Full Press Release Details
Purple Biotech Reports Third Quarter 2025 Financial
Results and Provides Business Update
Initiated development of a second CAPTN-3 tri-specific
antibody targeting TROP2
Manufacturing milestone achieved for IM1240,
the first tri-specific 5T4-targeting antibody from the CAPTN-3 platform
Cash position of $10.5 million as of September
30, 2025, with an anticipated cash runway into the first half of 2027, supporting the development of our CAPTN-3 technology platform through
significant milestones
REHOVOT, Israel, Nov. 14, 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 September
30, 2025, and provided a business update.
"During the quarter, we secured the necessary funds to support
the development of our CAPTN-3 technology platform through significant milestones. We plan to conduct non-GLP and GLP toxicology studies,
submit an Investigational New Drug application (IND) and initiate a Phase 1 study for IM1240 in 2026. CAPTN-3 continues to produce tri-specific
NK and T cell engagers with a novel, differentiated tumor-associated antigen arm. IM1240, the first tri-specific antibody from the platform,
targets 5T4, and IM1305, with a TROP2 antigen-targeting arm, has recently entered the development pipeline," said Purple Biotech
CEO Gil Efron. "While the versatility and applicability of the CAPTN-3 tri-specific construct are only beginning to garner attention,
we believe in its synergistic, yet safe activation of both the innate and adaptive immune systems to help overcome tumor immune evasion."
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 September 30, 2025
Research and Development Expenses were $0.6 million for the three months
ended September 30, 2025, representing a decrease of $0.8 million, or 56.4%, from $1.3 million in the same period of 2024. The decrease
was primarily attributable to reduced costs associated with the CM24 Phase 2 study.
General and Administrative Expenses were $0.8 million for the three
months ended September 30, 2025, consistent with the $0.8 million reported in the same period of 2024, reflecting continued cost management
Operating Loss was $1.4 million for the three months ended September
30, 2025, a decrease of $0.8 million, or 35.8 %, compared to $2.1 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 $1.3 million for
the three months ended September 30, 2025, a decrease of $0.7 million compared to $2.0 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 September
30, 2025, compared to $1.5 million in the same period of 2024, representing a decrease of $1.4 million, primarily attributable to a lower
non-cash gain from the revaluation of outstanding warrants and issuance-related expenses.
Net Loss was $1.3 million, or $0.29 per basic and diluted ADS, for
the three months ended September 30, 2025, compared to a net loss of $0.7 million, or $0.39 per basic and diluted ADS, in the same period
of 2024. The year-over-year change was primarily attributable to a $0.8 million reduction in operating expenses and a $1.4 million decrease
in finance income, net.
As of September 30, 2025, Purple Biotech had cash and cash equivalents
and short-term deposits of $10.5 million. The Company's cash runway is expected into the first half of 2027.
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. IM1305 is the second tri-specific antibody from
the CAPTN-3 platform that targets the TROP2 TAA, which is expressed in variety of tumor types. 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
by competitors; dependence on the effectiveness of our patents and other protections for innovative products; our ability to obtain, maintain