Clinical Programs

Therapix Biosciences Reports Second Quarter 2017 Financial Results and Provides Business Update
- Conference Call and Webcast Today at 8:30 a.m. EDT / 5:30 a.m. PDT -

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.

Therapix Biosciences

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

SOURCE Therapix Biosciences

For further information: +972-3-616-7055