On November 14, 2018 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics (MBTs) to treat age-related diseases, reported financial results for the third quarter ended September 30, 2018, and provided a business update (Press release, CohBar, NOV 14, 2018, View Source [SID1234531310]).

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"As we previously discussed, we are moving forward with our plan to address the mild but persistent injection site reactions observed in our Phase 1 clinical trial of CB4211, under development for NASH and obesity," said Simon Allen, Chief Executive Officer of CohBar. "We will be sharing this plan shortly with the FDA, and look forward to the agency’s timely feedback and resuming clinical activities as expeditiously as possible."

"This first groundbreaking study of a mitochondria based therapeutic in humans will help inform us not only for the development of CB4211, but also for the development of other potential therapeutics from our large portfolio of novel peptides. We continue to believe in the potential of MBTs to treat a broad range of age-related diseases with large-population indications, including type 2 diabetes, cancer, neurodegenerative disease and cardiovascular disease," Mr. Allen concluded.

Third Quarter and Recent Business Highlights:

Clinical Study Update for CB4211. On November 5, 2018, the company announced the temporary suspension of its ongoing Phase 1 clinical study of CB4211, its lead MBT candidate under development as a potential treatment for non-alcoholic steatohepatitis (NASH) and obesity, in order to address mild injection site reactions that have been unexpectedly persistent. The company has a plan to address the persistent reactions and is seeking feedback from the FDA before resuming the clinical study.

Partnership with LifeSci Advisors. CohBar engaged LifeSci Advisors LLC ("LifeSci"), a leading New York-based investor relations consultancy serving life science companies, to implement a comprehensive investor outreach program that will include analyst and investor targeting/outreach, non-deal roadshows, corporate communications, and Key Opinion Leader (KOL) events in the field of mitochondria based therapeutics and age-related diseases.

Investment and Scientific Community Outreach. During the third quarter, CohBar’s CEO Simon Allen presented an overview of the Company and its clinical development program at the Bio Investor Forum. Additionally, company management met with investors during the H.C. Wainwright 20th Annual Global Investment Conference.
During the third quarter, CohBar’s founders, Dr. Pinchas Cohen and Dr. Nir Barzilai, continued to be recognized as international leaders in the study of aging, age-related diseases and mitochondrial science.

Dr. Cohen co-authored a number of papers published in scientific journals during the quarter including "Humanin Prevents Age-Related Cognitive Decline in Mice and is Associated with Improved Cognitive Age in Humans," in Nature Scientific Reports; "Chronic Treatment with the Mitochondrial Peptide Humanin Prevents Age-related Myocardial Fibrosis in Mice," in American Journal of Heart Circulation Physiology; "Characterizing the Protective Effects of SHLP2, a Mitochondrial-Derived Peptide, in Macular Degeneration," in Nature Scientific Reports; and "Mitochondrial biology and prostate cancer ethnic disparity," Carcinogenesis. Dr. Cohen also received a major grant from the National Institutes of Health recognizing his ground-breaking work in the field of mitochondrial science entitled, "Humanin is an AD resilience factor through its interaction with APOE4."

Dr. Barzilai delivered a keynote speech at the Aging Cell Conference in Sitges, Spain and co-authored a number of scientific papers published during the quarter including: "Aging as a Biological Target for Prevention and Therapy," in JAMA; "A framework for selection of blood-based biomarkers for geroscience-guided clinical trials: Report from the TAME Biomarkers Workgroup," in Geroscience; "Targeting Senescence," in Nature Medicine; "APOE Alleles and Extreme Human Longevity," Journals of Gerontology; "40 Years of IGF1: The Jekyll and Hyde of the Aging Brain," in Journal of Molecular Endocrinology; "Late-Life Targeting of the IGF1 Receptor Improves Healthspan and Lifespan in Female Mice," in National Communications.
Third Quarter 2018 Financial Highlights

Cash and Investments. CohBar had cash and investments of $24,223,712 on September 30, 2018, compared to $8,452,459 on December 31, 2017.

R&D Expenses. Research and development expenses were $3,435,509 in the three months ended September 30, 2018, compared to $2,316,454 in the prior year quarter. The increase was primarily due to the costs of our clinical activities and a net increase in stock-based compensation related to performance equity grants that vested within the current year quarter, offset by a decrease in costs related to the timing of IND-enabling activities incurred in the prior year period.

G&A Expenses. General and administrative expenses were $1,061,709 for the three months ended September 30, 2018, compared to $549,505 in the prior year quarter. The increase in general and administrative expenses was primarily due to an increase in stock-based compensation related to performance equity grants that vested within the current year quarter, the costs associated with new grants made since the prior year period and an increase in directors fees in the current quarter.

Net Loss. For the three months ended September 30, 2018, net loss was $4,613,042, or $0.11 per basic and diluted share, compared to a net loss of $2,861,107, or $0.07 per basic and diluted share, for the three months ended September 30, 2017.

Details for Conference Call

Date: November 14, 2018
Time: 5:00 p.m. Eastern Time

- Dial-in U.S. and Canada: (888) 394-8218
- Dial-in International: (323) 701-0225
- Conference ID Number: 1659879

We kindly request that you call into the conference audio approximately 10 minutes before the start time so that we can begin promptly.

An audio replay of the call will be available beginning at 8:00 p.m. Eastern Time on November 14, 2018, through 11:59 p.m. Eastern Time on December 5, 2018. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID# 1659879. The audio replay will also be available at www.cohbar.com from November 14 through December 5, 2018.

About CB4211
CohBar’s lead program is based on CB4211, a first-in-class mitochondria based therapeutic (MBT) that has demonstrated significant therapeutic potential in preclinical models of nonalcoholic steatohepatitis (NASH) and obesity. CB4211 is a novel and improved analog of MOTS-c, a naturally occurring mitochondrial-derived peptide (MDP) which was discovered in 2012 by CohBar founder Dr. Pinchas Cohen and his academic collaborators and has been shown to play a significant role in the regulation of metabolism. In July 2018, CB4211 entered a Phase 1a/1b clinical trial which includes a potential activity readout relevant to NASH and obesity. In November 2018, the company announced the temporary suspension of the trial to address mild injection site reactions that were unexpectedly persistent. NASH has been estimated to affect as many as 12% of adults in the U.S., and there is currently no approved treatment for the disease.

On November 14, 2018 The Janssen Pharmaceutical Companies of Johnson & Johnson reported the submission of two Type II variation applications to the European Medicines Agency (EMA) seeking approval for the expanded use of IMBRUVICA (ibrutinib) (Press release, Johnson & Johnson, NOV 14, 2018, View Source [SID1234531468]). One application seeks to include use of ibrutinib in combination with obinutuzumab in previously untreated adults with chronic lymphocytic leukaemia (CLL) and to add long-term follow-up data from the existing label studies RESONATETM (PCYC-1112) and RESONATETM-2 (PCYC-1115). The second is for use of ibrutinib plus rituximab for the treatment of previously untreated and relapsed/refractory adults with Waldenström’s macroglobulinemia (WM).

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"Today’s news brings us one step closer to potentially offering ibrutinib in new combinations for patients where unmet needs still persist," said Dr. Catherine Taylor, Haematology Therapy Area Lead, Europe, Middle East and Africa (EMEA), Janssen-Cilag Limited. "Ibrutinib continues to demonstrate clinical benefit over the long term for a broad
group of patients living with blood cancer, and we look forward to working with relevant authorities to secure approval of these new combinations."

Ibrutinib, a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, is jointly developed and commercialised by Janssen Biotech, Inc., and Pharmacyclics LLC, an AbbVie company. The CLL submission is supported by positive results from the Phase 3 iLLUMINATE (PCYC1130) study which investigated ibrutinib in combination with obinutuzumab versus
chlorambucil plus obinutuzumab in patients with newly diagnosed CLL.

1 Study findings from iLLUMINATE will also be featured as an oral presentation (abstract #691), whilst further analysis of RESONATETM and RESONATETM-2 results in comparison with real-world evidence databases (abstract #4427) will be included at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place in San Diego next month.1,2 A supplemental New Drug Application (sNDA) which was also recently submitted to the U.S. Food and Drug Administration (FDA) received Priority Review.

2 In WM, the submission is supported by data from the Phase 3 iNNOVATE (PCYC-1127) study evaluating ibrutinib in combination with rituximab, versus rituximab with placebo, in patients with previously untreated and relapsed/refractory WM.

3 Follow-up efficacy and safety findings from the iNNOVATE study will also be presented at ASH (Free ASH Whitepaper) 2018 (abstract
#149).

4 In August 2018, the FDA approved ibrutinib in combination with rituximab for the treatment of WM based on the data from iNNOVATE.

5 Additional information about both studies can be found at www.ClinicalTrials.gov (NCT02264574 and NCT02165397).
6,7
#ENDS#

About ibrutinib
Ibrutinib is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, which works by forming a strong covalent bond with BTK to block the transmission of cell survival signals within the malignant B-cells.8 By blocking this BTK protein, ibrutinib helps kill and reduce the number of cancer cells, thereby delaying progression of the cancer.9 Ibrutinib is currently approved in Europe for the following uses:10

 Chronic lymphocytic leukaemia (CLL): As a single agent for the treatment of adult patients with previously untreated CLL, and as a single agent or in combination with bendamustine and rituximab (BR) for the treatment of adult patients with CLL who have received at least one prior therapy.

 Mantle cell lymphoma (MCL): Adult patients with relapsed or refractory mantle cell MCL.

 Waldenström’s macroglobulinemia (WM): Adult patients who have received at least one prior therapy or in first-line treatment for patients unsuitable for chemoimmunotherapy.

The most common adverse reactions seen with ibrutinib include diarrhoea, neutropenia, haemorrhage (e.g., bruising), musculoskeletal pain, nausea, rash, and pyrexia.10

For a full list of side effects and information on dosage and administration, contraindications and other precautions when using ibrutinib please refer to the Summary of Product Characteristics for further information.

About CLL
CLL is typically a slow-growing blood cancer of the white blood cells.11 The overall incidence of CLL in Europe is approximately 4.92 cases per 100,000 persons per year with rates amongst men and women approximately 5.87 and 4.01 cases per 100,000 persons per year, respectively.

12 CLL is predominantly a disease of the elderly, with a median age of 72 years at diagnosis.13
CLL is a chronic disease; median overall survival ranges between 18 months and more than 10 years, according to the stage of disease.14 The disease eventually progresses in the majority of patients, and patients are faced with fewer treatment options with each relapse. Patients are often prescribed multiple lines of therapy as they relapse or become resistant to treatments.
3
About Waldenström’s macroglobulinemia
Waldenström’s macroglobulinemia (WM) is a rare form of non-Hodgkin’s lymphoma (NHL).15 It causes overproduction of a protein called monoclonal immunoglobulin M (IgM) antibody, which causes a thickening of the blood.
16 Incidence rates among men and women in Europe are approximately 7.3 and 4.2 per million persons, respectively.17 The causes of WM are unknown, with it typically affecting older adults and being slightly more
common in men than women.15,17

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/