As filed with the Securities and Exchange Commission on August 29, 2025 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 PURPLE BIOTECH LTD. (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Israel 2834 Not applicable (I.R.S. Employer Identification No.) 4 Oppenheimer Street Science Park Rehovot 76 ...

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 [3] - The company's oncology pipeline includes CAPTN-3, CM24, and NT219, which are designed to enhance immune response against tumors [3] Pipeline Details - CAPTN-3 is a preclinical platform of conditionally activated tri-specific antibodies that engage T cells and NK cells to induce a localized immune response within the tumor microenvironment [3] - CM24 is a humanized monoclonal antibody that blocks CEACAM1, a target that supports tumor immune evasion and survival [3] - NT219 is a dual inhibitor targeting IRS1/2 and STAT3, showing anti-tumor activity in combination with cetuximab for recurrent and/or metastatic squamous cell carcinoma of the head and neck [3] Recent Events - The CEO of Purple Biotech, Gil Efron, will participate in a fireside chat and 1x1 investor meetings at the H.C. Wainwright 27 Annual Global Investment Conference scheduled for September 8-10, 2025 [1][2]

[Financial Statements](index=3&type=section&id=Financial%20Statements) [Condensed Consolidated Unaudited Interim Statements of Financial Position](index=3&type=section&id=Condensed%20Consolidated%20Unaudited%20Interim%20Statements%20of%20Financial%20Position) The company's financial position as of June 30, 2025, shows a decrease in total assets and equity compared to December 31, 2024, primarily driven by a reduction in cash and cash equivalents, alongside a notable decrease in current liabilities Key Financial Position Data (USD thousand) | Metric | June 30, 2025 | December 31, 2024 | Change | | :-------------------------- | :------------ | :---------------- | :----- | | Total assets | 34,378 | 37,038 | (2,660) | | Total current assets | 6,313 | 8,908 | (2,595) | | Cash and cash equivalents | 4,736 | 7,401 | (2,665) | | Total current liabilities | 2,189 | 3,987 | (1,798) | | Warrants (liability) | 267 | 1,149 | (882) | | Total equity | 32,049 | 32,911 | (862) | [Condensed Consolidated Unaudited Interim Statements of Operations and Other Comprehensive Income](index=4&type=section&id=Condensed%20Consolidated%20Unaudited%20Interim%20Statements%20of%20Operations%20and%20Other%20Comprehensive%20Income) For the six months ended June 30, 2025, the company significantly reduced its operating loss and net loss compared to the prior year, primarily due to a substantial decrease in research and development expenses Key Operations Data (USD thousand) | Metric | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change (YoY) | | :---------------------------------- | :--------------------------- | :--------------------------- | :----------- | | Research and development expenses | 1,312 | 5,814 | (4,502) | | Sales, general and administrative expenses | 1,329 | 1,840 | (511) | | Operating loss | 2,641 | 7,856 | (5,215) | | Loss for the period | 1,545 | 6,196 | (4,651) | | Basic and diluted loss per Share (USD) | 0.003 | 0.023 | (0.020) | | Basic and diluted loss per ADS (USD) | 0.57 | 4.6 | (4.03) | [Condensed Consolidated Unaudited Interim Statements of Changes in Equity](index=5&type=section&id=Condensed%20Consolidated%20Unaudited%20Interim%20Statements%20of%20Changes%20in%20Equity) The company's total equity decreased from January 1, 2025, to June 30, 2025, influenced by accumulated losses, partially offset by proceeds from ADS issuances and share-based payments Key Equity Changes (USD thousand) | Metric | Balance as of Jan 1, 2025 | Balance as of June 30, 2025 | Change | | :------------------------------------ | :------------------------ | :-------------------------- | :----- | | Total equity | 32,911 | 32,049 | (862) | | Issuance of ADSs, net of issuance costs | - | 531 | 531 | | Share-based payments | - | 152 | 152 | | Loss for the period | - | (1,545) | (1,545) | [Condensed Consolidated Unaudited Interim Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Unaudited%20Interim%20Statements%20of%20Cash%20Flows) The company experienced a net decrease in cash and cash equivalents for the six months ended June 30, 2025, primarily due to cash used in operating activities, although the net cash outflow from operations significantly improved year-over-year Key Cash Flow Data (USD thousand) | Metric | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change (YoY) | | :---------------------------------- | :--------------------------- | :--------------------------- | :----------- | | Net cash used in operating activities | (3,522) | (9,058) | 5,536 | | Net cash provided by investing activities | 364 | 399 | (35) | | Net cash provided by financing activities | 469 | 701 | (232) | | Net decrease in cash and cash equivalents | (2,689) | (7,958) | 5,269 | | Cash and cash equivalents at end of period | 4,736 | 6,524 | (1,788) | [Notes to the Condensed Consolidated Unaudited Interim Financial Statements](index=8&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Unaudited%20Interim%20Financial%20Statements) [Note 1 - General](index=8&type=section&id=Note%201%20-%20General) This note provides an overview of Purple Biotech Ltd.'s business as a clinical-stage oncology company, details its financial condition including accumulated losses and going concern assessment, and discusses the potential impact of the 'Iron Swords' war in Israel [Reporting Entity and Business Overview](index=8&type=section&id=Reporting%20Entity%20and%20Business%20Overview) - Purple Biotech Ltd. is a clinical-stage company developing first-in-class therapies to overcome tumor immune evasion and drug resistance[11](index=11&type=chunk) - The company's oncology pipeline includes CM24 (monoclonal antibody blocking CEACAM1), NT219 (dual inhibitor targeting IRS1/2 and STAT3), and CAPTN-3 (preclinical tri-specific antibody platform)[11](index=11&type=chunk) - The Group comprises Purple Biotech Ltd. and its subsidiaries: TyrNovo Ltd., FameWave Ltd., Immunorizon Ltd., and Purple Biotech GmbH (currently dissolving)[11](index=11&type=chunk)[12](index=12&type=chunk)[13](index=13&type=chunk) [Financial Condition and Going Concern](index=8&type=section&id=Financial%20Condition%20and%20Going%20Concern) - As of June 30, 2025, the Group has incurred accumulated losses of **USD 146.2 million**, primarily due to development efforts[13](index=13&type=chunk) - Operations have been financed mainly through private and public financing rounds, raising a total of **USD 109.2 million** net of issuance expenses[13](index=13&type=chunk) - Management believes existing cash will be sufficient to fund operations for at least the next 12 months, with plans for out-licensing, alternative financing, or expenditure reduction thereafter, though there is no assurance of securing additional capital on favorable terms[14](index=14&type=chunk)[15](index=15&type=chunk) [Impact of "Iron Swords" War](index=9&type=section&id=Impact%20of%20%22Iron%20Swords%22%20War) - The 'Iron Swords' war in October 2023 has led to a decrease in Israel's economic activity, supply chain disruptions, manpower shortages, and currency fluctuations[15](index=15&type=chunk) - Hostilities could adversely affect the Company's operations, results, and ability to raise capital, despite most manufacturing and R&D being conducted outside Israel[15](index=15&type=chunk) - The duration and severity of the ongoing conflict and its effects on the Company's business, operations, and financial conditions are currently unpredictable[16](index=16&type=chunk) [Note 2 - Basis of Preparation](index=9&type=section&id=Note%202%20-%20Basis%20of%20Preparation) These condensed consolidated interim financial statements are prepared in accordance with IAS 34 and should be read in conjunction with the annual financial statements, with management's judgments and estimates remaining consistent - The consolidated financial statements are prepared in accordance with IAS 34 Interim Financial Reporting and should be read in conjunction with the annual financial statements for the year ended December 31, 2024[17](index=17&type=chunk) - The significant judgments and principal assumptions used in the estimation of uncertainty are consistent with those applied in the Annual Financial Statements[20](index=20&type=chunk) [Note 3 - Material Accounting Policies](index=10&type=section&id=Note%203%20-%20Material%20Accounting%20Policies) The accounting policies applied in these interim financial statements are consistent with those used in the Group's Annual Financial Statements - The accounting policies applied in these condensed consolidated interim financial statements are the same as those applied by the Group in its Annual Financial Statements[21](index=21&type=chunk) [Note 4 - Capital and Reserves](index=10&type=section&id=Note%204%20-%20Capital%20and%20Reserves) During the first six months of 2025, the company issued 248 thousand ADSs under its ATM program, generating USD 664 thousand in gross proceeds, net of USD 27 thousand in issuance costs ADS Issuance Summary | Metric | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------- | :--------------------------- | :--------------------------- | | ADSs Issued (thousands) | 248 | 180 | | Gross Proceeds (USD thousand) | 664 | 936 | | Issuance Costs (USD thousand) | 27 | 37 | [Note 5 - Financial Instruments](index=11&type=section&id=Note%205%20-%20Financial%20Instruments) The company's financial instruments measured at fair value include securities and warrants, with the financial liability for warrants significantly decreasing due to revaluation Financial Instruments Measured at Fair Value (USD thousand) | Instrument | June 30, 2025 | December 31, 2024 | | :---------------------------------- | :------------ | :---------------- | | Securities (Level 3) | 326 | 275 | | Financial liability of July 2024 warrants (Level 3) | 267 | 1,149 | - The financial liability of the July 2024 warrants decreased by **USD 882 thousand** due to revaluation during the period[25](index=25&type=chunk) - Warrants are valued using the Black-Scholes method, considering expected term, volatility, annual risk-free interest, and dividend yield[25](index=25&type=chunk) [Note 6 - Share-based payments](index=11&type=section&id=Note%206%20-%20Share-based%20payments) The company granted USD 26 thousand in share-based payments during the three months ended June 30, 2025, and recorded gross expenses of USD 152 thousand for the six-month period - Share-based payments amounting to **USD 26 thousand** were granted during the three-month period ended June 30, 2025[26](index=26&type=chunk) - Gross expenses of **USD 152 thousand** for share-based payments were recorded for the six months ended June 30, 2025, net of **USD 12 thousand** forfeited[26](index=26&type=chunk)

Core Insights - Purple Biotech Ltd. has made significant scientific advancements and operational progress in the first half of 2025, despite a challenging market environment [2][8] - The company 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 [10] Scientific Progress - CM24, an α-CEACAM1 monoclonal antibody, is advancing towards a biomarker-driven Phase 2b study targeting approximately 165 patients with second-line pancreatic ductal adenocarcinoma (PDAC) [3][7] - The Phase 2 dataset for NT219 demonstrated strong objective response rates (ORR) of 25% in the intent-to-treat group compared to 7% in the control group, and 37.5% in biomarker-enriched subgroups [7] - The overall survival (OS) hazard ratio (HR) for the intent-to-treat group was 0.81, with biomarker-enriched subgroups showing HRs of 0.05 and 0.28, indicating compelling efficacy signals [7] Upcoming Catalysts - The company plans to submit an investigational new drug (IND) application for the first development candidate from the CAPTN-3 platform in 2026, with first-in-human trials expected to follow IND approval [8] - Interim Phase 2 data for NT219 is anticipated in 2026, along with new preclinical data for next-generation assets [8] Financial Management - Purple Biotech maintained disciplined cash management in the first half of 2025, with expectations for financial runway extending into mid-2026 [8] - Additional funding will be required to support future clinical studies [8]

Core Insights - Purple Biotech Ltd. presented new preclinical data on its CAPTN-3 tri-specific antibody platform at the EACR 2025, showcasing its potential to overcome tumor immune evasion and drug resistance [1][2] Group 1: CAPTN-3 Platform Overview - The CAPTN-3 platform enables the creation of tri-specific antibodies that activate both innate and adaptive immune systems, enhancing anti-tumor responses [2][6] - The lead product, IM1240, targets the 5T4 antigen and has shown robust in vivo anti-tumor activity, particularly in triple negative breast cancer models [7][10] - The design includes an anti-NKG2A arm that synergizes with the anti-CD3 arm, demonstrating significant cytotoxic effects against solid tumor cells [3][4][5] Group 2: Mechanism of Action - The CAPTN-3 platform features a conditional activation mechanism, where the CD3 arm is activated only in the tumor microenvironment, minimizing systemic effects [6][7] - The anti-NKG2A arm plays a crucial role in reinvigorating exhausted T cells, enhancing their ability to kill tumor cells [4][5] - The platform's design allows for a modular approach, enabling the development of various tribodies with different target combinations [7][10] Group 3: Clinical Implications - Preclinical data indicate that the CAPTN-3 platform can lead to sustained tumor regression in animal models, highlighting its therapeutic potential [5][7] - The platform's ability to engage both T cells and NK cells suggests a promising avenue for developing effective cancer therapies [6][10] - The company is advancing multiple candidates within its oncology pipeline, including CM24 and NT219, alongside CAPTN-3 [10]

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 [6] - The company's oncology pipeline includes NT219, CM24, and CAPTN-3, with NT219 being a dual inhibitor targeting IRS1/2 and STAT3 [6][7] Clinical Study Initiation - A Phase 2 clinical study has been initiated to evaluate NT219 in combination with either pembrolizumab or cetuximab for patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) [1][4] - The study is led by Dr. Antonio Jimeno at the University of Colorado Anschutz Medical Campus and structured into two single-arm cohorts [3] Mechanism of Action - NT219 is designed to induce degradation of IRS1/2 and inhibit phosphorylation of STAT3, blocking their signaling pathways [2] - Previous Phase 1 studies showed safety and anti-tumor activity of NT219 in combination with cetuximab, with two partial responses and five patients with stable disease [4] Market Potential - The SCCHN treatment market is projected to reach $5 billion by 2030, highlighting the need for more effective treatments due to challenges like tumor heterogeneity and therapeutic resistance [5]

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][3] - The company will present its novel CAPTN-3 tri-specific antibody platform at the EACR 2025 Annual Congress in Lisbon, Portugal [1][2] 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 [3] - A Phase 2 study of CM24 in combination with nivolumab and chemotherapy for pancreatic ductal adenocarcinoma showed significant improvement across all efficacy endpoints [3] - NT219 is a dual inhibitor targeting IRS1/2 and STAT3, with a completed Phase 1 study demonstrating anti-tumor activity in combination with cetuximab for recurrent and/or metastatic squamous cell carcinoma of the head and neck [3] - CAPTN-3 is a preclinical platform utilizing conditionally activated tri-specific antibodies to engage T cells and NK cells, aiming to enhance localized immune responses within the tumor microenvironment [3] - The first tri-specific antibody, IM1240, targets the 5T4 antigen, which is associated with various solid tumors and poor clinical outcomes [3]

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].