On November 15, 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 nine months ended September 30, 2024 (Press release, Purple Biotech, NOV 15, 2024, View Source [SID1234648443]).
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"Marking what we believe to be the most significant value-driving event for Purple Biotech’s clinical programs to date, we are on track to complete CM24’s Phase 2 study in pancreatic cancer and report topline results by the end of this year," stated Purple Biotech’s CEO, Gil Efron. "The interim Phase 2 CM24 data released so far demonstrated efficacy, and new biomarker data indicate potential to further improve outcomes in a future study through the use of one or more serum biomarkers for patient selection. This would position CM24 as a potentially promising CEACAM1 and Neutrophils Extracellular Trap (NET) targeted therapy. While we advance CM24 as a second line treatment for pancreatic cancer, we are planning to address additional unmet needs in other indications based on CM24’s demonstrated mechanism of action in our Phase 2 study. Our cash runway now extends into the fourth quarter of 2025. We continue to advance our clinical assets and believe we will be soon well positioned for partnerships across our pipeline."
Q3 2024 and Recent Clinical & Corporate Highlights:
● Phase 2 CM24 pancreatic cancer study on track for conclusion with topline data expected in 2024: Serum biomarkers may improve outcomes in future studies
New positive biomarker findings for CM24, a multi-functional CEACAM1 inhibitor, were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Advances in Pancreatic Cancer Research in a poster titled "Exploratory biomarker evaluation of the randomized Phase 2 cohort of CM24 in combination with nivolumab and chemotherapy in advanced/metastatic pancreatic cancer".
The summary of findings presented at AACR (Free AACR Whitepaper) include the following:
ü High CEACAM1 and low PDL1 expression in tumors, as well as their combination were identified as potential biomarkers associated with improved overall survival (OS) of pancreatic ductal adenocarcinoma (PDAC) patients (HR=0.1 and prolongation of 4.1 months in median OS, P = 0.01, for the combination), which support the CM24/nivolumab combined treatment
ü Improved OS was demonstrated for patients with selected pretreatment serum neutrophil extracellular trap (NET) marker myeloperoxidase (MPO) levels (HR=0.38 and prolongation of 3.3 months in median OS, P = 0.1), with a similar trend in patients with NET-positive tumors
ü The results presented in the poster propose NETs as a novel mechanism of action and a potential biomarker for CM24-based therapy
ü New biomarker data supports the potential for future biomarker-guided studies and the exploration of CM24’s efficacy in other cancers where the novel target CEACAM1 plays a key role in cancer progression and immune evasion.
More recent biomarker data specific to serum CEACAM1, associated with a 79% reduction in risk of death were announced by Purple Biotech in November 2024:
PDAC patients who had pretreatment serum CEACAM1 levels between 6K and 15K pg/mL demonstrated the best outcomes following treatment with CM24 and nivolumab in combination with irinotecan/fluoropyrimidine based chemotherapy compared to chemotherapy alone.
ü Median progression free survival (PFS) of this group was 4.6 months (hazard ratio [HR] < 0.1, P = 0.003)
ü Risk of death was reduced by 79% (HR = 0.21, P = 0.04)
ü Median OS increased from 3.6 months with chemotherapy alone to 8.7 months with the combination therapy.
The Phase 2 randomized study is evaluating CM24 in combination with Bristol Myers Squibb’s PD-1 inhibitor nivolumab plus standard of care (SoC) chemotherapy as a second line treatment of patients with PDAC. In the experimental arms of the study patients were treated 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 across 18 centers in the U.S., Spain and Israel. 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.
● NT219 Phase 2 study in head and neck cancer planned to commence H1 2025
A Phase 2 study of NT219, a first-in-class, small molecule dual inhibitor of IRS1/2 and STAT3, is planned to commence in the first half of 2025. The recommended Phase 2 dose of 100 mg/kg was achieved in the prior Phase 1/2 dose escalation study, which demonstrated anti-tumor activity at the target exposure level and was well tolerated in combination with cetuximab as a second line treatment of recurrent metastatic squamous cell carcinoma of the head and neck.
● CAPTN-3 tri-specific platform data presented at key molecular targets and cancer therapeutics conference
New data regarding Purple Biotech’s novel tri-specific antibody platform, CAPTN-3, were presented at the 36th European Organization for Research and Treatment of Cancer, National Cancer Institute, American Association for Cancer Research (AACR) (Free AACR Whitepaper) (EORTC-NCI-AACR) (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics (the "Triple Meeting") in a poster titled "CAPTN-3: A novel platform of conditionally activated T cell and NK cell engagers". CAPTN-3 demonstrated sustained tumor regression in a triple negative breast cancer in-vivo model as well as dose dependent activity and synergistic effect of the engager arms in non-small cell lung cancer patient-derived explants. Purple Biotech’s lead tribody candidate, IM1240, demonstrated that cytokine release is 5T4-dependent and suppressed by the conditionally activated capping technology, suggesting a potentially beneficial safety profile of this tribody. The data further demonstrated additional tribodies, suggesting CAPTN-3’s plug and play platform capability. Purple Biotech continues to accumulate data supporting the benefit of dual engagement of both T cells and NK cells
Financial Results for the Three Months Ended September 30, 2024
Research and Development Expenses were $1.3 million, a decrease of $3.3 million, or 71.7%, compared to $4.6 million in the same period of 2023, mainly due to reduced clinical trials expenses.
Sales, General and Administrative Expenses were $0.8 million, compared to $1.2 million in the same period of 2023, a decrease of $0.4 million, or 33.3%, mainly due to a decrease in salary and salary related costs and share based payment expenses.
Operating Loss was $2.1 million, a decrease of $3.6 million, or 63.2%, compared to $5.7 million in the same period of 2023, mainly due to the decrease in research and development expenses.
Adjusted Operating Loss (as reconciled below) was $2 million, a decrease of $3.3 million, compared to $5.3 million in the same period of 2023.
Net Loss for the three months ended September 30, 2024, was $0.7 million, or $0.39 per basic and diluted ADS, compared to a net loss of $5 million, or $4.63 per basic and diluted ADS, in the same period of 2023. The decrease in net loss was mainly due to the decrease in research and development 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 September 30, 2024, was $2.4 million, a decrease of $2.4 million or 50% compared to $4.8 million for the three months ended September 30, 2023.
As of September 30, 2024, Purple Biotech had cash and cash equivalents and short-term deposits of $6.3 million. Purple Biotech now has a cash runway into the fourth quarter of 2025.
During the three months ended September 30, 2024, the Company sold, under the Open Market Sale Agreement with Jefferies LLC, approximately 76 thousand ADSs, at an average price of $6.5 per ADS. Net proceeds to the Company were approximately $0.5 million, net of issuance expenses.
Financial Results for the Nine Months Ended September 30, 2024
Research and Development Expenses were $7.2 million, a decrease of $4.6 million, or 39%, compared to $11.8 million in the same period of 2023. The decrease was mainly due to reduced clinical trials expenses.
Sales, General and Administrative Expenses were $2.6 million, a decrease of $1.6 or 38.1%, compared to $4.2 million in the same period of 2023, mainly due to a decrease in salary and salary related expenses and share based payment expenses.
Operating Loss was $10 million, a decrease of $6 million, or 37.5%, compared to $16 million in the same period of 2023, mainly due to the decrease in research and development expenses.
Adjusted Operating Loss (as reconciled below) was $9.4 million, a decrease of $4.9 million, compared to $14.3 million in the same period of 2023.
Net Loss for the nine months ended September 30, 2024 was $6.9 million, or $4.57 loss per basic and diluted ADS, compared to a net loss of $15.1 million, or $14.47 loss per basic and diluted ADS, in the same period of 2023. The decrease in net loss was mainly due to a $6 million decrease in operating expenses and $3.3 million income from change in fair value of warrants.
Adjusted net loss (as reconciled below) for the nine months ended September 30, 2024 was $9.5 million, compared to $13.7 million for the nine months ended September 30, 2023.