On May 21, 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 March 31, 2025 (Press release, Purple Biotech, MAY 21, 2025, View Source [SID1234653275]).
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"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) (Free AACR Whitepaper) 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:
● Final Phase 2 data for CM24 study presented at AACR (Free AACR Whitepaper) Annual Meeting 2025
● Statistically significant efficacy in biomarker subgroup analyses was observed:
● 78% reduction in risk of death and 81% reduction in risk of progression or death in defined pretreatment ranges of serum or tumor CEACAM1 subgroup
● 61% reduction in risk of death and 72% reduction in risk of progression or death in defined pretreatment ranges of serum CEACAM1 or myeloperoxidase (MPO) subgroup
● 90% reduction in risk of death and 81% reduction in risk of progression or death in high tumor CEACAM1 and low PD-L1 combined positive score (CPS) subgroup
● The biomarkers identified in the CM24 Phase 2 study are planned to be used for patient selection in the Phase 2b study, planned to be initiated in the second half of 2025
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 (Free AACR Whitepaper) 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.
● NT219 Phase 2 Head and Neck Cancer trial to evaluate NT219 with standard-of-care drugs. NT219 to be combined with pembrolizumab (Keytruda) or cetuximab (Erbitux)
● New positive head and neck cancer data presented at AACR (Free AACR Whitepaper)
● NT219’s suppression of brain metastasis in colorectal cancer published in Neuro Oncology
● Patent in U.S. enhances global IP protection for commercialization
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 (Free AACR Whitepaper) 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-β-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/β-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 cancer.
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.
● Pre-clinical research collaboration with Icahn School of Medicine at Mount Sinai for CAPTN-3 tri-specific antibody platform
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.
● Strengthened the management team with the appointment of Shai Lankry as Chief Financial Officer
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.