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Purple Biotech Ltd.

Foreign Filer Report Aug 29, 2018

7004_rns_2018-08-29_435cc391-2421-41de-8b00-adbae8f952bb.pdf

Foreign Filer Report

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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

of the Securities Exchange Act of 1934

For the month of August 2018

Commission File Number: 001-37643

KITOV PHARMA LTD. (Translation of registrant's name into English)

One Azrieli Center, Round Tower, Tel Aviv 6701101, Israel (Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover 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 Regulation S-T Rule 101(b)(1): ____

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____

On August 29, 2018, Kitov Pharma Ltd. (the "Company" or the "Registrant") issued a Press Release: "Kitov Pharma Provides Corporate Update and Reports First Half 2018 Financial Results." A copy of this press release, together with the Company's unaudited condensed consolidated interim financial statements as of June 30, 2018, and for the six months then ended, are furnished herewith as Exhibits 99.1 and 99.2, respectively.

Exhibits

99.1 Press Release
99.2 The Registrant's unaudited condensed consolidated interim financial statements as of June 30, 2018, and for the six months then ended.

The information contained within this report on Form 6-K and all Exhibits attached hereto should be read in conjunction with (1) our Unaudited Condensed Consolidated Interim Financial Statements as of June 30, 2018, and for the six months then ended; and, (2) our audited consolidated financial statements for the year ended December 31, 2017, which appears in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 5, 2018, as well as the other information contained in such Annual Report on Form 20-F and in our Registration Statements and Prospectuses filed with the SEC.

The text which is found under the headings entitled "Financial Results for Six Months Ended June 30, 2018" and "Balance Sheet Highlights", respectively, in Exhibit 99.1 attached hereto; and, the entire Exhibit 99.2 attached hereto, are all hereby incorporated by reference into each of the Registrant's Registration Statements on Form F-3 filed with the Securities and Exchange Commission on December 12, 2016 (Registration file numbers 333-207117, 333-211477 and 333-215037), the Registrant's Registration Statement on Form S-8 filed with the Securities and Exchange Commission on May 20, 2016 (Registration file number 333-211478), the Registrant's Registration Statement on Form S-8 filed with the Securities and Exchange Commission on June 6, 2017 (Registration file number 333-218538), and the Registrant's Registration Statement on Form F-3 filed with the Securities and Exchange Commission on July 16, 2018 (Registration file number 333-226195).

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.

KITOV PHARMA LTD.

August 29, 2018 By: /s/ Simcha Rock

Simcha Rock CFO and Director

Kitov Pharma Provides Corporate Update and Reports First Half 2018 Financial Results

Tel Aviv, Israel, August 29, 2018 - Kitov Pharma Ltd. (NASDAQ/TASE: KTOV), an innovative biopharmaceutical company, today provided a corporate update and reported financial results for the six months ended June 30, 2018.

"The first half of 2018 has been a transformational period for Kitov," said Kitov's CEO, Isaac Israel. "Most importantly, we received U.S. Food and Drug Administration (FDA) approval to market Consensi™ (amlodipine and celecoxib) oral tablets for the simultaneous treatment of pain caused by osteoarthritis, as well as hypertension. We are now focused on securing an optimal U.S. commercialization partner for Consensi™ in the U.S. who has the capability to execute a successful product launch and provide Kitov with a solid on-going revenue stream."

"Moreover, we are excited about the continued progress we have achieved in advancing NT-219, our promising cancer therapy drug candidate," continued Mr. Israel. "We have generated compelling pre-clinical results for NT-219 to date, and expect to submit an Investigational New Drug application to the FDA and to initiate clinical trials for NT-219 in 2019."

"Finally, following our recent fund raise of approximately \$8.1 million in gross proceeds, we are supported by a strong balance sheet with approximately \$11.8 million in cash and deposits and no debt as of June 30, 2018," concluded Mr. Israel.

Recent Corporate Highlights:

  • Received FDA approval to market Consensi™ in the U.S.
  • Signed a License Agreement for Consensi™ for the territory of China with Hebei Changshan Biochemical Pharmaceutical Co., Ltd., a leading Chinese pharmaceutical company; Received \$1 million down payment and entitled to receive additional milestone payments of up to \$8.5 million, as well as potential double-digit royalties
  • Raised \$8,150,000 in gross proceeds through a registered direct offering
  • Completed the acquisition of additional shares in TyrNovo from unaffiliated minority shareholders; Kitov now holds 97% of TyrNovo's issued and outstanding shares, with the remaining 3% held by the TyrNovo founder and CTO
  • Reported positive pre-clinical data from NT219 demonstrating its dose-dependent anti-tumor efficacy, supporting planned IND in 2019
  • Entered into a Stipulation of Settlement with respect to the two U.S. shareholder class-action lawsuits; settlement consideration of \$2.0 million expected to be fully covered by Kitov's insurance carriers

Expected Upcoming Milestones:

  • Secure a U.S. commercialization partner for Consensi™
  • Product launch of Consensi™ in the U.S. by our commercialization partner
  • Expand global commercialization network for Consensi™ to additional territories
  • Initiate regulatory approval process for Consensi™ in China and South Korea, by our partners
  • Complete GLP toxicology studies for NT-219
  • Complete manufacturing of GMP NT-219 drug product for clinical trials
  • Submit an IND and initiate clinical trials for NT-219

The information contained below should be read in conjunction with (1) our Unaudited Condensed Consolidated Interim Financial Statements as of June 30, 2018, and for the six months then ended; and, (2) our audited consolidated financial statements for the year ended December 31, 2017, which appears in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 5, 2018, as well as the other information contained in such Annual Report on Form 20-F and in our Registration Statements and Prospectuses filed with the SEC.

Financial Results for Six Months Ended June 30, 2018

Revenues for the six months ended June 30, 2018 were \$1.0 million, consisting of an up-front payment from Changshan Biochemical Pharmaceutical Co., Ltd. in accordance with the terms of the License Agreement for Consensi™. There were no revenues in the six months ended June 30, 2017.

Research and development expenses for the six months ended June 30, 2018, were \$2.8 million, an increase of 13%, compared to \$2.5 million for the six months ended June 30, 2017. The increase resulted primarily from higher expenses related to pre-clinical trials for NT-219, partially offset by a reduction in expenses related to Consensi™, following submission of the NDA in 2017 and receipt of FDA approval in May 2018.

General and administrative expenses for the six months ended June 30, 2018, were \$3.4 million, an increase of 34%, compared to \$2.5 million for the six months ended June 30, 2017. The increase resulted from increases in legal fees, as well as increases in business development and other advisory services and officers' and directors' insurance.

Other income for the six months ended June 30, 2018, was \$0.9 million, representing a reversal of other expenses of \$1.0 million for the six months ended June 30, 2017, which consisted of the fair value of rights granted to Taoz, a minority shareholder in TyrNovo, upon the Company's acquisition of Taoz's shares in TyrNovo in June 2018, net of expenses associated with the acquisition.

Finance expense for the six months ended June 30, 2018, was \$0.8 million and was primarily related to the valuation of non-registered warrants issued in 2017 and expenses related to non-registered warrants issued in 2018. Finance income for the six months ended June 30, 2017, was \$0.1 million and was primarily related to interest on bank deposits.

The Company's net loss for the six months ended June 30, 2018, amounted to \$5.2 million, compared with a loss of \$6.0 million for the corresponding period in 2017.

Balance Sheet Highlights

  • Cash, cash equivalents and short-term deposits totaled \$11.8 million at June 30, 2018, compared to 7.4 million on December 31, 2017. The increase compared to December 31, 2017, reflects net cash of approximately \$7.4 million raised in a direct registered offering completed in June 2018, plus revenues of \$1.0 million, less cash used in operations.
  • Shareholders equity totaled \$10.7 million, including \$0.5 million in non-controlling interests as of June 30, 2018, compared to \$8.7 million as of December 31, 2017.

About Kitov Pharmaceuticals

Kitov Pharma (Kitov Pharma Ltd.; NASDAQ/TASE: KTOV) is an innovative biopharmaceutical drug development company. Leveraging deep regulatory and clinical-trial expertise, Kitov's veteran team of healthcare and business professionals maintains a proven track record in streamlined endto-end drug development and approval. Kitov's flagship combination drug, Consensi™ achieved the primary efficacy endpoints for its Phase III and Phase III/IV clinical trials, and was approved by the FDA for patients suffering from osteoarthritis pain and hypertension. NT219, which is developed by its majority-owned subsidiary, TyrNovo Ltd., is a novel patented small molecule designed to overcome cancer drug resistance that is currently in preclinical development. By lowering development risk and cost through fast-track regulatory approval of innovative therapeutic candidates, Kitov is committed to delivering rapid ROI and long-term potential to investors, while making a meaningful impact on people's lives.

Forward-Looking Statements

Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of forwardlooking 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. You should not place undue reliance on these forward-looking statements, which are not guarantees of future performance. Forward-looking statements reflect our current views, expectations, beliefs or intentions with respect to future events, and are subject to a number of assumptions, involve known and unknown risks, many of which are beyond our control, as well as uncertainties and other factors that may cause our actual results, performance or achievements to be significantly different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause or contribute to such differences include, among others, risks relating to: risks and uncertainties associated with obtaining court approval of the proposed settlement of the two U.S. shareholder class-action lawsuits, the number of plaintiffs who may opt-out of the proposed settlement, and whether any proposed settlement is appealed; the fact that drug development and commercialization involves a lengthy and expensive process with uncertain outcomes; our ability to successfully develop and commercialize our pharmaceutical products; the expense, length, progress and results of any clinical trials; the lack of sufficient funding to finance the clinical trials; the impact of any changes in regulation and legislation that could affect the pharmaceutical industry; the difficulty in receiving the regulatory approvals necessary in order to commercialize our products; the difficulty of predicting actions of the U.S. Food and Drug Administration or any other applicable regulator of pharmaceutical products; the regulatory environment and changes in the health policies and regimes in the countries in which we operate; the uncertainty surrounding the actual market reception to our pharmaceutical products once cleared for marketing in a particular market; the introduction of competing products; patents attained by competitors; dependence on the effectiveness of our patents and other protections for innovative products; our ability to obtain, maintain and defend issued patents with protective claims; the commencement of any patent interference or infringement action; our ability to prevail, obtain a favorable decision or recover damages in any such action; and the exposure to litigation, including patent litigation, and/or regulatory actions; the continued uncertainty surrounding an investigation by the Israel Securities Authority into our historical public disclosures and the potential impact of such investigation on the trading of our securities or on our clinical, commercial and other business relationships; or on receiving the regulatory approvals necessary in order to commercialize our products; the uncertainty of the impact of such investigation and/or the proposed settlement of the two U.S. shareholder class-action lawsuits on the Israeli class action civil litigation in connection with the investigation which is still continuing, and other factors that are discussed in our in our Annual Report on Form 20-F for the year ended December 31, 2017 and in our other filings with the SEC, including our cautionary discussion of risks and uncertainties under 'Risk Factors' in our Registration Statements, Prospectuses and Annual Reports. These are factors that we believe could cause our actual results to differ materially from expected results. Other factors besides those we have listed could also adversely affect us. Any forward-looking statement in this press release speaks only as of the date which it is made. We disclaim any intention or obligation to publicly update or revise any forward-looking statement, or other information contained herein, whether as a result of new information, future events or otherwise, except as required by applicable law. You are advised, however, to consult any additional disclosures we make in our reports to the SEC, which are available on the SEC's website, http://www.sec.gov

Condensed Consolidated Unaudited Interim Statements of Financial Position as of

June 30,
2018
December 31,
2017
USD USD
thousand thousand
Assets
Cash and cash equivalents 5,363 3,947
Short term deposits 6,467 3,488
Other current assets 344 548
Total current assets 12,174 7,983
Fixed assets, net 30 28
Intangible assets 6,172 6,172
Total assets 18,376 14,183
Liabilities
Accounts payable
767 215
Other payables 2,159 1,746
Derivative liabilities 4,318 2,012
Total current liabilities 7,244 3,973
Non - current liabilities
Derivative liability - 1,030
Post-employment benefit liabilities 470 492
470 1,522
Equity
Share capital, no par value - -
Share premium 44,437 35,979
Receipts on account of warrants 7,415 7,415
Capital reserve for share-based payments 1,713 1,725
Capital reserve from transactions with related parties 761 761
Capital reserve from transactions with non- controlling interest (859) -
Accumulated loss (43,325) (38,472)
Equity attributable to owners of the Company 10,142 7,408
Non-controlling interests 520 1,280
Total equity 10,662 8,688
Total liabilities and equity 18,376 14,183

Condensed Consolidated Unaudited Interim Statements of Operations and Other Comprehensive Income

For the six months ended
June 30
2018 2017
USD USD
thousand
thousand
Revenues 1,000 -
Research and development expenses 2,842 2,516
General and administrative expenses 3,394 2,524
Other expenses (income), net (866) 1,029
Total expenses 5,370 6,069
Operating loss
4,370 6,069
Finance expense 837 7
Finance income (24) (63)
Finance expense (income), net 813 (56)
Loss for the period 5,183 6,013
Loss attributable to:
Owners of the Company 4,853 5,824
Non-controlling interests 330 189
5,183 6,013
Loss per share
Basic and diluted loss per share - USD 0.02 0.04
Number of shares used in calculation 248,117,119 163,781,022
Contact:
Simcha Rock, Chief Financial Officer and Director

+972-3- 9333121 ext. #105 [email protected]

Kitov Pharma Ltd.

Condensed Consolidated Unaudited Interim Financial Statements As of June 30, 2018

Contents

Page
Condensed Consolidated Unaudited Interim Financial Statements as of June 30, 2018
Condensed Consolidated Interim Statements of Financial Position 2
Condensed Consolidated Interim Statements of Operations and Other Comprehensive Income 3
Condensed Consolidated Interim Statements of Changes in Equity 4
Condensed Consolidated Interim Statements of Cash Flows 6
Notes to the Condensed Consolidated Interim Financial Statements 7

Condensed Consolidated Unaudited Interim Statements of Financial Position as of

Note June 30,
2018
USD
thousand
December 31,
2017
USD
thousand
Assets
Cash and cash equivalents 5,363 3,947
Short term deposits 6,467 3,488
Other current assets 344 548
Total current assets 12,174 7,983
Fixed assets, net 30 28
Intangible assets 6,172 6,172
Total assets 18,376 14,183
Liabilities
Accounts payable 767 215
Other payables 2,159 (*) 1,746
Derivative liabilities 5 4,318 2,012
Total current liabilities 7,244 3,973
Non - current liabilities
Derivative liability 4 - 1,030
Post-employment benefit liabilities 470 492
470 1,522
Equity
Share capital, no par value - -
Share premium 44,437 35,979
Receipts on account of warrants 7,415 7,415
Capital reserve for share-based payments 1,713 1,725
Capital reserve from transactions with related parties 761 761
Capital reserve from transactions with non-controlling interest (859) -
Accumulated loss (43,325) (*) (38,472)
Equity attributable to owners of the Company 10,142 7,408
Non-controlling interests 520 1,280
Total equity 10,662 8,688
Total liabilities and equity 18,376 14,183

(*) Restated due to full retrospective method of adoption of IFRS 15, see Note 3(2).

The accompanying notes are an integral part of these condensed consolidated interim financial statements.

Condensed Consolidated Unaudited Interim Statements of Operations and Other Comprehensive Income

For the six months ended
June 30
Note 2018
USD
thousand
2017
USD
thousand
Revenues 8 1,000 -
Research and development expenses
General and administrative expenses
Other expenses (income), net
4 2,842
3,394
(866)
2,516
2,524
1,029
Total expenses 5,370 6,069
Operating loss 4,370 6,069
Finance expense
Finance income
Finance expense (income), net
837
(24)
813
7
(63)
(56)
Loss for the period 5,183 6,013
Loss attributable to:
Owners of the Company
Non-controlling interests
4,853
330
5,183
5,824
189
6,013
Loss per share
Basic and diluted loss per share - USD
0.02 0.04
Number of shares used in calculation 248,117,119 163,781,022

The accompanying notes are an integral part of these condensed consolidated interim financial statements.

Condensed Consolidated Unaudited Interim Statements of Changes in equity

Attributable to owners of the Company
Share
capital
Share
premium
Receipts
on
account
of
warrants
Capital
reserve
for share
based
payments
Capital
reserve
from
transactions
with related
parties
Capital
reserve
from
transactions
with Non
controlling
interest
USD thousand
Accumulated
loss
Total Non
controlling
interests
Total
equity
For the six months ended
June 30, 2018:
Balance as of January 1, 2018
(restated) see Note 3
- 35,979 7,415 1,725 761 - (38,472) 7,408 1,280 8,688
Issuance of American
Depository Shares (ADSs)
on the NASDAQ, net of
issuance costs
- 4,276 - - - - - 4,276 - 4,276
Issuance of shares due to
RSUs vesting
- 139 - (139) - - - - - -
Exercise of warrants - 2,133 - - - - - 2,133 - 2,133
Share issuance due to
acquisition of Non
controlling interest (see
Note 4) - 1,856 - - - (859) - 997 (861) 136
Share-based payments - 54 - 127 - - - 181 431 612
Loss for the period - - - - - - (4,853) (4,853) (330) (5,183)
Balance as of June 30, 2018 - 44,437 7,415 1,713 761 (859) (43,325) 10,142 520 10,662

The accompanying notes are integral part of these condensed consolidated interim financial statements.

Condensed Consolidated Unaudited Interim Statements of Changes in equity

Attributable to owners of the Company
Share
capital
Share
premium
Receipts
on
account
of
warrants
Capital
reserve
for share
based
payments
Capital
reserve
from
transactions
with related
parties
USD thousand
Accumulated
loss
Total Non
controlling
interests
Total
equity
For the six months ended
June 30, 2017:
Balance as of January 1,
2017
- 30,826 7,415 583 761 (26,200) 13,385 - 13,385
Share issuance due to an
acquisition of a subsidiary
- 1,800 - - - - 1,800 2,016 3,816
Share-based payments - - - 1,283 - - 1,283 - 1,283
Loss for the period - - - - - (5,824) (5,824) (189) (6,013)
Balance as of June 30, 2017 - 32,626 7,415 1,866 761 (32,024) 10,644 1,827 12,471

Condensed Consolidated Unaudited Interim Statements of Cash Flows

For the six months ended
June 30
2018
USD
2017
USD
thousand thousand
Cash flows from operating activities:
Loss for the period (5,183) (6,013)
Adjustments:
Depreciation 3 2
Finance expenses (income), net 813 (56)
Share-based payments 612 1,283
Expenses (income) in regards with settlement with a minority shareholder of a subsidiary (see Note 4) (866) 1,000
(4,621) (3,784)
Changes in assets and liabilities:
Changes in receivables 202 (536)
Changes in accounts payables 525 (240)
Changes in other payables 412 (303)
Changes in post - employment benefit liabilities - 172
1,139 (907)
Net cash used in operating activities (3,482) (4,691)
Cash flows from investing activities:
Acquisition of subsidiary, net of cash acquired - (1,732)
Decrease (increase) in short term deposits (3,061) 357
Acquisition of fixed assets (5) (3)
Net cash used in investing activities (3,066) (1,378)
Cash flows from financing activities:
Proceeds from warrants exercised 515 -
Repayment of short term bank credit - (16)
Proceeds from issuance of shares and ADSs 4,683 -
Share and ADS issuance expenses paid (407) -
Proceeds from issuance of warrants 3,467 -
Warrants issuance expenses paid (301) -
Repayment of loans from related parties - (130)
Interest paid (7) (8)
Interest received 24 -
Net cash provided by (used in) financing activities 7,974 (154)
Net increase (decrease) in cash and cash equivalents 1,426 (6,223)
Cash and cash equivalents at the beginning of the period 3,947 6,758
Effect of translation adjustments on cash and cash equivalents (10) (8)
Cash and cash equivalents at the end of the period 5,363 527

The accompanying notes are an integral part of these condensed consolidated interim financial statements.

Note 1 - General

A. Reporting entity

Kitov Pharma Ltd. (formerly "Kitov Pharmaceuticals Holdings Ltd.") (hereinafter: "the Company") is an Israeli company, that was incorporated in Israel as a private company in August 1968, and has been listed for trading on the Tel Aviv Stock Exchange since September 1978. In October 2012, the Company disposed of all of its previous operations, and in July 2013, the Company acquired shares of Kitov Pharmaceuticals Ltd. (hereinafter: "Kitov") from its shareholders, in exchange for the Company's shares (hereinafter: "the Acquisition").

In January 2018, the Company changed its name to Kitov Pharma Ltd.

The Company's securities (American Depository Shares ("ADS") as well as Series A warrants) were listed for trading on the NASDAQ in November 2015. Each ADS represents 20 ordinary shares with no par value. Each Series A Warrant enables the purchase of 1 ADS.

In December 2017, the Company completed its merger with its wholly owned subsidiary, Kitov, with the Company remaining as the surviving entity. The Company received the Merger Certificate from the Israeli Registrar of Companies with a merger date effective as of December 14, 2017. As set forth in the Agreement and Plan of Merger between the Company and Kitov, and in accordance with Section 103 of the Israeli Income Tax Ordinance [New Version], 1961, the merger shall be deemed to have been consummated on, and effective as of, December 31, 2017.

The Company's address is One Azrieli Center, Round Tower, 132 Menachem Begin Road, Tel Aviv 671101, Israel.

In January 2017, the Company acquired the majority of shares of TyrNovo Ltd (hereinafter: TyrNovo"). In each of March and June 2018, the Company acquired additional shares of TyrNovo from various minority shareholders, see also Note 4.

The Company together with TyrNovo are referred to, in these financial statements, as the "Group".

As of the date of the financial statements, the Group is engaged, through Kitov, in the development of combination drugs that treat two clinical conditions simultaneously, pain caused by osteoarthritis and hypertension, and through TyrNovo, in the development of a small molecule that has demonstrated the potential to overcome resistance to multiple anti-cancer drugs.

Since incorporation through June 30, 2018, the Group has incurred losses and negative cash flows from operations mainly attributed to its development efforts and has an accumulated deficit of USD 43 million. The Group has financed its operations mainly through private and public financing rounds. Management anticipates that its existing capital resources will be adequate to satisfy liquidity requirements for at least 12 months. At present, the Company has limited revenue and may require additional funding for future plans. However, there is no assurance that, if required, the Company will be able to raise additional capital to provide the required liquidity.

Note 2 - Basis of Preparation

A. Statement of compliance

These condensed consolidated interim financial statements have been prepared in accordance with IAS 34 Interim Financial Reporting and do not include all of the information required for full annual financial statements. They should be read in conjunction with the financial statements as at and for the year ended December 31, 2017 (hereinafter - "the Annual Financial Statements"). They do not include all of the information required for a complete set of IFRS financial statements. However, selected explanatory notes are included to explain events and transactions that are significant to an understanding of the changes in the Group's financial position and performance since the last annual financial statements.

These condensed consolidated interim financial statements were authorized for issue by the Group's Board of Directors on August 28, 2018.

B. Use of judgments and estimates

The preparation of financial statements in conformity with IFRS requires management to make judgments, estimates and assumptions that affect the application of accounting policies and the reported amounts of assets, liabilities, income and expenses. Actual results may differ from these estimates.

The significant judgements made by management in applying the Group's accounting policies and the key sources of estimation uncertainty were the same as those described in the Annual Financial Statements, except for new significant judgments and key sources of estimation uncertainty related to the application of IFRS 15, which are described in Note 4.

C. Fair value measurement

The Group's management regularly reviews significant unobservable inputs and valuation adjustments, including obtaining valuations prepared by third parties and assessing the evidence to support the conclusion that these valuations meet the requirements of IFRS, including the level in the fair value hierarchy in which the valuations should be classified.

Significant valuation issues are reported to the Group Audit Committee.

When measuring the fair value of an asset or a liability, the Group uses market observable data as far as possible. Fair values are categorized into different levels in a fair value hierarchy based on the inputs used in the valuation techniques as follows:

  • Level 1: quoted prices in active markets for identical assets or liabilities.
  • Level 2: inputs other than quoted prices included in Level 1, that are observable for the asset or liability, either directly or indirectly.
  • Level 3: inputs for the asset or liability that are not based on observable market data.

If the inputs used to measure the fair value of an asset or a liability might be categorized in different levels of the fair value hierarchy, then the fair value measurement is categorized in its entirety in the same level of the fair value hierarchy as the lowest level input that is significant to the entire measurement.

The Group recognizes transfers between levels of the fair value hierarchy at the end of the reporting period during which the change has occurred.

Further information about the assumptions made in measuring fair value of share based payments and derivative liabilities are included in Notes 7 and 6, respectively.

Note 3 - Significant Accounting Policies

Except as described below in Items 1-2, the accounting policies applied by the Group in these condensed consolidated interim financial statements are the same as those applied by the Group in its Annual Financial Statements.

Presented hereunder is a description of the changes in accounting policies applied in these condensed consolidated interim financial statements and their effect:

Initial application of new standards, amendments to standards and interpretations

As from January 1, 2018 the Group applies the new standards and amendments to standards described below:

(1) IFRS 9 (2014), Financial Instruments

As from January 1, 2018 the Group applies IFRS 9 (2014), Financial Instruments (in this item: "the standard" or "IFRS 9"), which replaces IAS 39, Financial Instruments: Recognition and Measurement (in this item "IAS 39"). The Group has chosen to apply the standard and the amendment to the standard as from January 1, 2018. The application of this standard has no impact on the Group's financial statements.

Presented hereunder are the principal changes in accounting policies following application of the standard as from January 1, 2018:

Classification and measurement of financial assets and financial liabilities

Financial assets and financial liabilities are recognized initially on the trade date at which the Group becomes a party to the contractual provisions of the instrument. Generally, a financial asset or financial liability is initially measured at fair value plus, in the case of a financial asset or financial liability not at fair value through profit or loss, transaction costs that are directly attributable to the acquisition or issuance of the financial asset or financial liability.

Financial liabilities - classification, subsequent measurement and gains and losses

Financial liabilities are classified as measured at amortized cost or fair value through profit or loss. A financial liability is measured at fair value through profit or loss if it is classified as held for trading, is a derivative instrument or is designated for measurement as such at initial recognition. Financial liabilities at fair value through profit or loss are measured at fair value, with the net gains and losses, including any interest expenses, being recognized in profit or loss. Other financial liabilities are subsequently measured at amortized cost using the effective interest method. Interest expenses and foreign exchange gains and losses are recognized in profit or loss. Any gain or loss on derecognition is also recognized in profit or loss.

Note 3 - Significant Accounting Policies (contd.)

Derecognition of financial liabilities

Financial liabilities are derecognized when the contractual obligation of the Group expires or is discharged or cancelled. Furthermore, a substantial modification of the terms of an existing financial liability, or an exchange between an existing borrower and existing lender of debt instruments with substantially different terms, are accounted for as an extinguishment of the original financial liability and the recognition of a new financial liability at fair value. The difference between the carrying amount of the extinguished financial liability and the consideration paid (including any non-cash assets transferred or assumed liabilities), is recognized in profit or loss.

(2) IFRS 15, Revenue from Contracts with Customers

The Group applies, for the first time, IFRS 15 Revenue from Contracts with customers. As required by IAS 34, the nature and effect of these changes are disclosed below.

The standard introduces a new five step model for recognizing revenue from contracts with customers:

(1) Identifying the contract with the customer.

  • (2) Identifying distinct performance obligations in the contract.
  • (3) Determining the transaction price.
  • (4) Allocating the transaction price to distinct performance obligations.
  • (5) Recognizing revenue when the performance obligations are satisfied.

Under IFRS 15, revenue is recognized at an amount that reflects the consideration to which the entity expects to be entitled in exchange for transferring goods or services to a customer.

The standard requires entities to exercise judgement, taking into consideration all of the relevant facts and circumstances when applying each step of the model to contracts with their customers.

The Group adopted IFRS 15 using the full retrospective method of adoption. The effect of adopting IFRS 15 is, as follows:

Impact on the statement of financial position as of December 31, 2017:

According to
the previous According to
policy The change IFRS 15
USD
USD
USD
thousands thousands thousands
Deferred income 95 (95) -
Accumulated loss (38,567) 95 (38,472)

The Group's revenues are derived from license and commercialization agreements.

Note 3 - Significant Accounting Policies (contd.)

The impact from the adoption of IFRS 15 Revenue from Contracts with Customers relates to the timing of the recognition of income from an upfront payment received under a license and commercialization agreement. Under IFRS 15, management concluded that this agreement is accounted for as a right to use license of IP, and the performance obligation to transfer the licenses to the counterparty to the agreement (the licensee) has been satisfied. Under IAS 18, upfront and milestone payments received were deferred and amortized to other revenue over the term of the agreements. Therefore, upon adoption of IFRS 15, the deferred revenue, in relation to the upfront payments received, have been derecognized and the impact accordingly recognized to retained earnings in the amount of USD 95 thousand.

The aforementioned amount was received in October 2017, therefore adoption of IFRS 15 affected the reported revenues in the second half of 2017.

Presented hereunder are the new significant accounting policies regarding revenue recognition that were applied following the application of IFRS 15:

Revenue

The Group recognizes revenue from upfront and milestone payments at the point in time when the upfront payment is received and when the milestone criteria is highly probable to be met. The revenue is measured according to the amount of the consideration to which the Group expects to be entitled.

The Group will recognize sales based royalty income earned through a license when the underlying sales will occur.

Determining the transaction price

The transaction price is the amount of the consideration to which the Group expects to be entitled in exchange for the license and commercialization agreement. The Group takes into account the effects of all the following elements when determining the transaction price: variable consideration, the existence of a significant financing component, non-cash consideration, and consideration payable to the customer.

Variable consideration

The Group includes variable consideration, or part of it, in the transaction price only when it is highly probable that its inclusion will not result in a significant revenue reversal in the future when the uncertainty has been subsequently resolved. At the end of each reporting period and if necessary, the Group revises the amount of the variable consideration included in the transaction price.

Right to use and right to access

To determine whether the Group's promise to grant a license provides a customer with either a right to access the Group's IP or a right-to-use the Group's IP, the Group considers whether a customer can direct the use of, and obtain substantially all of the remaining benefits from, a license at the point in time at which the license is granted.

A license is considered a "right-to-use" license when the customer maintains control of the IP upon its transfer. However, if the grantor of the license maintains involvement with the IP after its transfer, and the customer cannot direct the use of, and obtain substantially all of the remaining benefits from the license, then the license is considered a right-to-access license.

Note 4 - Acquisitions of non-controlling interest during the current period

A. In October 2017, the Company signed an agreement for the acquisition of an additional 27% stake in TyrNovo (the "Newly Acquired TyrNovo Shares"), from a group of unaffiliated minority shareholders of TyrNovo, who collectively held 4,024 ordinary shares, or approximately 27%, of TyrNovo. In exchange for these Newly Acquired TyrNovo Shares, the Company issued to these unaffiliated minority shareholders of TyrNovo, in aggregate, 13,169,689 newly issued ordinary shares (equivalent to 658,484 American Depositary Shares or ADSs) of the Company, which, at that time, represented approximately 6% of the Company's issued and outstanding share capital.

The closing of this transaction took place on March 15, 2018, following which the Company held approximately 91.9% of TyrNovo's issued and outstanding ordinary shares.

The carrying amount of TyrNovo's net assets in the consolidated financial statements on the date of the acquisition was USD 2,821 thousand. The Group recognized a decrease in non-controlling interests of USD 768 thousand, an increase in share premium of USD 1,483 thousand and a decrease in a capital reserve for transactions with non-controlling interest of USD 715 thousand.

B. In June 2018, the Company signed an agreement with a minority shareholder in TyrNovo, Taoz, for the acquisition of 4.1% of its holding in TyrNovo. In exchange for these shares and for the waiving of investment rights and put options it was previously granted, which are described in Note 12 to the Annual Financial Statements, the Company issued to Taoz 2,816,900 newly issued ordinary shares (equivalent to 140,845 American Depositary Shares or ADSs) of the Company. The fair value of the shares issued as consideration for the acquisition of TyrNovo Shares amounted to USD 237 thousand. The fair value of the shares issued in consideration for waving the rights amounted to USD 136 thousand. As part of the agreement, the Company committed to register the newly issued shares for trading. The registration statement, registering the Company's ADSs representing the newly issued shares for trading, was declared effective by the SEC as of August 8, 2018. In addition, the Company committed to pay Taoz in cash the difference between the share price of Kitov's shares on the closing date to that on the registration date, in the event Kitov's share price is lower on the registration date than on the closing date.

The carrying amount of TyrNovo's net assets in the consolidated financial statements on the date of the acquisition was USD 1,977 thousand. The Group recognized a decrease in non-controlling interests of USD 93 thousand, an increase in share premium of USD 237 thousand and a decrease in a capital reserve for transactions with non-controlling interest of USD 144 thousand.

In addition, the Company derecognized the derivative liability of 1,030, recognized an amount of USD 894 thousand as other income and an increase in share premium of USD 136 deriving from the waiving of the rights, as described above.

The closing of this transaction took place on June 15, 2018, following which the Company held approximately 97.4% of TyrNovo's issued and outstanding ordinary shares.

Note 5 - Capital and reserves

During the reported periods, the following shares were issued:

For the six months ended
June 30, June 30,
2018 2017
Number of shares in
thousands
Opening balance 224,443 153,237
Issuance of ADSs (see A below) 65,200 -
Share-based payments (see C below) 1,246 -
Share issuance due to the acquisition of a subsidiary - 11,293
Share issuance due to the acquisition of Non-controlling interest (see Note 4) 15,987 -
Exercise of warrants (see B below) 12,135 -
319,011 164,530

A. In June 2018, in a registered direct offering on the NASDAQ, the Company raised USD 8.1 million gross (approximately USD 7.4 million net of placement agent fees and other offering related expenses).

In this registered direct offering, the Company issued 3,260,000 ADSs and, in a concurrent private placement, 1,630,000 non-listed warrants to purchase 1,630,000 ADSs. Each non-listed warrant is exercisable until December 5, 2023 at an exercise price of USD 2.80 per ADS. The warrant holders have the option to exercise cashless, and the warrants were therefore accounted for as a derivative liability. The ADS's issued were recorded in equity in an amount of USD 4,276 thousand, net of issuance expenses. The warrants were recorded as a liability in the amount of USD 3,467. Issuance expenses related to the warrants, in the amount of USD 301 thousand were recorded to finance expense. This derivative instrument is classified as a Level 3 financial instrument.

B. During the reported period 343 thousand warrants, issued in July 2017, were exercised into 6,862 thousand shares for a consideration of USD 515 thousand, and 484 thousand warrants, issued in July 2017, were exercised into 5,273 thousand shares on a cashless exercise. Subsequently, an amount of USD 1,618 was recorded to share premium against derivative liabilities.

As at June 30, 2018, the fair value of the outstanding warrants issued in July 2017 amounted to USD 851 thousand. This derivative instrument is classified as a Level 3 financial instrument.

C. During the reporting period the Company issued 1,246 thousand ordinary shares on account of vested RSUs granted in 2017.

Note 6 - Financial Instruments

  • A. The carrying amounts of certain financial assets and liabilities including cash and cash equivalents, short-term deposits, other current assets, accounts and other payables are the same or proximate to their fair value.
  • B. Fair value hierarchy of financial instruments measured at fair value:

Details regarding fair value measurement at Level 3 at June 30, 2018:

Financial instrument Valuation method for
determining fair value
Significant unobservable inputs
Warrants issued June 5, 2018 Black - Scholes expected term
expected volatility
annual risk free interest
dividend yield
5.5 years
115.67%
2.84%
0%
Warrants issued July 14, 2017 Black - Scholes expected term
expected volatility
annual risk free interest
dividend yield
4.5 years
109.05%
2.75%
0%

Note 7 - Share-based payments

In January 2018, TyrNovo's board of directors decided to grant certain of its employees 1,170 options to purchase TyrNovo's Ordinary Shares. The options have an exercise price equals to NIS 1 per one ordinary share, and were fully vested at the date of grant. The options are exercisable for 7 years from grant date.

The fair value of these options as of the grant date was measured at USD 431 thousand. During the six-month period ended June 30, 2018 the Company recorded an expense of USD 431 thousand, of which USD 402 thousand are to key management personnel.

These options were measured using the binominal model. The following inputs were used in the measurement of the fair value of these share based payments:

Share Price (USD) 368.9
Expected Volatility (%) 79.16%
Expected Duration (years) 7
Exercise Coefficient 2.0-2.8
Dividend Yield (%) 0%
Risk Free Rate Interest (%) 2.4%

The annual Expected Volatility applied was based on the historical weighted average volatility of relevant comparable companies, for a period corresponding to the share options' contractual term.

The risk-free interest rate for periods within the contractual life of the option is based on the United States Treasury yield curve in effect at the time of grant.

Note 8 - Revenues

In May 2018 the Company entered into a definitive license and commercialization agreement for the Chinese market, granting exclusive rights to import, manufacture and distribute its lead drug candidate, Consensi™, in China to Hebei Changshan Biochemical Pharmaceutical Co., Ltd. (Changshan Pharma), a Chinese public company traded on the Shenzhen Stock Exchange.

Changshan Pharma will be responsible for financing and seeking regulatory approval for Consensi™ in China. Under the terms of the agreement, in June 2018, following the U.S. FDA approval of Consensi™ on May 31, 2018, the Company received USD 1 million. In addition, the Company is entitled to receive up to an aggregate of USD 2.5 million for certain predefined regulatory milestones in China, up to an aggregate of USD 6.0 million for predefined commercial milestones, and up to 12% royalties on net sales.

The Company has adopted IFRS 15 and recognized revenue in the amount of USD 1 million, see also Note 3.

Note 9 - Claims

In June 2018 the Company entered into a Memorandum of Understanding and subsequently, in July 2018 entered into a Stipulation of Settlement with respect to the shareholder class action lawsuits pending against it. As previously disclosed, in Note 13B. to the Annual Financial Statements, these lawsuits were filed against the Company alleging violations of U.S. federal securities laws.

Under the terms of the proposed settlement, the purported classes in all of the Actions will receive aggregate consideration of USD 2.0 million. The settlement consideration, as well as ancillary expenses, is expected to be funded by the Company's insurance carriers.

When the proposed settlement becomes effective, the Company and its directors and officers will be released from the claims that were asserted or could have been asserted in the Actions by class members participating in the settlement.

The proposed settlement is subject to the completion of final documentation, preliminary and final Court approval by the District Court for the Southern District of New York and dismissal by the plaintiffs with prejudice of the Actions before the Superior Court for the State of California, funding of the USD 2.0 million in cash by the Company's insurance carriers, and other customary closing conditions.

There have been no material changes in all other claims since the issuance of the Annual Financial Statements.

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