Full Press Release Details
Biosciences Reports Third Quarter 2017 Financial Results and Provides Business Update
Conference Call and Webcast Today at 8:30 a.m. EDT / 5:30 a.m. PDT -
AVIV, Israel, November 9, 2017 /PRNewswire/ -- Therapix Biosciences Ltd. (Nasdaq: TRPX), a specialty clinical-stage pharmaceutical
company specializing in the development of cannabinoid-based treatments, today reported financial results for the three and nine
months ended September 30, 2017. The Company will host a conference call and webcast today to discuss the financial results and
to provide an update on current developments with respect to its clinical programs.
Summary - Third quarter 2017 vs. third quarter 2016 (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"):
November 09, 2017, 8:30 am Eastern Time / 5:30 am Pacific Time
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available until Nov. 16, 2017
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Table 1: Balance Sheet [based on an effective exchange rate of 3.529 NIS/USD for September 30, 2017]:
| USD in Thousands | ||||||||
| December 31, | September 30, | |||||||
| 2016 | 2017 | |||||||
| Audited | Unaudited | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash | $ | 676 | $ | 10,735 | ||||
| Restricted cash | 11 | 35 | ||||||
| Accounts receivable | 117 | 188 | ||||||
| Subtotal, current assets | 804 | 10,958 | ||||||
| NON-CURRENT ASSETS: | ||||||||
| Prepaid public offering costs | 430 | - | ||||||
| Property | 11 | 31 | ||||||
| Subtotal, non-current assets | 441 | 31 | ||||||
| TOTAL ASSETS | $ | 1,245 | $ | 10,989 | ||||
| LIABILITIES AND EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Trade payables | $ | 590 | $ | 546 | ||||
| Other accounts payable | 82 | 151 | ||||||
| Subtotal, current liabilities | 672 | 697 | ||||||
| EQUITY ATTRIBUTABLE TO EQUITY HOLDERS OF THE COMPANY: | ||||||||
| Share capital | $ | 1,088 | $ | 3,709 | ||||
| Share premium | 26,612 | 36,447 | ||||||
| Share-based payment transactions | 4,443 | 4,610 | ||||||
| Foreign currency translation reserve | 316 | 944 | ||||||
| Transactions with noncontrolling interests | 261 | 261 | ||||||
| Accumulated deficit | (32,147 | ) | (35,679 | ) | ||||
| Total equity | 573 | 10,292 | ||||||
| TOTAL LIABILITIES AND EQUITY | $ | 1,245 | $ | 10,989 |
Table 2: Profit or Loss [based on an effective exchange rate of 3.563 NIS/USD
for the quarter ended September 30, 2017]:
| USD in thousands | ||||||||||||||||
| Three months ended | Nine months ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2016 | 2017 | 2016 | 2017 | |||||||||||||
| Unaudited | ||||||||||||||||
| Research and development expenses, net | $ | 219 | $ | 338 | $ | 595 | $ | 1,033 | ||||||||
| General and administrative expenses | 340 | 774 | 975 | 2,150 | ||||||||||||
| Subtotal | 559 | 1,112 | 1,570 | 3,183 | ||||||||||||
| Other income | (33 | ) | - | (7 | ) | - | ||||||||||
| Operating loss | 526 | 1,112 | 1,563 | 3,183 | ||||||||||||
| Finance income | - | (80 | ) | (1 | ) | - | ||||||||||
| Finance expenses | 10 | - | 16 | 349 | ||||||||||||
| Loss | $ | 536 | $ | 1,032 | $ | 1,578 | $ | 3,532 | ||||||||
| Attributable to: | ||||||||||||||||
| Equity holders of the Company | 536 | 1,032 | 1,564 | 3,532 | ||||||||||||
| Non-controlling interests | - | - | 14 | - | ||||||||||||
| $ | 536 | $ | 1,032 | $ | 1,578 | $ | 3,532 | |||||||||
| Basic and diluted loss per ADS attributable to equity holders of the Company | $ | 0.57 | $ | 0.30 | $ | 1.73 | $ | 1.31 |
Table 3: Comprehensive Income [based on an effective exchange rate of 3.563 NIS/USD
for the quarter ended September 30, 2017]:
| USD in thousands | ||||||||||||||||
| Three months ended | Nine months ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2016 | 2017 | 2016 | 2017 | |||||||||||||
| Unaudited | ||||||||||||||||
| Net loss | $ | (536 | ) | $ | (1,032 | ) | $ | (1,578 | ) | $ | (3,532 | ) | ||||
| Other comprehensive income to be reclassified to profit or loss in subsequent periods Adjustments arising from translating financial statements from functional currency to presentation currency | (17 | ) | (116 | ) | (33 | ) | 628 | |||||||||
| Total other comprehensive income (loss) | (17 | ) | (116 | ) | (33 | ) | 628 | |||||||||
| Total comprehensive loss | (553 | ) | (1,148 | ) | (1,611 | ) | (2,904 | ) | ||||||||
| Attributable to: | ||||||||||||||||
| Equity holders of the Company | (553 | ) | (1,148 | ) | (1,597 | ) | (2,904 | ) | ||||||||
| Non-controlling interests | - | - | (14 | ) | - | |||||||||||
| TOTAL | $ | (553 | ) | $ | (1,148 | ) | $ | (1,611 | ) | $ | (2,904 | ) |
Table 4: Cash Flows [based on an effective exchange rate of 3.563 NIS/USD for
the quarter ended September 30, 2017]:
| USD in thousands | ||||||||||||||||
| Three months ended | Nine months ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2016 | 2017 | 2016 | 2017 | |||||||||||||
| Cash flows from operating activities: | ||||||||||||||||
| Net loss | $ | (536 | ) | $ | (1,032 | ) | $ | (1,578 | ) | $ | (3,532 | ) | ||||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||||||
| Depreciation and amortization | 1 | 2 | 4 | 4 | ||||||||||||
| Share-based payment expense | (229 | ) | 32 | (21 | ) | 167 | ||||||||||
| Finance expenses, net | (17 | ) | (83 | ) | (22 | ) | 363 | |||||||||
| Gain from sale of investments in investees | (33 | ) | - | (33 | ) | - | ||||||||||
| (278 | ) | (49 | ) | (72 | ) | 534 | ||||||||||
| Working capital adjustments: | ||||||||||||||||
| decrease (increase) in accounts receivable | 22 | 52 | 15 | (58 | ) | |||||||||||
| increase in prepaid public offering costs | (155 | ) | (155 | ) | ||||||||||||
| Increase (decrease) in trade payables | 253 | 30 | 293 | (106 | ) | |||||||||||
| Increase (decrease) in other accounts payable | 3 | 25 | 41 | 58 | ||||||||||||
| 123 | 107 | 194 | (106 | ) | ||||||||||||
| Net cash used in operating activities | (691 | ) | (974 | ) | (1,456 | ) | (3,104 | ) | ||||||||
| Cash flows from investing activities: | ||||||||||||||||
| Increase in restricted cash | - | (22 | ) | - | (22 | ) | ||||||||||
| Purchase of equipment | (1 | ) | (15 | ) | (5 | ) | (22 | ) | ||||||||
| Net cash provided by (used in) investing activities | (1 | ) | (37 | ) | (5 | ) | (44 | ) | ||||||||
| Cash flows from financing activities: | ||||||||||||||||
| Proceeds from issuance of share capital and share options (net of issuance expenses) | 1,106 | - | 1,106 | 12,900 | ||||||||||||
| Net cash provided by financing activities | 1,106 | - | 1,106 | 12,900 | ||||||||||||
| Exchange rate differences on cash and cash equivalents in foreign currency | 17 | 82 | 17 | (364 | ) | |||||||||||
| Translation differences on cash and cash equivalents | 25 | (120 | ) | 44 | 671 | |||||||||||
| Increase (decrease) in cash | 456 | (1,049 | ) | (294 | ) | 10,059 | ||||||||||
| Cash at the beginning of the period | 823 | 11,784 | 1,573 | 676 | ||||||||||||
| Cash at the end of the period | $ | 1,279 | $ | 10,735 | $ | 1,279 | $ | 10,735 |
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
| USD in Thousands | ||||||||||||||||
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
| 2016 | 2017 | 2016 | 2017 | |||||||||||||
| (a) | ||||||||||||||||
| Proceeds from sale of an investment in previously consolidated subsidiary: | ||||||||||||||||
| The subsidiary' assets and liabilities at date of sale: | ||||||||||||||||
| Non-current liabilities | (204 | ) | - | (204 | ) | - | ||||||||||
| Non-controlling interests | 171 | - | 171 | - | ||||||||||||
| Gain (loss) from sale of subsidiary | 33 | - | 33 | - | ||||||||||||
| (b) | ||||||||||||||||
| Significant non-cash transactions: | ||||||||||||||||
| Unpaid issuance costs | 155 | - | 155 | - |
Table 5: Changes in Equity [based on an effective exchange
rate of 3.529 NIS/USD for September 30, 2017]:
| Attributable to equity holders of the Company | ||||||||||||||||||||||||||||
| Issued Capital | Share premium | 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 | $ | 1,088 | $ | 26,612 | $ | 4,443 | $ | 316 | $ | 261 | $ | (32,147 | ) | $ | 573 | |||||||||||||
| Loss | - | - | - | - | - | (636 | ) | $ | (636 | ) | ||||||||||||||||||
| Total other comprehensive loss | - | - | - | 315 | - | - | 315 | |||||||||||||||||||||
| Total comprehensive loss | - | - | - | 315 | - | (636 | ) | (321 | ) | |||||||||||||||||||
| Issuance of shares | 2,287 | 8,493 | - | - | - | - | 10,780 | |||||||||||||||||||||
| Share-based payment | - | - | 64 | - | - | - | 64 | |||||||||||||||||||||
| Balance at March 31, 2017 | $ | 3,375 | $ | 35,105 | $ | 4,507 | $ | 631 | $ | 261 | $ | (32,783 | ) | $ | 11,096 | |||||||||||||
| Loss | (1,864 | ) | (1,864 | ) | ||||||||||||||||||||||||
| Total other comprehensive loss | 429 | 429 | ||||||||||||||||||||||||||
| Total comprehensive loss | - | - | - | 429 | - | (1,864 | ) | (1,435 | ) | |||||||||||||||||||
| Issuance of shares | 334 | 1,342 | - | - | - | - | 1,676 | |||||||||||||||||||||
| Share-based payment | - | - | 71 | - | - | - | 71 | |||||||||||||||||||||
| Balance at June 30, 2017 | $ | 3,709 | $ | 36,447 | $ | 4,578 | $ | 1,060 | $ | 261 | $ | (34,647 | ) | $ | 11,408 | |||||||||||||
| Loss | - | - | - | - | - | (1,032 | ) | (1,032 | ) | |||||||||||||||||||
| Total other comprehensive loss | - | - | - | (116 | ) | - | - | (116 | ) | |||||||||||||||||||
| Total comprehensive loss | - | - | - | (116 | ) | - | (1,032 | ) | (1,148 | ) | ||||||||||||||||||
| Share-based payment | - | - | 32 | - | - | - | 32 | |||||||||||||||||||||
| Balance at June 30, 2017 | $ | 3,709 | $ | 36,447 | $ | 4,610 | $ | 944 | $ | 261 | $ | (35,679 | ) | $ | 10,292 |
Table 6: R&D and G&A Detail [based on an effective
exchange rate of 3.563 NIS/USD for the quarter ended September 30, 2017]:
| USD in Thousands | ||||||||||||||||
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
| 2016 | 2017 | 2016 | 2017 | |||||||||||||
| Research and Development Expenses: | ||||||||||||||||
| Clinical studies | $ | - | $ | 150 | $ | 46 | $ | 407 | ||||||||
| R&A and preclinical studies | 30 | 39 | 110 | 197 | ||||||||||||
| General expenses | 11 | 14 | 26 | 121 | ||||||||||||
| Salaries and benefits | 53 | 59 | 145 | 197 | ||||||||||||
| Stock based compention | 21 | 8 | 84 | 32 | ||||||||||||
| Regulatory and other expenses | - | 30 | 20 | 41 | ||||||||||||
| Chemistry & formulation studies | 104 | 38 | 164 | 38 | ||||||||||||
| Subtotal, R&D expenses | 219 | 338 | 595 | 1,033 | ||||||||||||
| General and Administative Expenses: | ||||||||||||||||
| Investor relations and buisness development | $ | 69 | $ | 206 | $ | 188 | $ | 730 | ||||||||
| Professional & directors fees | 98 | 215 | 249 | 487 | ||||||||||||
| Salaries and benefits | 64 | 232 | 233 | 567 | ||||||||||||
| Rent and office maintenance | 66 | 98 | 145 | 231 | ||||||||||||
| Stock based compensation | 43 | 23 | 160 | 135 | ||||||||||||
| Subtotal, G&A expenses | 340 | 774 | 975 | 2,150 | ||||||||||||
| TOTAL | $ | 559 | $ | 1,112 | $ | 1,570 | $ | 3,183 |
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 synthetic cannabinoid
(dronabinol): THX-110 and THX-120 for the treatment of Tourette syndrome (TS) and Obstructive Sleep Apnea (OSA); THX-130 for the
treatment of Mild Cognitive Impairment (MCI) and Traumatic Brain Injury (TBI); and THX-150 for the treatment of infectious diseases.
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 and Obstructive Sleep Apnea. It is based on two components:
(1) dronabinol (an FDA approved synthetic analog of 9-tetrahydracannabinol, or "THC"), which is the psychoactive
molecule in the cannabis plant, 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 orally administered THC, while reducing the required dosage and decreasing associated
deleterious adverse events.
a first-in-class, proprietary investigational drug candidate for the treatment of Tourette syndrome. THX-120 contains the two
active ingredients, THC and PEA in a single pill.
THX-130 (Previously referred to as THX-ULD01):
is a proprietary, new, ultra-low dose formulation of dronabinol, which is intended to provide a treatment for Mild Cognitive Impairment
(MCI). TXH-130 is being developed to be delivered either by sublingual or nasal administration. 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 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.
is a drug candidate intended for the treatment of infectious diseases. It consists of dronabinol and/or palmitoylethanolamide
(PEA) and selected antibacterial agent and possesses antimicrobial synergy potential.
syndrome is a neuropsychiatric disorder, characterized by physical (motor) tics and vocal (phonic) tics. Motor or phonic tics
are sudden, brief, intermittent, involuntary or semi-voluntary movements or sounds, respectively. They typically consist of brief,
coordinated, repetitive movements, gestures, or utterances that mimic fragments of normal behavior. The tics associated with Tourette
syndrome can have significant effects on the academic and social development of children as well as affecting their overall self-esteem
and mental health. Although the majority of children experience a decrease in their tics during adolescence, the worst symptoms
are usually experienced by adults with intractable Tourette syndrome.
Obstructive Sleep Apnea:
to the Mayo Clinic, obstructive sleep apnea, or OCA, is a potentially serious sleep disorder. It causes breathing to repeatedly
stop and start during sleep. There are several types of sleep apnea, but the most common is obstructive sleep apnea. This type
of apnea occurs when your throat muscles intermittently relax and block your airway during sleep. A noticeable sign of obstructive
sleep apnea is snoring. OSA affects 29.4 million American men and women, which represents 12 percent of the U.S. adult population,
according to The American Academy of Sleep Medicine (AASM) and Frost & Sullivan.
Mild Cognitive Impairment:
cognitive impairment ("MCI") is an intermediate stage between the expected cognitive decline of normal aging and the
more-serious decline of dementia. It can involve problems with memory, language, thinking and judgment that are greater than normal
age-related changes. MCI causes cognitive changes that are serious enough to be noticed by the individuals experiencing them,
or to other people, but the changes are not severe enough to interfere with daily life or independent function. People with MCI,
especially those involving memory problems, are more likely to develop Alzheimer's disease or other dementias than people without
MCI. MCI is a widespread condition that increases with age at a rate of 10% among 70-79-year-olds and 25% among 80-89-year-olds.
There is currently no FDA approved treatment for MCI.
Antimicrobial Resistance:
to the World Health Organization, antimicrobial resistance, classified as a 'serious threat', occurs when microorganisms are exposed
to antimicrobial drugs. As a result, medicines become ineffective and infections persist, increasing the risk of spread. New resistance
mechanisms are emerging globally, threatening the ability to treat common infectious diseases. Without effective antimicrobials
for prevention and treatment of infections, medical procedures such as organ transplantation, cancer chemotherapy, diabetes management
and major surgery are jeopardized. Antimicrobial resistance increases the cost of healthcare with lengthier stays in hospitals
and more intensive care required.
to the U.S. Centers for Disease Control and Prevention in conjunction with research conducted at Tufts University, antibiotic-resistant
infections add considerable and avoidable costs to the already overburdened U.S. healthcare system. In most cases, antibiotic-resistant
infections require prolonged and/or costlier treatments, extend hospital stays, necessitate additional doctor visits and healthcare
use, and result in greater disability and death compared with infections that are easily treatable with antibiotics.
press release contains forward-looking statements about the Company's expectations, beliefs, and intentions. Forward-looking statements
can be identified by the use of forward-looking words such as "believe", "expect", "intend", "plan",
"may", "should", "could", "might", "seek", "target", "will",
"project", "forecast", "continue" or "anticipate" or their negatives or variations of
these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. Such
forward-looking statements used in this press release include, among other things, references to the clinical and commercial potential