TEL AVIV, Israel, Nov. 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.
Financial 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):
- Net loss of $1.03 million, or
$0.30 per ADS, for the three months
ended September 30, 2017, compared to
a net loss of $0.54 million, or
$0.57 per ADS, for the three months
ended September 30, 2016. For the
nine months ended September 30, 2017,
net loss of $3.53 million, or
$1.31 per ADS, compared to a net loss
of $1.58 million, or $1.73 per ADS, for the comparable period in 2016.
The third quarter 2017 net loss included $80,000 of income due to exchange rate
differences on balances of cash and cash equivalents (classified as
finance income), versus $10,000 of
expenses incurred during the corresponding period in 2016.
- Research and development ("R&D") expenses amounted to
$0.34 million for the three months
ended September 30, 2017, compared to
approximately $0.22 million for the
three months ended September 30,
2016. For the nine months ended September 30, 2017, R&D expenses amounted to
$1.03 million, compared to
$0.59 million for the comparable
period in 2016. The increase in R&D expenses for the third
quarter 2017 resulted primarily from higher expenses in connection
with the clinical trials, which was partially offset by a decrease
in chemistry and formulation studies.
- General and administrative expenses ("G&A") amounted to
$0.77 million for the three months
ended September 30, 2017, compared to
$0.34 million for the three months
ended September 30, 2016. The
increase resulted primarily from a rise in salaries and benefits,
investor relations and business development activities, as well as
professional and directors' fees. These increases were the result
of an increase in the number of employees and professional
contractors, as well as costs associated with becoming a publicly
traded company on NASDAQ.
- Cash totaled $10.7 million as of
September 30, 2017, compared to
$11.8 million as of June 30, 2017. The decrease in cash primarily
resulted from increased R&D and G&A expenses as detailed
above. The Company currently believes that its cash balance will be
sufficient to maintain its current operations into the third
quarter of 2018.
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 (n=18) is ongoing and 17 patients
have been enrolled to date. The final patient is currently
projected to be enrolled later this month.
- The Phase IIb, placebo-controlled 13-week clinical trial for
THX-110 in TS is anticipated to be conducted exclusively at the
Hannover Medical School in Germany
and the Company currently anticipates submitting the
Investigational Medicinal Product Dossier ("IMPD") for this trial
by the end of 2017.
- Therapix has entered into an exclusive agreement with Catalent
Pharma Solutions for the formulation, development and clinical
manufacturing of THX-110.
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.
- In November, Therapix entered into a product development
agreement with Cure Pharmaceuticals (NASDAQ: CURR), ("Cure"). The
joint effort will attempt to formulate a proprietary
cannabinoid-based product based on Cure's patented, multilayer oral
thin film (OTF), CureFilm™, for the treatment of a wide range of
sleep disorders. This agreement is an extension of the recently
announced partnership between Therapix, Cure and Israel's Assuta Medical Centers, Ltd. to
develop first-in-class therapeutic products in the fields of
personalized medicine and cannabinoids.
Mild Cognitive Impairment ("MCI"):
- The Company has completed the development of a formulation of
sublingual administration of THC with expected enhanced
bioavailability for its ultra-low-dose formulation of THC
(THX-130). The Company is continuing work on a nasal delivery
formulation.
- Institutional Review Board ("IRB") approval for the
Pharmacokinetics (PK) study, which is currently projected to be
initiated in the first quarter of 2018, has been received.
- In a pre-clinical study, proprietary ultra-low-dose THC
treatment significantly reversed age-related cognitive impairment
in old mice (p≤0.01). These data were presented at the
International Association for Cannabinoid Medicines' (IACM) 9th
Conference on Cannabinoids in Medicine.
- In the anticipated proof-of-concept study in MCI, the Company
expects to evaluate cognition in Traumatic Brain Injury ("TBI")
patients who are generally symptomatic with significant cognitive
dysfunction. The primary endpoint is expected to measure the
cognitive functions post injury. The Company is about to initiate a
similar pre-clinical study in small animals.
Antimicrobial:
- In October 2017, Therapix, in
collaboration with the Weizmann Institute of Science and the Tel
Aviv Sourasky Medical Center, initiated non-clinical studies of
THX-150, a pharmaceutical composition of dronabinol (synthetic
∆9-tetrahydracannabinol) and/or palmitoylethanolamide (PEA), to
evaluate its efficacy along with a selected antibacterial agent
that the Company believes may possess synergies.
Pain:
- The Company is currently evaluating several possible internal
initiatives and collaborations with external entities with the aim
of developing cannabinoid-based therapeutics and treatments of the
management of chronic pain.
Conference Call & Webcast:
Thursday, November 09, 2017,
8:30 am Eastern Time / 5:30 am Pacific Time
Participant Dial-In Numbers:
Toll-Free:
|
+1-877-870-4263
|
Toll/International:
|
+1-412-317-0790
|
Webcast:
|
https://www.webcaster4.com/Webcast/Page/1726/23160
|
Replay, available until Nov. 16,
2017
Replay Dial-In Numbers:
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
|
|
Nine months
ended
|
|
|
September
30,
|
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
|
|
Nine months
ended
|
|
|
|
|
September
30,
|
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
Administrative Expenses:
|
|
|
|
|
|
|
|
|
|
|
Investor relations
and business 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
|
|
|
|
|
|
|
|
|
|
|
|
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 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.
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 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.
About TXH-120:
THX-120, 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.
About THX-130 (Previously referred to as THX-ULD01):
THX-130 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.
About THX-150:
THX-150 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.
About Tourette Syndrome:
Tourette 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.
About Obstructive Sleep Apnea:
According 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.
About Mild Cognitive Impairment:
Mild 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.
About Antimicrobial Resistance:
According 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.
According 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.
Forward-Looking Statements:
This 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 of the Company's product candidates. Actual results could
differ from those projected in any forward-looking statements due
to numerous factors. Such factors include, among others, our
ability to raise the additional funding needed to continue to
pursue our business and product development plans, the inherent
uncertainties associated with developing new products or
technologies, our ability to obtain regulatory approval for our
product candidates, our ability to commercialize our product
candidates, competition in the industry in which we operate and
overall market conditions. Any forward-looking statement in this
press release speaks only as of the date of this press release. The
Company undertakes no obligation to publicly update or review any
forward-looking statement, whether as a result of new information,
future developments or otherwise, except as may be required by any
applicable securities laws. More detailed information about the
risks and uncertainties affecting the Company is contained under
the heading "Risk Factors" in Therapix Biosciences Ltd.'s annual
report on Form 20-F dated May 1, 2017
filed with the SEC, which is available on the SEC's website,
www.sec.gov.
For further information:
Investor Contact:
Josh
Blacher, CFO, Therapix Biosciences,
josh@therapixbio.com
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SOURCE Therapix Biosciences