Full Press Release Details
Biotech Provides Corporate Update and Reports Second Half and Full Year 2020 Financial Results
Rehovot, Israel, March 01, 2021
(GLOBE NEWSWIRE) -- Purple Biotech Ltd. ("Purple Biotech") (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 and 12-months ended December 31, 2020.
"We have recently achieved substantial progress in multiple
key aspects of our business," said Isaac Israel, Chief Executive Officer. "Most importantly, our promising anti-cancer
product development pipeline continues to advance our Phase 1/2 clinical studies for NT219, a dual inhibitor, novel small
molecule targeting IRS1/2 and STAT3. We completed patient recruitment of the second dose level in the single agent dose-escalation
phase, demonstrating the drug to be safe and well tolerated in the treated patients. We expect to begin imminently our Phase 1b/2
studies for CM24, our monoclonal antibody drug candidate blocking CEACAM1, a novel immune checkpoint that supports tumor immune
evasion and survival through multiple pathways. Our robust clinical development activities are supported by a strong balance sheet,
as we raised $68.5 million in 2020, ended the year with $60.8 million in cash, and we believe we are well-funded to support our
currently planned corporate initiatives until 2024."
"As part of the completion of
our transformation to a corporate mission dedicated to developing first-in-class oncology therapies, we were honored to ring the
Nasdaq stock market opening bell on January 5, 2021 to commemorate the successful evolution of our business and the Company's
name change to Purple Biotech. We are firmly committed to improving the lives of cancer patients globally, and look forward to
executing on the opportunities that lie ahead of us in 2021 and beyond," concluded Mr. Israel.
Recent Corporate Highlights
Financial Results for the Six
Months Ended December 31, 2020
Research and Development Expenses were $4.4 million, an increase of $3.4 million, or 342%, compared to $1.0 million in the
same period of 2019. The increase was due to expenses related to the NT219 clinical trials initiated in 2020 and the preparation
for the anticipated initiation of the CM24 clinical trials, including manufacturing costs.
Selling, General and Administrative
(SG&A) Expenses were $4.1 million, compared to $2.8 million in the same period of 2019, an increase of $1.3 million. The
increase was due mainly to a $0.9 million increase in expenses related to stock options granted to directors and employees in the
second and third quarters of 2020 and a $0.3 million increase in director and officer insurance expenses.
Operating Loss was $8.3 million,
an increase of $4.7 million, or 131%, compared to $3.6 million in the same period of 2019.
On a non-IFRS basis (as reconciled
below), adjusted operating loss was $6.4 million, an increase of $3.6 million, compared to $2.8 million in the same period
Net Loss for the second half
of 2020 was $0.3 million, or $0.48 per diluted share, compared to a net loss of $3.3 million, or $1.70 per diluted share, in the
second half of 2019. The decrease in net loss was due to $7.5 million in income from a change in the fair value of derivatives,
partially offset by an increase of $4.5 million in operating expenses.
Financial Results for the Full
Year Ended December 31, 2020
Revenues were $1.0 million for the year ended December 31, 2020, unchanged from the $1.0 million reported for the year ended
Research and Development Expenses
were $7.5 million, an increase of $4.8 million, or 180%, compared to $2.7 million for the year ended December 31, 2019. The increase
was due to expenses related to the NT219 clinical trials initiated in 2020 and the preparation for the anticipated initiation of
the CM24 clinical trials, including manufacturing costs.
SG&A Expenses were $6.3
million, compared to $6.1 million for the year ended December 31, 2019.
Operating Loss was $12.6 million,
an increase of $5.5 million, or 76%, compared to $7.2 million for the year ended December 31, 2019.
On a non-IFRS basis (as reconciled
below), adjusted operating loss was $10.0 million, compared to $5.9 million, an increase of $4.1 million, for the year ended
Net Loss for the year ended
December 31, 2020, was $28.1 million, or $2.44 per diluted share, compared to a net loss of $5.9 million, or $3.00 per diluted
share, in the same period of 2019.
The increase was due to $17.1 million increase in expenses on account of warrants mainly from a change in the fair value of derivatives
and an increase of $4.8 million in R&D expenses.
As of December 31, 2020, Purple Biotech
had cash and cash equivalents and short- and long-term deposits of $60.8 million, compared to $4.4 million at December 31, 2019.
Purple Biotech believes that its cash position will provide sufficient resources for its currently anticipated ongoing needs until
About Purple Biotech
Purple Biotech Ltd. (the "Company"; NASDAQ/TASE: PPBT) is a clinical-stage company focusing on advancing first-in-class
therapies to overcome tumor immune evasion and drug resistance in order to create successful long-lasting treatments for people
with cancer. The Company's oncology pipeline includes NT219 and CM24. NT219 is a small molecule targeting the novel cancer
drug resistance pathways IRS1/2 and STAT3. The Company is currently advancing NT219 as a monotherapy treatment of advanced solid
tumors and in combination with cetuximab for the treatment of recurrent or metastatic squamous cell carcinoma of head and neck
cancer (SCCHN) in a phase 1/2 study. CM24 is a monoclonal antibody blocking CEACAM1, a novel immune checkpoint that supports tumor
immune evasion and survival through multiple pathways. The Company plans to advance CM24 as a combination therapy with anti-PD-1
checkpoint inhibitors in selected cancer indications in a phase 1 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 , a 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. Consensi is being sold in the U.S. by Burke Therapeutics, the marketing partner of the Company's U.S. distributor,
Coeptis Pharmaceuticals. The Company has also partnered to commercialize Consensi in China and South Korea. The Company has recently
relocated its corporate headquarters to Rehovot, Israel. For more information, please visit http://www.purple-biotech.com.
Forward-Looking Statements and Safe
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