STOCK TITAN

Purple Biotech Reports Second Quarter 2024 Financial Results and Business Highlights

Rhea-AI Impact
(Neutral)
Rhea-AI Sentiment
(Neutral)
Tags

Purple Biotech (NASDAQ/TASE: PPBT) reported positive interim data from its Phase 2 CM24 pancreatic cancer study at ASCO 2024. The CM24+nivolumab+NAL-IRI/5FU/LV combination showed improvements in overall survival, progression-free survival, and objective response rate compared to standard-of-care. The company is evaluating expanding CM24's clinical program based on its novel CEACAM1 target on Neutrophil Extracellular Traps.

Financial highlights for Q2 2024 include:

  • R&D expenses decreased 35.1% to $2.4 million
  • Operating loss decreased 31.4% to $3.5 million
  • Net loss decreased to $2.4 million ($0.09 per ADS)
  • Cash runway extended to Q3 2025

Purple Biotech expects additional interim data in Q3 2024 and final topline results in Q4 2024.

Purple Biotech (NASDAQ/TASE: PPBT) ha riportato dati intermedi positivi dallo studio di Fase 2 CM24 sul cancro pancreatico all'ASCO 2024. La combinazione CM24+nivolumab+NAL-IRI/5FU/LV ha mostrato miglioramenti nella sopravvivenza complessiva, nella sopravvivenza libera da progressione e nel tasso di risposta obiettiva rispetto al trattamento standard. L'azienda sta valutando l'espansione del programma clinico di CM24 basato sul suo nuovo target CEACAM1 sulle Trappole Extracellulari dei Neutrofili.

Tra i risultati finanziari per il secondo trimestre del 2024 vi sono:

  • Le spese per R&S sono diminuite del 35,1%, raggiungendo i 2,4 milioni di dollari
  • La perdita operativa è diminuita del 31,4%, a 3,5 milioni di dollari
  • La perdita netta è scesa a 2,4 milioni di dollari (0,09 dollari per ADS)
  • La disponibilità di liquidità è stata estesa fino al terzo trimestre del 2025

Purple Biotech si aspetta dati intermedi aggiuntivi nel terzo trimestre del 2024 e risultati finali nel quarto trimestre del 2024.

Purple Biotech (NASDAQ/TASE: PPBT) reportó datos interinos positivos de su estudio de Fase 2 CM24 sobre cáncer pancreático en ASCO 2024. La combinación de CM24+nivolumab+NAL-IRI/5FU/LV mostró mejoras en la supervivencia general, en la supervivencia libre de progresión y en el tasa de respuesta objetiva en comparación con el tratamiento estándar. La compañía está evaluando la expansión del programa clínico de CM24 basado en su nuevo objetivo CEACAM1 en Trampas Extracelulares de Neutrófilos.

Los aspectos financieros destacados del segundo trimestre de 2024 incluyen:

  • Los gastos en I+D disminuyeron un 35,1%, llegando a 2,4 millones de dólares
  • La pérdida operativa disminuyó un 31,4%, a 3,5 millones de dólares
  • La pérdida neta se redujo a 2,4 millones de dólares (0,09 dólares por ADS)
  • La proyección de efectivo se extendió hasta el tercer trimestre de 2025

Purple Biotech espera datos interinos adicionales en el tercer trimestre de 2024 y resultados finales en el cuarto trimestre de 2024.

퍼플 바이오텍 (NASDAQ/TASE: PPBT)이 ASCO 2024에서 췌장암에 대한 2상 CM24 연구의 긍정적인 중간 데이터 결과를 보고했습니다. CM24+nivolumab+NAL-IRI/5FU/LV 조합은 표준 치료에 비해 전체 생존율, 무진행 생존율, 객관적 반응률에서 개선을 보여주었습니다. 이 회사는 백혈구 세포 외 기질의 새로운 CEACAM1 목표에 기반하여 CM24의 임상 프로그램 확장을 평가하고 있습니다.

2024년 2분기 재무 하이라이트는 다음과 같습니다:

  • 연구 및 개발 비용이 35.1% 감소하여 240만 달러에 도달
  • 운영 손실이 31.4% 감소하여 350만 달러
  • 순손실이 240만 달러로 감소 (ADS당 0.09달러)
  • 현금 잔여 기간이 2025년 3분기까지 연장됨

퍼플 바이오텍은 2024년 3분기에 추가 중간 데이터와 2024년 4분기에 최종 결과를 기대하고 있습니다.

Purple Biotech (NASDAQ/TASE: PPBT) a rapporté des données intermédiaires positives de son étude de Phase 2 CM24 sur le cancer du pancréas lors de l'ASCO 2024. La combinaison CM24+nivolumab+NAL-IRI/5FU/LV a montré des améliorations dans la survie globale, la survie sans progression et le taux de réponse objective par rapport aux traitements standards. L'entreprise envisage d'étendre le programme clinique de CM24 basé sur sa nouvelle cible CEACAM1 sur les Pièges Extracellulaires des Neutrophiles.

Les principaux points financiers pour le deuxième trimestre 2024 incluent :

  • Les dépenses en R&D ont diminué de 35,1 % pour atteindre 2,4 millions de dollars
  • La perte d'exploitation a diminué de 31,4 % pour atteindre 3,5 millions de dollars
  • La perte nette a diminué à 2,4 millions de dollars (0,09 dollars par ADS)
  • La trésorerie a été prolongée jusqu'au troisième trimestre 2025

Purple Biotech s'attend à des données intermédiaires supplémentaires au troisième trimestre 2024 et à des résultats finaux au quatrième trimestre 2024.

Purple Biotech (NASDAQ/TASE: PPBT) hat auf der ASCO 2024 positive Zwischenresultate seiner Phase-2-Studie zu CM24 bei Bauchspeicheldrüsenkrebs veröffentlicht. Die Kombination aus CM24+nivolumab+NAL-IRI/5FU/LV zeigte im Vergleich zur Standardbehandlung Verbesserungen in der Gesamtüberlebensrate, der progressionsfreien Überlebenszeit und der objektiven Ansprechrate. Das Unternehmen prüft eine Erweiterung des klinischen Programms von CM24 basierend auf dem neuartigen Ziel CEACAM1 auf Neutrophilen Extrazellulären Fallen.

Die finanziellen Höhepunkte für das 2. Quartal 2024 umfassen:

  • Die F&E-Ausgaben sind um 35,1 % auf 2,4 Millionen Dollar gesunken
  • Der operative Verlust ging um 31,4 % auf 3,5 Millionen Dollar zurück
  • Der Nettoverlust reduzierte sich auf 2,4 Millionen Dollar (0,09 Dollar pro ADS)
  • Die Liquiditätsreserve wurde bis zum 3. Quartal 2025 verlängert

Purple Biotech erwartet zusätzliche Zwischenresultate im 3. Quartal 2024 und endgültige Ergebnisse im 4. Quartal 2024.

Positive
  • Positive interim data from Phase 2 CM24 pancreatic cancer study showing improvements in overall survival, progression-free survival, and objective response rate
  • 26% reduction in risk of death and 2.1 months median OS prolongation in CM24 combination arm
  • 28% reduction in risk of progression with 1.9 months median PFS improvement
  • 26% overall response rate in experimental arm vs 6% in control arm
  • Cash runway extended to Q3 2025
  • R&D expenses decreased by 35.1% to $2.4 million in Q2 2024
  • Operating loss decreased by 31.4% to $3.5 million in Q2 2024
  • Net loss decreased to $2.4 million ($0.09 per ADS) in Q2 2024
Negative
  • Gemcitabine/nab-paclitaxel-based part of the study was impacted by informative censoring, rendering it unsuitable for analysis

Insights

Purple Biotech's Q2 2024 results show a significant improvement in financial health. The company reduced its net loss by 53.2% year-over-year to $2.2 million, primarily due to decreased R&D expenses and increased financial income. The cash runway extension to Q3 2025 provides stability for upcoming milestones.

The positive interim results from the CM24 Phase 2 pancreatic cancer study are particularly noteworthy. Improvements in overall survival, progression-free survival and objective response rate could potentially lead to a breakthrough in pancreatic cancer treatment, a notoriously difficult-to-treat cancer with a large market opportunity.

However, investors should note the cash position of $7.4 million as of June 30, 2024, which is relatively low for a clinical-stage biotech company. The recent $2 million from warrant exercises provides some relief, but further financing may be necessary before Q3 2025.

The interim results from the CM24 Phase 2 study in pancreatic cancer are highly promising. A 26% reduction in death risk and 28% reduction in progression risk are significant in this aggressive cancer type. The 26% overall response rate compared to 6% in the control arm is particularly impressive.

The potential of CM24 as a novel oncologic target affecting Neutrophil Extracellular Traps (NETs) is intriguing. If validated, this could open new avenues for cancer treatment beyond pancreatic cancer. The identification of myeloperoxidase (MPO) as a potential predictive biomarker adds another layer of precision to patient selection.

However, it's important to await the final topline data expected in Q4 2024 and the results of the planned FDA meeting in H1 2025 to fully assess CM24's potential impact on standard of care.

Purple Biotech's focus on first-in-class therapies targeting tumor immune evasion and drug resistance positions it well in the competitive oncology market. The positive interim results for CM24 in pancreatic cancer, a notoriously difficult-to-treat cancer, could potentially disrupt the current treatment landscape.

The company's strategy to expand CM24's clinical program into biomarker-driven studies for additional indications is smart, potentially broadening its market reach. The novel mechanism of action targeting CEACAM1 on NETs could differentiate Purple Biotech from competitors.

However, the company's cash resources and recent workforce reduction by 33% raise concerns about its ability to fully capitalize on its potential without additional financing. The biotech sector's current challenging funding environment could pose difficulties for Purple Biotech in securing necessary capital to advance its promising pipeline.

Positive randomized Phase 2 CM24 pancreatic cancer study interim data presented at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting demonstrates improvement in overall survival, progression free survival, objective response rate and all other efficacy endpoints in the combination of CM24+nivolumab and NAL-IRI/5FU/LV chemotherapy cohort

Evaluating expansion of CM24 clinical program to a biomarker driven study in additional indications based on CEACAM1 novel oncology target on Neutrophil Extracellular Traps (NETs) in addition to enhancing immune response through the inhibition of CEACAM1 to CEACAM1 interactions

Cash runway extended to Q3 2025

REHOVOT, Israel, Aug. 16, 2024 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. (“Purple Biotech” or “the Company”) (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that overcome tumor immune evasion and drug resistance, today announced financial results for the three and six months ended June 30, 2024.

“We were very pleased to report CM24 phase 2 study positive interim results during the last quarter which demonstrated strong results across all efficacy measures compared to the control arm in the NAL-IRI part of the study. The fact that this was a small study and the consistency of the benefit across all efficacy endpoints amplify the potential meaningfulness of the results,” stated Gil Efron, Chief Executive Officer of Purple Biotech. “Also highly encouraging is the additional data suggesting serum pre dose NET marker myeloperoxidase (MPO) as a potential predictive biomarker of CM24 benefit. This biomarker data together with previous clinical results demonstrating reduction in the serum NET marker in pancreatic ductal adenocarcinoma (PDAC) patients treated with CM24, and preclinical results demonstrating the effect of CM24 on NET-related activities, support the potential of CEACAM1 on NETs as a novel oncologic target. We are evaluating the expansion of our CM24 clinical program to biomarker-driven studies in additional indications, based on this novel mechanism of action.”

“Having reprioritized our activities, together with the recent financing, we extended our cash runway into the third quarter of 2025, providing a longer lead time to reach our milestones, including more Phase 2 CM24 pancreatic cancer interim data at a medical conference in Sept 2024 and topline results in Q4 2024. Additionally, in the first half of 2025 we expect to have an end of Phase 2 meeting with the U.S. Food and Drug Administration to discuss our plans for pivotal studies with CM24, while we continue to evaluate potential collaborations for our pipeline.”

Q2 2024 and Recent Clinical & Corporate Highlights:

  • CM24 randomized Phase 2 pancreatic cancer study interim data presented at ASCO 2024 Late Breaking Session
    • Data demonstrate improvement in overall survival (OS), progression free survival (PFS), objective response rate (ORR) and all other efficacy endpoints in the CM24+nivolumab+Nal-IRI/5FU/LV experimental arm as compared with the standard-of-care (SoC) control arm
    • New CM24 potential predictive biomarkers for overall survival benefit were identified
    • Additional interim data expected Q3 2024
    • Final topline data expected in Q4 2024
    • The gemcitabine/nab-paclitaxel-based part of the study was impacted by informative censoring of the control arm that led to an imbalance between the control and experimental cohorts, rendering this part of the study unsuitable for analysis; this part of the study has no impact on the CM24+nivolumab+Nal-IRI/5FU/LV portion of the study

Purple Biotech’s poster titled “Interim results of the Randomized Phase 2 Cohort of Study FW-2020-01 Assessing the Efficacy, Safety and Pharmacodynamics of CM24 in combination with Nivolumab and Chemotherapy in Advanced/Metastatic Pancreatic Cancer” was selected by the American Society of Clinical Oncology (ASCO) for a Late Breaking presentation at its 2024 Annual Meeting.

The Phase 2 study is evaluating CM24 in combination with Bristol Myers Squibb’s PD-1 inhibitor nivolumab plus SoC chemotherapy in second line pancreatic ductal adenocarcinoma (PDAC) patients compared to SoC chemotherapy alone. The experimental arms of the study treat patients with CM24 plus nivolumab and one of two SoC chemotherapies, gemcitabine/nab-paclitaxel or Nal-IRI/5FU/LV, while patients in the control arms are administered with either respective chemotherapies alone. Sixty three patients have been enrolled in the randomized study across 18 centers in the U.S., Spain and Israel.

The summary of findings at the interim analysis for the CM24+nivolumab+Nal-IRI/5FU/LV regimen as compared with SoC chemotherapy alone as of May 22, 2024, cut-off includes the following:

  • 26% reduction in the risk of death combined with median OS prolongation at 2.1 months
  • 28% reduction in the risk of progression with median progression free survival (PFS) at 1.9 months
  • 26% overall response rate (ORR) in the experimental arm compared to 6% in the control arm
  • CA19-9, a validated and clinically predictive PDAC biomarker, consistently decreased in the CM24 treatment arm vs. control
  • Additional data from Purple Biotech’s Phase 2 study suggest that NET-related baseline MPO levels below the threshold may predict OS improvement when comparing the CM24+nivolumab+Nal-IRI/5FU/LV vs. Nal-IRI/5FU/LV arms
  • The CM24+nivolumab+Nal-IRI/5FU/LV regimen was well tolerated

Further evaluation of the data in the second part of the study concluded that unlike in the Nal-IRI/5FU/LV part, the gemcitabine/nab-paclitaxel-based portion of the study was significantly impacted by informative censoring of the control arm that resulted in an imbalance between the control and experimental arms, rendering this part of the study unsuitable for analysis. The study was designed as a two-part study, with each of the Nal-IRI/5FU/LV and the gemcitabine/nab-paclitaxel parts as a standalone, and therefore the analysis of each part is independent.

Final top line data is expected to be reported before the end of 2024 while additional interim data is expected to be presented at a medical conference in September 2024.

  • NT219’s efficacy in suppressing cancer stem cell-mediated resistance to KRASG12C and KRASG12D inhibitors in solid tumors presented at AACR 2024
  • Phase 1 dose escalation study of NT219 in combination with cetuximab in recurrent/metastatic head and neck cancer concluded
  • Early activity, PK and biomarker analysis for NT219 therapy were presented at the AACR 2024

Key findings were shared in two poster presentations, “NT219, a dual inhibitor of IRS1/2 and STAT3, suppresses cancer stem cell mediated resistance to KRASG12C and KRASG12D inhibitors in solid tumors” and “Early activity and biomarker evaluation of NT219 in combination with cetuximab in a Phase 1/2 study of recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN)” at the American Association for Cancer Research (AACR) 2024 Annual Meeting. NT219 was found to significantly suppress cancer stem cells, suggesting a novel therapy and new mechanism to combat cancer recurrence and overcoming resistance to KRAS(G12C) and KRAS(G12D) inhibitors in non-small cell lung cancer (NSCLC) and PDAC cells, respectively. NT219 reverses acquired resistance to KRAS inhibitors by addressing both cellular escape pathways and cancer stem cell mechanisms. Potential biomarkers for NT219 treatment were presented in an additional poster at AACR 2024, and on-target effects of the therapy were demonstrated in patients’ tumors. Analysis of pre-treatment patients’ biopsies suggests that activated IGF1R and STAT3 could serve as potential biomarkers for NT219 treatment. These findings should be verified in a larger number of patients in the next clinical study.

Financial Results for the Three Months Ended June 30, 2024

Research and Development Expenses were $2.4 million, a decrease of $1.3 million, or 35.1%, compared to $3.7 million in the same period of 2023, mainly due reduced chemistry, manufacturing and controls (“CMC”) costs and clinical trials expenses.

Sales, General and Administrative Expenses were $0.9 million, compared to $1.4 million in the same period of 2023, a decrease of $0.5 million, mainly due to salary and salary related costs.

Operating Loss was $3.5 million, a decrease of $1.6 million, or 31.4%, compared to $5.1 million in the same period of 2023, mainly due to the decrease in R&D expenses.

Adjusted Operating Loss (as reconciled below) was $3.2 million, a decrease of $1.4 million, compared to $4.6 million in the same period of 2023.

Net Loss for the three months ended June 30, 2024, was $2.4 million, or $0.09 per basic and diluted ADS, compared to a net loss of $5.2 million, or $0.25 per basic and diluted ADS, in the same period of 2023. The decrease in net loss was mainly due to a decrease in R&D expenses and an increase in financial income related to changes in fair value of warrants.

Adjusted Net Loss (as reconciled below) for the three months ended June 30, 2024, was $2.2 million, a decrease of $2.5 million or 53.2% compared to $4.7 million for the three months ended June 30, 2023.

As of June 30, 2024, Purple Biotech had cash and cash equivalents and short-term deposits of $7.4 million. On July 2, 2024, Purple Biotech announced the receipt of $2 million in gross proceeds from the exercise of warrants in connection with a warrant exercise and reload transaction. The Company has reprioritized its activities, and, in combination with cost saving measures including a 33% reduction in its workforce, Purple Biotech now has a cash runway into the third quarter of 2025.

Financial Results for the Six Months Ended June 30, 2024

Research and Development Expenses were $5.8 million, a decrease of $1.4 million, or 19.4%, compared to $7.2 million in the same period of 2023. The decrease was mainly due to reduced CMC costs and clinical trials expenses.

Sales, General and Administrative Expenses were $1.8 million, a decrease of $1.2 or 40%, compared to $3.1 million in the same period of 2023, mainly due to salary and salary related expenses and share based payment expenses.

Operating Loss was $7.9 million, a decrease of $2.4 million, or 23.3%, compared to $10.3 million in the same period of 2023, mainly due to decrease in operating expenses.

Adjusted Operating Loss (as reconciled below) was $7.4 million, a decrease of $1.6 million, compared to $9.0 million in the same period of 2023.

Net Loss for the six months ended June 30, 2024, was $6.2 million, or $0.23 loss per basic and diluted ADS, compared to a net loss of $10.1 million, or $0.49 loss per basic and diluted ADS, in the same period of 2023. The decrease in net loss was mainly due to a $2.4 million decrease in operating expenses.

Adjusted net loss (as reconciled below) for the six months ended June 30, 2024, was $5.7 million, compared to $8.8 million in the six months ended June 30, 2023.

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 share-based compensation expenses. 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 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 first-in-class therapies that seek to overcome tumor immune evasion and drug resistance. The Company's oncology pipeline includes CM24, NT219 and IM1240. CM24 is a humanized monoclonal antibody that blocks CEACAM1, that 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 a proof of concept of these novel pathways, the Company is advancing CM24 as a combination therapy with anti-PD-1 checkpoint inhibitors in a Phase 2 study for the treatment of pancreatic ductal adenocarcinoma (PDAC). The Company has entered into a clinical collaboration agreement with Bristol Myers Squibb for the Phase 2 clinical trials to evaluate the combination of CM24 with the PD-1 inhibitor nivolumab in addition to chemotherapy. 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 SCCHN (R/N SCCHN). The Company is advancing CAPTN-3, a preclinical platform of conditionally-activated tri-specific antibody that engages 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, and thereby potentially increases 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 5T4 expressed in a variety of solid tumors and is correlated 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, 2023 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:
Lior Fhima
Chief Financial Officer
IR@purple-biotech.com


Purple Biotech Ltd.
 
Condensed Consolidated Unaudited Interim Statements of Financial Position
  June 30,  December 31, 
  2024  2023 
  USD
thousand
  USD
thousand
 
Assets      
Cash and cash equivalents  6,524   14,489 
Short term deposits  845   850 
Other investments  22   73 
Other current assets  473   376 
         
Total current assets  7,864   15,788 
         
Non-current assets        
Right of use assets  240   316 
Fixed assets, net  119   154 
Intangible assets  27,842   28,044 
         
Total non–current assets  28,201   28,514 
         
Total assets  36,065   44,302 
         
Liabilities        
Lease liability - short term  182   188 
Accounts payable  3,042   3,532 
Other payables  2,145   3,463 
Warrants  1,099   2,518 
         
Total current liabilities  6,468   9,701 
         
Non-current liabilities        
Lease liability  79   163 
Post-employment benefit liabilities  141   141 
         
Total non-current liabilities  220   304 
         
Equity        
Share capital, no par value  -   - 
Share premium  135,597   133,184 
Receipts on account of warrants  28,467   28,467 
Capital reserve for share-based payments  8,972   10,088 
Capital reserve from transactions with related parties  761   761 
Capital reserves from hedging  (2)  19 
Capital reserve from transactions with non-controlling interest  (859)  (859)
Accumulated loss  (143,620)  (137,453)
         
Equity attributable to owners of the Company  29,316   34,207 
Non-controlling interests  61   90 
         
Total equity  29,377   34,297 
         
Total liabilities and equity  36,065   44,302 



Purple Biotech Ltd.
 
Condensed Consolidated Unaudited Interim Statements of Operations and Other Comprehensive Income
  For the six months
ended

June 30,
  For the three months
ended

June 30,
 
  2024
  2023  2024
  2023 
  USD
thousand
  USD
thousand
  USD
thousand
  USD
thousand
 
             
Research and development expenses  5,814    7,203   2,391    3,705 
Sales, general and administrative expenses  1,840    3,054   865    1,430 
Impairment loss  202    -   202    - 
                 
Operating loss  7,856    10,257   3,458    5,135 
                 
Change in fair value of warrants  (1,419)   -   (946)   - 
Finance expense  41    207   24    148 
Finance income  (282)   (401)  (121)   (123)
                 
Finance expense (income), net  (1,660)   (194)  (1,043)   25 
                 
Loss for the period  6,196    10,063   2,415    5,160 
                 
Other Comprehensive Profit:                
Items that will be transferred to profit or loss:                
Loss (profit) on cash flow hedges  21    (4)   6    (5)
                 
Total comprehensive loss for the period  6,217    10,059   2,421    5,155 
                 
Loss attributable to:                
Owners of the Company  6,167    10,016   2,405    5,138 
Non-controlling interests  29    47   10    22 
                 
   6,196    10,063   2,415    5,160 
                 
Total comprehensive loss attributable to                
Owners of the Company  6,188    10,012   2,411    5,133 
Non-controlling interests  29    47   10    22 
                 
   6,217    10,059   2,421    5,155 
                 
Loss per share data                
Basic and diluted loss per ADS – USD  0.23    0.49   0.09    0.25 
                 
Number of ADSs used in calculation  26,772,229    20,425,638   27,532,024    21,006,218 



Reconciliation of Adjusted Operating Loss

  For the six months ended
June 30,

 For the three months ended
June 30,
  2024 2023 2024 2023
  USD
thousand
 USD
thousand
 USD
thousand
 USD
thousand
      
Operating loss for the period 7,856 10,257 3,458 5,135
Less ESOP expenses (484) (1,245) (218) (493)
  7,372 9,012 3,240 4,642



Reconciliation of Adjusted Net Loss

  For the six months ended
June 30,

 For the three months ended
June 30,
  2024 2023 2024 2023
  USD
thousand
 USD
thousand
 USD
thousand
 USD
thousand
      
Loss for the period  6,196 10,063 2,415 5,160
Less ESOP expenses (484) (1,245) (218) (493)
  5,712 8,818 2,197 4,667



Purple Biotech Ltd.
 
Condensed Consolidated Unaudited Interim Statements of Cash Flows
 
  For the six months
ended

June 30,
 
  2024
  2023 
  USD
thousand
  USD
thousand
 
Cash flows from operating activities:      
Loss for the period  (6,196)   (10,063)
Adjustments:        
Depreciation  97    99 
Impairment loss  202    - 
Finance expenses (income), net  (1,660)   (194)
Share-based payments  484    1,245 
         
   (7,073)   (8,913)
         
Changes in assets and liabilities:        
Changes in other investments and other current assets  (162)   (118)
Changes in accounts payables  (490)   (628)
Changes in other payables  (1,333)   (1,467)
Changes in post-employment benefit liabilities  -    (161)
         
   (1,985)   (2,374)
         
Net cash used in operating activities  (9,058)   (11,287)
         
Cash flows from investing activities:        
Acquisition of subsidiary, net of cash acquired  -    (3,549)
Proceed from other investments  187    - 
Interest received  207    548 
Decrease in short-term deposits  5    15,806 
Acquisition of fixed assets  -    (4)
         
Net cash provided by investing activities  399    12,801 
         
Cash flows from financing activities:        
Proceeds from issuance ADSs  938    881 
ADS issuance expenses paid  (125)   (137)
Repayment of lease liability  (91)   (84)
Interest paid  (21)   (29)
         
Net cash provided by financing activities  701    631 
         
Net increase (decrease) in cash and cash equivalents  (7,958)   2,145 
Cash and cash equivalents at the beginning of the period  14,489    15,030 
Effect of translation adjustments on cash and cash equivalents  (7)   27 
         
Cash and cash equivalents at the end of the period  6,524    17,202 

FAQ

What were the key results from Purple Biotech's CM24 Phase 2 pancreatic cancer study?

Purple Biotech's CM24 Phase 2 study showed a 26% reduction in risk of death, 2.1 months median OS prolongation, 28% reduction in risk of progression, and 26% overall response rate in the CM24+nivolumab+NAL-IRI/5FU/LV combination arm compared to standard-of-care.

When does Purple Biotech (PPBT) expect to report final topline data for the CM24 Phase 2 study?

Purple Biotech expects to report final topline data for the CM24 Phase 2 study before the end of 2024, with additional interim data expected to be presented at a medical conference in September 2024.

How has Purple Biotech (PPBT) extended its cash runway?

Purple Biotech has extended its cash runway to Q3 2025 through reprioritizing activities, implementing cost-saving measures including a 33% workforce reduction, and receiving $2 million from warrant exercises in July 2024.

What were Purple Biotech's (PPBT) key financial results for Q2 2024?

In Q2 2024, Purple Biotech reported R&D expenses of $2.4 million (down 35.1%), operating loss of $3.5 million (down 31.4%), and net loss of $2.4 million ($0.09 per ADS), showing significant reductions compared to Q2 2023.

Purple Biotech Ltd. American Depositary Shares

NASDAQ:PPBT

PPBT Rankings

PPBT Latest News

PPBT Stock Data

8.42M
2.53M
2.87%
9.33%
1.25%
Biotechnology
Healthcare
Link
United States of America
Rehovot