UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
Under the Securities Exchange Act of 1934
For the month of: October 2020 (Report No. 2)
Commission file number: 001- 38041
THERAPIX BIOSCIENCES LTD.
(Translation of registrant’s name into English)
16 Abba Hillel Road
Ramat Gan 5250608, Israel
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulations S-T Rule 101(b)(1):_____
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulations S-T Rule 101(b)(7):_____
CONTENTS
This Report of Foreign Private Issuer on Form 6-K consists of (i) the Registrant’s Unaudited Consolidated Interim Financial Statements as of June 30, 2020, which is attached hereto as Exhibit 99.1; and (ii) the Registrant’s Management’s Discussion and Analysis of Financial Condition and Results of Operations for the six months ended June 30, 2020, which is attached hereto as Exhibit 99.2.
This Report on Form 6-K is incorporated by reference into the registration statements on Form F-3 (File No. 333-225745 and File No. 333-233417) and on Form S-8 (File No. 333-225773) of the Company, filed with the Securities and Exchange Commission, to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.
1
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Therapix Biosciences Ltd. | ||
Date: October 8, 2020 | By | /s/ Oz Adler |
Name: | Oz Adler | |
Title: | Chief Financial Officer |
2
Exhibit 99.1
THERAPIX BIOSCIENCES LTD.
INTERIM CONSOLIDATED FINANCIAL STATEMENTS
AS OF JUNE 30, 2020
UNAUDITED
INDEX
1
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
The accompanying notes are an integral part of the interim consolidated financial statements.
2
THERAPIX BIOSCIENCES LTD.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
June 30, | December 31, | |||||||||||||
2020 | 2019 | 2019 | ||||||||||||
Unaudited | Audited | |||||||||||||
Note | USD in thousands | |||||||||||||
LIABILITIES AND EQUITY | ||||||||||||||
CURRENT LIABILITIES: | ||||||||||||||
Credit from others | 6d | $ | 6 | $ | 64 | 67 | ||||||||
Trade payables | 1,108 | 885 | 864 | |||||||||||
Other accounts payable | 65 | 138 | 108 | |||||||||||
Short-term loan | 3b | 61 | - | - | ||||||||||
Convertible component | 3b | 397 | - | - | ||||||||||
Convertible debentures | - | 993 | - | |||||||||||
Conversion component of convertible debentures | - | 142 | - | |||||||||||
1,637 | 2,222 | 1,039 | ||||||||||||
NON- CURRENT LIABILITIES: | ||||||||||||||
Lease liability | 6d | - | 116 | 94 | ||||||||||
Warrants | 3b, 4b, 6c | 598 | 486 | 7 | ||||||||||
598 | 602 | 101 | ||||||||||||
EQUITY (DEFICIT) ATTRIBUTABLE TO EQUITY HOLDERS OF THE COMPANY: | 4 | |||||||||||||
Share capital | 15,629 | 4,529 | 6,323 | |||||||||||
Share premium (*) | 32,092 | 38,821 | 39,777 | |||||||||||
Reserve from share-based payment transactions | 4,872 | 4,691 | 4,862 | |||||||||||
Foreign currency translation reserve | 497 | 497 | 497 | |||||||||||
Transactions with non-controlling interests | 6c | 559 | 261 | 261 | ||||||||||
Accumulated deficit | (54,344 | ) | (49,541 | ) | (51,706 | ) | ||||||||
(695 | ) | (742 | ) | 14 | ||||||||||
Non-controlling interests | 6c | 53 | - | - | ||||||||||
Total equity (deficit) | (642 | ) | (742 | ) | 14 | |||||||||
$ | 1,593 | $ | 2,082 | $ | 1,154 |
(*) Warrants exercisable into shares as of December 31, 2019 were reclassified into Share premium.
The accompanying notes are an integral part of the interim consolidated financial statements.
3
CONSOLIDATED STATEMENTS OF PROFIT OR LOSS AND OTHER COMPREHENSIVE LOSS
Six
months ended
|
Year Ended
December 31, |
|||||||||||||
2020 | 2019 | 2019 | ||||||||||||
Unaudited | Audited | |||||||||||||
Note | USD in thousands | |||||||||||||
Research and development expenses | 5a | $ | 493 | $ | 499 | $ | 1,639 | |||||||
General and administrative expenses | 5b | 970 | 1,550 | 2,469 | ||||||||||
Operating loss | 1,463 | 2,049 | 4,108 | |||||||||||
Finance income | (29 | ) | (210 | ) | (305 | ) | ||||||||
Finance expenses | 1,204 | 475 | 676 | |||||||||||
Loss from continuing operations | 2,638 | 2,314 | 4,479 | |||||||||||
Loss from discontinued operations, net | - | 207 | 207 | |||||||||||
Loss | 2,638 | 2,521 | 4,686 | |||||||||||
Total comprehensive loss | 2,638 | 2,521 | 4,686 | |||||||||||
Attributable to: | ||||||||||||||
Equity holders of the Company (continuing operations) | 2,638 | 2,314 | 4,479 | |||||||||||
Equity holders of the Company (discontinued operations) | - | 315 | 315 | |||||||||||
Non-controlling interests | - | (108 | ) | (108 | ) | |||||||||
2,638 | 2,521 | 4,686 | ||||||||||||
Basic and diluted net loss per share attributable to equity holders of the Company: | ||||||||||||||
Loss from continuing operations | 0.01 | 0.02 | 0.03 | |||||||||||
Loss from discontinued operations | - | 0.002 | 0.002 | |||||||||||
0.01 | 0.022 | 0.032 | ||||||||||||
Basic and diluted net loss per ADS attributable to equity holders of the Company: | ||||||||||||||
Loss from continuing operations | 0.28 | 0.60 | 1.04 | |||||||||||
Loss from discontinued operations | - | 0.08 | 0.07 | |||||||||||
$ | 0.28 | $ | 0.68 | $ | 1.11 |
The accompanying notes are an integral part of the interim consolidated financial statements.
4
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY (DEFICIT)
For the six months ended June 30, 2020
Attributable to equity holders of the Company | ||||||||||||||||||||||||||||||||||||
Share
|
Share
|
Reserve
|
Transactions
with non- controlling interests |
Foreign
currency translation reserve |
Accumulated
deficit |
Total |
Non-
|
Total
|
||||||||||||||||||||||||||||
Unaudited | ||||||||||||||||||||||||||||||||||||
USD in thousands | ||||||||||||||||||||||||||||||||||||
Balance at January 1, 2020 | $ | 6,323 | $ | 39,777 | $ | 4,862 | $ | 261 | $ | 497 | $ | (51,706 | ) | $ | 14 | $ | - | $ | 14 | |||||||||||||||||
Loss | (2,638 | ) | (2,638 | ) | - | (2,638 | ) | |||||||||||||||||||||||||||||
Issue of share capital | 9,306 | (7,844 | ) | - | - | - | - | 1,462 | - | 1,462 | ||||||||||||||||||||||||||
Non-controlling interests | - | - | - | 298 | - | - | 298 | 53 | 351 | |||||||||||||||||||||||||||
Expiration of share options | - | 159 | (159 | ) | - | - | - | - | - | - | ||||||||||||||||||||||||||
Cost of share-based payment | - | - | 169 | - | - | - | 169 | - | 169 | |||||||||||||||||||||||||||
Balance at June 30, 2020 | $ | 15,629 | $ | 32,092 | $ | 4,872 | $ | 559 | $ | 497 | $ | (54,344 | ) | $ | (695 | ) | $ | 53 | $ | (642 | ) |
(*) | Warrants exercisable into shares as of December 31, 2019 were reclassified into Share premium. |
The accompanying notes are an integral part of the interim consolidated financial statements.
5
THERAPIX BIOSCIENCES LTD.
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
For the six months ended June 30, 2019
Attributable to equity holders of the Company | ||||||||||||||||||||||||||||||||||||
Share capital |
Share
premium |
Reserve
from share-
|
Transactions
with non- controlling interests |
Foreign
currency translation reserve |
Accumulated
deficit |
Total |
Non-
controlling
|
Total
Equity
|
||||||||||||||||||||||||||||
Unaudited | ||||||||||||||||||||||||||||||||||||
USD in thousands | ||||||||||||||||||||||||||||||||||||
Balance at January 1, 2019 | $ | 3,822 | $ | 38,108 | $ | 4,409 | $ | 261 | $ | 497 | $ | (46,912 | ) | $ | 185 | $ | (108 | ) | $ | 77 | ||||||||||||||||
Loss | - | - | - | - | - | (2,629 | ) | (2,629 | ) | 108 | (2,521 | ) | ||||||||||||||||||||||||
Issue of share capital (net of issue
expenses) (1) |
628 | 442 | - | - | - | - | 1,070 | - | 1,070 | |||||||||||||||||||||||||||
Conversion of convertible debentures | 79 | 171 | - | - | - | - | 250 | - | 250 | |||||||||||||||||||||||||||
Expiration of share options | - | 100 | (100 | ) | - | - | - | - | - | - | ||||||||||||||||||||||||||
Cost of share-based payment | - | - | 382 | - | - | - | 382 | - | 382 | |||||||||||||||||||||||||||
Balance at June 30, 2019 | $ | 4,529 | $ | 38,821 | $ | 4,691 | $ | 261 | $ | 497 | $ | (49,541 | ) | $ | (742 | ) | $ | - | $ | (742 | ) |
(1) | Net of issue expenses of $248 thousand. |
The accompanying notes are an integral part of the interim consolidated financial statements.
6
THERAPIX BIOSCIENCES LTD.
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
For the year ended December 31, 2019
Attributable to equity holders of the Company | ||||||||||||||||||||||||||||||||||||
Share
|
Share
|
Reserve
|
Transactions
with non- controlling interests |
Foreign
currency translation reserve |
Accumulated
deficit |
Total |
Non-
|
Total
|
||||||||||||||||||||||||||||
Audited | ||||||||||||||||||||||||||||||||||||
USD in thousands | ||||||||||||||||||||||||||||||||||||
Balance at January 1, 2019 | $ | 3,822 | $ | 38,108 | $ | 4,409 | $ | 261 | $ | 497 | $ | (46,912 | ) | $ | 185 | $ | (108 | ) | $ | 77 | ||||||||||||||||
Income (loss) | - | - | - | - | - | (4,794 | ) | (4,794 | ) | 108 | (4,686 | ) | ||||||||||||||||||||||||
Issue of share capital, net of issue expenses (2) | 1,777 | 322 | - | - | - | - | 2,099 | - | 2,099 | |||||||||||||||||||||||||||
Conversion of convertible
debentures |
724 | 783 | - | - | - | - | 1,507 | - | 1,507 | |||||||||||||||||||||||||||
Registration of the resale of warrants | - | 464 | - | - | - | - | 464 | - | 464 | |||||||||||||||||||||||||||
Expiration of share options | - | 100 | (100 | ) | - | - | - | - | - | - | ||||||||||||||||||||||||||
Cost of share-based payment | - | - | 553 | - | - | - | 553 | - | 553 | |||||||||||||||||||||||||||
Balance at December 31, 2019 | $ | 6,323 | $ | 39,777 | $ | 4,862 | $ | 261 | $ | 497 | $ | (51,706 | ) | $ | 14 | $ | - | $ | 14 |
(*) | Warrants exercisable into shares as of December 31, 2019 were reclassified into Share premium. |
(2) | Net of issue expenses of $469 thousand. |
The accompanying notes are an integral part of the interim consolidated financial statements.
7
CONSOLIDATED STATEMENTS OF CASH FLOWS
Six
months ended
|
Year Ended
December 31, |
|||||||||||
2020 | 2019 | 2019 | ||||||||||
Unaudited | Audited | |||||||||||
USD in thousands | ||||||||||||
Cash flows from operating activities: | ||||||||||||
Loss | $ | (2,638 | ) | $ | (2,521 | ) | $ | (4,686 | ) | |||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||
Adjustments to the profit or loss items: | ||||||||||||
Depreciation and amortization | 33 | 144 | 179 | |||||||||
Impairment loss of equipment | - | 1,223 | 1,223 | |||||||||
Cost of share-based payment | 169 | 382 | 553 | |||||||||
Finance expenses, net | 710 | 46 | 156 | |||||||||
912 | 1,795 | 2,111 | ||||||||||
Working capital adjustments: | ||||||||||||
Decrease (increase) in other accounts receivable | (557 | ) | 158 | 329 | ||||||||
Increase (decrease) in trade payables | 193 | (743 | ) | (840 | ) | |||||||
Decrease in other accounts payable | (43 | ) | (706 | ) | (736 | ) | ||||||
Decrease in related parties | - | (874 | ) | (874 | ) | |||||||
(407 | ) | (2,165 | ) | (2,121 | ) | |||||||
Net cash used in operating activities | $ | (2,133 | ) | $ | (2,891 | ) | $ | (4,696 | ) |
The accompanying notes are an integral part of the interim consolidated financial statements.
8
THERAPIX BIOSCIENCES LTD.
CONSOLIDATED STATEMENTS OF CASH FLOWS
Six
months ended
|
Year Ended
December 31, |
|||||||||||
2020 | 2019 | 2019 | ||||||||||
Unaudited | Audited | |||||||||||
USD in thousands | ||||||||||||
Cash flows from investing activities: | ||||||||||||
Investment in restricted bank deposits | - | $ | (1 | ) | $ | (1 | ) | |||||
Purchase of property and equipment | - | - | (1 | ) | ||||||||
Proceeds from sale of property and equipment | - | 724 | 724 | |||||||||
Repayment of convertible loans | - | 546 | 546 | |||||||||
Net cash provided by investing activities | - | 1,269 | 1,268 | |||||||||
Cash flows from financing activities: | ||||||||||||
Issue of share capital (net of issue expenses) | 43 | 1,110 | 2,216 | |||||||||
Issue of warrants and convertible component | 1,398 | 682 | 682 | |||||||||
Payment of issue expenses related to previous period | - | (30 | ) | (30 | ) | |||||||
Interest paid on lease liability | (8 | ) | (10 | ) | (17 | ) | ||||||
Repayment of lease liability | (26 | ) | (22 | ) | (47 | ) | ||||||
Net cash provided by financing activities | 1,407 | 1,730 | 2,804 | |||||||||
Exchange rate differences on cash and cash equivalents and restricted deposits in foreign currency | - | - | 9 | |||||||||
- | - | 9 | ||||||||||
Increase (decrease) in cash and cash equivalents | (726 | ) | 108 | (615 | ) | |||||||
Cash and cash equivalents at the beginning of the period | 870 | 1,485 | 1,485 | |||||||||
Cash and cash equivalents at the end of the period | 144 | $ | 1,593 | $ | 870 |
The accompanying notes are an integral part of the interim consolidated financial statements.
9
THERAPIX BIOSCIENCES LTD.
CONSOLIDATED STATEMENTS OF CASH FLOWS
Six months ended June 30, |
Year Ended December 31, | ||||||||||||
2020 | 2019 | 2019 | |||||||||||
Unaudited | Audited | ||||||||||||
USD in thousands | |||||||||||||
(a) | Significant non-cash transactions: | ||||||||||||
Conversion of debentures into share capital | $ | - | $ | 250 | $ | 1,507 | |||||||
Registration of warrants | $ | - | $ | - | $ | 464 | |||||||
Unpaid issue expenses | $ | - | $ | 40 | $ | 116 | |||||||
Investment in associate | $ | 742 | $ | - | $ | - | |||||||
Exercise of warrants | $ | 1,419 | $ | - | $ | - | |||||||
Modification of leasing agreement | $ | 101 | $ | - | $ | - |
The accompanying notes are an integral part of the interim consolidated financial statements.
10
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1:- GENERAL
a. | Therapix Biosciences Ltd. (“Therapix” or the “Company”), a pharmaceutical company, was incorporated in Israel and commenced its operations on August 23, 2004. Until March 2014, Therapix and its subsidiaries at the time (the “Group”) were mainly engaged in developing several innovative immunotherapy products and Therapix’s own patents in the immunotherapy field. In August 2015, the Company decided to adopt a different business strategy according to which it would focus on developing a portfolio of approved drugs based on cannabinoid molecules. With this focus, the Company is currently engaged in the following development programs based on Δ9-tetrahydrocannabinol and/or non-psychoactive cannabidiol for the treatment of Tourette syndrome and for the treatment of obstructive sleep apnea (“OSA”), pain and autism spectrum disorder. |
The Company was a dual-listed company, which had its ordinary shares, New Israeli Shekel (“NIS”) 0.1 par value each (“Ordinary Shares”), traded on the Tel-Aviv Stock Exchange Ltd. (“TASE”) from December 26, 2005 until it delisted such shares from the TASE on August 7, 2018, and has had its American Depository Shares (“ADSs”) listed on the Nasdaq Capital Market (“Nasdaq”) since March 27, 2017 (see Note 7a, “Subsequent Events After the Reporting Period” for additional information). The Company completed an initial public offering (“IPO”) of its ADSs in the United States on March 27, 2017 and raised approximately $13.7 million. Since the IPO, the Company has had its ADSs registered with the U.S. Securities and Exchange Commission (“SEC”).
As of June 30, 2020, Therapix has two wholly owned subsidiaries, both of which are companies incorporated under the laws of Israel (the “Subsidiaries”): (1) Brain Bright Ltd. (“Brain Bright”); and (2) Evero Health Ltd. (“Evero”).
Both of the Subsidiaries are private companies, and as of the date of these financial statements, Brain Bright is an inactive company with no assets or liabilities. Therapix also owns approximately 27% of Lara Pharm Ltd.’s (“Lara”) share capital. Lara is a private company incorporated under the laws of Israel which, to the best knowledge of the Company, does not engage in any business, and in any event, Therapix does not have significant influence on Lara since it has no representation in Lara’s board of directors. The Company wrote-off the entire investment in Lara in 2015.
On October 3, 2018 (the “Acquisition Date”), Therapix obtained control over Therapix Healthcare Resources Inc. (“THR”), a Delaware corporation, which was established on July 31, 2018, by holding 82.36% of THR’s equity. On June 27, 2019, following the finalization of THR’s dissolution, Therapix deconsolidated THR.
b. | These interim consolidated financial statements should be read in conjunction with the Company's annual financial statements for the year ended December 31, 2019, and accompanying notes, that were published on June 15, 2020 (the "2019 Annual Consolidated Financial Statements"). |
11
THERAPIX BIOSCIENCES LTD.
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1:- GENERAL (cont.)
c. | All information in the interim financial statements regarding the ADSs assumes that all of the Company's Ordinary Shares have been converted into ADSs. Each ADS represents 40 ordinary shares (see Note 4a). See Note 7a, “Subsequent Events After the Reporting Period” for additional information. |
d. | The Company incurred a net loss of approximately $2.6 million and had negative cash flows from operating activities of approximately $2.1 million for the six-month period ended on June 30, 2020. As of June 30, 2020, the Company had an accumulated deficit of approximately $51.7 million as a result of recurring operating losses. As the Company presently has no activities that generate revenues, the Company's continued operation is dependent on its ability to raise funding from external sources. This dependency will continue until the Company will be able to finance its operations by selling its products or commercializing its technology. Also, all of the Company’s current research and development operations are in abeyance and require additional funds before they can progress. In addition, the Company's management believes that the balance of cash held by the Company as of October 8, 2020 (the “Approval Date”), in which the interim consolidated financial statements for the period ended June 30, 2020, were approved, will not be sufficient to finance its operating activities in the foreseeable future. These factors raise substantial doubt about the Company's ability to continue as a "going concern". |
e. | The interim consolidated financial statements of the Company for the six-month period ended on June 30, 2020, were approved for issue on October 8, 2020. In connection with the preparation of the interim consolidated financial statements and in accordance with authoritative guidance for subsequent events, the Company evaluated subsequent events after the consolidated statements of financial position date of June 30, 2020, through October 8, 2020, the date on which the unaudited interim consolidated financial statements were available to be issued. |
NOTE 2:- SIGNIFICANT ACCOUNTING POLICIES
Basis of preparation of the interim consolidated financial statements:
The Interim Consolidated Financial Statements have been prepared in accordance with International Accounting Standard (“IAS”) 34, "Interim Financial Reporting". The significant accounting policies adopted in the preparation of the interim consolidated financial statements are consistent with those followed in the preparation of the 2019 Annual Consolidated Financial Statements.
12
THERAPIX BIOSCIENCES LTD.
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
NOTE 3:- CONVERTIBLE LOANS
a. | On January 15, 2020, the Company entered into a bridge loan agreement (the "Bridge Loan") with a third party, in which the third party lent to the Company $50 thousand (the "Bridge Loan Amount"). On April 17, 2020, the Bridge Loan Amount was fully repaid by the Company, including interest in the amount of $2 thousand. Accordingly, the Bridge Loan was terminated with no further effect. |
b. | On March 19, 2020, the Company entered into a securities purchase agreement pursuant to which it will make a private placement (the “Private Placement”) with Dekel Pharmaceutical Ltd. (which was considered as a related party to the Company at the time of the Private Placement. As of the Approval Date, it is no longer a related party to the Company), of convertible promissory notes (the “Notes”), with an aggregate original principal amount of approximately $350 thousand, at an aggregate purchase price of $315 thousand in several tranches, spread across a twelve-month period. In addition, the Company issued a warrant to purchase up to 314,285 ADSs of the Company (the “Private Placement Warrant”) and 40,000 ADSs. The initial tranche of the Private Placement was for a principal amount of $220 thousand at a purchase price of $198 thousand. The Notes are unsecured, have a maturity date of March 23, 2021, bear interest at a rate of 12% per annum, and may be converted, at the election of the holder, into ADSs at an initial conversion price of $0.35 per ADS (the “Fixed Conversion Price”), subject to adjustments. After the six-month anniversary of the issuance of the Notes, the conversion price shall be equal to the lower of the Fixed Conversion Price or 70% of the lowest trading price of the ADSs as reported on Nasdaq or any exchange upon which the ADSs or Ordinary Shares of the Company are traded at such time, for the 20 prior trading days including the day upon which a notice of conversion is received by the Company or its transfer agent. The Private Placement Warrant is exercisable at any time on or after the actual closing date and on or prior to the close of business on the five-year anniversary of the date of issuance, at an initial exercise price of $0.35 per ADS, subject to adjustment. |
Valuation process and techniques:
The Company’s management considers the appropriateness of the valuation methods and inputs and may request that alternative valuation methods are applied to support the valuation arising from the method chosen.
The valuation of the Notes, warrants and ADSs was set in accordance with International Financial Reporting Standard (“IFRS”) 9 and IAS 32, “Financial Instruments: Presentation” (“IAS 32”). IFRS 9 and IAS 32 determine the accepted method in allocating the consideration received from a bundle of securities. According to the guidelines of IFRS 9 and IAS 32, the allocation is based on the method of the remainder of consideration, when there is a hierarchy regarding the financial instruments measured at fair value and the financial instruments recognized as the remainder of consideration.
According to IFRS 9 and IAS 32, the allocation is based on the following hierarchy:
- | Derivative and other financial instrument measured at fair value through its contractual life. |
- | Financial liabilities and other complex instruments which are not recognized at fair value. |
- | Equity instruments. |
13
THERAPIX BIOSCIENCES LTD.
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
NOTE 3:- CONVERTIBLE LOANS (cont.)
IFRS 9 and IAS 32 also determine that a derivative which may be settled other than by the exchange of a fixed amount of cash or another financial asset for a fixed number of the entity’s own equity instruments, will be defined as a financial liability, measured and presented at fair value each period. Accordingly, and as mentioned in the securities purchase agreement, in the event of conversion, the number of shares to be issued is unknown (not fixed). Therefore, according to the definition mentioned above, the conversion component and warrants are classified as a financial liabilities that will be measured at fair value, through profit or loss, as of the issuance date and on any following financial reporting date (accordingly, issue expenses related to the derivative will be recorded through profit or loss). No consideration will be left to attribute to the debt and equity instruments (except for the par value of the issuance of 40,000 ADSs mentioned above).
The valuation of the conversion component and warrants of Convertible Debentures were set at fair value, as required in IFRS 9, and in accordance with IFRS 13, “Fair value measurement” (“IFRS 13”), and was categorized as Level 3 by the Company.
General Overview of Valuation Approaches used in the Valuation:
Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.
Economic methodology:
The warrants’ fair value was calculated using the Black–Scholes–Merton model, which takes into account the parameters as disclosed below for each period valuated, in which a valuation was performed at (i) the issuance date, and (ii) each reporting date with the following assumptions:
June 30,
2020 |
March 23,
2020 |
|||||||
Dividend yield (%) | 0 | 0 | ||||||
Expected volatility (%) | 129.32 | 122.01 | ||||||
Risk-free interest rate (%) | 0.29 | 0.38 | ||||||
Underlying Share Price ($) | 0.62 | 0.43 | ||||||
Exercise price ($) | 0.35 | 0.35 | ||||||
Warrants fair value ($) | 0.55 | 0.36 |
The conversion component fair value was calculated using the Monte Carlo Simulation Model, an option pricing model which takes into account the parameters as disclosed below for each period valuated, in which a valuation was performed at (i) the issuance date, and (ii) each reporting date with the following assumptions:
June 30,
2020 |
March 23,
2020 |
|||||||
Expected volatility (%) | 150.33 | 116.51 | ||||||
Risk-free interest rate (%) | 0.16 | 0.17 | ||||||
Underlying Share Price ($) | 0.62 | 0.43 | ||||||
Conversion Price ($) | 0.35 | 0.35 |
14
THERAPIX BIOSCIENCES LTD.
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
NOTE 4: EQUITY
a. | Composition of share capital as of June 30, 2020, June 30, 2019 and December 31, 2019: |
June 30, 2020 | December 31, 2019 | June 30, 2019 | ||||||||||||||||||||||
Authorized |
Issued
and
|
Authorized |
Issued and
outstanding |
Authorized |
Issued and
outstanding |
|||||||||||||||||||
Number of shares | ||||||||||||||||||||||||
Ordinary Shares of NIS 0.1 par value each | 1,000,000,000 | 563,521,454 | 300,000,000 | 228,788,014 | 300,000,000 | 165,966,494 |
Description of ADSs:
The Bank of New York Mellon, as depositary, will register and deliver ADSs. Each ADS represents 40 Ordinary Shares, (or the right to receive 40 Ordinary Shares) deposited with the principal Tel Aviv office of Bank Hapoalim, as custodian for the depositary. Each ADS also represents any other securities, cash or other property which may be held by the depositary.
b. | On April 1, 2020 the Company entered into a definitive securities purchase agreement (the “April 2020 Purchase Agreement”) with institutional investors to purchase of 4,166,668 units, each consisting of (i) one pre-funded warrant to purchase one ADS and (ii) one Series B warrant to purchase one ADS, at a purchase price of $0.2999 per unit. The Series B warrants have an exercise price of $0.43 per ADS, are exercisable upon issuance and expire five years from the date of issuance. The offering resulted in gross proceeds to the Company of approximately $1.25 million. The closing of the sale of the securities took place on April 3, 2020. After the closing of the April 2020 Purchase Agreement and until the Approval Date, all pre-funded warrants were exercised. In addition, 4,161,668 of the Series B warrants were exercised pursuant to a cashless exercise mechanism as described in the April 2020 Purchase Agreement for no further consideration to the Company. As of the Approval Date, there were 5,000 Series B warrants unexercised. |
The Series B warrants are classified as a financial liability that will be measured at fair value, through profit or loss, as of the issuance date and on any following financial reporting date (accordingly, issue expenses related to the Series B warrants will be recorded through profit or loss). No consideration will be left to attribute to the pre-funded warrants, which is an equity instrument.
The valuation of the conversion component of the Series B warrants was set at fair value, as required in IFRS 9, and in accordance with IFRS 13, and was categorized as Level 3 by the Company.
15
THERAPIX BIOSCIENCES LTD.
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
NOTE 4: EQUITY (cont.)
Hereinafter is the reconciliation of the fair value measurements that are categorized within Level 3 of the fair value hierarchy in financial instruments:
Balance at January 1, 2020 | $ | - | ||
Issuance at April 3, 2020 | $ | 1,250 | ||
Net change in fair value of the Series B warrants designated at fair value
through profit or loss |
172 | |||
Conversion part of Series B warrants | (1,419 | ) | ||
Balance at June 30, 2020 | $ | 3 |
c. | On January 15, 2020, the general meeting the Company’s shareholder approved an increase of the Company’s authorized share capital to 1,000,000,000 Ordinary Shares. |
NOTE 5:- ADDITIONAL INFORMATION TO THE ITEMS OF PROFIT OR LOSS
Six
months ended
|
Year Ended
December 31, |
||||||||||||
2020 | 2019 | 2019 | |||||||||||
Unaudited | Audited | ||||||||||||
USD in thousands | |||||||||||||
a. | Research and development expenses: | ||||||||||||
Wages and related expenses | $ | 181 | $ | 133 | $ | 435 | |||||||
Share-based payment | 100 | 19 | 165 | ||||||||||
Clinical studies | 1 | 56 | 240 | ||||||||||
Regulatory, professional and other expenses | 178 | 45 | 437 | ||||||||||
Research and preclinical studies | 33 | 190 | 277 | ||||||||||
Chemistry and formulations | - | 56 | 85 | ||||||||||
493 | 499 | 1,639 | |||||||||||
b. | General and administrative expenses: | ||||||||||||
Wages and related expenses | 106 | 224 | 382 | ||||||||||
Share-based payment | 69 | 363 | 388 | ||||||||||
Professional and directors' fees | 679 | 598 | 1,065 | ||||||||||
Business development expenses | 5 | 215 | 387 | ||||||||||
Office maintenance, rent and other expenses | 53 | 38 | 72 | ||||||||||
Investor relations and business expenses | 7 | 45 | 63 | ||||||||||
Regulatory expenses | 51 | 67 | 112 | ||||||||||
$ | 970 | $ | 1,550 | 2,469 |
16
THERAPIX BIOSCIENCES LTD.
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
NOTE 6:- SIGNIFICANT EVENTS DURING THE REPORTING PERIOD
a. | In December 2019, a novel strain of coronavirus (“COVID-19”), was identified in Wuhan, China. This virus continued to spread globally and, as of June 2020, has spread to over 200 countries, including Israel. The spread of COVID-19 from China to other countries has resulted in the World Health Organization declaring the outbreak of COVID-19 as a “pandemic,” or a worldwide spread of a new disease, on March 11, 2020. Many countries around the world have imposed quarantines and restrictions on travel and mass gatherings to slow the spread of COVID-19. As of the Approval Date, restrictions are imposed on businesses and the public in Israel and around the world. In Israel, these restrictions were loosened for several months; however, in late September 2020 restrictions on business activity in Israeli were implemented and it is unclear as to when any of the restrictions will be loosened again. |
Due to the impact of the COVID-19 pandemic on the business, consultants and service providers of the Company, the Company was unable to file its annual report on Form 20-F for the year ended December 31, 2019 (the “Annual Report”) by the normally prescribed deadline of April 30, 2020, due to insufficient time to facilitate the internal and external review process. The Company filed its Annual Report on June 15, 2020, 45 days after the original due date of its Annual Report, in reliance upon the exemption set forth in the SEC’s March 25, 2020 Order (Release No. 34-88318), which under certain conditions exempts reporting companies form making certain filings required under the Securities and Exchange Act of 1934, as amended, for up to 45 after the normally prescribed deadline.
The Company’s operations and business have experienced disruption due to the unprecedented conditions surrounding the COVID-19 pandemic spreading throughout Israel and the world. The Company has been following the recommendations of local health authorities to minimize exposure risk for its team members for the past several months, including the temporary closures of its offices and having team members work remotely.
The Company is still assessing its business operations and system supports and the impact that the COVID-19 pandemic may have on the results and financial condition. To date, the Company has taken action to reduce its operating expenses in the short term, but there can be no assurance that these remedial measures will enable the Company to avoid part or all of any impact from the spread of the COVID-19 or its consequences, including downturns in business sentiment generally or in its sector in particular. In addition, the impact of COVID-19 may cause delays to future clinical trials and may make it difficult for to recruit patients to clinical trials.
The Company will continue to monitor the situation, in which as described above, the Company expects the COVID-19 pandemic to continue having an impact on the Company’s operations and the entire world during the following months.
b. | As part of the changes in the Board’s composition, Dr. Yafit Stark and Mr. Zohar Heiblum resigned from the Board on December 31, 2019, and Mr. Amit Berger resigned from the Board during March 2020. All three former directors resigned for personal reasons and not due to any dispute with management. In March 2020, two new independent members were elected to fill vacancies on the Board - Mr. Todd Viollete and Mr. Gilad Bar Lev. In May 2020, Prof. Ari Shamiss and Mr. Arie Webber also were elected to fill vacancies as independent Board members. |
17
THERAPIX BIOSCIENCES LTD.
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
NOTE 6:- SIGNIFICANT EVENTS DURING THE REPORTING PERIOD (cont.)
c. | On May 15, 2020, the Company entered into a series of transactions (together, the “Joint Venture Transaction”), including a definitive share transfer agreement with Capital Point Ltd. (“Capital Point”), an Israeli holding company traded on the TASE, and Evero, pursuant to which Capital Point sold to Evero 5,952,469 ordinary shares, NIS 0.01 par value each, of Coeruleus Ltd. (the “Purchased Coeruleus Shares” and “Coeruleus,” respectively), an Israeli company, and an affiliated company (in which Capital Point owns approximately 40% the issues and outstanding share capital) of Capital Point, engaged in, among others, developing innovative medications based on the active generic substance flumazenil, including a sublingual spray to reduce the side effects of hypnotic sleep medication, and a sublingual spray to improve function and quality of life in patients with hepatic encephalopathy. The Purchased Coeruleus Shares represented approximately 35% of the issued and outstanding share capital of Coeruleus. In consideration thereof, Evero issued and sold to Capital Point 176,470 ordinary shares, NIS 1.00 par value each, constituting 15% of the issued and outstanding share capital of Evero, which were valued at $351 thousand, based on apportionment of the fair market value of the Company as reflected in the Nasdaq. Following the transaction Capital Point held approximately 5% of Coeruleus’ issued and outstanding share capital. The transaction costs of $51 thousand were also capitalized as part of the investment in associate. |
As part of the Joint Venture Transaction, the Company transferred to Evero its THX-110 sleep technology, to be fully owned by Evero, under the terms and conditions of an asset purchase agreement. In addition, the Company issued to Capital Point a warrant (the “Capital Point Warrant”) to purchase $340 thousand of ADSs of the Company. Pursuant to the terms of the Capital Point Warrant, the exercise price per ADS is equal to the closing price of the Company’s ADSs on the trading day on which the notice of exercise was actually received by the Company, and shall be paid by transferring to the Company a duly executed share transfer deed for 9,577 ordinary shares of Evero. The Capital Point Warrant are exercisable for twelve-months starting from the twelve-month anniversary of the issuance date, which was May 15, 2020.
d. | In view of the global coronavirus crisis, the Company modified its lease agreement and decided to vacate its offices at the end of the original lease period and not to extend to the options periods (see Note 7d). In the event of any change in the expected exercise of the lease extension option, the Company remeasures the lease liability based on the revised lease term using a revised discount rate as of the date of the change in expectations. The total change is recognized in the carrying amount of the right-of-use asset until it is reduced to zero, and any further reductions are recognized in profit or loss. |
NOTE 7:- SUBSEQUENT EVENTS AFTER THE REPORTING PERIOD
a. | In accordance with a written notice from the Nasdaq Hearings Panel on June 30, 2020 detailing its decision to delist the Company’s ADSs from the Nasdaq, suspension of trading in the ADSs on Nasdaq became effective at the opening of business on July 2, 2020. As of July 8, 2020, the Company’s ADSs became eligible to trade on the OTC Pink Marketplace under the symbol “TRPXY”. |
18
THERAPIX BIOSCIENCES LTD.
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
NOTE 7:- SUBSEQUENT EVENTS AFTER THE REPORTING PERIOD (cont.)
b. | On June 29, 2020, the Company entered into definitive agreements with several accredited and institutional investors providing for the issuance of an aggregate of 5.2 million ADSs at a purchase price of $0.50 per ADS, and warrants to purchase up to 2.6 million ADSs in a private placement (the “June 2020 Private Placement”). On the same day, the Court granted a temporary injunction until the Court hearing that was scheduled to occur on July 8, 2020. Following the Court hearing, the Court ruled that the parties reached a mutual agreement according to which Pure Capital withdrew the application for the temporary injunction, subject to the Company’s commitment that the Meeting be held on July 28, 2020 as planned. |
On June 30, 2020, L.I.A. Pure Capital Ltd. (“Pure Capital”), a shareholder of the Company that requested to summon a special general meeting of the shareholders of the Company, which was subsequently scheduled for July 28, 2020 by the Company (the “Meeting”) in order to replace the Company’s then-current Board with nominees designated by Pure Capital, submitted to the Tel Aviv-Jaffa District Court (the “Court”) a petition for an injunction of the contemplated June 2020 Private Placement.
The Company confirmed that its previously announced June 2020 Private Placement was terminated and was no longer in effect, and the ADSs that were to be issued under the June 2020 Private Placement would therefore not be entitled to vote in the Meeting since they were not issued.
c. | On July 23, 2020, the Company submitted to the Court a petition pursuant to the Israeli Insolvency and Economic Rehabilitation Law, 2018, to commence proceedings for the economic rehabilitation of the Company (the “Petition”). In the Petition submitted to the Court, the Company stated that it is insolvent (as determined by the cash flow test) and unable to pay its debts to the Company’s creditors. On August 11, 2020, Pure Capital proposed to deposit $1.5 million with the Company’s temporary trustee nominated by the Court to cover and pay all of the Company’s debts, without derogating from any other creditor’s rights towards the Company (the “Pure Capital Proposal”). The Pure Capital Proposal was made subject to the replacement of the Company’s Board with Pure Capital’s designated nominees that were voted upon at the adjourned annual general meeting held on August 4, 2020 (as discussed below). The Court issued an order on August 14, 2020 (the “Order”), approving the Pure Capital Proposal and settlement agreement submitted to the Court by the parties thereto. |
In accordance with the terms of the Order and following the deposit by Pure Capital, the Company’s current members of the Board were replaced by: Itschak Shrem (chairman), Amitai Weiss (also appointed to act as the Company’s Chief Executive Officer), Moshe Revach, Lior Amit, Lior Vider and Liat Sidi. Following the issuance of the Order, a related case that was filed by Pure Capital with the Court was withdrawn as well.
d. | On July 30, 2020, the Company did not exercise the option period under its lease agreement and vacated its offices. The Company’s deposit in the amount of $24 thousand, initially made in connection with its offices lease agreement, was returned to the Company, which amount deducted the lessor’s expenses. |
19
THERAPIX BIOSCIENCES LTD.
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
NOTE 7:- SUBSEQUENT EVENTS AFTER THE REPORTING PERIOD (cont.)
e. | On August 4, 2020, following an adjournment thereof on July 28, 2020, the Company convened an annual and special general meeting of its shareholders, whereby, inter alia, the shareholders approved an increase to the Company’s share capital from 1,000,000,000 Ordinary Shares to 10,000,000,000 Ordinary Shares. In addition, shareholders of the Company voted against the proposal proposed by Pure Capital to remove the then current members of the Board and to approve the nominations of nominees proposed by Pure Capital. |
f. | On August 6, 2020, Pure Capital filed with the Court, requesting an order to have the results of the Company’s annual general meeting held on August 4, 2020 declared invalid, mainly due to the Company’s reliance on discretionary voting of the depositary bank for the Company’s ADSs. The Court asked for the Company and directors’ response by no later than August 13, 2020, which was subsequently extended. |
On August 11, 2020, Pure Capital proposed to deposit $1.5 million with the Company’s temporary trustee nominated by the Court to cover and pay all of the Company’s debts, without derogating from any other creditor’s rights towards the Company (the “Pure Capital Proposal”). The Pure Capital Proposal was made subject to the replacement of the Company’s Board with Pure Capital’s designated nominees that were voted upon at the adjourned annual general meeting held on August 4, 2020 (as discussed below).
The Court issued an order on August 14, 2020 (the “Order”), approving the Pure Capital Proposal and settlement agreement submitted to the Court by the parties thereto. In accordance with the terms of the Order and following the deposit by Pure Capital, the Company’s current members of the Board were replaced by: Itschak Shrem (chairman), Amitai Weiss (also appointed to act as the Company’s Chief Executive Officer), Moshe Revach, Lior Amit, Lior Vider and Liat Sidi. Following the issuance of the Order, a related case that was filed by Pure Capital with the Court was withdrawn as well.
20
THERAPIX BIOSCIENCES LTD.
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
NOTE 7:- SUBSEQUENT EVENTS AFTER THE REPORTING PERIOD (cont.)
g. | On September 8, 2020, we entered into a certain credit agreement, or the Credit Facility, with M.R.M. Merchavit Holdings and Management Ltd., or the Lender, whereby the Lender agreed to extend a line of credit to us in the aggregate amount of $200 thousand, or the Credit Amount. According to the terms of the Credit Facility, $100 thousand of the Credit Amount, or the Loan Amount, was immediately drawn on the date of the Credit Facility, and the remaining $100 thousand may be drawn on an as-needed basis. The Loan Amount is due upon the earlier of one year from September 8, 2020 or at such time that we raise $1.5 million. The Lender is entitled to a transaction and interest fee of $5 thousand (plus VAT) that was offset from the Credit Facility for the immediately drawn $100 thousand and 5% from any additional withdrawal amount from the Credit Facility. |
h. | On September 17, 2020, following an adjournment thereof on September 10, 2020, the Company convened a special general meeting of its shareholders, whereby the shareholders approved, inter alia, (i) an increase to the Company’s share capital from 10,000,000,000 Ordinary Shares to 15,000,000,000 Ordinary Shares; and (ii) a reverse split of the Company’s share capital up to a ratio of 20:1 (the “Reverse Split”). |
On October 1, 2020, the Company’s Board of Directors resolved that the final of the Reverse Split will be 20:1, expected to be effective after the close of business on October 16, 2020. Concurrently with the Reverse Split, the Company expects to change the ratio of its ADSs to its Ordinary Shares from each ADS representing 40 Ordinary Shares to each ADS representing 140 Ordinary Shares. This will result in a reverse split on the Company’s American Depositary Receipt program.
21
Exhibit 99.2
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of our financial condition and results of operations provides information that we believe to be relevant to an assessment and understanding of our results of operations and financial condition for the periods described. This discussion should be read in conjunction with our interim consolidated financial statements and the notes to such financial statements, which are included in this Report on Form 6-K. In addition, this information should also be read in conjunction with the information contained in our Annual Report on Form 20-F for the year ended December 31, 2019, or the Annual Report, including the consolidated annual financial statements as of December 31, 2019 and their accompanying notes included therein, filed with the Securities and Exchange Commission, or the SEC, on June 15, 2020.
Unless otherwise indicated, all references to the terms “we”, “us”, “our”, “Therapix”, “the Company” and “our Company” refer to Therapix Biosciences Ltd. and its wholly-owned subsidiaries. References to “Ordinary Shares,” “ADSs” and “warrants” refer to the ordinary shares, American Depositary Shares and warrants, respectively, of Therapix.
We report financial information under International Financial Reporting Standards, as issued by the International Accounting Standards Board and none of the financial statements were prepared in accordance with generally accepted accounting principles in the United States.
References to “U.S. dollars,” “USD” and “$” are to currency of the United States of America, and references to “NIS” are to New Israeli Shekels. Unless otherwise indicated, U.S. dollar translations of NIS amounts presented herein are translated using the rate of NIS 3.466 to $1.00, the exchange rate reported by the Bank of Israel on June 30, 2020.
Forward-Looking Statements
The following discussion contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Forward-looking statements are often characterized by the use of forward-looking terminology such as “may,” “will,” “expect,” “anticipate,” “estimate,” “continue,” “believe,” “should,” “intend,” “project” or other similar words, but are not the only way these statements are identified. These forward-looking statements may include, but are not limited to, statements relating to our objectives, plans and strategies, statements that contain projections of results of operations or of financial condition, expected capital needs and expenses, statements relating to the research, development, completion and use of our products, and all statements (other than statements of historical facts) that address activities, events or developments that we intend, expect, project, believe or anticipate will or may occur in the future. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties. We have based these forward-looking statements on assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, among other things:
● | our ability to obtain a listing and effectively comply with the listing requirements of Nasdaq; | |
● | our ability to raise capital through the issuance of additional securities; |
● | our ability to advance the development our product candidates, including the anticipated starting and ending dates of our anticipated clinical trials; | |
● | our assessment of the potential of our product candidates to treat certain indications; | |
● | our ability to successfully receive approvals from the FDA, or other regulatory bodies, including approval to conduct clinical trials, the scope of those trials and the prospects for regulatory approval of, or other regulatory action with respect to our product candidates, including the regulatory pathway to be designated to our product candidates; | |
● | the regulatory environment and changes in the health policies and regimes in the countries in which we operate, including the impact of any changes in regulation and legislation that could affect the pharmaceutical industry; | |
● | our ability to commercialize our existing product candidates and future sales of our existing product candidates or any other future potential product candidates; | |
● | our ability to meet our expectations regarding the commercial supply of our product candidates; | |
● | the overall global economic environment; | |
● | the impact of COVID-19 and resulting government actions on us; | |
● | the impact of competition and new technologies; | |
● | general market, political and economic conditions in the countries in which we operate; | |
● | projected capital expenditures and liquidity; | |
● | the impact of competition and new technologies; | |
● | changes in our strategy; and | |
● | litigation. |
More detailed information about the risks and uncertainties affecting us is contained under the heading “Risk Factors” in our Annual Report filed with the SEC on June 15, 2020, which is available on the SEC’s website, www.sec.gov, and in our periodic filings with the SEC.
You should not put undue reliance on any forward-looking statements. Any forward-looking statements in this discussion are made as of the date hereof, and we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Overview
We are a specialty clinical-stage pharmaceutical company. Our focus is creating and enhancing a portfolio of technologies and assets based on cannabinoid therapies. With this focus, we are currently engaged in the following development programs based on Δ9-tetrahydrocannabinol, or THC, and/or non-psychoactive cannabidiol, or CBD: THX-110 for the treatment of Tourette syndrome, or TS, and for the treatment of obstructive sleep apnea; THX-160 for the treatment of chronic and acute pain; and THX-210 for the treatment of autism spectrum disorder and epilepsy.
2
THX-110 is a combination therapy candidate based on two components: (1) THC, which is the major cannabinoid molecule in the cannabis plant, and (2) CannAmide™, a proprietary palmitoylethanolamide, or PEA, formulation. PEA is an endogenous fatty acid amide that belongs to the class of nuclear factor agonists, which are molecules that regulate the expression of genes. We believe that the combination of THC and PEA may induce a reaction known as the “entourage effect,” which we further believe has strong potential to treat Tourette syndrome and obstructive sleep apnea.
THX-160 is a proprietary pharmaceutical preparation containing a CB2 Receptor agonist for the treatment of pain. This innovative CB2 receptor agonist was synthesized by Raphael Mechoulam, Ph.D., Professor of Medicinal Chemistry at the Hebrew University, and a member of the Therapix Scientific Advisory Board.
Modulating CB2 receptor activity by selective CB2 receptor agonists holds unique therapeutic potential for addressing pain conditions.
Also based on the “entourage effect,” we are developing THX-210, a proprietary preparation candidate containing non-psychoactive CBD and CannAmide. THX-210 is intended for the treatment of autism spectrum disorder and epilepsy.
Pursuant to the positive results obtained in a phase IIa TS study conducted at Yale School of Medicine, we are developing a regulatory dossier to be submitted to the Federal Institute for Drugs and Medical Devices for our TS program (THX-110). In addition, we announced in November 2019 positive top line results from our Phase IIa clinical study in obstructive sleep apnea, which we believe suggests that THX-110 positively affects symptoms in adult subjects with obstructive sleep apnea. Following the recent successful completion of the Phase IIa obstructive sleep apnea clinical study, we are now assessing business and clinical strategies for further development of this program.
For our proprietary THX-160, we plan to continue the pre-clinical studies by developing multiple tests for mechanism of action evaluation and identifying pain indication and formulation development.
Following positive results in a pre-clinical study that consisted of in vitro tests which showed synergy between CBD and PEA, we announced in December 2019 progression of THX-210 into a clinical stage, and our plans to initiate a randomized, double blind placebo-controlled study to evaluate the efficacy, safety and tolerability of THX-210 in treating patients with autism spectrum disorder.
In July 2019, we announced the issuance of a product license for our proprietary PEA oral tablet CannAmide™ by Health Canada’s Natural and Non-prescription Health Products Directorate, or the NNHPD, for the recommended use as an anti-inflammatory and to help relieve chronic pain. This license was issued by the NNHPD under the authority of the Natural Health Products Regulations. Dosage form of the described natural health product is tablets composed of 400mg PEA with a recommended dose of one tablet three times a day. Chronic pain is estimated to affect 38% of people worldwide, and according to an analysis by the World Health Organization, half of the most prevalent conditions responsible for living with disability is characterized by the presence of different kinds of pain. With the NNHPD license, we are able to offer safe and beneficial non-opiate pain management products. CannAmide™ is a cannabimimetic compound that regulates endocannabinoid levels by enhancing receptor sensitivity and inhibiting their metabolism, and is particularly attractive therapeutically as it appears to have a very high safety profile with low or no abuse liability. Although numerous clinical trials have shown the favorable effect of PEA as an analgesic agent it has low solubility.
Operating Results
To date, we have not generated revenue from the sale of any product, and we do not expect to generate significant revenue within the next year at least. As of June 30, 2020, we had an accumulated deficit of approximately $54.3 million. Our financing activities are described below under “Liquidity and Capital Resources – Financing Activities.”
Operating Expenses
Our current operating expenses consist of two components – research and development expenses, and general and administrative expenses.
Research and Development Expenses
Our research and development expenses consist primarily of salaries and related personnel expenses, share-based compensation expenses, consulting and subcontractor expenses and other related research and development expenses.
3
The following table discloses the breakdown of research and development expenses:
Six-month period ended
June 30, |
||||||||
2020 | 2019 | |||||||
(unaudited) | (unaudited) | |||||||
(in thousands of USD) | ||||||||
Wages and related expenses | 181 | 133 | ||||||
Share-based payments | 100 | 19 | ||||||
Clinical studies | 1 | 56 | ||||||
Research & preclinical studies | 33 | 190 | ||||||
Chemistry & formulations | - | 56 | ||||||
Regulatory and other expenses | 178 | 45 | ||||||
493 | 499 |
General and Administrative Expenses
General and administrative expenses consist primarily of salaries, share-based compensation expense, professional service fees for accounting, legal, bookkeeping, facilities and other general and administrative expenses.
The following table discloses the breakdown of general and administrative expenses:
Six-month period ended
June 30, |
||||||||
2020 | 2019 | |||||||
(unaudited) | (unaudited) | |||||||
(in thousands of USD) | ||||||||
Wages and related expenses | 106 | 224 | ||||||
Share-based payment | 69 | 363 | ||||||
Professional and directors fees | 679 | 598 | ||||||
Investor relations and business expenses | 7 | 45 | ||||||
Office maintenance, rent and other expenses | 53 | 38 | ||||||
Regulatory expenses | 51 | 67 | ||||||
Business development | 5 | 215 | ||||||
Total | 970 | 1,550 |
Comparison of the six-months ended June 30, 2020 to the six-months ended June 30, 2019
Research and Development Expenses, net
Our research and development expenses for the six months ended June 30, 2020 amounted to $493,000, representing a decrease of $6,000, or 1.2%, compared to $499,000 for the six months ended June 30, 2019. The decrease was primarily attributable to a decrease of $268,000 in clinical and preclinical studies, reflecting the ending of clinical and preclinical studies that were ended in previous year and a decrease in chemistry & formulations expenses offset by an increase of $262,000 in wages and related expenses, share-based payments and regulatory and other expenses, reflecting the preparation for upcoming pre-clinical and clinical studies.
General and Administrative Expenses
Our general and administrative expenses totaled $0.97 million for the six months ended June 30, 2020, a decrease of $0.58 million, or 37%, compared to $1.55 million for the six months ended June 30, 2019. The decrease resulted primarily from a decrease of $0.21 million in business development expenses and a decrease of $0.12 million in wages and related expenses reflecting the Company's efforts to reduce these expenses.
4
Operating Loss
As a result of the foregoing, our operating loss for the six months ended June 30, 2020 was $1.46 million, compared to an operating loss of $2.0 million for the six months ended June 30, 2019, a decrease of $0.54 million, or 27%.
Finance Expense and Income
Financial expense and income consist of revaluation of debt instruments presented at fair value, related issuance expenses of debt instruments and bank fees.
We recognized financial income for the six months ended June 30, 2020 of $29,000, representing a decrease of $181,000 compared to financial income of $210,000 for the six months ended June 30, 2019. The decrease was primarily due to a change in the fair value of debt instruments for six months ended June 30, 2019.
We recognized financial expense for the six months ended June 30, 2020 of $1.2 million, representing an increase of $725,000 compared to financial expenses of $475,000 for the six months ended June 30, 2019. The increase was primarily due to a change in the fair value of debt instruments and other transactional costs.
Discontinued operations, net
Our loss from discontinued operations, net totaled $207,000 for the six months ended June 30, 2019. On March 26, 2019, due in part to significant losses incurred by our former controlled subsidiary, Therapix Healthcare Resources Inc., or THR, as well as its failure to maintain required licenses to operate its facilities, the our board of directors resolved that THR will commence a liquidation process of its assets, a process which ended on June 27, 2019, with the confirmation of THR’s dissolution by submitting all documents required by law. Since April 2019, THR had no employees and all business operations were discontinued. Accordingly, we presented all profit or loss results relevant to THR for the six month period ended on June 30, 2019, as income (loss) from discontinued operations, net. Also, as of June 27, 2019, THR had no assets or liabilities and recorded an income in the amount of $616,000 (THR recorded a loss of $2.4 million during the period since consolidation on October 3, 2018, up until December 31, 2018).
Total Comprehensive Loss
Our total comprehensive loss for the six months ended June 30, 2020 was $2.64 million, representing an increase $120,000, or 4.8%, compared to $2.52 million for the six months ended June 30, 2019.
Liquidity and Capital Resources
Overview
As of June 30, 2020, we had $180,000 in cash, including short term restricted deposits.
The table below presents our cash flows:
Six months ended June 30, | ||||||||
2020 | 2019 | |||||||
(unaudited) | (unaudited) | |||||||
(In thousands of USD) | ||||||||
Net cash used in operating activities | (2,133 | ) | (2,891 | ) | ||||
Net cash provided by (used in) investing activities | - | 1.269 | ||||||
Net cash provided by (used in) financing activities | 1,407 | 1.730 |
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Operating Activities
Net cash used in operating activities was $2.13 million for the six months ended June 30, 2020, compared with net cash used in operating activities of $2.89 million for the six months ended June 30, 2019. The decrease is primarily due to decreases in adjustments to the profit or loss items of impairment loss of equipment of $1.22 million offset by a decrease in working capital adjustments for the six months ended June 30, 2019.
Investing Activities
Net cash used in investing activities was $0 for the six months ended June 30, 2020, compared with net cash provided by investing activities of $1.27 million for the six months ended June 30, 2019. The decrease is primarily due to proceeds from the sale of property and equipment of $724,000 and repayment of a convertible loan of $546,000 in the 2019 period.
On May 15, 2020, the Company entered into a series of transactions, or together, the Joint Venture Transaction, including a definitive share transfer agreement with Capital Point Ltd., or Capital Point, an Israeli holding company traded on the Tel Aviv Stock Exchange, and Evero Health Ltd., or Evero, pursuant to which Capital Point sold to Evero 5,952,469 ordinary shares, NIS 0.01 par value each, of Coeruleus Ltd., or the Purchased Coeruleus Shares and “Coeruleus, respectively), an Israeli company, and an affiliated company (in which Capital Point owned approximately 40% the issues and outstanding share capital) of Capital Point, engaged in, among others, developing innovative medications based on the active generic substance flumazenil, including a sublingual spray to reduce the side effects of hypnotic sleep medication, and a sublingual spray to improve function and quality of life in patients with hepatic encephalopathy. The Purchased Coeruleus Shares represented approximately 35% of the issued and outstanding share capital of Coeruleus. In consideration thereof, Evero issued and sold to Capital Point 176,470 ordinary shares, NIS 1.00 par value each, constituting 15% of the issued and outstanding share capital of Evero, which were valued at $351,000, based on apportionment of the fair market value of the Company as reflected in the Nasdaq. Following the transaction, Capital Point held approximately 5% of Coeruleus’ issued and outstanding share capital. The transaction costs of $51,000 were also capitalized as part of the investment in an associate.
In connection with the Joint Venture Transaction, we issued a warrant to purchase $340,000 of ADSs representing our Ordinary Shares. Pursuant to the terms of the warrant, the exercise price per ADS is equal to the closing price of the ADSs on the trading day on which the notice of exercise was actually received by us, and shall be paid by transferring to Therapix a duly executed share transfer deed for 9,577 ordinary shares of Evero. The warrant will be exercisable for 12 months starting from the 12-month anniversary of the issuance date.
Financing Activities
Net cash provided by financing activities of $1.4 million in the six months ended June 30, 2020 consisted mainly of $1.4 million of net proceeds from the issuance of share capital and warrants. Net cash used in financing activities in the six months ended June 30, 2019 consisted of $1.7 million of net proceeds from the issuance of share capital and warrants.
On March 19, 2020, we entered into a securities purchase agreement with respect to a private placement of convertible notes in the aggregate amount of $220,000, warrants to purchase up to 314,285 ADSs, and 40,000 ADSs. The private placement closed on April 6, 2020.
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On April 1, 2020 the Company entered into a securities purchase agreement (the “April 2020 Purchase Agreement”) with institutional investors to purchase of 4,166,668 units, each consisting of (i) one pre-funded warrant to purchase one ADS and (ii) one Series B warrant to purchase one ADS, at a purchase price of $0.2999 per unit. The Series B warrants have an exercise price of $0.43 per ADS, are exercisable upon issuance and expire five years from the date of issuance. The offering resulted in gross proceeds to the Company of approximately $1.25 million. The closing of the sale of the securities took place on April 3, 2020. As of October 6, 2020, all of the pre-funded warrants have been exercised. In addition, 4,161,668 of the Series B warrants were exercised pursuant to a cashless exercise mechanism as described in the April 2020 Purchase Agreement for no further consideration to us. As of October 6, 2020, there were 5,000 Series B warrants unexercised.
On July 23, 2020, we submitted to the Tel Aviv-Jaffa District Court, or the Court, a petition pursuant to the Israeli Insolvency and Economic Rehabilitation Law, 2018, to commence proceedings for our economic rehabilitation. On August 11, 2020, Pure Capital Ltd., or Pure Capital, proposed to deposit $1.5 million with the Company’s temporary trustee nominated by the Court to cover and pay all of the Company’s debts, without derogating from any other creditor’s rights towards the Company, or the Pure Capital Proposal. The Pure Capital Proposal was made subject to the replacement of the Company’s Board of Directors with Pure Capital’s designated nominees that were voted upon at the adjourned annual general meeting held on August 4, 2020. The Court issued an order on August 14, 2020, or the Order, approving the Pure Capital Proposal and settlement agreement submitted to the Court by the parties thereto. In accordance with the terms of the Order and following the deposit by Pure Capital, the Company’s members of the Board were replaced.
Current Outlook
We have financed our operations to date primarily through proceeds from sales of our Ordinary Shares and ADSs as well as exercises of warrants and options to purchase Ordinary Shares or ADSs, as the case may be. We have incurred losses and generated negative cash flows from operations since August 2004. Since August 2004, we have not generated any revenue from the sale of product candidates and we do not expect to generate revenues from sale of our product candidates in the next few years.
As of June 30, 2020, our cash was $144,000.
We believe that our existing cash resources will not be sufficient to finance our operating activities in the foreseeable future; rather, we expect that we will require substantial additional capital to complete the development of, and to commercialize, our product candidates and to continue as a going concern. If we do seek to raise additional capital, there can be no guarantee or assurance that we will be successful in raising such additional capital or that the term of such capital raise will be on terms favorable to us. In addition, as we continue to assess the effects of COVID-19, we do believe that it is possible that the COVID-19 pandemic may make financing opportunities scarcer or more difficult.
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In addition, our operating plans may change as a result of many factors that may currently be unknown to us, and we may need to seek additional financing sooner than planned. For example, as a result of COVID-19, we have taken action to reduce our operating expenses in the short term. There can be no assurance that the analysis that we have undertaken or remedial measures that have been enacted will enable us to avoid part or all of any impact from the spread of COVID-19 or its consequences, including downturns in business sentiment generally or in our sector in particular. In addition to COVID-19, our future capital requirements will depend on many factors, including:
● | the progress and costs of our research and development activities; | |
● | the costs of manufacturing our product candidates; | |
● | the costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights; | |
● | the potential costs of contracting with third parties to provide marketing and distribution services for us or for building such capacities internally; and | |
● | the magnitude of our general and administrative expenses. |
Until we can generate significant recurring revenues, we expect to satisfy our future cash needs through debt and/or equity financings (such as our March 2017, April 2019, December 2019, March 2020 and April 2020 offerings of ADSs and/or warrants). We cannot be certain that additional funding will be available to us on acceptable terms, if at all. In addition, although we were able to raise financing in April 2020 Offering, which was during the COVID-19 pandemic, there can be no assurance that we will be able to raise financing again while the COVID-19 pandemic is ongoing. If funds are not available, we may be required to delay, reduce the scope of, or eliminate research or development plans for, or commercialization efforts with respect to our product candidates and possibly cease operations.
Critical Accounting Policies
The preparation of financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, obligations and expenses during the reporting periods. A comprehensive discussion of our critical accounting policies is included in “Item 5. Operating and Financial Review and Prospects - Management’s Discussion and Analysis of Financial Condition and Results of Operations” section in our Annual Report.
Off-Balance Sheet Arrangements
We currently do not have any off-balance sheet arrangements.
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