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

TEL AVIV, Israel, Dec. 3, 2018 /PRNewswire/ -- Therapix Biosciences Ltd. (TRPX) (the "Company" or "Therapix"), a specialty, clinical-stage pharmaceutical company focusing on the development of cannabinoid-based treatments, issued today its financial results for the three and nine months ended September 30, 2018. The functional currency of the Company is New Israeli Shekel; for presentation purposes, the financial data herein is presented in USD).

Quarter Hghlights

• Net loss of $1.7 million, or $0.5  per ADS, for the three months ended September 30, 2018, compared to a net loss of $1 million, or $0.3 per ADS, for the three months ended September 30, 2017. For the nine months ended September 30, 2018, net loss of $5 million, or $1.43 per ADS, compared to a net loss of $3.5 million, or $1.31 per ADS, for the comparable period in 2017. The first nine months of 2018 included a net gain of $299,000 in income due to exchange rate differences on balances of cash and cash equivalents (classified as finance income), versus a net gain of $365,000 during the corresponding period in 2017.

• Research and development ("R&D") expenses amounted to $0.7 million for the three months ended September 30, 2018, compared to approximately $0.34 million for the three months ended September 30, 2017. For the nine months ended September 30, 2018, R&D expenses amounted to $2.34 million, compared to $1 million for the comparable period in 2017. The increase in R&D expenses for the first nine months 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 September 30, 2018, compared to $0.78 million for the three months ended September 30, 2017. For the nine months ended September 30, 2018, G&A expenses amounted to $3.2 million, compared to $2.2 million for the comparable period in 2017.  The increase resulted primarily from hiring new employees, rise in wages and related expenses, investor relations and business expenses, business development expenses and professional and directors' fees.

• Cash totaled $2 million as of September 30, 2018, compared to $9.2 million as of December 31, 2017. The decrease in cash resulted primarily 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):

• Following encouraging results obtained from the Phase IIa clinical trial at Yale University, the Phase IIb, placebo-controlled 12-week clinical trial for THX-110 in TS has been initiated in Germany. The Company currently anticipates first patient enrollment at the first half of 2019; top line results are expected in the second half of 2020.

Obstructive Sleep Apnea (OSA):

• Within the framework of Therapix's "Entourage Effect" program and as previously announced, the Company is currently running a Phase IIa 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 2018 in accordance with the original work plan and timeline. The first patient enrolled in August 2018. Currently seven subjects have been recruited to the study and top line results are expected in the first half of 2019.

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) had been completed in Dalhousie University, Halifax, Canada. The results demonstrated beneficial effects of either single or multiple injections of THX-130 on selected parameters of repeated brain injuries.

Antimicrobial:

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

As previously described, 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 bacterial strains. Moreover, we began an additional set of in vitro studies intended to evaluate the mechanism of action attributed to THX-150 antibacterial effect.  In addition, the Company continues its animal study of a microbial infection to test the potential efficacy and safety of THX-150.

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