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8-K – Current report

On March 15, 2016 Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, reported financial results for the year ended December 31, 2015 (Filing, Annual, Galectin Therapeutics, 2015, MAR 15, 2016, View Source [SID:1234509541]). These results are included in the Company’s Annual Report on Form 10-K, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.

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Management Commentary
"Numerous clinical advancements during 2015 with our lead compound GR-MD-02 form the basis for a productive 2016, and we look forward to reporting on a number of important development milestones throughout the year," said Peter G. Traber, M.D., president, chief executive officer and chief medical officer of Galectin Therapeutics. "Of particular note, during 2015 we began two Phase 2 studies with GR-MD-02 in non-alcoholic steatohepatitis, or NASH, a disease that has been gaining considerable awareness not only among clinicians, but also among the general population. NASH is a significant and growing problem, and treatment will require considerable healthcare resources. Our compound is being investigated in NASH with cirrhosis in our NASH-CX trial, and in NASH with advanced fibrosis in our NASH-FX trial. We expect to report top-line data from our NASH-FX trial by the end of September of this year. Enrollment in our NASH-CX trial is on schedule and we expect to report top-line data by the end of 2017. We are very excited about the potential for GR-MD-02 in the treatment paradigm of a global market estimated to reach $35 billion by the middle of the next decade."

Dr. Traber continued, "In addition to data from the NASH-FX trial, we expect to report data from a 10-patient Phase 2 open-label study with GR-MD-02 in moderate-to-severe plaque psoriasis in September 2016. Also, our partners at the Providence Portland Cancer Center are studying GR-MD-02 in combination with the checkpoint inhibitors Yervoy and Keytruda in two separate Phase 1b studies in advanced metastatic melanoma. We look forward to initial data from select cohorts in both studies later this year, but are dependent on the Providence Portland Cancer Center to conduct and fund these trials. Preclinical work in cancer models with GR-MD-02 added to checkpoint inhibitors showed a boost in anti-tumor immunity, a reduction in tumor size and increased survival, and we are eager to learn if this activity will be duplicated in humans.

"We strengthened our U.S. patent position during 2015 and more recently obtained an extension of coverage for method of use patents of pectin compounds in a number of fibrotic diseases, including pulmonary fibrosis. We are formulating plans to leverage our intellectual property. Also in recent weeks we named lead independent director Marc Rubin, M.D. as chairman of our board of directors. Dr. Rubin is a leading bioscience industry executive with more than 25 years of senior management and board experience in the development and commercialization of pharmaceuticals.

"In January 2016, we announced that the United States District Court for Northern Georgia had dismissed all claims against it and certain officers, directors and shareholder 10X Fund L.P. alleged in a Consolidated Securities Class Action originally filed in July 2014 and all claims against certain officers and directors alleged in a Consolidated Shareholder Derivative Action originally filed in August 2014. The Court entered final judgments of dismissals in both actions, that is, dismissals "with prejudice", based on the Court’s finding that any further amendment of the complaints would be futile. Plaintiffs have filed notice of intent to appeal in both matters. On March 3, 2016, the Nevada State Court dismissed a shareholder derivative complaint filed against the Company’s officers and directors in Nevada and entered a final judgment in favor of the defendants. The plaintiff has 30 days to appeal after the final judgment order. We are pleased that these matters appear very close to final resolution in favor of the Company and our officers and directors.

"In summary, we believe that Galectin is in a solid position from clinical, financial and leadership perspectives. I look forward to continuing consistent outreach to the investment community via frequent CEO Perspective blog postings and conference participation, among other activities to keep our shareholders informed of our plans, accomplishments and milestones," Dr. Traber concluded.

Financial Results
For the year ended December 31, 2015, the Company reported a net loss applicable to common stockholders of $21.1 million, or $0.88 per share, compared with a net loss applicable to common stockholders of $17.0 million, or $0.78 per share, for 2014. The increase is largely due to higher research and development expenses primarily related to the Phase 2 clinical program.

Research and development expense for 2015 was $13.1 million, compared with $8.4 million for 2014. The increase primarily relates to costs for the Phase 2 clinical trials begun in 2015, partially offset by lower preclinical costs.

General and administrative expense for 2015 was $7.0 million, compared with $7.0 million for 2014.

As of December 31, 2015, the Company had $25.8 million of non-restricted cash and cash equivalents. The Company believes it has sufficient cash to fund currently planned operations and research and development activities through March 31, 2017.

8-K – Current report

On March 15, 2016 Champions Oncology, Inc. (CSBR), engaged in the development of advanced technology solutions and services to personalize the development and use of oncology drugs, reported its financial results for the third quarter ended January 31, 2016 (Filing, Q3, Champions Oncology, 2016, MAR 15, 2016, View Source [SID:1234509539]).

Third Quarter and Recent Business Highlights:
·
Delivered record core bookings of new contracts to pharma and biotech customers
· TOS revenue growth of 55%
· Launched AML product line
· Reduced cash burn to under $1M for the quarter
·
Initiated sponsored correlative trial of TumorGraft PDX models in sarcoma patients

Joel Ackerman, Champions Oncology CEO, stated, "This was a great quarter for Champions. We are executing against our strategy and the results have been excellent. Our revenue growth remains very strong and our cash burn rate is coming down quickly as we predicted. The pharmaceutical and biotech industry is embracing the depth and breadth of our platform and the leading indicators for future growth are very strong."

Financial Results

Revenue was $2.6 million and $1.8 million for the three months ended January 31, 2016 and 2015, respectively, an increase of $800,000 or 39.5%. Revenue was $8.3 million and $5.6 million for the nine months ended January 31, 2016 and 2015, respectively, an increase of $2.7 million or 48.4%. Total operating expense was $4.9 million and $5.2 million for the three months ended January 31, 2016 and 2015, respectively, a decrease of $300,000 or (6.2%). Total operating expense was $16.1 million and $16.5 million for the nine months ended January 31, 2016 and 2015, respectively, a decrease of $400,000 or (2.1%).

Champions reported a loss before income tax expense of $2.4 million and $2.8 million for the three months ended January 31, 2016 and 2015, respectively, a decrease of $400,000 or (15.1%). Excluding stock-based compensation of $567,000 and $657,000 for the three months ended January 31, 2016 and 2015, Champions recognized a net loss of $1.8 million and $2.2 million, respectively.

Champions reported a loss before income tax expense of $7.8 million and $9.4 million for the nine months ended January 31, 2016 and 2015, respectively, a decrease of $1.6 million or (17.4%). Excluding stock-based compensation of $2.1 million and $2.3 million for the nine months ended January 31, 2016 and 2015, Champions recognized a net loss of $5.8 million and $7.2 million, respectively.

Net cash used in operations was $864,000 and $2.4 million for the three months ended January 31, 2016 and 2015, respectively, a decrease of $1.5M or (64%). The reduction in cash burn is the result of revenue growth, aggressive expense management and payments received in advance of revenue recognition.

Operating Results

Translational Oncology Solutions (TOS):

TOS revenue was $2.1 million and $1.4 million for the three months ended January 31, 2016 and 2015, respectively, an increase of $700,000, or 55.2%. The increase is due to increased bookings, both in the number and size of the studies, in prior quarters due to the expansion of the TOS sales team and growth of the platform.

TOS cost of sales was $1.6 million and $1.3 million for the three months ended January 31, 2016 and 2015, respectively, an increase of $300,000, or 25.1%. Gross margin was 23.8% and 5.5% for the three months ended January 31, 2016 and 2015, respectively. Quarterly gross margins vary based on timing differences between expense and revenue recognition. The improvement in gross margin was due to higher TOS revenue leveraged off the fixed cost component of the lab combined with effective management of the variable lab costs.

Personalized Oncology Solutions (POS):

POS revenue was $416,000 and $453,000 for the three months ended January 31, 2016 and 2015, respectively, a decrease of $37,000 or (8.2%). The decrease is due to a decline of $215,000 in implant and panel revenue offset by an increase of $162,000 in sequencing revenue.

POS cost of sales was $479,000 and $674,000 for the three months ended January 31, 2016 and 2015, respectively, a decrease of $195,000, or (28.9%). Gross margin was (15.1%) and (48.8%) for the three months ended January 31, 2016 and 2015, respectively. The improvement resulted from a shift to a higher margin revenue product contributing to POS revenue and aggressively managing our lab costs.

Research and development expense was $1 million and $1.1 million for three months ended January 31, 2016 and 2015, respectively, a decrease of $100,000, or (8.6%). The decrease is due to lower expenses in genomic characterization of our Champions TumorGraft Bank for the current quarter.

Sales and marketing expense for the three months ended January 31, 2016 and 2015 was $779,000 and $1.1 million, respectively, a decrease of $321,000 or (28.8%). The decrease is due to the consolidation of the sales and marketing resources of the POS and TOS division, including combining both under one commercial business leader.

General and administrative expense for the three months January 31, 2016 and 2015 was $1.04 million and $1.09 million, respectively, a decrease of $50,000, or (4.1%).

Conference Call Information

The Company will host a conference call today at 9:00 a.m. EDT (6:00 a.m. PDT) to discuss its third quarter 2016 financial results. To access the conference call, domestic participants should dial 800-875-3456, Canadian participants should dial 800-648-0973, and international participants should dial 302-607-2001. The participant passcode is "Champions Oncology."

Full details of the Company’s financial results will be available Wednesday, March 16, 2016 in the Company’s Form 10-Q at www.championsoncology.com.

* Non-GAAP Financial Information

See the attached Reconciliation of GAAP net loss to non-GAAP net loss for an explanation of the amounts excluded to arrive at non-GAAP net loss and related non-GAAP net loss per share amounts for the three and nine months ended January 31, 2016 and 2015. Non-GAAP financial measures provide investors and management with supplemental measures of operating performance and trends that facilitate comparisons between periods before and after certain items that would not otherwise be apparent on a GAAP basis. Certain unusual or non-recurring items that management does not believe affect the Company’s basic operations do not meet the GAAP definition of unusual or non-recurring items. Non-GAAP net loss and non-GAAP net loss per share are not, and should not be viewed as a substitute for similar GAAP items. Champions’ defines non-GAAP dilutive loss per share amounts as non-GAAP net loss divided by the weighted average number of diluted shares outstanding. Champions’ definition of non-GAAP net loss and non-GAAP diluted loss per share may differ from similarly named measures used by others.

FDA grants Roche's Cancer Immunotherapy Atezolizumab priority review for advanced bladder cancer

On March 15, 2016 Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for atezolizumab (anti-PDL1; MPDL3280A) for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who had disease progression during or following platinum-based chemotherapy in the metastatic setting, or whose disease worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant) (Press release, Hoffmann-La Roche , MAR 15, 2016, View Source [SID:1234509538]). Urothelial carcinoma accounts for 90 percent of all bladder cancers and can also be found in the renal pelvis, ureter and urethra.

"Atezolizumab was granted Priority Review designation based on results of the IMvigor 210 study, which showed the medicine shrank tumors in a type of advanced bladder cancer, and the majority responding to treatment continued to respond after nearly a year of follow up," said Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development. "The treatment options available for advanced bladder cancer are very limited, and we are committed to working with the FDA to bring the first anti-PDL1 cancer immunotherapy to people with this disease as quickly as possible."

A Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention or diagnosis of a serious disease. Atezolizumab was granted Breakthrough Therapy Designation by the FDA in May 2014 for the treatment of people whose metastatic bladder cancer expresses the protein PD-L1 (programmed death ligand-1). Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases and to help ensure that people have access to them through FDA approval as soon as possible. The BLA submission for atezolizumab is based on results of the IMvigor 210 Phase II study, and the FDA will make a decision on approval by Sept. 12, 2016. Atezolizumab is also being studied in a number of other cancers.

About the IMvigor 210 study

IMvigor 210 is an open-label, multicenter, single-arm Phase II study that evaluated the safety and efficacy of atezolizumab in people with locally advanced or mUC, regardless of PD-L1 expression. People in the study whose disease had progressed during or following previous treatment with a platinum-based chemotherapy regimen (n=311) received a 1200-mg intravenous dose of atezolizumab on day one of 21-day cycles until loss of clinical benefit. The primary endpoint of the study was objective response rate (ORR) as assessed by an independent review facility (IRF) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Secondary endpoints included duration of response (DOR), overall survival, progression-free survival and safety.

In an updated analysis based on 11.7 months of median follow up, atezolizumab shrank tumors (ORR) in 15 percent (95 percent CI: 11, 19) of people evaluable for efficacy and safety (n=310) whose disease progressed after platinum-based chemotherapy.

Atezolizumab shrank tumors in 26 percent (95 percent CI: 18, 36) of people whose disease had medium and high levels of PD-L1 expression (n=100). Median DOR was not reached at the time of analysis; with a median duration of follow up of 11.7 months, 84 percent (38/45) of people had an ongoing response. The most common Grade 3 to 4 treatment-related adverse events included: fatigue (2 percent), decreased appetite, fever (pyrexia), anemia, enzymes in the blood (ALT and AST increase), joint pain (arthralgia), difficulty breathing (dyspnea), inflammation of the lung wall (pneumonitis), inflammation of the lining of the colon (colitis), hypertension and hypotension (all 1 percent). There were no treatment-related Grade 5 adverse events.

In addition to IMvigor 210, Genentech has an ongoing, confirmatory Phase III study (IMvigor 211), which compares atezolizumab to chemotherapy in people whose bladder cancer has progressed on at least one prior platinum-containing regimen.

About metastatic urothelial cancer
According to the American Cancer Society (ACS), it is estimated that more than 76,000 Americans will be diagnosed with bladder cancer in 2016, and about 11 percent of new diagnoses are made when bladder cancer is in advanced stages. There is a dramatic difference in survival rates between early and advanced bladder cancer. The ACS estimates that approximately 96 percent of people will live five or more years when diagnosed with the earliest stage of the disease, compared to 39 percent when diagnosed in advanced stages (stage III-IV) of the disease. Men are about three to four times more likely to get bladder cancer during their lifetime than women.

About atezolizumab
Atezolizumab (also known as MPDL3280A; anti-PDL1) is an investigational monoclonal antibody designed to bind with a protein called programmed death ligand-1 (PD-L1). Atezolizumab is designed to directly bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with PD-1 and B7.1 receptors. By inhibiting PD-L1, atezolizumab may enable the activation of T cells. Atezolizumab may also affect normal cells.

About personalised cancer immunotherapy
The aim of personalised cancer immunotherapy (PCI) is to provide individual patients with treatment options that are tailored to their specific needs. Our PCI research and development programme comprises more than 20 investigational candidates, eight of which are in clinical trials. All studies include the prospective evaluation of biomarkers to determine which people may be appropriate candidates for our medicines. In the case of atezolizumab (also known as MPDL3280A), PCI begins with the PD-L1 (programmed death ligand-1) IHC assay based on the SP142 antibody developed by Roche Tissue Diagnostics. The goal of PD-L1 as a biomarker is to identify those people most likely to experience clinical benefit with atezolizumab as a single agent and those who may be appropriate candidates for combination therapies; the purpose is not to exclude patients from atezolizumab therapy, but rather to enable the design of combinations that will provide the greatest chance for transformative responses. The ability to combine atezolizumab with multiple chemotherapies may provide new treatment options to people across a broad range of tumours regardless of their level of PD-L1 expression.

BIND Therapeutics Reports Fourth Quarter and Full Year 2015 Financial Results and Announces Shift in Research and Discovery Strategy to Focus on Developing Innovative Medicines Based on ACCURINS® Platform

On March 15, 2016 BIND Therapeutics, Inc. (NASDAQ: BIND), a biotechnology company developing targeted and programmable therapeutics called ACCURINS, reported financial results for the fourth quarter and full year 2015 (Press release, BIND Therapeutics, MAR 15, 2016, View Source [SID:1234509533]). Additionally, the Company announced a shift in its research and discovery strategy to focus on the development of innovative medicines, primarily in cancer. Moving forward, BIND plans to focus on the development of therapeutics that leverage the ability of ACCURINS to incorporate novel combinations of targeting ligands and unique payloads including oligonucleotides and potent kinase inhibitors, creating synergistic properties in a single particle.

"Our new strategy is to build a pipeline of innovative medicines that address challenges that small molecule chemistry or antibody engineering have not been able to overcome," said Andrew Hirsch, president and chief executive officer, BIND Therapeutics. "Historically, nanoparticle-based therapies have used previously approved medicines as therapeutic payloads to provide equivalent efficacy with improved safety. Our new strategy leverages the unique attributes of ACCURINS, specifically their ability to precisely target cells and tissues with ligand-mediated binding while containing high concentrations of novel therapeutic payloads. We believe this approach will lead to innovative medicines with the potential to achieve therapeutic outcomes unachievable through existing therapeutic modalities."

ACCURINS possess several advantageous properties. The surface of ACCURINS can be functionalized with ligands that can achieve tissue localization, cellular internalization or biological activity, thereby increasing the number of therapeutic strategies available. In addition, the modular nature of ACCURINS enables the functionalization of more than one type of ligand on the surface. ACCURINS are also able to incorporate novel therapeutic payloads with diverse physical and chemical properties, including oligonucleotides and potent kinase inhibitors. The release rate of Accurin payloads can also be controlled to optimize the amount of drug getting to the target tissue over the optimal amount of time.

"Our internal discovery efforts leverage the modular nature of ACCURINS, allowing us to efficiently engineer ideal combinations of tumor-directed targeting ligands and new classes of therapeutic payloads," said Jonathan Yingling, Ph.D., chief scientific officer of BIND. "When encapsulating oligonucleotide-based payloads, ACCURINS have the potential to protect against enzymatic degradation and clearance in the plasma, target tissues beyond the liver, and concentrate them in target cells through ligand-mediated binding that results in tumor cell death. By incorporating small molecule kinase inhibitors, we believe ACCURINS can control the biological activity of tumor-protective immune cells and reverse the immunosuppressed tumor microenvironment. Following optimization of lead product candidates and completion of preclinical studies, we anticipate initiation of clinical testing for one or more of our proprietary innovative product candidates as early as 2018."

BIND remains committed to its ongoing collaborations and clinical-stage programs. The Company’s collaborations with AstraZeneca and Pfizer are intended to enable greater inhibition of important cellular pathways with our collaborators’ proprietary kinase inhibitors. Additionally, the Company expects to communicate topline data from the ongoing iNSITE 1 and 2 trials with BIND-014 in squamous cell non-small cell lung cancer (NSCLC), advanced cervical cancer and head and neck cancer in April 2016. As previously announced, further development of BIND-014 is contingent upon data from these trials.

Anticipated 2016 Milestones:

Report topline data on the full 40 patients in iNSITE 1 squamous NSCLC trial with BIND-014

Report Stage 1 data from iNSITE 2 trial with BIND-014 in advanced cervical and head and neck cancers

Report in vivo proof-of-concept (POC) data for targeting tumor associated macrophages

Identify first ACCURINS-based immuno-oncology product concept

Report initial in vivo POC data for discovery programs, with preclinical pharmacokinetic and efficacy data expected in second half of 2017

In vivo POC data for targeting guanylate cyclase-C (GC-C) receptors expressed on tumors, specifically GI malignancies

Further in vivo POC data in delivering single and double stranded RNA fragments to target cells and achieving target knock-down

Demonstrate in vitro and in vivo POC for achieving endosomal escape with double stranded RNA

2015 Business and Pipeline Highlights:

Continued preclinical work, and generated promising initial data, on Accurin versions of anti-infective and oligonucleotide-based therapies

Continued preclinical work related to targeting of tumor-associated macrophages

Strengthened scientific leadership and corporate governance with appointment of Jonathan Yingling, Ph.D., as chief scientific officer for BIND, and appointment of Arthur Tzianabos, Ph.D., to Board of Directors

Completed preclinical development for AZD2811, an Accurin containing AstraZeneca’s Aurora B Kinase inhibitor, for which AstraZeneca initiated a phase 1 clinical study in the fourth quarter of 2015

Advanced collaboration with Pfizer following its exercise of its option to obtain an exclusive license to develop and commercialize an Accurin drug candidate

Achieved $4.0 million milestone with AstraZeneca for dosing first patient in Accurin AZD2811 phase 1 clinical trial

Received $2.5 million option exercise fee from Pfizer to acquire an exclusive license for the development and commercialization of first compound covered by the agreement

Recognized $14.3 million in 2015 in revenue from milestones, option exercises and reimbursable expenses related to our collaborations with AstraZeneca, Pfizer and Roche

Enrolled patients in phase 2 iNSITE 1 and iNSITE 2 trials allowing the Company to report clinical data in April 2016

Completed build out of dedicated manufacturing space, through an arrangement with a large contract manufacturing organization, that is capable of producing ACCURINS at the double-digit kilogram scale

Fourth Quarter and Full Year 2015 Financial Results

Fourth quarter and full year 2015 revenue was $6.4 million and $15.4 million, compared to $3.0 million and $10.4 million for the same periods in 2014, respectively. The increase in revenue for the fourth quarter and full year 2015 was primarily due to the achievement of the $4 million milestone upon dosing of the first patient in Accurin AZD2811 phase 1 clinical trial.

Fourth quarter and full year 2015 research and development (R&D) expenses were $11.1 million and $37.3 million compared to $8.0 million and $28.9 million for the same periods in 2014, respectively. The increase in R&D expenses for the fourth quarter of 2015 compared to the fourth quarter of 2014 was primarily due to higher clinical development expenses of BIND-014 and reimbursable manufacturing expenses related to Accurin AZD2811. The increase in R&D expenses for the full year 2015 compared to the full year 2014 was primarily due to headcount growth to support the development of BIND’s internal programs and our collaborations, which led to an increase in salaries and benefits, higher reimbursable manufacturing expenses related to Accurin AZD2811 and increased clinical development expenses of BIND-014.

Fourth quarter and full year 2015 general and administrative expenses were $4.6 million and $17.6 million, respectively, compared to $4.2 million and $15.1 million for the fourth quarter and full year 2014, respectively.

Fourth quarter net loss was $7.6 million, or $0.37 per basic and diluted share, compared to a net loss of $8.5 million, or $0.51 per basic and diluted share for the fourth quarter of 2014. 2015 net loss was $36.6 million, or $1.81 per basic and diluted share, compared to a net loss of $32.5 million, or $1.97 per basic and diluted share for 2014.

Cash, cash equivalents and short-term investments were $36.9 million as of December 31, 2015. The Company continues to expect its cash, cash equivalents and short-term investments will fund anticipated operations into the fourth quarter of 2016.

AVEO Oncology Reports Full Year 2015 Financial Results and Provides Business Update

On March 15, 2016 AVEO Oncology (NASDAQ:AVEO) reported financial results for the full year ended December 31, 2015 and provided a business update (Press release, AVEO, MAR 15, 2016, View Source;p=RssLanding&cat=news&id=2148504 [SID:1234509532]).

"Over the course of 2015, AVEO has streamlined its organization and taken a fresh strategic direction to create increased shareholder value. In 2016, we are squarely focused on furthering the execution of this strategy," said Michael Bailey, president and chief executive officer. "We remain focused on retaining rights to develop our three oncology-focused clinical programs in North America, while seeing our pipeline advanced by partners in the lab, clinic and through the regulatory process in geographies or disease areas outside of our strategic focus." Mr. Bailey concluded: "We are evaluating all options for funding the clinical and regulatory development of tivozanib in North America, including TIVO-3, the Company’s Phase 3 U.S. pivotal study of tivozanib in the third line treatment of patients with renal cell cancer, and a PD1 combination study. Subject to the outcome of our settlement discussions with the SEC, the Company could be in a position to begin patient enrollment in the TIVO-3 Study in the second quarter of 2016."

Recent Updates

Exclusive Licensing Agreement for Tivozanib in Europe with EUSA Pharma and Submission of a Marketing Authorization Application for Tivozanib in Renal Cell Carcinoma. In February 2016, AVEO and EUSA Pharma announced that EUSA Pharma has submitted a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for tivozanib as a first line treatment for renal cell carcinoma (RCC). In December 2015, AVEO and EUSA Pharma announced an exclusive license agreement in which AVEO granted EUSA Pharma European rights to tivozanib for the treatment of advanced RCC. The agreement also includes a number of additional territories outside North America, including South America and South Africa, and potential additional indications. Under the terms of the agreement, AVEO received an upfront research and development funding payment of $2.5 million, and is eligible for up to $394 million in potential payments and milestones, assuming successful achievement of specified development, regulatory and commercialization objectives, as well as a tiered royalty ranging from a low double-digit up to mid-twenty percent on net sales of tivozanib in the agreement’s territories. A percentage of milestone and royalty payments received by AVEO are due to Kyowa Hakko Kirin as a sublicensing fee.

Exclusive Licensing Agreement for Tivozanib in Russia and other territories with Pharmstandard Group and Acceptance of Registration Dossier for Tivozanib in RCC by the Ministry of Health of the Russian Federation. In February 2016, AVEO announced that a registration dossier seeking to obtain marketing authorization of tivozanib as a first line treatment of advanced RCC has been accepted by the Ministry of Health of the Russian Federation. The dossier was submitted in December 2015 by Pharmstandard Group. In August 2015, AVEO licensed Pharmstandard rights to the development, manufacture and commercialization of tivozanib in the territories of Russia, Ukraine and the Commonwealth of Independent States, for all indications other than non-oncologic diseases or conditions of the eye. AVEO is eligible to receive up to $7.5 million in connection with the first marketing authorization of tivozanib in Russia. AVEO is also eligible to receive a high single-digit royalty on net sales, if any, in the above mentioned territories. A percentage of any milestone and royalty payments received by AVEO are due to Kyowa Hakko Kirin as a sublicensing fee.

Settlement discussions with the Securities and Exchange Commission. AVEO previously announced that the staff (the "SEC Staff") of the Securities and Exchange Commission (the "SEC") and AVEO have entered into discussions for the settlement of potential claims that the SEC may bring against the Company asserting that the Company previously violated federal securities laws by omitting to disclose to investors a recommendation made to the Company by the U.S. Food and Drug Administration in May 2012 that the Company conduct an additional clinical trial with respect to tivozanib. The Company’s settlement discussions with the SEC have continued, and the Company has accrued an estimated settlement liability, for accounting purposes, of $4.0 million in its financial statements as of December 31, 2015. There can be no assurance, however, that a settlement will be achieved with the SEC, or that any settlement we enter into with the SEC will be within the estimated settlement liability accrued.

Receipt of $3.5 Million AV-380 Inventory Reimbursement Payment from Novartis. AVEO previously announced that Novartis exercised its right under its license agreement for AV-380, AVEO’s first-in-class, potent, humanized inhibitory antibody targeting growth differentiation factor 15 (GDF15), to acquire AVEO’s inventory of clinical quality drug substance. This reimbursement payment of approximately $3.5 million was received in the first quarter of 2016. Novartis acquired an exclusive, worldwide license for the development and commercialization of AV-380 and related antibodies in August 2015. Under terms of the agreement, AVEO received an upfront payment of $15 million and the reimbursement payment of approximately $3.5 million, and is eligible to receive clinical, regulatory and sales-based milestone payments totaling $308 million, assuming successful advancement of the product. AVEO will also be eligible to receive tiered royalties on product sales ranging from high single digits to a low double-digit.
Full Year 2015 Financial Highlights

AVEO ended 2015 with $34.1 million in cash and investments.

Total collaboration revenue for 2015 was approximately $19.0 million compared with $18.1 million for 2014. The increase was primarily due to the recognition of $18.5 million of revenue associated with the receipt of a $15.0 million upfront payment for our license of AV-380 to Novartis and Novartis’ subsequent purchase of clinical material for $3.5 million. These amounts were partially offset by a decrease of $3.6 million of revenue from Astellas following the termination of our collaboration agreement in 2014 and a decrease of $14.3 million of revenue recognized from our arrangement with Biogen due to the one-time recognition of previously deferred revenue following an amendment to our agreement in 2014.

Research and development (R&D) expense for 2015 was $12.9 million compared with $38.3 million for 2014. The decrease in R&D expense was primarily due to a reduction in personnel-related, IT, and facilities expenses following AVEO’s January 2015 strategic restructuring as well as a decrease in outsourced services costs primarily related to the completion of the manufacture of AV-380 material in 2014; and a decrease in medical affairs and external clinical trial costs associated with the decreased number of active patients enrolled in our clinical trials.

General and administrative (G&A) expenses for 2015 were $14.2 million compared to $18.6 million for 2014. The decrease is primarily the result of a decrease in personnel-related, facilities, IT, insurance and other infrastructure costs following the Company’s January 2015 strategic restructuring as well as a decrease in external legal costs associated with various ongoing legal matters. These amounts were partially offset by $4.0 million in expense incurred in 2015 related to the accrual of an estimated settlement liability, for accounting purposes, related to the potential SEC claims and an increase in depreciation expense due to the acceleration of depreciation in connection with the termination of our lease agreement of 650 East Kendall Street in September 2014.

Restructuring and lease exit expense for 2015 was $4.4 million compared with $11.7 million for 2014. The expenses incurred during 2015 relate to costs associated with elimination of our research function and the associated reductions in headcount as part of our January 2015 restructuring. The expenses incurred during 2014 relate to costs associated with partially vacating and subsequently terminating the agreement for our leased space at 650 East Kendall Street, which occurred in September 2014.
Net loss for 2015 was $15.0 million, or a loss of $0.27 per basic and diluted share compared with net loss of $52.7 million or a loss of $1.01 per basic and diluted share for 2014.
Updated Financial Guidance

AVEO believe that its cash resources would allow the Company to fund its current operations into the fourth quarter of 2017. This estimate does not include the payment of potential licensing milestones or the uncommitted costs of conducting any contemplated clinical trials, and assumes no milestone payments from AVEO’s partners, no additional funding from new partnership agreements, no equity financings, no debt financings or accelerated repayment thereof and no further sales of equity under the Company’s ATM. This estimate also does not include any amount AVEO may agree to pay in excess of the estimated settlement liability, for accounting purposes, that the Company has established with respect to a potential settlement of claims with the SEC, as described in the Company’s 2015 annual report filed on Form 10-K.

28th Annual ROTH Conference

In lieu of a financial results conference call, AVEO will be presenting a corporate update at the 28th Annual ROTH Conference tomorrow, March 16, 2016, at 9:00 a.m. Pacific Time. A live webcast of the presentation can be accessed by visiting the investors section of the company’s website at www.aveooncology.com. A replay of the webcast will be archived for 30 days following the presentation date.