Full Press Release Details
Biotech Reports Second Half and Full-Year 2021 Financial Results
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.
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."
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.
Results for the Year Ended December 31, 2021
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
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.
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.
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.
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.
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.
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
Results for the Six Months Ended June 30, 2021
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.
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.
Loss was $7.8 million, a decrease of $0.5 million, or 6%, compared to $8.3 million in the same period of 2020.
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
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.
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.
Statements and Safe Harbor Statement
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.
& Chief Financial Officer
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 |