REHOVOT, Israel, Oct. 20, 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 that on October 16, 2025, it received a letter from the Listings Qualifications Department of The Nasdaq Stock Market LLC ("Nasdaq") notifying the Company that it is not in compliance with the minimum bid price requirement set forth in Nasdaq ...

Core Viewpoint - Purple Biotech Ltd. is advancing its clinical-stage therapies, particularly NT219, which targets tumor immune evasion and drug resistance, and has received an intention to grant a European Patent for its combination therapies [1][2][3] Company Overview - Purple Biotech is a clinical-stage company focused on developing first-in-class therapies to combat tumor immune evasion and drug resistance, with a pipeline that includes NT219, CAPTN-3, and CM24 [4] - The company is headquartered in Rehovot, Israel, and is publicly traded on NASDAQ and TASE under the ticker PPBT [4] Patent and Intellectual Property - The European Patent Office intends to grant a patent for NT219 combinations with leading immunotherapies, which could provide broad protection until 2036 [2] - The patent covers combinations of NT219 with various immunotherapies and chemotherapies, aimed at enhancing treatment sensitivity for resistant tumors [2] Clinical Development - A Phase 2 study for NT219 in combination with immunotherapy is underway, specifically targeting squamous cell carcinoma of the head and neck [3][5] - The study evaluates NT219 with pembrolizumab and cetuximab, building on previous Phase 1 results that showed anti-tumor activity [3][5] - Preclinical data supports the synergistic effects of NT219 with immunotherapy, indicating a shift in the tumor microenvironment from immunosuppressive to immunoreactive [3] Therapeutic Mechanism - NT219 functions as a dual inhibitor targeting IRS1/2 and STAT3, both of which are critical in drug resistance and tumor immune evasion [3][5] - The company is also developing CAPTN-3, a platform of tri-specific antibodies designed to enhance immune response within the tumor microenvironment [4]

Core Viewpoint - Purple Biotech Ltd. has successfully closed a public offering of 5,999,999 American Depositary Shares (ADSs) at a price of $1.00 per share, with additional short-term warrants potentially raising gross proceeds of approximately $12 million if fully exercised [1][3]. Group 1: Offering Details - The public offering included 5,999,999 ADSs, each representing 200 ordinary shares, and short-term warrants to purchase up to 11,999,998 ADSs [1]. - The gross proceeds from the offering were approximately $6 million before deducting fees and expenses [3]. - The short-term warrants have an exercise price of $1.00 per ADS and are exercisable immediately, expiring twenty-four months from issuance [1][3]. Group 2: Use of Proceeds - The net proceeds from the offering will be used for the development of oncology therapeutic candidates and for general working capital and corporate purposes [3]. Group 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 [6]. - The company's oncology pipeline includes CAPTN-3, CM24, and NT219, with CAPTN-3 being a preclinical platform of conditionally activated tri-specific antibodies [6]. - CM24 is a humanized monoclonal antibody targeting CEACAM1, and NT219 is a dual inhibitor targeting IRS1/2 and STAT3, with ongoing clinical studies demonstrating anti-tumor activity [6].

Company Performance - Neonode Inc. experienced a stock price drop of approximately 68.34%, closing at $6.81, down from a year high of $29.9, influenced by market reactions to company developments and industry trends [2][8] - Artelo Biosciences saw a 50.34% decrease in its stock price, closing at $4.35, amid ongoing clinical trials and a public offering priced at $3 million [3][8] - 707 Cayman Holdings Limited faced a 48.45% decline in its stock price to $0.39, potentially due to challenges in the retail sector and exploring a crypto treasury reserve with Precious Choice Global Limited [4][8] - Aethlon Medical's stock price fell by 45.76% to $0.73, possibly linked to recent performance updates and investor sentiment towards the healthcare sector, with a public offering valued at $4.5 million [5] - Purple Biotech's stock price decreased by 43.54%, closing at $0.80, which may be related to clinical trial results and market conditions affecting biotech firms [6] Market Trends - The significant price movements of these companies highlight the importance of monitoring market trends, company developments, and broader economic factors that can impact stock performance [7]

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 CAPTN-3, CM24, and NT219, with innovative mechanisms targeting various cancer indications [6][7] Public Offering Details - Purple Biotech announced a public offering of 5,999,999 American Depositary Shares (ADSs) at a price of $1.00 per share, with short-term warrants to purchase up to 11,999,998 ADSs [1][3] - The gross proceeds from the offering are expected to be approximately $6 million, with potential additional proceeds of about $12 million from the exercise of short-term warrants [3] Use of Proceeds - The net proceeds from the offering will be utilized for the development of oncology therapeutic candidates and for general working capital and corporate purposes [3] Regulatory Information - The offering is conducted under a registration statement on Form F-1, which was declared effective by the SEC on September 4, 2025 [4]

Core Insights - Purple Biotech Ltd. is advancing its tri-specific antibody IM1240, targeting the tumor-associated antigen 5T4, towards first-in-human clinical trials with an IND submission planned for 2026 [1][6] - The collaboration with Dr. Amir Horowitz focuses on evaluating the CAPTN-3 antibody's effects on patient-derived tumor biopsies, particularly in treatment-resistant cancers [2][3] - IM1240 has shown to induce cancer cell apoptosis in resistant head and neck cancer biopsies, demonstrating a unique synergistic effect not observed in related bispecific antibodies [3][4] Company Overview - Purple Biotech is a clinical-stage company developing therapies to overcome tumor immune evasion and drug resistance, with a pipeline that includes CAPTN-3, CM24, and NT219 [6] - The CAPTN-3 platform utilizes conditionally activated tri-specific antibodies to engage T cells and NK cells, aiming for a strong immune response localized within the tumor microenvironment [6] - IM1240 is the first tri-specific antibody targeting the 5T4 antigen, which is associated with advanced disease and poor clinical outcomes in various solid tumors [6] Research and Development - Dr. Horowitz's research indicates that targeting NKG2A provides a selective checkpoint inhibition strategy, enhancing antitumor activity while minimizing off-target effects [4][5] - Analysis of approximately 26,000 human transcriptomes supports the design of IM1240, showing consistent expression of NKG2A with 5T4 in solid tissues [1][4] - The CAPTN-3 platform's unique design allows for the activation of immune cell subsets with high anti-tumor activity, potentially improving safety and efficacy [4][5]

Core Insights - Purple Biotech is advancing the development of a tri-specific antibody targeting TROP2, which is part of its CAPTN-3 platform aimed at overcoming tumor immune evasion and drug resistance [1][2][8] - The company plans to submit an Investigational New Drug (IND) application for its first CAPTN-3 tri-specific antibody, IM1240, in 2026 [1] - Encouraging preclinical results have shown sustained tumor regression in human triple negative breast cancer (TNBC) models, with significant cell death in various tumor types at low doses [4][5] 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 [8] - The company's oncology pipeline includes CAPTN-3, CM24, and NT219, with CAPTN-3 being a preclinical platform of conditionally activated tri-specific antibodies [8][9] - The CAPTN-3 platform utilizes a unique mechanism of action that engages both innate and adaptive immune systems to enhance anti-tumoral responses [8] Technology and Mechanism - The tri-specific antibody IM1305 includes a masked anti-CD3 arm designed to reduce off-target effects while enhancing efficacy in the tumor microenvironment [3][6] - TROP2 is expressed in various solid tumors and is linked to poor prognosis, making it a significant target for therapeutic development [5][6] - The CAPTN-3 platform's ability to recruit multiple immune effectors (T and NK cells) is expected to provide a strong rationale for its effectiveness across diverse tumor types [6][7] Future Prospects - The company is optimistic about the growing interest in TROP2 as a therapeutic target and aims to leverage its technological advancements to accelerate development timelines [7] - Purple Biotech believes that its CAPTN-3 platform can generate multiple programs and expand partnership opportunities in the oncology space [7]

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]