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Purple Biotech Reports Fourth Quarter and Full-Year 2024 Financial Results

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Purple Biotech (NASDAQ/TASE: PPBT) announced its Q4 and full-year 2024 financial results, highlighting successful clinical trials for its oncology assets. The company reported positive final results from CM24's Phase 2 study in pancreatic cancer, showing a 79% reduction in death risk for biomarker-selected patients. NT219 is advancing to Phase 2 trials for head and neck cancer in combination with pembrolizumab and cetuximab.

Financial highlights for Q4 2024 include:

  • Research and Development expenses decreased 90.4% to $0.5 million
  • Operating loss reduced 84.1% to $1 million
  • Net loss decreased to $0.4 million ($0.2 per basic ADS)
  • Cash position of $8.2 million, providing runway into mid-2026

The company raised $2.8 million through a registered direct offering and an additional $1.5 million through ADS sales. The CAPTN-3 platform showed promising preclinical data, demonstrating sustained tumor regression in triple-negative breast cancer models.

Purple Biotech (NASDAQ/TASE: PPBT) ha annunciato i risultati finanziari del Q4 e dell'intero anno 2024, evidenziando il successo degli studi clinici per i suoi asset oncologici. L'azienda ha riportato risultati finali positivi dallo studio di Fase 2 di CM24 nel cancro pancreatico, mostrando una riduzione del 79% del rischio di morte per i pazienti selezionati in base ai biomarcatori. NT219 sta avanzando verso studi di Fase 2 per il cancro testa-collo in combinazione con pembrolizumab e cetuximab.

I punti salienti finanziari per il Q4 2024 includono:

  • Le spese per ricerca e sviluppo sono diminuite del 90,4% a $0,5 milioni
  • La perdita operativa è stata ridotta dell'84,1% a $1 milione
  • La perdita netta è scesa a $0,4 milioni ($0,2 per ADS di base)
  • Posizione di cassa di $8,2 milioni, garantendo liquidità fino a metà 2026

L'azienda ha raccolto $2,8 milioni attraverso un'offerta diretta registrata e ulteriori $1,5 milioni attraverso vendite di ADS. La piattaforma CAPTN-3 ha mostrato dati preclinici promettenti, dimostrando una regressione tumorale sostenuta in modelli di cancro al seno triplo negativo.

Purple Biotech (NASDAQ/TASE: PPBT) anunció sus resultados financieros del cuarto trimestre y del año completo 2024, destacando ensayos clínicos exitosos para sus activos oncológicos. La compañía reportó resultados finales positivos del estudio de Fase 2 de CM24 en cáncer de páncreas, mostrando una reducción del 79% en el riesgo de muerte para los pacientes seleccionados por biomarcadores. NT219 avanza a ensayos de Fase 2 para cáncer de cabeza y cuello en combinación con pembrolizumab y cetuximab.

Los aspectos financieros destacados del cuarto trimestre de 2024 incluyen:

  • Los gastos en investigación y desarrollo disminuyeron un 90.4% a $0.5 millones
  • La pérdida operativa se redujo un 84.1% a $1 millón
  • La pérdida neta disminuyó a $0.4 millones ($0.2 por ADS básico)
  • Posición de efectivo de $8.2 millones, proporcionando liquidez hasta mediados de 2026

La compañía recaudó $2.8 millones a través de una oferta directa registrada y un adicional de $1.5 millones a través de ventas de ADS. La plataforma CAPTN-3 mostró datos preclínicos prometedores, demostrando una regresión tumoral sostenida en modelos de cáncer de mama triple negativo.

Purple Biotech (NASDAQ/TASE: PPBT)는 2024년 4분기 및 연간 재무 결과를 발표하며, 자사의 종양학 자산에 대한 성공적인 임상 시험을 강조했습니다. 이 회사는 췌장암에 대한 CM24의 2상 연구에서 긍정적인 최종 결과를 보고했으며, 바이오마커로 선택된 환자에서 사망 위험이 79% 감소했습니다. NT219는 펨브롤리주맙 및 세툭시맙과 병용하여 두경부암에 대한 2상 시험으로 진행되고 있습니다.

2024년 4분기 재무 하이라이트는 다음과 같습니다:

  • 연구 및 개발 비용이 90.4% 감소하여 50만 달러에 달했습니다.
  • 영업 손실이 84.1% 감소하여 100만 달러가 되었습니다.
  • 순손실이 40만 달러로 감소했습니다(기본 ADS당 0.2달러).
  • 현금 보유액은 820만 달러로, 2026년 중반까지의 운영 자금을 제공합니다.

회사는 등록된 직접 제공을 통해 280만 달러를 모금했으며, 추가로 ADS 판매를 통해 150만 달러를 모금했습니다. CAPTN-3 플랫폼은 삼중 음성 유방암 모델에서 지속적인 종양 퇴화를 보여주는 유망한 전임상 데이터를 나타냈습니다.

Purple Biotech (NASDAQ/TASE: PPBT) a annoncé ses résultats financiers pour le quatrième trimestre et l'année entière 2024, mettant en avant des essais cliniques réussis pour ses actifs en oncologie. La société a rapporté des résultats finaux positifs de l'étude de Phase 2 de CM24 dans le cancer du pancréas, montrant une réduction de 79 % du risque de décès pour les patients sélectionnés selon des biomarqueurs. NT219 avance vers des essais de Phase 2 pour le cancer de la tête et du cou en combinaison avec le pembrolizumab et le cetuximab.

Les points forts financiers du quatrième trimestre 2024 incluent :

  • Les dépenses de recherche et développement ont diminué de 90,4 % pour atteindre 0,5 million de dollars
  • La perte d'exploitation a été réduite de 84,1 % à 1 million de dollars
  • La perte nette a diminué à 0,4 million de dollars (0,2 dollar par ADS de base)
  • Position de trésorerie de 8,2 millions de dollars, garantissant des liquidités jusqu'à mi-2026

La société a levé 2,8 millions de dollars grâce à une offre directe enregistrée et 1,5 million de dollars supplémentaires grâce à des ventes d'ADS. La plateforme CAPTN-3 a montré des données précliniques prometteuses, démontrant une régression tumorale soutenue dans des modèles de cancer du sein triple négatif.

Purple Biotech (NASDAQ/TASE: PPBT) hat seine finanziellen Ergebnisse für das vierte Quartal und das Gesamtjahr 2024 bekannt gegeben und erfolgreiche klinische Studien für seine Onkologie-Assets hervorgehoben. Das Unternehmen berichtete über positive Endergebnisse aus der Phase-2-Studie von CM24 bei Bauchspeicheldrüsenkrebs, die eine 79%ige Verringerung des Sterberisikos bei biomarker-ausgewählten Patienten zeigte. NT219 schreitet in Phase-2-Studien für Kopf- und Halskrebs in Kombination mit Pembrolizumab und Cetuximab voran.

Finanzielle Highlights für das 4. Quartal 2024 umfassen:

  • Forschungs- und Entwicklungskosten sanken um 90,4% auf 0,5 Millionen Dollar
  • Betriebsverlust reduzierte sich um 84,1% auf 1 Million Dollar
  • Der Nettoverlust verringerte sich auf 0,4 Millionen Dollar (0,2 Dollar pro Basis-ADS)
  • Liquidität von 8,2 Millionen Dollar, die bis Mitte 2026 reicht

Das Unternehmen hat 2,8 Millionen Dollar durch ein registriertes Direktangebot und weitere 1,5 Millionen Dollar durch ADS-Verkäufe gesammelt. Die CAPTN-3-Plattform zeigte vielversprechende präklinische Daten, die eine anhaltende Tumorrückbildung in Modellen von triple-negativem Brustkrebs demonstrieren.

Positive
  • CM24 showed strong efficacy with 79% reduction in death risk for biomarker-selected patients
  • Significant decrease in operating loss by 84.1% to $1 million in Q4
  • R&D expenses reduced by 90.4%, improving cost efficiency
  • Secured $4.3 million in additional funding through offerings
  • Cash runway extended into mid-2026
Negative
  • Net loss of $0.4 million in Q4 2024
  • Cash position of $8.2 million may require additional funding before mid-2026
  • Share dilution from new ADS sales under Open Market Sale Agreement

Insights

Purple Biotech's Q4 and full-year 2024 results reveal significant financial improvement with Q4 operating loss decreasing 84.1% year-over-year to $1 million and full-year operating loss down 50.7% to $11 million. This substantial reduction stems primarily from decreased R&D expenses, which fell 90.4% in Q4 to $0.5 million, indicating the completion of major clinical trial activities. The company has successfully extended its cash runway into mid-2026 with $8.2 million in cash and equivalents, bolstered by $2.8 million from a registered direct offering and $1.5 million from ADS sales.

The financial improvements coincide with critical value-driving clinical milestones. CM24's positive Phase 2 results in pancreatic cancer revealed a compelling biomarker correlation, with CEACAM1-positive patients showing a 79% reduced risk of death. This biomarker-driven approach could significantly enhance the asset's commercial prospects by enabling targeted therapy across multiple cancer indications. Meanwhile, NT219's progression to Phase 2 in head and neck cancer and the University of Colorado collaboration represent key derisking events. The expanded patent protection for NT219 in combination with EGFR antibodies strengthens the company's intellectual property position in major markets.

From a strategic perspective, Purple Biotech is evolving from broad clinical development to more targeted approaches, exemplified by the biomarker focus for CM24. This precision medicine strategy could potentially improve approval pathways and commercial opportunities while optimizing resource allocation. The Mount Sinai collaboration for CAPTN-3 adds institutional validation to their early-stage platform. While still operating at a loss, the significant cost reductions and extended runway provide breathing room to reach additional value-creating milestones before requiring substantial additional financing.

Purple Biotech's clinical data reveals promising developments across their oncology pipeline. CM24's Phase 2 results in second-line pancreatic cancer demonstrate a rational biomarker-driven strategy with significant survival benefits. The identification of serum CEACAM1 as a predictive biomarker is particularly compelling, with biomarker-positive patients showing a 79% reduction in mortality risk. This represents a substantial improvement in a notoriously difficult-to-treat cancer with therapeutic options. The additional discovery that myeloperoxidase (MPO) serves as another potential predictive marker further strengthens the precision medicine approach.

NT219's dual inhibition of IRS1/2 and STAT3 represents a mechanistically sound approach to overcome resistance to both immunotherapy and EGFR inhibitors. The planned Phase 2 trial design is noteworthy for including both anti-PD1 (pembrolizumab) and anti-EGFR (cetuximab) combination arms in recurrent/metastatic head and neck cancer. This dual-pathway strategy addresses both tumor-intrinsic resistance mechanisms and immune evasion simultaneously. The involvement of Dr. Antonio Jimeno, a recognized expert in head and neck cancer, adds clinical credibility to this program.

The CAPTN-3 platform's tri-specific approach targeting both innate and adaptive immunity represents a differentiated strategy in the crowded T-cell engager space. The conditional activation technology addressing cytokine release syndrome is particularly important for safety. The Mount Sinai collaboration will provide valuable insights into tumor immune evasion mechanisms that could inform patient selection strategies. The platform's demonstrated activity in triple-negative breast cancer models and patient-derived lung cancer explants suggests potential broad applicability across difficult-to-treat solid tumors. Purple Biotech's overall strategy of developing biomarker-guided therapies targeting immune evasion and drug resistance aligns well with current oncology paradigms.

Completed successful clinical trials for CM24 and NT219 oncology assets, demonstrating clinical benefits and identifying potential biomarkers

CM24 is well positioned for personalized treatment, with planned biomarker-driven Phase 2b study based on serum biomarkers CEACAM1 and myeloperoxidase

NT219 headed into Phase 2 head and neck cancer study in combination with pembrolizumab (anti-PD1) and in combination with cetuximab (anti-EGFR)

CAPTN-3 tri-specific platform yields promising preclinical data, supporting its differentiated benefit and well positioning it in the multi-specific/engagers antibody space

REHOVOT, Israel, March 10, 2025 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance, today announced financial results for the three and twelve months ended December 31, 2024.

“Our major value-driving milestones in 2024 included completing successful trials for both of our clinical-stage programs, CM24 and NT219, as well as expanding the body of exciting preclinical data for our CAPTN-3 tri-specific platform, supporting its differentiated benefit,” stated Gil Efron, Purple Biotech CEO.

“CM24 met all of its efficacy endpoints in the randomized Phase 2 second-line pancreatic cancer trial, which also generated significant biomarker data that is now informing the design of our Phase 2b study for CM24, which we plan to initiate in the second half of 2025. As a biomarker-driven study, the Phase 2b study may evaluate CM24 across multiple oncology indications.

“Earlier in 2024, we concluded the dose escalation study for NT219, demonstrating activity in combination with cetuximab, good safety profile, and determining the recommended Phase 2 dose. This enabled us to move forward with a Phase 2 study in head and neck cancer in collaboration with the University of Colorado, which we expect will commence patient enrollment in the first half of 2025.

“We believe that our CAPTN-3 platform is well-positioned and differentiated in the T cell engagers (TCE) and multi-specific space, uniquely unleashes both innate and adaptive immune cells against the tumor, demonstrating synergistic effect of the T cell and NK cell activating arms. The unique NKG2A arm in the lead compound acts as a checkpoint inhibitor, enabling simultaneous NK and T cell activation, including effector subsets with high antitumor activity. We are excited about our CAPTN-3 collaboration with the Icahn School of Medicine at Mount Sinai. Our cash runway is expected to extend into mid-2026, providing us with the time to potentially deliver on more catalysts this year, in order to achieve our ambitious programs across all three assets,” Mr. Efron concluded.

Q4 2024 and Recent Clinical & Corporate Highlights:

  • CM24 Planned to Advance into Phase 2b Study Supported by Biomarker Data
    • Positive final results from randomized Phase 2 study of CM24 in second line pancreatic cancer
    • Serum CEACAM1 biomarker associated with 79% reduction in risk of death

Purple Biotech reported positive final results from the randomized Phase 2 study of CM24, a humanized monoclonal antibody that blocks CEACAM1, in patients with second-line pancreatic ductal adenocarcinoma (PDAC). CM24, in combination with nivolumab and Nal-IRI/5FU/LV chemotherapy, demonstrated consistent improvements across all efficacy endpoints. The enhanced results in patients with elevated CEACAM1 and other serum markers suggest that selecting a biomarker-enriched patient population could further enhance CM24's efficacy, potentially positioning it as a treatment for multiple CEACAM1-expressing malignancies in line with its mechanism of action. A biomarker-enriched patient population analysis based on pretreatment serum CEACAM1 levels demonstrated a significant improvement in the treatment arm over the control arm, with a 79% reduction in risk of death (HR 0.21, p = 0.04), a median overall survival (OS) improvement of 5.1 months, and over 90% reduction in the risk of progression or death (HR < 0.1, p = 0.003), with a median progression-free survival (PFS) improvement of 2.9 months and improvement in the objective response rate (ORR) of 50% in the treatment arm compared to 0% in the control arm.

Additional biomarker analysis revealed statistically significant results for 80% of the patients (24 out of 30) with serum CEACAM1 (5-16K pg/mL) or serum NET marker myeloperoxidase (MPO) (200-600 ng/mL) demonstrating 61% reduction in the risk of death (HR 0.39, p= 0.039) and 72% reduction in the risk of progression or death (PFS HR 0.28, P 0.006) following treatment with CM24 and nivolumab in combination with Nal-IRI/5FU/LV chemotherapy compared to same chemotherapy alone. In addition, median PFS increased by 2.2 months, and median OS increased by 2.4 months, from 5.5 months with chemotherapy alone to 7.9 months with the combination therapy.

  • NT219 Advances into Phase 2 Head and Neck Cancer Trial
    • Includes treatment arm of NT219 which we combine for the first time with pembrolizumab (Keytruda) immunotherapy, as well as expansion arm of NT219 combined with cetuximab
    • Collaboration with University of Colorado
    • Latest patent in U.S. enhances global IP protection

The Phase 2 study will evaluate the efficacy and safety of NT219 which we combine for the first time with standard-of-care checkpoint inhibitors, such as pembrolizumab (Keytruda), for the treatment of recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) and in combination with epidermal growth factor receptor (EGFR) blockers, such as cetuximab (Erbitux), which demonstrated activity in Purple Biotech’s Phase 1 dose escalation study. The Phase 2 study, expected to begin in the first half of 2025, is designed with two single-arm cohorts: one will evaluate NT219 in combination with pembrolizumab, and the other will evaluate NT219 in combination with cetuximab for the treatment of R/M SCCHN. Additionally, the study will explore potential biomarkers identified in a previous clinical study of NT219. 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.

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. We believe this additional patent positions the Company well for the potential future commercialization of NT219.

  • CAPTN-3 Tri-Specific Antibody Platform Preclinical Studies Advance Toward First-in-Human Clinical Trials
    • New data presented at EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics
    • Research collaboration with Icahn School of Medicine at Mount Sinai

New data on CAPTN-3 were presented at the 36th European Organization for Research and Treatment of Cancer, National Cancer Institute, American Association for Cancer Research (EORTC-NCI-AACR) Symposium on Molecular Targets and Cancer Therapeutics. CAPTN-3 demonstrated sustained tumor regression in a triple-negative breast cancer in-vivo model, as well as dose-dependent activity and a synergistic effect of the engager arms in non-small cell lung cancer patient-derived explants. IM1240, Purple’s lead tribody candidate, demonstrated that cytokine release is 5T4-dependent and suppressed by the conditionally activated capping technology, suggesting a potentially beneficial safety profile.

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.

Financial Results for the Three Months Ended December 31, 2024

Research and Development Expenses were $0.5 million, a decrease of $4.7 million, or 90.4%, compared to $5.2 million in the same period of 2023, primarily due to reduced clinical trials expenses.

Sales, General and Administrative Expenses were $0.6 million, compared to $1.0 million in the same period of 2023, a decrease of $0.4 million, or 40%, primarily due to a decrease in salary and salary related expenses and share based payment expenses.

Operating Loss was $1 million, a decrease of $5.3 million, or 84.1%, compared to $6.3 million in the same period of 2023, primarily due to the decrease in research and development expenses.

Adjusted Operating Loss (as reconciled below) was $1 million, a decrease of $5 million, compared to $6.0 million in the same period of 2023, primarily due to the decrease in research and development expenses.

Net Loss for the three months ended December 31, 2024, was $0.4 million, or $0.2 loss per basic ADS and $0.26 loss per diluted ADS, compared to a net loss of $4.9 million, or $3.8 per basic and diluted ADS, in the same period of 2023. The decrease in net loss was primarily due to the decrease in research and development expenses.

As of December 31, 2024, Purple Biotech had cash and cash equivalents and short-term deposits of $8.2 million, providing the Company a cash runway into mid-2026.

During the three months ended December 31, 2024, the Company raised $2.8 million through a registered direct offering. In addition, during the period the Company sold approximately 298 thousand ADSs, at an average price of $3.5 per ADS, under the Open Market Sale Agreement with Jefferies LLC, resulting in net proceeds to the Company of approximately $1.5 million, net of issuance expenses.

Financial Results for the Twelve Months Ended December 31, 2024

Research and Development Expenses were $7.6 million, a decrease of $9.4 million, or 55.3%, compared to $17 million in the same period of 2023. The decrease was primarily due to reduced clinical trials expenses.

Sales, General and Administrative Expenses were $3.2 million, a decrease of $2.0, or 38.5%, compared to $5.2 million in the same period of 2023, primarily due to a decrease in salary and salary related expenses and share based payment expenses.

Operating Loss was $11 million, a decrease of $11.3 million, or 50.7%, compared to $22.3 million in the same period of 2023, primarily due to the decrease in research and development expenses.

Adjusted Operating Loss (as reconciled below) was $10.4 million, a decrease of $10 million, compared to $20.4 million in the same period of 2023, primarily due to the decrease in research and development expenses.

Net Loss for the year ended December 31, 2024 was $7.3 million, or $4.44 loss per basic ADS and $4.99 loss per diluted ADS, compared to a net loss of $20 million, or $17.96 loss per basic and diluted ADS, in the same period of 2023. The decrease in net loss was primarily due to a $11.3 million decrease in operating expenses and a $1.4 million increase in financial income net.

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, is 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 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:
IR@purple-biotech.com


Purple Biotech Ltd.

Consolidated Statements of Financial Position as of December 31,

 2024  2023 
 USD thousands  USD thousands 
      
Assets     
Cash and cash equivalents7,401  14,489 
Short term deposits848  850 
Other investments275  73 
Other current assets384  376 
      
Total current assets8,908  15,788 
      
Non-current assets     
Right to use assets164  316 
Fixed assets, net124  154 
Intangible assets27,842  28,044 
      
Total non - current assets28,130  28,514 
      
Total assets37,038  44,302 
      
Liabilities     
Current maturity of lease liabilities183  188 
Trade payable1,455  3,532 
Warrants1,149  (*)2,518 
Other payables1,200  3,463 
      
Total current liabilities3,987  9,701 
      
Non-current liabilities     
      
Lease liability-  163 
Post-employment benefit liabilities140  141 
      
Total non - current liabilities140  304 
      
Equity     
      
Share capital, no par value-  - 
Share premium147,631  133,184 
Receipts on account of warrants21,145  28,467 
Capital reserve for share-based payments8,875  10,088 
Capital reserve from transactions with related parties761  761 
Capital reserve from hedging-  19 
Capital reserve from transactions with non- controlling interest(859) (859)
Accumulated loss(144,693) (137,453)
      
Equity attributable to owners of the Company32,860  34,207 
Non-controlling interests51  90 
Total equity32,911  34,297 
      
Total liabilities and equity37,038  44,302 


*  Restated following amendments to IAS 1

 


Consolidated Unaudited Statements of Operations and Other Comprehensive Loss

 For the year ended
December 31,
  For the three months ended
December 31,
 
 2024  2023  2024  2023 
 USD
thousands
  USD
thousands
  USD
thousands
  USD
thousands
 
Research and development expenses7,620  17,034  458  5,242 
Sales, general and administrative expenses3,183  5,237  558  1,025 
Impairment loss202  -  -  - 
            
Operating Loss11,005  22,271  1,016  6,267 
            
Change in fair value of warrants(3,341) (3,497) (76) (3,497)
Finance expenses483  2,195  (69) 2,089 
Finance income(868) (992) (456) - 
Finance income, net(3,726) (2,294) (601) (1,408)
            
Loss for the period7,279  19,977  415  4,859 
            
Other comprehensive loss:           
Items that will be transferred to profit or loss:           
Loss (profit) from cash flow hedges19  (25) (2) (21)
Total comprehensive loss for the period7,298  19,952  413  4,838 
            
Loss attributable to:           
Owners of the Company7,240  19,880  410  4,828 
Non-controlling interests39  97  5  31 
 7,279  19,977  415  4,859 
            
Total comprehensive loss attributable to:           
Owners of the Company7,259  19,855  408  4,807 
Non-controlling interests39  97  5  31 
 7,298  19,952  413  4,838 
            
Loss per share data           
            
Basic loss per ADS - USD4.44  (*)17.96   (*)0.20
  3.8 
Diluted loss per ADS - USD4.99  (*)17.96   (*)0.26
  3.8 
            
Number of ADSs used in calculating basic loss per ADS1,639,566  (*)1,106,665   (*)2,048,319
  (*)1,289,488 
Number of ADSs used in calculating diluted loss per ADS1,639,787  (*)1,106,665  2,048,764  (*)1,289,488 
            


*  Restated to reflect a 1:20 reverse ratio of the ADS’s, that took place September 2024.


Consolidated Statements of Cash Flows for the year ended December 31,

 2024  2023 
      
Cash flows from operating activities:     
Loss for the year(7,279) (19,977)
      
Adjustments:     
Depreciation186  197 
Impairment loss202  - 
Finance income, net(3,726) (2,294)
Share-based payments582  1,875 
      
 (10,035) (20,199)
      
Changes in assets and liabilities:     
Changes in other current assets96  178 
Changes in trade payables(2,076) 1,334 
Changes in other payables(2,352) (1,076)
Changes in post-employment benefit liabilities-  (162)
 (4,332) 274 
Net cash used in operating activities(14,367) (19,925)
      
Cash flows from investing activities:     
Acquisition of subsidiary, net of cash acquired-  (3,549)
Proceed from other investments187  875 
Acquisition of intangible asset-  - 
Decrease in short term deposits2  15,803 
Decrease in long term deposits-  - 
Interest received320  755 
Acquisition of fixed assets-  (3)
Net cash provided by investing activities509  13,881 
      
Cash flows from financing activities:     
Proceeds from issuance of ADSs5,809  1,563 
ADS issuance expenses paid(556) (229)
Proceeds from issuance of warrants and prefunded warrants-  5,000 
Proceeds from warrant inducement transaction2,028  - 
Warrants issuance expenses paid(280) (661)
Repayment of lease liability(183) (168)
Interest paid(44) (56)
Net cash provided by financing activities6,774  5,449 
      
Net increase (decrease) in cash and cash equivalents(7,084) (595)
Cash and cash equivalents at the beginning of the year14,489  15,030 
Effect of translation adjustments on cash and cash equivalents(4) 54 
Cash and cash equivalents at end of the year7,401  14,489 


Reconciliation of Non-IFRS Financial Results

Reconciliation of Adjusted Operating Loss

 For the year ended  For the three months ended 
 December 31,  December 31, 
 2024  2023  2024  2023 
 USD thousands  USD thousands  USD thousands  USD thousands 
            
Operating loss for the period11,005  22,271  1,016  6,267 
Less ESOP expenses(582) (1,875) 34  (181)
            
 10,423  20,396  1,050  6,086 

FAQ

What were the key biomarker results for PPBT's CM24 drug in pancreatic cancer trials?

CM24 showed 79% reduction in death risk and 90% reduction in progression risk for patients with elevated CEACAM1 levels, with 5.1 months improvement in median overall survival.

When will Purple Biotech (PPBT) initiate the Phase 2b study for CM24?

Purple Biotech plans to initiate the biomarker-driven Phase 2b study for CM24 in the second half of 2025.

What is PPBT's current cash runway as of Q4 2024?

Purple Biotech reported $8.2 million in cash and cash equivalents, providing runway into mid-2026.

How much did Purple Biotech's R&D expenses decrease in Q4 2024?

R&D expenses decreased by 90.4% to $0.5 million compared to $5.2 million in Q4 2023.

When will PPBT begin patient enrollment for NT219's Phase 2 head and neck cancer trial?

Patient enrollment for NT219's Phase 2 trial is expected to commence in the first half of 2025.
Purple Biotech Ltd

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