Full Press Release Details
Purple Biotech Reports Second Quarter 2023 Financial
Financial results represent clinical
trials progress with recruitment at a pace faster than expected in CM24 Phase 2 study
Clinical data from both studies
expected in the coming months
Cash runway extended into H1 2025
REHOVOT, Israel, August 22, 2023 -- Purple Biotech
Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies
that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, today announced financial results
for the second quarter and six months ended June 30, 2023.
"During the second quarter of 2023 we
continued to advance our lead clinical programs, CM24 in the treatment of pancreatic cancer and NT219 for head and neck cancer,
while prudently managing our development and operating expenses. Our financial results in the first half of 2023 represent our
clinical trials' progress with recruitment at a pace faster than expected in our CM24 study. As we reprioritize our objectives from
time to time, we have extended our cash runway into the first half of 2025," stated Purple Biotech CEO, Gil Efron.
"In the coming months, we look forward
to announcing milestones including interim data from our randomized Phase 2 CM24 study as well as results from our Phase 1 NT219
dose escalation study. In addition, we are excited to commence work on IM1240, our newly acquired tri-specific antibody."
"I am excited to return to working with our
dedicated team after my medical leave. I would like to thank Isaac Israel, the management, and our employees for their great work during
my absence," Gil Efron added.
Financial Results for the three Months Ended
Research and Development Expenses were $3.7
million, an increase of $1.7 million or 85%, compared to $2 million in the same period of 2022 mainly due to higher enrollment rate to
our clinical trials.
Selling, General and Administrative Expenses were
$1.4 million, a decrease of $0.1 million or 7%, compared to $1.5 million in the same period of 2022.
Operating Loss was $5.1 million, an increase
of $1.5 million or 42% compared to $3.6 million in the same period of 2022 mainly due to higher research and development expenses.
On a non-IFRS basis (as reconciled
below), adjusted operating loss was $4.6 million, an increase of $1.6 million or 53%, compared to $3 million in the
same period of 2022 mainly due to higher research and development expenses.
Net Loss for the three months ended June
30, 2023 was $5.2 million, or $0.25 loss per basic and diluted ADS, compared to a net loss of $3.6 million, or $0.2 loss per basic and
diluted ADS, in the three months ended June 30, 2022. Adjusted net loss for the three months ended June 30, 2023 was $4.7 million,
an increase of $1.7 million or 57% compared to $3 million in the three months ended June 30, 2022.
Financial Results for the Six Months Ended
Research and Development Expenses were $7.2
million, a decrease of $0.8 million, or 10%, compared to $8 million in the same period of 2022. The decrease was mainly due to a decrease
of $3.4 million in chemistry, manufacturing, and controls (CMC) expenses representing batch manufacturing in 2022, offset by an increase of $2 million in clinical expenses and
$0.6 million in other research and development expenses in support of our growing clinical and development activities.
Sales, General and Administrative Expenses were
$3.0 million, compared to $2.9 million in the same period of 2022, an increase of $0.1 million.
Operating Loss was $10.3 million, a decrease
of $0.6 million, or 6%, compared to $10.9 million in the same period of 2022.
On a non-IFRS basis (as reconciled below), adjusted
operating loss was $9 million, a decrease of $1 million, compared to $10 million in the same period of 2022, mainly due to a
decrease in research and development expenses.
Net Loss for the six months ended June
30, 2023 was $10.0 million, or $0.49 loss per basic and diluted ADS, compared to a net loss of $10.9 million, or $0.61 loss per basic
and diluted ADS, in the same period of 2022. The decrease in net loss was mainly due to a decrease of $0.6 million in operating expenses.
Adjusted net loss for the six months ended June 30, 2023 was $8.8 million, a decrease from $10.0 million in the six months ended
As of June 30, 2023, Purple Biotech had cash and
cash equivalents and short-term deposits of $18.0 million. This cash position provides a cash runway into the first half of 2025.
During the six months ended June 30, 2023, the Company
sold, under the Open Market Sale Agreementsm with Jefferies LLC, approximately 479,000 ADSs, at an average price of $1.83 per
ADS. Net proceeds to the Company were approximately $0.85 million, net of direct issuance expenses.
Non-IFRS Financial Measures.
This press release includes information about certain
financial measures that are not prepared in accordance with International Financial Reporting Standards ("IFRS"), including
adjusted operating loss and adjusted net loss. These non-IFRS measures are not based on any standardized methodology prescribed by IFRS
and are not necessarily comparable to similar measures presented by other companies. Adjusted operating loss and adjusted net loss adjust
for share-based compensation expenses. The Company's management and board of directors utilize these non-IFRS financial measures to evaluate
the Company's performance. The Company provides these non- IFRS measures of the Company's performance to investors because its management
believes that these non- IFRS financial measures, when viewed with the Company's results under IFRS and the accompanying reconciliations,
are useful in identifying underlying trends in ongoing operations. However, these non- IFRS measures are not measures of financial performance
under IFRS and, accordingly, should not be considered as alternatives to IFRS measures as indicators of operating performance. Further,
these non-IFRS measures should not be considered measures of the Company's liquidity. A reconciliation of certain IFRS to non-IFRS financial
measures has been provided in the tables included in this press release.
About Purple Biotech
Purple Biotech Ltd. (NASDAQ/TASE: PPBT) is a clinical-stage
company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance. The Company's oncology pipeline
includes NT219, CM24 and IM1240. NT219 is a dual inhibitor, novel small molecule that simultaneously targets IRS1/2 and STAT3. In a Phase
1/2 study of NT219, the Company is currently advancing it in a dose escalation as a monotherapy treatment of solid tumors, and in a dose
escalation in combination with cetuximab for the treatment of recurrent and metastatic squamous cell carcinoma of the head and neck (SCCHN)
or colorectal adenocarcinoma (CRC). These studies will be followed by an expansion phase of NT219 at its recommended Phase 2 level in
combination with cetuximab in patients with recurrent and 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 a Phase 2 study for the treatment of pancreatic ductal adenocarcinoma
(PDAC). The Company has entered into a clinical collaboration agreement with Bristol Myers Squibb for the Phase 2 clinical trials to evaluate
the combination of CM24 with the PD-1 inhibitor nivolumab in addition to chemotherapy. IM1240 is a preclinical, conditionally-activated
tri-specific antibody that engages both T cells and NK cells to mount a strong, localized immune response within the tumor microenvironment.
The third arm specifically targets the Tumor Associated Antigen (TAA) 5T4 that is expressed in a variety of solid tumors and is correlated
with advanced disease, increased invasiveness and poor clinical outcomes. IM1240 has a cleavable capping technology that confines the
compound's therapeutic activity to the local tumor microenvironment, and thereby potentially increases the anticipated therapeutic window
in patients. 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, CM24 and IM1240; the process by which such