Full Press Release Details
Purple Biotech Reports Fourth Quarter and Full-Year
2023 Financial Results
REHOVOT, Israel, March 5, 2024 -- 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
fourth quarter and full year ended December 31, 2023.
"Our two lead oncology candidates, CM24 and NT219, designed to
overcome tumor immune evasion, made significant clinical progress over the past year in difficult to treat indications, positioning them
well as potential second line treatments in pancreatic and head and neck cancer. The acquisition last year of our conditionally activated
T cells and NK cell engagers platform strongly positions us with a very promising and differentiated approach to cancer treatment, as
multi-specifics have garnered increasing industry attention. We look ahead to key data read outs in 2024, backed by a cash runway to take
us well into the first half of 2025," stated Gil Efron, Chief Executive Officer of Purple Biotech.
2023 and Recent Clinical & Corporate Highlights:
The Company's Phase 2 study for CM24, a multi-functional
immune checkpoint inhibitor, dosed its first PDAC patient in February 2023 and completed enrollment of approximately 60 patients
ahead of schedule in December of 2023 through 18 centers in the U.S., Spain and Israel. The Phase 2 study (NCT04731467) is
evaluating CM24 in combination with Bristol Myers Squibb's nivolumab plus chemotherapy in PDAC patients as a
second line treatment as compared to standard of care chemotherapy alone.
The primary endpoint is overall survival (OS). Interim data are expected
in H1 2024, with topline data expected to follow in H2 2024.
At the American Association for
Cancer Research (AACR) Special Conference on pancreatic cancer, Purple Biotech presented new potential PDAC biomarker data for CM24.
The data showed potential association of a high expression of CEACAM1 on tumor infiltrating lymphocytes, CM24's target, with treatment
outcomes and decrease in Neutrophil Extracellular Traps (NETs) marker following treatment with CM24, in PDAC patients. This demonstrated
the potential of CM24's novel mechanism of action (MOA) in treating pancreatic cancer.
In a Phase 1 dose escalation study (NCT04474470) of NT219, a
first-in-class small molecule dual inhibitor of IRS 1/2 and STAT3, Purple Biotech determined 100mg/kg as the recommended Phase 2
dose for NT219 in combination with Erbitux (cetuximab) in the treatment of R/M SCCHN. Detailed results from the study were
presented at the European Society of Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Congress 2024 in Paris. Safety
profile was well tolerated and manageable. Of the 7 evaluable R/M SCCHN patients treated at the highest doses of 50 and 100mg/kg,
the tumor objective response rate (ORR) was 29% and the disease control rate (DCR) was 71%, both highly encouraging results. Median
follow-up across all dose levels was 9.4 months as of the cutoff date (95% CI: 3.4-10.0, 8 out of 15 patients remaining in
A Phase 2 study of NT219 in combination with cetuximab as a
second line treatment for R/M SCCHN is planned to commence in H1 2024. The Company is supported by its newly formed Head and Neck
Cancer Scientific Advisory Board, which provided us their guidance on clinical studies for NT219 in combination with cetuximab as a second
line treatment and potentially in combination with a PD1 inhibitor as a first line treatment.
At the AACR Annual Meeting 2023 in Orlando, Florida, results presented
from a preclinical study demonstrated the potential of NT219 to work synergistically with either anti-PD1 or anti-CTLA4 drugs to reprogram
the immune profile in the tumor microenvironment and convert resistant tumors to responders. The study was led by researchers at The University
of Texas MD Anderson Cancer Center.
In February 2023, Purple Biotech acquired a platform of conditionally
activated T cell and NK cell engagers that selectively activate immune response within the tumor microenvironment. The platform's
lead tribody in development, IM1240, which is expected to be ready for an Investigational New Drug (IND) filing with the U.S. Food and
Drug Administration in approximately two years, targets the antigen 5T4 to induce a strong immune system response against cancer cells.
5T4 is highly expressed on certain tumors and correlates with poor prognosis.
Financial Results for the Year Ended December 31, 2023
Research and Development Expenses were $17 million, an
increase of $0.7 million, or 4.3%, compared to $16.3 million in 2022. The increase was mainly due to expenses related to the ongoing NT219
and CM24 clinical trials, including chemistry, manufacturing and controls (CMC) expenses.
Selling, General and Administrative Expenses were
$5.2 million, compared to $6.3 million in 2022, a decrease of $1.1 million mainly due to a decrease in salary, insurance and share
based payment expenses.
Operating Loss was $22.3 million, a decrease of $0.3 million,
or 1.3%, compared to $22.6 million 2022. The decrease was mainly due to the decrease in selling, general and administrative expenses offset
by the increase in research and development expenses.
Finance income for 2023 was $2.3 million, an increase of $1.5 million,
or 188%, compared to $0.8 million in 2022. The increase was mainly due to the change in the fair value valuation of warrants.
On a non-IFRS basis (as reconciled below), adjusted operating
loss was $20.4 million, an increase of $0.2 million, compared to $20.2 million in 2022, mainly due to the increased operating
loss of $0.3 million offset by decrease in share based payment expenses of $0.5 million.
Net Loss for 2023 was $20 million, or $0.90 per basic and diluted
share, compared to a net loss of $21.8 million, or $1.20 per basic and diluted share, in 2022. The decrease in net loss was mainly due
to the increase in finance income and decrease in selling, general and administrative expenses. Adjusted net loss for
2023 was $22.1 million, an increase from $19.6 million in the full year of 2022.
As of December 31, 2023, Purple Biotech had cash and cash equivalents
and short-term deposits of $15.3 million, compared to $31.7 million on December 31, 2022. This cash position provides a cash runway into
the first half of 2025.
During the year ended December 31, 2023, the Company sold, under the
Open Market Sale Agreement with Jefferies LLC, approximately 1,044,000 ADSs, at an average price of $1.63 per ADS. Net proceeds to
the Company were approximately $1.5 million, net of issuance expenses.
Financial Results for the Three Months Ended December 31, 2023
Research and Development Expenses were
$5.2 million, an increase of $0.4 million, or 8.3%, compared to $4.8 million in the same period of 2022. The increase was mainly due
to expenses related to the CM24 and NT219 clinical trials.
Selling, General and Administrative Expenses were
$1 million, compared to $1.8 million in the same period of 2022, a decrease of $0.8 million, mainly due to salary and share based payment
Operating Loss was $6.3 million, a decrease of $0.3 million,
or 4.5%, compared to $6.6 million in the same period of 2022.
On a non-IFRS basis (as reconciled below), adjusted
operating loss was $6.0 million, an increase of $0.2 million, compared to $5.8 million in the same period of 2022, mainly due
to an increase in research and development expenses.
Finance income for the three months ended December 31, 2023 was
$1.4 million, an increase of $0.8 million, or 133%, compared to $0.6 million in the same period of 2022. The increase was mainly due to
the change in the fair value evaluation of warrants.
Net Loss for the three months ended December 31, 2023 was $4.9
million, or $0.19 per basic and diluted share, compared to a net loss of $6.0 million, or $0.33 per basic and diluted, in the three months
ended December 31, 2022. The decrease in net loss was mainly due to an increase in financial income from financial instruments.
net loss for the three months ended December 31, 2023 was $8.1 million, an increase from $5.4 million in the same period of 2022.
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.