On November 21, 2023 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, reported financial results for the third quarter and nine months ended September 30, 2023 (Press release, Purple Biotech, NOV 21, 2023, View Source [SID1234637905]).
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"We are pleased to report that we expect to complete patient enrollment in our Phase 2 randomized CM24 pancreatic cancer study soon, ahead of our previous plan and that might result in earlier than anticipated analysis of interim and top line overall survival (OS) data during 2024. The interim data look will occur in 2024 when sufficient progression free survival (PFS) and OS events are registered and enable a meaningful data interpretation for a larger number of patients. Recently reported biomarker data demonstrates CM24’s mechanism of action for this important indication in dire need of a more effective drug that prolongs survival," stated Purple Biotech CEO, Gil Efron.
"Our Phase 1/2 dose escalation study of NT219 in head and neck cancer demonstrated initial activity at the dose level of 50 mg/kg. We continue dose optimization at a higher dose level and expect to report additional data during the first half of 2024 in parallel to preparing to enter a Phase 2 study."
"With a cash runway that extends more than two years, through the second half of 2025, Purple Biotech is very well positioned to execute on multiple value-driving milestones. Moreover, we expect 2024 to be a year with major clinical data catalysts."
Q3 2023 and Recent Corporate Highlights:
● CM24 Pancreatic Cancer Program Advances
o Phase 2 enrollment ahead of schedule
o Interim results for PFS and OS expected in H1 2024 with topline results expected in H2 2024
o Biomarker data supporting MOA presented at AACR (Free AACR Whitepaper)
Patient enrollment in the Phase 2 study of CM24 was accelerated and the Company’s plan to enroll approximately 60 patients is expected to be completed soon, ahead of schedule. Since OS and PFS are event-based endpoints, a meaningful estimate of the endpoint can be achieved once sufficient events occur in the study arms. We expected this to happen in 2024 when enough PFS and OS events are registered and enable meaningful data interpretation for a larger number of patients. The acceleration allows the Company to reduce the total cost of the trial and to report, possibly earlier than expected, an interim OS analysis, the study’s primary endpoint, together with the analysis of PFS during 1H 2024. The randomized Phase 2 study (NCT04731467), in clinical collaboration with Bristol Myers Squibb (BMS), is evaluating CM24 in combination with BMS’s nivolumab plus chemotherapy in PDAC patients as a second line treatment as compared to chemotherapy alone.
New biomarker data for CM24 were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference: Pancreatic Cancer in a scientific poster titled "Phase 1 Study of CM24 in Combination with Nivolumab in Patients with Advanced Pancreatic Cancer – Survival, Exploratory Biomarkers and Effect on Neutrophil Extracellular Traps (NETs)". The study showed a high expression of CEACAM1, CM24’s target, on neutrophils and Neutrophil Extracellular Traps (NETs), and that there are enhanced levels of serum NETs in PDAC patients. This study demonstrated for the first time that CM24 treatment significantly reduced the level of NET marker in patients’ serum, suggesting CM24’s novel mechanism of action (MOA) in treating pancreatic cancer.
● NT219 Positive Phase 1/2 Interim Results in Head & Neck Cancer
o Anti-tumor activity with confirmed partial responses in highest, to date, dose cohort
o Phase 2 study is being designed
o Fortified IP protection with new patent
Initial anti-tumor activity was demonstrated at the 50mg/kg dose level of NT219 at 50mg/kg in combination with cetuximab in the Phase 1 dose escalation study. A dose-dependent increase in drug exposure of NT219 was reported and target engagement was observed in tumor samples, with 2 of the 4 evaluable recurrent and metastatic squamous cell carcinoma of the head and neck patients dosed at 50mg/kg demonstrated confirmed partial response.
A new patent was granted in China for NT219’s pharmaceutical composition. The new patent protects the method which prevents the conversion of NT219 from its active form to a less active form and supports maintenance of the active form during manufacturing, storage, and handling until administered to the patient.
Financial Results for the three Months Ended September 30, 2023
Research and Development Expenses were $4.6 million, an increase of $1.1 million, or 31.43%, compared to $3.5 million in the same period of 2022. The increase was mainly due to clinical trials expenses in our CM24 study.
Selling, General and Administrative Expenses were $1.2 million, a decrease of $0.4 million, or 25%, compared to $1.6 million in the same period of 2022. The decrease was mainly due to a decrease in share based payment expenses.
Operating Loss was $5.7 million, an increase of $0.7 million, or 14%, compared to $5.0 million in the same period of 2022. The increase was mainly due to the increase in research and development expenses.
On a non-IFRS basis (as reconciled below), adjusted operating loss was $5.3 million, an increase of $0.9 million, compared to $4.4 million in the same period of 2022.
Net Loss for the three months ended September 30, 2023 was $5 million, or $0.23 per basic and diluted ADS, compared to a net loss of $4.8 million, or $0.27 per basic and diluted ADS, in the three months ended September 30, 2022. Adjusted net loss for the three months ended September 30, 2023 was $4.6 million, an increase from $4.1 million in the three months ended September 30, 2022.
Financial Results for the Nine Months Ended September 30, 2023
Research and Development Expenses were $11.8 million, an increase of $0.3 million, or 2.6%, compared to $11.5 million in the same period of 2022. The increase was mainly due to clinical trials expenses in our CM24 study offset by lower CMC costs in 2023.
Selling, General and Administrative Expenses were $4.2 million, a decrease of $0.3 million, or 6.67%, compared to $4.5 million in the same period of 2022. The decrease was mainly due to a decrease in share base payment and insurance costs.
Operating Loss was $16 million, compared to $16 million in the same period of 2022.
On a non-IFRS basis (as reconciled below), adjusted operating loss was $14.3 million, a decrease of $0.1 million, compared to $14.4 million in the same period of 2022.
Net Loss for the nine months ended September 30, 2023 was $15.1 million, or $0.72 loss per basic and diluted ADS, compared to a net loss of $15.7 million, or $0.87 loss per basic and diluted ADS, in the same period of 2022. The decrease in net loss was mainly due to an increase of $0.6 million in finance income. Adjusted net loss for the nine months ended September 30, 2023 was $13.4 million, a decrease from $14.1 million in the nine months ended September 30, 2022.
As of September 30, 2023, the Company had $15.9 million in cash, cash equivalents and short-term deposits. In October 2023 the Company raised an additional gross amount of $5 million which extended the cash runway to the second half of 2025.
During the nine months ended September 30, 2023, the Company sold, under the Open Market Sale Agreementsm with Jefferies LLC, approximately 1,040 thousand ADSs, at a weighted average price of $1.499 per ADS. Net proceeds to the Company, were approximately $1.5 million, net of direct issuance expenses.