TEL AVIV, Israel, Aug. 20, 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 – 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.
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.
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.
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.
On July 31, 2018, the Company entered into an Agreement for Convertible Equity (the “Convertible Equity Agreement”) with Therapix Healthcare Resources, Inc. (“THR”), which is a company incorporated in Delaware and an unaffiliated third party. Under the Convertible Equity Agreement, the Company loaned an aggregate of $1,300,000 (the “Loan”) to THR. The maturity date of the Loan, which accrues interest at a rate of nine percent (9%) per annum, will be upon demand of the Company at any time after August 1, 2018, the closing date (the “Maturity Date”). At the election of the Company, the entire Loan shall be converted into that number of shares of the most senior class of shares of THR existing at the time of such conversion, at a price per share equal to the fair market value of such shares as shall be determined by THR’s Board of Directors, it being acknowledged that, following the exercise of such conversion right, the Company shall hold 20.96% of THR. In addition, the Company shall have the right to appoint 50% of the members of the THR Board of Directors. The proceeds of the Loan were used by THR to acquire eight pain clinics, seven of which are located in Tennessee and one in Arkansas, as well as a fully equipped laboratory in Tennessee from Anesthesia Services Associates PLLC. (d/b/a Comprehensive Pain Specialist) on August 1, 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 molecules 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.
THX-130 is a proprietary, innovative, formulation of ultra-low dose 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.
THX-150 is a drug candidate intended for the treatment of infectious diseases. It consists of dronabinol or dronabinol with PEA and a selected antibacterial agent, which possesses antimicrobial synergy potential.
THX-160 is a drug candidate intended for the treatment of pain. It consists of a CB2 receptor agonist with or without the opioid.
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
SOURCE Therapix Biosciences Ltd.
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