EX-99.1 2 ea155092ex99-1_purplebio.htm PURPLE BIOTECH REPORTS SECOND HALF AND FULL-YEAR 2021 FINANCIAL RESULTS

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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