Full Press Release Details
Purple Biotech Reports Second Quarter 2022 Financial
REHOVOT, Israel, August 4, 2022 (GLOBE NEWSWIRE)
-- Purple Biotech Ltd. ("Purple Biotech," or the "Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing
first-in-class, effective and durable therapies by harnessing the power of the tumor microenvironment to overcome tumor immune evasion
and drug resistance, today announced financial results for the second quarter ended June 30, 2022.
"This is the first report of Purple Biotech
financial results since my appointment as Chief Executive Officer," said Gil Efron, Chief Executive Officer of Purple Biotech. "It
is an opportunity for me to emphasize our main objectives. Purple Biotech has two exciting and innovative lead assets in development.
We are focused on performing robust studies aiming to achieve meaningful clinical data and are continuing to explore opportunities to
expand our current clinical programs to additional indications, while maintaining our cash runway, currently through the end of 2024.
We are seeking opportunities for additional assets and collaborations to increase our footprint, through accretive transactions. I believe
that together with strong science and by leveraging on our capabilities we can achieve these objectives and solidify Purple Biotech as
a significant player within the oncology field."
Recent Corporate Highlights
In June, Purple presented Phase 1 interim
monotherapy data of the ongoing Phase 1/2 clinical trial of NT219 at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting,
demonstrating encouraging safety & efficacy profile including one confirmed partial response in gastroesophageal junction cancer patient
and stable disease in 75% of patients with mutated-KRAS colorectal cancer.
Company initiated the Phase 2 portion of its ongoing study of CM24, a first-in-class monoclonal antibody with the potential to treat multiple
cancers. The Phase 2 is an open-label, multicenter study in patients with metastatic pancreatic cancer (PDAC) to evaluate the safety and
tolerability of CM24 in combination with the PD-1 inhibitor Opdivo (nivolumab) and chemotherapy. The primary study endpoint is to
evaluate preliminary efficacy in 2nd line PDAC.
This follows the recent favorable safety
and efficacy data supporting the advancement of CM24 at the recommended phase 2 dose of 20 mg/Kg. The data from the Phase 1b study of
CM24 in combination with Opdivo (nivolumab) was presented in a poster entitled "Interim Safety and Efficacy Results from
a Phase 1b Study of CM24 in Combination with Nivolumab in Adults with Advanced Solid Tumors" at the American Association of Cancer
Research (AACR) 2022 Annual Meeting in May.
"Based on this progress last quarter, starting
from phase 2, we will be performing randomized studies, such as our CM24 study in PDAC, which we are now in the process of expanding accordingly,"
added Efron. "The recent clinical data for NT219 together with previously published preclinical results have shown the potential
of NT219 on solid tumors harboring KRAS mutation and we are looking into the development of NT219 for treatment of mutated KRAS patients.
In addition, Insulin Receptor Substrates 1/2 (IRS) was identified as one of the pathways for resistance mechanism to other treatments
in this field, opening this opportunity for NT219, which is the only IRS inhibitor in clinical development to date."
"We are ending the quarter in a strong financial
position with $38.7 million in cash, cash equivalent short term and long term deposits and a cash runway of two and a half years as we
continue to control our costs while advancing our programs. I'm proud of the progress made in the last quarter and we look forward
to continuing to advance our clinical stage programs on behalf of cancer patients."
Financial Results for the three Months Ended
Research and Development Expenses were $2
million, same as to $2 million in the same period of 2021.
Selling, General and Administrative Expenses were
$1.5 million, same as to $1.5 million in the same period of 2021.
Operating Loss was $3.6 million, same as the
$3.6 million in the same period of 2021.
On a non-IFRS basis (as reconciled below), adjusted
operating loss was $3 million, an increase of $0.1 million, compared to $2.9 million in the same period of 2021.
Net Loss for the three months ended June
30, 2022 was $3.6 million, or $0.20 per basic and diluted ADS, compared to a net loss of $3.6 million, or $0.21 per basic and diluted
ADS, in the three months ended June 30, 2021. Adjusted net loss for the three months ended June 30, 2022 was $2.9 million, the
same as in the three months ended June 30, 2021.
Financial Results for the Six Months Ended
Research and Development Expenses were
$8.0 million, an increase of $1.1 million, or 15.9%, compared to $6.9 million in the same period of 2021. The increase was mainly due
to an increase of $500 thousand in CMC expenses in support of our clinical studies and $300 thousands in wages in support of our growing
development activities.
Sales, General and Administrative Expenses
were $2.9 million, compared to $3.1 million in the same period of 2021, a decrease of $0.2 million. The decrease was mainly due to
a decrease in employee equity-based compensation (ESOP) costs.
Operating Loss from continuing operations
was $10.9 million, an increase of $0.8 million, or 7.9%, compared to $10.1 million in the same period of 2021.
On a non-IFRS basis (as reconciled below), adjusted
operating loss was $10 million, an increase of $1.3 million, compared to $8.7 million in the same period of 2021, mainly due
to an increase in R&D expenses.
Net Loss for the first six months
ended June 30, 2022 was $10.8 million, or $0.61 per basic and diluted ADS, compared to a net loss of $10.2 million, or $0.58 per basic
and diluted ADS, in the same period of 2021. The increase in net loss was mainly due to an increase of $0.8 million in operating expenses.
Adjusted net loss for the first six months ended June 30, 2022 was $10 million, an increase from $8.7 million in the first six
months ended June 30, 2021.
During the six months ended June 30, 2022, the
Company sold, under the Open Market Sale Agreementsm with Jefferies LLC, approximately 179 thousand ADSs, at an average price
of $3.64 per ADS. Net proceeds to the Company, were approximately $0.57 million, net of issuance expenses.
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, 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 SCCHN. 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. The Company initiated a phase 2 study for the treatment of pancreatic ductal adenocarcinoma
(PDAC). The Company has entered into a clinical collaboration agreement, as amended, with Bristol Myers Squibb for the phase 1/2 clinical
trials to evaluate the combination of CM24 with the PD-1 inhibitor nivolumab (Opdivo ) in addition to chemotherapy. The Company's
corporate headquarters are located in Rehovot, Israel. For more information, please visit https://purple-biotech.com/.
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