On November 13, 2018 Novocure (NASDAQ: NVCR) reported more than 70 presentations on Tumor Treating Fields, including five oral presentations, reported that it will be featured at the 23rd Annual Meeting of the Society for Neuro-Oncology (SNO) on Nov. 15 through Nov. 19 in New Orleans. External authors prepared more than 50 of the presentations, pointing to a growing interest in Novocure’s proprietary Tumor Treating Fields platform. Presentations span 21 research areas with more than 5 percent of all conference abstracts at the 23rd Annual Meeting of the Society for Neuro-Oncology discussing Tumor Treating Fields.

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Novocure announces more than 70 presentations on Tumor Treating Fields at 23rd Annual Meeting of the Society for Neuro-Oncology

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"We are pleased to have a record number of presentations on Novocure’s proprietary platform featured this year at SNO’s Annual Meeting," said Dr. Eilon Kirson, Novocure’s Chief Science Officer and Head of Research and Development. "Presentations cover a broad range of topics from cell biology, radiation therapy and immunology to clinical trials and patient care, which we believe point to a growing and diversifying interest in Tumor Treating Fields from clinicians and researchers around the world. We are excited to engage the oncology community at SNO and to continue collaborating to realize the full potential of Tumor Treating Fields."

New clinical data from investigator sponsored pilot trials will be shared studying Tumor Treating Fields in progressive pediatric gliomas, Tumor Treating Fields prior to and with radiation for newly diagnosed glioblastoma (GBM),Tumor Treating Fields in combination with a personalized mutation-derived tumor vaccine for newly diagnosed GBM, and targeted skull remodeling surgery to maximize Tumor Treating Fields intensity for recurrent GBM.

Post-hoc analyses of Novocure’s EF-14 phase 3 pivotal trial in newly diagnosed GBM will highlight improved patient outcomes associated with higher delivered doses of Tumor Treating Fields, the potential combination of Tumor Treating Fields with lomustine and the absence of a negative impact on health-related quality of life in the EORTC QLQ-C30 and BN20 scales when Tumor Treating Fields was added to temozolomide.

Preclinical data will highlight the potential role of Tumor Treating Fields as an activator of the immune system, supporting further investigation into the combination of Tumor Treating Fields and immunotherapy. Other abstracts will include insights on the relative response to Tumor Treating Fields across certain cell lines, the potential for novel array layouts to improve efficacy of Tumor Treating Fields, the potential effect of Tumor Treating Fields on blood brain barrier permeability and the potential synergistic effect of Tumor Treating Fields in combination with PARP inhibitors.

Health economics and outcomes research data will discuss the cost effectiveness of Tumor Treating Fields across multiple populations and assessment frameworks.

Abstracts on Tumor Treating Fields can be viewed online and include the following:

Oral presentations

(HOUT-16) The cost effectiveness of Tumor Treating Fields treatment for patients with newly diagnosed glioblastoma based on the EF-14 trial. G. Guzauskas. 5:00 to 5:04 p.m. CST Saturday, Nov. 17. (E-talks group 3: Health outcomes / neurological complications of cancer and cancer therapy / quality of life / radiotherapy / surgical therapy / CNS metastases)

(ACTR-46) Higher doses of TTFields in the tumor are associated with improved patient outcome. M. Ballo. 5:32 to 5:36 p.m. CST Saturday, Nov. 17. (E-talks group 1: Adult therapeutics / immunology)

(ACTR-43) Open-label phase 1 clinical trial testing personalized and targeted skull remodeling surgery to maximize TTFields intensity for recurrent glioblastoma – Interim analysis and safety assessment. A. Korshoej. 9:40 to 9:45 a.m. CST Sunday, Nov. 18. (Concurrent session 7A: Adult clinical trials II)

(HOUT-18) Cost effectiveness of treating glioblastoma patients age 65 years or older with Tumor Treating Fields plus temozolomide versus temozolomide alone. G. Guzauskas. 10:30 to 10:40 a.m. CST Sunday, Nov. 18. (Concurrent session 8B: Practical & applied neuro-oncology II)

(IMMU-71) Evaluating the compatibility of tumor treating electric fields with key anti-tumoral T cell functions. G. Diamant. 11:50 to 11:55 a.m. CST Sunday, Nov. 18. (Concurrent session 8C: Immunology – Preclinical and clinical II)

Poster presentations: Adult clinical trials – Non-immunologic

(ACTR-01) Safety Analyses of Tumor Treating Fields in Combination with Lomustine in the EF14 Phase 3 Clinical Study. A. Kinzel. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(ACTR-49) Pricottf: A Phase I/II Trial of Tumor Treating Fields Prior and Concomitant to Radiotherapy in Newly Diagnosed Glioblastoma. M. Glas. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

Poster presentation: Angiogenesis

(ANGI-11) Tumor Treating Fields (TTFields) Inhibit Cancer Cell Migration and Invasion by Inducing Reorganization of the Actin Cytoskeleton and Formation of Cell Adhesions. M. Giladi. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

Poster presentations: Adult clinical trials – Immunologic

(ATIM-02) Tumor Treating Fields in Combination with Bevacizumab in Recurrent or Progressive Meningioma in a Phase 2 Study. P. Kumthekar. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(ATIM-03) TTFields and Pulsed Bevacizumab in Patients with Bevacizumab-refractory Recurrent Glioblastoma: A Phase 2 Study. D. Tran. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(ATIM-31) Phase I Study of Tumor Treatment Fields and a Personalized Mutation-derived Tumor Vaccine in Patients with Newly Diagnosed Glioblastoma. A. Hormigo. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

Poster presentations: Cell biology and metabolism

(CBMT-03) A Novel Metabolic PET Tracer Strategy to Determine Early Effects of Tumor Treating Fields (TTFields). C. Patel. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(CBMT-29) Induction of Autophagy Following TTFields Application Serves as a Survival Mechanism Mediated by AMPK Activation. M. Giladi. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

Poster presentations: Computational omics

(COMP-15) Meta-analysis of Cancer Cell Lines Based on Their Response to Tumor Treating Fields (TTFields). M. Giladi. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(COMP-19) Water-content Based Electric Property Tomography (wEPT) for Modelling Delivery of Tumor Treating Fields to the Brain. Z. Bomzon. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

Poster presentation: Drug resistance

(DRES-11) A Systems Approach for Determining the Mechanism of Resistance to Tumor Treating Fields in Glioblastoma. D. Chen. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

Poster presentations: Experimental therapies

(EXTH-01) Modeling the Safety of Topical Agents for Skin Toxicity Associated with Tumor Treating Fields Therapy in Glioblastoma. M. Lacouture. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(EXTH-24) Exposure to Tumor Treating Fields Inhibits DNA Repair, Induces Replication Stress and Renders Tumor Cells Sensitive to Agents That Impinge upon These Pathways. M. Story. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(EXTH-38) A New Computational Method for Comprehensive Estimation of Anti Tumor Efficacy of Tumor Treating Fields (TTFields). A. Korshoej. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(EXTH-40) Optimizing Array Layouts for Glioblastoma Therapy with Tumor Treating Fields (TTFields). A. Korshoej. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(EXTH-41) Effects of Tumor Treating Fields (TTFields) on Blood Brain Barrier (BBB) Permeability. A. Kessler. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(EXTH-62) The Dielectric Properties of Malignant Glioma Tissue. M. Proescholdt. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(EXTH-74) Molecular Mechanisms of Anti-tumor Action of TTFields Determined by Measurements and Modeling of Electro-conductive Properties of Microtubules. J. Tuszynki. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

Poster presentations: Health outcome measures

(HOUT-06) Pattern of low field intensity recurrence in high-grade gliomas following Tumor Treatment Field therapy. R. Briggs. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(HOUT-09) Using the ASCO (Free ASCO Whitepaper) and ESMO (Free ESMO Whitepaper) Frameworks to Assess the Clinical Value of Tumor Treating Fields for Newly Diagnosed Glioblastoma Multiforme. C. Proescholdt. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(HOUT-17) Elderly Patients >65 years of Age with Newly Diagnosed Glioblastoma Multiforme Gain Life Time from Treatment with Tumor Treating Fields and Temozolomide. G. Guzauskas. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(HOUT-25) Adherence to Tumor Treating Fields in Patients with High-grade Glioma – A Single Center Experience. A. Kessler. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(HOUT-26) Survival Outcomes in Glioblastoma Patients Using TTFields: The Baylor Scott & White Medical Center in Central Texas Experience. A. Padhye. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(HOUT-27) The Challenge of Health Utility Values for Glioblastoma Patients with Long-term Survival. C. Proescholdt. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(HOUT-28) Clinical Experience with Tumor Treating Fields (TTFields, Optune) in Israel – Patient Acceptance and Safety. T. Siegal. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(HOUT-30) Tumor Treating Fields (TTFields) in Combination with Lomustine (CCNU) and Temozolomide (TMZ) in Patients with Newly Diagnosed Glioblastoma (GBM). M. Glas. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(HOUT-31) Care patterns and treatment efficacy: A clinical series of primary glioblastoma with an emphasis on older adults. M. Hultman. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(HOUT-36) Institutional Compliance with Tumor Treating Fields for Glioblastoma. R. Bonomi. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

Poster presentations: Immunology

(IMMU-42) TTFields Induces Immunogenic Cell Death and STING Pathway Activation Through Cytoplasmic Double-stranded DNA in GBM. D. Chen. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(IMMU-52) Tumor Treating Fields (TTFields) Induce Immunogenic Cell Death Resulting in Enhanced Antitumor Efficacy When Combined with anti-pd-1 Therapy. T. Voloshin. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(IMMU-53) Impact of Tumor-treating Fields (TTFields) on the Immunogenicity of Glioma Cells. M. Silginer. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

Poster presentations: Innovations in patient care

(INNV-01) PROTECT Study: PRO Phylactic Skin Toxicity Therapy with Clindamycin and Clobetasol or Skin Barrier in Glioblastoma Patients Treated with Tumor Treating Fields. M. Lacouture. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(INNV-03) Safety and Adverse Event Profile of Tumor Treating Fields Use in the EMEA Region – a Real-world Data Analysis. M. Glas. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(INNV-04) Safety and Adverse Event Profile of Tumor Treating Fields in Glioblastoma – a Global Post-market Surveillance Analysis. U. Weinberg. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(INNV-17) Tumour Treating Fields: Acceptable to a UK Population? M. Jenkinson. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(INNV-23) Safety and Adverse Event Profile of Tumor Treating Fields in Elderly Patients – a Post-market Surveillance Analysis. W. Shi. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(INNV-24) Safety of Tumor Treating Fields in Glioblastoma Patients with Implanted Non-programmable and Programmable Shunts, and Pacemakers/defibrillators. Y. Kew. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(INNV-29) Experience with TTFields (Optune) in Pediatric High Grade Glioma Patients in Israel. M. Yalon. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(INNV-30) Tumor Treating Fields and Radiotherapy for Newly Diagnosed glioblastoma: Safety and Efficacy Results from a Pilot Study. R. Grossman. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(INNV-31) User Experience with New, Aesthetically Improved Transducer Arrays for Delivery of Tumor Treating Fields for Glioblastoma. A. Kinzel. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(INNV-48) Tumor Treating Fields Utilization in a Glioblastoma Patient with a Preexisting Cardiac Pacemaker: The First Reported Case. S. McClelland. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

Poster presentation: Neurological complications of cancer and cancer therapy

(NCMP-21) Real-world Surveillance Data for Tumor Treating Fields Affirm the Tolerability of Tumor Treating Fields for the Treatment of Glioblastoma in the United States. D. Tran. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

Poster presentation: Neuro-cognitive outcomes

(NCOG-06) Predicting Tumor Treating Field Compliance Using Neurocognitive Testing. K. Qualls. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

Poster presentations: Neuro-imaging

(NIMG-04) Diffusion Restriction on MR Imaging in the T2 Hyperintense, but Otherwise Normal-appearing White Matter of Glioblastoma Patients Treated with TTFields Correlates with Survival. J. Vymazal. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(NIMG-34) The Impact of Tumor Treating Fields (TTFields) on Brain Anatomy Using Computational Anatomy Analysis. A. Hottinger. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(NIMG-48) Volumetric Response to TTFields in Newly Diagnosed GBM. C. Freyschlag. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(NIMG-49) Electric Field Intensities Delivered by Tumor-treating Fields (TTFields) to Glioblastoma Regions: Effect on Treatment Response Assessed by Amino Acid PET. C. Juhasz. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(NIMG-72) A Novel Array Layout for Delivering TTFields to the Whole Brain. Z. Bomzon. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

Poster presentation: Molecular pathology and classification – Adult and pediatric

(PATH-27) Identifying the Genetic Signature of Response in a Phase II Study of Tumor Treating Fields in Recurrent Glioblastoma. D. Tran. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

Poster presentations: Pediatric clinical trials

(PDCT-07) Feasibility Trial of Optune for Children with Recurrent or Progressive Supratentorial High-grade Glioma and Ependymoma: A Pediatric Brain Tumor Consortium Study. E. Hwang. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(PDCT-11) Surveillance Data Demonstrates the Tolerability of Tumor Treating Fields in Pediatric Glioma Patients. D. Hanson. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(PDCT-12) A Phase I Trial of Tumor Treating Fields with and Without Concomitant Temozolomide and Bevacizumab in Pediatric Patients with High-grade Glioma and Ependymoma. D. Hanzon. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

Poster presentation: Pediatric tumors

(PDTM-19) Tumour Treating Fields (TTFields) Exhibit Efficacy on High-grade Paediatric Brain Tumour Cell Lines. J. Branter. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

Poster presentations: Quality of life and palliative care

(QOLP-01) Effects of Tumor Treating Fields on Health-related Quality of Life (HRQoL) in Newly Diagnosed Glioblastoma: An Exploratory Analysis of the EF-14 Randomized Phase III Trial. T. Walbert. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(QOLP-15) Safety and Adverse Event Profile of Tumor Treating Fields in Anaplastic Glioma – a Post-marketing Surveillance Analysis. D. Bota. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

Poster presentation: Randomized brain tumor trials in development

(RBTT-05) Tumor Treating Fields and Radiosurgery for Supra- and/or Infratentorial Brain Metastases (1-10) from NSCLC in the Phase 3 METIS Study. M. Mehta. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

Poster presentations: Radiation biology and DNA repair

(RDNA-02) Tumor Treating Fields Differentially Alter Homologous Recombination in Patient Derived Glioma Cells versus Established Lines. L. Bronk. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(RDNA-07) idh1-mutant Glioblastoma (GBM) Cells from a Patient Post-tumor Treating Fields (TTFields) Therapy Are Sensitive to TTFields in vitro. S. Mittal. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(RDNA-10) Histopathological and Genomic Characterization of Glioblastoma (GBM) Resected After Tumor Treating Fields (TTFields) Therapy. S. Michelhaugh. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(RDNA-17) Power Density Loss Can Be Used to Defined Tumor Treating Fields Dose. Z. Bomzon. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

Poster presentations: Radiation therapy

(RTHP-12) Comparative Analysis of Tumor Treating Fields Using Conventional versus Alternative Array Placement for Posterior Fossa Glioblastoma. E. Wong. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(RTHP-13) Tumor-treating Fields Therapy Is Compatible with Standard Chemoradiotherapy for Glioblastoma. L. Kleinberg. 7:30 to 9:30 p.m. CST Friday, Nov. 16.

(RTHP-14) Tumor-treating Fields for Glioblastoma: Numerical Simulation Explores Sub-cellular Mechanisms. K. Carlson. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

Poster presentations: Tumor microenvironment

(TMIC-10) Autopsy Study on the Effects of Tumor Treatment Fields in Recurrent Glioblastoma: Preliminary Results. A. Barrington. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

(TMIC-38) Enhanced Efficacy of Tumor Treating Fields and Aurora B Kinase Inhibitor Combination in Glioma Cell Lines. M. Giladi. 5:00 to 7:00 p.m. CST Saturday, Nov. 17.

On November 13, 2018 Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris"), a biopharmaceutical company studying topsalysin (PRX302), a first-in-class, pore-forming protein, in late-stage clinical trials for the treatment of patients with urological diseases, reported financial results for the third quarter 2018 and recent corporate highlights (Press release, Sophiris Bio, NOV 13, 2018, View Source [SID1234531295]).

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"During the third quarter, we reported top-line six-month biopsy data from two additional patients following a single administration of topsalysin in our ongoing Phase 2b clinical trial in low to intermediate risk localized prostate cancer," said Randall E. Woods, president and CEO of Sophiris. "Both patients were considered partial responders, bringing the total number of patients with a partial response to 15 out of the 37. We continue to believe that the data obtained to date from the single administration of topsalysin supports advancing topsalysin into a single Phase 3 trial for the treatment of localized prostate cancer. We remain on track to report data by the end of next month from patients who received a second administration of topsalysin as part of our Phase 2b trial. Finally, we are preparing for Phase 3 guidance meetings with regulatory agencies. We expect these meetings to take place in the first half of 2019, after which we will provide an update on our Phase 3 trial design."

Third Quarter Corporate Highlights:

Updates from Phase 2b trial in localized prostate cancer. In the third quarter, Sophiris reported top-line six-month follow-up biopsy data from the final two patients enrolled in the trial with pre-identified, clinically-significant localized prostate cancer that were treated with a single administration of topsalysin.

Based on the six-month follow-up biopsy results, 27% of patients (10/37) demonstrated a clinical response. Of the 10 clinical responders in the Phase 2b trial, six patients experienced a complete ablation with no histological evidence of the targeted tumor remaining. In addition, 41% of patients (15/37) were considered partial responders, meaning that while an effect was seen, some clinically-significant lesion remained as identified by targeted biopsy. 68% of patients (25/37) demonstrated a partial or clinical response to the single administration of topsalysin.

The Phase 2b study was designed to include an option for qualified patients to receive a second administration of topsalysin six-months after the first administration, provided: (1) the patient did not have any clinically-significant adverse events to either topsalysin or the dosing procedure and (2) some response to the first administration was observed following a targeted biopsy. The objective of re-administering topsalysin is to assess the safety of giving a second administration of topsalysin and to determine if additional clinical benefit is observed six-months after the second administration.

The Company expects to have six-month follow-up safety and biopsy data from patients who received a second administration of topsalysin in its ongoing Phase 2b trial in localized prostate cancer patients next month.

Preparations for Phase 3 trial in localized prostate cancer. The Company believes that the data generated in the single-administration portion of the Phase 2b prostate cancer study supports the advancement of the program into a single Phase 3 pivotal trial. Currently, the Company is in the process of preparing information for regulatory guidance meetings with the U.S. Food and Drug Administration and the European Medicines Agency which are expected to take place in the first half of 2019, after which the Company will provide an update on the Phase 3 trial design. The Company will evaluate whether future clinical development will include an option to administer a second dose of topsalysin once the Company receives more information from the 10 patients who have received a second dose.

Interest only period extended under loan and security agreement. In September the Company announced that it had met the requirements within its existing loan and security agreement with Silicon Valley Bank to extend the interest only period to March 31, 2019. The Company will begin making interest and principal payments starting on April 1, 2019 and ending on the final payment date of September 1, 2021.

Financial Results:

At September 30, 2018, the Company had cash, cash equivalents and securities available-for-sale of $14.5 million and working capital of $11.7 million. The Company expects that its existing cash and cash equivalents will be sufficient to fund its operations through June 2019, assuming no new clinical trials are initiated. The Company will require significant additional funding to advance topsalysin in clinical development. As of September 30, 2018, the outstanding principal balance of the Company’s term loan was $7 million on which the Company is currently making monthly interest only payments.

For the three months ended September 30, 2018

The Company reported a net loss of $2.9 million or ($0.10) per share for the three months ended September 30, 2018, compared to net loss of $2.7 million or ($0.09) per share for the three months ended September 30, 2017.

Research and development expenses

Research and development expenses were $1.8 million for the three months ended September 30, 2018, compared to $1.6 million for the three months ended September 30, 2017. The increase in research and development costs is primarily attributable to increases in the costs associated with manufacturing activities for topsalysin offset in part by a decrease in clinical costs associated with its Phase 2b clinical trial of topsalysin for the treatment of localized prostate cancer.

General and administrative expenses

General and administrative expenses were $1.2 million for the three months ended September 30, 2018, compared to $1.7 million for the three months ended September 30, 2017. The decrease in general and administrative expense is primarily due to decreases in marketing research activities and to a lesser extent a decrease in personnel related expenses.

Gain on revaluation of the warrant liability

Gain on revaluation of the warrant liability was $0.2 million for the three months ended September 30, 2018, compared to a gain of $0.7 million for the three months ended September 30, 2017. As these warrants may require the Company to pay the warrant holder cash under certain provisions of the warrant, the Company accounts for these warrants as a liability, and the Company is required to calculate the fair value of these warrants each reporting date. The non-cash gain reported for the three months ended September 30, 2018, is associated with a decrease in the fair value of the Company’s warrant liability from June 30, 2018, to September 30, 2018, which is calculated using a Black-Scholes pricing model. Certain inputs utilized in the Company’s Black-Scholes fair value calculation may fluctuate in future periods based upon factors which are outside of the Company’s control. A significant change in one or more of these inputs used in the calculation of the fair value may cause a significant change to the fair value of the Company’s warrant liability, which could also result in a material non-cash gain or loss being reported in the Company’s consolidated statement of operations and comprehensive loss.

For the nine months ended September 30, 2018

The Company reported a net loss of $12.3 million or ($0.41) per share for the nine months ended September 30, 2018 compared to a net loss of $4.7 million or ($0.15) per share for the nine months ended September 30, 2017.

Research and development expenses

Research and development expenses were $8.7 million for the nine months ended September 30, 2018 compared to $4.2 million for the nine months ended September 30, 2017. The increase in research and development costs is primarily attributable to increases in the costs associated with manufacturing activities for topsalysin.

General and administrative expenses

General and administrative expenses were $3.5 million for the nine months ended September 30, 2018 compared to $4.4 million for the nine months ended September 30, 2017. The decrease in general and administrative expense is primarily due to decreases in non-cash stock-based compensation expense and marketing research activities and to lesser extent a decrease in its personnel related costs.

Gain on revaluation of the warrant liability

Gain on revaluation of the warrant liability was $0.1 million for the nine months ended September 30, 2018 as compared to a gain of $3.9 million for the nine months ended September 30, 2017. The non-cash gain reported for the nine months ended September 30, 2018, is associated with a decrease in the fair value of the Company’s warrant liability from December 31, 2017, to September 30, 2018.

On November 13, 2018 Medigene AG (FSE: MDG1, Frankfurt, Prime Standard, SDAX), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies for the treatment of cancer, reported financial results for the first 9 months of 2018 and provided a review of recent accomplishments and anticipated upcoming milestones (Press release, MediGene, NOV 13, 2018, View Source [SID1234531242]). The company further improved its financial guidance for the fiscal year 2018.

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Major events in the first three quarters of 2018:
– Start of a Phase I/II clinical trial with T cell receptor-modified T cell therapy (TCR-T) MDG1011 in blood cancers including Acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and multiple myeloma (MM)
– Expansion of TCR alliance with bluebird bio from four to six TCR projects
– Raise of EUR 32.3 million in oversubscribed private placement to new and existing investors
– Strengthened patent portfolio with new TCR patents in USA and Europe
– Presented data on the successful production of dendritic cell (DC) vaccines for the current Phase I/II clinical trial
– Collaboration with Structured Immunity on improved T cell receptor development

Update Immunotherapies
– Authority approves simplified criteria for patient recruitment in Phase I/II trial with TCR-therapy MDG1011: The German regulatory authority, the Paul-Ehrlich-Institut (PEI), has approved Medigene’s amendment of the trial inclusion criteria. Initial trial protocol required inclusion of one patient per indication (AML, MDS, MM) in a dose cohort of three patients. The adjusted trial protocol requires at least one patient with MM and at least one patient with either AML or MDS. The adjusted trial protocol enables more flexibility and potentially more rapid enrollment of patients. Moreover, an analytical method for determining PRAME expression has been optimized, which results in an increase in the number of potential patients for the clinical trial.
– Successful manufacturing of the first personalized cell product MDG1011: The first personalized MDG1011 cell product was successfully manufactured with patient-specific T cells in compliance with the clinical trial protocol in the course of the trial. A sufficient number of therapeutic TCR-modified T cells with autologous T cells were generated despite the advanced disease stage of the patient. However, the patient could not be treated with the therapeutic product because he dropped out of the trial beforehand due to rapid progression of the underlying disease.
– Preparations to increase the number of trial centers started: Medigene is undertaking intensive preparations with a number of additional hospitals in order to increase the number of centers to allow for an accelerated patient recruitment.

Prof. Dolores Schendel, CEO of Medigene AG, comments: "We are delighted to show that the manufacturing of our highly innovative product MDG1011 worked well with a patient’s own cells in our first-in-man and first-in-country trial with a TCR-modified T cell therapy. The modified study protocol and the expansion of the study centers will improve the general admission for the treatment of these critically ill patients. Our financials are on track and the guidance reflects our intensive research and development activities in the further development of our immunotherapies."

Nine months’ financial results:
– Total revenue increased by 11% to EUR 8.0 million
– Revenue from the core business of immunotherapies increased by 38% to EUR 4.7 million
– Research and development (R&D) expenses increased as planned by 20% to EUR 13.3 million due to extension of the preclinical and clinical development activities for immunotherapy programs
– EBITDA loss increased as anticipated by 5% to EUR 10.7 million
– Net loss increased by 14 % to EUR 12.2 million due to higher R&D expenses and currency effects
– Cash & cash equivalents and time deposits of EUR 76.3 million as at September 30, 2018
– Further improvement of the financial guidance 2018

Financial guidance 2018:
Medigene further improves the financial guidance for 2018 which was raised in the 6M financial statement:
– The Company continues to expect total revenue of EUR 9.5 – 10.5 million in 2018.
– Due to lower than estimated clinical trial costs in 2018, the company now expects to spend EUR 19 – 21 million for the full year 2018 (previous guidance: EUR 21 – 23 million).
– As a result, Medigene is expecting to make a loss at EBITDA level of EUR 16 – 18 million (previous guidance: EUR 18 – 20 million).
– Excluding the proceeds from the capital increase conducted in May 2018, Medigene forecasts a total cash usage of EUR 12 – 14 million for 2018 (previous guidance: EUR 15 – 17 million)
– This forecast does not include potential future milestone payments or cash flows from existing or future partnerships or transactions, as the occurrence of such events and their timing and amount depend to a large extent on external parties and therefore cannot be reliably predicted by Medigene.
– Based on its current planning, the Company has sufficient financial resources to fund business operations beyond the planning horizon of two years.

Outlook immunotherapies:
T cell receptor-modified T cells (TCR-Ts)
The Company is planning to commence treatment of the first dose cohort in the Phase I/II clinical trial of Medigene’s TCR-T MDG1011 therapy for acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and multiple myeloma (MM). Phase I focuses on the safety and tolerability of the treatment with MDG1011.
In addition to the MDG1011 clinical trial, Medigene will also work on characterizing new TCR candidates for future Medigene-sponsored clinical trials and collecting preclinical data to prepare applications for further clinical TCR-T trials. In addition, Medigene will continue its successful and expanded collaboration with bluebird bio and expects to make further progress on TCR candidate discovery.

Dendritic cell vaccines (DCs)
Medigene continues its ongoing Phase I/II clinical trial with the DC vaccine to treat acute myeloid leukemia (AML). Data from all patients over a treatment duration of one year is expected in the fourth quarter of 2018. This corresponds to the half-way point of the full treatment period. This interim analysis is planned to be presented at scientific conferences in 2019. The final clinical data from the Phase I/II trial are expected at the conclusion of the two-year treatment for all patients towards the end of 2019.

The full version of the quarterly statement 9M-2018 can be downloaded here: www.medigene.com/investors-media/reports-presentations/

Conference call and webcast: A telephone conference (webcast) in English will be held today at 3:00 pm CET (Munich/Frankfurt) / 9:00 am EST (New York) and transmitted live via webcast. Access and transmission of the synchronized presentation slides and a recording of the presentation is available on the homepage of Medigene at www.medigene.com/investors-media/reports-presentations/webcasts/

On November 13, 2018 Vernalis Research, a Ligand Company, reported that it has earned multiple success milestones under its drug discovery collaboration with Daiichi Sankyo Company, Limited (Daiichi Sankyo) that began in December of 2017 (Press release, Vernalis, NOV 13, 2018, View Source [SID1234531261]).

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The research utilizes Vernalis’ fragment and structure-based drug discovery platform for two undisclosed oncology targets. Additionally, a final success payment has been earned for one target and the research collaboration continues for the second target. The financial terms of the collaboration are not disclosed.

Mike Wood, Ph.D. Research Director of Vernalis Research, commented, "We are delighted with the success we have achieved in our close collaboration with the scientists at Daiichi Sankyo. This is another excellent endorsement of our world-leading fragment and structure-based drug discovery platform and we look forward to the potential for continued success in our collaboration with Daiichi Sankyo."

On November 13, 2018 Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, reported financial results for its third fiscal quarter, which ended September 30, 2018, and provided a business update (Press release, Galectin Therapeutics, NOV 13, 2018, View Source [SID1234531296]). These results are included in the Company’s Quarterly Report on Form 10-Q, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.

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Harold H. Shlevin, Ph.D., President and Chief Executive Officer of Galectin Therapeutics, said, "Our central focus remains advancing our plan for a Phase 3 clinical trial program with GR-MD-02 in NASH cirrhosis, for which we continue to make progress. Importantly, we have been collaborating with leading NASH experts who have been enlisted to help strengthen the overall plan. We are simultaneously scaling-up manufacture of clinical supplies and conducting other required activities prior to starting the Phase 3 trial."

"In addition, we are pursuing other opportunities where our galectin-3 inhibitor GR-MD-02 has demonstrated encouraging clinical results. On September 20, 2018, we reported that the investigators were encouraged by the reported Objective Response Rate (ORR) of the GR-MD-02 and KEYTRUDA combination immunotherapy trial for all cohorts relative to the ORR from randomized studies with KEYTRUDA alone in patients with advanced melanoma. The investigators also reported on six patients with head and neck cancer that exhibited a 33% ORR and 67% Disease Control Rate (DCR). As a result of these encouraging preliminary findings, the investigators will be expanding the trial to include additional patients. Further details are available in that press release. As a company we are very pleased with our productive collaboration with Providence Cancer Institute.

"We continued to enhance the scope of our intellectual property protections and expand basic patent approvals in key markets and countries. During this quarter, we had the following patents either granted or allowed:

Galactose-pronged carbohydrate compounds for the treatment of diabetic nephropathy and associated in Europe, Australia, and China

Composition of novel carbohydrate drug for treatment of human disease in Japan

Method for enhancing specific immunotherapies in China, Israel and Japan

Compositions of novel carbohydrate drugs for treatment of NASH and NAFLD in Mexico and South Africa

We also note that patent applications have been filed on behalf of Galectin Sciences LLC related to small molecule inhibitors of galectin-3 and various other activities.

"At quarter end, our funding is sufficient to support continued pursuit of this multi-pronged strategy, all based upon the strong foundation of our proprietary molecule and the potential it represents. Our goal is to unlock the value of our proprietary technology and capitalize on the pressing need for solutions to the growing NASH epidemic and other diseases where our anti-fibrotic compound can be therapeutic."

Richard E. Uihlein, Chairman of the Board, added, "This has been another quarter of steady progress across the broad range of possibilities for GR-MD-02. I am pleased with the progress Dr. Shlevin and the team are making and look forward to the ultimate submission of our Phase 3 plan and the exciting opportunities it can create."

Summary of Key Development Programs and Updates

Continuing to develop plans for a Phase 3 clinical trial program with our galectin-3 inhibitor GR-MD-02 in NASH cirrhosis, incorporating advice and guidance obtained in a meeting with the FDA and our external advisors. Details of the Phase 3 clinical trial design, including projected timings and costs, will be announced once the planning phase has been completed and the Company has a final clinical trial protocol that is acceptable to the FDA.

As highlighted above, in conjunction with Providence Cancer Institute, announced additional preliminary clinical data from cohort 3 of an investigator-initiated Phase 1b clinical trial of GR-MD-02 used in combination with KEYTRUDA (pembrolizumab) in patients with metastatic melanoma for which KEYTRUDA is indicated or those patients whose melanoma progressed during or recently after KEYTRUDA monotherapy. Those results indicated:

Combination immunotherapy of GR-MD-02 and KEYTRUDA for all cohorts reported showed an Objective Response Rate of 50% (seven of fourteen patients). These response rates from this small cohort are encouraging as they were higher than expected with KEYTRUDA alone

A Disease Control Rate of nine out of fourteen patients (64%) with advanced melanoma, which the principal investigator characterized as ‘very encouraging’

The combination was also very well tolerated, and treatment appears to be associated with fewer adverse events than expected with KEYTRUDA alone

When aggregated with the cohorts previously reported, the data shows a 50% Objective Response Rate in advanced melanoma with GR-MD-02 in combination with KEYTRUDA whereas the published response rate of KEYTRUDA alone is 33% in advanced melanoma

In addition to advanced melanoma patients, the Providence Cancer Institute clinical trial enrolled six patients with head and neck cancer in this Phase 1b trial with a 33% Objective Response Rate and a 67% Disease Control Rate

Providence Portland will be expanding the size of the 4 mg/kg GR-MD-02 cohort including additional melanoma patients as well as head and neck cancer patients. These results together with earlier results will help guide decision on advancing development to Phase 2.

Back Bay Life Science Advisors, under contract with the Company, continues to support the Company’s exploration of strategic alternatives.

Upcoming Scientific Presentations and Conferences

Dr. Harold H. Shlevin will be making a presentation, titled "Physiological Control Systems Involving Galectins in the Treatment of Diseases" at the 2nd Annual Anti-Fibrotic Drug Development Summit (AFDD) on November 29.

A poster presentation titled "The noninvasive point of care MBT accurately predicts decompensation events better than MELD in compensated (MELD<15) NASH cirrhotics" authored by Naga Chalasani, et al. and based on results obtained from Galectin Therapeutics’ NASH-CX Phase 2 Clinical Trial will be presented by Exalenz Bioscience at The Liver Meeting, the annual meeting of the American Association for the Study of Liver Diseases (AASLD) on November 9-13, 2018. The poster illustrates Exalenz Bioscience’s 13C-Methacetin Breath Test’s (MBT) ability to predict decompensation in compensated NASH cirrhotics.

Other Activities

Management participated with a number of other companies pursuing a NASH therapy in the ROTH Capital Battle of the NASH Thrones Investor Conference on October 17.

Dr. Harold H. Shlevin participated in the H.C. Wainwright 20th Global Investment Conference on September 6, 2018.

Dr. Shlevin concluded, "Galectin Therapeutics has developed a novel compound, GR-MD-02, a galectin-3 inhibitor, which we believe has the potential to be effective in treating a wide range of diseases wherein elevated levels of galectin protein and inflammation play key roles in the pathophysiology of the diseases. Most immediately, we are focused on advancing our Phase 3 trial in NASH Cirrhosis. However, we continue to investigate a variety of other preclinical applications where research shows that GR-MD-02’s antifibrotic capabilities may help provide more effective treatment in a variety of conditions. We believe this is the best path to build value in our overall galectin franchise and maximize potential of this platform technology to treat other diseases."

Financial Results

For the three months ended September 30, 2018, the Company reported a net loss applicable to common stockholders of $3.0 million, or $0.07 per share, compared with a net loss applicable to common stockholders of $4.7 million, or $0.13 per share, for the three months ended September 30, 2017. The decrease is largely due to lower research and development expenses primarily related to the winding down of the Phase 2 NASH clinical program somewhat offset by higher non-cash stock compensation expenses.

Research and development expense for the three months ended September 30, 2018, was $1.5 million, compared with $3.5 million for the three months ended September 30, 2017. The decrease primarily reflects lower research and development expenses primarily related to the winding down of the Phase 2 NASH clinical program somewhat offset by higher non-cash stock compensation expenses.

General and administrative expense for quarter was $1.2 million, compared with $0.9 million for the prior year, with the increase being primarily related to higher investor relations, business development and non-cash stock compensation expenses.

As of September 30, 2018, the Company had $10.1 million of non-restricted cash and cash equivalents. The Company believes current cash on hand and access to a $10 million line of credit (unused at September 30, 2018) are sufficient to fund currently planned operations and research and development activities through at least September 30, 2019.