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

TEL AVIV, Israel, May 31, 2018 /PRNewswire/ -- Therapix Biosciences Ltd. (Nasdaq: TRPX) a specialty, clinical-stage pharmaceutical company focusing on the development of cannabinoid-based treatments, issued today its financial summary - first quarter 2018 vs. first 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 $2.05 million, or $0.59 per ADS, for the three months ended March 31, 2018, compared to a net loss of $0.64 million, or $0.54 per ADS, for the three months ended March 31, 2017. The first quarter 2018 net loss included $90,000 of income due to exchange rate differences on balances of cash and cash equivalents (classified as finance income), versus $7,000 of income incurred during the corresponding period in 2017.
• Research and development ("R&D") expenses amounted to $0.99 million for the three months ended March 31, 2018, compared to approximately $0.24 million for the three months ended March 31, 2017. The increase in R&D expenses for the first quarter 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 $1.13 million for the three months ended March 31, 2018, compared to $0.4 million for the three months ended March 31, 2017. The increase resulted primarily from a 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 $7.5 million as of March 31, 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. The Company currently believes that its cash balance will be sufficient to maintain its current operations into the second quarter of 2019.

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 will be 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 is anticipated to 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 2019.

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 earlier this month 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, the Company has initiated a Phase IIa, investigator-initiated trial for the treatment of low back pain using THX-110, at the Clinical Research Institute, TN, USA. The study was initiated earlier this month, in accordance with the original work plan and timeline.

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.
• Therapix entered into a product development agreement with Cure Pharmaceuticals ("Cure") (NASDAQ: CURR), to formulate a proprietary cannabinoid-based product to deliver the ultra low dose technology. The product will be based on Cure's patented, multilayer oral thin film (OTF), CureFilm™, for the treatment of a wide range of sleep disorders.

Antimicrobial:

• We have successfully completed the first stage of our pre-clinical program to evaluate the potential efficacy of our proprietary compound THX-150.

THX-150 is a pharmaceutical composition of dronabinol (synthetic ∆9-tetrahydracannabinol) and/or palmitoylethanolamide (PEA) along with a selected antibacterial agent that possesses synergy potential. Our objective is to use our entourage technology in association with THC to increase the efficacy of existing antibiotic drugs especially in antibiotic-resistant bacteria strains. We anticipate the next step of the research will be to understand the mechanism of action of THX-150. In addition, we anticipate initiating a study in an animal model of a microbial infection to test the potential efficacy and safety of THX-150 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 containing of synthetic CB2 receptor agonist. The efficacy of THX-160 was measured as a stand-alone therapy and as an opioid sparing agent. A second follow-up in vivo study was recently completed. The study evaluated the dosage regiment of the active ingredients, as well as their optimal therapeutic ratio.

Table 1: Consolidated Statements of Financial Position [based on an effective exchange rate of 3.514 NIS/USD as of March 31, 2018]:

Table 2: Consolidated Statements of Profit or Loss [based on the average exchange rate of 3.46 NIS/USD for the three-month period ended March 31, 2018]:

Table 3: Consolidated Statements of Comprehensive Income [based on the average exchange rate of 3.46 NIS/USD for the three-month period ended March 31, 2018]:

Table 4: Consolidated Statements of Changes in Equity [mainly based on the average exchange rate of 3.46 NIS/USD for the three-month period ended March 31, 2018]:

Table 5: Consolidated Statements of Cash Flows [based on the average exchange rate of 3.46 NIS/USD for the three-month period ended March 31, 2018]:

Table 6: R&D and G&A Detail [based on the average exchange rate of 3.46 NIS/USD for the three-month period ended March 31, 2018]:

About Therapix Biosciences Ltd.:

Therapix Biosciences Ltd. is a specialty clinical-stage pharmaceutical company led by an experienced team of Senior Executives and Scientists. Our focus is creating and enhancing a portfolio of technologies and assets based on cannabinoid pharmaceuticals. With this focus, the Company is currently engaged in the following drug development programs based on repurposing an FDA-approved cannabinoid (Dronabinol): THX-110 for the treatment of Tourette syndrome (TS), for the treatment of Obstructive Sleep Apnea (OSA), and the treatment of pain; THX-130 for the treatment of Mild Cognitive Impairment (MCI) and Traumatic Brain Injury (TBI); THX-150 for the treatment of infectious diseases; and THX-160 for the treatment of pain. Please visit our website for more information at www.therapixbio.com

About TXH-110 (Previously referred to as THX-TS01 and THX-OSA01):

THX-110 is a combination drug candidate for the treatment of Tourette syndrome, Obstructive Sleep Apnea and pain. It is composed of two components: (1) dronabinol (an FDA approved analog of ∆9-tetrahydracannabinol, or "THC"), and (2) palmitoylethanolamide ("PEA"), which is an endogenous fatty acid amide that belongs to the class of nuclear factor agonists, which are proteins that regulate the expression of genes. The combination of THC and PEA may induce a reaction known as the "Entourage Effect". The basic tenet of the entourage effect is that cannabinoids work together, or possess synergy, and affect the body in a mechanism similar to the body's own endocannabinoid system, which is a group of molecules and receptors in the brain that mediates the psychoactive effects of cannabis. This entourage effect may account for the pharmacological actions of PEA. Based on an activity enhancement of other physiological compounds, PEA may indirectly stimulate the cannabinoid receptors by potentiating their affinity for a receptor or by inhibiting their metabolic degradation, and by doing so, may increase the uptake of cannabinoid compounds, such as THC. Thus, it is speculated that the presence of the PEA molecule could increase the efficacy of THC, while reducing the required dosage and decreasing associated deleterious adverse events.

About THX-130

THX-130 is a proprietary, innovative, ultra-low dose formulation of dronabinol, which is intended to provide a treatment for Mild Cognitive Impairment (MCI). Recent pre-clinical animal studies have found that an ultra-low dose of THC could potentially protect the brain from long-term cognitive impairment, which may be caused by aging, lack of oxygen supply, seizures or use of drugs. Certain pre-clinical studies also suggest that ultra-low doses of THC cause animals to improve performance in behavioral tests that measure learning and memory.

About THX-150:

THX-150 is a drug candidate intended for the treatment of infectious diseases. It consists of dronabinol or dronabinol with palmitoylethanolamide (PEA) and a selected antibacterial agent, which possesses antimicrobial synergy potential.

About THX-160:

THX-160 is a drug candidate intended for the treatment of pain. It consists of a CB2 receptor agonist with or without the opioid.

Forward-Looking Statements:

This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Because such statements deal with future events and are based on Therapix's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Therapix could differ materially from those described in or implied by the statements in this press release. For example, forward-looking statements include statements regarding the Company's plans with respect to its clinical trials and its intent to report material developments and information regarding such trials. In addition, historic results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading "Risk Factors" in Therapix Biosciences Ltd.'s Annual Report on Form 20-F filed with the Securities and Exchange Commission (SEC) on April 30, 2018 and in subsequent filings with the SEC. Except as otherwise required by law, Therapix disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.

For further information:
Oz Adler, CFO  
[email protected]

Investor Contact:
Suzanne Lyons, Investor Relations Director  
[email protected]

Media Contact:
Sydney Masters,
[email protected]
M: 917-584-8385

SOURCE Therapix Biosciences Ltd

Related Links

http://www.therapixbio.com