Core Insights - Purple Biotech Ltd. presented final Phase 2 data for CM24 at the AACR Annual Meeting 2025, showing significant efficacy in biomarker subgroup analyses, which supports the patient selection strategy for the upcoming Phase 2b study planned for the second half of 2025 [4][6] - The company is advancing its pipeline with NT219, which is on track for a Phase 2 study in head and neck cancer, and the CAPTN-3 tri-specific platform is moving towards first-in-human clinical trials [2][3] Clinical Developments - CM24 demonstrated a 78% reduction in risk of death and an 81% reduction in risk of progression or death in specific biomarker subgroups [6] - NT219 will be evaluated in a Phase 2 study in combination with pembrolizumab or cetuximab for recurrent/metastatic squamous cell carcinoma of the head and neck [5][7] - New data on NT219 presented at AACR highlighted its ability to overcome immune evasion mechanisms in head and neck cancer [8] Financial Performance - Research and Development Expenses decreased by 76.5% to $0.8 million for the three months ended March 31, 2025, compared to $3.4 million in the same period of 2024 [11] - General and Administrative Expenses also decreased to $0.6 million from $1 million year-over-year [12] - The net loss for the period was $0.5 million, significantly reduced from $3.8 million in the same period of 2024, reflecting a decrease in operating expenses [15] Cash Position - As of March 31, 2025, the company had cash and cash equivalents of $6.7 million, providing a cash runway into mid-2026 [15] - The company sold approximately 63 thousand ADSs at an average price of $3.5 per ADS, generating net proceeds of approximately $166 thousand [16] Intellectual Property - A new U.S. patent for NT219 enhances global IP protection for its use in combination with EGFR antibodies, positioning the company well for future commercialization [10]

Core Insights - Purple Biotech Ltd. has appointed Shai Lankry as Chief Financial Officer, bringing over 20 years of financial leadership in biotech and healthcare [1][2][3] Company Overview - Purple Biotech is a clinical-stage company focused on developing first-in-class therapies to overcome tumor immune evasion and drug resistance [4] - The company's oncology pipeline includes CM24, NT219, and CAPTN-3, targeting various cancer indications [4] Leadership Background - Shai Lankry has extensive experience in U.S. and European biotech markets, previously serving as CFO for Gamida Cell Ltd. and holding key financial roles at West Pharmaceutical Services and MacroCure Ltd. [3] - Lankry's experience includes leading a U.S. IPO and M&A transactions, which aligns with Purple Biotech's strategic goals [1][3] Pipeline Highlights - CM24 is a humanized monoclonal antibody that blocks CEACAM1, showing promise in a Phase 2 study for pancreatic ductal adenocarcinoma [4] - NT219 is a dual inhibitor that has demonstrated anti-tumor activity in combination with cetuximab for recurrent and/or metastatic squamous cell carcinoma of the head and neck [4] - CAPTN-3 is a preclinical platform of tri-specific antibodies designed to enhance immune response within the tumor microenvironment [4]

Core Viewpoint - Purple Biotech Ltd. announced promising results from a Phase 2 study of CM24 in combination with nivolumab and chemotherapy for pancreatic cancer, highlighting significant survival benefits and the potential for biomarker-driven studies [1][2][3]. Study Findings - The combination therapy was well tolerated and showed improvements in overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR) in previously treated pancreatic ductal adenocarcinoma (PDAC) patients [3][5][6]. - A 90% reduction in risk of death and an 81% reduction in risk of progression or death were observed in patients with high tumor CEACAM1 and low PD-L1 combined positive score [4][9]. - The study identified serum CEACAM1 and myeloperoxidase (MPO) as potential predictive biomarkers for CM24-based therapy, suggesting a multifaceted mechanism of action [9][10]. Efficacy Parameters - The experimental arm demonstrated a 2.4-month prolongation in OS and a 1.9-month prolongation in PFS compared to the control arm [5][8]. - The ORR was higher in the experimental arm at 25% compared to 6.7% in the control arm, and the DCR was 62.5% versus 46.7% [5][6]. - Continuous decrease in CA19-9 levels was observed in the experimental arm, indicating a positive treatment response [5][6]. Future Directions - The next Phase 2b study is expected to include an additional group testing CM24 alone, with patient selection based on identified biomarkers, potentially expanding to other cancer indications [7][8]. - The findings from this study may guide the treatment of patients who are more likely to benefit from CM24 therapy, enhancing the understanding of CEACAM1 and its role in cancer biology [6][9]. Company Overview - Purple Biotech Ltd. is focused on developing first-in-class therapies to overcome tumor immune evasion and drug resistance, with a pipeline that includes CM24, NT219, and CAPTN-3 [8][10].

Core Viewpoint - Purple Biotech Ltd. is advancing its clinical-stage therapy NT219, which targets tumor immune evasion and drug resistance, with promising data presented at the AACR 2025 Annual Meeting [1][3][10] Group 1: NT219 Overview - NT219 is a novel dual inhibitor of IRS1/2 and STAT3, currently in a Phase 2 study for recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC) in combination with pembrolizumab and cetuximab [2][10] - The mechanism of NT219 involves suppression of STAT3 and degradation of IRS1/2, which blocks IGF1R/IRS and downstream AKT and β-catenin signaling pathways [3][7] Group 2: Clinical Data and Biomarkers - Significant upregulation of STAT3, IRS1/2, and β-catenin was observed in HNSCC tumors compared to normal tissues, indicating potential biomarkers for NT219-based therapy [3][7] - The data suggest that activated forms of STAT3 and IGF1R correlate with patient response to NT219 treatment, supporting their role as potential biomarkers [7][12] Group 3: Efficacy in Colorectal Cancer - NT219 has shown anti-tumor efficacy in colorectal cancer (CRC) models, with APC-loss and activated β-catenin identified as potential biomarkers for treatment response [5][12] - The therapy has demonstrated the ability to reverse chemo-resistance and enhance the efficacy of existing chemotherapy regimens [12] Group 4: Future Directions - The findings from the AACR meeting are expected to guide study design, patient selection, and combination therapy strategies for NT219 [3][7] - Purple Biotech is committed to advancing NT219 in collaboration with the University of Colorado for R/M HNSCC patients [10]

Core Insights - The study identifies IRS2 as a significant driver of brain metastasis in colorectal cancer, suggesting that targeting IRS2 with NT219 may provide a new therapeutic strategy [1][2][4] - The combination of NT219 and 5-fluorouracil (5-FU) has been shown to inhibit the formation of colorectal cancer brain metastasis and extend survival in preclinical models [2][5] - Approximately 20% of colorectal cancer patients present with distant metastasis at diagnosis, with an additional 50% developing metastasis later, highlighting the potential impact of NT219 on patient outcomes [2] Company Overview - Purple Biotech Ltd. is a clinical-stage company focused on developing first-in-class therapies to overcome tumor immune evasion and drug resistance, with a pipeline that includes NT219, CM24, and CAPTN-3 [7] - NT219 is a novel small molecule designed to degrade IRS1/2 and block downstream signaling pathways, currently advancing into a Phase 2 study for recurrent and/or metastatic squamous cell carcinoma of the head and neck [1][7] - The company aims to leverage NT219's unique mechanism of action to expand clinical development opportunities in colorectal cancer and other malignancies [2][7] Research Findings - The study analyzed over 35,000 colorectal cancer samples, revealing a distinct genomic profile associated with brain metastasis and highlighting the role of IRS2 in this process [4] - Elevated IRS2 expression is linked to the promotion of brain metastasis through modulation of the β-catenin pathway and oxidative phosphorylation [4][5] - The findings support the potential of NT219 as a therapeutic strategy against colorectal cancer brain metastasis, offering new avenues for treatment [5]

Company Overview - Purple Biotech Ltd. is a clinical-stage company focused on developing first-in-class therapies to overcome tumor immune evasion and drug resistance [2] - The company's oncology pipeline includes CM24, NT219, and CAPTN-3, targeting various cancer indications [2] Pipeline Details - CM24 is a humanized monoclonal antibody that blocks CEACAM1, demonstrating improvement in a Phase 2 study for pancreatic ductal adenocarcinoma when combined with nivolumab and chemotherapy [2] - NT219 is a dual inhibitor targeting IRS1/2 and STAT3, showing anti-tumor activity in a Phase 1 study and advancing to a Phase 2 study in collaboration with the University of Colorado [2] - CAPTN-3 is a preclinical platform of conditionally activated tri-specific antibodies designed to induce a strong immune response within the tumor microenvironment [2] Upcoming Events - The CEO of Purple Biotech, Gil Efron, will participate in a panel discussion at the Canaccord Genuity Horizons in Oncology Virtual Conference on April 7, 2025 [1]