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Therapix 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

Key Takeaway: 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 pharmac

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
Toll-Free: +1-877-870-4263
Toll/International: +1-412-317-0790
Webcast: https://www.webcaster4.com/Webcast/Page/1726/23160
available until Nov. 16, 2017
Toll-Free: +1-877-344-7529
Toll/International: +1-412-317-0088
Passcode: 10113655
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
Last updated: Nov 9, 2017