Therapix Biosciences Reports Second Quarter 2018 Financial Results and Provides Business Update

TEL AVIV, Israel, Aug. 20, 2018 /PRNewswire/ -- Therapix Biosciences Ltd. (TRPX) a specialty, clinical-stage pharmaceutical company focusing on the development of cannabinoid-based treatments, issued today its financial summary - second quarter 2018 vs. second quarter 2017 (Note: The functional currency of the Company is New Israeli Shekel; for presentation purposes, the financial data herein is presented in USD):

• Net loss of $1.2 million, or $0.35 per ADS, for the three months ended June 30, 2018, compared to a net loss of $1.86 million, or $1.10 per ADS, for the three months ended June 30, 2017. For the six months ended June 30, 2018, net loss of $3.26 million, or $0.93 per ADS, compared to a net loss of $2.5 million, or $1.07 per ADS, for the comparable period in 2017. The first half of 2018 net loss included $0.31 million of income due to exchange rate differences on balances of cash and cash equivalents (classified as finance income), versus $0.45 million of expense incurred during the corresponding period in 2017.
• Research and development ("R&D") expenses amounted to $0.65 million for the three months ended June 30, 2018, compared to approximately $0.46 million for the three months ended June 30, 2017. For the six months ended June 30, 2018, R&D expenses amounted to $1.64 million, compared to $0.7 million for the comparable period in 2017. The increase in R&D expenses for the first half of 2018 resulted primarily from higher expenses in connection with the clinical trials, including expenses for R&D and preclinical studies, wages and related expenses, and regulatory and other expenses.
• General and administrative expenses ("G&A") amounted to $1 million for the three months ended June 30, 2018, compared to $0.97 million for the three months ended June 30, 2017. For the six months ended June 30, 2018, G&A expenses amounted to $2.14 million, compared to $1.37 million for the comparable period in 2017.  The increase resulted primarily from hiring of new employees, rise in wages and related expenses, investor relations and business expenses, business development expenses as well as professional and directors' fees. These increases were the result of the continuance of the clinical trials and an increase in the number of the Company's employees.
• Cash totaled $5.1 million as of June 30, 2018, compared to $9.2 million as of December 31, 2017. The decrease in cash primarily resulted from increased R&D and G&A expenses as detailed above.

Business update and developments in the Company's clinical R&D programs:

Tourette Syndrome (TS):

• The Phase IIa clinical study for THX-110 in TS at Yale University was completed. Sixteen patients were enrolled in the study. The Company recently reported top line results, and the results were further presented at the annual meeting of the European Society for the Study of Tourette Syndrome by principal investigator Dr. Michael Bloch.
• The Phase IIb, placebo-controlled 12-week clinical trial for THX-110 in TS will be conducted in Germany. The Company currently anticipates first patient enrollment by the end of the third quarter, as anticipated by the original work plan and timeline. Top line results are expected in the first half of 2020.

Obstructive Sleep Apnea (OSA):

• Within the framework of Therapix's "Entourage Effect" program, the Company has initiated a Phase IIa, sponsor-initiated trial for the treatment of OSA using the Company's proprietary cannabinoid-based technology, THX-110, at Assuta Medical Center in Israel. The study was initiated in June in accordance with the original work plan and timeline. Top line results are expected in the first half of 2019.

Chronic Pain:

• Within the framework of Therapix's "Entourage Effect" program and as previously announced, a Phase IIa investigator-initiated trial was initiated for the treatment of chronic pain using THX-110, in the USA.

Mild Cognitive Impairment (MCI):

• A pre-clinical study evaluating the effect of the THX-130, proprietary ultra-low-dose THC, in a rodent model for cognitive impairment related to traumatic brain injury (TBI) was initiated in Dalhousie University, Halifax, Canada. Results are expected by the second half of this year.

Antimicrobial:

• We are continuing our development program as planned to evaluate the potential efficacy of our proprietary drug candidate THX-150.

THX-150 is a pharmaceutical composition of dronabinol (synthetic ∆9-tetrahydracannabinol) with or without palmitoylethanolamide (PEA) along with a selected antibacterial agent that may possess synergy potential. Our objective is to use our entourage technology in association with THC to potentially increase the efficacy of existing antibiotic drugs especially in antibiotic-resistant bacteria strains. In addition, we have initiated a study in an animal model of a microbial infection to test the potential efficacy and safety of THX-150 in accordance with the plan schedule during the second half of 2018.

Pain:

• We have successfully completed two pre-clinical studies in acute and chronic pain in rodent models evaluating the potential efficacy of the Company's proprietary compound THX-160. THX-160 is a pharmaceutical formulation candidate containing a synthetic CB2 receptor agonist. The efficacy of THX-160 was measured as a stand-alone therapy and as an opioid sparing agent. In the preclinical studies, THX-160 was well tolerated and did not cause any significant adverse clinical effects. In addition, efficacy studies demonstrated the analgesic superiority of THX-160 over control and were comparable to high-dose morphine analgesic effects and in some instances exerted greater potency. The efficacy and safety of THX-160 was shown for both acute and chronic pain.

• 1
• 2
• 3