REHOVOT, Israel, June 04, 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, today announced a poster presentation on its novel CAPTN-3 tri-specific antibody platform, will be featured at the Annual Congress of the European Association for Cancer Research (EACR) 2025, being held in Lisbon, Portugal from June 16 – 19, 2025. Company Con ...

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 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]

Core Insights - Purple Biotech Ltd. is a clinical-stage company focused on developing first-in-class therapies to combat tumor immune evasion and drug resistance [1][4] - The company will present key findings at the 2025 American Association for Cancer Research Meeting, including studies on CM24 for pancreatic cancer and NT219 for colorectal and head and neck cancers [1][2][3][4] Company Overview - Purple Biotech's oncology pipeline includes CM24, NT219, and CAPTN-3, with CM24 being a humanized monoclonal antibody targeting CEACAM1, which is involved in tumor immune evasion [4] - The company has completed a Phase 2 study for CM24 in combination with nivolumab and chemotherapy, showing significant improvements across all efficacy endpoints and identifying two potential serum biomarkers [4] - NT219 is a dual inhibitor targeting IRS1/2 and STAT3, demonstrating 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 conditionally activated tri-specific antibodies designed to enhance localized immune responses within the tumor microenvironment [4] Upcoming Presentations - The final analysis of the randomized Phase 2 cohort of CM24 with nivolumab and chemotherapy will be presented on April 30, 2025 [2] - A study on APC-loss as a potential biomarker for NT219 treatment in colorectal cancer will be presented on April 27, 2025 [3] - Research on NT219's ability to overcome immune evasion mechanisms in head and neck squamous cell carcinoma will be presented on April 28, 2025 [3]

Financial Performance and Capital Requirements - The company is a clinical stage biotechnology firm with a history of operating losses and expects to incur significant additional losses in the future[26]. - Additional capital will be needed to achieve strategic objectives, and failure to raise sufficient capital would significantly impair future operations[26]. - The company has incurred approximately $144.7 million in losses from the commencement of its pharmaceutical research and development activities through December 31, 2024[34]. - The company may need to raise substantial additional funds to develop and commercialize its therapeutic candidates, as current cash and short-term investments are insufficient[39]. - The company may face dilution of ownership interest if additional capital is raised through equity sales[38]. - The tightening of equity markets has made it more challenging for the company to raise capital at reasonable valuations[159]. Regulatory and Compliance Challenges - Clinical trials may fail to demonstrate the safety and efficacy of therapeutic candidates, delaying regulatory approval and commercialization[26]. - The company is subject to extensive regulatory review and must demonstrate the safety and efficacy of its therapeutic candidates through lengthy clinical trials[43]. - Regulatory approval processes are lengthy and expensive, with potential delays impacting future revenue generation[51]. - Regulatory compliance is critical, as failure to adhere to FDA and other regulatory standards could result in sanctions, including fines and delays in marketing approvals[79]. - The healthcare regulatory environment is in flux, with ongoing legislative initiatives that could affect the company's ability to commercialize products[147]. - Compliance with federal and state healthcare laws is critical, as violations could lead to significant penalties and adversely affect financial results[150]. Product Development and Clinical Trials - The company currently has two oncology therapeutic candidates, CM24 and NT219, in the clinical trial phase, neither of which has been approved for marketing[34]. - The company is in the process of developing and commercializing new therapeutic candidates, which may not have been administered to humans yet[26]. - The company faces significant challenges in obtaining regulatory approvals for its therapeutic candidates, which could delay commercialization and revenue generation[43]. - The company is experiencing delays in clinical trials due to various factors, including regulatory consensus and patient recruitment challenges[13]. - The company may need to conduct additional studies if manufacturing or formulation changes are made to therapeutic candidates, potentially delaying commercialization[94]. - Manufacturing complexities for therapeutic candidates like CM24 and NT219 may lead to increased costs and supply delays, impacting clinical trial timelines[105]. Market and Competitive Landscape - The company operates in a rapidly changing and competitive oncology market, which may impact its ability to maintain and grow its business[34]. - The pharmaceutical and biotechnology industry is highly competitive, with many companies developing products for the same indications as the company's therapeutic candidates[136]. - The company faces intense competition from pharmaceutical and biotechnology firms with greater R&D capabilities and resources, which may render its oncology therapeutic candidates noncompetitive[137]. - The potential acceptance of alternative therapies may limit market acceptance of the company's formulations, impacting revenue generation[138]. - There are uncertainties regarding the market acceptance and reimbursement coverage for the therapeutic candidates, which may affect future revenue potential[109]. Third-Party Reliance and Risks - The company relies on third parties for CMC, research, and clinical trials, and their performance may not meet quality standards[26]. - The company anticipates continued reliance on third-party manufacturers for the production of its therapeutic candidates if marketing approval is obtained from regulatory agencies[34]. - The company relies heavily on third-party manufacturers for the production of its oncology therapeutic candidates, which may affect future profit margins and timely commercialization[71]. - The authenticity and accuracy of third-party data used for regulatory submissions cannot be guaranteed, which poses a risk to obtaining marketing authorizations[70]. - The company faces risks related to collaboration partners potentially not fulfilling their obligations, which could delay clinical trials and development plans[107]. Intellectual Property and Legal Risks - The company may face challenges related to intellectual property claims, which could delay or prevent the commercialization of its therapeutic candidates[165]. - The company’s ability to protect its intellectual property rights is uncertain, which could lead to loss of market share and adversely affect its financial condition[174]. - The company may not be able to prevent third parties from infringing its patents, which could allow competitors to commercialize similar products without compensation[180]. - There is a risk of adverse determinations in patent rights challenges that could reduce the scope of the company's patents or allow third parties to compete without payment[195]. - The company may face costly patent-related litigation, which could adversely affect its business and financial condition[194]. Financial and Operational Risks - Revenue and profits are heavily dependent on adequate reimbursement from third-party payers for oncology therapeutic candidates, which may not be guaranteed[139]. - The reimbursement approval process is time-consuming and costly, potentially delaying revenue realization for approved products[141]. - Legislative proposals to constrain medical product expenditures may negatively impact reimbursement rates for oncology therapeutic candidates[143]. - Changes in coverage and reimbursement policies by government and private payers could significantly affect the company's financial condition[144]. - The company faces risks related to significant drug product liability claims, which could divert management attention and increase litigation costs[156]. External Factors and Global Risks - The company is exposed to various global risks that could adversely affect its business, including changes in foreign exchange rates and political unrest[122]. - The company has not experienced material disruptions to its operations due to the ongoing conflict in Israel, but prolonged conflict could adversely affect its financial condition[205]. - Political instability in Israel, including recent changes to the judicial system, may negatively impact the business environment and the company's operations[209]. - Cybersecurity threats, including ransomware attacks, pose risks to the company's operations and could disrupt drug development programs[160].

Clinical Trials and Research - CM24 achieved a 79% reduction in risk of death (HR 0.21, p = 0.04) in a biomarker-enriched patient population during the Phase 2 study for second-line pancreatic cancer, with a median overall survival improvement of 5.1 months[6] - NT219 is advancing into a Phase 2 study for recurrent/metastatic squamous cell carcinoma of the head and neck, combining with pembrolizumab and cetuximab, with patient enrollment expected to start in the first half of 2025[8] - CAPTN-3 platform demonstrated sustained tumor regression in preclinical studies, showing potential for enhanced tumor-specific immunity against various cancer types[12] - The U.S. Patent and Trademark Office issued a patent for NT219 in combination with EGFR antibodies, enhancing global IP protection for the drug[11] Financial Performance - Research and Development Expenses for Q4 2024 were $0.5 million, a decrease of 90.4% compared to $5.2 million in Q4 2023, primarily due to reduced clinical trial expenses[14] - Operating Loss for Q4 2024 was $1 million, a decrease of 84.1% from $6.3 million in Q4 2023, attributed to lower research and development expenses[15] - Net Loss for the year ended December 31, 2024, was $7.3 million, a significant decrease from $20 million in 2023, reflecting a $11.3 million reduction in operating expenses[23] - Sales, General and Administrative Expenses for the year were $3.2 million, a decrease of 38.5% compared to $5.2 million in 2023, mainly due to reduced salary-related expenses[21] - Operating loss for the year ended December 31, 2024, was USD 11,005 thousand, a reduction of 50.7% compared to USD 22,271 thousand in 2023[31] - Total comprehensive loss for the year ended December 31, 2024, was USD 7,298 thousand, down from USD 19,952 thousand in 2023, a reduction of 63.4%[31] Cash and Assets - As of December 31, 2024, the company had cash and cash equivalents of $8.2 million, providing a cash runway into mid-2026[18] - Cash and cash equivalents at the end of 2024 were USD 7,401 thousand, down 48.8% from USD 14,489 thousand at the end of 2023[33] - Total current assets decreased from USD 15,788 thousand in 2023 to USD 8,908 thousand in 2024, a decline of approximately 43.5%[30] Liabilities and Equity - Total liabilities decreased from USD 9,701 thousand in 2023 to USD 3,987 thousand in 2024, a reduction of approximately 58.9%[30] - Proceeds from issuance of ADSs increased significantly to USD 5,809 thousand in 2024 from USD 1,563 thousand in 2023[32] - Basic loss per ADS improved from USD 17.96 in 2023 to USD 4.44 in 2024, a decrease of approximately 75.7%[31] - Net cash used in operating activities for 2024 was USD 14,367 thousand, compared to USD 19,925 thousand in 2023, a decrease of 28.4%[32]

Core Insights - Purple Biotech has successfully completed clinical trials for its oncology assets CM24 and NT219, demonstrating clinical benefits and identifying potential biomarkers for personalized treatment [1][2][3] Clinical Developments - CM24 met all efficacy endpoints in a Phase 2 trial for second-line pancreatic cancer, with plans for a biomarker-driven Phase 2b study to start in the second half of 2025 [3][7] - NT219 is advancing into a Phase 2 study for head and neck cancer, combining with pembrolizumab and cetuximab, with patient enrollment expected in the first half of 2025 [4][9] - The CAPTN-3 tri-specific platform has shown promising preclinical data, indicating its potential in the multi-specific antibody space [1][5] Financial Performance - For Q4 2024, Purple Biotech reported a net loss of $0.4 million, a significant decrease from $4.9 million in the same period of 2023, primarily due to reduced research and development expenses [18][19] - Research and development expenses for the year ended December 31, 2024, were $7.6 million, down 55.3% from $17 million in 2023 [20][21] - The company had cash and cash equivalents of $8.2 million as of December 31, 2024, providing a cash runway into mid-2026 [18][23] Patent and Collaboration - A new U.S. patent for NT219 enhances global intellectual property protection, positioning the company for potential future commercialization [10][14] - Purple Biotech has entered a research collaboration with the Icahn School of Medicine at Mount Sinai to explore the immunoregulation of NK and T cells within the tumor microenvironment [12][15]