UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

FORM 10-Q

 

 

 

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended June 30, 2020

 

OR

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

FOR THE TRANSITION PERIOD FROM                      TO                     

 

Commission File Number 001-37521

 

 

 

INTEC PHARMA LTD.

(Exact name of Registrant as specified in its Charter)

 

 

 

Israel   Not Applicable

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

     

12 Hartom Street

Har Hotzvim, Jerusalem

  9777512
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number, including area code: +972-2 - 586-4657

 

 

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Ordinary Shares, no par value    NTEC   The Nasdaq Capital Market

 

Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. YES ☒ NO ☐

 

Indicate by check mark whether the Registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit and post such files). YES ☒ NO ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer Accelerated filer
Non-accelerated filer ☐   Smaller reporting company
Emerging growth company    

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☒

 

Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES ☐ NO ☒

 

The number of shares of Registrant’s ordinary shares outstanding as of August 5, 2020: 71,839,492

 

 

 

 
 

 

TABLE OF CONTENTS

 

PART I — FINANCIAL INFORMATION  
    Page
Item 1. Condensed Consolidated Financial Statements (Unaudited) 1
  Condensed Consolidated Balance Sheets F-2
  Condensed Consolidated Statements of Operations F-3
  Condensed Consolidated Statement of Changes in Shareholders’ Equity F-4
  Condensed Consolidated Statements of Cash Flows F-6
  Notes to Condensed Consolidated Financial Statements F-7
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 2
Item 3. Quantitative and Qualitative Disclosures About Market Risk 8
Item 4. Controls and Procedures 8
   
PART II —  OTHER INFORMATION  
     
Item 1. Legal Proceedings 9
Item 1A. Risk Factors 9
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 10
Item 3. Defaults upon Senior Securities 10
Item 4. Mine Safety Disclosures 10
Item 5. Other Information 10
Item 6. Exhibits 10

 

i

 

 

PART I. FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

 

 

 

 

 

 

 

 

 

 

INTEC PHARMA LTD.

 

UNAUDITED CONDENSED CONSOLIDATED

FINANCIAL STATEMENTS

 

AS OF JUNE 30, 2020

 

 

 

 

 

 

 

 

 

 

 

1

 

 

INTEC PHARMA LTD.

 

UNAUDITED CONDENSED CONSOLIDATED

FINANCIAL STATEMENTS

 

TABLE OF CONTENTS

 

  Page
   
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS:  
Consolidated Balance Sheets F-2
Consolidated Statements of Operations F-3
Consolidated Statements of Changes in Shareholders’ Equity F-4
Consolidated Statements of Cash Flows F-6
Notes to Consolidated Financial Statements F-7 - F-14

 

 

 

 

 

 

 

F-1

 

 

INTEC PHARMA LTD.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

 

    June 30,     December 31,  
    2020     2019  
    U.S. dollars in thousands  
Assets            
CURRENT ASSETS:                
Cash and cash equivalents   $ 13,799     $ 9,292  
Investment in marketable securities (Note 3)    
-
      770  
Prepaid expenses and other receivables     1,307       3,683  
TOTAL CURRENT ASSETS     15,106       13,745  
                 
NON-CURRENT ASSETS:                
Property and equipment, net     1,967       2,575  
Operating lease right-of-use assets     993       1,243  
Other assets (Note 4a)     3,717       3,717  
TOTAL NON-CURRENT ASSETS     6,677       7,535  
                 
TOTAL ASSETS   $ 21,783     $ 21,280  
                 
Liabilities and shareholders’ equity                
CURRENT LIABILITIES -                
Accounts payable and accruals:                
Trade   $ 382     $ 3,507  
Other (Note 6)     3,997       4,835  
TOTAL CURRENT LIABILITIES     4,379       8,342  
LONG-TERM LIABILITIES -                
Non-current operating lease liabilities     536       799  
Other liabilities     690       604  
TOTAL LONG-TERM LIABILITIES     1,226       1,403  
TOTAL LIABILITIES     5,605       9,745  
                 
COMMITMENTS AND CONTINGENT LIABILITIES (Note 4)    
 
     
 
 
SHAREHOLDERS’ EQUITY:                
Ordinary shares, with no par value - authorized: 100,000,000 Ordinary Shares as of June 30, 2020 and December 31, 2019; issued and outstanding: 69,428,032 and 35,892,209 Ordinary Shares as of June 30, 2020 and December 31, 2019, respectively     727       727  
Additional paid-in capital     211,691       200,231  
Accumulated deficit     (196,240 )     (189,423 )
TOTAL SHAREHOLDERS’ EQUITY     16,178       11,535  
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY   $ 21,783     $ 21,280  

  

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

 

F-2

 

 

INTEC PHARMA LTD.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

    Three months ended
June 30
    Six months ended
June 30
 
    2020     2019     2020     2019  
   

U.S. dollars

in thousands

   

U.S. dollars

in thousands

 
OPERATING EXPENSES:                                
RESEARCH AND DEVELOPMENT EXPENSES, net   $ (1,275 )   $ (7,860 )   $ (3,299 )   $ (16,402 )
GENERAL AND ADMINISTRATIVE EXPENSES     (1,630 )     (2,144 )     (3,345 )     (4,334 )
OPERATING LOSS     (2,905 )     (10,004 )     (6,644 )     (20,736 )
FINANCIAL INCOME (EXPENSES), net     4       33       (66 )     143  
LOSS BEFORE INCOME TAX     (2,901 )     (9,971 )     (6,710 )     (20,593 )
INCOME TAX     (46 )     (38 )     (107 )     (72 )
NET LOSS   $ (2,947 )   $ (10,009 )   $ (6,817 )   $ (20,665 )

 

   

U.S. dollars

 
LOSS PER SHARE BASIC AND DILUTED   $ (0.05 )   $ (0.30 )   $ (0.12 )   $ (0.62 )
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER ORDINARY SHARE IN THOUSANDS     62,820       33,300       54,913      

 

33,274

 

 

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

 

F-3

 

 

(Continued) - 1

 

INTEC PHARMA LTD.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY

(Unaudited)

 

    Ordinary Shares     Additional paid-in capital     Accumulated Deficit     Total  
    Number of shares     Amounts     Amounts  
          U.S. dollars in thousands  
BALANCE AT JANUARY 1, 2019     33,232,988     $ 727     $ 194,642       (141,824 )   $ 53,545  
CHANGES IN THE SIX-MONTH PERIOD ENDED JUNE 30, 2019:                                        
Exercise of options     69,812      
-
      268      
-
      268  
Share-based compensation (Note 5)            
-
      1,961      
-
      1,961  
Net loss     -      
-
     
-
      (20,665 )     (20,665 )
BALANCE AT JUNE 30, 2019     33,302,800     $ 727     $ 196,871     $ (162,489 )   $ 35,109  
                                         
BALANCE AT JANUARY 1, 2020     35,892,209     $ 727     $ 200,231     $ (189,423 )   $ 11,535  
CHANGES IN THE SIX-MONTH PERIOD ENDED JUNE 30, 2020:                                        
Issuance of ordinary shares, net of issuance costs (Note 5a(1))     831,371      
-
      421      
-
      421  
Issuance of ordinary shares and warrants, net of issuance costs (Note 5a(2))     16,250,000      
-
      5,692      
-
      5,692  
Issuance of ordinary shares and warrants, net of issuance costs (Note 5a(3))     16,291,952      
-
      4,426      
-
      4,426  
Exercise of warrants (Note 5a(2))     162,500               65               65  
Share-based compensation (Note 5)     -      
-
      856      
-
      856  
Net loss     -      
-
     
-
      (6,817 )     (6,817 )
BALANCE AT JUNE 30, 2020     69,428,032     $ 727     $ 211,691     $ (196,240 )   $ 16,178  

 

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

 

F-4

 

 

(Continued) - 2

 

INTEC PHARMA LTD.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY

(Unaudited)

 

    Ordinary Shares     Additional paid-in capital     Accumulated Deficit     Total  
    Number of shares     Amounts     Amounts  
          U.S. dollars in thousands  
BALANCE AT APRIL 1, 2019     33,297,371     $ 727     $ 195,842       (152,480 )   $ 44,089  
CHANGES IN THE THREE-MONTH PERIOD ENDED JUNE 30, 2019:                                        
Exercise of options     5,429      
-
      11      
-
      11  
Share-based compensation     -      
-
      1,018      
-
      1,018  
Net loss     -      
-
     
-
      (10,009 )     (10,009 )
BALANCE AT JUNE 30, 2019     33,302,800     $ 727     $ 196,871     $ (162,489 )   $ 35,109  
                                         
BALANCE AT APRIL 1, 2020     52,973,580     $ 727     $ 206,786     $ (193,293 )   $ 14,220  
CHANGES IN THE THREE-MONTH PERIOD ENDED JUNE 30, 2020:                                        
Issuance of ordinary shares and warrants, net of issuance costs (Note 5a(3))     16,291,952      
-
      4,426      
-
      4,426  
Exercise of warrants (Note 5a(2))     162,500      
-
      65      
-
      65  
Share-based compensation     -      
-
      414      
-
      414  
Net loss     -      
-
     
-
      (2,947 )     (2,947 )
BALANCE AT JUNE 30, 2020     69,428,032     $ 727     $ 211,691     $ (196,240 )   $ 16,178  

 

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

 

F-5

 

 

INTEC PHARMA LTD.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

    Six months ended June 30  
    2020     2019  
    U.S. dollars in thousands  
CASH FLOWS FROM OPERATING ACTIVITIES:            
Net loss   $ (6,817 )   $ (20,665 )
Adjustments required to reconcile net loss to net cash used in operating activities:                
Depreciation     611       431  
Exchange differences on cash and cash equivalents     49       (19 )
Change in right of use asset     250       351  
Change in lease liabilities     (263 )     (243 )
Gains on marketable securities     (2 )     (5 )
Share-based compensation     856       1,961  
Changes in operating assets and liabilities:                
Decrease (increase) in prepaid expenses and other receivables     2,376       (136 )
Increase in deferred tax assets     -       (148 )
Increase (decrease) in accounts payable and accruals     (3,963 )     583  
Increase in other liabilities     86       163  
Net cash used in operating activities     (6,817 )     (17,727 )
CASH FLOWS FROM INVESTING ACTIVITIES:                
Purchase of property and equipment     (3 )     (151 )
Investment in other assets     -       (1,435 )
Proceeds from disposal of marketable securities, net     772       576  
Net cash provided by (used in) investing activities     769       (1,010 )
CASH FLOWS FROM FINANCING ACTIVITIES:                
Proceeds from issuance of ordinary shares, net of issuance costs (Note 5a(1))     421       -  
Proceeds from issuance of ordinary shares and warrants, net of issuance costs (Note 5a(2))     5,692       -  
Proceeds from issuance of ordinary shares and warrants, net of issuance costs (Note 5a(3))     4,426       -  
Proceeds from exercise of warrants     65       -  
Proceeds from exercise of options     -       268  
Net cash provided by financing activities     10,604       268  
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS     4,556       (18,469 )
CASH AND CASH EQUIVALENTS AT BEGINNING OF THE PERIOD     9,292       39,246  
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS     (49 )     19  
CASH AND CASH EQUIVALENTS AT END OF THE PERIOD   $ 13,799     $ 20,796  
                 
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES:                
Liability with respect to property and equipment   $ -     $ 502  
Liability with respect to other assets (see note 4a)   $ -     $ 1,114  
                 
SUPPLEMENTARY DISCLOSURE OF CASH FLOW INFORMATION -                
Taxes paid   $ -     $ 50  
Interest received   $ 27     $ 263  

 

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

 

F-6

 

 

INTEC PHARMA LTD.

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)

(Unaudited)

 

NOTE 1 - NATURE OF OPERATIONS AND BASIS OF PRESENTATION:

 

a. Nature of operations

 

1) Intec Pharma Ltd. (“Intec”) is engaged in the development of proprietary technology which enables the gastric retention of certain drugs. The technology is intended to significantly improve the efficiency of the drugs and substantially reduce their side-effects or the effective doses.

 

Intec is a limited liability public company incorporated in Israel.

 

Intec’s ordinary shares are traded on the NASDAQ Capital Market (“NASDAQ”).

 

In September 2017, Intec incorporated a wholly-owned subsidiary in the United States of America in the State of Delaware - Intec Pharma Inc. (the “Subsidiary”, together with Intec - “the Company”). The Subsidiary was incorporated mainly to provide Intec executive and management services, including business development, medical affairs and investor relationship activities outside of Israel.

 

2) The Company engages in research and development activities and has not yet generated revenues from operations. On July 22, 2019, the Company announced top-line results according to which its Phase III clinical trial for AP-CD/LD did not achieve its primary and secondary endpoints. Accordingly, there is no assurance that the Company’s operations will generate positive cash flows. As of June 30, 2020, the cumulative losses of the Company were approximately $196.2 million. Management expects that the Company will continue to incur losses from its operations, which will result in negative cash flows from operating activities.

 

The Company believes that it has adequate cash to fund its ongoing activities into the third quarter of 2021. Its ability to execute its operating plan beyond the third quarter of 2021 is dependent on its ability to obtain additional capital principally through entering into collaborations, strategic alliances, or license agreements with third parties and/or raising capital from the public and/or private investors and/or institutional investors.  The negative outcome of the Phase III clinical trial that was announced on July 22, 2019 and uncertainty regarding the Company’s development programs is expected to adversely affect its ability to obtain funding and there is no assurance that it will be successful in obtaining the level of financing needed for its activities. If the Company is unsuccessful in securing sufficient financing, it may need to curtail or cease operations. In addition, the COVID-19 pandemic ,also known as “coronavirus”, that was reported in Wuhan, China in late 2019 and that has spread globally, has resulted in significant financial market volatility and uncertainty in recent months. Many countries around the world, including in Israel and the United States, have implemented significant governmental measures to control the spread of the virus, including temporary closure of businesses, severe restrictions on travel and the movement of people, and other material limitations on the conduct of business. The Company has implemented remote working and work place protocols for its employees in accordance with government requirements. The implementation of measures to prevent the spread of coronavirus have resulted in disruptions to the Company’s partnering efforts which depend, in part, on attendance at in-person meetings, industry conferences and other events. It is still too early to assess the full impact of the coronavirus outbreak and the extent to which the coronavirus impacts the Company’s operations will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration and severity of the outbreak, and the actions that may be required to contain the coronavirus or treat its impact. As of the date of issuance of these condensed consolidated financial statements, the extent to which the COVID-19 pandemic may materially impact the Company’s financial condition, liquidity, or results of operations is uncertain.

 

F-7

 

 

INTEC PHARMA LTD.

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)

(Unaudited)

 

NOTE 1 - NATURE OF OPERATIONS AND BASIS OF PRESENTATION (continued):

 

Furthermore, the estimation process required to prepare the Company’s consolidated financial statements required assumptions to be made about future event and conditions and the impact of COVID-19 in the Company’s financial results, and while Company’s management believe such assumptions are reasonable, they are inherently subjective and uncertain. The Company’s actual results could differ materially from those estimates. As a result of these uncertainties, there is substantial doubt about the Company’s ability to continue as a going concern within one year after the issuance date of these financial statements.

 

These financial statements have been prepared assuming that the Company will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty.

 

3) On March 1, 2019, the Company entered into a Sales Agreement (the “Sales Agreement”) with Cowen and Company, LLC (“Cowen”). During January 2020, the Company sold 831,371 ordinary shares under the Sales Agreement raising a total of approximately $421 thousand (net of issuance expenses of $15 thousand). For more details see note 5a(1).

 

On February 3, 2020, the Company completed an underwritten public offering and raised a total of approximately $5.7 million (net of underwriting discounts, commissions and other offering expenses in the amount of approximately $800 thousand). For more details see note 5a(2).

 

In addition, on May 6, 2020, the Company completed a registered direct offering and concurrent private placement raising a total of approximately $4.5 million (net of placement agent and other offering expenses in the amount of approximately $500 thousand). For more details see note 5a(3).

 

  4) On September 3, 2019, the Company was notified by NASDAQ that it was not in compliance with the minimum bid price requirements for continued listing on the NASDAQ. The notification provided that the Company had 180 calendar days, or until March 2, 2020, to regain compliance. On March 3, 2020, the Company was notified that it is eligible for an additional 180 calendar day period, or until August 31, 2020, to regain compliance. As a result of tolling of compliance periods by NASDAQ, on April 17, 2020, the Company was notified that the term to regain compliance was extended until November 13, 2020.  To regain compliance, the bid price of the Company’s ordinary shares must have a closing bid price of at least $1.00 per share for a minimum of 10 consecutive business days. Accordingly, on July 15, 2020, the Company’s shareholders approved amendments to the Company’s articles of association to effect a reverse share split of its ordinary shares at a ratio with the range from 1-for-5 to 1-for-25, to be effective at the ratio and on a date to be determined by the board of directors in its sole discretion provided the reverse split is effected no later than July 15, 2021. Failure to meet these requirements could result in a delisting of the Company’s ordinary shares which could negatively impact the Company’s ability to raise capital.

 

F-8

 

 

INTEC PHARMA LTD.

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)

(Unaudited)

 

NOTE 1 - NATURE OF OPERATIONS AND BASIS OF PRESENTATION (continued):

 

b. Basis of presentation

 

The unaudited interim condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America (“US GAAP”) and S-X Article 10 for interim financial statements. Accordingly, they do not contain all information and notes required by US GAAP for annual financial statements. In the opinion of management, these unaudited condensed consolidated interim financial statements reflect all adjustments, which include normal recurring adjustments, necessary for a fair statement of the Company’s consolidated financial position as of June 30, 2020, the consolidated results of operations, changes in equity for the three and six-month periods ended June 30, 2020 and 2019 and cash flows for the six-month periods ended June 30, 2020 and 2019.

 

These unaudited interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s annual financial statements for the year ended December 31, 2019, as filed in the 10-K on March 13, 2020. The condensed balance sheet data as of December 31, 2019 included in these unaudited condensed consolidated financial statements was derived from the audited financial statements for the year ended December 31, 2019 but does not include all disclosures required by US GAAP for annual financial statements.

 

The results for the six-month period ended June 30, 2020 are not necessarily indicative of the results expected for the year ending December 31, 2020.

 

F-9

 

 

INTEC PHARMA LTD.

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)

(Unaudited)

 

NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES:

 

a. Principles of consolidation

 

The consolidated financial statements include the accounts of Intec and its Subsidiary. Intercompany balances and transactions have been eliminated upon consolidation.

 

b. Fair value measurement

 

Fair value is based on the price that would be received from the sale of an asset or that would be paid to transfer a liability in an orderly transaction between market participants at the measurement date. In order to increase consistency and comparability in fair value measurements, the guidance establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described as follows:

 

Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs.

 

Level 2: Observable prices that are based on inputs not quoted on active markets but corroborated by market data.

 

Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs.

 

In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and considers counterparty credit risk in its assessment of fair value.

 

F-10

 

 

INTEC PHARMA LTD.

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)

(Unaudited)

 

NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (continued):

 

c. Loss per share

 

Loss per share, basic and diluted, is computed on the basis of the net loss for the period divided by the weighted average number of ordinary shares outstanding during the period. Diluted loss per share is based upon the weighted average number of ordinary shares and of ordinary shares equivalents outstanding when dilutive. Ordinary share equivalents include outstanding stock options and warrants which are included under the treasury stock method when dilutive.

 

The following share options and warrants were excluded from the calculation of diluted loss per ordinary share because their effect would have been anti-dilutive for the periods presented (share data):

 

     

Three months ended

June 30

   

Six months ended

June 30

 
      2020     2019     2020     2019  
  Outstanding stock options     4,657,554       4,401,151       4,333,363       4,296,573  
  Warrants     21,128,749      
-
      15,740,145      
-
 

 

d. Research and development expenses, net

 

Research and development expenses, net for the six-month period ended June 30, 2019, include participation in research and development expenses in the amount of approximately $815 thousand. For the six-month period ended June 30, 2020, the Company had no participation in research and development expenses.

  

NOTE 3 - MARKETABLE SECURITIES

 

The Company’s marketable securities included bonds issued by the State of Israel and corporate bonds with a minimum of A rating by global rating agencies. These assets are recorded as fair value with changes recorded in the statement of operations as “financial income (expenses), net”, as the Company chose to apply the fair value option. These assets are categorized as Level 1.

 

As of June 30, 2020, the Company had no marketable securities. As of December 31, 2019, the amount of the marketable securities is approximately $770 thousand.

 

The gain, net from changes in marketable securities for the six-month periods ended June 30, 2020 and 2019 amounted to approximately $2 thousand and $5 thousand, respectively.

 

NOTE 4 - COMMITMENTS AND CONTINGENT LIABILITIES:

 

a. LTS Process Development Agreement

 

In December 2018, the Company entered into a Process Development Agreement for Manufacturing Services with Lohmann Therapie-Systeme AG (“LTS”) for the manufacture of AP-CD/LD (the “Agreement”). Under the Agreement, the Company will bear the costs incurred by LTS to acquire the production equipment for AP-CD/LD (“Equipment”) which amounted to approximately €6.8 million (approximately $7.8 million), and this amount will later be reimbursed to the Company by LTS in the form of a reduction in the purchase price of the AP-CD/LD product. As of December 31, 2019, the Company paid in full all the consideration and has recognized the Equipment as non-current other assets.

 

In 2019, the Company performed an impairment assessment on certain of its long-lived assets which resulted an impairment charge of the Equipment in the amount of approximately $4.1 million. As of December 31, 2019, the fair value of the Equipment was approximately $3.7 million.

 

F-11

 

 

INTEC PHARMA LTD.

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)

(Unaudited)

 

NOTE 4 - COMMITMENTS AND CONTINGENT LIABILITIES (continued):

 

The Agreement also contains several termination rights which are expected to be included in a definitive manufacturing and supply agreement. As of June 30, 2020, the Company has a liability in the amount of €2.0 million (approximately $2.2 million) for LTS’s facility upgrading costs. This liability will be paid to LTS only if the Company decides not to continue with the project or commercialization of AP-CD/LD.

 

b. Lawsuit

 

In December, 2019, two former directors and officers (the “plaintiffs”) filed a statement of claim with the Jerusalem District Labor Court alleging breach of contract related to a purported vesting of certain options issued to the plaintiffs pursuant to the execution of the LTS Agreement and further alleging payments due for unredeemed vacation days.

 

The plaintiffs are seeking pecuniary damages of NIS 2.4 million (approximately $700 thousand) plus interest and linkage to the Israeli CPI. In addition, the plaintiffs have filed motions to obtain liens on the Company’s assets to secure any future recovery. That motion was withdrawn pursuant to the court’s recommendation at the conclusion of a hearing held on February 9, 2020.

 

The Company records a provision in its financial statements to the extent that it concludes that a contingent liability is probable, and the amount thereof is estimable.

 

The Company together with its legal advisors believe that it has good defense arguments to the claims against it and filed a statement of defense to the complaint on March 8, 2020 in which it rejected all of the plaintiffs’ claims. Accordingly, management assessed the likelihood of damages and concluded that no provisions are needed to be recorded within the financial statements regarding the matter disclosed in this note.

 

NOTE 5 - SHARE CAPITAL:

 

a. Changes in share capital

 

1) On March 1, 2019, the Company entered into a Sales Agreement with Cowen which provides that, upon the terms and subject to the conditions and limitations in the Sales Agreement, the Company may elect from time to time, to offer and sell ordinary shares through an “at-the-market” equity offering program through Cowen acting as sales agent. The issuance and sale of ordinary shares by the Company under the offering program is being made pursuant to the Company’s effective “shelf” registration statement on Form S-3 filed with the SEC on March 1, 2019 and declared effective on March 28, 2019, as amended by a prospectus supplement filed on March 13, 2020. On May 4, 2020, the Company terminated the prospectus supplement, but the sales agreement remains in full force and effect.

 

During January 2020, the Company sold 831,371 ordinary shares under the Sales Agreement at an average price of $0.525 per share for aggregate net proceeds of approximately $421 thousand, net of issuance expenses of approximately $15 thousand.

 

2) On February 3, 2020, the Company completed an underwritten public offering, pursuant to which the Company issued 15,280,000 ordinary shares, pre-funded warrants to purchase 970,000 ordinary shares and warrants to purchase 16,250,000 ordinary shares. Each pre-funded warrant was exercisable at an exercise price of $0.0001 per share. All the pre-funded warrants were exercised following the closing of the offering. Each ordinary share and warrant or pre-funded warrant and warrant were sold together at a combined price of $0.40.  Each warrant shall be exercisable at an exercise price of $0.40 per share and has a term of five years from the date of issuance.

 

F-12

 

 

INTEC PHARMA LTD.

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)

(Unaudited)

 

NOTE 5 - SHARE CAPITAL (continued):

  

The Company has also concluded that the warrants are classified as equity, since they meet all criteria for equity classification. The total net proceeds were approximately $5.7 million, after deducting underwriting discounts, commissions and other offering expenses in the amount of $800 thousand. In June 2020, warrants to purchase 162,500 ordinary shares were exercised for consideration of $65 thousand. As of June 30, 2020, warrants to purchase 16,087,500 ordinary shares remained outstanding. In July 2020, warrants to purchase 730,000 ordinary shares were exercised for consideration of $292 thousand.

 

3) On May 6, 2020, the Company completed a registered direct offering, pursuant to which the Company sold and issued to certain institutional investors 16,291,952 ordinary shares at a purchase price per share of $0.3069. In addition, in a concurrent private placement, the Company also sold and issued to the purchasers in the offering unregistered warrants to purchase 8,145,976 ordinary shares. Each warrant shall be exercisable at an exercise price of $0.245 per share and has a term of five and one-half years from the date of issuance. The Company has also concluded that the warrants are classified as equity, since it meets all criteria for equity classification. The total net proceeds were approximately $4.5 million, after deducting placement agent and other offering expenses in the amount of approximately $500 thousand. As of June 30, 2020, no warrants were exercised. In July 2020, warrants to purchase 1,681,460 ordinary shares were exercised for consideration of approximately $412 thousand.

  

b. Share-based compensation:

 

1) In January 2016, the Company's board of directors approved a new option plan (the "2015 Plan"). Originally, the maximum number of ordinary shares reserved for issuance under the 2015 Plan was 700,000 ordinary shares for grants to directors, employees and consultants. In July 2016, an increase of 700,000 ordinary shares was approved by the board of directors.

 

In December 2017, June 2018 and December 2019, an increase of 2,100,000, 1,000,000 and 1,000,000 ordinary shares, respectively, was approved by the Company’s shareholders at a general meeting of shareholders. In July 2020, the Company’s shareholders approved a further increase (see note 7a).

 

As of June 30, 2020, 1,069,764 shares remain available for grant under the Plan.

 

In the six months ended June 30, 2020 and 2019, the Company granted options as follows:

 

      Six months ended June 30, 2020  
      Number of options granted     Exercise price     Vesting period     Expiration  
  Employees    

645,000

    $

0.4287

    3 years     7 years  

 

      Six months ended June 30, 2019  
      Number of options granted     Exercise price range     Vesting period range     Expiration  
  Employees*    

1,065,000

     

$7.63-$7.64

    3 years     7 years  
  Directors     120,000     $

4.86

    3 years     7 years  

 

* On August 22, 2019, the Company reduced the exercise price of these options to $0.44.

 

The fair value of options granted to employees and directors during the six months ended June 30, 2020, and 2019 was $127 thousand and $4.0 million, respectively.

 

F-13

 

 

INTEC PHARMA LTD.

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)

(Unaudited)

 

NOTE 5 - SHARE CAPITAL (continued):

 

The fair value of options granted to employees and directors on the date of grant was computed using the Black-Scholes model. The underlying data used for computing the fair value of the options are as follows:

 

      Six months ended June 30  
      2020     2019  
  Value of ordinary share   $ 0.28       $4.34-$7.46  
  Dividend yield     0 %     0 %
  Expected volatility     102.58 %     53.32%-54.55 %
  Risk-free interest rate     1.42 %     1.76%-2.57 %
  Expected term     5 years       5 years  

  

2) The following table illustrates the effect of share-based compensation on the statements of operations:

 

      Three months ended June 30     Six months ended
June 30
 
      2020     2019     2020     2019  
      U.S. dollars in thousands     U.S. dollars in thousands  
  Research and development expenses, net   $ 175     $ 597     $ 359     $ 1,167  
  General and administrative expenses     239       421       497       794  
      $ 414     $ 1,018     $ 856     $ 1,961  

   

NOTE 6 - ACCOUNTS PAYBLE AND ACCRUALS - OTHER:

 

      June 30,     December 31,  
      2020     2019  
      U.S. dollars in thousands  
  Expenses payable   $ 2,773     $ 2,838  
  Salary and related expenses, including social security and other taxes     459       1,277  
  Current operating lease liabilities     532       544  
  Accrual for vacation days and recreation pay for employees     211       154  
  Other     22       22  
      $ 3,997     $ 4,835  

 

NOTE 7 - EVENTS SUBSEQUENT TO JUNE 30, 2020

 

  a. Following the annual meeting of the Company’s shareholders on July 15, 2020, (i) the Company granted 300,000 options to purchase ordinary shares to the Company’s Chief Executive Officer, at a per share exercise price of $0.3075.  The options will vest over a three -year period, with one-third of the options vesting at the end of the first anniversary of the date of grant, and the remaining options vesting in eight equal quarterly installments following the first anniversary of the grant date. The options will expire seven years after the date of grant. The value of the benefit in respect of the said options, as calculated on the grant date, is approximately $73 thousand; (ii) the Company granted an aggregate of 200,000 options to purchase ordinary shares to its non-employee directors, at a per share exercise price of $0.3075. The options will vest over a three-year period, with one-third of the options vesting at the end of the first anniversary of the date of grant, and the remaining options vesting in eight equal quarterly installments following the first anniversary of the grant date. The options will expire seven years after the date of grant. The value of the benefit in respect of the said options, as calculated on the grant date, is approximately $48 thousand; (iii) the Company increased its authorized share capital from 100,000,000 ordinary shares to 350,000,000 ordinary shares; and (iv) the Company increased the number of ordinary shares reserved under the 2015 Plan by 3,500,000 to 9,000,000.

 

b. In July 2020, warrants to purchase 2,411,460 ordinary shares were exercised for consideration of approximately $704 thousand.

  

 

 

 

 

 

 

 

 

  

F-14

 

 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

The following discussion and analysis 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 together with our condensed consolidated interim financial statements and the notes to the financial statements, which are included in this Quarterly Report on Form 10-Q. This information should also be read in conjunction with the information contained in our Annual Report on Form 10-K for the year ended December 31, 2019, filed with the Securities and Exchange Commission on March 13, 2020, including the consolidated annual financial statements as of December 31, 2019 and their accompanying notes included therein. We have prepared our condensed consolidated interim financial statements in accordance with U.S. GAAP.

 

This Quarterly Report on Form 10-Q of Intec Pharma Ltd. contains forward-looking statements about our expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. These forward-looking statements are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in Quarterly Report on Form 10-Q are made as of the date of this Quarterly Report on Form 10-Q, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of our control. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the following: our limited operating history and history of operating losses, our ability to continue as a going concern, our ability to obtain additional financing, the impact of the outbreak of coronavirus on our operations, our ability to successfully operate our business or execute our business plan, the timing and cost of our clinical trials, the completion and receiving favorable results in our clinical trials, our ability to obtain and maintain regulatory approval of our product candidates, our ability to protect and maintain our intellectual property and licensing arrangements, our ability to develop, manufacture and commercialize our product candidates, the risk of product liability claims, the availability of reimbursement, and the influence of extensive and costly government regulation. More detailed information about the risks and uncertainties affecting us is contained under the heading “Risk Factors” included in our most recent Annual Report on Form 10-K filed with the SEC on March 13, 2020, and in other filings that we have made and may make with the Securities and Exchange Commission in the future. 

 

All references to “we,” “us,” “our,” “Intec”, “the Company” and “our Company” in this Quarterly Report on Form 10-Q are to Intec Pharma Ltd. and its U.S. subsidiary Intec Pharma Inc., unless the context otherwise requires.

 

Overview

 

We are a clinical stage biopharmaceutical company focused on developing drugs based on our proprietary Accordion Pill platform technology, which we refer to as the Accordion Pill. Our Accordion Pill is an oral drug delivery system that is designed to improve the efficacy and safety of existing drugs and drugs in development by utilizing an efficient gastric retention, or, GR and specific release mechanism. Our product pipeline currently includes several product candidates in various stages. Our leading product candidate, Accordion Pill Carbidopa/Levodopa, or, AP-CD/LD, is being developed for the indication of treatment of Parkinson’s disease symptoms in advanced Parkinson’s disease patients.

 

In July 2019, we announced top-line results from our pivotal Phase III clinical for AP-CD/LD for the treatment of advanced Parkinson’s disease known as the ACCORDANCE study in which the ACCORDANCE study did not meet its target endpoints. While AP-CD/LD provided treatment for Parkinson’s disease symptoms, it did not demonstrate statistically superiority over immediate release CD/LD on the primary endpoint of OFF time reduction under the conditions established in the protocol. Treatment-emergent adverse effects observed with AP-CD/LD were generally consistent with the known safety profile of CD/LD formulations and no new safety issues were observed throughout the double-blinded study, during the gastroscopy safety sub-study or the 12-month open-label extension study. From our review of the data, we have observed a meaningful reduction in OFF time in certain subsets of patients. We have completed the analysis of the full data set and we are currently seeking to partner AP-CD/LD as the basis for the strategy for AP-CD/LD moving forward.

 

Previously, we successfully completed a Phase II clinical trial for AP-CD/LD for the treatment of Parkinson’s disease symptoms in advanced Parkinson’s disease patients and in February 2019, we announced that AP-CD/LD met the primary endpoint in a pharmacokinetic, or PK study, comparing the AP-CD/LD 50/500mg dosed three times daily, the most common dose used in our ACCORDANCE study, to 1.5 tablets of CD/LD immediate release (Sinemet™) 25/100 dosed five times per day in Parkinson’s disease patients.

 

We have invested in the commercial scale manufacture of AP-CD/LD, for which we are in partnership with LTS Lohmann Therapie-Systeme AG (LTS) in Andernach, Germany. In October 2019, we completed the qualification studies for the commercial scale manufacture of the Accordion Pill and we have initiated the validation and stability studies of certain batches which are expected to serve as the clinical material for the next Phase 3 clinical trial plan. We have suspended further validation and stability studies and we intend to initiate the validation and stability studies of the remaining batches upon partnering the AP-CD/LD program.

 

2

 

 

In addition, we have initiated a clinical development program for our Accordion Pill platform with the two primary cannabinoids contained in cannabis sativa, which we refer to as AP-Cannabinoids. We are formulating and testing CBD and THC for the treatment of various pain indications. AP-Cannabinoids are designed to extend the absorption phase of CBD and THC, with the goal of more consistent levels for an improved therapeutic effect, which may address several major drawbacks of current methods of treatment, such as short duration of effect, delayed onset, variability of exposure, variability of the administered dose and adverse events that correlate with peak levels. In March 2017, we initiated a Phase I single-center, single-dose, randomized, three-way crossover clinical trial in Israel to compare the safety, tolerability and PK of AP-THC/CBD with Sativex®, an oral buccal spray containing CBD and THC that is commercially available outside of the United States. Initial results demonstrated that the Accordion Pill platform is well suited to safely deliver CBD and THC with significant improvements in exposure compared with Sativex®. In December 2018, we initiated a PK study of AP-THC and the results of the study demonstrate that the custom designed AP delivery system in the AP-THC PK study did not meet our expectations. We are continuing to advance the AP-Cannabinoids clinical development program and we are seeking to launch a PK study with the optimized AP-THC in 2020.

 

While the ACCORDANCE results were not what we expected, we continue to believe in the potential of the Accordion Pill platform. In December 2018, we reported that we successfully developed an Accordion Pill for a Novartis proprietary compound that met the required in vitro specifications set forth in a feasibility agreement with Novartis. In 2019 we completed the human PK study and its results demonstrated that the AP met the technical requirements set forth by Novartis. In December 2019, Novartis, following an internal and revised commercial strategic assessment, advised us that this program no longer meets Novartis’ mid to long-term strategic goals. Novartis paid us $1.5 million on conclusion of the program. We restructured our clinical manufacturing planned to support this program in order to reduce costs.

 

In May 2019, we reported entering into a research collaboration agreement with Merck for the development of a custom-designed AP for one of Merck’s proprietary compounds. We met the required in vitro specifications for that compound but do not anticipate an in-vivo study in 2020. We continue discussions with Merck regarding further development collaboration with the Accordion Pill.

 

We continue to advance discussions with other potential pharmaceutical partners for the development of new custom-designed APs. We believe the data from our ACCORDANCE trial enhances those discussions as it validates the AP platform and provides long-term safety data.

 

In late 2019, a novel strain of COVID-19, also known as coronavirus, was reported in Wuhan, China. While initially the outbreak was largely concentrated in China, it has now spread to countries across the globe, including in Israel and the United States. Many countries around the world, including in Israel and the United States, have implemented significant governmental measures to control the spread of the virus, including temporary closure of businesses, severe restrictions on travel and the movement of people, and other material limitations on the conduct of business. We implemented remote working and work place protocols for our employees in accordance with government requirements. The implementation of measures to prevent the spread of coronavirus have resulted in disruptions to our partnering efforts which depend, in part, on attendance at in-person meetings, industry conferences and other events. It is still too early to assess the full impact of the coronavirus outbreak and the extent to which the coronavirus impacts our operations will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration and severity of the outbreak, and the actions that may be required to contain the coronavirus or treat its impact.

 

Results of Operations

 

The table below provides our results of operations for the periods indicated.

 

      Three months ended
June 30
    Six months ended
June 30
 
      2020     2019     2020     2019  
      (dollars in thousands)  
                           
  Research and development expenses, net   $ (1,275 )   $ (7,860 )   $ (3,299 )   $ (16,402 )
  General and administrative expenses     (1,630 )     (2,144 )     (3,345 )     (4,334 )
  Operating loss     (2,905 )     (10,004 )     (6,644 )     (20,736 )
  Financial income (expenses), net     4       33       (66 )     143  
  Loss before income tax     (2,901 )     (9,971 )     (6,710 )     (20,593 )
  Income tax     (46 )     (38 )     (107 )     (72 )
  Net loss   $ (2,947 )   $ (10,009 )   $ (6,817 )   $ (20,665 )

 

3

 

 

Three and Six Months Ended June 30, 2020 Compared to Three and Six Months Ended June 30, 2019

 

Research and Development Expenses, Net

 

Our research and development expenses, net, for the three months ended June 30, 2020 amounted to approximately $1.3 million, a decrease of approximately $6.6 million, or 84%, compared to approximately $7.9 million for the three months ended June 30, 2019. Our research and development expenses, net, for the six months ended June 30, 2020 amounted to approximately $3.3 million, a decrease of approximately $13.1 million, or 80%, compared to approximately $16.4 million for the six months ended June 30, 2019. The decrease for the three and six-month periods was primarily due to the completion of our ACCORDANCE study and Open Label Extension study during 2019, decrease in expenses related to the scale up activities for the commercial scale manufacturing, decrease in payroll and related expenses, mostly due to a reduction in headcount, and share-based compensation.

 

General and Administrative Expenses

 

Our general and administrative expenses for the three months ended June 30, 2020 amounted to approximately $1.6 million, a decrease of approximately $500,000, or 24%, compared to approximately $2.1 million for the three months ended June 30, 2019. Our general and administrative expenses for the six months ended June 30, 2020 amounted to approximately $3.3 million, a decrease of approximately $1.0 million, or 23%, compared to approximately $4.3 million for the six months ended June 30, 2019. The decrease for the three and six-month periods was primarily related to a decrease in payroll and related expenses, including reduction in headcount, share-based compensation and reduction in associated expenses.

 

Operating Loss

 

As a result of the foregoing, for the three months ended June 30, 2020 our operating loss was approximately $2.9 million, a decrease of approximately $7.1 million, or 71%, compared to our operating loss for the three months ended June 30, 2019 of approximately $10 million. For the six months ended June 30, 2020 our operating loss was approximately $6.6 million, a decrease of approximately $14.1 million, or 68%, compared to our operating loss for the six months ended June 30, 2019 of approximately $20.7 million. The decrease for the three and six-month periods was due to a decrease in research and development expenses, net and general and administrative expenses, as detailed above.

 

Financial Income (expenses), Net

 

For the three months ended June 30, 2020, we had financial income from interest on cash and cash equivalents in the amount of approximately $17,000, offset by financial expenses from foreign currency exchange expenses in the amount of approximately $13,000 and bank fees. For the three months ended June 30, 2019, we had financial income from interest on cash and cash equivalents in the amount of approximately $92,000, offset by financial expenses from foreign currency exchange expenses in the amount of approximately $54,000 and bank fees.

 

For the six months ended June 30, 2020, we had financial expenses from foreign currency exchange expenses in the amount of approximately $89,000 and bank fees, offset by financial income from interest on cash and cash equivalents in the amount of approximately $27,000 and financial income from change in fair value of marketable securities in the amount of approximately $2,000. For the six months ended June 30, 2019, we had financial income from interest on cash and cash equivalents in the amount of approximately $282,000 offset by financial expenses from foreign currency exchange expenses in the amount of approximately $128,000 and bank fees.  

 

Income tax

 

For the three and six months ended June 30, 2020 and 2019, we have not generated taxable income in Israel. However, for the three months ended June 30, 2020 and 2019, we incurred tax expenses in our U.S. subsidiary in the amount of $46,000 and $38,000, respectively, and for the six months ended June 30, 2020 and 2019 we incurred tax expenses in our U.S. subsidiary in the amount of $107,000 and $72,000, respectively.

 

Net Loss

 

Based on the foregoing, for the three months ended June 30, 2020 our net loss was approximately $2.9 million, a decrease of approximately $7.1 million, or 71%, compared to net loss for the three months ended June 30, 2019 of approximately $10.0 million. For the six months ended June 30, 2020 our net loss was approximately $6.8 million, a decrease of approximately $13.9 million, or 67%, compared to our net loss for the six months ended June 30, 2019 of approximately $20.7 million. The decrease for the three and six-month periods was mainly due to a decrease in research and development expenses, net, and general and administrative expenses, as detailed above.

 

4

 

 

Liquidity and Resources

 

Since our inception, we have funded our operations primarily through public and private offerings (in Israel and in the U.S.) of our equity securities, grants from the IIA and other grants from organizations such as the Michael J. Fox Foundation, and payments received under the feasibility and related agreements we have entered into with multinational pharmaceutical companies, pursuant to which we are entitled to full coverage of our development costs with regard to the projects specified in those agreements.

 

As of June 30, 2020, we had cash and cash equivalents of approximately $13.8 million. As of December 31, 2019, we had cash and cash equivalents and marketable securities of approximately $10.1 million. In February 2020, we completed an underwritten public offering, pursuant to which we issued 15,280,000 ordinary shares, pre-funded warrants to purchase 970,000 ordinary shares and warrants to purchase 16,250,000 ordinary shares. Each pre-funded warrant was exercisable at an exercise price of $0.0001 per share. All the pre-funded warrants were exercised following the closing of the offering. Each ordinary share and warrant or pre-funded warrant and warrant were sold together at a combined price of $0.40. Each warrant is exercisable at an exercise price of $0.40 per share and has a term of five years from the date of issuance. The total net proceeds were approximately $5.7 million, after deducting underwriting discounts, commissions and other offering expenses in the amount of approximately $800,000. In addition, in May 2020, we completed a registered direct offering with certain institutional investors pursuant to which we sold 16,291,952 ordinary shares and in a concurrent private placement, we issued to the investors in the offering warrants to purchase up to 8,145,976 ordinary shares. The warrants are immediately exercisable and expire five and one-half years from issuance at an exercise price of $0.245 per share, subject to adjustment as set forth therein. The total net proceeds were approximately $4.5 million, after deducting placement agent and other offering expenses in the amount of approximately $500,000.

 

Net cash used in operating activities was approximately $6.8 million for the six months ended June 30, 2020 compared with net cash used in operating activities of approximately $17.7 million for the six months ended June 30, 2019. This decrease resulted primarily from a decrease in our research and development activities in the amount of approximately $13.1 million, offset by changes in operating asset and liability items of approximately $2.0 million.

 

We had positive cash flow from investing activities of approximately $769,000 for the six months ended June 30, 2020 compared to negative cash flow from investing activities of approximately $1.0 million for the six months ended June 30, 2019. This change resulted primarily from an investment in the establishment of the commercial scale manufacturing in the amount of approximately $1.4 million in the six months ended June 30, 2019 and an increase in proceeds from the disposal of marketable securities in the amount of approximately $200,000.

 

Net cash provided by financing activities for the six months ended June 30, 2020 was approximately $10.6 million, which was provided primarily by the proceeds from our registered direct in May 2020 that resulted in net proceeds of approximately $4.5 million, proceeds from our underwritten public offering in February 2020 that resulted in net proceeds of approximately $5.7 million and by the funds received from the sale of our ordinary shares under our “at-the-market” equity offering program that resulted in net proceeds of approximately $421,000. Net cash provided by financing activities for the six months ended June 30, 2019 was approximately $268,000, which was provided by the proceeds from the exercise of options by employees.

 

At-the-Market Equity Offering Program

 

Pursuant to that certain Sales Agreement, dated March 1, 2019, or the Sales Agreement, by and between us and Cowen and Company, LLC, we may elect from time to time, to offer and sell ordinary shares through an “at the market offering” as defined in Rule 415(a)(4), or the ATM Offering, promulgated under the Securities Act having an aggregate offering price of up to $75,000,000. Under a prospectus supplement dated March 28, 2019, we sold an aggregate of 2,775,883 ordinary shares for gross proceeds of $2.6 million. On March 13, 2020, we updated the aggregate amount that may be issued and sold under the ATM Offering and filed a prospectus supplement pursuant to which we may offer and sell, from time to time, ordinary shares having an aggregate offering price of up to $9.8 million. From March 13, 2020 to May 4, 2020, we did not issue or sell any of our ordinary shares under the ATM Offering. On May 4, 2020, we terminated the prospectus supplement dated March 13, 2020, but the Sales Agreement remains in full force and effect. 

 

Aspire Capital Financing Arrangement

 

On December 2, 2019, we entered into a purchase agreement, or the Purchase Agreement, with Aspire Capital Fund LLC, or Aspire Capital, pursuant to which provides that, upon the terms and conditions set forth therein, Aspire Capital is committed to purchase up to an aggregate of $10.0 million of our ordinary shares over the 30-month term of the Purchase Agreement. Concurrently with entering into the Purchase Agreement, we also entered into a registration rights agreement with Aspire Capital, or the Registration Rights Agreement, in which we agreed to file with the SEC one or more registration statements, as necessary, and to the extent permissible and subject to certain exceptions, to register for sale under the Securities Act for the sale of our ordinary shares that have been and may be issued to Aspire Capital under the Purchase Agreement.

 

5

 

 

We filed with the SEC a prospectus supplement to our effective shelf registration statement on Form S-3 (File No. 333-230016) registering all of the ordinary shares that may be offered to Aspire Capital from time to time. Under the Purchase Agreement, on any trading day selected by us, we have the right, in our sole discretion, to present Aspire Capital with a purchase notice, each, a Purchase Notice, directing Aspire Capital (as principal) to purchase up to 200,000 of our ordinary shares in an amount no greater than $500,000 per business day, up to $10.0 million of our ordinary shares in the aggregate at a per share price, or the Purchase Price, equal to the lesser of:

 

  the lowest sale price of our ordinary shares on the purchase date; or

 

 

the arithmetic average of the three (3) lowest closing sale prices for our ordinary shares during the ten (10) consecutive trading days ending on the trading day immediately preceding the purchase date.

 

We and Aspire Capital also may mutually agree to increase the dollar amount to greater than $500,000 and the number of ordinary shares that may be sold to as much as an additional 2,000,000 ordinary shares per business day, respectively.

 

In addition, on any date on which we submit a Purchase Notice to Aspire Capital in an amount equal to at least 200,000 ordinary shares, we also have the right, in our sole discretion, to present Aspire Capital with a volume-weighted average price purchase notice, each, a VWAP Purchase Notice, directing Aspire Capital to purchase an amount of ordinary shares equal to up to 30% of the aggregate of our ordinary shares traded on our principal market on the next trading day, or the VWAP Purchase Date, subject to a maximum number of 250,000 ordinary shares. The purchase price per share pursuant to such VWAP Purchase Notice is generally 97% of the volume-weighted average price for our ordinary shares traded on our principal market on the VWAP Purchase Date.

 

The Purchase Price will be adjusted for any reorganization, recapitalization, non-cash dividend, share split, or other similar transaction occurring during the period(s) used to compute the Purchase Price. We may deliver multiple Purchase Notices and VWAP Purchase Notices to Aspire Capital from time to time during the term of the Purchase Agreement, so long as the most recent purchase has been completed.

  

As a result of certain lock-up provisions in our recent registered direct offering, we could not effect any sales under the Purchase Agreement until after August 4, 2020 unless we receive prior written approval from the purchasers in the registered direct offering. The Purchase Agreement provides that we and Aspire Capital shall not effect any sales under the Purchase Agreement on any purchase date where the closing sale price of our ordinary shares is less than $0.25. There are no trading volume requirements or restrictions under the Purchase Agreement, and we will control the timing and amount of sales of our ordinary shares to Aspire Capital. Aspire Capital has no right to require any sales by us, but is obligated to make purchases from us as directed by us in accordance with the Purchase Agreement. There are no limitations on use of proceeds, financial or business covenants, restrictions on future funding, rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement. In consideration for entering into the Purchase Agreement, concurrently with the execution of the Purchase Agreement, we issued to Aspire Capital the Commitment Shares. The Purchase Agreement may be terminated by us at any time, at its discretion, without any cost to us. Aspire Capital has agreed that neither we nor any of our agents, representatives and affiliates shall engage in any direct or indirect short-selling or hedging of our ordinary shares during any time prior to the termination of the Purchase Agreement. Any proceeds from us received under the Purchase Agreement are expected to be used to fund our research and development activities, for working capital and for general corporate purposes.

 

The Purchase Agreement provides that the number of ordinary shares that may be sold pursuant to the Purchase Agreement will be limited to 7,002,394 ordinary shares, or the Exchange Cap, which represents 19.99% of our outstanding ordinary shares on December 2, 2019, unless shareholder approval or an exception pursuant to the rules of the Nasdaq Capital Market is obtained to issue more than 19.99%. This limitation will not apply if, at any time the Exchange Cap is reached and at all times thereafter, the average price paid for all ordinary shares issued under the Purchase Agreement is equal to or greater than $0.48978, which is the price equal to the closing sale price of our ordinary shares immediately preceding the execution of the Purchase Agreement. We are not required or permitted to issue any ordinary shares under the Purchase Agreement if such issuance would breach its obligations under the rules or regulations of the Nasdaq Capital Market or other applicable law (including, without limitation, the Israeli Companies Law – 1999, as amended, or the Israeli Companies Law). We may, in our sole discretion, determine whether to obtain shareholder approval to issue more than 19.99% of our outstanding ordinary shares hereunder if such issuance would require shareholder approval under the rules or regulations of the Nasdaq Capital Market or the Israeli Companies Law.

  

Current Outlook

 

We believe that further fund raising will be required in order to complete the research and development of all of our product candidates, including the manufacturing activities of the AP-CD/LD. We believe that we have adequate cash to fund our ongoing activities into the third quarter of 2021. Our ability to execute our operating plan beyond the third quarter of 2021 is dependent on our ability to obtain additional capital principally through license agreements with third parties and capital raising from the public, private investors and institutional investors, such as through the public offering that we completed in February 2020 raising a total of $5.7 million, net, and the registered direct offering and concurrent private placement that we completed in May 2020 raising a total of approximately $4.5 million, net. We may also engage with a partner in order to share the costs associated with the development and manufacturing of our product candidates. We are closely monitoring ongoing developments in connection with the coronavirus pandemic, which has resulted in disruptions to our partnering efforts and may negatively impact our commercial prospects and our ability to raise capital. As of the date of issuance of these condensed consolidated financial statements, the extent to which the COVID-19 pandemic may materially impact our financial condition, liquidity, or results of operations is uncertain. Furthermore, the estimation process required to prepare our consolidated financial statements required assumptions to be made about future event and conditions and the impact of COVID-19 in our financial results, and while we believe such assumptions are reasonable, they are inherently subjective and uncertain. Our actual results could differ materially from those estimates. As a result, there is substantial doubt about our ability to continue as a going concern within one year after the date our consolidated financial statements are issued. For more information, see note 1(a)(2) in our condensed consolidated financial statements for the six months ended June 30, 2020.

 

6

 

 

Developing drugs, conducting clinical trials, obtaining commercial manufacturing capabilities and commercializing products is expensive and we will need to raise substantial additional funds to achieve our strategic objectives. We will require significant additional financing in the future to fund our operations, including if and when we progress into additional clinical trials of our product candidates, obtain regulatory approval for one or more of our product candidates, obtain commercial manufacturing capabilities and commercialize one or more of our product candidates. Our future capital requirements will depend on many factors, including, but not limited to:

 

  the progress and costs of our clinical trials and other research and development activities;

 

  the scope, prioritization and number of our clinical trials and other research and development programs;

 

  the amount of revenues and contributions we receive under future licensing, collaboration, development and commercialization arrangements with respect to our product candidates;

 

  the impact of the coronavirus outbreak;

 

  the costs of the development and expansion of our operational infrastructure;

 

  the costs and timing of obtaining regulatory approval for one or more of our product candidates;

 

  the ability of us, or our collaborators, to achieve development milestones, marketing approval and other events or developments under our potential future licensing agreements;

 

  the costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights;

 

  the costs and timing of securing manufacturing arrangements for clinical or commercial production;

 

  the costs of contracting with third parties to provide sales and marketing capabilities for us or establishing such capabilities ourselves;

 

  the costs of acquiring or undertaking development and commercialization efforts for any future products, product candidates or technology;

 

  the magnitude of our general and administrative expenses;
     
  market conditions; and

 

  any cost that we may incur under future in- and out-licensing arrangements relating to one or more of our product candidates.

 

Until we can generate significant recurring revenues, we expect to satisfy our future cash needs through capital raising or by out-licensing applications of one or more of our product candidates. We cannot be certain that additional funding will be available to us on acceptable terms, if at all. 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, one or more of our product candidates and make necessary change to our operations to reduce the level of our expenditures in line with available resources. 

 

Off-Balance Sheet Arrangements

 

We have no off-balance sheet arrangements that have had or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors.

 

Critical Accounting Policies

 

This discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these consolidated financial statements requires us to make estimates that affect the reported amounts of our assets, liabilities and expenses. Significant accounting policies employed by us, including the use of estimates, are presented in the notes to the consolidated financial statements included elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2019. We periodically evaluate our estimates, which are based on historical experience and on various other assumptions that we believe to be reasonable under the circumstances. Critical accounting policies are those that are most important to the portrayal of our financial condition and results of operations and require our subjective or complex judgments, resulting in the need to make estimates about the effect of matters that are inherently uncertain. If actual performance should differ from historical experience or if the underlying assumptions were to change, our financial condition and results of operations may be materially impacted.

 

Our critical accounting policies and estimates are disclosed in our Annual Report on Form 10-K for the year ended December 31, 2019.  There have been no material changes to those policies during the six months ended June 30, 2020.

 

7

 

 

Recently Issued Accounting Pronouncements

 

None.

 

Item 3. Quantitative and Qualitative Disclosures about Market Risk

 

Not required for smaller reporting companies.

 

Item 4. Disclosure Controls and Procedures

 

We maintain disclosure controls and procedures that are designed to provide reasonable assurance that information required to be disclosed by us in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can only provide reasonable assurance of achieving the desired control objectives, and in reaching a reasonable level of assurance, management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

 

Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, we have evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of June 30, 2020. Based on that evaluation, our principal executive officer and principal financial officer have concluded that as of June 30, 2020 these disclosure controls and procedures were effective at the reasonable assurance level.

 

Changes in Internal Control over Financial Reporting

 

There was no change in our internal control over financial reporting identified in connection with the evaluation required by Rules 13a-15(d) and 15d-15(d) under the Exchange Act that occurred during the quarter ended June 30, 2020 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. 

 

8

 

 

PART II. OTHER INFORMATION

 

Item 1. Legal Proceedings

 

From time to time, we may become involved in various lawsuits and legal proceedings, which arise in the ordinary course of business. Litigation is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may harm our business. There are currently no pending material legal proceedings, and we are currently not aware of any legal proceedings or claims against us or our property that we believe will have any significant effect on our business, financial position or operating results. None of our officers or directors is a party against us in any legal proceeding.

 

On December 19, 2019, Zvi Joseph and Giora Carni, former officers and directors of the Company, filed a complaint with the Jerusalem District Labor Court alleging breach of contract related to the purported vesting of certain options issued to the plaintiffs and further alleging payments due for unredeemed vacation days. The plaintiffs are seeking pecuniary damages of NIS 2,443,098 (approximately $700,000) plus interest and linkage to the Israeli Consumer Price Index. In addition, the plaintiffs have filed motions to obtain liens on our assets to secure any future recovery. These motions were withdrawn pursuant to the Court’s recommendation at the conclusion of a pretrial hearing held on February 9, 2020. We together with our legal advisors believe that we have good defense arguments to the claims against us and filed a statement of defense to the complaint on March 8, 2020 in which we rejected all of the plaintiffs’ claims. Accordingly, we assessed the likelihood of damages and concluded that no provisions are needed to be recorded within the financial statements regarding this matter.

 

Item 1A. Risk Factors

 

Our business is subject to risks arising from the outbreak of coronavirus which has impacted and continues to impact our business.

 

Public health epidemics or outbreaks could adversely impact our business. In late 2019, a novel strain of COVID-19, also known as coronavirus, was reported in Wuhan, China. While initially the outbreak was largely concentrated in China, it has now spread to countries across the globe, including in Israel and the United States. Many countries around the world, including in Israel and the United States, have implemented significant governmental measures to control the spread of the virus, including temporary closure of businesses, severe restrictions on travel and the movement of people, and other material limitations on the conduct of business. We implemented remote working and work place protocols for our employees in accordance with government requirements. The implementation of measures to prevent the spread of coronavirus have resulted in disruptions to our partnering efforts which depend, in part, on attendance at in-person meetings, industry conferences and other events. It is still too early to assess the full impact of the coronavirus outbreak and the extent to which the coronavirus impacts our operations will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration and severity of the outbreak, and the actions that may be required to contain the coronavirus or treat its impact. In particular, the continued spread of the coronavirus globally could materially adversely impact our operations and workforce, including our research and development, partnering efforts, and our ability to raise capital, each of which in turn could have a material adverse impact on our business, financial condition and results of operation.

 

If we fail to comply with the continued listing requirements of the Nasdaq Capital Market, our ordinary shares may be delisted and the price of our ordinary shares and our ability to access the capital markets could be negatively impacted.

 

On September 3, 2019, we were notified by Nasdaq that we were not in compliance with the minimum bid price requirements set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on the Nasdaq Capital Market. Nasdaq Listing Rule 5550(a)(2) requires listed securities to maintain a minimum bid price of $1.00 per share, and Nasdaq Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid price requirement exists if the deficiency continues for a period of 30 consecutive business days. The notification provided that we had 180 calendar days, or until March 2, 2020, to regain compliance with Nasdaq Listing Rule 5550(a)(2). On March 3, 2020, we were notified by Nasdaq that we are eligible for an additional 180 calendar day period, or until August 31, 2020, to regain compliance. On April 17, 2020, we were notified by Nasdaq that as a result of tolling of compliance periods by Nasdaq, our term to regain compliance was extended until November 13, 2020. To regain compliance, the bid price of our ordinary shares must have a closing bid price of at least $1.00 per share for a minimum of 10 consecutive business days.

 

On July 15, 2020, our shareholders approved amendments to our articles of association to effect a reverse share split of our ordinary shares at a ratio with the range from 1-for-5 to 1-for-25, to be effective at the ratio and on a date to be determined by the board of directors in its sole discretion provided the reverse split is effected no later than July 15, 2021. If we implement a reverse share split, it is not uncommon for the market price of a company’s shares to decline in the period following a reverse share split. If the market price of our ordinary shares declines following the reverse share split, the percentage decline may be greater than would occur in the absence of a reverse share split. In addition, if we implement a reverse share split the liquidity of our ordinary shares may decrease as a result of the corresponding reduction in the number of shares that are outstanding following such split and the reverse share split may increase the number of shareholders who own odd lots (less than 100 shares) of our ordinary shares, creating the potential for such shareholders to experience an increase in the cost of selling their shares and greater difficulty effecting such sales.

 

9

 

 

Failure to meet applicable Nasdaq continued listing standards could result in a delisting of our ordinary shares. A delisting of our ordinary shares from Nasdaq could materially reduce the liquidity of our ordinary shares and result in a corresponding material reduction in the price of our ordinary shares. In addition, delisting could harm our ability to raise capital on terms acceptable to us, or at all, and may result in the potential loss of confidence by investors, employees and fewer business development opportunities.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

None.

 

Item 3. Defaults Upon Senior Securities

 

None.

 

Item 4. Mine Safety Disclosures

 

Not applicable.

 

Item 5. Other Information

 

None.

 

Item 6. Exhibits

 

Exhibit No.   Exhibit Description
     
3.1   Articles of Association of Intec Pharma Ltd., as amended (incorporated herein by reference to Exhibit 3.4 of the Company’s Annual Report on Form 10-K filed with the SEC on February 27, 2019)
     
31.2*   Certification of Principal Financial Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a), promulgated under the Securities Exchange Act of 1934, as amended
     
32.1#   Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
     
32.2#   Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
     
101.INS*   XBRL Instance Document
     
101.SCH*   XBRL Taxonomy Extension Schema Document
     
101.CAL*   XBRL Taxonomy Extension Calculation Linkbase Document
     
101.DEF*   XBRL Taxonomy Extension Definition Linkbase Document
     
101.LAB*   XBRL Taxonomy Extension Labels Linkbase Document
     
101.PRE*   XBRL Taxonomy Extension Presentation Linkbase Document

   

  * Filed herewith
  # Furnished herewith

 

10

 

 

SIGNATURES

 

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  Intec Pharma Ltd.
     
Date: August 5, 2020 By: /s/ Jeffrey A. Meckler
    Jeffrey A. Meckler
    Chief Executive Officer and Vice Chairman
    (Principal Executive Officer)
     
Date: August 5, 2020 By: /s/ Nir Sassi
    Nir Sassi
    Chief Financial Officer
    (Principal Financial and Accounting Officer)

 

 

11

 

 

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