On August 16, 2024 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, reported financial results for the three and six months ended June 30, 2024 (Press release, Purple Biotech, AUG 16, 2024, View Source [SID1234645963]).
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"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 (Free ASCO Whitepaper) 2024 Late Breaking Session
o 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
o New CM24 potential predictive biomarkers for overall survival benefit were identified
o Additional interim data expected Q3 2024
o Final topline data expected in Q4 2024
o 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) (Free ASCO Whitepaper) 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:
ü 26% reduction in the risk of death combined with median OS prolongation at 2.1 months
ü 28% reduction in the risk of progression with median progression free survival (PFS) at 1.9 months
ü 26% overall response rate (ORR) in the experimental arm compared to 6% in the control arm
ü CA19-9, a validated and clinically predictive PDAC biomarker, consistently decreased in the CM24 treatment arm vs. control
ü 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
ü 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 (Free AACR Whitepaper) 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 (Free AACR Whitepaper) 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) (Free AACR Whitepaper) 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 (Free AACR Whitepaper) 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 $10.0 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.