Full Press Release Details
Purple Biotech Reports First Quarter 2025 Financial
Final CM24 Phase 2 data presented at AACR Annual
Meeting 2025, strengthening patient selection strategy for CM24 Phase 2b study planned to be initiated in Second Half of 2025
NT219 data presented at AACR Annual Meeting
2025; NT219 Phase 2 study in head and neck cancer on track to be initiated in First Half of 2025
CAPTN-3 differentiated T-cells and NK cells
engagers tri-specific platform advances toward first-in-human clinical trials
REHOVOT, Israel, May 21, 2025 (GLOBE
NEWSWIRE) -- Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage
company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance, announced today
financial results for the three months ended March 31, 2025.
"We are pleased to report continued progress
on our milestones, including additional confirmatory biomarker data from our randomized Phase 2 study of CM24 and the collaboration for
our upcoming NT219 plus cetuximab or pembrolizumab Phase 2 trial in head and neck cancer. The latest data presentations for these two
important assets at the recent American Association for Cancer Research (AACR) annual meeting provide further evidence for, and increase
our confidence in, patient selection and potential positive outcomes," stated Purple Biotech CEO Gil Efron. "In parallel,
our promising CAPTN-3 T-cells and NK cells engagers platform continues to generate compelling pre-clinical data, and we look forward to
presenting these data on our tri-body technology at an upcoming scientific conference. We are advancing our pipeline while prudently managing
expenses, with a cash runway through mid-2026."
Recent Clinical & Corporate Highlights:
Purple Biotech reported final results from its
randomized Phase 2 study of CM24 in pancreatic ductal adenocarcinoma patients in a poster presentation titled "Final analysis of
the randomized Phase 2 cohort of CM24 with nivolumab and chemotherapy in pancreatic cancer & potential serum biomarkers" at the
AACR Annual Meeting 2025 held in April 2025. Statistically significant efficacy in biomarker subgroup analyses was observed. These findings
support the patient selection strategy for the Phase 2b study of CM24, which is planned to be initiated in the second half of 2025.
A Phase 2 study of NT219 for the treatment
of recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) will combine NT219 with the standard-of-care
anti-PD1 checkpoint inhibitor pembrolizumab (Keytruda) or with the epidermal growth factor receptor (EGFR) blocker cetuximab
(Erbitux). The study will also explore potential biomarkers that were previously identified in a prior NT219 study. The
investigator-initiated Phase 2 trial is led by Dr. Antonio Jimeno, Professor and Director of the Head and Neck Cancer Program at the
University of Colorado Anschutz Medical Campus.
Two posters reporting new positive NT219 data
were presented at AACR Annual Meeting 2025. The poster titled "NT219 overcomes immune evasion mechanisms in head and neck squamous
cell carcinoma (HNSCC)" demonstrated that NT219 inhibits major targets and signaling pathways that play a key role in tumor immune
evasion, including STAT3 and IRS-to- -catenin pathways. In a clinical setting, upregulation of pIGF1R and pSTAT3 were correlated
with patient response and suggested as potential biomarkers for NT219 treatment. These and other findings demonstrated the potential of
NT219 to restore the efficacy of immunotherapies and expand the patient population that can benefit from these drugs. The poster titled
"APC-loss as a potential biomarker for NT219 treatment in colorectal cancer" suggested that the response to NT219 is associated
with enhanced wnt/ -catenin signaling or loss of function mutation of its negative regulator APC (APC-loss).
An independent study of NT219 titled "IRS2
as a driver of brain metastasis in colorectal cancer: a potential target for novel therapeutic strategies" was published in the peer
reviewed journal Neuro Oncology. The findings demonstrate that a combination therapy of NT219 and 5-fluorouracil (5-FU) inhibits
colorectal cancer brain metastasis through the IRS2 pathway. The research conducted by Prof. Ido Wolf, Dr. Tami Rubinek, and their team
at Tel Aviv University and Sourasky Medical Center found that IRS2, a novel target of NT219, is a driver of brain metastasis in colorectal
The U.S. Patent and Trademark Office issued a
patent for NT219 used in combination with EGFR antibodies for treating cancer patients who have acquired resistance to EGFR therapies.
This latest U.S. patent completes the geographic patent protection for NT219 used in combination with cetuximab in major markets, such
as the United States, Europe, China and Japan, and we believe this additional patent positions the Company well for the potential future
commercialization of NT219.
Purple Biotech entered into a Research Collaboration
Agreement with the Icahn School of Medicine at Mount Sinai in New York to explore the immunoregulation of NK and T cells within the tumor
microenvironment by CAPTN-3 multi-specific engagers, designed with the purpose of enhancing tumor-specific immunity against various cancer
types. This collaboration offers an opportunity to deepen the understanding of tumor immune evasion mechanisms that CAPTN-3 uniquely addresses,
with the goal of paving the way for effective treatments for many challenging tumor indications. Purple Biotech is working with Principal
Investigator Amir Horowitz, PhD, and his team at Mount Sinai to validate the unique aspects of the CAPTN-3 design in a wide screen of
patient-derived tumors, potentially providing new insights for overcoming resistance to standard frontline immunotherapies.
Financial Results for the Three Months Ended March 31, 2025
Research and Development Expenses were
$0.8 million for the three months ended March 31, 2025, reflecting a decrease of $2.6 million, or 76.5%, from $3.4 million in the same
period of 2024. The reduction was primarily due to reduced clinical trial related expenses.
General and Administrative Expenses were
$0.6 million for the three months ended March 31, 2025, compared to $1 million in the same period of 2024, representing a decrease of
$0.4 million, mainly due to a $0.3 million reduction in cash and non-cash salaries and related expenses.
Operating Loss was $1.4 million for the
three months ended March 31, 2025, a decrease of $3.1 million, or 68.9%, compared to $4.5 million in the same period of 2024, mainly due
to the decrease in research and development expenses.
Adjusted Operating Loss (as reconciled
below) was $1.3 million for the three months ended March 31, 2025, a decrease of $2.9 million, compared to $4.2 million in the same period
of 2024, primarily due to the decrease in research and development expenses.
Finance Income, net was $1.0 million for
the three months ended March 31, 2025, compared to $0.7 million in the same period of 2024, representing an increase of $0.3 million,
primarily attributable to a non-cash gain resulting from the revaluation of outstanding warrants.
Net Loss was $0.5 million, or $0.17
per basic and diluted ADS for the three months ended March 31, 2025, compared to a net loss of $3.8 million, or $2.8 per basic and diluted
ADS, in the same period of 2024. The decrease in net loss was mainly due to the $3.1 million decrease in operating expenses and $0.3 million
increase in finance income, net.
As of March 31, 2025, Purple Biotech had cash
and cash equivalents and short-term deposits of $6.7 million. This cash position provides a cash runway into mid 2026.
During the three months ended March 31, 2025,
the Company sold, under the Open Market Sale AgreementSM with Jefferies LLC, approximately 63 thousand ADSs, at an average
price of $3.5 per ADS. Net proceeds to the Company were approximately $166 thousand, net of 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. This non-IFRS measure is not based on any standardized methodology prescribed by IFRS and is not necessarily
comparable to similar measures presented by other companies. Adjusted operating loss adjusts for non-cash share-based compensation expenses.
The Company's management and board of directors utilize this non-IFRS financial measure to evaluate the Company's performance. The Company
provides this non-IFRS measure of the Company's performance to investors because management believes that this non-IFRS financial
measure, when viewed with the Company's results under IFRS and the accompanying reconciliations, are useful in identifying underlying
trends in ongoing operations. However, this non-IFRS measure is not a measure of financial performance under IFRS and, accordingly, should
not be considered as an alternative to IFRS measures as indicators of operating performance. Further, this non-IFRS measure should not
be considered a measure 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 CM24, NT219, and CAPTN-3. CM24 is a humanized monoclonal
antibody that blocks CEACAM1, which supports tumor immune evasion and survival through multiple pathways. CEACAM1 on tumor cells, immune
cells and neutrophils extracellular traps is a novel target for the treatment of multiple cancer indications. As proof of concept of these
novel pathways, the Company completed a Phase 2 study for the treatment of pancreatic ductal adenocarcinoma (PDAC) with CM24 as a combination
therapy with the anti-PD-1 checkpoint inhibitor nivolumab and chemotherapy, demonstrating clear and consistent improvement across all