Full Press Release Details
Purple Biotech Reports Second Quarter 2025 Financial
Platform validating preclinical data presented
at EACR 2025 for CAPTN-3 tri-specific T cell engager show synergistic activity of the platform's masked CD3, NKG2A, and tumor-associated
First CAPTN-3 trispecific antibody
targeting novel tumor associated antigen, 5T4, advances toward first-in-human clinical trials, with IND submission
Positive Phase 2 data from CM24 study in
biomarker-enriched pancreatic ductal adenocarcinoma (PDAC) reported at AACR 2025
NT219 Phase 2 study in head and neck cancer
initiated in June 2025
REHOVOT, Israel, August 6, 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
"Our CAPTN-3 tri-specific antibody platform is
differentiated not only by its masked CD3 arm for conditional T cell activation, but also by the addition of an NKG2A arm for
additional T cell and NK cell activation, and a third arm targeting the tumor-associated antigen. This approach is supported by
other masked TCEs showing early safety and efficacy signals," stated Purple Biotech CEO Gil Efron. "We are focusing our
activities on advancing IM1240, our first CAPTN-3 antibody, through IND-enabling studies, with the goal of initiating a Phase 1
study in 2026. Additionally, we have now established a clear path forward for CM24 for its Phase 2b study, utilizing the
predictive biomarkers we observed in the Phase 2 trial, and we are seeking partners or investment to support this next
Recent Clinical and Corporate Highlights:
CAPTN-3 Tri-Specific Antibody Platform
CM24 ( -CEACAM1 monoclonal antibody)
NT219 (IRS1/2 degrader and STAT3 blocker)
Financial Results for the Three Months Ended June 30, 2025
Research and Development Expenses were $0.6 million for
the three months ended June 30, 2025, reflecting a decrease of $1.8 million, or 76.9%, from $2.4 million in the same period of 2024. The
decrease was primarily due to reduced costs associated with the CM24 Phase 2 study.
General and Administrative Expenses were $0.7 million for
the three months ended June 30, 2025, compared to $1.1 million in the same period of 2024, representing a decrease of $0.4 million, or
36.0%, mainly due to a $0.2 million decrease in a non-cash expense and $0.2 million reduction in cash and non-cash salaries and related
Operating Loss was $1.2 million for the three months ended
June 30, 2025, a decrease of $2.2 million, or 64.3%, compared to $3.5 million in the same period of 2024, mainly due to the decrease in
the CM24 Phase 2 study expenses.
Adjusted Operating Loss (as reconciled below) was $1.2
million for the three months ended June 30, 2025, a decrease of $2.0 million, compared to $3.2 million in the same period of 2024, primarily
due to the decrease in the CM24 Phase 2 study expenses.
Finance Income, net was $0.1 million for the three months
ended June 30, 2025, compared to $1.0 million in the same period of 2024, representing a decrease of $0.9 million, primarily attributable
to a decrease in non-cash gain resulting from the revaluation of outstanding warrants.
Net Loss was $1.1 million, or $0.40 per basic and diluted
ADS for the three months ended June 30, 2025, compared to a net loss of $2.4 million, or $1.80 per basic and diluted ADS, in the same
period of 2024. The decrease in net loss was mainly due to the $2.2 million decrease in operating expenses and $0.9 million decrease in
finance income, net.
As of June 30, 2025, Purple Biotech had cash and cash equivalents and
short-term deposits of $5.6 million. The Company cash runway is expected into the third quarter of 2026.
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 CAPTN-3, CM24 and NT219. The Company is advancing CAPTN-3, a preclinical platform of conditionally
activated tri-specific antibodies, which engage both T cells and NK cells to induce a strong, localized immune response within the
tumor microenvironment. The cleavable capping technology confines the compound's therapeutic activity to the local tumor
microenvironment, thereby potentially increasing the anticipated therapeutic window in patients. The third arm specifically targets
the Tumor Associated Antigen (TAA). The technology presents a novel mechanism of action by unleashing both innate and adaptive
immune systems to mount an optimal anti-tumoral immune response. IM1240 is the first tri-specific antibody in development that
targets the 5T4 antigen, which is expressed in a variety of solid tumors and is associated with advanced disease, increased
invasiveness, and poor clinical outcomes. 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 neutrophil 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 efficacy endpoints and
the identification of two potential serum biomarkers and other potential tissue biomarkers. NT219 is a dual inhibitor, novel small
molecule that simultaneously targets IRS1/2 and STAT3. A Phase 1 dose escalation study was concluded as a monotherapy and in
combination with cetuximab, in which NT219 demonstrated anti-tumor activity in combination with cetuximab in second-line patients
with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). A Phase 2 study in collaboration with the
University of Colorado Anschutz Medical Campus, to treat R/M SCCHN patients with NT219 in combination with cetuximab or pembrolizumab was initiated. The
Company's corporate headquarters are located in Rehovot, Israel. For more information, please
visit https://purple-biotech.com/.
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.
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 early stage
therapeutic candidates 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 and commercialization involves a lengthy and expensive
process with uncertain outcomes; our ability to successfully develop and commercialize our pharmaceutical products; the expense, length,
progress and results of any clinical trials; the impact of any changes in regulation and legislation that could affect the pharmaceutical
industry; the difficulty in receiving the regulatory approvals necessary in order to commercialize our products; the difficulty of predicting
actions of the U.S. Food and Drug Administration or any other applicable regulator of pharmaceutical products; the regulatory environment
and changes in the health policies and regimes in the countries in which we operate; the uncertainty surrounding the actual market reception
to our pharmaceutical products once cleared for marketing in a particular market; the introduction of competing products; patents obtained