PPBT
Purple BiotechDDocument history
Earnings documents stored for PPBT.
Investor releaseQuarter not tagged2026-08-07Purple Biotech Reports Second Quarter 2026 Financial Results
GlobeNewswire
Purple Biotech Reports Second Quarter 2026 Financial Results
New preclinical data presented at European Association for Cancer Research (EACR) 2026 Annual Congress, which further validates the differentiated profile of IM1240's anti-tumor activity, favorable safety and pharmacokinetic profile, and broad therapeutic window IM1240 tri-specific antibody (capped-CD3x5T4xNKG2A) is aimed at entering clinical studies in 2027 Total Cash Position of $6.1 million as of June 30, 2026, provides a runway through mid-2027 based on current management estimates REHOVOT, Israel, Aug. 07, 2026 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing a next-generation immunotherapy platform designed to maximize anti-cancer potency while minimizing toxicity, today announced financial results for the three and six months ended June 30, 2026, and provided an update on recent business progress, including new data supporting the differentiation and partnering potential of our CAPTN-3 platform. “We are encouraged by the interest in our differentiated CAPTN-3 T-cell engager platform. The consistent preclinical data generated to date continue to strengthen the platform's differentiated profile, demonstrating an expanded therapeutic window enabled by both enhanced anti-tumor activity through NKG2A engagement and our CD3 capping technology. These findings further support IM1240 as a compelling candidate as we advance toward the clinic. Our total cash position of approximately $6.1 million as of June 30, 2026, is expected to provide a cash runway through mid-2027 based on current management estimates. We continue to pursue a strategic collaboration to support the clinical advancement of IM1240 while preserving shareholder value, and to evaluate financing alternatives to support the planned Phase 1 study.” Recent Clinical & Corporate Highlights: Presented new preclinical data at EACR 2026 supporting IM1240’s safety, pharmacokinetic profile and broad therapeutic window A non-GLP toxicology study in non-human primates validates the CAPTN-3 masking strategy and supports the planned advancement of IM1240 toward a first-in-human clinical study in 2027. IM1240 demonstrated an approximately 8-fold longer half-life and 16-fold greater systemic exposure compared to the non-capped variant, together with dose-proportional pharmacokinetics and a broad therapeutic window. The CAPTN-3 ma…Read full documentShow less
New preclinical data presented at European Association for Cancer Research (EACR) 2026 Annual Congress, which further validates the differentiated profile of IM1240's anti-tumor activity, favorable safety and pharmacokinetic profile, and broad therapeutic window IM1240 tri-specific antibody (capped-CD3x5T4xNKG2A) is aimed at entering clinical studies in 2027 Total Cash Position of $6.1 million as of June 30, 2026, provides a runway through mid-2027 based on current management estimates REHOVOT, Israel, Aug. 07, 2026 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing a next-generation immunotherapy platform designed to maximize anti-cancer potency while minimizing toxicity, today announced financial results for the three and six months ended June 30, 2026, and provided an update on recent business progress, including new data supporting the differentiation and partnering potential of our CAPTN-3 platform. “We are encouraged by the interest in our differentiated CAPTN-3 T-cell engager platform. The consistent preclinical data generated to date continue to strengthen the platform's differentiated profile, demonstrating an expanded therapeutic window enabled by both enhanced anti-tumor activity through NKG2A engagement and our CD3 capping technology. These findings further support IM1240 as a compelling candidate as we advance toward the clinic. Our total cash position of approximately $6.1 million as of June 30, 2026, is expected to provide a cash runway through mid-2027 based on current management estimates. We continue to pursue a strategic collaboration to support the clinical advancement of IM1240 while preserving shareholder value, and to evaluate financing alternatives to support the planned Phase 1 study.” Recent Clinical & Corporate Highlights: Presented new preclinical data at EACR 2026 supporting IM1240’s safety, pharmacokinetic profile and broad therapeutic window A non-GLP toxicology study in non-human primates validates the CAPTN-3 masking strategy and supports the planned advancement of IM1240 toward a first-in-human clinical study in 2027. IM1240 demonstrated an approximately 8-fold longer half-life and 16-fold greater systemic exposure compared to the non-capped variant, together with dose-proportional pharmacokinetics and a broad therapeutic window. The CAPTN-3 masking strategy mitigated peripheral T-cell activation and systemic cytokine release. IM1240 induced minimal IL-6 and TNF-α at a dose of 10 mg/kg, whereas the non-capped variant induced robust cytokine release at a dose of 0.03 mg/kg. Generated new patient-derived tumor data supporting IM1240’s differentiated mechanism and anti-tumor activity Data generated in collaboration with the laboratory of Amir Horowitz, PhD, at the Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai, demonstrated that all tested patient-derived tumor samples responded to IM1240 treatment. IM1240 induced apoptosis of PD-1-resistant patient-derived biopsies from six head and neck squamous cell carcinoma (HNSCC) metastatic lymph node samples and one enfortumab vedotin/pembrolizumab-resistant muscle-invasive bladder cancer sample, with both the CD3 and NKG2A functional arms required for full activity. In a PD-1/chemotherapy-resistant non-small cell lung cancer (NSCLC) patient-derived explant, IM1240 induced mature tertiary lymphoid structures (TLS) - immune cell organizations associated with effective anti-tumor immunity and favorable clinical prognosis - while increasing CD8 T-cell and NK-cell abundance and reducing regulatory T cells (Tregs) and tumor cells. These effects were not observed with IM1340, the NKG2A loss-of-function variant, underscoring the essential and differentiated contribution of the NKG2A arm. Financial Results for the Three Months Ended June 30, 2026 Research and Development Expenses were $0.7 million for the three months ended June 30, 2026, as compared to $0.6 million for the corresponding period in 2025, representing an increase of $0.1 million. The increase is primarily attributable to the advancement of the IM1240 development program, partially offset by a decrease in clinical expenses associated with the CM24 and NT219 programs. General and Administrative Expenses were $0.6 million for the three months ended June 30, 2026, as compared to $0.7 million for the corresponding period in 2025, representing a decrease of $0.1 million, primarily due to lower regulatory and professional services expenses. Operating Loss was $1.3 million for the three months ended June 30, 2026, representing an increase of $0.1 million as compared to $1.2 million for the corresponding period in 2025. Adjusted Operating Loss (as reconciled below) was $1.2 million for the three months ended June 30, 2026, as compared to $1.2 million for the corresponding period in 2025. Financial Income, Net was $1.7 million for the three months ended June 30, 2026, as compared to $0.1 million for the corresponding period in 2025. The increase is primarily attributable to a higher non-cash gain arising from the revaluation of outstanding warrants. Net Income was $0.4 million for the three months ended June 30, 2026, as compared to a net loss of $1.1 million for the corresponding period in 2025. The change was primarily driven by increased finance income resulting from changes in the fair value of outstanding warrants. Adjusted Net Loss (as reconciled below) was $1.2 million for the three months ended June 30, 2026, as compared to $1.1 million for the corresponding period in 2025. Adjusted net loss excludes non-cash share-based compensation expenses and finance income resulting from changes in the fair value of outstanding warrants. As of June 30, 2026, Purple Biotech had cash and cash equivalents and short-term deposits of $6.1 million, which, based on current management estimates, are expected to provide the Company with a cash runway through mid-2027. Non-IFRS Financial Measures This press release includes information about certain financial measures that are not prepared in accordance with International Financial Reporting Standards ("IFRS"), including adjusted operating loss and adjusted net loss. These non-IFRS measures are not based on any standardized methodology prescribed by IFRS and are not necessarily comparable to similar measures presented by other companies. Adjusted operating loss and adjusted net loss adjust for non-cash share-based compensation expenses, and adjusted net loss also adjusts for finance income from financial instruments. The Company's management and board of directors utilize these non-IFRS financial measures to evaluate the Company's performance. The Company provides these non-IFRS measures of the Company's performance to investors because management believes that these non-IFRS financial measures, when viewed with the Company's results under IFRS and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, these non-IFRS measures are not measures of financial performance under IFRS and, accordingly, should not be considered in isolation or as alternatives to IFRS measures as indicators of operating performance. Further, these non-IFRS measures should not be considered measures of the Company's liquidity. A reconciliation of certain IFRS to non-IFRS financial measures has been provided in the tables included in this press release. About Purple Biotech Purple Biotech Ltd. (NASDAQ/TASE: PPBT) is a clinical-stage company developing a next-generation immunotherapy platform designed to maximize anti-cancer potency while minimizing toxicity. The Company is focused on advancing its lead program, CAPTN-3 - a platform of masked tri-specific antibodies that simultaneously target tumors while engaging both T cells and NK cells. Capping technology confines immune activation to the tumor microenvironment, significantly expanding the therapeutic window compared to conventional T-cell engagers. The platform's lead candidate, IM1240, is advancing toward the clinic, and its second candidate, IM1305, is in preclinical development. The Company's pipeline also includes additional clinical-stage assets, for which further development is pending partnering or investment, including CM24, a CEACAM1-blocking antibody that demonstrated improved outcomes across all efficacy endpoints in a Phase 2 study for the treatment of pancreatic ductal adenocarcinoma, and NT219, a dual IRS1/2 and STAT3 inhibitor that completed a Phase 2 study for the treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck. The Company is headquartered in Rehovot, Israel. For additional information about the Company, please visit: https://purple-biotech.com. Forward-Looking Statements and Safe Harbor Statement Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements that are not statements of historical fact, and may be identified by words such as "believe", "expect", "intend", "plan", "may", "should", "could", "might", "seek", "target", "will", "project", "forecast", "continue" or "anticipate" or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. You should not place undue reliance on these forward-looking statements, which are not guarantees of future performance. Forward-looking statements reflect our current views, expectations, beliefs or intentions with respect to future events, and are subject to a number of assumptions, involve known and unknown risks, many of which are beyond our control, as well as uncertainties and other factors that may cause our actual results, performance or achievements to be significantly different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause or contribute to such differences include, among others, risks relating to: the plans, strategies and objectives of management for future operations; product development for NT219, CM24 and CAPTN-3; the process by which such early stage therapeutic candidates could potentially lead to an approved drug product is long and subject to highly significant risks, particularly with respect to a joint development collaboration; the fact that drug development and commercialization involves a lengthy and expensive process with uncertain outcomes; our ability to successfully develop and commercialize our pharmaceutical products; the expense, length, progress and results of any clinical trials; the impact of any changes in regulation and legislation that could affect the pharmaceutical industry; the difficulty in receiving the regulatory approvals necessary in order to commercialize our products; the difficulty of predicting actions of the U.S. Food and Drug Administration or any other applicable regulator of pharmaceutical products; the regulatory environment and changes in the health policies and regimes in the countries in which we operate; the uncertainty surrounding the actual market reception to our pharmaceutical products once cleared for marketing in a particular market; the introduction of competing products; patents obtained by competitors; dependence on the effectiveness of our patents and other protections for innovative products; our ability to obtain, maintain and defend issued patents; the commencement of any patent interference or infringement action against our patents, and our ability to prevail, obtain a favorable decision or recover damages in any such action; and the exposure to litigation, including patent litigation, and/or regulatory actions, and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2025 as such factors may be updated from time to time in our other filings with the U.S. Securities and Exchange Commission ("SEC"), including our cautionary discussion of risks and uncertainties under "Risk Factors" in our Registration Statements and Annual Reports. These are factors that we believe could cause our actual results to differ materially from expected results. Other factors besides those we have listed could also adversely affect us. Any forward-looking statement in this press release speaks only as of the date on which it is made. We disclaim any intention or obligation to publicly update or revise any forward-looking statement or other information contained herein, whether as a result of new information, future events or otherwise, except as required by applicable law. You are advised, however, to consult any additional disclosures we make in our reports to the SEC, which are available on the SEC's website, https://www.sec.gov. CONTACTS: Company Contact:[email protected]
Investor releaseQuarter not tagged2026-05-15Purple Biotech Reports First Quarter 2026 Financial Results and Business Highlights
GlobeNewswire
Purple Biotech Reports First Quarter 2026 Financial Results and Business Highlights
New data from IM1240 (capped-CD3 × 5T4 × NKG2A) tri-specific antibody demonstrated potent anti-tumor activity across all treatment-resistant patient-derived tumor samples Established CAPTN-3 Scientific Advisory Board with leading experts in T-cell engager development, NK cell biology and translational oncology Expanded collaboration with Converge Bio to apply generative AI to accelerate the design and optimization of next-generation tri-specific antibodies Total Cash Position of $6.4 million as of March 31, 2026, expected to provide runway into 2027 based on current management estimates REHOVOT, Israel, May 15, 2026 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing a next-generation immunotherapy platform designed to maximize anti-cancer potency while minimizing toxicity, today announced financial results for the three months ended March 31, 2026 and provided an update on recent business progress. "We continue to advance the CAPTN-3 platform as a core value driver,” said Gil Efron, Purple Biotech CEO. “New patient-derived tumor data, generated with our collaborators at Mount Sinai, further supports IM1240’s differentiated tri-specific design and its potential to overcome tumor immune evasion and resistance in difficult-to-treat solid tumors. Importantly, the data continues to support the contribution of the NKG2A arm, which enhanced anti-tumor activity across tested samples and improved the therapeutic index. In parallel, our newly formed Scientific Advisory Board and collaboration with Converge Bio provide important scientific and computational expertise as we seek to expand the broader potential of CAPTN-3. Over the remainder of 2026, we plan to build on this momentum by generating additional efficacy evidence across potential indications and advancing new tri-specific antibody combinations.” Q1 2026 and Recent Clinical & Corporate Highlights: Generated new patient-derived tumor data supporting IM1240’s differentiated mechanism and anti-tumor activity Data generated in the lab of Amir Horowitz, PhD, at the Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai, demonstrated that all tested patient-derived tumor samples responded to IM1240 treatment. IM1240 demonstrated activity across treatment-resistant samples, including PD-1 or PD-1/ chemo resistant head an…Read full documentShow less
New data from IM1240 (capped-CD3 × 5T4 × NKG2A) tri-specific antibody demonstrated potent anti-tumor activity across all treatment-resistant patient-derived tumor samples Established CAPTN-3 Scientific Advisory Board with leading experts in T-cell engager development, NK cell biology and translational oncology Expanded collaboration with Converge Bio to apply generative AI to accelerate the design and optimization of next-generation tri-specific antibodies Total Cash Position of $6.4 million as of March 31, 2026, expected to provide runway into 2027 based on current management estimates REHOVOT, Israel, May 15, 2026 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing a next-generation immunotherapy platform designed to maximize anti-cancer potency while minimizing toxicity, today announced financial results for the three months ended March 31, 2026 and provided an update on recent business progress. "We continue to advance the CAPTN-3 platform as a core value driver,” said Gil Efron, Purple Biotech CEO. “New patient-derived tumor data, generated with our collaborators at Mount Sinai, further supports IM1240’s differentiated tri-specific design and its potential to overcome tumor immune evasion and resistance in difficult-to-treat solid tumors. Importantly, the data continues to support the contribution of the NKG2A arm, which enhanced anti-tumor activity across tested samples and improved the therapeutic index. In parallel, our newly formed Scientific Advisory Board and collaboration with Converge Bio provide important scientific and computational expertise as we seek to expand the broader potential of CAPTN-3. Over the remainder of 2026, we plan to build on this momentum by generating additional efficacy evidence across potential indications and advancing new tri-specific antibody combinations.” Q1 2026 and Recent Clinical & Corporate Highlights: Generated new patient-derived tumor data supporting IM1240’s differentiated mechanism and anti-tumor activity Data generated in the lab of Amir Horowitz, PhD, at the Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai, demonstrated that all tested patient-derived tumor samples responded to IM1240 treatment. IM1240 demonstrated activity across treatment-resistant samples, including PD-1 or PD-1/ chemo resistant head and neck squamous cell carcinoma metastatic lymph nodes and enfortumab vedotin + PD-1-resistant muscle-invasive bladder cancer. Data further supports the contribution of IM1240’s NKG2A arm, which significantly enhanced anti-tumor activity across tested samples and improved the therapeutic index. In a patient-derived non-small cell lung cancer (NSCLC) biopsy, IM1240 induced mature tertiary lymphoid structures (TLS) associated with effective anti-tumor immune response and favorable prognosis, corresponding with observed anti-tumor efficacy. Established Scientific Advisory Board to support CAPTN-3 development Formed a CAPTN-3 Scientific Advisory Board (SAB) composed of experts in T-cell engager development, NK and T cell biology, translational science, and clinical oncology. The SAB is expected to provide strategic guidance as the company advances IM1240 toward clinical development and continues to evaluate broader development opportunities for the CAPTN-3 platform. Expanded collaboration with Converge Bio to apply generative AI to tri-specific antibody development The collaboration leverages Converge Bio’s proprietary generative AI platform to support the design and optimization of novel tri-specific antibodies for oncology. The AI-driven strategy is intended to accelerate discovery timelines, improve candidate quality and developability, and expand CAPTN-3’s potential across additional high-value solid tumor targets and resistance mechanisms. Advancing IM1240 and IM1305 pre-clinical development toward first-in-human studies in 2027 IM1240 remains the Company’s lead development priority, with IM1305, targeting TROP2, continuing to support the broader platform opportunity. Following the prior announcement that further development of CM24 and NT219 would require partnering or additional investment, the Company has redirected resources toward CAPTN-3 as its core development priority. Financial Results for the Three Months Ended March 31, 2026 Research and Development Expenses were $1.2 million for the three months ended March 31, 2026, reflecting an increase of $0.5 million, from $0.8 million in the same period of 2025. The increase was primarily driven by higher chemistry, manufacturing, and controls (CMC) development activities related to the CAPTN-3 platform. General and Administrative Expenses were $1.0 million for the three months ended March 31, 2026, compared to $0.6 million in the same period of 2025, representing an increase of $0.4 million, mainly due to higher payroll expenses as well as increased professional services and related expenses. Adjusted Operating Loss (as reconciled below) was $2.1 million for the three months ended March 31, 2026, compared to $1.3 million in the same period of 2025, reflecting an increase of $0.8 million, primarily attributable to the higher operating expenses described above. Finance Income, Net was $2.2 million for the three months ended March 31, 2026, compared to $1.0 million in the same period of 2025, reflecting an increase of $1.2 million, mainly due to non-cash warrant-related income due to changes in fair value measurement. Net Loss was $0.1 million for the three months ended March 31, 2026, compared to a net loss of $0.5 million in the same period of 2025. The decrease in net loss was mainly driven by finance income, net, primarily resulting from changes in the fair value of warrants, partially offset by higher operating expenses. Adjusted Net Loss (as reconciled below) for the three months ended March 31, 2026, was $2.1 million, an increase of $0.8 million, compared to $1.3 million in the same period of 2025, mainly reflecting financial income related to changes in the fair value of financial instruments. As of March 31, 2026, Purple Biotech had cash and cash equivalents and short-term deposits of $6.4 million, which is expected to provide the Company with a cash runway into 2027. Non-IFRS Financial Measures This press release includes information about certain financial measures that are not prepared in accordance with International Financial Reporting Standards ("IFRS"), including adjusted operating loss and adjusted net loss. These non-IFRS measures are not based on any standardized methodology prescribed by IFRS and are not necessarily comparable to similar measures presented by other companies. Adjusted operating loss and adjusted net loss adjust for non-cash share-based compensation expenses, and adjusted net loss also adjusts for finance income from financial instruments. The Company's management and board of directors utilize these non-IFRS financial measures to evaluate the Company's performance. The Company provides these non-IFRS measures of the Company's performance to investors because management believes that these non-IFRS financial measures, when viewed with the Company's results under IFRS and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, these non-IFRS measures are not measures of financial performance under IFRS and, accordingly, should not be considered in isolation or as alternatives to IFRS measures as indicators of operating performance. Further, these non-IFRS measures should not be considered measures of the Company's liquidity. A reconciliation of certain IFRS to non-IFRS financial measures has been provided in the tables included in this press release. About Purple Biotech Purple Biotech Ltd. (NASDAQ/TASE: PPBT) is a clinical-stage company developing a next-generation immunotherapy platform designed to maximize anti-cancer potency while minimizing toxicity. The Company is focused on advancing its lead program, CAPTN-3 - a platform of masked tri-specific antibodies that simultaneously target tumors while engaging both T cells and NK cells. Capping technology confines immune activation to the tumor microenvironment, significantly expanding the therapeutic window compared to conventional T-cell engagers. The platform’s lead candidate, IM1240, is advancing toward the clinic, and its second candidate, IM1305, is in preclinical development. The Company’s pipeline also includes additional clinical-stage assets, for which further development is pending partnering or investment, including CM24, a CEACAM1-blocking antibody that demonstrated improved outcomes across all efficacy endpoints in a Phase 2 study for the treatment of pancreatic ductal adenocarcinoma, and NT219, a dual IRS1/2 and STAT3 inhibitor in a Phase 2 study for the treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck. The Company is headquartered in Rehovot, Israel. For additional information about the Company, please visit: https://purple-biotech.com Forward-Looking Statements and Safe Harbor Statement Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements that are not statements of historical fact, and may be identified by words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. You should not place undue reliance on these forward-looking statements, which are not guarantees of future performance. Forward-looking statements reflect our current views, expectations, beliefs or intentions with respect to future events, and are subject to a number of assumptions, involve known and unknown risks, many of which are beyond our control, as well as uncertainties and other factors that may cause our actual results, performance or achievements to be significantly different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause or contribute to such differences include, among others, risks relating to: the plans, strategies and objectives of management for future operations; product development for NT219, CM24 and CAPTN-3; the process by which such early stage therapeutic candidates could potentially lead to an approved drug product is long and subject to highly significant risks, particularly with respect to a joint development collaboration; the fact that drug development and commercialization involves a lengthy and expensive process with uncertain outcomes; our ability to successfully develop and commercialize our pharmaceutical products; the expense, length, progress and results of any clinical trials; the impact of any changes in regulation and legislation that could affect the pharmaceutical industry; the difficulty in receiving the regulatory approvals necessary in order to commercialize our products; the difficulty of predicting actions of the U.S. Food and Drug Administration or any other applicable regulator of pharmaceutical products; the regulatory environment and changes in the health policies and regimes in the countries in which we operate; the uncertainty surrounding the actual market reception to our pharmaceutical products once cleared for marketing in a particular market; the introduction of competing products; patents obtained by competitors; dependence on the effectiveness of our patents and other protections for innovative products; our ability to obtain, maintain and defend issued patents; the commencement of any patent interference or infringement action against our patents, and our ability to prevail, obtain a favorable decision or recover damages in any such action; and the exposure to litigation, including patent litigation, and/or regulatory actions, and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2025 as such factors may be updated from time to time in our other filings with the U.S. Securities and Exchange Commission ("SEC"), including our cautionary discussion of risks and uncertainties under "Risk Factors" in our Registration Statements and Annual Reports. These are factors that we believe could cause our actual results to differ materially from expected results. Other factors besides those we have listed could also adversely affect us. Any forward-looking statement in this press release speaks only as of the date on which it is made. We disclaim any intention or obligation to publicly update or revise any forward-looking statement or other information contained herein, whether as a result of new information, future events or otherwise, except as required by applicable law. You are advised, however, to consult any additional disclosures we make in our reports to the SEC, which are available on the SEC's website, https://www.sec.gov. CONTACTS: Company Contact: [email protected] Purple Biotech Ltd. Consolidated Unaudited Statements of Financial Position as of: Purple Biotech Ltd. Consolidated Unaudited Statement of Operations for the three months ended Reconciliation of Adjusted Operating Loss for the three months ended Reconciliation of Adjusted Net Loss for the three months ended Consolidated Unaudited Statements of Cash Flow
Investor releaseQuarter not tagged2026-03-13Purple Biotech Reports Fourth Quarter and Full Year 2025 Financial Results
GlobeNewswire
Purple Biotech Reports Fourth Quarter and Full Year 2025 Financial Results
Focus shifted to development of first tri-specific antibody from the CAPTN-3 platform, IM1240, targeting 5T4 tumor-associated antigen, and second tri-specific antibody, IM1305, named as development candidate, targeting TROP2 Achieved toxicology and manufacturing milestones for IM1240, demonstrating an expanded therapeutic window and commercially viable yield Positive preclinical data presented at ESMO Immuno-Oncology Congress 2025 demonstrates multi-arm anti-tumor activity for both IM1240 and IM1305 Total Cash Position of $9.5 million as of December 31, 2025, expected to provide runway into 2027 REHOVOT, Israel, March 13, 2026 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. ("Purple Biotech" or the "Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing a next-generation immunotherapy platform designed to maximize anti-cancer potency while minimizing toxicity, today announced financial results for the three and twelve months ended December 31, 2025. "In 2025, we focused on the CAPTN-3 platform and the value it can generate for patients and shareholders, naming a second tri-specific antibody from the platform, IM1305, and strengthening the preclinical data package for the first tri-specific antibody, IM1240. In addition, the capital we raised in 2025 is expected to provide runway into 2027, covering preparations for IM1240 Phase 1 study initiation,” said Gil Efron, Purple Biotech CEO. “During the past year, we made efforts to partner both CM24 and NT219 and, as previously reported, we will not be able to continue developing these assets until we obtain a strategic investment or a partner." “We are excited by the increasing interest in assets similar to CAPTN-3. With a cash position of $9.5 million at the end of 2025, and with data demonstrating that tri-specific antibodies from the CAPTN-3 platform deliver in vivo efficacy, a favorable therapeutic window, and scalable manufacturability, we look forward to sharing additional data and advancing the program over the course of this year,” Gil concluded. Q4 2025 and Recent Clinical & Corporate Highlights: New data on the CAPTN-3 platform were presented at the ESMO Immuno-Oncology Congress 2025, with CAPTN-3's two lead tri-specific antibodies: Demonstrated significant and sustained tumor regression achieved by the CAPTN-3 platform across two distinct tri-specific antibodies, IM1240 and IM1305, targeting differe…Read full documentShow less
Focus shifted to development of first tri-specific antibody from the CAPTN-3 platform, IM1240, targeting 5T4 tumor-associated antigen, and second tri-specific antibody, IM1305, named as development candidate, targeting TROP2 Achieved toxicology and manufacturing milestones for IM1240, demonstrating an expanded therapeutic window and commercially viable yield Positive preclinical data presented at ESMO Immuno-Oncology Congress 2025 demonstrates multi-arm anti-tumor activity for both IM1240 and IM1305 Total Cash Position of $9.5 million as of December 31, 2025, expected to provide runway into 2027 REHOVOT, Israel, March 13, 2026 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. ("Purple Biotech" or the "Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing a next-generation immunotherapy platform designed to maximize anti-cancer potency while minimizing toxicity, today announced financial results for the three and twelve months ended December 31, 2025. "In 2025, we focused on the CAPTN-3 platform and the value it can generate for patients and shareholders, naming a second tri-specific antibody from the platform, IM1305, and strengthening the preclinical data package for the first tri-specific antibody, IM1240. In addition, the capital we raised in 2025 is expected to provide runway into 2027, covering preparations for IM1240 Phase 1 study initiation,” said Gil Efron, Purple Biotech CEO. “During the past year, we made efforts to partner both CM24 and NT219 and, as previously reported, we will not be able to continue developing these assets until we obtain a strategic investment or a partner." “We are excited by the increasing interest in assets similar to CAPTN-3. With a cash position of $9.5 million at the end of 2025, and with data demonstrating that tri-specific antibodies from the CAPTN-3 platform deliver in vivo efficacy, a favorable therapeutic window, and scalable manufacturability, we look forward to sharing additional data and advancing the program over the course of this year,” Gil concluded. Q4 2025 and Recent Clinical & Corporate Highlights: New data on the CAPTN-3 platform were presented at the ESMO Immuno-Oncology Congress 2025, with CAPTN-3's two lead tri-specific antibodies: Demonstrated significant and sustained tumor regression achieved by the CAPTN-3 platform across two distinct tri-specific antibodies, IM1240 and IM1305, targeting different tumor antigens Transcriptomic analysis across ~11,000 TCGA samples showed that NKG2A expression is strongly associated with tumor expression of 5T4 or TROP2, supporting the inclusion of the NKG2A arm in CAPTN-3 designs NKG2A arm significantly contributes to IM1240 anti-cancer immune activity in PD1-resistant patient-derived explants Toxicology study demonstrated an expanded therapeutic window for IM1240 (capped-CD3x5T4xNKG2A) IM1240 demonstrated improved tolerability in a toxicology study at doses up to 300-fold higher than a non-capped comparator, with significantly reduced immune-related toxicity, including minimal cytokine release. These results highlight the unique safety profile of this approach, which may address a key limitation of certain current T-cell engagers, where cytokine release syndrome can restrict dosing IM1240's pharmacokinetic profile showed increased systemic exposure and a prolonged circulating half-life, enabled by its human serum albumin moiety and capping design Achieved manufacturing milestone for IM1240 Achieved commercially viable yield for IM1240, positioning the program competitively for anticipated future development Validates the potential scalability of the CAPTN-3 tri-specific antibody platform Financial Results for the Three Months Ended December 31, 2025 Research and Development Expenses were $1.8 million, an increase of $1.4 million, compared to $0.5 million in the same period of 2024, primarily due to CAPTN-3 platform CMC (chemistry, manufacturing, and controls) development activities. General and Administrative Expenses were $1.1 million, compared to $0.6 million in the same period of 2024, an increase of $0.6 million, primarily attributable to increased professional services fees and higher cash and non-cash compensation expenses. Impairment Loss Expenses were $20.5 million for the period, in connection with the impairment of in-process research and development assets related to CM24 and NT219 as of December 31, 2025. Following the Company’s determination that the continued development of CM24 and NT219 is contingent upon partnering or the availability of additional financing under the circumstances, and in light of the Company’s focus of its development efforts on CAPTN-3, the Company determined that the recoverable value of the CM24 and NT219 assets was less than their carrying value, resulting in the recognition of $20.5 million of impairment charges related to these programs. Operating Loss was $23.4 million, an increase of $22.4 million, compared to $1.0 million in the same period of 2024, primarily reflecting the $20.5 million non-cash impairment expenses recognized during the period. Adjusted Operating Loss (as reconciled below) was $2.9 million, compared to $1.0 million in the same period of 2024 primarily reflecting the increase in CAPTN-3 platform development activities. Financial Expenses, Net, were $0.2 million, compared to financial income of $0.6 million in the same period of 2024, primarily due to fair value adjustments of warrants and foreign exchange rate fluctuations. Net Loss was $23.6 million, an increase of $23.1 million, compared to $0.4 million in the same period of 2024, primarily reflecting the $20.5 million non-cash impairment expenses recognized during the period. As of December 31, 2025, Purple Biotech had cash and cash equivalents and short-term deposits of $9.5 million, which is expected to provide the Company with a cash runway into 2027. Financial Results for the Twelve Months Ended December 31, 2025 Research and Development Expenses were $3.7 million, a decrease of $3.9 million, compared to $7.6 million in the same period of 2024. The decrease was primarily due to lower clinical trial expenses, partially offset by CMC development activities related to the CAPTN-3 platform. General and Administrative Expenses were $3.2 million, consistent with the same period of 2024. Impairment Loss Expenses were $20.5 million for the year ended December 31, 2025. The Company determined that the recoverable value of the CM24 and NT219 assets was less than their carrying value as of December 31, 2025, resulting in the recognition of $20.5 million of impairment charges related to these programs. No impairment loss expenses were recognized in 2024. Operating Loss was $27.5 million, an increase of $16.5 million, compared to $11 million in the same period of 2024, primarily reflecting the $20.5 million non-cash impairment expenses recognized during the period, partially offset by lower clinical trial expenses. Adjusted Operating Loss (as reconciled below) was $6.7 million, compared to $10.4 million in the same period of 2024 primarily reflecting the decrease in clinical trial expenses. 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, or $44.4 loss per basic and diluted ADS, in the same period of 2024. The increase in net loss was primarily due to the $20.5 million non-cash impairment expenses recognized during the period. Non-IFRS Financial Measures This press release includes information about certain financial measures that are not prepared in accordance with International Financial Reporting Standards ("IFRS"), including adjusted operating loss. This non-IFRS measure is not based on any standardized methodology prescribed by IFRS and is not necessarily comparable to similar measures presented by other companies. Adjusted operating loss adjusts for non-cash share-based compensation expenses and non-cash impairment expenses. The Company's management and board of directors utilize this non-IFRS financial measure to evaluate the Company's performance. The Company provides this non-IFRS measure of the Company's performance to investors because management believes that this non-IFRS financial measure, when viewed with the Company's results under IFRS and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, this non-IFRS measure is not a measure of financial performance under IFRS and, accordingly, should not be considered as an alternative to IFRS measures as indicators of operating performance. Further, this non-IFRS measure should not be considered a measure of the Company's liquidity. A reconciliation of certain IFRS to non-IFRS financial measures has been provided in the tables included in this press release. About Purple Biotech Purple Biotech Ltd. (NASDAQ/TASE: PPBT) is a clinical-stage company developing a next-generation immunotherapy platform designed to maximize anti-cancer potency while minimizing toxicity. The Company is focused on advancing its lead program, CAPTN-3 - a platform of masked tri-specific antibodies that simultaneously target tumors while engaging both T cells and NK cells. Capping technology confines immune activation to the tumor microenvironment, significantly expanding the therapeutic window compared to conventional T-cell engagers. The platform’s lead candidate, IM1240, is advancing toward the clinic, and its second candidate, IM1305, is in preclinical development. The Company’s pipeline also includes additional clinical-stage assets, for which further development is pending partnering or investment, including CM24, a CEACAM1-blocking antibody that demonstrated improved outcomes across all efficacy endpoints in a Phase 2 study for the treatment of pancreatic ductal adenocarcinoma, and NT219, a dual IRS1/2 and STAT3 inhibitor in a Phase 2 study for the treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck. The Company is headquartered in Rehovot, Israel. For additional information about the Company, please visit: https://purple-biotech.com Forward-Looking Statements and Safe Harbor Statement Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements that are not statements of historical fact, and may be identified by words such as "believe", "expect", "intend", "plan", "may", "should", "could", "might", "seek", "target", "will", "project", "forecast", "continue" or "anticipate" or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. You should not place undue reliance on these forward-looking statements, which are not guarantees of future performance. Forward-looking statements reflect our current views, expectations, beliefs or intentions with respect to future events, and are subject to a number of assumptions, involve known and unknown risks, many of which are beyond our control, as well as uncertainties and other factors that may cause our actual results, performance or achievements to be significantly different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause or contribute to such differences include, among others, risks relating to: the plans, strategies and objectives of management for future operations; product development for NT219, CM24, IM1240 and IM1305; the process by which such early stage therapeutic candidates could potentially lead to an approved drug product is long and subject to highly significant risks, particularly with respect to a joint development collaboration; the fact that drug development and commercialization involves a lengthy and expensive process with uncertain outcomes; our ability to successfully develop and commercialize our pharmaceutical products; the expense, length, progress and results of any clinical trials; the impact of any changes in regulation and legislation that could affect the pharmaceutical industry; the difficulty in receiving the regulatory approvals necessary in order to commercialize our products; the difficulty of predicting actions of the U.S. Food and Drug Administration or any other applicable regulator of pharmaceutical products; the regulatory environment and changes in the health policies and regimes in the countries in which we operate; the uncertainty surrounding the actual market reception to our pharmaceutical products once cleared for marketing in a particular market; the introduction of competing products; patents obtained by competitors; dependence on the effectiveness of our patents and other protections for innovative products; our ability to obtain, maintain and defend issued patents; the commencement of any patent interference or infringement action against our patents, and our ability to prevail, obtain a favorable decision or recover damages in any such action; and the exposure to litigation, including patent litigation, and/or regulatory actions, and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2024, as such factors may be updated from time to time in our other filings with the U.S. Securities and Exchange Commission ("SEC"), including our cautionary discussion of risks and uncertainties under "Risk Factors" in our Registration Statements and Annual Reports. These are factors that we believe could cause our actual results to differ materially from expected results. Other factors besides those we have listed could also adversely affect us. Any forward-looking statement in this press release speaks only as of the date which it is made. We disclaim any intention or obligation to publicly update or revise any forward-looking statement or other information contained herein, whether as a result of new information, future events or otherwise, except as required by applicable law. You are advised, however, to consult any additional disclosures we make in our reports to the SEC, which are available on the SEC's website, https://www.sec.gov. CONTACTS: Company Contact: [email protected]
Investor releaseQuarter not tagged2025-11-14Purple Biotech Reports Third Quarter 2025 Financial Results and Provides Business Update
GlobeNewswire
Purple Biotech Reports Third Quarter 2025 Financial Results and Provides Business Update
Initiated development of a second CAPTN-3 tri-specific antibody targeting TROP2 Manufacturing milestone achieved for IM1240, the first tri-specific 5T4-targeting antibody from the CAPTN-3 platform Cash position of $10.5 million as of September 30, 2025, with an anticipated cash runway into the first half of 2027, supporting the development of our CAPTN-3 technology platform through significant milestones REHOVOT, Israel, Nov. 14, 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, announced today financial results for the three months ended September 30, 2025, and provided a business update. “During the quarter, we secured the necessary funds to support the development of our CAPTN-3 technology platform through significant milestones. We plan to conduct non-GLP and GLP toxicology studies, submit an Investigational New Drug application (IND) and initiate a Phase 1 study for IM1240 in 2026. CAPTN-3 continues to produce tri-specific NK and T cell engagers with a novel, differentiated tumor-associated antigen arm. IM1240, the first tri-specific antibody from the platform, targets 5T4, and IM1305, with a TROP2 antigen-targeting arm, has recently entered the development pipeline,” said Purple Biotech CEO Gil Efron. “While the versatility and applicability of the CAPTN-3 tri-specific construct are only beginning to garner attention, we believe in its synergistic, yet safe activation of both the innate and adaptive immune systems to help overcome tumor immune evasion.” Recent Clinical and Corporate Highlights: CAPTN-3 Tri-Specific Antibody Platform Nominated IM1305 as the second tri-specific antibody development candidate from the CAPTN-3 platform, targeting TROP2 in addition to masked CD3 and NKG2A arms (capped-CD3xTROP2xNKG2A) IM1240, the first CAPTN-3 tri-specific antibody development candidate targeting 5T4 (capped-CD3x5T4xNKG2A), achieved a manufacturing and scalability milestone with a commercially viable yield. In collaboration with Mt. Sinai Principal Investigator Dr. Amir Horowitz, demonstrated IM1240-induced tumor cell death in patient-derived, treatment-resistant head and neck biopsies IM1240 is advancing toward first-in-human clinical trials, with IND submission and study initiation…Read full documentShow less
Initiated development of a second CAPTN-3 tri-specific antibody targeting TROP2 Manufacturing milestone achieved for IM1240, the first tri-specific 5T4-targeting antibody from the CAPTN-3 platform Cash position of $10.5 million as of September 30, 2025, with an anticipated cash runway into the first half of 2027, supporting the development of our CAPTN-3 technology platform through significant milestones REHOVOT, Israel, Nov. 14, 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, announced today financial results for the three months ended September 30, 2025, and provided a business update. “During the quarter, we secured the necessary funds to support the development of our CAPTN-3 technology platform through significant milestones. We plan to conduct non-GLP and GLP toxicology studies, submit an Investigational New Drug application (IND) and initiate a Phase 1 study for IM1240 in 2026. CAPTN-3 continues to produce tri-specific NK and T cell engagers with a novel, differentiated tumor-associated antigen arm. IM1240, the first tri-specific antibody from the platform, targets 5T4, and IM1305, with a TROP2 antigen-targeting arm, has recently entered the development pipeline,” said Purple Biotech CEO Gil Efron. “While the versatility and applicability of the CAPTN-3 tri-specific construct are only beginning to garner attention, we believe in its synergistic, yet safe activation of both the innate and adaptive immune systems to help overcome tumor immune evasion.” Recent Clinical and Corporate Highlights: CAPTN-3 Tri-Specific Antibody Platform Nominated IM1305 as the second tri-specific antibody development candidate from the CAPTN-3 platform, targeting TROP2 in addition to masked CD3 and NKG2A arms (capped-CD3xTROP2xNKG2A) IM1240, the first CAPTN-3 tri-specific antibody development candidate targeting 5T4 (capped-CD3x5T4xNKG2A), achieved a manufacturing and scalability milestone with a commercially viable yield. In collaboration with Mt. Sinai Principal Investigator Dr. Amir Horowitz, demonstrated IM1240-induced tumor cell death in patient-derived, treatment-resistant head and neck biopsies IM1240 is advancing toward first-in-human clinical trials, with IND submission and study initiation planned for 2026 CM24 (α-CEACAM1 monoclonal antibody) The biomarkers identified in the CM24 Phase 2 study will be used for patient selection in the Phase 2b study, which is subject to partnering. Detailed design for the next study focuses on two main objectives: A separate arm testing CM24 alone in combination with standard of care to assess the contribution of each component. The second arm will test CM24 plus anti-PD1 plus standard of care. The third arm will test standard of care alone. Selection of patients based on the identified biomarkers, which are expected to result in better outcomes for patients in the treatment arms. NT219 (IRS1/2 degrader and STAT3 blocker) Received an intention to grant a European patent covering NT219 combinations with immunotherapies or MEK inhibitors to overcome tumor resistance Ongoing NT219 Phase 2 study in recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) to evaluate NT219 in combination with pembrolizumab (Keytruda) or cetuximab (Erbitux) The Phase 2 study is led by Dr. Antonio Jimeno, Professor and Director of the Head and Neck Cancer Program, and Principal Investigator Dr. Alice Weaver, at the University of Colorado Anschutz Medical Campus Received an intention to grant a European patent covering NT219 combinations with immunotherapies or MEK inhibitors to overcome tumor resistance Ongoing NT219 Phase 2 study in recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) to evaluate NT219 in combination with pembrolizumab (Keytruda) or cetuximab (Erbitux) The Phase 2 study is led by Dr. Antonio Jimeno, Professor and Director of the Head and Neck Cancer Program, and Principal Investigator Dr. Alice Weaver, at the University of Colorado Anschutz Medical Campus Financial Results for the Three Months Ended September 30, 2025 Research and Development Expenses were $0.6 million for the three months ended September 30, 2025, representing a decrease of $0.8 million, or 56.4%, from $1.3 million in the same period of 2024. The decrease was primarily attributable to reduced costs associated with the CM24 Phase 2 study. General and Administrative Expenses were $0.8 million for the three months ended September 30, 2025, consistent with the $0.8 million reported in the same period of 2024, reflecting continued cost management discipline. Operating Loss was $1.4 million for the three months ended September 30, 2025, a decrease of $0.8 million, or 35.8 %, compared to $2.1 million in the same period of 2024, mainly due to the decrease in the CM24 Phase 2 study expenses. Adjusted Operating Loss (as reconciled below) was $1.3 million for the three months ended September 30, 2025, a decrease of $0.7 million compared to $2.0 million in the same period of 2024, primarily due to the decrease in the CM24 Phase 2 study expenses. Finance Income, net, was $0.1 million for the three months ended September 30, 2025, compared to $1.5 million in the same period of 2024, representing a decrease of $1.4 million, primarily attributable to a lower non-cash gain from the revaluation of outstanding warrants and issuance-related expenses. Net Loss was $1.3 million, or $0.29 per basic and diluted ADS, for the three months ended September 30, 2025, compared to a net loss of $0.7 million, or $0.39 per basic and diluted ADS, in the same period of 2024. The year-over-year change was primarily attributable to a $0.8 million reduction in operating expenses and a $1.4 million decrease in finance income, net. As of September 30, 2025, Purple Biotech had cash and cash equivalents and short-term deposits of $10.5 million. The Company’s cash runway is expected into the first half of 2027. About Purple Biotech Purple Biotech Ltd. (NASDAQ/TASE: PPBT) is a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance. The Company’s oncology pipeline includes CAPTN-3, CM24 and NT219. The Company is advancing CAPTN-3, a preclinical platform of conditionally activated tri-specific antibodies, which engage both T cells and NK cells to induce a strong, localized immune response within the tumor microenvironment. The cleavable capping technology confines the compound’s therapeutic activity to the local tumor microenvironment, thereby potentially increasing the anticipated therapeutic window in patients. The third arm specifically targets the Tumor Associated Antigen (TAA). The technology presents a novel mechanism of action by unleashing both innate and adaptive immune systems to mount an optimal anti-tumoral immune response. IM1240 is the first tri-specific antibody in development that targets the 5T4 antigen, which is expressed in a variety of solid tumors and is associated with advanced disease, increased invasiveness, and poor clinical outcomes. IM1305 is the second tri-specific antibody from the CAPTN-3 platform that targets the TROP2 TAA, which is expressed in variety of tumor types. CM24 is a humanized monoclonal antibody that blocks CEACAM1, which supports tumor immune evasion and survival through multiple pathways. CEACAM1 on tumor cells, immune cells and neutrophil extracellular traps is a novel target for the treatment of multiple cancer indications. As proof of concept of these novel pathways, the Company completed a Phase 2 study for the treatment of pancreatic ductal adenocarcinoma (PDAC) with CM24 as a combination therapy with the anti-PD-1 checkpoint inhibitor nivolumab and chemotherapy, demonstrating clear and consistent improvement across all efficacy endpoints and the identification of two potential serum biomarkers and other potential tissue biomarkers. NT219 is a dual inhibitor, novel small molecule that simultaneously targets IRS1/2 and STAT3. A Phase 1 dose escalation study was concluded as a monotherapy and in combination with cetuximab, in which NT219 demonstrated anti-tumor activity in combination with cetuximab in second-line patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). A Phase 2 study in collaboration with the University of Colorado Anschutz Medical Campus, to treat R/M SCCHN patients with NT219 in combination with cetuximab or pembrolizumab was initiated. The Company’s corporate headquarters are located in Rehovot, Israel. For more information, please visit https://purple-biotech.com/. Non-IFRS Financial Measures This press release includes information about certain financial measures that are not prepared in accordance with International Financial Reporting Standards (“IFRS”), including adjusted operating loss. This non-IFRS measure is not based on any standardized methodology prescribed by IFRS and is not necessarily comparable to similar measures presented by other companies. Adjusted operating loss adjusts for non-cash share-based compensation expenses. The Company’s management and board of directors utilize this non-IFRS financial measure to evaluate the Company’s performance. The Company provides this non-IFRS measure of the Company’s performance to investors because management believes that this non-IFRS financial measure, when viewed with the Company’s results under IFRS and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, this non-IFRS measure is not a measure of financial performance under IFRS and, accordingly, should not be considered as an alternative to IFRS measures as indicators of operating performance. Further, this non-IFRS measure should not be considered a measure of the Company’s liquidity. A reconciliation of certain IFRS to non-IFRS financial measures has been provided in the tables included in this press release. Forward-Looking Statements and Safe Harbor Statement Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements that are not statements of historical fact, and may be identified by words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. You should not place undue reliance on these forward-looking statements, which are not guarantees of future performance. Forward-looking statements reflect our current views, expectations, beliefs or intentions with respect to future events, and are subject to a number of assumptions, involve known and unknown risks, many of which are beyond our control, as well as uncertainties and other factors that may cause our actual results, performance or achievements to be significantly different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause or contribute to such differences include, among others, risks relating to: the plans, strategies and objectives of management for future operations; product development for NT219, CM24 and IM1240; the process by which such early stage therapeutic candidates could potentially lead to an approved drug product is long and subject to highly significant risks, particularly with respect to a joint development collaboration; the fact that drug development and commercialization involves a lengthy and expensive process with uncertain outcomes; our ability to successfully develop and commercialize our pharmaceutical products; the expense, length, progress and results of any clinical trials; the impact of any changes in regulation and legislation that could affect the pharmaceutical industry; the difficulty in receiving the regulatory approvals necessary in order to commercialize our products; the difficulty of predicting actions of the U.S. Food and Drug Administration or any other applicable regulator of pharmaceutical products; the regulatory environment and changes in the health policies and regimes in the countries in which we operate; the uncertainty surrounding the actual market reception to our pharmaceutical products once cleared for marketing in a particular market; the introduction of competing products; patents obtained by competitors; dependence on the effectiveness of our patents and other protections for innovative products; our ability to obtain, maintain and defend issued patents; the commencement of any patent interference or infringement action against our patents, and our ability to prevail, obtain a favorable decision or recover damages in any such action; and the exposure to litigation, including patent litigation, and/or regulatory actions, and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2024 and in our other filings with the U.S. Securities and Exchange Commission (“SEC”), including our cautionary discussion of risks and uncertainties under “Risk Factors” in our Registration Statements and Annual Reports. These are factors that we believe could cause our actual results to differ materially from expected results. Other factors besides those we have listed could also adversely affect us. Any forward-looking statement in this press release speaks only as of the date on which it is made. We disclaim any intention or obligation to publicly update or revise any forward-looking statement or other information contained herein, whether as a result of new information, future events or otherwise, except as required by applicable law. You are advised, however, to consult any additional disclosures we make in our reports to the SEC, which are available on the SEC’s website, https://www.sec.gov. CONTACTS: Company Contact: [email protected] Reconciliation of Adjusted Operating Loss
Investor releaseQuarter not tagged2025-08-06Purple Biotech Reports Second Quarter 2025 Financial Results
GlobeNewswire
Purple Biotech Reports Second Quarter 2025 Financial Results
Platform validating preclinical data presented at EACR 2025 for CAPTN-3 tri-specific T cell engager show synergistic activity of the platform’s masked CD3, NKG2A, and tumor-associated antigen arms First CAPTN-3 trispecific antibody targeting novel tumor associated antigen, 5T4, advances toward first-in-human clinical trials, with IND submission expected in 2026 Positive Phase 2 data from CM24 study in biomarker-enriched pancreatic ductal adenocarcinoma (PDAC) reported at AACR 2025 NT219 Phase 2 study in head and neck cancer initiated in June 2025 REHOVOT, Israel, Aug. 06, 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, announced today financial results for the three months ended June 30, 2025. “Our CAPTN-3 tri-specific antibody platform is differentiated not only by its masked CD3 arm for conditional T cell activation, but also by the addition of an NKG2A arm for additional T cell and NK cell activation, and a third arm targeting the tumor-associated antigen. This approach is supported by other masked TCEs showing early safety and efficacy signals,” stated Purple Biotech CEO Gil Efron. “We are focusing our activities on advancing IM1240, our first CAPTN-3 antibody, through IND-enabling studies, with the goal of initiating a Phase 1 study in 2026. Additionally, we have now established a clear path forward for CM24 for its Phase 2b study, utilizing the predictive biomarkers we observed in the Phase 2 trial, and we are seeking partners or investment to support this next study.” Recent Clinical and Corporate Highlights: CAPTN-3 Tri-Specific Antibody Platform Showcased comprehensive in vivo and ex vivo data at EACR 2025, highlighting the synergistic activity of the platform’s masked CD3, NKG2A, and tumor-associated antigen arms Platform was spotlighted by Dr. Amir Horowitz at ASGCT 2025 for its approach to targeting the HLA-E/NKG2A axis to selectively activate NK and CD8+ T cells, potentially addressing treatment resistance First investigational new drug (IND) application from the CAPTN-3 platform, for IM1240 capped-CD3x5T4xNKG2A antibody, is expected to be submitted in 2026 CM24 (α-CEACAM1 monoclonal antibody) Final Phase 2 data for CM24 study presented at AACR Annual Meeting 2025 Stati…Read full documentShow less
Platform validating preclinical data presented at EACR 2025 for CAPTN-3 tri-specific T cell engager show synergistic activity of the platform’s masked CD3, NKG2A, and tumor-associated antigen arms First CAPTN-3 trispecific antibody targeting novel tumor associated antigen, 5T4, advances toward first-in-human clinical trials, with IND submission expected in 2026 Positive Phase 2 data from CM24 study in biomarker-enriched pancreatic ductal adenocarcinoma (PDAC) reported at AACR 2025 NT219 Phase 2 study in head and neck cancer initiated in June 2025 REHOVOT, Israel, Aug. 06, 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, announced today financial results for the three months ended June 30, 2025. “Our CAPTN-3 tri-specific antibody platform is differentiated not only by its masked CD3 arm for conditional T cell activation, but also by the addition of an NKG2A arm for additional T cell and NK cell activation, and a third arm targeting the tumor-associated antigen. This approach is supported by other masked TCEs showing early safety and efficacy signals,” stated Purple Biotech CEO Gil Efron. “We are focusing our activities on advancing IM1240, our first CAPTN-3 antibody, through IND-enabling studies, with the goal of initiating a Phase 1 study in 2026. Additionally, we have now established a clear path forward for CM24 for its Phase 2b study, utilizing the predictive biomarkers we observed in the Phase 2 trial, and we are seeking partners or investment to support this next study.” Recent Clinical and Corporate Highlights: CAPTN-3 Tri-Specific Antibody Platform Showcased comprehensive in vivo and ex vivo data at EACR 2025, highlighting the synergistic activity of the platform’s masked CD3, NKG2A, and tumor-associated antigen arms Platform was spotlighted by Dr. Amir Horowitz at ASGCT 2025 for its approach to targeting the HLA-E/NKG2A axis to selectively activate NK and CD8+ T cells, potentially addressing treatment resistance First investigational new drug (IND) application from the CAPTN-3 platform, for IM1240 capped-CD3x5T4xNKG2A antibody, is expected to be submitted in 2026 CM24 (α-CEACAM1 monoclonal antibody) Final Phase 2 data for CM24 study presented at AACR Annual Meeting 2025 Statistically significant efficacy in biomarker subgroup analyses was observed: 78% reduction in risk of death and 81% reduction in risk of progression or death in patients with defined pretreatment ranges of serum or tumor CEACAM1 and 37.5% objective response rate (ORR) in this subgroup compared to 0% in the respective control group 61% reduction in risk of death and 72% reduction in risk of progression or death in patients with defined pretreatment ranges of serum CEACAM1 or myeloperoxidase (MPO) and 31% ORR in this subgroup compared to 0% in the respective control group 90% reduction in risk of death and 81% reduction in risk of progression or death in high tumor CEACAM1 and low PD-L1 combined positive score (CPS) subgroup The biomarkers identified in the CM24 Phase 2 study are planned to be used for patient selection in the Phase 2b study NT219 (IRS1/2 degrader and STAT3 blocker) Biomarker insights from the Phase 1 study were presented at AACR Annual Meeting 2025 Initiated NT219 Phase 2 study in recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) to evaluate NT219 in combination with pembrolizumab (Keytruda) or cetuximab (Erbitux) Phase 2 study is led by Dr. Antonio Jimeno, Professor and Director of the Head and Neck Cancer Program, and Principal Investigator Dr. Alice Weaver, at the University of Colorado Anschutz Medical Campus Financial Results for the Three Months Ended June 30, 2025 Research and Development Expenses were $0.6 million for the three months ended June 30, 2025, reflecting a decrease of $1.8 million, or 76.9%, from $2.4 million in the same period of 2024. The decrease was primarily due to reduced costs associated with the CM24 Phase 2 study. General and Administrative Expenses were $0.7 million for the three months ended June 30, 2025, compared to $1.1 million in the same period of 2024, representing a decrease of $0.4 million, or 36.0%, mainly due to a $0.2 million decrease in a non-cash expense and $0.2 million reduction in cash and non-cash salaries and related expenses. Operating Loss was $1.2 million for the three months ended June 30, 2025, a decrease of $2.2 million, or 64.3%, compared to $3.5 million in the same period of 2024, mainly due to the decrease in the CM24 Phase 2 study expenses. Adjusted Operating Loss (as reconciled below) was $1.2 million for the three months ended June 30, 2025, a decrease of $2.0 million, compared to $3.2 million in the same period of 2024, primarily due to the decrease in the CM24 Phase 2 study expenses. Finance Income, net was $0.1 million for the three months ended June 30, 2025, compared to $1.0 million in the same period of 2024, representing a decrease of $0.9 million, primarily attributable to a decrease in non-cash gain resulting from the revaluation of outstanding warrants. Net Loss was $1.1 million, or $0.40 per basic and diluted ADS for the three months ended June 30, 2025, compared to a net loss of $2.4 million, or $1.80 per basic and diluted ADS, in the same period of 2024. The decrease in net loss was mainly due to the $2.2 million decrease in operating expenses and $0.9 million decrease in finance income, net. As of June 30, 2025, Purple Biotech had cash and cash equivalents and short-term deposits of $5.6 million. The Company cash runway is expected into the third quarter of 2026. About Purple Biotech Purple Biotech Ltd. (NASDAQ/TASE: PPBT) is a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance. The Company’s oncology pipeline includes CAPTN-3, CM24 and NT219. The Company is advancing CAPTN-3, a preclinical platform of conditionally activated tri-specific antibodies, which engage both T cells and NK cells to induce a strong, localized immune response within the tumor microenvironment. The cleavable capping technology confines the compound’s therapeutic activity to the local tumor microenvironment, thereby potentially increasing the anticipated therapeutic window in patients. The third arm specifically targets the Tumor Associated Antigen (TAA). The technology presents a novel mechanism of action by unleashing both innate and adaptive immune systems to mount an optimal anti-tumoral immune response. IM1240 is the first tri-specific antibody in development that targets the 5T4 antigen, which is expressed in a variety of solid tumors and is associated with advanced disease, increased invasiveness, and poor clinical outcomes. CM24 is a humanized monoclonal antibody that blocks CEACAM1, which supports tumor immune evasion and survival through multiple pathways. CEACAM1 on tumor cells, immune cells and neutrophil extracellular traps is a novel target for the treatment of multiple cancer indications. As proof of concept of these novel pathways, the Company completed a Phase 2 study for the treatment of pancreatic ductal adenocarcinoma (PDAC) with CM24 as a combination therapy with the anti-PD-1 checkpoint inhibitor nivolumab and chemotherapy, demonstrating clear and consistent improvement across all efficacy endpoints and the identification of two potential serum biomarkers and other potential tissue biomarkers. NT219 is a dual inhibitor, novel small molecule that simultaneously targets IRS1/2 and STAT3. A Phase 1 dose escalation study was concluded as a monotherapy and in combination with cetuximab, in which NT219 demonstrated anti-tumor activity in combination with cetuximab in second-line patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). A Phase 2 study in collaboration with the University of Colorado Anschutz Medical Campus, to treat R/M SCCHN patients with NT219 in combination with cetuximab or pembrolizumab was initiated. The Company’s corporate headquarters are located in Rehovot, Israel. For more information, please visit https://purple-biotech.com/. Non-IFRS Financial Measures This press release includes information about certain financial measures that are not prepared in accordance with International Financial Reporting Standards (“IFRS”), including adjusted operating loss. This non-IFRS measure is not based on any standardized methodology prescribed by IFRS and is not necessarily comparable to similar measures presented by other companies. Adjusted operating loss adjusts for non-cash share-based compensation expenses. The Company’s management and board of directors utilize this non-IFRS financial measure to evaluate the Company’s performance. The Company provides this non-IFRS measure of the Company’s performance to investors because management believes that this non-IFRS financial measure, when viewed with the Company’s results under IFRS and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, this non-IFRS measure is not a measure of financial performance under IFRS and, accordingly, should not be considered as an alternative to IFRS measures as indicators of operating performance. Further, this non-IFRS measure should not be considered a measure of the Company’s liquidity. A reconciliation of certain IFRS to non-IFRS financial measures has been provided in the tables included in this press release. Forward-Looking Statements and Safe Harbor Statement Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements that are not statements of historical fact, and may be identified by words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. You should not place undue reliance on these forward-looking statements, which are not guarantees of future performance. Forward-looking statements reflect our current views, expectations, beliefs or intentions with respect to future events, and are subject to a number of assumptions, involve known and unknown risks, many of which are beyond our control, as well as uncertainties and other factors that may cause our actual results, performance or achievements to be significantly different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause or contribute to such differences include, among others, risks relating to: the plans, strategies and objectives of management for future operations; product development for NT219, CM24 and IM1240; the process by which such early stage therapeutic candidates could potentially lead to an approved drug product is long and subject to highly significant risks, particularly with respect to a joint development collaboration; the fact that drug development and commercialization involves a lengthy and expensive process with uncertain outcomes; our ability to successfully develop and commercialize our pharmaceutical products; the expense, length, progress and results of any clinical trials; the impact of any changes in regulation and legislation that could affect the pharmaceutical industry; the difficulty in receiving the regulatory approvals necessary in order to commercialize our products; the difficulty of predicting actions of the U.S. Food and Drug Administration or any other applicable regulator of pharmaceutical products; the regulatory environment and changes in the health policies and regimes in the countries in which we operate; the uncertainty surrounding the actual market reception to our pharmaceutical products once cleared for marketing in a particular market; the introduction of competing products; patents obtained by competitors; dependence on the effectiveness of our patents and other protections for innovative products; our ability to obtain, maintain and defend issued patents; the commencement of any patent interference or infringement action against our patents, and our ability to prevail, obtain a favorable decision or recover damages in any such action; and the exposure to litigation, including patent litigation, and/or regulatory actions, and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2024 and in our other filings with the U.S. Securities and Exchange Commission (“SEC”), including our cautionary discussion of risks and uncertainties under “Risk Factors” in our Registration Statements and Annual Reports. These are factors that we believe could cause our actual results to differ materially from expected results. Other factors besides those we have listed could also adversely affect us. Any forward-looking statement in this press release speaks only as of the date on which it is made. We disclaim any intention or obligation to publicly update or revise any forward-looking statement or other information contained herein, whether as a result of new information, future events or otherwise, except as required by applicable law. You are advised, however, to consult any additional disclosures we make in our reports to the SEC, which are available on the SEC’s website, https://www.sec.gov. CONTACTS: Company Contact: [email protected] Condensed Consolidated Unaudited Interim Statements of Operations and Other Comprehensive Income
Investor releaseQuarter not tagged2025-05-21Purple Biotech Reports First Quarter 2025 Financial Results
GlobeNewswire
Purple Biotech Reports First Quarter 2025 Financial Results
Final CM24 Phase 2 data presented at AACR Annual Meeting 2025, strengthening patient selection strategy for CM24 Phase 2b study planned to be initiated in Second Half of 2025 NT219 data presented at AACR Annual Meeting 2025; NT219 Phase 2 study in head and neck cancer on track to be initiated in First Half of 2025 CAPTN-3 differentiated T-cells and NK cells engagers tri-specific platform advances toward first-in-human clinical trials REHOVOT, Israel, May 21, 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, announced today financial results for the three months ended March 31, 2025. “We are pleased to report continued progress on our milestones, including additional confirmatory biomarker data from our randomized Phase 2 study of CM24 and the collaboration for our upcoming NT219 plus cetuximab or pembrolizumab Phase 2 trial in head and neck cancer. The latest data presentations for these two important assets at the recent American Association for Cancer Research (AACR) annual meeting provide further evidence for, and increase our confidence in, patient selection and potential positive outcomes,” stated Purple Biotech CEO Gil Efron. “In parallel, our promising CAPTN-3 T-cells and NK cells engagers platform continues to generate compelling pre-clinical data, and we look forward to presenting these data on our tri-body technology at an upcoming scientific conference. We are advancing our pipeline while prudently managing expenses, with a cash runway through mid-2026.” Recent Clinical & Corporate Highlights: Final Phase 2 data for CM24 study presented at AACR Annual Meeting 2025 Statistically significant efficacy in biomarker subgroup analyses was observed: 78% reduction in risk of death and 81% reduction in risk of progression or death in defined pretreatment ranges of serum or tumor CEACAM1 subgroup 61% reduction in risk of death and 72% reduction in risk of progression or death in defined pretreatment ranges of serum CEACAM1 or myeloperoxidase (MPO) subgroup 90% reduction in risk of death and 81% reduction in risk of progression or death in high tumor CEACAM1 and low PD-L1 combined positive score (CPS) subgroup The biomarkers identified in the CM24 Phase 2 study are planned to be used…Read full documentShow less
Final CM24 Phase 2 data presented at AACR Annual Meeting 2025, strengthening patient selection strategy for CM24 Phase 2b study planned to be initiated in Second Half of 2025 NT219 data presented at AACR Annual Meeting 2025; NT219 Phase 2 study in head and neck cancer on track to be initiated in First Half of 2025 CAPTN-3 differentiated T-cells and NK cells engagers tri-specific platform advances toward first-in-human clinical trials REHOVOT, Israel, May 21, 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, announced today financial results for the three months ended March 31, 2025. “We are pleased to report continued progress on our milestones, including additional confirmatory biomarker data from our randomized Phase 2 study of CM24 and the collaboration for our upcoming NT219 plus cetuximab or pembrolizumab Phase 2 trial in head and neck cancer. The latest data presentations for these two important assets at the recent American Association for Cancer Research (AACR) annual meeting provide further evidence for, and increase our confidence in, patient selection and potential positive outcomes,” stated Purple Biotech CEO Gil Efron. “In parallel, our promising CAPTN-3 T-cells and NK cells engagers platform continues to generate compelling pre-clinical data, and we look forward to presenting these data on our tri-body technology at an upcoming scientific conference. We are advancing our pipeline while prudently managing expenses, with a cash runway through mid-2026.” Recent Clinical & Corporate Highlights: Final Phase 2 data for CM24 study presented at AACR Annual Meeting 2025 Statistically significant efficacy in biomarker subgroup analyses was observed: 78% reduction in risk of death and 81% reduction in risk of progression or death in defined pretreatment ranges of serum or tumor CEACAM1 subgroup 61% reduction in risk of death and 72% reduction in risk of progression or death in defined pretreatment ranges of serum CEACAM1 or myeloperoxidase (MPO) subgroup 90% reduction in risk of death and 81% reduction in risk of progression or death in high tumor CEACAM1 and low PD-L1 combined positive score (CPS) subgroup The biomarkers identified in the CM24 Phase 2 study are planned to be used for patient selection in the Phase 2b study, planned to be initiated in the second half of 2025 Purple Biotech reported final results from its randomized Phase 2 study of CM24 in pancreatic ductal adenocarcinoma patients in a poster presentation titled "Final analysis of the randomized Phase 2 cohort of CM24 with nivolumab and chemotherapy in pancreatic cancer & potential serum biomarkers" at the AACR Annual Meeting 2025 held in April 2025. Statistically significant efficacy in biomarker subgroup analyses was observed. These findings support the patient selection strategy for the Phase 2b study of CM24, which is planned to be initiated in the second half of 2025. NT219 Phase 2 Head and Neck Cancer trial to evaluate NT219 with standard-of-care drugs. NT219 to be combined with pembrolizumab (Keytruda) or cetuximab (Erbitux) New positive head and neck cancer data presented at AACR NT219’s suppression of brain metastasis in colorectal cancer published in Neuro Oncology Patent in U.S. enhances global IP protection for commercialization A Phase 2 study of NT219 for the treatment of recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) will combine NT219 with the standard-of-care anti-PD1 checkpoint inhibitor pembrolizumab (Keytruda) or with the epidermal growth factor receptor (EGFR) blocker cetuximab (Erbitux). The study will also explore potential biomarkers that were previously identified in a prior NT219 study. The investigator-initiated Phase 2 trial is led by Dr. Antonio Jimeno, Professor and Director of the Head and Neck Cancer Program at the University of Colorado Anschutz Medical Campus. Two posters reporting new positive NT219 data were presented at AACR Annual Meeting 2025. The poster titled "NT219 overcomes immune evasion mechanisms in head and neck squamous cell carcinoma (HNSCC)" demonstrated that NT219 inhibits major targets and signaling pathways that play a key role in tumor immune evasion, including STAT3 and IRS-to-β-catenin pathways. In a clinical setting, upregulation of pIGF1R and pSTAT3 were correlated with patient response and suggested as potential biomarkers for NT219 treatment. These and other findings demonstrated the potential of NT219 to restore the efficacy of immunotherapies and expand the patient population that can benefit from these drugs. The poster titled “APC-loss as a potential biomarker for NT219 treatment in colorectal cancer" suggested that the response to NT219 is associated with enhanced wnt/β-catenin signaling or loss of function mutation of its negative regulator APC (APC-loss). An independent study of NT219 titled "IRS2 as a driver of brain metastasis in colorectal cancer: a potential target for novel therapeutic strategies" was published in the peer reviewed journal Neuro Oncology. The findings demonstrate that a combination therapy of NT219 and 5-fluorouracil (5-FU) inhibits colorectal cancer brain metastasis through the IRS2 pathway. The research conducted by Prof. Ido Wolf, Dr. Tami Rubinek, and their team at Tel Aviv University and Sourasky Medical Center found that IRS2, a novel target of NT219, is a driver of brain metastasis in colorectal cancer. The U.S. Patent and Trademark Office issued a patent for NT219 used in combination with EGFR antibodies for treating cancer patients who have acquired resistance to EGFR therapies. This latest U.S. patent completes the geographic patent protection for NT219 used in combination with cetuximab in major markets, such as the United States, Europe, China and Japan, and we believe this additional patent positions the Company well for the potential future commercialization of NT219. Pre-clinical research collaboration with Icahn School of Medicine at Mount Sinai for CAPTN-3 tri-specific antibody platform Purple Biotech entered into a Research Collaboration Agreement with the Icahn School of Medicine at Mount Sinai in New York to explore the immunoregulation of NK and T cells within the tumor microenvironment by CAPTN-3 multi-specific engagers, designed with the purpose of enhancing tumor-specific immunity against various cancer types. This collaboration offers an opportunity to deepen the understanding of tumor immune evasion mechanisms that CAPTN-3 uniquely addresses, with the goal of paving the way for effective treatments for many challenging tumor indications. Purple Biotech is working with Principal Investigator Amir Horowitz, PhD, and his team at Mount Sinai to validate the unique aspects of the CAPTN-3 design in a wide screen of patient-derived tumors, potentially providing new insights for overcoming resistance to standard frontline immunotherapies. Strengthened the management team with the appointment of Shai Lankry as Chief Financial Officer Financial Results for the Three Months Ended March 31, 2025 Research and Development Expenses were $0.8 million for the three months ended March 31, 2025, reflecting a decrease of $2.6 million, or 76.5%, from $3.4 million in the same period of 2024. The reduction was primarily due to reduced clinical trial related expenses. General and Administrative Expenses were $0.6 million for the three months ended March 31, 2025, compared to $1 million in the same period of 2024, representing a decrease of $0.4 million, mainly due to a $0.3 million reduction in cash and non-cash salaries and related expenses. Operating Loss was $1.4 million for the three months ended March 31, 2025, a decrease of $3.1 million, or 68.9%, compared to $4.5 million in the same period of 2024, mainly due to the decrease in research and development expenses. Adjusted Operating Loss (as reconciled below) was $1.3 million for the three months ended March 31, 2025, a decrease of $2.9 million, compared to $4.2 million in the same period of 2024, primarily due to the decrease in research and development expenses. Finance Income, net was $1.0 million for the three months ended March 31, 2025, compared to $0.7 million in the same period of 2024, representing an increase of $0.3 million, primarily attributable to a non-cash gain resulting from the revaluation of outstanding warrants. Net Loss was $0.5 million, or $0.17 per basic and diluted ADS for the three months ended March 31, 2025, compared to a net loss of $3.8 million, or $2.8 per basic and diluted ADS, in the same period of 2024. The decrease in net loss was mainly due to the $3.1 million decrease in operating expenses and $0.3 million increase in finance income, net. As of March 31, 2025, Purple Biotech had cash and cash equivalents and short-term deposits of $6.7 million. This cash position provides a cash runway into mid 2026. During the three months ended March 31, 2025, the Company sold, under the Open Market Sale AgreementSM with Jefferies LLC, approximately 63 thousand ADSs, at an average price of $3.5 per ADS. Net proceeds to the Company were approximately $166 thousand, net of issuance expenses. Non-IFRS Financial Measures This press release includes information about certain financial measures that are not prepared in accordance with International Financial Reporting Standards ("IFRS"), including adjusted operating loss. This non-IFRS measure is not based on any standardized methodology prescribed by IFRS and is not necessarily comparable to similar measures presented by other companies. Adjusted operating loss adjusts for non-cash share-based compensation expenses. The Company's management and board of directors utilize this non-IFRS financial measure to evaluate the Company's performance. The Company provides this non-IFRS measure of the Company's performance to investors because management believes that this non-IFRS financial measure, when viewed with the Company's results under IFRS and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, this non-IFRS measure is not a measure of financial performance under IFRS and, accordingly, should not be considered as an alternative to IFRS measures as indicators of operating performance. Further, this non-IFRS measure should not be considered a measure of the Company's liquidity. A reconciliation of certain IFRS to non-IFRS financial measures has been provided in the tables included in this press release. About Purple Biotech Purple Biotech Ltd. (NASDAQ/TASE: PPBT) is a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance. The Company's oncology pipeline includes CM24, NT219, and CAPTN-3. CM24 is a humanized monoclonal antibody that blocks CEACAM1, which supports tumor immune evasion and survival through multiple pathways. CEACAM1 on tumor cells, immune cells and neutrophils extracellular traps is a novel target for the treatment of multiple cancer indications. As proof of concept of these novel pathways, the Company completed a Phase 2 study for the treatment of pancreatic ductal adenocarcinoma (PDAC) with CM24 as a combination therapy with the anti-PD-1 checkpoint inhibitor nivolumab and chemotherapy, demonstrating clear and consistent improvement across all efficacy endpoints and the identification of two potential serum biomarkers. NT219 is a dual inhibitor, novel small molecule that simultaneously targets IRS1/2 and STAT3. A Phase 1 dose escalation study was concluded as a monotherapy and in combination with cetuximab, in which NT219 demonstrated anti-tumor activity in combination with cetuximab in second-line patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). The Company is advancing NT219 into a Phase 2 study in collaboration with the University of Colorado, to treat R/M SCCHN patients in combination with cetuximab or pembrolizumab. The Company is advancing CAPTN-3, a preclinical platform of conditionally activated tri-specific antibodies, which engage both T cells and NK cells to induce a strong, localized immune response within the tumor microenvironment. The cleavable capping technology confines the compound's therapeutic activity to the local tumor microenvironment, thereby potentially increasing the anticipated therapeutic window in patients. The third arm specifically targets the Tumor Associated Antigen (TAA). The technology presents a novel mechanism of action by unleashing both innate and adaptive immune systems to mount an optimal anti-tumoral immune response. IM1240 is the first tri-specific antibody in development that targets the 5T4 antigen, which is expressed in a variety of solid tumors and is associated with advanced disease, increased invasiveness, and poor clinical outcomes. The Company's corporate headquarters are located in Rehovot, Israel. For more information, please visit https://purple-biotech.com/. Forward-Looking Statements and Safe Harbor Statement Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements that are not statements of historical fact, and may be identified by words such as "believe", "expect", "intend", "plan", "may", "should", "could", "might", "seek", "target", "will", "project", "forecast", "continue" or "anticipate" or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. You should not place undue reliance on these forward-looking statements, which are not guarantees of future performance. Forward-looking statements reflect our current views, expectations, beliefs or intentions with respect to future events, and are subject to a number of assumptions, involve known and unknown risks, many of which are beyond our control, as well as uncertainties and other factors that may cause our actual results, performance or achievements to be significantly different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause or contribute to such differences include, among others, risks relating to: the plans, strategies and objectives of management for future operations; product development for NT219, CM24 and IM1240; the process by which such early stage therapeutic candidates could potentially lead to an approved drug product is long and subject to highly significant risks, particularly with respect to a joint development collaboration; the fact that drug development and commercialization involves a lengthy and expensive process with uncertain outcomes; our ability to successfully develop and commercialize our pharmaceutical products; the expense, length, progress and results of any clinical trials; the impact of any changes in regulation and legislation that could affect the pharmaceutical industry; the difficulty in receiving the regulatory approvals necessary in order to commercialize our products; the difficulty of predicting actions of the U.S. Food and Drug Administration or any other applicable regulator of pharmaceutical products; the regulatory environment and changes in the health policies and regimes in the countries in which we operate; the uncertainty surrounding the actual market reception to our pharmaceutical products once cleared for marketing in a particular market; the introduction of competing products; patents obtained by competitors; dependence on the effectiveness of our patents and other protections for innovative products; our ability to obtain, maintain and defend issued patents; the commencement of any patent interference or infringement action against our patents, and our ability to prevail, obtain a favorable decision or recover damages in any such action; and the exposure to litigation, including patent litigation, and/or regulatory actions, and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2024 and in our other filings with the U.S. Securities and Exchange Commission ("SEC"), including our cautionary discussion of risks and uncertainties under "Risk Factors" in our Registration Statements and Annual Reports. These are factors that we believe could cause our actual results to differ materially from expected results. Other factors besides those we have listed could also adversely affect us. Any forward-looking statement in this press release speaks only as of the date on which it is made. We disclaim any intention or obligation to publicly update or revise any forward-looking statement or other information contained herein, whether as a result of new information, future events or otherwise, except as required by applicable law. You are advised, however, to consult any additional disclosures we make in our reports to the SEC, which are available on the SEC's website, https://www.sec.gov. CONTACTS: Company Contact: [email protected] Purple Biotech Ltd. Consolidated Unaudited Statements of Financial Position as of: Purple Biotech Ltd. Consolidated Unaudited Statement of Operations for the three months ended Reconciliation of Adjusted Operating Loss for the three months ended Consolidated Unaudited Statements of Cash Flow

