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Tessa Therapeutics Announces Acquisition of Euchloe Bio

On March 23, 2016 Tessa Therapeutics, an immunotherapy company dedicated to revolutionizing the treatment of cancer, reported the full acquisition of Euchloe Bio, a biotechnology company specializing in the development and commercialization of antibodies to treat cancer (Press release, Tessa Therapeutics, MAR 23, 2017, View Source [SID1234518253]). Euchloe’s portfolio includes a number of highly potent checkpoint receptor antagonists and immune system agonists.

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Since Euchloe Bio’s spin-out from A*STAR’s Singapore Immunology Network (SIgN), the company has advanced several antibody drug candidates for clinical trials including its suite of checkpoint inhibitors (PD1, PDL1, CTLA4, Tim3 and Lag3 antibodies). Euchloe has also developed a number of these projects in combination with Tessa’s Virus Specific T cell (VST) platform technology. Euchloe’s technologies show strong potential to increase the effectiveness of Tessa’s VST therapies and expand Tessa’s pipeline to a broader range of cancers. Euchloe is collaborating with Tessa on the development of next-generation chimeric antigen receptor (CAR) technologies that are expected to show high specificity and efficacy, for a superior safety profile.

Euchloe Bio has made significant progress in its antibody development program since Tessa’s initial investment in the company last year. The combination of the technologies and research & development capabilities of the two companies is expected to realize strong synergies. Euchloe’s focus will remain on the development and commercialization of antibodies as stand-alone and combination therapies, while research efforts will continue to be led by its founder, Dr Cheng-I Wang.

Andrew Khoo, co-founder and CEO of Tessa Therapeutics, commented on the acquisition "Tessa and Euchloe have worked closely together since Tessa’s initial investment last year. We are very excited by the progress of the Euchloe team, thus the full acquisition of Euchloe Bio was a natural next step for us. Euchloe’s capabilities will help us deepen our understanding and ability to modulate the complex immunological environment around solid tumors and further strengthen our clinical trial pipeline."

Associate Professor John E. Connolly, Chief Scientific Officer of Tessa Therapeutics, said "I have known Dr Wang for many years and he is a leader in his field. Euchloe Bio’s strong expertise and extensive range of proprietary antibodies is an excellent complement to Tessa’s existing portfolio. The strong pre-clinical data we are seeing suggests that the combination of our technologies has strong potential to deliver further breakthroughs in cancer immunotherapy."
Dr Cheng-I Wang, founder of Euchloe Bio, said "We are delighted to complete our integration with Tessa Therapeutics, with whom we have been collaborators for some time. Tessa’s VST platform has proven its ability to extend immunotherapy treatment to solid tumors and I am excited by the promise of combining our different approaches. I look forward to working as a part of the Tessa team to deliver a real change in the lives of cancer patients."

Verastem Reports Year-End 2016 Financial Results

On March 23, 2017 Verastem, Inc. (NASDAQ: VSTM), focused on discovering and developing drugs to treat cancer, reported financial results for the year ended December 31, 2016, and also provided an overview of certain corporate developments (Press release, Verastem, MAR 23, 2017, View Source [SID1234518251]).

"2016 was a year of significant achievement for Verastem with the in-licensing of duvelisib, a late-stage, clinical product candidate with broad potential across B-cell and T-cell lymphoid malignancies, and the advancement of defactinib into clinical development in combination with immuno-oncology agents," said Robert Forrester, President and Chief Executive Officer of Verastem. "As we enter 2017, we are laser-focused on several important milestones, beginning with reporting top-line duvelisib data from the Phase 3 DUO study in chronic lymphocytic leukemia (CLL) expected mid-year 2017. There remains an unmet medical need for patients with relapsed CLL. We believe duvelisib has potential as a convenient, oral monotherapy with an expected and manageable safety profile for patients with relapsed CLL. For defactinib, we look forward to advancing our ongoing combination trials into important expansion cohorts across several high unmet need indications."

Mr. Forrester continued, "On the financial front, we ended 2016 with $80.9 million in cash, cash equivalents and investments, which we believe is sufficient to support our research and development programs and operations into 2018. In March 2017, we entered into a loan facility with Hercules Capital, Inc. for up to $25.0 million, subject to certain conditions including positive DUO data, which would provide us with additional financial flexibility to advance duvelisib."

Fourth Quarter 2016 and Recent Highlights:
Duvelisib
In-licensed Late-stage, Complementary Oncology Product Candidate Duvelisib – Verastem and Infinity Pharmaceuticals, Inc. (Infinity) announced the signing of an agreement under which Verastem licensed exclusive worldwide rights to develop and commercialize duvelisib, an investigational product candidate currently in development for hematologic malignancies. Duvelisib is well aligned with Verastem’s strategic focus of developing novel anti-cancer therapeutics that modulate the tumor microenvironment. The transaction provides a new oncology product candidate with demonstrated activity in lymphoid malignancies.
Ongoing Phase 3 DUO Study in Relapsed or Refractory CLL – The safety and efficacy of duvelisib is currently being evaluated in the randomized Phase 3 DUO study in patients with relapsed or refractory CLL. In the DUO study, approximately 300 patients were randomized 1:1 to receive duvelisib (25mg BID) or ofatumumab (8 weekly infusions, starting with an initial intravenous dose of 300mg on day 1 followed by 7 weekly doses of 2,000mg, then 2,000mg monthly for 4 cycles). The primary endpoint of this study is progression free survival (PFS). Key secondary endpoints include overall response rate (ORR), overall survival, duration of response (DOR) and safety. Verastem expects to report top-line data from the DUO study in mid-year 2017.
Positive Phase 2 DYNAMO Data Reported at ASH (Free ASH Whitepaper) 2016 – Positive Phase 2 clinical data from the DYNAMO study demonstrating the clinical activity of duvelisib in patients with relapsed refractory indolent non-Hodgkin lymphoma (iNHL) were presented at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2016. In an oral presentation, titled "A phase 2 study demonstrating the clinical activity of duvelisib in patients with relapsed refractory indolent non-Hodgkin lymphoma," (Publication ID: 1218) Ian Flinn, M.D., Ph.D. (Director, Hematologic Malignancies Program, Sarah Cannon Research Institute), described results from 129 patients with double refractory iNHL (median 3 prior anti-cancer regimens, range 1-18). The study met its primary endpoint, achieving an ORR of 46% as determined by an independent review committee (IRC) (p=0.0001; 95% CI 0.37-0.55). Among disease subgroups, the ORR was 41% in follicular lymphoma (n=83), 68% in small lymphocytic lymphoma (n=28), and 33% in marginal zone lymphoma (n=18). The median DOR among all patients was 9.9 months. Notably, 83% of patients had reductions in the size of their target lymph nodes per the IRC. Duvelisib was generally well tolerated, with an expected and manageable safety profile with appropriate risk mitigation. The DYNAMO study showed that duvelisib monotherapy has a favorable benefit-risk profile in refractory iNHL patients and may represent an important treatment option in this population.
Defactinib (VS-6063)
Dosed the First Patient in Combination Trial of Defactinib and Avelumab in Patients with Ovarian Cancer – As announced in January 2017, the first patient was dosed in a new clinical trial evaluating avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, in combination with Verastem’s defactinib, an investigational focal adhesion kinase (FAK) inhibitor, in patients with advanced ovarian cancer. This multicenter, open-label, dose-escalation and dose-expansion Phase 1/2 clinical trial is designed to assess the safety, pharmacokinetics, pharmacodynamics, and initial observations of clinical activity of the avelumab/defactinib combination in patients with recurrent or refractory stage III-IV ovarian cancer. The study is being conducted in collaboration with the alliance between Merck KGaA, Darmstadt, Germany, which in the U.S. and Canada operates as EMD Serono, and Pfizer, and is expected to enroll approximately 100 patients at up to 15 sites across the U.S.
Corporate and Financial
Hagop Youssoufian, MSc, M.D., Named Head of Hematology and Oncology Development – In January 2017, Dr. Youssoufian assumed this leadership role at Verastem to oversee the clinical and regulatory development of Verastem’s pipeline, including duvelisib, and provide overall strategic and tactical leadership to our hematology-oncology clinical programs. Dr. Youssoufian brings over 25 years of product development and commercialization experience to Verastem, having served in senior leadership roles at several oncology-focused companies, including BIND Therapeutics, Progenics Pharmaceuticals, Ziopharm Oncology, Imclone Systems, Sanofi Aventis and Bristol-Myers Squibb where he was involved in the development of Sprycel, Taxotere and Erbitux.
Additional Key Personnel Appointments – Recently, Michael Ferraresso joined Verastem as Vice President, Commercial Operations, and Verastem also appointed several highly experienced individuals to the Clinical and Scientific Advisory Board including:
Lori Kunkel, M.D., Former Chief Medical Officer, Pharmacyclics
Edmund J. Pezalla, M.D., MPH, Former VP, Pharmaceutical Policy and Strategy at Aetna
Greg Berk, M.D., Former Chief Medical Officer, Verastem
Cheryl Cohen, Former Chief Commercial Officer, Medivation
Brian Stuglik, PharmD., Former VP and Chief Marketing Officer, Oncology Global Marketing, Eli Lilly
Secured $25 Million Loan Facility – In March 2017, Verastem entered into a Loan and Security Agreement with Hercules Capital, Inc. for up to $25.0 million in financing. Verastem received the first $2.5 million of financing under the Loan and Security Agreement when the transaction closed. The proceeds will be used for Verastem’s ongoing research and development programs and for general corporate purposes. Additional tranches of up to $22.5 million in aggregate will be available subject to certain conditions, including positive data from the Phase 3 DUO clinical trial evaluating duvelisib in patients with relapsed or refractory CLL.
Full Year 2016 Financial Results
Net loss for the year ended December 31, 2016 (2016 Period) was $36.4 million, or $0.99 per share, as compared to a net loss of $57.9 million, or $1.61 per share, for the year ended December 31, 2015 (2015 Period). Net loss includes non-cash stock-based compensation expense of $6.2 million and $9.7 million for the 2016 Period and 2015 Period, respectively.
Research and development expense for the 2016 Period was $19.8 million compared to $40.6 million for the 2015 Period. The $20.8 million decrease from the 2015 Period to the 2016 Period was primarily related to a decrease of $15.6 million in external contract research organization expense for outsourced biology, chemistry, development and clinical services, which includes our clinical trial costs, a $3.4 million decrease in personnel related costs, primarily due to the reduction in workforce in October 2015, a decrease of $1.3 million in stock-based compensation expense and a decrease of $1.5 million in lab supplies, travel and other research and development expense. These decreases were partially offset by an increase of approximately $947,000 in consulting and professional fees.
General and administrative expense for the 2016 Period was $17.2 million compared to $17.6 million for the 2015 Period. The approximate $411,000 decrease from the 2015 Period to the 2016 Period primarily resulted from a decrease of $2.1 million in stock-based compensation expense. This decrease was partially offset by increases of $1.1 million in consulting and professional fees, approximately $280,000 in personnel costs, and a net increase of approximately $306,000 of other general and administrative costs.
As of December 31, 2016, Verastem had cash, cash equivalents and investments of $80.9 million compared to $110.3 million as of December 31, 2015. Verastem used $29.5 million for operating activities during the 2016 Period.
The number of outstanding common shares as of December 31, 2016, was 36,992,418.
Financial Guidance
Based on our current operating plans, we expect to have sufficient cash, cash equivalents and investments to fund our research and development programs and operations into 2018.
Conference Call Information

ImmunoCellular Therapeutics and Memgen Announce Letter of Intent for Potential Joint Immuno-Oncology Collaboration

On March 23, 2017 ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) and Memgen, LLC ("Memgen") reported the signing of a non-binding letter of intent to exclusively negotiate the terms to possibly establish an immuno-oncology strategic collaboration focused on conducting clinical trials combining the companies’ respective cancer immunotherapy product candidates (Press release, ImmunoCellular Therapeutics, MAR 23, 2017, View Source [SID1234518250]). The discussions pertain to ImmunoCellular’s dendritic cell (DC)-based immunotherapy product candidates, ICT-107 and ICT-140, and Memgen’s ISF35, a viral cancer immunotherapy encoding an optimized version of CD40 ligand. Combining DC-based and viral oncology immunotherapeutic approaches could provide a novel way to stimulate CD40 to possibly induce a potent, specific and effective anti-tumor response. Insights from these combination trials, if successful, could also lead to later combination trials with other immune-oncology technologies, including checkpoint inhibitors.

"We are excited about the potential to work with Memgen," said Anthony Gringeri, PhD, ImmunoCellular President and Chief Executive Officer. "Memgen’s viral cancer immunotherapy, ISF35, has the potential to enhance the activity of ImmunoCellular’s immuno-oncology product candidates, including ICT-107. The ability to stimulate CD40 with a viral vector could play an important role in increasing the efficacy of dendritic cell immunotherapies. We look forward to potentially testing these therapies in combination trials."

"We’re very pleased to have the opportunity to work with ImmunoCellular Therapeutics and its DC product candidates, including ICT-107 in glioblastoma," said Mark Cantwell, PhD, Memgen Chief Scientific Officer. "Preclinical research presented at the 2016 American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting showed that ISF35 in combination with checkpoint inhibitors induces anti-tumor immune responses, expands tumor specific CD8 T cells, and has the potential to eradicate brain tumors. The combination of ISF35 and ICT-107 with checkpoint inhibitors may provide a multi-pronged antitumor immune response. This includes ISF35’s CD40-driven dendritic and T cell activation and expansion, ICT-107’s tumor-specific antigen presentation, and checkpoint inhibitor release of the PD-1 pathway-mediated inhibition of the antitumor immune response."

If the parties agree upon the terms of a strategic collaboration, including financials, development, supply and control, ImmunoCellular and Memgen plan to work together to determine the best clinical strategy to leverage the collaboration.

About ICT-107 and ICT-140

ICT-107 is a dendritic cell-based immunotherapy targeting six tumor-associated antigens on glioblastoma stem cells. ICT-107 is currently being tested in a phase 3 registration trial in patients with newly diagnosed glioblastoma. The ongoing phase 3 registrational trial of ICT-107 is designed as a randomized, double-blind, placebo-controlled study of HLA-A2+ subjects, which is being conducted at about 120 sites in the US, Canada and the EU, with plans to randomize 542 patients with newly diagnosed glioblastoma. The primary endpoint in the trial is overall survival. Secondary endpoints include progression-free survival and safety, as well as overall survival in the two pre-specified MGMT subgroups.

For patients, families and physicians seeking additional information about the ICT-107 phase 3 trial, please consult www.clinicaltrials.gov.

ICT-140 is a dendritic cell-based immunotherapy targeting seven tumor-associated antigens expressed on ovarian cancer cells. ImmunoCellular plans to conduct a phase 2 clinical trial in patients with ovarian cancer, pending available resources.

About ISF35

ISF35 is a viral cancer immunotherapy encoding an optimized form of CD40 ligand. Direct intratumoral delivery of ISF35, a non-replicating adenovirus encoding CD40 ligand, activates tumor-specific T cells through immunostimulation of dendritic cells. ISF35 generates an effective anti-tumor immune response and complements checkpoint inhibitors, a class of immuno-oncology (IO) drugs that removes the brakes tumors attempt to use to stop a T cell anti-tumor immune response.

Preclinical studies have shown that ISF35 in combination with checkpoint inhibitors cures 40% of mice with an aggressive B16 melanoma tumor, and eradicates melanoma brain metastases. These data add to the extensive clinical experience of ISF35 in chronic lymphocytic leukemia where safety and activity have been demonstrated. Preclinical research evaluating ISF35 in combination with PD-1, PD-L1, and CTLA-4 checkpoint inhibitors is guiding the clinical development of ISF35

BioLineRx Announces Acquisition of Agalimmune Ltd. to Accelerate Expansion of Immuno-Oncology Pipeline

On March 23, 2017 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported that it has acquired Agalimmune Ltd., a private UK-based company with an innovative, anti-cancer immunotherapy platform. Acquisition consideration consisted of a $6 million upfront payment, of which $3 million is in cash and the remainder in BioLineRx shares (Press release, BioLineRx, MAR 23, 2017, View Source [SID1234518249]). Additional future payments may be made based on development and commercial milestones.

Agalimmune’s lead compound is AGI-134, a synthetic alpha-Gal immunotherapy in development for solid tumors. AGI-134 harnesses the body’s pre-existing, highly abundant anti-alpha-Gal antibodies to induce a systemic, specific anti-tumor response to the patient’s own tumor neo-antigens. This response not only kills the tumor cells at the site of injection, but also brings about a durable, follow-on, anti-metastatic immune response.

AGI-134 has completed numerous pre-clinical studies, demonstrating robust protection against the development of secondary tumors in a model of melanoma with a single dose only. Synergy has also been demonstrated in additional pre-clinical studies when combined with a PD-1 immune checkpoint inhibitor, offering the potential to broaden the utility of such immunotherapies, and improve the rate and duration of responses in multiple cancer types. AGI-134 is in near-clinical development and is expected to commence a first-in-man study in patients with solid tumors in the first half of 2018.

Philip Serlin, Chief Executive Officer of BioLineRx, stated, "Immuno-oncology is one of the most promising approaches for the treatment of cancer. Although a number of current immunotherapies are receiving widespread attention, many solid tumors are still able to evade the immune system’s surveillance. Most immunotherapies work best in highly mutated tumors that are infiltrated with immune cells, known as ‘hot’ tumors. Unfortunately, the overwhelming majority of tumors are ‘cold’ tumors, and thus transforming a ‘cold’ tumor into a ‘hot’ tumor is a major objective in cancer treatment."

"In this regard, Agalimmune’s lead asset, AGI-134, harnesses naturally occurring, pre-existing antibodies to elicit a tumor-specific immune response that is unique to the treated individual and provides a universal, small-molecule approach to personalized immunotherapy. The subsequent stimulation and recruitment of T cells, which recognize the patient’s own neo-antigens, to the tumor site, has the potential of transforming ‘cold’ tumors into ‘hot’ ones. Through this important acquisition, we will also benefit from Agalimmune’s complementary immunology expertise and facilities in the UK, which support our strategic focus in this area. We are enthusiastic to incorporate into our pipeline this promising near-clinical asset, which substantially strengthens our position in the immuno-oncology space," added Mr. Serlin.

"We are very excited that we found an ideal partner for our promising therapeutic pipeline. We are extremely impressed by BioLineRx’s proven drug development capabilities, as well as their meaningful collaborations with global pharmaceutical companies," said Damian Marron, CEO of Agalimmune. "We strongly believe in the value of our unique platform and we look forward to its accelerated clinical development by BioLineRx."

About Agalimmune and AGI-134

Agalimmune Ltd. is a biopharmaceutical company with an innovative anti-cancer immunotherapy pipeline for generating a systemic, adaptive immune response to solid tumors. It was established in 2013 and is headquartered in London, England with laboratories in Sandwich, England and Boston, Massachusetts.

AGI-134, Agalimmune’s lead molecule is a synthetic alpha-Gal immunotherapy in development for solid tumors. AGI-134 harnesses the body’s pre-existing, highly abundant, anti-alpha-Gal antibodies to induce a systemic, specific anti-tumor response to the patient’s own tumor neo-antigens. This response not only kills the tumor cells at the site of injection, but also brings about a durable, follow-on anti-metastatic immune response. Alpha-Gal is a cell-surface carbohydrate antigen which is not expressed by humans, unlike virtually all other mammals and bacteria. Therefore, humans universally produce and maintain high levels of anti-Gal antibodies, due to exposure to alpha-Gal on bacteria in the digestive system.

AGI-134 is injected into the tumor, where it coats the tumor cell membranes, resulting in alpha-Gal being exposed on the tumor cell surface. Anti-Gal antibodies bind to the alpha-Gal part of AGI-134 to produce an initial immune response that activates complement-dependent and antibody-dependent cellular cytotoxicity (cell death). This cytotoxicity generates immune-tagged cells and cellular debris that trigger an uptake of tumor-associated antigens by antigen-presenting cells (APCs). These APCs induce a follow-on systemic immune response by the activation and clonal expansion of T cells (CD8+) to the patient’s own neo-antigens. This approach not only targets the primary injectable tumor, but has also demonstrated efficacy against existing distant secondary tumors. Furthermore, the mechanism of action suggests the potential of long-term protection against future metastases. The use of intratumoral alpha-Gal glycolipids to treat solid tumors was invented by Prof. Uri Galili, Ph.D., while at the University of Massachusetts, from where the intellectual property rights were licensed. The intellectual property rights relating to AGI-134 were in-licensed from KODE Biotech Ltd., the inventors of AGI-134.

BioLineRx Reports Year End 2016 Financial Results

On March 23, 2017 BioLineRx Ltd. (NASDAQ: BLRX, TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology,reported its financial results for the year ended December 31, 2016 (Press release, BioLineRx, MAR 23, 2017, View Source [SID1234518246]).

Highlights and achievements in 2016 and to date:

Acquired Agalimmune Ltd., a UK-based biopharmaceutical company developing immunotherapeutic cancer treatments, thereby broadening and bolstering BioLineRx’s presence in immuno-oncology. Agalimmune’s novel lead compound, AGI-134, harnesses the body’s pre-existing, highly abundant, anti-alpha-Gal antibodies to drive a patient-specific, systemic, anti-tumor response for various cancer indications. AGI-134 may also bring about a long-lasting, protective, follow-on, anti-tumor immune response, and has exhibited synergies in combination with check-point inhibitor therapies;

Signed extensive immuno-oncology collaboration with Genentech, a member of the Roche Group, for several Phase 1b studies for BL-8040 in combination with Genentech’s Atezolizumab, in multiple solid tumor indications, including pancreatic cancer, gastric cancer and non-small cell lung cancer, as well as AML. The collaboration may also be expanded into additional indications;

Signed immuno-oncology collaboration with MSD (known as Merck in the US and Canada), and subsequently initiated a Phase 2a study in pancreatic cancer for BL-8040 in combination with Merck’s KEYTRUDA;

Initiated Phase 2b immuno-oncology collaboration with MD Anderson Cancer Center for additional BL-8040 and KEYTRUDA combination study in pancreatic cancer, as part of strategic clinical research immunotherapy collaboration between MSD and MD Anderson Cancer Center;

Reported partial results data on Phase 2 open label study for BL-8040 as novel stem cell mobilization treatment. Interim results support BL-8040 as a one-day dosing regimen for rapid mobilization of substantial amounts of stem cells, a significant improvement over the current standard of care which requires four-to-six daily injections of G-CSF.

In-licensed three new projects under strategic collaboration with Novartis, including two novel liver fibrosis/failure projects, and a novel anti-inflammatory treatment for dry eye syndrome;

Presented growing body of clinical evidence surrounding BL-8040 at leading medical and scientific conferences, including the American Society of Hematology (ASH) (Free ASH Whitepaper), Society of Hematologic Oncology (SOHO), and American Association for Cancer Research (AACR) (Free AACR Whitepaper);

Expanded geographic reach with new joint venture in China for development of novel drug candidates; and

Appointed Philip A. Serlin as CEO.
Expected upcoming significant milestones for 2017 and 2018:

Initiation of Phase 2/3 registrational study for BL-8040 in stem-cell mobilization for autologous transplantation expected in H2 2017;

Completion of Phase 2 study for BL-8040 in stem-cell mobilization for allogeneic transplantation, expected by year end;

Partial results from the immuno-oncology Phase 2a study for pancreatic cancer for BL-8040 in combination with Merck’s KEYTRUDA expected in H2 2017; top line results expected in H2 2018;

Initiation of Phase 1b immuno-oncology studies for BL-8040 in combination with Genentech’s Atezolizumab in multiple solid tumor indications and AML expected in H2 2017; partial results expected in H2 2018; and

Initiation of Phase 1 immuno-oncology study for AGI-134 in multiple solid tumor indications expected in H1 2018.
Philip A. Serlin, Chief Executive Officer of BioLineRx, remarked, "2016 demonstrated BioLineRx’s strengths, as we leveraged our BL-8040 oncology platform to initiate combination studies with industry leaders in the field of immuno-oncology, while steadily advancing our multiple other clinical studies. In addition, we continued to validate our asset discovery and development capabilities, with the addition of an immunology and fibrosis franchise following the in-licensing of three programs under our Novartis collaboration. As we enter 2017, we are pleased to have just announced our first acquisition, of Agalimmune Ltd., adding a unique oncology platform to our pipeline, which significantly expands and strengthens our immuno-oncology offering."

"We remain focused on building a robust clinical-stage oncology and immunology therapeutic pipeline offering us exciting potential business opportunities. We believe BioLineRx is at a very significant stage, with key milestones in the next 12-18 months," Mr. Serlin concluded.

Financial Results for the Year Ended December 31, 2016

Research and development expenses for the year ended December 31, 2016 were $11.2 million, a decrease of $0.3 million, or 2.6%, compared to $11.5 million for the year ended December 31, 2015. The decrease results primarily from a decrease in spending on BL-7010, partially offset by increased spending on new projects.

Sales and marketing expenses for the year ended December 31, 2016 were $1.4 million, an increase of $0.4 million, or 40.0%, compared to $1.0 million for the year ended December 31, 2015. The increase results primarily from consultancy services related to BL-8040 and new projects.

General and administrative expenses for the year ended December 31, 2016 were $4.0 million, an increase of $0.3 million or 8.1%, compared to $3.7 million for the year ended December 31, 2015. The increase results primarily from one-time salary-related payments and an increase in professional fees.

The Company’s operating loss for the year ended December 31, 2016 amounted to $16.5 million, compared with an operating loss of $16.2 million for the year ended December 31, 2015.

Net non-operating income of $0.2 million was recognized for the year ended December 31, 2016, a decrease of $1.2 million compared to net non-operating income of $1.4 million for the year ended December 31, 2015. Non-operating expenses and income for both periods primarily relate to fair-value adjustments of liabilities on account of warrants issued in the private and direct placements which we conducted in February 2012 and 2013. These fair-value adjustments were highly influenced by our share price at each period end.

Net ﬁnancial income for the year ended December 31, 2016 was $0.5 million, compared to net financial income of $0.4 million for the year ended December 31, 2015. Net financial income for the two periods primarily relates to investment income earned on our bank deposits, as well as banking fees.

The Company’s net loss for the year ended December 31, 2016 amounted to $15.8 million, compared with a net loss of $14.4 million for the year ended December 31, 2015.

The Company held $35.6 million in cash, cash equivalents and short-term bank deposits as of December 31, 2016.

Net cash used in operating activities for the year ended December 31, 2016 was $14.5 million, compared to $14.2 million for the year ended December 31, 2015. The increase in net cash used in operating activities in 2016 was primarily the result of an increase in our operating loss.

Net cash provided by investing activities for the year ended December 31, 2016 was $9.3 million, compared to $15.6 million cash used in investing activities for the year ended December 31, 2015. 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, 2016 was $2.1 million, compared to $29.5 million for the year ended December 31, 2015. The cash flows in 2016 primarily reflect the funding under the share purchase agreement with LPC. The cash flows in 2015 primarily reflect the underwritten public offering of our ADSs in March 2015.