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 February 2022

Commission File Number: 001-37643

 

PURPLE BIOTECH LTD.

(Translation of registrant’s name into English)

 

4 Oppenheimer Street, Science Park, Rehovot 7670104, 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 February 9, 2022, Purple Biotech Ltd. (the “Company” or the “Registrant”) issued a press release, “Purple Biotech Reports Second Half and Full-Year 2021 Financial Results”, which is attached hereto as Exhibit 99.1.

 

Exhibit  
   
99.1 Purple Biotech Reports Second Half and Full-Year 2021 Financial Results

 

Incorporation by Reference

 

This Form 6-K, including all exhibits attached hereto, is hereby incorporated by reference into each of 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), the Registrant’s Registration Statement on Form F-3, as amended, originally filed with the Securities and Exchange Commission on July 16, 2018 (Registration file number 333-226195), the Registrant’s Registration Statement on Form S-8 filed with the Securities and Exchange Commission on March 28, 2019 (Registration file number 333-230584), the Registrant’s Registration Statement on Form F-3 filed with the Securities and Exchange Commission on September 16, 2019 (Registration file number 333-233795), the Registrant’s Registration Statement on Form F-3 filed with the Securities and Exchange Commission on December 2, 2019 (Registration file number 333-235327), the Registrant’s Registration Statement on Form F-3 filed with the Securities and Exchange Commission on May 13, 2020 (Registration file number 333- 238229), the Registrant’s Registration Statement on Form S-8 filed with the Securities and Exchange Commission on May 18, 2020 (Registration file number 333-238481) and each of the Registrant’s Registration Statements on Form F-3 filed with the Securities and Exchange Commission on July 10, 2020 (Registration file numbers 333-239807 and 333-233793), to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.

 

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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. 

 

February 9, 2022 PURPLE BIOTECH LTD.
   
  By: /s/ Isaac Israel
    Isaac Israel
    Chief Executive Officer

 

 

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Exhibit 99.1

 

Purple Biotech Reports Second Half and Full-Year 2021 Financial Results

 

REHOVOT, Israel, February 9, 2022 - Purple Biotech Ltd. (“Purple Biotech”, or the “Company”) (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class, effective and durable therapies by overcoming tumor immune evasion and drug resistance, today announced financial results for the year and the six months ended December 31, 2021.

 

“We achieved significant progress in the advancement of our promising oncology pipeline during this year with notable data releases in both of our lead candidates,” said Gil Efron, President and Chief Financial Officer of Purple Biotech. “For NT219, we are currently treating patients in the fourth dose cohort monotherapy arm of the ongoing Phase 1/2 clinical trial and have initiated the first dose level in the combination arm of the study together with cetuximab for patients with squamous cell carcinoma of head and neck (SCCHN). For CM24, we are about to complete dose escalation of the phase 1b/2 of the study and will soon initiate the expansion arms of the study in non-small-cell lung cancer (NSCLC) and pancreatic cancer. We are encouraged by the preliminary data reported from the first patients treated in each of the studies released in 2021 and are planning to expand both programs to additional promising indications in 2022.”

 

“We continue to be focused on development of our robust oncology programs, supported by a strong balance sheet. With $47.4 million in cash, cash equivalent, short and long-term deposits at the end of December 2021, our cash runway extends into 2024,” concluded Mr. Efron.

 

Financial Results for the Year Ended December 31, 2021

 

Research and Development Expenses were $11.8 million, an increase of $4.6 million, or 64%, compared to $7.2 million in the same period of 2020. The increase was due to expenses related to the ongoing NT219 and CM24 clinical trials, including the manufacturing of drug for the studies.

 

Selling, General and Administrative Expenses were $6.1 million, compared to $6.0 million in the same period of 2020, an increase of $0.1 million.

 

Operating Loss was $17.9 million, an increase of $4.7 million, or 36%, compared to $13.2 million in the same period of 2020. The increase was mainly due to the increase in research and development expenses.

 

On a non-IFRS basis (as reconciled below), adjusted operating loss was $15.8 million, an increase of $5.2 million, compared to $10.6 million in the same period of 2020, mainly due to the increased expenses for clinical studies and manufacturing of drug for these studies.

 

Net Loss for 2021 was $18.5 million, or $1.05 per basic and diluted share, compared to a net loss of $28 million, or $2.45 per basic and diluted share, in 2020. The decrease in net loss was mainly due to $15.7 million in expenses related to a change in the fair value of derivatives, offset by an increase of $4.7 million in operating expenses. Adjusted net loss for the year was $15.7 million, an increase from $10.4 million in the full year of 2020.

 

As of December 31, 2021, Purple Biotech had cash and cash equivalents and short- and long-term deposits of $47.4 million, compared to $60.8 million on December 31, 2020. The Company believes that its cash position will provide sufficient resources to support its currently anticipated ongoing needs into 2024.

 

Discontinued Operation. As previously reported, COVID-19 adversely impacted the launch of Consensi in the United States. In October 2021, the Company agreed, together with its then U.S distributor for Consensi, Coeptis Pharmaceuticals Inc., to terminate the distribution agreement. Despite our efforts to identify an alternative distributor for Consensi in the U.S., we concluded that commercialization of Consensi, both in the U.S market and elsewhere, is not likely to generate significant revenue and achieve profitability in the near term. In order to reduce the expenses involved in maintaining the product, it was concluded to discontinue Consensi activities and to allocate the funds to our core oncology activities. In parallel, the agreements with Kuhnil Pharmaceuticals Inc.’s for the territory of South Korea and Hebei Changshan Biochemical Pharmaceutical Co., Ltd. for the territory of China were terminated. Consequently, the Company is reporting Consensi as a discontinued operation. Loss from discontinued operation in 2021 was $0.6 million compared to profit from discontinued operation of $0.6 million in 2020. The decrease in profit is mainly due to a decrease in Consensi revenues of $1.0 million generated in 2020.

 

 

 

 

Financial Results for the Six Months Ended June 30, 2021

 

Research and Development Expenses were $4.9 million, an increase of $0.6 million, or 14%, compared to $4.3 million in the same period of 2020. The increase was due to expenses related to the CM24 clinical trials that started in the first half of 2021.

 

Selling, General and Administrative Expenses were $2.9 million, compared to $3.9 million in the same period of 2020, a decrease of $1 million. The decrease was mainly due to a $0.9 million decrease in employee equity-based compensation (ESOP) costs.

 

Operating Loss was $7.8 million, a decrease of $0.5 million, or 6%, compared to $8.3 million in the same period of 2020.

 

On a non-IFRS basis (as reconciled below), adjusted operating loss was $7.1 million, a decrease of $0.7 million, compared to $6.4 million in the same period of 2020, mainly to decrease in Selling, General and Administrative Expenses offset by increase in R&D expenses.

 

Net Loss for the second half of 2021 was $8.3 million, or $0.47 per basic and diluted share, compared to a net loss of $0.2 million, or $0.01 per basic share and $0.47 per diluted share, in the second half of 2020. The increase in net loss was mainly due to decrease of $7.9 million in income related to a change in the fair value of derivatives, offset by an increase of $0.5 million in operating expenses and decrease of $1 million in revenues. Adjusted net loss for the second half of 2021 was $7.0 million, an increase from $6.3 million in the second half of 2020.

 

About Purple Biotech

 

Purple Biotech Ltd. is a clinical-stage company developing first-in-class therapies by overcoming tumor immune evasion and drug resistance. The Company’s oncology pipeline includes NT219 and CM24. NT219 is a dual inhibitor, novel small molecule that simultaneously targets IRS1/2 and STAT3. The Company is currently advancing NT219 as a monotherapy treatment of solid tumors, and have initiated a dose escalation of NT219 in combination with cetuximab for the treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck cancer (SCCHN) or colorectal adenocarcinoma in a phase 1/2 study, to be followed by an expansion phase of NT219 at its recommended phase 2 level in combination with cetuximab in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck cancer. CM24 is a humanized monoclonal antibody that blocks CEACAM1, an immune checkpoint protein that supports tumor immune evasion and survival through multiple pathways. The Company is advancing CM24 as a combination therapy with anti-PD-1 checkpoint inhibitors in selected cancer indications in a phase 1b study followed by a phase 2 for the treatment of non-small cell lung cancer and pancreatic cancer. The Company has entered into a clinical collaboration agreement, as amended, with Bristol Myers Squibb for the planned phase 1/2 clinical trials to evaluate the combination of CM24 with the PD-1 inhibitor nivolumab (Opdivo®) in patients with non-small cell lung cancer and in combination with nivolumab in addition to nab-paclitaxel (ABRAXANE®) in patients with pancreatic cancer. The Company’s corporate headquarters are located in Rehovot, Israel. For more information, please visit https://www.purple-biotech.com.

 

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Forward-Looking Statements and Safe Harbor Statement

 

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. Such forward-looking statements include, but are not limited to, statements that are not statements of historical fact, and may be identified by 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: the plans, strategies and objectives of management for future operations; product development for NT219 and CM24; the process by which early stage therapeutic candidates such as NT219 and CM24 could potentially lead to an approved drug product is long and subject to highly significant risks, particularly with respect to a joint development collaboration; 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 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 obtained by competitors; dependence on the effectiveness of our patents and other protections for innovative products; our ability to obtain, maintain and defend issued patents; the commencement of any patent interference or infringement action against our patents, and 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, and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2020 and in our other filings with the U.S. Securities and Exchange Commission (“SEC”), including our cautionary discussion of risks and uncertainties under “Risk Factors” in our Registration Statements 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, https://www.sec.gov.

 

Company Contact:

 

Gil Efron

 

President & Chief Financial Officer

 

IR@purple-biotech.com

 

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Purple Biotech Ltd.

 

Consolidated Unaudited Statements of Financial Positions

 

    As of December 31,  
    2021     2020  
    USD thousands     USD thousands  
             
Current assets            
Cash and cash equivalents     10,890       11,247  
Short term deposits     36,310       46,558  
Trade receivables     -       500  
Other current assets     1,273       977  
                 
Total current assets     48,473       59,282  
                 
Non-current assets                
Other investments     187       -  
Right to use assets     619       790  
Fixed assets, net     277       178  
Long term deposits     160       3,071  
Intangible assets     20,482       20,482  
                 
Total assets     70,198       83,803  
                 
Current liabilities                
Lease liability -short term     199       207  
Accounts payable     1,473       1,198  
Other payables     2,578       1,693  
                 
Total current liabilities     4,250       3,098  
                 
Non-current liabilities                
                 
Lease liability     550       688  
Post-employment benefit liabilities     292       265  
                 
Total non-current liabilities     842       953  
                 
Equity                
                 
Share capital, no par value     -       -  
Share premium     123,951       118,909  
Receipts on account of warrants     28,017       29,984  
Capital reserve for share based payment     8,862       8,115  
Capital reserve from transactions with related parties     761       761  
Capital reserve from transactions with non-controlling interest     (859 )     (859 )
Accumulated loss     (95,905 )     (77,521 )
                 
Equity attributable to owners of the Company     64,827       79,389  
Non-controlling interest     279       363  
                 
Total equity     65,106       79,752  
                 
Total liabilities and equity     70,198       83,803  

 

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Purple Biotech Ltd.

 

Consolidated Unaudited Statements of Operations

 

    For the year ended     For the six months ended  
    December 31,     December 31,  
    2021     2020     2021     2020  
    USD thousands     USD thousands     USD thousands     USD thousands  
                         
Revenues     -       -       -       -  
                                 
Research and development expenses     11,827       7,238       4,867       4,324  
Sales, general and administrative expenses     6,107       6,001       2,914       3,948  
                                 
Total operating expenses     17,934       13,239       7,781       8,272  
                                 
Operating loss     17,934       13,239       7,781       8,272  
                                 
Expenses (income) on account of warrants     -       15,655               (7,928 )
Finance expenses     212       61       90       46  
Finance income     (320 )     (254 )     (124 )     (170 )
                                 
Finance expenses (income), net     (108 )     15,462       (34 )     (8,052 )
                                 
Loss for the year from continuing operations     17,826       28,701       7,747       220  
                                 
Loss (Profit) from discontinued operation     642       (627 )     508       38  
                                 
Loss attributable to:                                
Owners of the Company     18,384       27,999       8,209       220  
Non-controlling interests     84       75       46       38  
                                 
      18,468       28,074       8,255       258  
Loss per share date                                
Continuing operations                                
Basic loss per ADS - USD     1.01       2.50       0.44       0.01  
                                 
Diluted loss per ADS - USD     1.01       2.50       0.44       0.47  
                                 
Number of shares used in calculating basic loss per ADS     17,568,036       11,500,113       17,680,054       16,928,162  
                                 
Number of shares used in calculating diluted loss per ADS     17,568,036       11,500,113       17,680,054       17,160,018  
                                 

Discontinued operation

     
       
Basic loss (profit) per ADS – USD     0.04       (0.05 )     0.029       0.002  
                                 
Diluted loss (profit) per ADS - USD     0.04       (0.05 )     0.029       0.002  
                                 
Number of shares used in calculating basic loss per ADS     17,568,036       11,500,113       17,680,054       16,928,162  
                                 
Number of shares used in calculating diluted loss per ADS     17,568,036       11,500,113       17,680,054       17,160,018  

 

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Purple Biotech Ltd.

 

Consolidated Unaudited Statements of Cash Flow

 

    For the year ended     For the six months ended  
    December 31,     December 31,  
    2021     2020     2021     2020  
    USD thousands     USD thousands     USD thousands     USD thousands  
                         
Cash flows from operating activities from continuing operation:                        
Loss for the period from continuing operation     (17,826 )     (28,701 )     (7,747 )     (220 )
                                 
Adjustments:                                
Depreciation     231       235       124       143  
Finance expense (income), net     (108 )     15,462       (34 )     (8,052 )
Share-based payments     2,082       2,645       697       1,895  
                                 
      (15,621 )     (10,359 )     (6,960 )     (6,234 )
                                 
Changes in assets and liabilities:                                
Changes in trade receivables and other current assets     (316 )     1,002       (727 )     380  
Changes in accounts payable     266       (2,537 )     (340 )     32  
Changes in other payables     573       (572 )     1,122       (923 )
Changes in post-employment benefit liabilities     27       (20 )     27       19  
                                 
      550       (2,127 )     82       (492 )
                                 
Net cash used in operating activities from continuing operation     (15,071 )     (12,486 )     (6,878 )     (6,726 )
                                 
Cash flows from investing activities from continuing operation:                                
Cash assumed as part of acquisition of Famewave     -       69       -       -  
Decrease (increase) in deposits     13,162       (49,618 )     6,396       (49,618 )
Interest received     359       110       244       71  
Acquisition of fixed assets     (115 )     (156 )     (6 )     (156 )
                                 
Net cash provided by (used in) investing activities from continuing operation     13,406       (49,595 )     6,634       (49,703 )
                                 
Cash flows from financing activities from continuing operation:                                
Proceeds from issuance of ADSs     564       27,925       564       -  
ADS issuance expenses paid     (24 )     (2,074 )     (24 )     (34 )
Proceeds from issuance of warrants     -       26,574       -       -  
Warrants issuance expenses paid     -       (3,281 )     -       (150 )
Proceeds from exercise of warrants     1,200       19,547       -       5,627  
Repayment of lease liability     (153 )     (188 )     (80 )     (108 )
Interest paid     (75 )     (15 )     (38 )     (4 )
                                 
Net cash provided by financing activities from continuing operation     1,512       68,488       422       5,331  

 

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Purple Biotech Ltd.

 

Consolidated Unaudited Statements of Cash Flow (cont’d)

 

    For the year ended     For the six months ended  
    December 31,     December 31,  
    2021     2020     2021     2020  
    USD thousands     USD thousands     USD thousands     USD thousands  
                         
Cash flows in respect of discontinued operation as follows:                        
                         
Net cash from (used in) operating activities     (180 )     394       185       (725 )
Net cash from investing activities     -       -       -       -  
Net cash from financing activities     -       -       -       -  
                                 
Net cash from (used in) discontinued operation     (180 )     394       185       (725 )
                                 
Net increase (decrease) in cash and cash equivalents     (333 )     6,801       363       (51,823 )
Cash and cash equivalents at the beginning of the period     11,247       4,385       10,540       62,995  
Effect of translation adjustments on cash and equivalents     (24 )     61       (13 )     75  
                                 
Cash and cash equivalents at end of the period     10,890       11,247       10,890       11,247  

 

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Purple Biotech Ltd.

 

Reconciliation of Non-IFRS financial Results

 

 

Reconciliation of Adjusted Operating Loss

 

    For the year ended     For the six months ended  
    December 31,     December 31,  
    2021     2020     2021     2020  
    USD thousands     USD thousands     USD thousands     USD thousands  
                         
Operating loss for the year     17,934       13,239       7,781       8,272  
Less ESOP expenses     (2,082 )     (2,645 )     (697 )     (1,895 )
                                 
      15,852       10,594       7,084       6,377  

 

Reconciliation of Adjusted Net Loss

 

    For the year ended     For the six months ended  
    December 31,     December 31,  
    2021     2020     2021     2020  
    USD thousands     USD thousands     USD thousands     USD thousands  
                         
Net loss for the year     18,468       28,074       8,255       258  
Less warrant expenses     -       (15,655 )     -       7,928  
Less ESOP expenses     (2,082 )     (2,645 )     (697 )     (1,895 )
Less loss (profit) from discontinued operation     (642 )     627       (508 )     (38 )
                                 
      15,744       10,401       7,050       6,253  

 

 

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