On November 13, 2018 Tempest Therapeutics Inc. reported a poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting in Washington, D.C., describing lead compound TPST-1120’s two-pronged mechanism of directly targeting tumor cells dependent on fatty acid metabolism and driving a metabolic shift in the tumor microenvironment to glycolysis from fatty acid oxidation (Press release, Tempest Therapeutics, NOV 13, 2018, View Source [SID1234531259]). The resulting significant reductions in tumor growth and stimulation of durable anti-tumor immunity support Tempest’s rationale to advance the first-in-class oral small molecule inhibitor of PPAR alpha into clinical studies in patients with advanced solid tumors in early 2019.

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The poster titled "Antagonism of Peroxisome Proliferator Activated Receptor Alpha (PPARα) by TPST-1120 Suppresses Tumor Growth and Stimulates Anti-Tumor Immunity" describes studies that demonstrate significant anti-tumor efficacy of TPST-1120. As monotherapy, TPST-1120 prevented fatty acid oxidation and directly inhibited primary human tumor cells in culture and in human tumor xenografts in immune-deficient mice. In tumor-bearing immune-competent animals, TPST-1120 inhibited tumor growth as a single agent and in combination with chemotherapy or with anti-PD-1 antibodies.

For example, TPST-1120 plus gemcitabine significantly increased the long-term survival of mice with pancreatic tumors. TPST-1120 in combination with anti-PD-1 antibodies in mouse models of ovarian and colon cancer showed suppression of tumor growth and complete remissions in some animals. Importantly, cured mice were completely protected against autologous tumor re-challenge in the ovarian model, strongly suggesting immunological T cell memory against the primary tumor.

TPST-1120 elicits its potent anti-tumor effects through direct binding of the PPAR alpha transcription factor, inhibiting the expression of its regulated genes that are critical for fatty acid oxidation. Several malignancies such as hepatocellular carcinoma and renal cell cancer are reliant on fatty acid oxidation. In addition, suppressive immune cells in the tumor microenvironment such as a particular subset of macrophages, regulatory T cells and myeloid-derived suppressor cells all favor fatty acid oxidation. The utilization of fatty oxidation by tumor cells and suppressive immune cells underlines the tumor-intrinsic and tumor-extrinsic anti-tumor properties of TPST-1120.

"Immuno-metabolism is a rapidly evolving field, and it is increasingly recognized that regulating particular metabolic checkpoints that are essential to promote bio-energetic pathways necessary for sustaining tumor growth are important new targets in oncology. Our poster provides the rationale for advancing TPST-1120 into patients with advanced cancers and also provides insights into the clinical development of this first-in-human molecule," said Tom Dubensky, Ph.D., president and CEO of Tempest.

On November 13, 2018 Palatin Technologies, Inc. (NYSE American: PTN), a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems for the treatment of diseases with significant unmet medical need and commercial potential, reported results for its first fiscal quarter ended September 30, 2018 (Press release, Palatin Technologies, NOV 13, 2018, View Source [SID1234531294]).

Recent Highlights and Program Updates

Female Sexual Dysfunction / Vyleesi (bremelanotide)

●Vyleesi, the trade name for bremelanotide – Under development for Hypoactive Sexual Desire Disorder ("HSDD"):

¯FDA (U.S. Food and Drug Administration) set the PDUFA (Prescription Drug User Fee Act) action goal date of March 23, 2019 for completion of the review of the New Drug Application (NDA) for Vyleesi.

oSee 8-K filing today regarding the FDA’s review of the NDA submission for Vyleesi and the request for additional data.

¯AMAG Pharmaceuticals is the exclusive licensee for North America.

¯Palatin is in discussions with potential collaboration partners for certain regions outside of the licensed territories of North America, China and South Korea.

Anti-Inflammatory / Autoimmune Programs

●Melanocortin receptor 1 and 1/5 (MC1r, MC1/5r) agonists under development for the treatment of inflammatory and autoimmune diseases such as dry eye, uveitis, diabetic retinopathy and inflammatory bowel diseases:

¯PL-8177:

oAnnounced positive pharmacokinetics and pharmacodynamic results with no reported safety or tolerability concerns from a first-in-human Phase 1 safety study of subcutaneous dosing of PL-8177 in single and multiple ascending doses.

oData from a separate clinical study investigating an oral formulation of PL-8177 is currently expected by the end of calendar year 2018.

oProgram is under internal evaluation for orphan designations.

¯PL-8331 for ocular indications:

oPreclinical IND enabling activities commenced.

oProgram is under internal evaluation for orphan designations.

Natriuretic Peptide Program

¯PL-3994: Phase 2a, open label study in heart failure patients with preserved ejection fraction, targeted to commence in the first half of 2019.

¯PL-5028: Preclinical studies evaluating potential use in fibrotic disease ongoing.

Genetic Obesity Program

¯MC4r selective peptide and oral small molecule agonists: Commenced preclinical IND activities.

¯Program is under internal evaluation for orphan designations.

Corporate

¯Decreased debt from $7.2 million at June 30, 2018 to $5.3 million at September 30, 2018.

First Quarter Fiscal 2019 Financial Results

For the first fiscal quarter ended September 30, 2018, the Company reported a net loss of $(5.7) million, or $(0.03) per basic and diluted share, compared to net income of $10.6 million, or $0.05 per basic and diluted share, in the same period in 2017. The difference was primarily attributable to the recognition of $26.9 million in license and contract revenue during the 2017 period pursuant to our license agreements with AMAG and Fosun and secondarily attributable to the decrease in research and development expenses pursuant to the completion of our Vyleesi Phase 3 clinical trial program.

Revenue
The Company recognized $34,505 of revenue for the first fiscal quarter ended September 30, 2018, compared to $21.9 million in license and contract revenue related to our license agreement with AMAG and $5.0 million in license revenue related to the license agreement with Fosun for the quarter ended September 30, 2017.

Operating Expenses
Total operating expenses were $5.7 million for the first fiscal quarter ended September 30, 2018, compared to $15.7 million in the same period of 2017. The decrease in operating expenses was mainly attributable to the completion of the Vyleesi Phase 3 clinical trial program and ancillary studies necessary to file the NDA in HSDD in March 2018.

Other Income/Expense
Total other expense, net was $53,288 for the first fiscal quarter ended September 30, 2018 compared to $0.4 million for the same period of 2017. Total other expense, net for both periods consisted primarily of interest expense related to the Company’s venture debt offset by investment income.

Income Tax
Pursuant to the license agreement with Fosun, $500,000 was withheld in accordance with tax withholding requirements in China and was recorded as an expense during the fiscal year ended June 30, 2018. For the quarter ended September 30, 2017, Palatin incurred $225,255 in income tax expense utilizing an estimated effective annual income tax rate applied to income for the quarter and the remaining balance of $274,745 was included in prepaid expenses and other current assets at September 30, 2017. Any potential credit to be received by Palatin on its United States tax returns is currently offset by Palatin’s valuation allowance.

There was no income tax expense recorded in the quarter ended September 30, 2018.

Cash Position
At September 30, 2018, the Company had cash, cash equivalents, and accounts receivable aggregating $32.7, compared to cash and cash equivalents and accounts receivable of $38.0 million at June 30, 2018. Current liabilities were $8.5 million as of September 30, 2018, compared to $10.8 million as of June 30, 2018.

The Company believes that existing capital resources will be sufficient to fund its planned operations through at least the 2019 calendar year.

Palatin Drug Discovery Programs
In the conference call and webcast, management will update and discuss next steps in Palatin’s portfolio of drug development programs. These include Palatin’s melanocortin receptor­1 and receptor-1/5 agonist peptides for treatment of anti-inflammatory and autoimmune indications, receptor-4 peptide and small molecule agonists for the treatment of genetic obesity indications and natriuretic peptide receptor agonist compounds for treatment of cardiovascular and pulmonary indications.

Conference Call / Webcast
Palatin will host a conference call and webcast on November 13, 2018 at 11:00 a.m. Eastern Time to discuss the quarter ended September 30, 2018 results of operations and also provide an update on its programs under development. Individuals interested in listening to the conference call live can dial 1-877-260-1479 (US/Canada) or 1-334-323-0522 (international), conference ID 5988704. The webcast and replay can be accessed by logging on to the "Investor/Webcasts" section of Palatin’s website at View Source A telephone and webcast replay will be available approximately one hour after the completion of the call. To access the telephone replay, dial 1-888-203-1112 (US/Canada) or 1-719-457-0820 (international), passcode 5988704. The webcast and telephone replay will be available through November 20, 2018.

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On November 13, 2018 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported financial results and business highlights for the third quarter 2018 (Press release, Cyclacel, NOV 13, 2018, View Source [SID1234531427]). The Company’s net loss applicable to common shareholders for the three months ended September 30, 2018 was $2.1 million. As of September 30, 2018, cash and cash equivalents totaled $19.0 million.

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"We continue to execute on our strategy to rapidly develop CYC065 and CYC140 in hematological malignancies and CYC065 in advanced solid tumors," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "The Phase 1 study evaluating CYC065 in combination with venetoclax in patients with relapsed/refractory CLL and the CYC140 first-in-human study are open for enrollment. Two further protocols evaluating combinations of CYC065 and sapacitabine are in development. Our alliance with MD Anderson allows us to parallel track the development of our drugs in a cash-sparing manner while utilizing MD Anderson’s expertise to recruit patients across four studies. We estimate that our cash resources will be sufficient to fund operations until the second quarter of 2020. We are also pleased to report that the IST evaluating sapacitabine and olaparib in BRCA positive patients with breast cancer has started to enroll."

Key Company Highlights

·Announced a three-year strategic alliance agreement with The University of Texas MD Anderson Cancer Center enabling clinical evaluation of three Cyclacel medicines in patients with hematological malignancies. MD Anderson will conduct four clinical studies, with a total projected enrollment ofpatients, investigating CYC065, CYC140 and sapacitabine either as single agents or in combination with approved drugs.

·Opened for enrollment the Phase 1 clinical trial evaluating CYC065 in combination with venetoclax, a Bcl-2 inhibitor, in patients with relapsed/refractory CLL. Preclinical data presented at AACR (Free AACR Whitepaper) 2018 showed enhanced activity of CYC065 and venetoclax combination in CLL tumor samples, including those with 17p deletions. The combination also demonstrated activity in two CLL samples resistant to either agent alone, suggesting that dual targeting of Mcl-1 and Bcl-2 dependent mechanisms could induce synergistic cell death.

·First patient dosed in the Phase 1b/2 investigator-sponsored trial (IST) of sapacitabine with olaparib, an approved PARP inhibitor, in BRCA positive patients with breast cancer. Preclinical data support the hypothesis that dual targeting of the DNA damage response pathway by combining olaparib with sapacitabine may enhance the efficacy of standard of care treatment for BRCA positive patients with breast cancer.

·Activated the CYC140 first-in-human study in advanced leukemias. CYC140 is a novel, small molecule, selective polo-like-kinase 1 (PLK1) inhibitor. CYC140 is differentiated from other PLK1 inhibitors, demonstrating potent and selective target inhibition and high activity in xenograft models of human cancers when dosed orally at non-toxic doses.

þ 200 Connell Drive, Suite 1500, Berkeley Heights, NJ 07922, USA Tel +1 908 517 7330 Fax +1 866 271 3466

¨ 1 James Lindsay Place, Dundee, DD1 5JJ, UK Tel +44 1382 206 062 Fax +44 1382 206 067

www.cyclacel.com – [email protected]

·Progressed patient enrollment in part 2 of the Phase 1 study evaluating CYC065 monotherapy in patients with advanced solid tumors including those with Mcl-1, MYC or cyclin E amplified cancers relevant to CYC065’s mechanism of action. Part 2 is evaluating increased dosing frequency of two days per week for two weeks of a three-week cycle.

·Completed meetings with three European regulatory authorities with the objective of determining a potential regulatory pathway for sapacitabine in elderly AML. The regulators provided consistent guidance on next steps and Cyclacel is evaluating a potential request for a meeting with the Scientific Advice Working Party of the European Medicines Agency.

·Appointed Robert J. Spiegel, M.D. to the Board of Directors. Dr. Spiegel brings over 30 years of R&D and operational experience in the biopharmaceutical industry as well as advisory experience to venture capital and private equity funds.

·Entered into a Common Stock Sales Agreement with H.C. Wainwright & Co., LLC as sales agent, pursuant to which the agent may sell shares of common stock having an aggregate offering price of up to $5.0 million by any method that is deemed to be an "at the market offering" as defined in Rule 415 under the Securities Act of 1933 as amended.

Financial Highlights

As of September 30, 2018, cash and cash equivalents totaled $19.0 million compared to $23.9 million as of December 31, 2017. The decrease of $4.9 million in the nine-months was primarily due to net cash used in operating activities, including $1.2 million of R&D tax credit received from the United Kingdom government.

Research and development expenses were $1.2 million for the three months ended September 30, 2018 compared to $1.0 million for the same period in 2017.

General and administrative expenses were $1.3 million for the three months ended September 30, 2018 compared to $1.2 million for the same period in 2017.

Other income, net for the three months ended September 30, 2018 was $0.1 million compared to $36,000 for the same period of the previous year.

The United Kingdom R&D and tax credits were $0.3 million for the three months ended September 30, 2018 compared to $0.2 million for the same period in 2017.

Net loss for the three months ended September 30, 2018 was $2.1 million compared to $1.9 million for the same period in 2017. With the cash-sparing benefits accruing from the MD Anderson alliance the Company believes that cash and marketable securities, which were approximately $19.0 million as of September 30, 2018, will be sufficient to finance operations until the second quarter of 2020.

Conference call information:

US/Canada call: (877) 493-9121 / international call: (973) 582-2750

US/Canada archive: (800) 585-8367 / international archive: (404) 537-3406

Code for live and archived conference call is 3775807

For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.

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.