Full Press Release Details
Purple Biotech Reports Fourth Quarter and Full-Year
2022 Financial Results
Expands pipeline with acquisition of new tri-specific
Data readouts for two lead clinical programs
REHOVOT, Israel, February 8, 2023 -
(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 that harness the power of the tumor microenvironment to overcome tumor
immune evasion and drug resistance, today announced financial results for the year and the three months ended December 31, 2022.
"We are reporting our 2022 financial results
which are in line with our plans," said Gil Efron, Chief Executive Officer of Purple Biotech. "Our end-of-year balance sheet
is strong and enables us to execute our strategic plan. We started 2023 by acquiring an innovative platform of tri-specific antibodies
and we are looking forward to data readouts from both of our ongoing clinical programs. I believe that our diverse promising pipeline
is a good foundation for building a strong and sustainable oncology company.
"During 2022 we enhanced the CM24 trial,
reprioritizing its study arms and expanding the design to randomize the study - a good example of the thoughtful, flexible approach
we take to drug development. For NT219 we advanced the dose escalation Phase 1 study, both as monotherapy and in combination with cetuximab,
and have reached the 50mg/kg dose level in both arms. We anticipate reporting clinical data for both CM24 and NT219 during this coming
year. We just completed the acquisition of Immunorizon, thus securing a valuable portfolio of multi-specific antibodies that are highly
complementary to our existing clinical compounds targeting the tumor microenvironment."
Business Development, Post-Fiscal 2022
After the close of the 2022 fiscal year,
Purple Biotech expanded its product pipeline through the acquisition of private company Immunorizon Ltd.. This acquisition, signed on
February 2, 2023, brings a portfolio of potential multi-specific T and NK cell engager oncology therapies that selectively activate the
immune response within the tumor microenvironment. The lead asset targets the antigen 5T4, activating both T and NK cells to mount a powerful
immune system response against cancer cells; importantly, the compound includes a cleavable capping technology that has the potential
to widen the therapeutic index. The acquisition provides Purple Biotech with a technology platform for tri-specific antibody compounds
and offers the potential to further expand to additional targets. The Company anticipates bringing the first of these assets to IND filing
in approximately two years.
Also after the close of fiscal 2022,
Purple Biotech announced on January 3, 2023, a research collaboration with Mor Research Applications, the technology transfer subsidiary
of Clalit Healthcare Services. The agreement gives Purple first access to pre-clinical oncology product candidates owned by Mor, including
the option to fund early development, in-license selected drug assets and pursue their development and commercialization.
Corporate Updates for 2022
has amended the Phase 2 clinical trial evaluating the combination of its monoclonal antibody CM24, a potential new first-in-class mAb
that blocks the immune checkpoint CEACAM1 from supporting tumor immune evasion and survival, with the PD-1 inhibitor (nivolumab) plus
chemotherapy for patients with 2L metastatic pancreatic cancer (PDAC). The clinical trial design has been amended to randomize the study
comparing CM24+nivolumab+standard-of-care (SoC) chemotherapy against SoC chemotherapy. The study is ongoing, with patients being treated
in a run-in portion of the study, which includes up to 18 patients followed by approximately 60 patients in the randomized part of the
study. An interim analysis is expected in the second half of 2023 and a topline report on the overall study at the end of 2024.
Association of Cancer Research (AACR) Special Conference: Cancer Metastasis in November, Purple Biotech presented data that provide a
rationale for an innovative mechanism of action for CM24. "CM24, a Novel Anti-CEACAM1 mAb, Suppresses Neutrophil Extracellular Trap
(NET)-Induced Migration and Metastasis of Cancer Cells" focused on the compound's activity against neutrophil extracellular
arm of the Phase 1/2 clinical trial for NT219, participants are being treated at the 50 mg/kg dose level, which is the last dose to be
evaluated for monotherapy treatment. In the combination arm of NT219 + cetuximab, we are now recruiting for the 50 mg/kg dose of NT219.
As this trial progresses, Purple Biotech expects to reach the recommended Phase 2 dose (RP2D) this year and enter into the Phase 2 of
this study thereafter.
Financial Results for the Year Ended December
Research and Development Expenses were
$16.3 million, an increase of $4.5 million, or 38.1%, compared to $11.8 million in the same period of 2021. The increase was mainly due
to expenses related to the ongoing NT219 and CM24 clinical trials, including CMC expenses.
Selling, General and Administrative Expenses
were $6.3 million, compared to $6.1 million in the same period of 2021, an increase of $0.2 million.
Operating Loss was $22.6 million, an increase
of $4.7 million, or 26.3%, compared to $17.9 million in the same period of 2021. The increase was mainly due to the increase in research
and development expenses.
On a non-IFRS basis (as reconciled below), adjusted
operating loss was $20.2 million, an increase of $4.3 million, compared to $15.9 million in the same period of 2021, mainly due
to the increased expenses for clinical studies and manufacturing of drugs for these studies.
Net Loss for 2022 was $21.8 million,
or $1.20 per basic and diluted share, compared to a net loss of $18.5 million, or $1.01 per basic and diluted share, in 2021. The increase
in net loss was mainly due to $4.5 million in operating expenses, offset by a decrease of $0.6 million in loss from discontinued operation
and an increase in finance income of $0.5 million. Adjusted net loss for the year was $19.6 million, an increase from $15.7 million
in the full year of 2021.
As of December 31, 2022, Purple Biotech had cash
and cash equivalents, short- and long-term deposits of $31.7 million, compared to $47.4 million on December 31, 2021. This cash position
provides a cash runway into the second half of 2024.
During the year ended December 31, 2022, the Company
sold, under the Open Market Sale Agreement with Jefferies LLC, approximately 543 thousand ADSs, at an average price of $2.65 per
ADS. Net proceeds to the Company were approximately $1.3 million, net of issuance expenses.
Financial Results for the three Months Ended
Research and Development Expenses were
$4.8 million, an increase of $1.6 million, or 50%, compared to $3.2 million in the same period of 2021. The increase was mainly due to
expenses related to the CM24 and NT219 clinical trials and CMC expenses.
Selling, General and Administrative Expenses
were $1.8 million, compared to $1.5 million in the same period of 2021, an increase of $0.3 million.
Operating Loss was $6.6 million, an increase
of $1.9 million, or 40.4%, compared to $4.7 million in the same period of 2021.
On a non-IFRS basis (as reconciled below), adjusted
operating loss was $5.8 million, an increase of $1.4 million, compared to $4.4 million in the same period of 2021, mainly to
increase in R&D expenses offset by other income.
Net Loss for the three months ended
December 31, 2022 was $6.0 million, or $0.33 per basic and diluted share, compared to a net loss of $5.1 million, or $0.29 per basic and
diluted, in the three months ended December 31, 2021. The increase in net loss was mainly due to an increase in R&D expenses offset
by other income and increase in financial income. Adjusted net loss for the three months ended December 31, 2022 was $5.4 million,
an increase from $4.4 million in the same period of 2021.
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