Full Press Release Details
Biotech Reports Second Quarter 2024 Financial Results and Business Highlights
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, 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, today announced financial results for
the three and six months ended June 30, 2024.
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."
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
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:
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.
data is expected to be reported before the end of 2024 while additional interim data is expected to be presented at a medical conference
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
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
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.
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