TEL AVIV, Israel, Aug. 10, 2017 /PRNewswire/ -- Therapix
Biosciences Ltd. (Nasdaq: TRPX), a specialty clinical stage
pharmaceutical Company specializing in the development of
cannabinoid-based drugs, today reported financial results for the
three and six months ended June 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 – Second Quarter 2017 vs. Second 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 $1.9 million, or
$0.54 per ADS, for the three months
ended June 30, 2017, compared to a
net loss of $0.5 million, or
$0.61 per ADS, for the three months
ended June 30, 2016. This
period's net loss included $0.44
million of exchange rate differences on balances of cash and
cash equivalents, versus none incurred during the corresponding
period in 2016.
- Research and development ("R&D") expenses amounted to
approximately $0.46 million for the
three months ended June 30, 2017,
compared to approximately $0.23
million for the three months ended June 30, 2016. The increase resulted
primarily from a marked rise in expenses in connection with the
clinical trials, as well as a R&D studies.
- General and administrative expenses amounted to approximately
$0.97 million for the three months
ended June 30, 2017, compared to
approximately $0.30 million for the
three months ended June 30, 2016. The
increase resulted primarily from a rise in investor relations and
business development activities.
- Cash totaled $11.8 million as of
June 30, 2017, compared to
$12.1 million at March 31, 2017. The decrease in cash primarily
resulted from expenses incurred in our ongoing clinical trials,
other R&D expenses, investor relations and business development
activities and operational activities offset by additional net
proceeds raised in the Company's Initial Public Offering through
the complete exercise of the underwriter's overallotment option.
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:
- In the Company's ongoing study Phase IIa clinical trial in
Tourette's Syndrome at Yale University
(n=18), 12 patients have been enrolled to date; patient #13 is
scheduled to be screened this week. The last patient is
currently projected to be enrolled by the end of September or early
October, 2017, which is consistent with our previously disclosed
estimate. To date, ten patients have completed the entire
three-month treatment regimen.
- In the Yale study, patients that
have completed the initial 3-month treatment period have been given
the option to extend their treatment for an additional 3 months
based on a positive assessment of efficaciousness after the first 3
months. Of the 10 patients that have already completed the
initial 3-month treatment period, 8 patients have opted to extend
their treatment.
- Regarding our Phase IIb, placebo-controlled 13-week clinical
trial in Tourette's Syndrome, previously anticipated to be
conducted at the Hannover Medical School in Germany, we are currently assessing the option
to conduct a study in the United
States as well. We should be able to complete our
decision within a few weeks. This will cause an immaterial
delay in initiating the study.
- Concerning our second clinical program for our Ultra-Low-Dose
formulation of THC for the treatment of Mild Cognitive Impairment
("MCI"), the Company has completed the development of a formulation
of sublingual administration of THC with expected enhanced
bioavailability. Within the broader MCI indication, we are
now focusing on the narrower Traumatic Brain Injury ("TBI")
indication, and are now assessing the optimal regulatory pathway
for this program. As a result, this will likely cause a delay
in the initiation of the PK study. Nonetheless, we currently
project this study will be initiated in the fourth quarter of
2017. The duration of this study is expected to be 1
month. From there, the Company intends to advance to a
proof-of-concept trial. In addition to the sublingual
administration, we are currently working on a nasal delivery
formulation.
- In the anticipated proof-of-concept study in MCI, the Company
will be evaluating cognition in TBI patients who are generally
symptomatic with significant cognitive dysfunction. The
primary endpoint is expected to measure the cognitive functions
post injury. The Company currently intends to initiate a
similar pre-clinical study in small animals towards the end the
third quarter, 2017, or early fourth quarter 2017, which is
materially on track with our earlier disclosed estimate.
Conference Call &
Webcast:
Thursday, August
10, 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/1726/22002
Replay, available until Aug 17,
2017
Replay Dial-In
Numbers:
Toll-Free:
+1-877-344-7529
Toll/International: +1-412-317-0088
Passcode:
10110882
Table 1:
Balance Sheet:
|
|
|
|
USD in
Thousands
|
|
|
|
|
December
31,
|
|
March
31,
|
|
June
30,
|
|
|
|
|
2016
|
|
2017
|
|
2017
|
|
|
|
|
Audited
|
|
Unaudited
|
|
Unaudited
|
|
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
CURRENT
ASSETS:
|
|
|
|
|
|
|
|
|
Cash
|
|
$
676
|
|
$
12,054
|
|
$
11,784
|
|
|
Restricted
cash
|
|
11
|
|
12
|
|
13
|
|
|
Accounts
receivable
|
|
117
|
|
133
|
|
242
|
|
|
Subtotal,
current assets
|
|
804
|
|
12,199
|
|
12,039
|
|
|
|
|
|
|
|
|
|
|
NON-CURRENT
ASSETS:
|
|
|
|
|
|
|
|
|
Prepaid public
offering costs
|
|
430
|
|
-
|
|
-
|
|
|
Property
|
|
11
|
|
11
|
|
17
|
|
|
Subtotal,
non-current assets
|
|
441
|
|
11
|
|
17
|
|
|
TOTAL
ASSETS
|
|
$
1,245
|
|
$
12,210
|
|
$
12,056
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
EQUITY
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
|
|
|
Trade
payables
|
|
$
590
|
|
$
937
|
|
$
520
|
|
|
Other accounts
payable
|
|
82
|
|
177
|
|
128
|
|
|
Subtotal,
current liabilities
|
|
672
|
|
1,114
|
|
648
|
|
|
|
|
|
|
|
|
|
|
EQUITY
ATTRIBUTABLE TO EQUITY HOLDERS OF THE COMPANY:
|
|
|
|
|
Share
capital
|
|
$
1,088
|
|
$
3,375
|
|
$
3,709
|
|
|
Share
premium
|
|
26,612
|
|
35,105
|
|
36,447
|
|
|
Sharebased payment
transactions
|
|
4,443
|
|
4,507
|
|
4,578
|
|
|
Foreign currency
translation reserve
|
|
316
|
|
631
|
|
1,060
|
|
|
Transactions with
noncontrolling interests
|
|
261
|
|
261
|
|
261
|
|
|
Accumulated
deficit
|
|
(32,147)
|
|
(32,783)
|
|
(34,647)
|
|
|
Total
equity
|
|
573
|
|
11,096
|
|
11,408
|
|
|
TOTAL LIABILITIES
AND EQUITY
|
|
$
1,245
|
|
$
12,210
|
|
$
12,056
|
Table 2:
Profit or Loss:
|
|
USD in
thousands
|
|
|
Three months
ended
|
|
Six months
ended
|
|
|
June
30,
|
June
30,
|
|
|
2016
|
|
2017
|
|
2016
|
|
2017
|
|
|
Unaudited
|
|
|
|
|
|
|
|
|
|
|
Research and
development expenses, net
|
|
$
227
|
|
$
455
|
|
$
376
|
|
$
695
|
|
General and
administrative expenses
|
|
299
|
|
971
|
|
635
|
|
1,376
|
|
Subtotal
|
|
526
|
|
1,426
|
|
1,011
|
|
2,071
|
|
Other
expenses
|
|
26
|
|
-
|
|
26
|
|
-
|
|
Operating
loss
|
|
552
|
|
1,426
|
|
1,037
|
|
2,071
|
|
Finance
income
|
|
(9)
|
|
-
|
|
(1)
|
|
-
|
|
Finance
expenses
|
|
-
|
|
438
|
|
5
|
|
429
|
|
Loss
|
|
$
543
|
|
$
1,864
|
|
$
1,041
|
|
$
2,500
|
|
|
|
|
|
|
|
|
|
|
Attributable
to:
|
|
|
|
|
|
|
|
|
|
Equity holders of the
Company
|
|
533
|
|
1,864
|
|
1,027
|
|
2,500
|
|
Non-controlling
interests
|
|
10
|
|
-
|
|
14
|
|
-
|
|
|
$
543
|
|
$
1,864
|
|
$
1,041
|
|
$
2,500
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
loss per ADS attributable to equity holders of the
Company
|
|
$
0.61
|
|
$
0.54
|
|
$
1.18
|
|
$
1.08
|
Table 3:
Comprehensive Income:
|
|
USD in
Thousands
|
|
|
Three months
ended
|
|
Six months
ended
|
|
|
June
30,
|
June
30,
|
|
|
2016
|
|
2017
|
|
2016
|
|
2017
|
|
|
Unaudited
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
(543)
|
|
$
(1,864)
|
|
$
(1,041)
|
|
$
(2,500)
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive
income to be reclassified to profit or loss in subsequent
periods
|
|
|
|
|
|
|
|
|
|
Exchange differences
on translation of foreign operations
|
|
(18)
|
|
429
|
|
8
|
|
744
|
|
Total other
comprehensive income (loss)
|
|
(18)
|
|
429
|
|
8
|
|
744
|
|
Total comprehensive
loss
|
|
(561)
|
|
(1,435)
|
|
(1,033)
|
|
(1,756)
|
|
|
|
|
|
|
|
|
|
|
Attributable
to:
|
|
|
|
|
|
|
|
|
|
Equity holders of the
Company
|
|
(555)
|
|
(1,435)
|
|
(1,017)
|
|
(1,756)
|
|
Non-controlling
interests
|
|
(6)
|
|
-
|
|
(16)
|
|
-
|
|
TOTAL
|
|
$
(561)
|
|
$
(1,435)
|
|
$
(1,033)
|
|
$
(1,756)
|
Table 4:
Cash Flows:
|
|
USD in
Thousands
|
|
|
Three months
ended
|
|
Six months
ended
|
|
|
June
30,
|
June
30,
|
|
|
2016
|
|
2017
|
|
2016
|
|
2017
|
|
|
|
|
|
|
|
|
|
|
Cash flows from
operating activities:
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
(543)
|
|
$
(1,864)
|
|
$
(1,042)
|
|
$
(2,500)
|
|
|
|
|
|
|
|
|
|
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and
amortization
|
|
2
|
|
1
|
|
3
|
|
2
|
|
Share-based payment
expense
|
|
132
|
|
71
|
|
208
|
|
135
|
|
Finance expenses,
net
|
|
(5)
|
|
-
|
|
(5)
|
|
-
|
|
Exchange rate
differences on balances of cash and cash equivalents
|
|
-
|
|
453
|
|
-
|
|
446
|
|
|
129
|
|
525
|
|
206
|
|
583
|
|
Working capital
adjustments:
|
|
|
|
|
|
|
|
|
|
decrease (increase)
in accounts receivable
|
|
(42)
|
|
(102)
|
|
(7)
|
|
(110)
|
|
Increase (decrease)
in trade payables
|
|
2
|
|
(441)
|
|
40
|
|
(136)
|
|
Increase (decrease)
in other accounts payable
|
|
24
|
|
(54)
|
|
38
|
|
33
|
|
|
(16)
|
|
(597)
|
|
71
|
|
(213)
|
|
Net cash used in
operating activities
|
|
(430)
|
|
(1,936)
|
|
(765)
|
|
(2,130)
|
|
|
|
|
|
|
|
|
|
|
Cash flows from
investing activities:
|
|
|
|
|
|
|
|
|
|
Purchase of
equipment
|
|
-
|
|
(7)
|
|
(4)
|
|
(7)
|
|
Net cash provided by
(used in) investing activities
|
-
|
|
(7)
|
|
(4)
|
|
(7)
|
|
|
|
|
|
|
|
|
|
|
Cash flows from
financing activities:
|
|
|
|
|
|
|
|
|
|
Proceeds from
issuance of share capital and share options (net of issuance
expenses)
|
|
-
|
|
1,676
|
|
-
|
|
12,900
|
|
Net cash provided by
financing activities
|
|
-
|
|
1,676
|
|
-
|
|
12,900
|
|
|
|
|
|
|
|
|
|
|
Exchange rate
differences on balances of cash and cash equivalents
|
|
-
|
|
(453)
|
|
-
|
|
(446)
|
|
Translation
differences on cash and cash equivalents
|
(25)
|
|
450
|
|
19
|
|
791
|
|
Increase (decrease)
in cash
|
|
(455)
|
|
(270)
|
|
(750)
|
|
11,108
|
|
Cash at the beginning
of the period
|
|
1,278
|
|
12,054
|
|
1,573
|
|
676
|
|
Cash at the end of
the period
|
|
$
823
|
|
$
11,784
|
|
$
823
|
|
$
11,784
|
Table 5:
Changes in Equity:
|
|
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
|
Table 6:
R&D and G&A Detail:
|
|
|
|
USD in
Thousands
|
|
|
|
|
Three months
ended
|
|
Six months
ended
|
|
|
|
|
June
30,
|
June
30,
|
|
|
|
|
2016
|
|
2017
|
|
2016
|
|
2017
|
|
Research and
Development Expenses:
|
|
|
|
|
|
|
|
|
|
|
Clinical
studies
|
|
$
44
|
|
$
163
|
|
$
44
|
|
$
257
|
|
|
R&A and
preclinical studies
|
|
37
|
|
120
|
|
80
|
|
158
|
|
|
General
expenses
|
|
8
|
|
97
|
|
15
|
|
108
|
|
|
Salaries and
benefits
|
|
53
|
|
56
|
|
92
|
|
139
|
|
|
Stock based
compention
|
|
43
|
|
11
|
|
63
|
|
23
|
|
|
Regulatory and other
expenses
|
|
10
|
|
8
|
|
21
|
|
10
|
|
|
Chemistry &
formulation studies
|
|
32
|
|
-
|
|
61
|
|
-
|
|
|
Subtotal, R&D expenses
|
|
227
|
|
455
|
|
376
|
|
695
|
|
|
|
|
|
|
|
|
|
|
|
|
General and
Administative Expenses:
|
|
|
|
|
|
|
|
|
|
|
Investor relations
and buisness development
|
|
$
85
|
|
$
431
|
|
$
117
|
|
$
523
|
|
|
Professional &
directors fees
|
|
57
|
|
225
|
|
151
|
|
272
|
|
|
Salaries and
benefits
|
|
83
|
|
174
|
|
169
|
|
335
|
|
|
Rent and office
maintenance
|
|
11
|
|
80
|
|
79
|
|
135
|
|
|
Stock based
compensation
|
|
63
|
|
61
|
|
119
|
|
111
|
|
|
Subtotal, G&A expenses
|
|
299
|
|
971
|
|
635
|
|
1,376
|
|
TOTAL
|
|
$
526
|
|
$
1,426
|
|
$
1,011
|
|
$
2,071
|
About Therapix Biosciences:
Therapix Biosciences Ltd. is a specialty clinical-stage
pharmaceutical company led by an experienced team of senior
executives and scientists, focused on creating and enhancing a
portfolio of technologies and assets based on cannabinoid
pharmaceuticals. With this focus, the company is currently engaged
in two internal drug development programs based on repurposing an
FDA approved synthetic cannabinoid (dronabinol): THX-TS01 targets
to the treatment of Tourette's Syndrome; and THX-ULD01 targets the
high-value and under-served market of mild cognitive impairments.
Please visit our website for more information
at www.therapixbio.com
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. For
example, forward-looking statements are used in this press release
when we discuss our search for a U.S. based Chief Executive
Officer. These forward-looking statements involve certain risks and
uncertainties, including, among others, risks that could cause the
Company's results to differ materially from those expected by
Company management or otherwise described in or implied by the
statements in this press release. 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
View original
content:http://www.prnewswire.com/news-releases/therapix-biosciences-reports-second-quarter-2017-financial-results-and-provides-business-update-300502616.html
SOURCE Therapix Biosciences