Full Press Release Details
Therapix Biosciences Reports First Quarter 2018 Financial Results and Provides Business Update
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):
update and developments in the Company's clinical R&D programs:
Cognitive Impairment (MCI):
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
1: Consolidated Statements of Financial Position [based on an effective exchange rate of 3.514 NIS/USD as of March 31, 2018]:
| USD in Thousands | ||||||||
| March 31, | December 31, | |||||||
| 2018 | 2017 | |||||||
| Unaudited | Audited | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash | 7,509 | 9,195 | ||||||
| Restricted cash | 24 | 24 | ||||||
| Accounts receivable | 411 | 278 | ||||||
| 7,944 | 9,497 | |||||||
| NON-CURRENT ASSETS: | ||||||||
| Prepaid public offering costs | 55 | 19 | ||||||
| Property and equipment | 56 | 50 | ||||||
| 111 | 69 | |||||||
| TOTAL ASSETS | 8,055 | 9,566 | ||||||
| LIABILITIES AND EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Trade payables | 1,214 | 1,017 | ||||||
| Other accounts payable | 346 | 160 | ||||||
| 1,560 | 1,177 | |||||||
| EQUITY ATTRIBUTABLE TO EQUITY HOLDERS OF THE COMPANY: | ||||||||
| Share capital | 3,812 | 3,812 | ||||||
| Share premium | 36,829 | 36,612 | ||||||
| Reserve from share-based payment transactions | 5,332 | 5,311 | ||||||
| Foreign currency translation reserve | 698 | 782 | ||||||
| Transactions with noncontrolling interests | 261 | 261 | ||||||
| Accumulated deficit | -40,437 | -38,389 | ||||||
| Total equity | 6,495 | 8,389 | ||||||
| TOTAL LIABILITIES AND EQUITY | 8,055 | 9,566 |
2: Consolidated Statements of Profit or Loss [based on the average exchange rate of 3.46 NIS/USD for the three-month period ended
| USD in thousands | ||||||||||||
| Three months ended | Year ended | |||||||||||
| March 31, | December 31, | |||||||||||
| 2018 | 2017 | 2017 | ||||||||||
| Unaudited | Audited | |||||||||||
| Research and development expenses | $ | 995 | $ | 240 | $ | 1,943 | ||||||
| General and administrative expenses | 1,139 | 405 | 3,810 | |||||||||
| 2,134 | 645 | 5,753 | ||||||||||
| Other expense | - | - | 1 | |||||||||
| Operating loss | 2,134 | 645 | 5,754 | |||||||||
| Finance income | (88 | ) | (9 | ) | (1 | ) | ||||||
| Finance expenses | 2 | - | 491 | |||||||||
| Loss | $ | 2,048 | $ | 636 | $ | 6,244 | ||||||
| Attributable to: | ||||||||||||
| Equity holders of the Company | 2,048 | 636 | 6,244 | |||||||||
| Non-controlling interests | - | - | - | |||||||||
| $ | 2,048 | $ | 636 | $ | 6,244 | |||||||
| Basic and diluted net loss per share attributable to equity holders of the Company | $ | 0.01 | $ | 0.01 | $ | 0.05 | ||||||
| Basic and diluted loss per ADS attributable to equity holders of the Company | $ | 0.59 | $ | 0.54 | $ | 2.14 |
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]:
| USD in Thousands | ||||||||||||
| Three months ended | Year ended | |||||||||||
| March 31, | December 31, | |||||||||||
| 2018 | 2017 | 2017 | ||||||||||
| Unaudited | Audited | |||||||||||
| Net loss | $ | 2,048 | $ | 636 | $ | 6,244 | ||||||
| Amounts that will not be reclassified subsequently to profit or loss: | ||||||||||||
| Adjustments arising from translating financial statements from functional currency to presentation currency | 84 | (315 | ) | (461 | ) | |||||||
| Total other comprehensive income (loss) | 84 | (315 | ) | (461 | ) | |||||||
| Total comprehensive loss | 2,132 | 321 | 5,783 | |||||||||
| Attributable to: | ||||||||||||
| Equity holders of the Company | 2,132 | 321 | 5,783 | |||||||||
| Non-controlling interests | - | - | - | |||||||||
| TOTAL | $ | 2,132 | $ | 321 | $ | 5,783 |
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]:
| Attributable to equity holders of the Company | ||||||||||||||||||||||||||||
| Share capital | Share premium | Reserve from Share-based payment transactions | Transactions with non-controlling interests | Accumulated deficit | Foreign currency translation reserve | Total | ||||||||||||||||||||||
| Unaudited | ||||||||||||||||||||||||||||
| USD in thousands | ||||||||||||||||||||||||||||
| Balance at January 1, 2018 | $ | 3,812 | $ | 36,612 | $ | 5,311 | $ | 261 | $ | (38,389 | ) | $ | 782 | $ | 8,389 | |||||||||||||
| Loss | - | - | - | - | (2,048 | ) | - | (2,048 | ) | |||||||||||||||||||
| Total other comprehensive loss | - | - | - | - | - | (84 | ) | (84 | ) | |||||||||||||||||||
| Total comprehensive loss | - | - | - | - | (2,048 | ) | (84 | ) | (2,132 | ) | ||||||||||||||||||
| Share-based payment | - | - | 238 | - | - | - | 238 | |||||||||||||||||||||
| Expiration of share based options | - | 217 | (217 | ) | - | - | - | - | ||||||||||||||||||||
| Balance at March 31, 2018 | $ | 3,812 | $ | 36,829 | $ | 5,332 | $ | 261 | $ | (40,437 | ) | $ | 698 | $ | 6,495 |
| Attributable to equity holders of the Company | ||||||||||||||||||||||||||||
| Share capital | Share premium | Reserve from Share-based payment transactions | Transactions with non-controlling interests | Accumulated deficit | Foreign currency translation reserve | Total | ||||||||||||||||||||||
| Unaudited | ||||||||||||||||||||||||||||
| USD in thousands | ||||||||||||||||||||||||||||
| Balance at January 1, 2017 | $ | 1,087 | $ | 26,600 | $ | 4,449 | $ | 261 | $ | (32,145 | ) | $ | 321 | $ | 573 | |||||||||||||
| Loss | - | - | - | - | (636 | ) | - | (636 | ) | |||||||||||||||||||
| Total other comprehensive loss | - | - | - | - | - | 315 | 315 | |||||||||||||||||||||
| Total comprehensive loss | - | - | - | - | (636 | ) | 315 | (321 | ) | |||||||||||||||||||
| Issuance of shares (1) | 189 | 769 | - | - | - | - | 958 | |||||||||||||||||||||
| Issuance of shares (2) | 2,207 | 7,928 | - | - | - | - | 10,135 | |||||||||||||||||||||
| Share-based payment | - | - | 64 | - | - | - | 64 | |||||||||||||||||||||
| Balance at March 31, 2017 | $ | 3,483 | $ | 35,297 | $ | 4,513 | $ | 261 | $ | (32,781 | ) | $ | 636 | $ | 11,409 |
| Attributable to equity holders of the Company | ||||||||||||||||||||||||||||
| Share capital | Share premium | Reserve from Share-based payment transactions | Transactions with non-controlling interests | Accumulated deficit | Foreign currency translation reserve | Total | ||||||||||||||||||||||
| Audited | ||||||||||||||||||||||||||||
| USD in thousands | ||||||||||||||||||||||||||||
| Balance at December 31, 2016 | $ | 1,087 | $ | 26,600 | $ | 4,449 | $ | 261 | $ | (32,145 | ) | $ | 321 | $ | 573 | |||||||||||||
| Loss | - | - | - | - | (6,244 | ) | - | (6,244 | ) | |||||||||||||||||||
| Total other comprehensive Income (loss) | - | - | - | - | - | 461 | 461 | |||||||||||||||||||||
| Total comprehensive loss | - | - | - | - | (6,244 | ) | 461 | (5,783 | ) | |||||||||||||||||||
| Issuance of shares (1) | 189 | 769 | - | - | - | - | 958 | |||||||||||||||||||||
| Issuance of shares (2) | 2,207 | 7,928 | - | - | - | - | 10,135 | |||||||||||||||||||||
| Issuance of shares (3) | 329 | 1,315 | - | - | - | - | 1,644 | |||||||||||||||||||||
| Share-based payments | - | - | 862 | - | - | - | 862 | |||||||||||||||||||||
| Balance at December 31, 2017 | $ | 3,812 | $ | 36,612 | $ | 5,311 | $ | 261 | $ | (38,389 | ) | $ | 782 | $ | 8,389 |
5: Consolidated Statements of Cash Flows [based on the average exchange rate of 3.46 NIS/USD for the three-month period ended
| USD in Thousands | ||||||||||||
| Three months ended | Year ended | |||||||||||
| March 31, | December 31, | |||||||||||
| Unaudited | Unaudited | Audited | ||||||||||
| 2018 | 2017 | 2017 | ||||||||||
| Cash flows from operating activities: | ||||||||||||
| Net loss | $ | (2,048 | ) | $ | (636 | ) | $ | (6,244 | ) | |||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||
| Depreciation and amortization | 3 | 1 | 5 | |||||||||
| Gain from sale of equipment | - | - | 1 | |||||||||
| Share-based payment expense | 238 | 64 | 862 | |||||||||
| Finance (income) expenses, net | (90 | ) | (7 | ) | 525 | |||||||
| 151 | 58 | 1,393 | ||||||||||
| Working capital adjustments: | ||||||||||||
| Increase in accounts receivable | (139 | ) | (8 | ) | (143 | ) | ||||||
| Increase in trade payables | 214 | 305 | 349 | |||||||||
| Increase in other accounts payable | 192 | 87 | 66 | |||||||||
| 267 | 384 | 272 | ||||||||||
| Net cash used in operating activities | (1,630 | ) | (194 | ) | (4,579 | ) | ||||||
| Cash flows from investing activities: | ||||||||||||
| Increase in restricted cash | - | - | (11 | ) | ||||||||
| Proceeds from sale of equipment | - | - | 2 | |||||||||
| Purchase of equipment | (9 | ) | - | (44 | ) | |||||||
| Net cash used in investing activities | (9 | ) | - | (53 | ) | |||||||
| Cash flows from financing activities: | ||||||||||||
| Prepaid public offering costs | (37 | ) | - | (18 | ) | |||||||
| Proceeds from issuance of share capital (net of issuance expenses) | - | 11,224 | 13,193 | |||||||||
| Net cash provided by financing activities | (37 | ) | 11,224 | 13,175 | ||||||||
| Exchange rate differences on cash and cash equivalents in foreign currency | 90 | 7 | (527 | ) | ||||||||
| Translation differences on cash and cash equivalents | (100 | ) | 341 | 503 | ||||||||
| Increase (decrease) in cash | (1,686 | ) | 11,378 | 8,519 | ||||||||
| Cash at the beginning of the period | 9,195 | 676 | 676 | |||||||||
| Cash at the end of the period | $ | 7,509 | $ | 12,054 | $ | 9,195 |
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]:
| USD in Thousands | ||||||||||||
| Three months ended | Year ended | |||||||||||
| March 31, | December 31, | |||||||||||
| Unaudited | Unaudited | Audited | ||||||||||
| 2018 | 2017 | 2017 | ||||||||||
| Research and Development Expenses: | ||||||||||||
| Clinical studies | $ | 254 | $ | 93 | $ | 511 | ||||||
| R&D and preclinical studies | 155 | 39 | 362 | |||||||||
| Wages and related expenses | 208 | 83 | 321 | |||||||||
| Share-based payment | 47 | 13 | 103 | |||||||||
| Regulatory and other expenses | 280 | 12 | 276 | |||||||||
| Chemistry & formulation studies | 51 | - | 330 | |||||||||
| R&D expenses | 995 | 240 | 1,943 | |||||||||
| General and Administrative Expenses: | ||||||||||||
| Investor relations and business expenses | $ | 109 | $ | 48 | $ | 871 | ||||||
| Professional & directors fees | 454 | 92 | 1,007 | |||||||||
| Regulatory expenses | 15 | 24 | 80 | |||||||||
| Business development | 91 | - | 74 | |||||||||
| Wages and related expenses | 227 | 158 | 808 | |||||||||
| Office maintenance, rent and other expenses | 52 | 32 | 211 | |||||||||
| Share-based payment | 191 | 51 | 759 | |||||||||
| G&A expenses | 1,139 | 405 | 3,810 | |||||||||
| TOTAL | $ | 2,134 | $ | 645 | $ | 5,753 |
Therapix Biosciences Ltd.:
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
TXH-110 (Previously referred to as THX-TS01 and THX-OSA01):
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.
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
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.
is a drug candidate intended for the treatment of pain. It consists of a CB2 receptor agonist with or without the opioid.
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
further information:
Suzanne Lyons, Investor Relations Director