Therapix Biosciences Reports Second Quarter 2017 Financial Results and Provides Business Update
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.
http://mma.prnewswire.com/media/507393/Therapix_Biosciences_Logo.jpg
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 Transactions with non-controlling
reserve 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
