB) analysis indicated a statistically significant worsening of response rate and progression-free survival (PFS) in the treatment arm in the overall intent-to-treat population, as well as a negative trend in each Notch biomarker subgroup and a strong trend to lack of benefit in the treatment arm for overall survival (OS), regardless of Notch biomarker levels. OncoMed conducted its own exploratory analysis of the unblinded Phase 2 data and confirmed key findings by the DSMB regarding futility of the ALPINE trial. Post-hoc, exploratory analyses conducted by OncoMed revealed subgroups of patients with decreased survival and a subgroup which appears to exhibit improved survival with tarextumab treatment.

In February 2016, OncoMed determined it would continue the "PINNACLE" Phase 2 trial of tarextumab in small cell lung cancer following a review of unblinded safety and efficacy data from both the ALPINE and PINNACLE studies by the U.S. Food and Drug Administration (FDA) and the PINNACLE DSMB. The PINNACLE study remains blinded to OncoMed, investigators and patients. Data from the Phase 2 PINNACLE trial are anticipated in 2017.

In February 2016, OncoMed presented updated survival data from the Phase 1b clinical trial of tarextumab plus chemotherapy in small cell lung cancer at the 16th Annual Targeted Therapies of Lung Cancer Meeting.

These data showed an apparent correlation between doses of tarextumab and duration of response. In 15 patients who received higher doses of tarextumab (at or above 12.5 mg/kg every three weeks) in combination with standard-of-care therapy, median PFS of 5.8 months and median OS of 16 months were observed.

Wnt Programs – Vantictumab (anti-Fzd7, OMP-18R5) and Ipafricept (Fzd8-Fc, OMP-54F28)

In November 2015, OncoMed and Bayer amended their agreement to enroll up to 12 additional subjects in the ongoing Phase 1b clinical trial of vantictumab in breast cancer and up to 12 additional subjects in the ongoing Phase 1b clinical trial of ipafricept in ovarian cancer. Bayer has agreed to reimburse OncoMed for all out-of-pocket expenses to support this additional patient enrollment.

In February 2016, OncoMed agreed with Bayer to discontinue two of the six ongoing Phase 1b trials of vantictumab and ipafricept due to changing standard-of-care paradigms and to better focus enrollment efforts and resource allocation. OncoMed expects to close out the Phase 1b trials of vantictumab in NSCLC and of ipafricept in hepatocellular carcinoma in the first half of 2016.

Non-GAAP Financial Measures
To supplement OncoMed’s financial results presented on a GAAP basis, OncoMed uses non-GAAP measures of net income and net loss and earnings per share that exclude non-cash expenses related to stock-based compensation expense, depreciation and amortization and deferred rent adjustment, and include deferred revenue. OncoMed management uses these non-GAAP financial measures to monitor and evaluate its operating results and trends on an ongoing basis, and internally for operating, budgeting and financial planning purposes. OncoMed management believes that these non-GAAP measures help investors better evaluate the company’s past financial performance and potential future results. Non-GAAP measures should not be considered in isolation or as a substitute for comparable GAAP accounting and investors should read them in conjunction with the company’s financial statements prepared in accordance with GAAP. The non-GAAP measures of net income and net loss and earnings per share may be different from, and not directly comparable to, similarly titled measures used by other companies. A description of the non-GAAP calculations and reconciliation to comparable GAAP financial measures is provided in the accompanying table entitled "Reconciliation of Non-GAAP Financial Measures."

On March 10, 2016 SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) reported financial results for the quarter and year ended December 31, 2015 (Filing, Q4/Annual, SciClone Pharmaceuticals, 2015, MAR 10, 2016, View Source [SID:1234509495]).

· Revenues: Revenues for the full year 2015 were $157.3 million, compared to $134.8 million for the full year of 2014. In the fourth quarter of 2015, revenues were $42.9 million, compared to $41.4 million for the same period in 2014.

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· GAAP Diluted EPS: GAAP diluted earnings per share for the full year 2015 were $0.56, compared to $0.48 for the full year of 2014. In the fourth quarter of 2015, GAAP diluted earnings per share were $0.24, compared to $0.07 for the same period in 2014.

· Non-GAAP Diluted EPS: Non-GAAP diluted earnings per share for the full year 2015 were $1.00, compared to $0.75 for the full year of 2014. In the fourth quarter of 2015, non-GAAP diluted earnings per share were $0.30, compared to $0.29 for the same period in 2014.

For the year ended December 31, 2015, SciClone reported revenues of $157.3 million, a 17% increase compared to $134.8 million for the same period last year. ZADAXIN revenues were $146.1 million for the year ended December 2015, a $20.0 million or 16% increase, compared to $126.1 million last year. Promotion services revenues were $2.9 million for the year ended December 31, 2015, a $0.1 million or 4% increase, compared to $2.8 million last year. Revenues in the fourth quarter of 2015 were $42.9 million, a $1.4 million or 3% increase, compared to $41.4 million for the same period in 2014. ZADAXIN revenues were $40.2 million in the fourth quarter of 2015, a $1.2 million or 3% increase, compared to $39.0 million for the same period in 2014. Promotion services revenues were $0.9 million for the fourth quarter of 2015, a $0.2 million or 29% increase, compared to $0.7 million in the same period in 2014.

On a GAAP basis, SciClone reported net income for the year ended December 31, 2015 of $29.5 million, or $0.59 and $0.56 per share on a basic and diluted basis, respectively, after deducting $10.8 million in settlement expense for the US Securities and Exchange Commission (SEC) investigation recorded in the second quarter of 2015, compared with net income of $25.2 million, or $0.49 and $0.48 on a basic and diluted basis, respectively, for the same period in 2014. SciClone’s net income in the fourth quarter of 2015 was $12.5 million, or $0.25 and $0.24 per share on a basic and diluted

basis, respectively, compared to net income of approximately $3.5 million, or $0.07 per share on a basic and diluted basis for the same period in 2014.

As previously disclosed, in February 2016, SciClone entered into a settlement agreement with the SEC that fully resolved the SEC’s investigation. Under the terms of the settlement agreement, SciClone paid a total of $12.8 million, including disgorgement, prejudgment interest, and a penalty. The payment is in line with the charges SciClone previously recorded and disclosed in its Form 10-Q filed with the SEC on August 10, 2015. As part of the agreement, the Company neither admits nor denies it engaged in any wrongdoing. The Department of Justice (DOJ) has also completed its related investigation and has declined to pursue any action.

SciClone reported non-GAAP net income for the year ended December 31, 2015 of $52.2 million, or $1.05 and $1.00 per share on a basic and diluted basis, respectively, compared with non-GAAP net income of $39.7 million, or $0.77 and $0.75 on a basic and diluted basis, respectively, for the prior year. SciClone’s non-GAAP net income in the fourth quarter of 2015 was $15.5 million, or $0.31 and $0.30 per share on a basic and diluted basis, respectively, compared with non-GAAP net income of $15.4 million, or $0.30 and $0.29 per share on a basic and diluted basis, respectively, for the same period of the prior year.

Friedhelm Blobel, PhD, SciClone’s Chief Executive Officer commented: "We are very pleased with our overall 2015 financial results, including the continuing success and growth of ZADAXIN, as well as the full resolution of the SEC and DOJ investigations. These important accomplishments position us well to continue our growth trajectory in 2016. We are especially pleased with the continued strong demand for ZADAXIN, which grew 16% over the prior year and thus clearly faster than its generic competitors, and remains a major growth driver for our company. DC Bead continues to gain traction in the marketplace, supported by successful implementation of academic marketing strategies, as does our overall oncology portfolio and our promoted products."

"Despite macro-economic variables, the China pharmaceutical market grew about 8% to 9% in 2015, still significantly outpacing Western market growth rates, and continuing to represent meaningful opportunities for SciClone to continue to expand our business. The extensive regulatory reforms underway in China are showing signs of increasing the speed and efficiency of drug reviews and approvals. We anticipate that this trend will continue, and have a beneficial impact on our ability to advance our development portfolio."

"We are looking forward to conducting a full review of strategic alternatives with the goal of maximizing shareholder value. We continue to believe that SciClone represents a unique opportunity in the China pharma market, and that our commercial experience, reputation for high quality products, industry-leading compliance and partner-of-choice status should translate into opportunities to benefit our stakeholders."

For the year ended December 31, 2015, SciClone reported sales and marketing (S&M) expenses of $54.0 million, compared with $48.5 million for last year. For the fourth quarter of 2015, S&M expenses were $14.9 million, compared with $13.5 million for the same period in 2014. The increase in S&M for the fourth quarter of 2015, compared to the same period in 2014, related to increases in our sales and marketing efforts for ZADAXIN and DC Bead.

For the year ended December 31, 2015, SciClone reported research and development (R&D) expenses of $12.3 million, which included $7.5 million in upfront and milestone payments related to new in-license arrangements, primarily with Theravance Biopharma, Inc., compared with $14.6 million for last year, which included $11.0 million in upfront payments under our in-license arrangement primarily related to The Medicines Company for two cardiovascular products, Angiomax (bivalirudin) and Cleviprex (clevidipine). R&D expenses for the three months ended December 31, 2015 were $3.6 million which included $2.0 million in milestone payments under our in-license arrangements, compared with $11.6 million for the same period last year, which included $11.0 million in upfront payments as noted above which were recorded in the fourth quarter of 2014.

For the year ended December 31, 2015, SciClone reported general and administrative (G&A) expenses of $27.9 million, compared with $22.7 million for last year. For the fourth quarter of 2015, G&A expenses were $6.5 million, compared with $5.3 million for the same period in 2014, an increase of $1.2 million primarily related to our China entity restructuring, higher professional consulting fees for business development strategy, higher stock-based compensation expense, and lower credits to bad debt expense for recovery of previously written-off accounts receivable.

As of December 31, 2015, cash, cash equivalents and short-term investments totaled $101.4 million excluding the $12.8 million of restricted cash held in escrow as of December 31, 2015 for the SEC settlement which was released and paid in February 2016, compared to $86.3 million as of December 31, 2014.

SciClone has had a share repurchase program under which its Board of Directors had authorized $80.5 million, of which approximately $78.1 million had been utilized through December 31, 2015. The share repurchase program expired on December 31, 2015 and is currently under strategic review by the Board.

SciClone has presented non-GAAP information above as the Company believes this non-GAAP information is useful for investors, taken in conjunction with SciClone’s GAAP financial statements, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of SciClone’s operating results as reported under GAAP. The non-GAAP calculations and reconciliation are provided in the accompanying table titled "Reconciliation of GAAP to Non-GAAP Net Income."

In light of the strategic review underway at SciClone, the Company does not plan to provide revenue and earnings per share guidance for 2016.

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 9, 2016 GenVec, Inc. (NASDAQ: GNVC) reported financial results for the fourth quarter and year ended December 31, 2015 (Press release, GenVec, MAR 9, 2016, View Source [SID:1234509430]). For the year ended December 31, 2015, the company reported a net loss of $6.5 million, or $0.39 per share, compared with a net loss of $2.5 million, or $0.16 per share, for the year ended December 31, 2014. The company ended the year with $8.7 million in cash, cash equivalents, and investments.

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"During 2015, CGF166 moved into the dose escalation portion of the Phase 1/2 trial in patients with severe hearing loss. In early January after a total of nine patients had been treated, we were notified by our partner Novartis that enrollment had been paused based on a review of data by the trial’s Data Safety Monitoring Board in accordance with prespecified criteria in the protocol," said Douglas J. Swirsky, president and CEO of GenVec. "It is important to note that we are not aware of any significant adverse events in the trial, and while there is no certainty, we believe that enrollment in the dose escalation portion will resume in the coming months. As a result, we believe that the trial will be completed sometime in 2017 as previously expected."

"During 2015 and early 2016, we accomplished a great deal to ramp up GenVec’s business development capabilities and focused our efforts on partnering with the goal of maximizing the value of our AdenoVerse gene delivery and manufacturing platform," Mr. Swirsky continued. "We advanced our work on a second-generation neural stem cell-based cancer treatment with our partner TheraBiologics, and strengthened our intellectual property portfolio, adding patents key to protecting and enabling work with our new gorilla and monkey adenovectors. These vectors are highly suited to the development of molecular vaccines and some of the newer gene-based medicine strategies, such as CAR-T and CRISPR/Cas-9. Last but not least, we’ve kept our operations lean and highly efficient, with a clear understanding that the task at hand is to maintain a low cash burn rate and build value through collaborations."

2016 Guidance

For 2016, GenVec anticipates a cash burn between $6 million and $7 million for 2016 and believes its existing resources are sufficient to fund operations into the second quarter of 2017.

2015 Financial Results

For 2015, revenue decreased 85% to $0.9 million from $6.0 million in 2014, a decrease in revenue for the year of $5.1 million versus the prior year. The decline was primarily the result of milestone payments totaling $5 million from Novartis in 2014; continuation of the CGF166 clinical trial enrollment during 2015 did not trigger additional milestone payments. Additionally, there was a $0.2 million reduction in revenues year-over-year from our work under the contract with the DHS related to our animal health program that was completed in February 2015.

Operating expenses for 2015 decreased 13% to $7.5 million from $8.6 million in 2014. General and administrative expenses decreased 22% to $4.9 million in 2015 from $6.3 million in 2014. In 2015, lower expenses were primarily attributable to the relocation of our corporate offices in 2014 and lower professional costs. These reduced costs were partially offset by increased personnel costs in 2015 as compared to 2014, incurred primarily to enhance GenVec’s business development capabilities.

Research and development expenses increased 13% to $2.6 million in 2015 from $2.3 million in 2014, primarily attributable to increased personnel costs.

Fourth Quarter 2015 Results

For the fourth quarter ended December 31, 2015, GenVec reported a net loss of $1.6 million, or $0.10 per share, compared with net income of $1.7 million, or $0.11 per share, for the comparable prior year period.

The company reported revenues of $0.2 million in the fourth quarter of 2015 compared to $3.5 million for the same period in 2014. The first patient was treated in Novartis’ Phase 1/2 clinical trial of CGF166 in October 2014, triggering a payment of $3 million to GenVec. No milestone payment was realized in the fourth quarter of 2015. Additionally, we experienced a $0.1 million reduction in fourth quarter 2015 revenue for services performed for Novartis in connection with this program as compared to the comparable prior year period. Our work under the contract with the DHS related to our animal health program was completed in February 2015; as a result we experienced reduced revenues of $0.2 million in the fourth quarter of 2015 as compared to the comparable prior year period.

Operating expenses in the fourth quarter of 2015 were $1.8 million, which is comparable to the prior year period. General and administrative expenses in the fourth quarter of 2015 were $1.3 million, which is an increase of 2% and is comparable to the prior year period. Research and development expenses decreased 7% in 2015 from $0.6 million in the fourth quarter of 2014 to $0.5 million in the fourth quarter of 2015 primarily resulting from lower professional costs.

Cash Position

As of March 3, 2016, the company had $7.2 million in cash, cash equivalents, and investments (unaudited).