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]

Core Insights - Purple Biotech is advancing NT219 in combination with EGFR antibody cetuximab into a Phase 2 study for head and neck cancer [1][3] - The U.S. Patent and Trademark Office has issued a patent for NT219, enhancing its protection in major markets [1][4] - The head and neck cancer treatment market is projected to reach $5 billion by 2030 [3] Company Overview - Purple Biotech Ltd. is a clinical-stage company focused on developing first-in-class therapies to combat tumor immune evasion and drug resistance [5] - The company's oncology pipeline includes NT219, CM24, and CAPTN-3, with NT219 being a dual inhibitor targeting IRS1/2 and STAT3 [5] - CM24 has shown promise in a Phase 2 study for pancreatic ductal adenocarcinoma, demonstrating improvement across efficacy endpoints [5] Intellectual Property - The newly issued patent for NT219 in combination with cetuximab completes geographic patent protection in the U.S., Europe, China, and Japan [4] - Purple Biotech's intellectual property portfolio includes a previously issued patent covering NT219 with small molecule EGFR inhibitors [4]

NT219, a novel agent designed to overcome tumor resistance to drug therapy, will be evaluated in combination with the standard-of-care head and neck cancer drugs pembrolizumab (Keytruda) or cetuximab (Erbitux) The study is conducted in collaboration with the University of Colorado Anschutz Medical Campus and is led by Dr. Antonio Jimeno, Professor and Director of the Head and Neck Cancer Program REHOVOT, Israel, Feb. 18, 2025 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NA ...

Core Insights - Purple Biotech Ltd. has entered into a Research Collaboration Agreement with the Icahn School of Medicine at Mount Sinai to explore the immunoregulation of NK and T cells within the tumor microenvironment (TME) using its CAPTN-3 multi-specific engagers, aiming to enhance tumor-specific immunity against various cancer types [1][6]. Company Overview - Purple Biotech is a clinical-stage company focused on developing first-in-class therapies that address tumor immune evasion and drug resistance, with a pipeline that includes CM24, NT219, and CAPTN-3 [5]. - CM24 is a humanized monoclonal antibody targeting CEACAM1, which plays a role in tumor immune evasion, and has shown efficacy in a Phase 2 study for pancreatic ductal adenocarcinoma [5]. - NT219 is a dual inhibitor targeting IRS1/2 and STAT3, demonstrating anti-tumor activity in combination with cetuximab in recurrent and/or metastatic squamous cell carcinoma of the head and neck [5]. Research Collaboration - The collaboration with the Icahn School of Medicine aims to deepen the understanding of the mechanisms of action for CAPTN-3 in preparation for human clinical studies [2]. - Dr. Amir Horowitz, the Principal Investigator, is an expert in immunoregulation and has identified the HLA-E/NKG2A axis as a significant inhibitory checkpoint pathway in solid tumors [2][3]. - The study will focus on how CAPTN-3 antibodies alter T and NK cell activation within the TME, particularly regarding HLA-E/NKG2A interactions [3]. CAPTN-3 Mechanism - CAPTN-3 is designed to promote innate-like antitumor functions by NK and CD8 T cells through conditional activation of the anti-CD3 arm at the TME and blockade of NKG2A [6][7]. - The technology aims to unleash both innate and adaptive immune systems to mount an optimal anti-tumoral immune response, potentially improving responses in resistant cancer patients [7].

REHOVOT, Israel, Dec. 05, 2024 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. (“Purple Biotech” or the “Company”) (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that overcome tumor immune evasion and drug resistance, today announced the closing of its previously announced registered direct offering of 472,668 of the Company’s American Depositary Shares (“ADSs”), each ADS representing 200 ordinary shares, at a purchase price of $6.00 per ADS. H.C. Wainwright & Co. acted as the exc ...

Purple Biotech (PPBT) , a clinical-stage oncology company, reported positive final results from the mid-stage study of its lead candidate, CM24, for treating pancreatic ductal adenocarcinoma (“PDAC”) patients. CM24 is a humanized monoclonal antibody that blocks CEACAM1, supporting tumor immune evasion and survival through multiple pathways.Purple Biotech states that treatment with CM24 in the phase II study demonstrated a clear and consistent improvement across all efficacy endpoints. A potential patient su ...

On Monday, Purple Biotech Ltd PPBT reported the final results from the randomized Phase 2 study of its lead oncology drug, CM24, a humanized monoclonal antibody that blocks CEACAM1, in patients with pancreatic ductal adenocarcinoma (PDAC).Purple Biotech stock is trading higher with a strong session volume of 9.7 million, compared to an average volume of 48.73K as per data from Benzinga Pro.The Phase 2 study evaluated CM24 in combination with Bristol Myers Squibb & Co’s BMY immune checkpoint inhibitor nivolu ...

Topline data from Phase 2 CM24 pancreatic cancer trial expected by the end of 2024 New CM24 biomarkers data presented during the third quarter of 2024 including two predicting serum biomarkers identified and associated with CM24 novel targets CAPTN-3 tri-specific antibody platform data presented at the ENA Symposium October 2024 REHOVOT, Israel, Nov. 15, 2024 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class th ...