Therapix Biosciences Reports First Quarter 2018 Financial Results and Provides Business Update
Therapix Biosciences Reports First Quarter 2018 Financial Results and Provides Business Update
TEL AVIV, Israel, May 31, 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 - first quarter 2018 vs. first 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 $2.05 million, or $0.59 per ADS, for the three months ended
March 31, 2018, compared to a net loss of $0.64 million, or $0.54 per
ADS, for the three months ended March 31, 2017. The first quarter 2018
net loss included $90,000 of income due to exchange rate differences on
balances of cash and cash equivalents (classified as finance income),
versus $7,000 of income incurred during the corresponding period in
2017.
-- Research and development ("R&D") expenses amounted to $0.99 million for
the three months ended March 31, 2018, compared to approximately $0.24
million for the three months ended March 31, 2017. The increase in R&D
expenses for the first quarter 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 $1.13 million
for the three months ended March 31, 2018, compared to $0.4 million for
the three months ended March 31, 2017. The increase resulted primarily
from a 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 $7.5 million as of March 31, 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. The Company currently
believes that its cash balance will be sufficient to maintain its
current operations into the second quarter of 2019.
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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 will be 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 is anticipated to 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 2019.
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 earlier this month 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, the
Company has initiated a Phase IIa, investigator-initiated trial for the
treatment of low back pain using THX-110, at the Clinical Research
Institute, TN, USA. The study was initiated earlier this month, in
accordance with the original work plan and timeline.
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.
-- Therapix entered into a product development agreement with Cure
Pharmaceuticals ("Cure") (NASDAQ: CURR), to formulate a proprietary
cannabinoid-based product to deliver the ultra low dose technology. The
product will be based on Cure's patented, multilayer oral thin film
(OTF), CureFilm(TM), for the treatment of a wide range of sleep
disorders.
Antimicrobial:
-- We have successfully completed the first stage of our pre-clinical
program to evaluate the potential efficacy of our proprietary compound
THX-150.
THX-150 is a pharmaceutical composition of dronabinol (synthetic Delta9-tetrahydracannabinol) and/or palmitoylethanolamide (PEA) along with a selected antibacterial agent that possesses synergy potential. Our objective is to use our entourage technology in association with THC to increase the efficacy of existing antibiotic drugs especially in antibiotic-resistant bacteria strains. We anticipate the next step of the research will be to understand the mechanism of action of THX-150. In addition, we anticipate initiating a study in an animal model of a microbial infection to test the potential efficacy and safety of THX-150 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
containing of synthetic CB2 receptor agonist. The efficacy of THX-160
was measured as a stand-alone therapy and as an opioid sparing agent. A
second follow-up in vivo study was recently completed. The study
evaluated the dosage regiment of the active ingredients, as well as
their optimal therapeutic ratio.
Table 1: Consolidated Statements of Financial Position [based on an effective exchange rate of 3.514 NIS/USD as of March 31, 2018]:
USD in Thousands
----------------
March 31, December 31,
2018 2017
---- ----
Unaudited Audited
--------- -------
ASSETS
------
CURRENT ASSETS:
Cash 7,509 9,195
Restricted
cash 24 24
Accounts
receivable 411 278
--- ---
7,944 9,497
----- -----
NON-CURRENT
ASSETS:
Prepaid public
offering
costs 55 19
Property and
equipment 56 50
--- ---
111 69
--- ---
TOTAL ASSETS 8,055 9,566
===== =====
LIABILITIES AND EQUITY
----------------------
CURRENT
LIABILITIES:
Trade payables 1,214 1,017
Other accounts
payable 346 160
--- ---
1,560 1,177
----- -----
EQUITY ATTRIBUTABLE TO EQUITY HOLDERS OF THE
COMPANY:
Share capital 3,812 3,812
Share premium 36,829 36,612
Reserve from
share-based
payment
transactions 5,332 5,311
Foreign
currency
translation
reserve 698 782
Transactions
with
noncontrolling
interests 261 261
Accumulated
deficit -40,437 -38,389
------- -------
Total equity 6,495 8,389
----- -----
TOTAL
LIABILITIES
AND EQUITY 8,055 9,566
===== =====
Table 2: Consolidated Statements of Profit or Loss [based on the average exchange rate of 3.46 NIS/USD for the three-month period ended March 31, 2018]:
USD in thousands
----------------
Three months ended Year ended
March 31, December 31,
--------- ------------
2018 2017 2017
---- ---- ----
Unaudited Audited
--------- -------
Research and development expenses $995 $240 $1,943
General and administrative expenses 1,139 405 3,810
----- --- -----
2,134 645 5,753
Other expense - - 1
--- --- ---
Operating loss 2,134 645 5,754
Finance income (88) (9) (1)
Finance expenses 2 - 491
--- --- ---
Loss $2,048 $636 $6,244
====== ==== ======
Attributable to:
Equity holders of the Company 2,048 636 6,244
Non-controlling interests - - -
--- --- ---
$2,048 $636 $6,244
====== ==== ======
Basic and diluted net loss per share attributable $0.01 $0.01 $0.05
to equity holders of the Company
Basic and diluted loss per ADS attributable to $0.59 $0.54 $2.14
equity holders of the Company
Table 3: Consolidated Statements of Comprehensive Income [based on the average exchange rate of 3.46 NIS/USD for the three-month period ended March 31, 2018]:
USD in Thousands
----------------
Three months ended Year ended
March 31, December 31,
--------- ------------
2018 2017 2017
---- ---- ----
Unaudited Audited
--------- -------
Net loss $2,048 $636 $6,244
Amounts that will not be reclassified subsequently to profit or loss:
Adjustments arising from translating financial 84 (315) (461)
statements from functional currency to presentation
currency
Total other comprehensive income (loss) 84 (315) (461)
--- ---- ----
Total comprehensive loss 2,132 321 5,783
----- --- -----
Attributable to:
Equity holders of the Company 2,132 321 5,783
Non-controlling interests - - -
--- --- ---
TOTAL $2,132 $321 $5,783
====== ==== ======
Table 4: Consolidated Statements of Changes in Equity [mainly based on the average exchange rate of 3.46 NIS/USD for the three-month period ended March 31, 2018]:
Attributable to equity holders of the Company
---------------------------------------------
Share Share Reserve Transactions with non-controlling Accumulated deficit Foreign currency translation
interests reserve Total
capital premium from
Share-based
payment
transactions
------------
Unaudited
---------
USD in thousands
----------------
Balance at January 1, 2018 $3,812 $36,612 $5,311 $261 $(38,389) $782 $8,389
Loss - - - - (2,048) - (2,048)
Total other comprehensive loss - - - - - (84) (84)
--- --- --- --- --- --- ---
Total comprehensive loss - - - - (2,048) (84) (2,132)
Share-based payment - - 238 - - - 238
Expiration of share based options - 217 (217) - - - -
--- --- ---- --- --- --- ---
Balance at March 31, 2018 $3,812 $36,829 $5,332 $261 $(40,437) $698 $6,495
====== ======= ====== ==== ======== ==== ======
Attributable to equity holders of the Company
---------------------------------------------
Share capital Share premium Reserve Transactions with non-controlling Accumulated deficit Foreign currency translation
interests reserve Total
from
Share-based
payment
transactions
------------
Unaudited
---------
USD in thousands
----------------
Balance at January 1, 2017 $1,087 $26,600 $4,449 $261 $(32,145) $321 $573
Loss - - - - (636) - (636)
Total other comprehensive loss - - - - - 315 315
--- --- --- --- --- --- ---
Total comprehensive loss - - - - (636) 315 (321)
Issuance of shares (1) 189 769 - - - - 958
Issuance of shares (2) 2,207 7,928 - - - - 10,135
Share-based payment - - 64 - - - 64
--- --- --- --- --- --- ---
Balance at March 31, 2017 $3,483 $35,297 $4,513 $261 $(32,781) $636 $11,409
====== ======= ====== ==== ======== ==== =======
Attributable to equity holders of the Company
---------------------------------------------
Share capital Share premium Reserve Transactions with non-controlling Accumulated deficit Foreign currency translation
interests reserve Total
from
Share-based
payment
transactions
------------
Audited
-------
USD in thousands
----------------
Balance at December 31, 2016 $1,087 $26,600 $4,449 $261 $(32,145) $321 $573
Loss - - - - (6,244) - (6,244)
Total other comprehensive Income (loss) - - - - - 461 461
--- --- --- --- --- --- ---
Total comprehensive loss - - - - (6,244) 461 (5,783)
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
Share-based payments - - 862 - - - 862
--- --- --- --- --- --- ---
Balance at December 31, 2017 $3,812 $36,612 $5,311 $261 $(38,389) $782 $8,389
====== ======= ====== ==== ======== ==== ======
(1) Net issuance expenses of $61,000
(2) Net issuance expenses of $1,865,000
(3) Net issuance expenses of $156,000
Table 5: Consolidated Statements of Cash Flows [based on the average exchange rate of 3.46 NIS/USD for the three-month period ended March 31, 2018]:
USD in Thousands
----------------
Three months ended Year ended
March 31, December 31,
--------- ------------
Unaudited Unaudited Audited
--------- --------- -------
2018 2017 2017
---- ---- ----
Cash flows from operating activities:
-------------------------------------
Net loss $(2,048) $(636) $(6,244)
------- ----- -------
Adjustments to reconcile
net loss to net cash
used in
operating activities:
Depreciation and
amortization 3 1 5
Gain from sale of
equipment - - 1
Share-based payment
expense 238 64 862
Finance (income)
expenses, net (90) (7) 525
--- --- ---
151 58 1,393
--- --- -----
Working capital adjustments:
Increase in accounts
receivable (139) (8) (143)
Increase in trade
payables 214 305 349
Increase in other
accounts payable 192 87 66
--- --- ---
267 384 272
--- --- ---
Net cash used in
operating activities (1,630) - (194) (4,579)
------ ---- ------
Cash flows from investing activities:
-------------------------------------
Increase in restricted
cash - - (11)
Proceeds from sale of
equipment - - 2
Purchase of equipment (9) - (44)
--- --- ---
Net cash used in
investing activities (9) - (53)
--- --- ---
Cash flows from financing activities:
-------------------------------------
Prepaid public offering
costs (37) - (18)
Proceeds from issuance
of share capital (net
of issuance - 11,224 13,193
expenses)
Net cash provided by
financing activities (37) 11,224 13,175
--- ------ ------
Exchange rate
differences on cash and
cash equivalents 90 7 (527)
in foreign currency
Translation differences
on cash and cash
equivalents (100) 341 503
---- --- ---
Increase (decrease) in
cash (1,686) 11,378 8,519
Cash at the beginning of
the period 9,195 676 676
----- --- ---
Cash at the end of the
period $7,509 $12,054 $9,195
====== ======= ======
Table 6: R&D and G&A Detail [based on the average exchange rate of 3.46 NIS/USD for the three-month period ended March 31, 2018]:
USD in Thousands
----------------
Three months ended Year ended
March 31, December 31,
--------- ------------
Unaudited Unaudited Audited
--------- --------- -------
2018 2017 2017
---- ---- ----
Research and Development Expenses:
Clinical
studies $254 $93 $511
R&D and
preclinical
studies 155 39 362
Wages and
related
expenses 208 83 321
Share-based
payment 47 13 103
Regulatory
and other
expenses 280 12 276
Chemistry &
formulation
studies 51 - 330
--- --- ---
R&D expenses 995 240 1,943
General and Administative Expenses:
Investor
relations
and buisness
expenses $109 $48 $871
Professional
& directors
fees 454 92 1,007
Regulatory
expenses 15 24 80
Business
development 91 - 74
Wages and
related
expenses 227 158 808
Office
maintenance,
rent and
other
expenses 52 32 211
Share-based
payment 191 51 759
--- --- ---
G&A expenses 1,139 405 3,810
TOTAL $2,134 $645 $5,753
=====
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 Delta9-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 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 THC, while reducing the required dosage and decreasing associated deleterious adverse events.
About THX-130
THX-130 is a proprietary, innovative, ultra-low dose formulation of 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 palmitoylethanolamide (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:
Suzanne Lyons, Investor Relations Director
Suzanne@therapixbio.com
Media Contact:
Sydney Masters,
Sydney@MastersMallory.com
M: 917-584-8385
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