On November 14, 2025 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, reported financial results for the three months ended September 30, 2025, and provided a business update.
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"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
● Nominated IM1305 as the second tri-specific antibody development candidate from the CAPTN-3 platform, targeting TROP2 in addition to masked CD3 and NKG2A arms (capped-CD3xTROP2xNKG2A)
● IM1240, the first CAPTN-3 tri-specific antibody development candidate targeting 5T4 (capped-CD3x5T4xNKG2A), achieved a manufacturing and scalability milestone with a commercially viable yield.
● In collaboration with Mt. Sinai Principal Investigator Dr. Amir Horowitz, demonstrated IM1240-induced tumor cell death in patient-derived, treatment-resistant head and neck biopsies
● IM1240 is advancing toward first-in-human clinical trials, with IND submission and study initiation planned for 2026
CM24 (α-CEACAM1 monoclonal antibody)
● The biomarkers identified in the CM24 Phase 2 study will be used for patient selection in the Phase 2b study, which is subject to partnering.
● Detailed design for the next study focuses on two main objectives:
○ A separate arm testing CM24 alone in combination with standard of care to assess the contribution of each component. The second arm will test CM24 plus anti-PD1 plus standard of care. The third arm will test standard of care alone.
○ Selection of patients based on the identified biomarkers, which are expected to result in better outcomes for patients in the treatment arms.
NT219 (IRS1/2 degrader and STAT3 blocker)
● Received an intention to grant a European patent covering NT219 combinations with immunotherapies or MEK inhibitors to overcome tumor resistance
● Ongoing NT219 Phase 2 study in recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) to evaluate NT219 in combination with pembrolizumab (Keytruda) or cetuximab (Erbitux)
● The Phase 2 study is led by Dr. Antonio Jimeno, Professor and Director of the Head and Neck Cancer Program, and Principal Investigator Dr. Alice Weaver, at the University of Colorado Anschutz Medical Campus
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 discipline.
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.
(Press release, Purple Biotech, NOV 14, 2025, View Source [SID1234659976])