TEL AVIV, Israel, Aug. 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):
- Net loss of $1.2 million, or
$0.35 per ADS, for the three months
ended June 30, 2018, compared to a
net loss of $1.86 million, or
$1.10 per ADS, for the three months
ended June 30, 2017. For the six
months ended June 30, 2018, net loss
of $3.26 million, or $0.93 per ADS, compared to a net loss of
$2.5 million, or $1.07 per ADS, for the comparable period in 2017.
The first half of 2018 net loss included $0.31 million of income due to exchange rate
differences on balances of cash and cash equivalents (classified as
finance income), versus $0.45
million of expense incurred during the corresponding period in
2017.
- Research and development ("R&D") expenses amounted to
$0.65 million for the three months
ended June 30, 2018, compared to
approximately $0.46 million for the
three months ended June 30, 2017. For
the six months ended June 30, 2018,
R&D expenses amounted to $1.64
million, compared to $0.7
million for the comparable period in 2017. The increase in
R&D expenses for the first half of 2018 resulted primarily from
higher expenses in connection with the clinical trials, including
expenses for R&D and preclinical studies, wages and related
expenses, and regulatory and other expenses.
- General and administrative expenses ("G&A") amounted to
$1 million for the three months ended
June 30, 2018, compared to
$0.97 million for the three months
ended June 30, 2017. For the six
months ended June 30, 2018, G&A
expenses amounted to $2.14 million,
compared to $1.37 million for the
comparable period in 2017. The increase resulted primarily
from hiring of new employees, rise in wages and related expenses,
investor relations and business expenses, business development
expenses as well as professional and directors' fees. These
increases were the result of the continuance of the clinical trials
and an increase in the number of the Company's employees.
- Cash totaled $5.1 million as of
June 30, 2018, compared to
$9.2 million as of December 31, 2017. The decrease in cash primarily
resulted from increased R&D and G&A expenses as detailed
above.
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 was completed. Sixteen patients
were enrolled in the study. The Company recently reported top line
results, and the results were further presented at the annual
meeting of the European Society for the Study of Tourette Syndrome
by principal investigator Dr. Michael
Bloch.
- The Phase IIb, placebo-controlled 12-week clinical trial for
THX-110 in TS will be conducted in Germany. The Company currently anticipates
first patient enrollment by the end of the third quarter, as
anticipated by the original work plan and timeline. Top line
results are expected in the first half of 2020.
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. The study was initiated in
June in accordance with the original work plan and timeline. Top
line results are expected in the first half of 2019.
Chronic Pain:
- Within the framework of Therapix's "Entourage Effect" program
and as previously announced, a Phase IIa investigator-initiated
trial was initiated for the treatment of chronic pain using
THX-110, in the USA.
Mild Cognitive Impairment (MCI):
- A pre-clinical study evaluating the effect of the THX-130,
proprietary ultra-low-dose THC, in a rodent model for cognitive
impairment related to traumatic brain injury (TBI) was initiated in
Dalhousie University, Halifax, Canada. Results are expected by the
second half of this year.
Antimicrobial:
- We are continuing our development program as planned to
evaluate the potential efficacy of our proprietary drug candidate
THX-150.
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.
Pain:
- We have successfully completed two pre-clinical studies in
acute and chronic pain in rodent models evaluating the potential
efficacy of the Company's proprietary compound THX-160. THX-160 is
a pharmaceutical formulation candidate containing a synthetic CB2
receptor agonist. The efficacy of THX-160 was measured as a
stand-alone therapy and as an opioid sparing agent. In the
preclinical studies, THX-160 was well tolerated and did not cause
any significant adverse clinical effects. In addition, efficacy
studies demonstrated the analgesic superiority of THX-160 over
control and were comparable to high-dose morphine analgesic effects
and in some instances exerted greater potency. The efficacy and
safety of THX-160 was shown for both acute and chronic pain.
CONSOLIDATED
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
|
CONSOLIDATED
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
|
CONSOLIDATED
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
|
CONSOLIDATED
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
|
CONSOLIDATED
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
|
CONSOLIDATED
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
|
CONSOLIDATED
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
|
CONSOLIDATED
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
|
CONSOLIDATED
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
|
R&D AND
G&A DETAIL
|
(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
|
Subsequent events:
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.
About THX-130:
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.
About THX-150:
THX-150 is a drug candidate intended
for the treatment of infectious diseases. It consists of dronabinol
or dronabinol with PEA and a selected antibacterial agent, which
possesses antimicrobial synergy potential.
About THX-160:
THX-160 is a drug candidate intended
for the treatment of pain. It consists of a CB2 receptor agonist
with or without the opioid.
Forward-Looking Statements:
This 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 or
otherwise.
For further information:
Oz Adler, CFO
Oz@therapixbio.com
Investor Contact:
Investor Relations
IR@therapixbio.com
View original
content:http://www.prnewswire.com/news-releases/therapix-biosciences-reports-second-quarter-2018-financial-results-and-provides-business-update-300699327.html
SOURCE Therapix Biosciences Ltd.