Full Press Release Details
Biotech Provides Corporate Update and Reports First Half 2021 Financial Results
Israel, August 5, 2021 - 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 provided
a corporate update and announced financial results for the six months ended June 30, 2021.
achieved significant progress in the advancement of our promising oncology pipeline during the first half of 2021," said Isaac
Israel, Chief Executive Officer of Purple Biotech. "For NT219, we are currently treating patients in the third dose cohort of our ongoing
Phase 1/2 clinical trial, and presented encouraging initial safety and efficacy results from this study at ASCO. The initial results
from the first dose level cohort demonstrated that NT219 was well-tolerated with minimal serious adverse events, and a partial response,
including complete remission at the largest target lesion, was observed in one refractory patient previously treated with four lines
of therapies. We expect to report additional data from higher dose levels of this study in the second half of this year. Moreover,
for CM24, we are currently recruiting patients into the second dose cohort of our ongoing Phase 1b/2 clinical trial. There were no dose-limiting
toxicities or serious clinically relevant adverse events observed in any patient enrolled
in the first cohort of the study and we intend to provide additional preliminary safety and efficacy data at an upcoming medical conference."
our robust clinical development programs are supported by a strong balance sheet. With $53.4 million in cash, cash equivalent, short
and long-term deposits at the end of June 2021, our cash runway extends into 2024," concluded Mr. Israel.
Corporate Highlights
Results for the Six Months Ended June 30, 2021
revenue was recorded for the six months ended June 30, 2021, as compared to $1.0 million for the same period of 2020.
and Development Expenses were $7.1 million, an increase of $4.0 million, or 129%, compared to $3.1 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
General and Administrative (SG&A) Expenses were $3.2 million, compared to $2.2 million in the same period of 2020, an increase
of $1 million. The increase was mainly due to a $0.6 million increase in ESOP costs and an increase in legal, consulting fees and insurance
Loss was $10.3 million, an increase of $6.0 million, or 139%, compared to $4.3 million in the same period of 2020.
a non-IFRS basis (as reconciled below), adjusted operating loss was $8.9 million, an increase of $5.3 million, compared
to $3.6 million in the same period of 2020, mainly due to the increased expenses for clinical studies and manufacturing of drug for these
Loss for the first half of 2021 was $10.2 million, or $0.59 per diluted share, compared to a net loss of $27.8 million, or $4.63
per diluted share, in the first half of 2020. The decrease in net loss was due to $23.5 million in expenses related to a change in the
fair value of derivatives, offset by an increase of $4.9 million in operating expenses and decrease of $1 million in revenues. Adjusted
net loss for the first half was $8.8 million, an increase from $3.5 million in the first half of 2020.
of June 30, 2021, Purple Biotech had cash and cash equivalents and short- and long-term deposits of $53.4 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.
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, followed by 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, and 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. 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 is also the owner of Consensi ,
an FDA-approved fixed-dose combination of celecoxib and amlodipine besylate, for the simultaneous treatment of osteoarthritis pain and
hypertension that was approved by the FDA for marketing in the U.S. The Company's corporate headquarters are located in Rehovot,
Israel. For more information, please visit https://www.purple-biotech.com.
Statements and Safe Harbor Statement
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, and our partners'
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.
& Chief Financial Officer
Consolidated Unaudited Interim Statements of Financial Position as of
| June 30, 2021 | December 31, 2020 | |||||||
| USD thousand | USD thousand | |||||||
| Assets | ||||||||
| Cash and cash equivalents | 10,540 | 11,247 | ||||||
| Short term deposits | 37,846 | 46,558 | ||||||
| Trade receivables | 500 | 500 | ||||||
| Other current assets | 1,115 | 977 | ||||||
| Total current assets | 50,001 | 59,282 | ||||||
| Non - current assets | ||||||||
| Right of use assets | 708 | 790 | ||||||
| Fixed assets, net | 283 | 178 | ||||||
| Long term deposits | 5,017 | 3,071 | ||||||
| Intangible assets | 20,482 | 20,482 | ||||||
| Total assets | 76,491 | 83,803 | ||||||
| Liabilities | ||||||||
| Lease liability - short term | 199 | 207 | ||||||
| Accounts payable | 2,071 | 1,198 | ||||||
| Other payables | 1,227 | 1,693 | ||||||
| Total current liabilities | 3,497 | 3,098 | ||||||
| Non - current liabilities | ||||||||
| Lease liability | 605 | 688 | ||||||
| Post-employment benefit liabilities | 265 | 265 | ||||||
| Total non-current liabilities | 870 | 953 | ||||||
| Equity | ||||||||
| Share capital, no par value | - | - | ||||||
| Share premium | 122,214 | 118,909 | ||||||
| Receipts on account of warrants | 28,015 | 29,984 | ||||||
| Capital reserve for share-based payments | 9,364 | 8,115 | ||||||
| Capital reserve from transactions with related parties | 761 | 761 | ||||||
| Capital reserve from transactions with non- controlling interest | (859 | ) | (859 | ) | ||||
| Accumulated loss | (87,696 | ) | (77,521 | ) | ||||
| Equity attributable to owners of the Company | 71,799 | 79,389 | ||||||
| Non-controlling interests | 325 | 363 | ||||||
| Total equity | 72,124 | 79,752 | ||||||
| Total liabilities and equity | 76,491 | 83,803 |
Consolidated Unaudited Interim Statements of Operations
| For the six months ended June 30 | ||||||||
| 2021 | 202 0 | |||||||
| USD thousand | USD thousand | |||||||
| Revenues | - | 1,000 | ||||||
| Research and development expenses | 7,091 | 3,133 | ||||||
| Sales, general and administrative expenses | 3,196 | 2,169 | ||||||
| Total operation expenses | 10,287 | 5,302 | ||||||
| Operating loss | 10,287 | 4,302 | ||||||
| Expenses (income) on account of warrants | - | 23,583 | ||||||
| Finance expense | 122 | 15 | ||||||
| Finance income | (196 | ) | (84 | ) | ||||
| Finance expense (income), net | (74 | ) | 23,514 | |||||
| Loss for the period | 10,213 | 27,816 | ||||||
| Loss attributable to: | ||||||||
| Owners of the Company | 10,175 | 27,779 | ||||||
| Non-controlling interests | 38 | 37 | ||||||
| 10,213 | 27,816 | |||||||
| Loss per share data | ||||||||
| Basic and diluted loss per ADS - USD | 0.59 | (*)4.63 | ||||||
| Number of shares used in calculation of basic and diluted loss per ADS | 17,454,161 | (*)6,009,105 |
Consolidated Statement of Cash Flows
| For the six months ended June 30 | ||||||||
| 2021 | 2020 | |||||||
| USD thousand | USD thousand | |||||||
| Cash flows from operating activities: | ||||||||
| Loss for the period | (10,213 | ) | (27,816 | ) | ||||
| Adjustments: | ||||||||
| Depreciation | 107 | 92 | ||||||
| Finance expenses (income), net | (74 | ) | 23,514 | |||||
| Share-based payments | 1,385 | 750 | ||||||
| (8,795 | ) | (3,460 | ) | |||||
| Changes in assets and liabilities: | ||||||||
| Changes in other current assets | (89 | ) | (379 | ) | ||||
| Changes in accounts payables | 815 | (893 | ) | |||||
| Changes in other payables | (489 | ) | 130 | |||||
| Changes in post - employment benefit liabilities | - | (39 | ) | |||||
| 237 | (1,181 | ) | ||||||
| Net cash used in operating activities | (8,558 | ) | (4,641 | ) | ||||
| Cash flows from investing activities: | ||||||||
| Cash assumed as part of acquisition of FameWave | - | 69 | ||||||
| Interest received | 115 | 93 | ||||||
| Decrease in deposits | 6,766 | - | ||||||
| Investment in Financial asset | - | - | ||||||
| Acquisition of fixed assets | (109 | ) | - | |||||
| Net cash provided by (used in) investing activities | 6,772 | 108 | ||||||
| Cash flows from financing activities: | ||||||||
| Proceeds from warrants exercised | 1,200 | 13,920 | ||||||
| Proceeds from issuance ADSs | - | 27,925 | ||||||
| ADS issuance expenses paid | - | (2,040 | ) | |||||
| Proceeds from issuance of warrants | - | 26,574 | ||||||
| Warrants issuance expenses paid | - | (3,131 | ) | |||||
| Repayment of lease liability | (73 | ) | (80 | ) | ||||
| Interest paid | (37 | ) | (11 | ) | ||||
| Net cash provided by financing activities | 1,090 | 63,157 | ||||||
| Net increase (decrease) in cash and cash equivalents | (696 | ) | 58,624 | |||||
| Cash and cash equivalents at the beginning of the period | 11,247 | 4,385 | ||||||
| Effect of translation adjustments on cash and cash equivalents | (11 | ) | (14 | ) | ||||
| Cash and cash equivalents at the end of the period | 10,540 | 62,995 | ||||||
| Non- Cash activities: | ||||||||
| Transfer of derivative instrument from liability to equity | - | 10,982 |
Biotech Reconciliation of Non-IFRS Financial Results
of Adjusted Operating Loss
| For the six months ended June 30, | ||||||||
| 2021 | 2020 | |||||||
| USD thousands | USD thousands | |||||||
| Operating loss for the period | 10,287 | 4,302 | ||||||
| Less ESOP expenses | (1,385 | ) | (750 | ) | ||||
| 8,902 | 3,552 |
of Adjusted Net Loss
| For the six months ended June 30, | ||||||||
| 2021 | 2020 | |||||||
| USD thousands | USD thousands | |||||||
| Net loss for the period | 10,213 | 27,816 | ||||||
| Less income (expenses) on account of warrants | - | (23,583 | ) | |||||
| Less ESOP expenses | (1,385 | ) | (750 | ) | ||||
| 8,828 | 3,483 |