Full Press Release Details
THERAPIX BIOSCIENCES LTD.
Therapix Biosciences Reports Second Quarter
2018 Financial Results and
Provides Business Update
AVIV, Israel, August 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):
Business update and developments
in the Company's clinical R&D programs:
Tourette Syndrome (TS):
Obstructive Sleep Apnea (OSA):
Mild Cognitive Impairment (MCI):
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.
STATEMENTS OF FINANCIAL POSITION
(Mainly based on an effective
exchange rate of 3.65 NIS/USD as of June 30, 2018)
| June 30, | December 31, | |||||||||||
| 2018 | 2017 | 2017 | ||||||||||
| Unaudited | Audited | |||||||||||
| USD in thousands | ||||||||||||
| ASSETS | ||||||||||||
| CURRENT ASSETS: | ||||||||||||
| Cash | 5,103 | 11,784 | 9,195 | |||||||||
| Restricted cash | 23 | 13 | 24 | |||||||||
| Accounts receivable | 448 | 242 | 278 | |||||||||
| Convertible loan | 705 | - | - | |||||||||
| 6,279 | 12,039 | 9,497 | ||||||||||
| NON-CURRENT ASSETS: | ||||||||||||
| Prepaid public offering costs | 53 | - | 19 | |||||||||
| Property and equipment | 53 | 17 | 50 | |||||||||
| 106 | 17 | 69 | ||||||||||
| 6,385 | 12,056 | 9,566 | ||||||||||
| LIABILITIES AND EQUITY (DEFICIT) | ||||||||||||
| CURRENT LIABILITIES: | ||||||||||||
| Trade payables | 1,077 | 543 | 1,017 | |||||||||
| Other accounts payable | 155 | 128 | 160 | |||||||||
| 1,232 | 671 | 1,177 | ||||||||||
| EQUITY ATTRIBUTABLE TO EQUITY HOLDERS OF THE COMPANY: | ||||||||||||
| Share capital | 3,812 | 3,812 | 3,812 | |||||||||
| Share premium | 36,989 | 36,612 | 36,612 | |||||||||
| Reserve from share-based payment transactions | 5,310 | 4,584 | 5,311 | |||||||||
| Foreign currency translation reserve | 432 | 760 | 782 | |||||||||
| Transactions with non-controlling interests | 261 | 261 | 261 | |||||||||
| Accumulated deficit | (41,651 | ) | (34,644 | ) | (38,389 | ) | ||||||
| Total equity | 5,153 | 11,385 | 8,389 | |||||||||
| 6,385 | 12,056 | 9,566 |
STATEMENTS OF PROFIT OR LOSS
(Based on the average exchange rate of
3.56 NIS/USD for the six-month period ended June 30, 2018)
| Six months ended June 30, | Three months ended June 30, | Year ended December 31, | ||||||||||||||||||
| 2018 | 2017 | 2018 | 2017 | 2017 | ||||||||||||||||
| Unaudited | Audited | |||||||||||||||||||
| USD in thousands | ||||||||||||||||||||
| Research and development expenses, net | 1,645 | 695 | 650 | 455 | 1,943 | |||||||||||||||
| General and administrative expenses | 2,139 | 1,376 | 1,000 | 971 | 3,810 | |||||||||||||||
| 3,784 | 2,071 | 1,650 | 1,426 | 5,753 | ||||||||||||||||
| Other expenses | - | - | - | - | 1 | |||||||||||||||
| Operating loss | 3,784 | 2,071 | 1,650 | 1,426 | 5,754 | |||||||||||||||
| Finance income | (525 | ) | - | (437 | ) | - | (1 | ) | ||||||||||||
| Finance expenses | 3 | 428 | 1 | 437 | 491 | |||||||||||||||
| Loss | 3,262 | 2,499 | 1,214 | 1,863 | 6,244 | |||||||||||||||
| Attributable to: | ||||||||||||||||||||
| Equity holders of the Company | 3,262 | 2,499 | 1,214 | 1,863 | 6,244 | |||||||||||||||
| Non-controlling interests | - | - | - | - | - | |||||||||||||||
| 3,262 | 2,499 | 1,214 | 1,863 | 6,244 | ||||||||||||||||
| Basic and diluted loss per share attributable to equity holders of the Company | 0.02 | 0.03 | 0.01 | 0.03 | 0.05 | |||||||||||||||
| Basic and diluted loss per ADS attributable to equity holders of the Company | 0.93 | 1.07 | 0.35 | 1.10 | 2.14 |
STATEMENTS OF COMPREHENSIVE INCOME
(Based on the average exchange rate of
3.56 NIS/USD for the six-month period ended June 30, 2018)
| Six months ended June 30, | Three months ended June 30, | Year ended December 31, | ||||||||||||||||||
| 2018 | 2017 | 2018 | 2017 | 2017 | ||||||||||||||||
| Unaudited | Audited | |||||||||||||||||||
| USD in thousands | ||||||||||||||||||||
| Net loss | 3,262 | 2,499 | 1,214 | 1,863 | 6,244 | |||||||||||||||
| Amounts that will not be reclassified subsequently to profit or loss: | ||||||||||||||||||||
| Adjustments arising from translation financial statements from functional currency to presentation currency | 350 | (439 | ) | 266 | (124 | ) | (461 | ) | ||||||||||||
| Total other comprehensive income (loss) | 350 | (439 | ) | 266 | (124 | ) | (461 | ) | ||||||||||||
| Total comprehensive loss | 3,612 | 2,060 | 1,480 | 1,739 | 5,783 | |||||||||||||||
| Attributable to: | ||||||||||||||||||||
| Equity holders of the Company | 3,612 | 2,060 | 1,480 | 1,739 | 5,783 | |||||||||||||||
| Non-controlling interests | - | - | - | - | - | |||||||||||||||
| 3,612 | 2,060 | 1,480 | 1,739 | 5,783 |
STATEMENTS OF CHANGES IN EQUITY
(Mainly based on the average exchange rate
of 3.56 NIS/USD for the six-month period ended June 30, 2018)
| Attributable to equity holders of the Company | ||||||||||||||||||||||||||||
| Share capital | Share premium | Reserve from share-based payment transactions | Foreign currency translation reserve | Transactions with non-controlling interests | Accumulated deficit | Total | ||||||||||||||||||||||
| Unaudited | ||||||||||||||||||||||||||||
| USD in thousands | ||||||||||||||||||||||||||||
| Balance at January 1, 2018 | 3,812 | 36,612 | 5,311 | 782 | 261 | (38,389 | ) | 8,389 | ||||||||||||||||||||
| Loss | - | - | - | - | - | (3,262 | ) | (3,262 | ) | |||||||||||||||||||
| Other comprehensive loss | - | - | - | (350 | ) | - | - | (350 | ) | |||||||||||||||||||
| Total comprehensive loss | - | - | - | (350 | ) | - | (3,262 | ) | (3,612 | ) | ||||||||||||||||||
| Share-Based payment | - | - | 376 | - | - | - | 376 | |||||||||||||||||||||
| Expiration of share options | - | 377 | (377 | ) | - | - | - | - | ||||||||||||||||||||
| Balance at June 30, 2018 | 3,812 | 36,989 | 5,310 | 432 | 261 | (41,651 | ) | 5,153 |
STATEMENTS OF CHANGES IN EQUITY
(Mainly based on the average exchange rate
of 3.56 NIS/USD for the six-month period ended June 30, 2018)
| Attributable to equity holders of the Company | ||||||||||||||||||||||||||||
| Share capital | Share premium | Reserve from share-based payment transactions | Foreign currency translation reserve | Transactions with non-controlling interests | Accumulated deficit | Total | ||||||||||||||||||||||
| Unaudited | ||||||||||||||||||||||||||||
| USD in thousands | ||||||||||||||||||||||||||||
| Balance at January 1, 2017 | 1,087 | 26,600 | 4,449 | 321 | 261 | (32,145 | ) | 573 | ||||||||||||||||||||
| Loss | - | - | - | - | - | (2,499 | ) | (2,499 | ) | |||||||||||||||||||
| Other comprehensive income | - | - | - | 439 | - | - | 439 | |||||||||||||||||||||
| Total comprehensive income (loss) | - | - | - | 439 | - | (2,499 | ) | (2,060 | ) | |||||||||||||||||||
| Share-Based payment | - | - | 135 | - | - | - | 135 | |||||||||||||||||||||
| 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 | |||||||||||||||||||||
| Balance at June 30, 2017 | 3,812 | 36,612 | 4,584 | 760 | 261 | (34,644 | ) | 11,385 |
| (1) Net issuance expenses of $61,000 |
| (2) Net issuance expenses of $1,865,000 |
| (3) Net issuance expenses of $156,000 |
STATEMENTS OF CHANGES IN EQUITY
(Mainly based on the average exchange rate
of 3.56 NIS/USD for the six-month period ended June 30, 2018)
| Attributable to equity holders of the Company | ||||||||||||||||||||||||||||
| Share capital | Share premium | Reserve from share-based payment transactions | Foreign currency translation reserve | Transactions with non-controlling interests | Accumulated deficit | Total | ||||||||||||||||||||||
| Unaudited | ||||||||||||||||||||||||||||
| USD in thousands | ||||||||||||||||||||||||||||
| Balance at March 31, 2018 | 3,812 | 36,829 | 5,332 | 698 | 261 | (40,437 | ) | 6,495 | ||||||||||||||||||||
| Loss | - | - | - | - | - | (1,214 | ) | (1,214 | ) | |||||||||||||||||||
| Other comprehensive loss | - | - | - | (266 | ) | - | - | (266 | ) | |||||||||||||||||||
| Total comprehensive loss | - | - | - | (266 | ) | - | (1,214 | ) | (1,480 | ) | ||||||||||||||||||
| Share-based payment | - | - | 138 | - | - | - | 138 | |||||||||||||||||||||
| Expiration of share options | - | 160 | (160 | ) | - | - | - | - | ||||||||||||||||||||
| Balance at June 30, 2018 | 3,812 | 36,989 | 5,310 | 432 | 261 | (41,651 | ) | 5,153 |
STATEMENTS OF CHANGES IN EQUITY
(Mainly based on the average exchange rate
of 3.56 NIS/USD for the six-month period ended June 30, 2018)
| Attributable to equity holders of the Company | ||||||||||||||||||||||||||||
| Share capital | Share premium | Reserve from share-based payment transactions | Foreign currency translation reserve | Transactions with non-controlling interests | Accumulated deficit | Total | ||||||||||||||||||||||
| Unaudited | ||||||||||||||||||||||||||||
| USD in thousands | ||||||||||||||||||||||||||||
| Balance at March 31, 2017 | 3,483 | 35,297 | 4,513 | 636 | 261 | (32,781 | ) | 11,409 | ||||||||||||||||||||
| Loss | - | - | - | - | - | (1,863 | ) | (1,863 | ) | |||||||||||||||||||
| Other comprehensive income | - | - | - | 124 | - | - | 124 | |||||||||||||||||||||
| Total comprehensive income (loss) | - | - | - | 124 | - | (1,863 | ) | (1,739 | ) | |||||||||||||||||||
| Share-based payment | - | - | 71 | - | - | - | 71 | |||||||||||||||||||||
| Issuance of shares (1) | 329 | 1,315 | - | - | - | - | 1,644 | |||||||||||||||||||||
| Balance at June 30, 2017 | 3,812 | 36,612 | 4,584 | 760 | 261 | (34,644 | ) | 11,385 |
(1) Net issuance expenses of $156,000
STATEMENTS OF CHANGES IN EQUITY
(Mainly based on the average exchange rate
of 3.56 NIS/USD for the six-month period ended June 30, 2018)
| Attributable to equity holders of the Company | ||||||||||||||||||||||||||||
| Share capital | Share premium | Reserve from share-based payment transactions | Foreign currency translation reserve | Transactions with non-controlling interests | Accumulated deficit | Total | ||||||||||||||||||||||
| Audited | ||||||||||||||||||||||||||||
| USD in thousands | ||||||||||||||||||||||||||||
| Balance at January 1, 2017 | 1,087 | 26,600 | 4,449 | 321 | 261 | (32,145 | ) | 573 | ||||||||||||||||||||
| Loss | - | - | - | - | - | (6,244 | ) | (6,244 | ) | |||||||||||||||||||
| Other comprehensive income | - | - | - | 461 | - | - | 461 | |||||||||||||||||||||
| Total comprehensive income (loss) | - | - | - | 461 | - | (6,244 | ) | (5,783 | ) | |||||||||||||||||||
| Share-Based payment | - | - | 862 | - | - | - | 862 | |||||||||||||||||||||
| 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 | |||||||||||||||||||||
| Balance at December 31, 2017 | 3,812 | 36,612 | 5,311 | 782 | 261 | (38,389 | ) | 8,389 |
| (1) Net issuance expenses of $61,000 |
| (2) Net issuance expenses of $1,865,000 |
| (3) Net issuance expenses of $156,000 |
STATEMENTS OF CASH FLOWS
(Based on the average exchange rate of
3.56 NIS/USD for the six-month period ended June 30, 2018)
| Six months ended June 30, | Three months ended June 30, | Year ended December 31, | ||||||||||||||||||
| 2018 | 2017 | 2018 | 2017 | 2017 | ||||||||||||||||
| Unaudited | Audited | |||||||||||||||||||
| USD in thousands | ||||||||||||||||||||
| Cash flows from operating activities: | ||||||||||||||||||||
| Net loss | (3,262 | ) | (2,499 | ) | (1,214 | ) | (1,863 | ) | (6,244 | ) | ||||||||||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||||||||||
| Depreciation and amortization | 6 | 2 | 3 | 1 | 5 | |||||||||||||||
| Gain from sale of equipment | - | - | - | - | 1 | |||||||||||||||
| Share-based payment expense | 376 | 135 | 138 | 71 | 862 | |||||||||||||||
| Finance expenses (incomes), net | (512 | ) | 446 | (422 | ) | 453 | 525 | |||||||||||||
| (130 | ) | 583 | (281 | ) | 525 | 1,393 | ||||||||||||||
| Working capital adjustments: | ||||||||||||||||||||
| Increase in accounts receivable | (189 | ) | (110 | ) | (50 | ) | (102 | ) | (143 | ) | ||||||||||
| Decrease (increase) in trade payables | 113 | (101 | ) | (101 | ) | (406 | ) | 349 | ||||||||||||
| Decrease (increase) in other accounts payable | 3 | 33 | (189 | ) | (54 | ) | 66 | |||||||||||||
| (73 | ) | (178 | ) | (340 | ) | (562 | ) | 272 | ||||||||||||
| Net cash used in operating activities | (3,465 | ) | (2,094 | ) | (1,835 | ) | (1,900 | ) | (4,579 | ) | ||||||||||
| Cash flows from investing activities: | ||||||||||||||||||||
| Increase in restricted cash | - | (2 | ) | - | (2 | ) | (11 | ) | ||||||||||||
| Proceed from sale of equipment | - | - | - | - | 2 | |||||||||||||||
| Purchase of equipment | (12 | ) | (7 | ) | (3 | ) | (7 | ) | (44 | ) | ||||||||||
| Grant of convertible loan | (500 | ) | - | (500 | ) | - | - | |||||||||||||
| Net cash used in investing activities | (512 | ) | (9 | ) | (503 | ) | (9 | ) | (53 | ) | ||||||||||
| Cash flows from financing activities: | ||||||||||||||||||||
| Prepaid public offering costs | (36 | ) | - | 1 | - | (18 | ) | |||||||||||||
| Proceeds from issuance of share capital (net of issuance expenses) | - | 13,167 | - | 1,943 | 13,193 | |||||||||||||||
| Net cash provided by (used in) financing activities | (36 | ) | 13,167 | 1 | 1,943 | 13,175 | ||||||||||||||
| Exchange rate differences on cash and cash equivalents in foreign currency | 308 | (446 | ) | 218 | (453 | ) | (527 | ) | ||||||||||||
| Translation differences on cash and cash equivalents | (387 | ) | 490 | (287 | ) | 149 | 503 | |||||||||||||
| Increase (decrease) in cash | (4,092 | ) | 11,108 | (2,406 | ) | (270 | ) | 8,519 | ||||||||||||
| Cash at the beginning of the period | 9,195 | 676 | 7,509 | 12,054 | 676 | |||||||||||||||
| Cash at the end of the period | 5,103 | 11,784 | 5,103 | 11,784 | 9,195 |
(Based on the average exchange rate of
3.56 NIS/USD for the six-month period ended June 30, 2018)
| Six months ended June 30, | Three months ended June 30, | Year ended December 31, | ||||||||||||||||||
| 2018 | 2017 | 2018 | 2017 | 2017 | ||||||||||||||||
| Unaudited | Audited | |||||||||||||||||||
| USD in thousands | ||||||||||||||||||||
| Research and Development Expenses: | ||||||||||||||||||||
| Clinical studies | 372 | 256 | 118 | 163 | 511 | |||||||||||||||
| R&D and preclinical studies | 423 | 158 | 268 | 119 | 362 | |||||||||||||||
| Wages and related expenses | 335 | 140 | 127 | 57 | 321 | |||||||||||||||
| Share-based payment | 80 | 24 | 33 | 11 | 103 | |||||||||||||||
| Regulatory and other expenses | 384 | 117 | 104 | 105 | 276 | |||||||||||||||
| Chemistry and formulation studies | 51 | - | - | - | 330 | |||||||||||||||
| 1,645 | 695 | 650 | 455 | 1,943 | ||||||||||||||||
| General and Administrative Expenses: | ||||||||||||||||||||
| Investor relations and business expenses | 164 | 388 | 55 | 340 | 871 | |||||||||||||||
| Professional and director fees | 713 | 394 | 259 | 302 | 1,007 | |||||||||||||||
| Regulatory expenses | 35 | 53 | 20 | 29 | 80 | |||||||||||||||
| Business development | 484 | - | 393 | - | 74 | |||||||||||||||
| Wages and related expenses | 347 | 343 | 120 | 185 | 808 | |||||||||||||||
| Office, maintenance, rent and other expenses | 100 | 87 | 48 | 55 | 211 | |||||||||||||||
| Share-based payment | 296 | 111 | 105 | 60 | 759 | |||||||||||||||
| 2,139 | 1,376 | 1,000 | 971 | 3,810 |
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.