Core Insights - Purple Biotech has announced a collaboration with Converge Bio to enhance its tri-specific antibody platform using generative AI for oncology applications [1][3] - The collaboration aims to accelerate drug discovery timelines and improve the quality of therapeutic candidates targeting solid tumors [1][4] Company Overview - Purple Biotech is a clinical-stage company focused on developing next-generation immunotherapy platforms that maximize anti-cancer potency while minimizing toxicity [9] - The company's lead program, CAPTN-3, involves masked tri-specific antibodies that engage both T cells and NK cells, enhancing therapeutic efficacy [8][9] Collaboration Details - The partnership will leverage Converge Bio's AI platform, which integrates large-scale biological data with predictive modeling to optimize antibody candidates [3][5] - This collaboration is expected to expand Purple Biotech's pipeline with high-quality candidates while reducing development timelines [4][6] Technology and Innovation - The CAPTN-3 platform utilizes proprietary capping technology to confine immune activation to the tumor microenvironment, significantly improving the therapeutic window compared to traditional T-cell engagers [8][9] - The collaboration aims to develop novel T cell engagers that combine optimal functional properties with favorable physicochemical characteristics [3][4] Strategic Goals - The integration of AI into Purple Biotech's development strategy positions the company at the forefront of innovation in multi-specific antibody therapies [3][5] - The collaboration is seen as a strategic expansion to address additional high-value oncology targets and resistance mechanisms [6]

Financial Position - Total cash position was $9.5 million as of December 31, 2025, expected to provide runway into 2027[1] - Total assets decreased to $17.572 million as of December 31, 2025, from $37.038 million in 2024[21] - Cash and cash equivalents at the end of the year on December 31, 2025, were $8,717,000, an increase from $7,401,000 at the beginning of the year[24] Expenses - Research and Development Expenses for Q4 2025 were $1.8 million, an increase of $1.4 million compared to $0.5 million in Q4 2024[6] - General and Administrative Expenses for Q4 2025 were $1.1 million, an increase of $0.6 million compared to $0.6 million in Q4 2024[7] - Research and development expenses for the year ended December 31, 2025, were $3,731,000, a decrease of 51% from $7,620,000 in 2024[22] - The impairment loss for the year ended December 31, 2025, was $20,482,000, a significant increase from $202,000 in 2024[22] Losses - Operating Loss for the year ended December 31, 2025, was $27.5 million, an increase of $16.5 million compared to $11 million in 2024[15] - Net Loss for the year ended December 31, 2025, was $26.4 million, or $54.9 loss per basic ADS, compared to a net loss of $7.2 million in 2024[16] - The total comprehensive loss for the year ended December 31, 2025, was $26,492,000, up from $7,298,000 in 2024, indicating a significant increase of 263%[22] - The loss per share for the year ended December 31, 2025, was $0.027, compared to $0.022 in 2024, representing a 23% increase[22] Cash Flow - The net cash used in operating activities for the year ended December 31, 2025, was $5,656,000, an improvement from $14,367,000 in 2024[24] - The company reported a non-IFRS adjusted operating loss of $6,667,000 for the year ended December 31, 2025, compared to $10,221,000 in 2024, reflecting a 35% improvement[25] - The company raised $3,153,000 from the issuance of ADSs during the year ended December 31, 2025, down from $5,809,000 in 2024[24] - The finance income, net for the year ended December 31, 2025, was a loss of $966,000, compared to a loss of $3,726,000 in 2024, indicating an improvement[24] Research and Development - Achieved commercially viable yield for IM1240, positioning the program competitively for future development[14] - Significant tumor regression demonstrated with IM1240 and IM1305, targeting different tumor antigens[5] - CAPTN-3 platform's lead candidate, IM1240, showed improved tolerability in toxicology studies at doses up to 300-fold higher than a non-capped comparator[5]

Financial Performance and Capital Needs - The company is a clinical stage biotechnology firm with a history of operating losses and anticipates incurring significant additional losses in the future[29]. - The company relies on a limited portfolio of therapeutic candidates for future revenue, which could impair its ability to achieve profitability[29]. - Additional capital will be necessary to develop and commercialize therapeutic candidates, and failure to raise sufficient capital could significantly impair future operations[29]. - The company has incurred approximately $171 million in losses from the commencement of its pharmaceutical research and development activities through December 31, 2025[37]. - 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[42]. - The company has a limited operating history, and its future revenue depends on the successful commercialization of its therapeutic candidates[38]. Regulatory and Clinical Trial Risks - The company is subject to regulatory approvals, and delays or rejections of IND, NDA, or BLA for therapeutic candidates could hinder commercialization efforts[27]. - The company has ongoing clinical trials that may fail to demonstrate the safety and efficacy of its therapeutic candidates, impacting regulatory approval[29]. - The company’s therapeutic candidates are subject to extensive regulatory review, and failure to demonstrate safety and efficacy could prevent or delay approval[46]. - Regulatory approval processes for therapeutic candidates are subject to delays due to factors such as government budget changes and workforce reductions at the FDA, which could adversely affect the company's business[50]. - Any material delay in obtaining regulatory approvals will increase costs and adversely affect the company's ability to generate future revenues[53]. - The company is subject to various regulatory requirements that could lead to delays in clinical trials and commercialization of therapeutic candidates[92][93]. Manufacturing and Supply Chain Challenges - The company anticipates continued reliance on third-party manufacturers for the production of active pharmaceutical ingredients (API) compliant with regulations[29]. - The company may experience difficulties in manufacturing its therapeutic candidates, which could delay supply for clinical trials[1]. - The company relies heavily on third-party manufacturers for the production of its oncology therapeutic candidates, which may affect profit margins and timely commercialization[71]. - The company does not own manufacturing facilities and is dependent on third-party vendors for APIs and other materials, which could lead to delays in clinical trials if supply is interrupted[73]. - Regulatory compliance is critical, and failure of third-party manufacturers to adhere to cGMPs could result in significant delays or suspension of clinical trials[78]. - Manufacturing complexities for therapeutic candidates like NT219, CM24, and IM1240 may lead to production delays and increased costs, impacting commercial viability[104][106]. Collaboration and Partnership Dependencies - The company emphasizes the importance of establishing collaborations for its therapeutic candidates to enhance development and commercialization prospects[29]. - Collaborative arrangements with third parties are essential for the company, but these collaborations may not be successful or may not yield anticipated benefits[58]. - The company relies on collaboration partners for clinical trials, and any failure in these collaborations could significantly delay development plans and revenue generation[100]. - Collaboration agreements may provide partners with rights to terminate, which could adversely affect product development efforts and financial stability[103]. Market and Competitive Landscape - The company operates in a rapidly changing and competitive market for oncology therapeutic candidates, which may impact its growth[1]. - The competitive landscape in the pharmaceutical and biotechnology industry is rapidly changing, with many companies developing products for the same indications, potentially impacting the company's market position[135]. - New drug delivery technologies and treatments developed by competitors may render the company's therapeutic candidates noncompetitive or obsolete[136]. - Market acceptance of the company's oncology therapeutic candidates may be limited due to the established use of alternative treatments with a longer history of effectiveness[137]. - Adequate reimbursement from third-party payers is critical for the company's revenue generation, and delays or limitations in reimbursement could adversely affect market acceptance[138]. Intellectual Property Risks - The company may face challenges in protecting its intellectual property rights, which could adversely affect its business[1]. - Third-party claims of intellectual property infringement could delay the development and commercialization of therapeutic candidates, impacting financial performance[166][167]. - The company may face future adversarial proceedings or litigation regarding patents that could negatively impact its ability to market drug candidates[168]. - There is uncertainty regarding the completeness of the company's patent searches, which may lead to potential infringement claims from third parties[170]. - The company may lose valuable intellectual property rights, which could adversely affect its business and financial condition[174]. Operational and Geopolitical Risks - The company faces risks related to the political, economic, and public health situations in Israel and other operational countries[29]. - The company is exposed to various global risks that could adversely affect its business, including changes in trade policies and geopolitical events[123]. - The global perception of Israel may lead to increased sanctions and negative measures against Israeli companies, potentially impacting business operations[209]. - The Israeli government is committed to covering the reinstatement value of direct damages caused by terrorist attacks or acts of war, but there is no assurance that this coverage will be maintained[208]. Management and Personnel Challenges - The CEO announced plans to step down in August 2026, which may create uncertainty and impact operations[120]. - The company faces challenges in attracting and retaining key personnel, which could adversely affect its business[121]. - Significant funds may be required to satisfy indemnification obligations due to claims against directors and officers, which could adversely affect the company's financial condition and limit funds available for shareholder claims[218]. Financial and Economic Conditions - Unfavorable macroeconomic conditions, including a 3.1% rise in the Consumer Price Index from January 2023 to January 2024, could adversely impact the company's financial results[157]. - Trade disputes and geopolitical tensions may exacerbate macroeconomic challenges, affecting capital access and overall business operations[159]. - Legislative and regulatory changes in the U.S. healthcare system may impose downward pressure on pricing and reimbursement rates for the company's products, impacting revenue potential[144].

Core Viewpoint - Purple Biotech Ltd. has regained compliance with Nasdaq's minimum bid price requirement, allowing for continued listing on the Nasdaq Capital Market [2]. Company Overview - Purple Biotech Ltd. is a clinical-stage company focused on developing a next-generation immunotherapy platform aimed at maximizing anti-cancer potency while minimizing toxicity [3]. - The company is advancing its lead program, CAPTN-3, which utilizes masked tri-specific antibodies to target tumors and engage T cells and NK cells [3]. - The lead candidate, IM1240, is progressing towards clinical trials, while the second candidate, IM1305, is in preclinical development [3]. - The pipeline includes additional clinical-stage assets such as CM24, a CEACAM1-blocking antibody, and NT219, a dual IRS1/2 and STAT3 inhibitor, both of which are in Phase 2 studies for various cancers [3].

Company Leadership Transition - Gil Efron will step down as CEO of Purple Biotech Ltd. effective August 2026 due to health considerations, but will continue to lead corporate development and remain on the Board of Directors [1][2] - The Board of Directors has initiated a search for a new CEO with experience in leading innovative biotechnology companies [2][3] - Efron has served in senior leadership roles for eight years, including as CFO and CEO, and has been instrumental in the company's strategic repositioning around the CAPTN-3 platform [3][4] CAPTN-3 Platform Overview - CAPTN-3 is Purple Biotech's lead program, featuring capped tri-specific antibodies that target tumor-associated antigens while engaging T cells and NK cells [4][5] - The proprietary capping technology confines immune activation to the tumor microenvironment, significantly expanding the therapeutic window compared to conventional T-cell engagers [4][5] - The lead candidates, IM1240 and IM1305, are in preclinical development, with IM1240 advancing toward clinical trials [5][6] Company Background - Purple Biotech Ltd. is a clinical-stage company focused on developing next-generation immunotherapy platforms aimed at maximizing anti-cancer potency while minimizing toxicity [5][6] - The company is headquartered in Rehovot, Israel, and is advancing its lead program, CAPTN-3, alongside additional clinical-stage assets [6]

Core Insights - The company is focusing on the development of tri-specific antibodies from the CAPTN-3 platform, specifically IM1240 and IM1305, targeting tumor-associated antigens 5T4 and TROP2 respectively [1][2] - Positive preclinical data indicates multi-arm anti-tumor activity for both IM1240 and IM1305, with an expanded therapeutic window and commercially viable yield achieved for IM1240 [1][3] - The company reported a total cash position of $9.5 million as of December 31, 2025, which is expected to provide operational runway into 2027 [1][13] Development Highlights - The CAPTN-3 platform has shown significant and sustained tumor regression across IM1240 and IM1305, with transcriptomic analysis supporting the inclusion of the NKG2A arm in designs [6][7] - IM1240 demonstrated improved tolerability in toxicology studies, with doses up to 300-fold higher than a non-capped comparator, and significantly reduced immune-related toxicity [6] - Manufacturing milestones for IM1240 have been achieved, positioning the program competitively for future development [5] Financial Performance - For the three months ended December 31, 2025, research and development expenses increased to $1.8 million from $0.5 million in the same period of 2024, primarily due to CAPTN-3 platform development activities [8] - General and administrative expenses rose to $1.1 million compared to $0.6 million in the same period of 2024, attributed to increased professional services fees [9] - The company recognized a $20.5 million impairment loss related to in-process research and development assets CM24 and NT219, reflecting a strategic focus on the CAPTN-3 platform [10][15] Loss and Cash Flow - The operating loss for the year ended December 31, 2025, was $27.5 million, an increase from $11 million in 2024, primarily due to the impairment expenses [16] - The net loss for the year was $26.4 million, or $54.9 loss per basic ADS, compared to a net loss of $7.2 million in 2024 [17] - Cash and cash equivalents at the end of 2025 were $8.7 million, up from $7.4 million at the end of 2024, indicating a net increase in cash flow [30]

Core Viewpoint - Purple Biotech Ltd. is changing the ratio of its American Depositary Shares (ADSs) to ordinary shares to regain compliance with Nasdaq's minimum bid price requirement, effective March 2, 2026 [1][2]. Group 1: ADS Ratio Change - The ADS Ratio will change from 1 ADS representing 200 ordinary shares to 1 ADS representing 2,000 ordinary shares, effectively a one-for-ten reverse ADS split [1][2]. - Registered holders of certificated ADSs must surrender their ADSs for cancellation to receive new ADSs, while holders of uncertificated ADSs will have their ADSs automatically exchanged [2]. - The new CUSIP number assigned due to the ADS Ratio Change is 74638P307, and the ADSs will continue to trade under the symbol "PPBT" on Nasdaq [2]. Group 2: Impact on Trading - The ADS trading price is expected to increase proportionally as a result of the ADS Ratio Change, enhancing its suitability for trading on Nasdaq [4]. - There is no assurance that the ADS trading price post-change will be equal to or greater than ten times the price before the change [4]. Group 3: Company Overview - Purple Biotech is a clinical-stage oncology company focused on developing therapies to overcome tumor immune evasion and drug resistance [5]. - The lead program, CAPTN-3, involves capped tri-specific antibodies targeting tumors while engaging T cells and NK cells, with candidates IM1240 and IM1305 in various stages of development [5]. - The pipeline includes clinical-stage assets like CM24 and NT219, targeting specific cancer types with promising outcomes in clinical studies [5].

Core Insights - IM1240, a tri-specific antibody from Purple Biotech's CAPTN-3 platform, has shown improved safety in a toxicology study, allowing doses up to 300-fold higher than a non-capped comparator with significantly reduced immune-related toxicity [1][2][3] - The pharmacokinetic profile of IM1240 indicates increased systemic exposure and a prolonged circulating half-life, supporting its therapeutic potential [1][3] - Purple Biotech plans to submit for regulatory approval for first-in-human clinical trials in the second half of 2026 [1] Study Results - The toxicology study demonstrated that IM1240's proprietary capping technology significantly reduced immune-related toxicity, including minimal cytokine release, compared to a non-capped comparator [2][3] - Hematologic findings in the study aligned with expected pharmacodynamic effects on immune activation, showcasing a favorable safety and tolerability profile [3] - The capping design of IM1240 allowed for a significant reduction in immune-related effects, maintaining modest cytokine release even at high doses [3] Pharmacokinetics - IM1240 exhibited a favorable pharmacokinetic profile characterized by dose-dependent increases in systemic exposure, as indicated by AUC and Cmax [3] - The findings support the dose-exposure relationship and provide proof of concept for the capping design and albumin incorporation contributing to IM1240's favorable pharmacokinetic profile [3] CAPTN-3 Platform Overview - The CAPTN-3 platform consists of capped tri-specific antibodies that target tumor-associated antigens while engaging T cells and NK cells, significantly expanding the therapeutic window compared to conventional T-cell engagers [4][5] - IM1240 targets the 5T4 antigen, while another candidate, IM1305, targets TROP2 and is currently in preclinical development [4][5] Company Background - Purple Biotech Ltd. is a clinical-stage oncology company focused on developing first-in-class therapies to overcome tumor immune evasion and drug resistance [5] - The company's pipeline includes additional clinical-stage assets, such as CM24 and NT219, which are in various stages of clinical trials [5]

Core Insights - The CAPTN-3 platform by Purple Biotech demonstrates significant tumor regression through two tri-specific antibodies, IM1240 and IM1305, targeting different tumor antigens [1][2] - The NKG2A arm is crucial for enhancing the anti-cancer immune activity of IM1240, particularly in PD1-resistant patient-derived explants [1][3] Group 1: CAPTN-3 Platform and Antibodies - The CAPTN-3 platform combines T-cell engagement, NKG2A-mediated immune activation, and tumor-antigen targeting into a single tri-specific molecule, showing potential for a synergistic immune response [2][3] - IM1240 has shown strong anti-tumor activity in PD1-resistant models, indicating its effectiveness even in previously resistant tumors [4][6] - IM1305, targeting TROP2, demonstrates high-affinity binding and potent tumor cell killing across various cancer types, reinforcing the platform's versatility [9] Group 2: Preclinical Data and Findings - New preclinical data presented at the ESMO Immuno-Oncology Congress 2025 highlights the anti-tumor activity of IM1240 in models resistant to PD1 therapy [1][2] - Transcriptomic analysis of approximately 11,000 TCGA samples indicates a strong association between NKG2A expression and tumor expression of 5T4 or TROP2, supporting the inclusion of the NKG2A arm in CAPTN-3 designs [1][6] - IM1305 induced sustained tumor regression in humanized triple-negative breast cancer mouse models at low doses, demonstrating broad application potential [7]

Core Insights - Purple Biotech Ltd. is set to present new preclinical data from its CAPTN-3 platform at the ESMO-IO 2025 Annual Congress, highlighting its potential in treating resistant cancers [1][3]. Company Overview - Purple Biotech is a clinical-stage company focused on developing first-in-class therapies aimed at overcoming tumor immune evasion and drug resistance [5]. - The company's oncology pipeline includes CAPTN-3, CM24, and NT219, with CAPTN-3 being a preclinical platform of conditionally activated tri-specific antibodies [5]. CAPTN-3 Platform - The CAPTN-3 platform can produce tri-specific antibodies that engage T cells and NK cells while binding to tumor-associated antigens, demonstrating strong synergy in preclinical studies [3]. - The platform's unique design allows for localized immune responses within the tumor microenvironment, potentially increasing the therapeutic window for patients [5]. Lead Program IM1240 - IM1240 is the first tri-specific antibody in development targeting the 5T4 antigen, which is associated with various solid tumors and poor clinical outcomes [5]. - New data from IM1240 will be showcased in multiple PD-1 resistant models at the upcoming congress [3]. Other Pipeline Products - CM24 is a humanized monoclonal antibody that blocks CEACAM1, a target for multiple cancer indications, and has shown improvement in a Phase 2 study for pancreatic ductal adenocarcinoma [5]. - NT219 is a dual inhibitor targeting IRS1/2 and STAT3, with demonstrated anti-tumor activity in combination with cetuximab in recurrent and/or metastatic squamous cell carcinoma of the head and neck [5]. Presentation Details - The presentation at the ESMO-IO 2025 Annual Congress will be led by Dr. Hadas Reuveni, focusing on the unique design of the CAPTN-3 platform [7].