On November 17, 2015 Merck (NYSE:MRK), known as MSD outside the United States and Canada, reported that data investigating the use of KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, in advanced non-small cell lung cancer, melanoma, classical Hodgkin lymphoma, multiple myeloma, and ER-positive/HER2-negative breast cancer will be presented at four medical congresses through the end of this year (Press release, Merck & Co, NOV 17, 2015, View Source [SID:1234508270]). In total, data from more than 30 abstracts will be presented at the Society for Melanoma Research (SMR) 2015 Congress in San Francisco, Nov. 18 – 21; the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Orlando, Florida, Dec. 5 – 8; the San Antonio Breast Cancer Symposium (SABCS), Dec. 8 – 12; and the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Asia 2015 Congress in Singapore, Dec. 18 – 21. By the end of 2015, data on the anti-tumor activity of KEYTRUDA will have been presented across more than 20 tumor types.

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"The field of immuno-oncology holds great potential across a broad spectrum of cancers," said Dr. Roy Baynes, senior vice president and head of global clinical development, Merck Research Laboratories. "Data for KEYTRUDA being presented at these scientific meetings include a first-time comparison to chemotherapy in advanced non-small cell lung cancer, novel combination data in advanced melanoma as well as first-time data in two additional tumor types, namely multiple myeloma and hormone receptor positive breast cancer, further demonstrating our deep commitment to advancing cancer treatment."

The KEYTRUDA clinical development program to date includes patients with more than 30 tumor types in more than 160 clinical trials, including more than 80 trials that combine KEYTRUDA with other cancer treatments.

A select list of KEYTRUDA data to be presented at these meetings includes:

SMR (data to be presented include three late breaking oral presentations and multiple posters on KEYTRUDA monotherapy)

Late Breaker Oral Presentation: Preliminary Data From a Phase 1/2 Study of Epacadostat (INCB024360) with Pembrolizumab as First-Line Treatment in Patients with Advanced/Metastatic Melanoma. O. Hamid. Saturday, Nov. 21, 2:50 p.m. PST. Location: Salon 9-15 (San Francisco Marriott Marquis).

Late Breaker Oral Presentation: Primary Analysis of MASTERKEY-265 Phase 1b Study of Talimogene Laherparepvec (T-VEC) and Pembrolizumab (pembro) for Unresectable Stage IIIB-IV Melanoma. G. Long. Saturday, Nov. 21, 3:20 p.m. PST. Location: Salon 9-15 (San Francisco Marriott Marquis).

Late Breaker Oral Presentation: KEYNOTE-029: Pembrolizumab (pembro) + Low-Dose Ipilimumab (ipi) For Advanced Melanoma. G. Long. Saturday, Nov. 21, 2:00 p.m. PST. Location: Salon 9-15 (San Francisco Marriott Marquis).
For more information about this congress, including a complete list of abstract titles, please visit the SMR 2015 website at www.melanomacongress.com.

ASH (data to be presented include four oral presentations and one poster presentation, including updated findings in classical Hodgkin lymphoma and first-time findings in multiple myeloma)

(Abstract #505) Oral Presentation: Pembrolizumab in Combination with Lenalidomide and Low-Dose Dexamethasone for Relapsed/Refractory Multiple Myeloma (RRMM): Keynote-023. J. San Miguel. Monday, Dec. 7, 7:00 a.m. EST. Location: Hall E1 (Orange County Convention Center).

(Abstract #584) Oral Presentation: PD-1 Blockade With Pembrolizumab in Patients With Classical Hodgkin Lymphoma After Brentuximab Vedotin Failure: Safety, Efficacy, and Biomarker Assessment. P. Armand. Monday, Dec. 7, 10:45 a.m. EST. Location: Hall E2 (Orange County Convention Center).

For more information about this congress, including a complete list of abstract titles, please visit the ASH (Free ASH Whitepaper) Annual Meeting website at www.hematology.org/Annual-Meeting.

SABCS (data to be presented include one oral presentation and three poster presentations, including first-time findings in ER-positive/HER2-negative breast cancer)

(Abstract #S5-07) Oral Presentation: Preliminary Efficacy and Safety of Pembrolizumab (MK-3475) in Patients with PD-L1–positive, Estrogen Receptor-positive (ER+)/HER2-negative Advanced Breast Cancer Enrolled in KEYNOTE-028. H. Rugo. Friday, Dec. 11, 11:00 a.m. CST. Location: Hall D (Henry B. Gonzalez Convention Center).
For more information about this congress, including a complete list of abstract titles, please visit the SABCS website at www.sabcs.org.

ESMO Asia (data to be presented include one oral presentation featured in the Presidential Symposium, one proffered paper presentation and seven poster presentations, including data comparing KEYTRUDA to chemotherapy in advanced non-small cell lung cancer)

(Abstract #LBA3) Presidential Symposium: KEYNOTE-010: Phase 2/3 Study of Pembrolizumab (MK-3475) vs Docetaxel for PD-L1–Positive NSCLC After Platinum-Based Therapy. R. Herbst. Sunday, Dec. 20, 5:00 p.m. SGT. Location: Hall 406 (Suntec Convention & Exhibition Centre).

(Abstract #315O) Proffered Paper Presentation: Antitumor Activity and Safety of Pembrolizumab in Patients with PD-L1-positive Nasopharyngeal Carcinoma: Interim Results From a Phase 1b Study. C. Hsu. Friday, Dec. 18, 2:50 p.m. SGT. Location: Hall 332 (Suntec Convention & Exhibition Centre).

For more information about this congress, including a complete list of abstract titles, please visit the ESMO (Free ESMO Whitepaper) Asia 2015 congress website at View Source

About KEYTRUDA (pembrolizumab) Injection 100 mg

KEYTRUDA is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

KEYTRUDA is indicated in the United States at a dose of 2 mg/kg administered as an intravenous infusion over 30 minutes every three weeks for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. KEYTRUDA is also indicated at the same dosing for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. These indications are approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for these indications may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Selected Important Safety Information for KEYTRUDA (pembrolizumab)

Pneumonitis, including fatal cases, occurred in patients receiving KEYTRUDA. Pneumonitis occurred in 12 (2.9%) of 411 melanoma patients, including Grade 2 or 3 cases in 8 (1.9%) and 1 (0.2%) patients, respectively, receiving KEYTRUDA. Pneumonitis occurred in 19 (3.5%) of 550 patients with NSCLC, including Grade 2 (1.1%), 3 (1.3%), 4 (0.4%), or 5 (0.2%) pneumonitis in patients, receiving KEYTRUDA. Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Colitis (including microscopic colitis) occurred in 4 (1%) of 411 patients with melanoma, including Grade 2 or 3 cases in 1 (0.2%) and 2 (0.5%) patients, respectively, receiving KEYTRUDA. Colitis occurred in 4 (0.7 %) of 550 patients with NSCLC, including Grade 2 (0.2%) or 3 (0.4%) colitis in patients receiving KEYTRUDA. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Hepatitis occurred in patients receiving KEYTRUDA. Hepatitis (including autoimmune hepatitis) occurred in 2 (0.5%) of 411 patients with melanoma, including a Grade 4 case in 1 (0.2%) patient, receiving KEYTRUDA. Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hypophysitis occurred in 2 (0.5%) of 411 patients with melanoma, including a Grade 2 case in 1 and a Grade 4 case in 1 (0.2% each) patient, receiving KEYTRUDA. Hypophysitis occurred in 1 (0.2 %) of 550 patients with NSCLC, which was Grade 3 in severity. Monitor patients for signs and symptoms of hypophysitis (including hypopituitarism and adrenal insufficiency). Administer corticosteroids and hormone replacement as indicated. Withhold KEYTRUDA for Grade 2 and withhold or discontinue for Grade 3 or Grade 4 hypophysitis.

Hyperthyroidism occurred in 5 (1.2%) of 411 patients with melanoma, including Grade 2 or 3 cases in 2 (0.5%) and 1 (0.2%) patients, respectively, receiving KEYTRUDA. Hypothyroidism occurred in 34 (8.3%) of 411 patients with melanoma, including a Grade 3 case in 1 (0.2%) patient, receiving KEYTRUDA. Hyperthyroidism occurred in 10 (1.8%) of 550 patients with NSCLC, including Grade 2 (0.7%) or 3 (0.3%). Hypothyroidism occurred in 38 (6.9%) of 550 patients with NSCLC, including Grade 2 (5.5%) or 3 (0.2%). Thyroid disorders can occur at any time during treatment. Monitor patients for changes in thyroid function (at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation) and for clinical signs and symptoms of thyroid disorders. Administer replacement hormones for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 hyperthyroidism.

Type 1 diabetes mellitus, including diabetic ketoacidosis, has occurred in patients receiving KEYTRUDA. Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer anti-hyperglycemics in patients with severe hyperglycemia.

Nephritis occurred in patients receiving KEYTRUDA. Nephritis occurred in 3 (0.7%) patients with melanoma, consisting of one case of Grade 2 autoimmune nephritis (0.2%) and two cases of interstitial nephritis with renal failure (0.5%), one Grade 3 and one Grade 4. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 nephritis.

Other clinically important immune-mediated adverse reactions can occur. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement of the adverse reaction to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following steroid taper. Permanently discontinue KEYTRUDA for any severe or Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

Across clinical studies with KEYTRUDA, the following clinically significant, immune-mediated adverse reactions have occurred: bullous pemphigoid and Guillain-Barré syndrome. The following clinically significant, immune-mediated adverse reactions occurred in less than 1% of patients with melanoma treated with KEYTRUDA: exfoliative dermatitis, uveitis, arthritis, myositis, pancreatitis, hemolytic anemia, and partial seizures arising in a patient with inflammatory foci in brain parenchyma. The following clinically significant, immune-mediated adverse reactions occurred in less than 1% of 550 patients with NSCLC treated with KEYTRUDA: rash, vasculitis, hemolytic anemia, serum sickness, and myasthenia gravis.

Infusion-related reactions, including severe and life-threatening reactions, have occurred in patients receiving KEYTRUDA. Monitor patients for signs and symptoms of infusion related reactions including rigors, chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever. For severe or life-threatening reactions, stop infusion and permanently discontinue KEYTRUDA.

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. If used during pregnancy, or if the patient becomes pregnant during treatment, apprise the patient of the potential hazard to a fetus. Advise females of reproductive potential to use highly effective contraception during treatment and for 4 months after the last dose of KEYTRUDA.

Among the 411 patients with metastatic melanoma, KEYTRUDA was discontinued for adverse reactions in 9% of 411 patients. Adverse reactions, reported in at least two patients, that led to discontinuation of KEYTRUDA were: pneumonitis, renal failure, and pain. Serious adverse reactions occurred in 36% of patients. The most frequent serious adverse reactions, reported in 2% or more of patients, were renal failure, dyspnea, pneumonia, and cellulitis. The most common adverse reactions (reported in at least 20% of patients) were fatigue (47%), cough (30%), nausea (30%), pruritus (30%), rash (29%), decreased appetite (26%), constipation (21%), arthralgia (20%), and diarrhea (20%).

Among the 550 patients with metastatic NSCLC, KEYTRUDA was discontinued due to adverse reactions in 14% of patients. Serious adverse reactions occurred in 38% of patients. The most frequent serious adverse reactions reported in 2% or more of patients were pleural effusion, pneumonia, dyspnea, pulmonary embolism, and pneumonitis. The most common adverse reactions (reported in at least 20% of patients) were fatigue (44%), decreased appetite (25%), dyspnea (23%), and cough (29%).

No formal pharmacokinetic drug interaction studies have been conducted with KEYTRUDA.

It is not known whether KEYTRUDA is excreted in human milk. Because many drugs are excreted in human milk, instruct women to discontinue nursing during treatment with KEYTRUDA and for 4 months after the final dose.

Safety and effectiveness of KEYTRUDA have not been established in pediatric patients.

On November 17, 2015 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that it will present eight posters at the 2015 San Antonio Breast Cancer Symposium (SABCS) being held Dec. 8 to 12, 2015 in San Antonio, Texas (Press release, Myriad Genetics, NOV 17, 2015, View Source [SID:1234508272]).

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"Myriad is committed to bringing transformative molecular diagnostics to people with cancer. Our data at SABCS showcase our expanding portfolio of companion diagnostics and their potential to help personalize treatments for people with breast cancer," said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetic Laboratories. "We’re also excited about several new studies that highlight the ability of our myRisk Hereditary Cancer test to identify patients at risk for hereditary cancers."

A list of the Myriad presentations at SABCS is below. Follow Myriad on Twitter via @MyriadGenetics and stay informed about symposium news and updates by using the hashtag #SABCS15.

myChoice HRD Poster Presentations

Title: The role of germline BRCA status and Homologous Recombination Deficiency and response to neoadjuvant weekly paclitaxel followed by anthracycline-based chemotherapy.
Date: Thursday, Dec. 10, 2015: 5:00 to 7:00 p.m. CT.
Location: Poster P3-07-29.

Title: Homologous recombination deficiency (HRD) as a predictive biomarker of response to preoperative systemic therapy (PST) in TBCRC008 comprising a platinum in HER2-negative primary operable breast cancer.
Date: Thursday, Dec. 10, 2015: 5:00 to 7:00 p.m. CT.
Location: Poster P3-07-13.

Title: Homologous recombination deficiency (HRD) as a predictive biomarker of response to neoadjuvant platinum-based therapy in patients with triple negative breast cancer (TNBC); A pooled analysis.
Date: Thursday, Dec. 10, 2015: 5:00 to 7:00 p.m. CT.
Location: Poster P3-07-12.
myRisk Hereditary Cancer Poster Presentations

Title: Predisposing germline mutations in an unselected academic breast cancer (BC) cohort.
Date: Wednesday, Dec. 9, 2015: 5:00 to 7:00 p.m. CT.
Location: Poster P1-08-07.

Title: The patient experience in a prospective trial of multiple-gene panel testing for cancer risk.
Date: Thursday, Dec. 10, 2015: 7:30 to 9:00 a.m. CT.
Location: Poster P2-09-07.

Title: Interim analysis of multiplex gene panel testing for inherited susceptibility to breast cancer.
Date: Friday, Dec. 11, 2015: 5:00 to 7:00 p.m. CT.
Location: Poster Discussion PD7-01.

Title: Multiplex Identification of genetic etiologies among women with bilateral breast cancer using a 25-gene hereditary cancer panel.
Date: Friday, Dec. 11, 2015: 5:00 to 7:00 p.m. CT.
Location: Poster Discussion PD7-02.

Title: Characterization of Li-Fraumeni syndrome diagnosed using a 25-gene hereditary cancer panel.
Date: Friday, Dec. 11, 2015: 5:00 to 7:00 p.m. CT.
Location: Poster Discussion PD7-03.

For more information about these presentations, please visit the SABCS website at View Source

(Filing, 10-Q, Vaccinogen, NOV 16, 2015, View Source [SID:1234508267])

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On November 16, 2015 Argos Therapeutics, Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of fully individualized immunotherapies for the treatment of cancer based on the Arcelis technology platform, reported financial results for the third quarter ended September 30, 2015 and provided an update on the Company’s clinical programs (Press release, Argos Therapeutics, NOV 16, 2015, View Source [SID:1234508242]).

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"We continue to advance toward our goal of becoming a fully-integrated commercial biotechnology company," said Jeff Abbey, president and chief executive officer. "We successfully completed enrollment in our phase 3 ADAPT trial of AGS-003 in metastatic renal cell carcinoma. The ADAPT trial continues to progress in line with our expectations and we anticipate the next interim data analysis, at approximately fifty percent of events, to occur in the first half of 2016. Additionally, an early stage investigator-initiated RCC trial of AGS-003 was begun at Roswell Park Cancer Institute in Buffalo, NY. With this study, for the first time we will be able to assess the effects of AGS-003 in patients with kidney cancer that has not spread to nearby lymph nodes or other parts of the body. This is an important opportunity to manufacture AGS-003 using a needle biopsy procedure for tumor collection prior to surgery, while directly studying immune changes within the primary tumor before and after administration of AGS-003."

"Also during the quarter, Argos formed its first Scientific Advisory Board to assist us with the continued advancement of our clinical development programs. We look forward to working closely with these renowned scientists and physicians as we design new trials of AGS-003 over the coming quarters in a variety of tumor types." Mr. Abbey went on, "We continue to take the steps and make the necessary investments in our centralized commercial manufacturing facility here in Durham. Lastly, as part of our debt facility with Horizon Technology Finance Corporation and Fortress Credit Co LLC, we drew down the second and final tranche of $12.5 million, which has helped provide us with additional capital to conduct critical operational activities."

Recent Operational Highlights:

In July 2015, the pivotal phase 3 ADAPT clinical trial of AGS-003 in combination with standard targeted therapy for the treatment of mRCC reached its enrollment goal of at least 450 randomized patients.

The breakdown of patients enrolled in the ADAPT study is approximately 73% intermediate risk patients, meaning they present with 1 or 2 risk factors at diagnosis, and approximately 27% poor risk patients, meaning they present with either 3 or 4 risk factors at diagnosis
In July 2015, the Company established a Scientific Advisory Board (SAB)
Inaugural members include distinguished oncologists and immunologists to provide perspectives in further research and development of AGS-003.

In July 2015 an investigator-initiated early stage RCC trial of AGS-003 commenced at Roswell Park Cancer Institute in Buffalo, NY.
In August 2015, the Company received the second and final tranche of $12.5 million under its debt facility with Horizon Technology Finance Corporation and Fortress Credit Co LLC.

Selected Third Quarter 2015 Financial Results

Net loss attributable to common stockholders for the three months ended September 30, 2015 was $20.1 million, or $0.97 per share, compared to a net loss attributable to common stockholders of $15.1 million, or $0.77 per share, for the same period in 2014. Net loss attributable to common stockholders for the nine months ended September 30, 2015 was $57.2 million, or $2.81 per share, compared to a net loss attributable to common stockholders of $37.9 million, or $2.29 per share, for the same period in 2014.

Revenue for the three months ended September 30, 2015 totaled $0.2 million compared to $0.4 million for the same period in 2014. Revenue for the nine months ended September 30, 2015 totaled $0.4 million compared to $1.7 million for the same period in 2014.

Research and development expense for the three months ended September 30, 2015 totaled $17.2 million compared to $13.0 million for the same period in 2014. Research and development expense for the nine months ended September 30, 2015 totaled $48.1 million compared to $32.0 million for the same period in 2014.

General and administrative expense for the three months ended September 30, 2015 totaled $2.7 million compared to $2.3 million for the same period in 2014. General and administrative expense for the nine months ended September 30, 2015 totaled $8.0 million compared to $6.1 million for the same period in 2014.

As of September 30, 2015, Argos’ cash, cash equivalents and short-term investments totaled $23.1 million compared to $56.2 million as of December 31, 2014.

On November 16, 2015 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, reported its financial results for the third quarter ended September 30, 2015 (Press release, BioLineRx, NOV 16, 2015, View Source;p=RssLanding&cat=news&id=2112560 [SID:1234508243]).

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Kinneret Savitsky, Ph.D., CEO of BioLineRx, remarked, "Our focus during the third quarter of 2015 was on continued clinical execution, primarily for BL-8040, our lead platform for the treatment of acute myeloid leukemia (AML) and other oncology and hematology indications. While we continued to advance the development of BL-8040 for the treatment of relapsed or refractory AML, as well as stem cell mobilization for transplantation purposes, in August we initiated a clinical study for BL-8040 as a novel consolidation treatment for AML, and we expect to initiate clinical studies in two additional indications in the upcoming months. We are also currently performing an extensive evaluation of BL-8040’s potential in the exciting immuno-oncology space, expanding upon our unique oncology platform. CXCR4 antagonists have been identified as potentially synergistic with immune checkpoint inhibitors. In this regard, we believe BL-8040’s best-in-class qualities make it a great candidate to explore such combinations."

"Earlier this month we reported positive results from the dose-escalation part of BL-8040’s Phase 2 clinical trial in relapsed or refractory AML, including clinical response (remission) data. The encouraging composite response rate of 38%, which will be presented for the first time at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, together with continued robust mobilization and apoptotic effects, strongly suggest that BL-8040 has potent anti-leukemic activity and, in combination with Ara-C, may improve the response typically achieved in this advanced AML population. We are looking forward to reporting top-line results from this study in early 2016. With regard to BL-8040 as a novel stem cell mobilization treatment, last month we held a meeting with the FDA, which has provided us with substantial clarification regarding the future development plan for this indication. We are gearing up to start a Phase 2 study in stem cell mobilization in the first quarter of 2016.

Dr. Savitsky continued, "After successfully completing a Phase 1/2 study for BL-7010 for the treatment of celiac disease, we are waiting for a response from the EU regulatory authorities regarding classification of BL-7010 as a medical device in Europe. Contingent upon this decision, we are planning to start the next efficacy study in celiac disease in the first half of 2016. In parallel, we are investing considerable efforts in examining alternative development and commercialization pathways for this promising product, including as a food supplement, in order to potentially address the multi-billion dollar market for gluten sensitivity, which also has a significantly shorter time to market, especially in the US.

"Our partner Omega Pharma, now part of Perrigo, is swiftly progressing in the development of BL-5010 as an OTC solution for the non-surgical removal of benign skin lesions. In September, they submitted an application for CE Mark designation for this product. Assuming successful completion of the CE Mark registration process, we expect the first sales in Europe to begin in 2016."

Dr. Savitsky concluded, "We continue to pursue various collaboration agreements to maximize the value of our current pipeline assets, including discussions with additional partners for the purpose of monetizing some of our non-core programs. In parallel to our internal pipeline development, we continue to screen potential assets to develop under our strategic partnership with Novartis, and we look forward to in-licensing promising therapeutic candidates for development under the collaboration in the near future. Finally, with over $50 million on our balance sheet, we remain well capitalized to execute on our development program and to achieve significant milestones across our expanded therapeutic pipeline well into 2018, and we look forward to demonstrating our enhanced value proposition over the coming months."

Financial Results for Quarter and Nine Months Ended September 30, 2015

Research and development expenses for the three months ended September 30, 2015 were $2.6 million, a decrease of $0.4 million, or 13.4%, compared to $3.0 million for the three months ended September 30, 2014. The decrease resulted primarily from decreased spending on BL-1110, BL-7010 and BL-5010 in the 2015 period, partially offset by increased spending on BL-8040. Research and development expenses for the nine months ended September 30, 2015 were $8.7 million, an increase of $0.2 million, or 2.3%, compared to $8.5 million for the nine months ended September 30, 2014. The small increase resulted primarily from increased spending on BL-8040 in the 2015 period, partially offset by decreased spending on BL-7010, BL-7040, BL-5010 and BL-8020.

Sales and marketing expenses for the three months ended September 30, 2015 were $0.3 million, substantially similar to the comparable period in 2014. Sales and marketing expenses for the nine months ended September 30, 2015 were $0.8 million, a decrease of $0.1 million, or 13.9%, compared to $0.9 million for the nine months ended September 30, 2014. The decrease resulted primarily from significant professional fees related to a number of material business development activities carried out during the nine-month period in 2014, which resulted in collaboration and outlicensing agreements.

General and administrative expenses for the three months ended September 30, 2015 were $0.8 million, substantially similar to the comparable period in 2014. General and administrative expenses for the nine months ended September 30, 2015 were $2.6 million, substantially similar to the comparable period in 2014.

The Company’s operating loss for the three months ended September 30, 2015 amounted to $3.6 million, compared with an operating loss of $4.1 million for the corresponding 2014 period. The Company’s operating loss for the nine months ended September 30, 2015 amounted to $12.1 million, substantially similar to the corresponding 2014 period.

Net non-operating income amounted to $2.0 million for the three months ended September 30, 2015, an increase of $0.6 million, compared to net non-operating income of $1.4 million for the three months ended September 30, 2014. Net non-operating income amounted to $1.1 million for the nine months ended September 30, 2015, a decrease of $2.3 million, compared to net non-operating income of $3.4 million for the nine months ended September 30, 2014. Non-operating income (expenses) for both periods primarily relate to fair-value adjustments of liabilities on account of the 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 (revaluation date).

Net financial income was immaterial for the three months ended September 30, 2015, compared to net financial income of $2.0 million for the three months ended September 30, 2014. Net financial income amounted to $0.3 million for the nine months ended September 30, 2015, compared to net financial income of $1.8 million for the nine months ended September 30, 2014. Net financial income (expenses) for the 2015 period primarily relates to investment income earned on our bank deposits, as well as banking fees. The 2014 period also includes significant exchange rate differences primarily relating to changes in the USD/NIS exchange rate.

The Company’s net loss for the three months ended September 30, 2015 amounted to $1.6 million, compared with a net loss of $0.7 million for the corresponding 2014 period. The Company’s net loss for the nine months ended September 30, 2015 amounted to $10.7 million, compared with a net loss of $6.9 million for the corresponding 2014 period.

The Company held $50.7 million in cash, cash equivalents and short-term bank deposits as of September 30, 2015.

Net cash used in operating activities was $11.0 million for the nine months ended September 30, 2015, substantially similar to the comparable period in 2014.

Net cash used in investing activities for the nine months ended September 30, 2015 was $18.7 million, compared to net cash used in investing activities of $15.6 million for the nine months ended September 30, 2014. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits and other investments during the respective periods.

Net cash provided by financing activities for the nine months ended September 30, 2015 was $29.3 million, compared to net cash provided by financing activities of $22.6 million for the nine months ended September 30, 2014. The cash flows from financing activities primarily reflect the underwritten public offerings of our ADSs in March 2015 and 2014.