On March 10, 2025 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance, reported financial results for the three and twelve months ended December 31, 2024 (Press release, Purple Biotech, MAR 10, 2025, View Source [SID1234651043]).
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"Our major value-driving milestones in 2024 included completing successful trials for both of our clinical-stage programs, CM24 and NT219, as well as expanding the body of exciting preclinical data for our CAPTN-3 tri-specific platform, supporting its differentiated benefit," stated Gil Efron, Purple Biotech CEO.
"CM24 met all of its efficacy endpoints in the randomized Phase 2 second-line pancreatic cancer trial, which also generated significant biomarker data that is now informing the design of our Phase 2b study for CM24, which we plan to initiate in the second half of 2025. As a biomarker-driven study, the Phase 2b study may evaluate CM24 across multiple oncology indications.
"Earlier in 2024, we concluded the dose escalation study for NT219, demonstrating activity in combination with cetuximab, good safety profile, and determining the recommended Phase 2 dose. This enabled us to move forward with a Phase 2 study in head and neck cancer in collaboration with the University of Colorado, which we expect will commence patient enrollment in the first half of 2025.
"We believe that our CAPTN-3 platform is well-positioned and differentiated in the T cell engagers (TCE) and multi-specific space, uniquely unleashes both innate and adaptive immune cells against the tumor, demonstrating synergistic effect of the T cell and NK cell activating arms. The unique NKG2A arm in the lead compound acts as a checkpoint inhibitor, enabling simultaneous NK and T cell activation, including effector subsets with high antitumor activity. We are excited about our CAPTN-3 collaboration with the Icahn School of Medicine at Mount Sinai. Our cash runway is expected to extend into mid-2026, providing us with the time to potentially deliver on more catalysts this year, in order to achieve our ambitious programs across all three assets.," Mr. Efron concluded.
Q4 2024 and Recent Clinical & Corporate Highlights:
● CM24 Planned to Advance into Phase 2b Study Supported by Biomarker Data
o Positive final results from randomized Phase 2 study of CM24 in second line pancreatic cancer
o Serum CEACAM1 biomarker associated with 79% reduction in risk of death
Purple Biotech reported positive final results from the randomized Phase 2 study of CM24, a humanized monoclonal antibody that blocks CEACAM1, in patients with second-line pancreatic ductal adenocarcinoma (PDAC). CM24, in combination with nivolumab and Nal-IRI/5FU/LV chemotherapy, demonstrated consistent improvements across all efficacy endpoints. The enhanced results in patients with elevated CEACAM1 and other serum markers suggest that selecting a biomarker-enriched patient population could further enhance CM24’s efficacy, potentially positioning it as a treatment for multiple CEACAM1-expressing malignancies in line with its mechanism of action. A biomarker-enriched patient population analysis based on pretreatment serum CEACAM1 levels demonstrated a significant improvement in the treatment arm over the control arm, with a 79% reduction in risk of death (HR 0.21, p = 0.04), a median overall survival (OS) improvement of 5.1 months, and over 90% reduction in the risk of progression or death (HR < 0.1, p = 0.003), with a median progression-free survival (PFS) improvement of 2.9 months and improvement in the objective response rate (ORR) of 50% in the treatment arm compared to 0% in the control arm.
Additional biomarker analysis revealed statistically significant results for 80% of the patients (24 out of 30) with serum CEACAM1 (5-16K pg/mL) or serum NET marker myeloperoxidase (MPO) (200-600 ng/mL) demonstrating 61% reduction in the risk of death (HR 0.39, p= 0.039) and 72% reduction in the risk of progression or death (PFS HR 0.28, P 0.006) following treatment with CM24 and nivolumab in combination with Nal-IRI/5FU/LV chemotherapy compared to same chemotherapy alone. In addition, median PFS increased by 2.2 months, and median OS increased by 2.4 months, from 5.5 months with chemotherapy alone to 7.9 months with the combination therapy.
● NT219 Advances into Phase 2 Head and Neck Cancer Trial
o Includes treatment arm of NT219 which we combine for the first time with pembrolizumab (Keytruda) immunotherapy, as well as expansion arm of NT219 combined with cetuximab
o Collaboration with University of Colorado
o Latest patent in U.S. enhances global IP protection
The Phase 2 study will evaluate the efficacy and safety of NT219 which we combine for the first time with standard-of-care checkpoint inhibitors, such as pembrolizumab (Keytruda), for the treatment of recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) and in combination with epidermal growth factor receptor (EGFR) blockers, such as cetuximab (Erbitux), which demonstrated activity in Purple Biotech’s Phase 1 dose escalation study. The Phase 2 study, expected to begin in the first half of 2025, is designed with two single-arm cohorts: one will evaluate NT219 in combination with pembrolizumab, and the other will evaluate NT219 in combination with cetuximab for the treatment of R/M SCCHN. Additionally, the study will explore potential biomarkers identified in a previous clinical study of NT219. The investigator-initiated Phase 2 trial is led by Dr. Antonio Jimeno, Professor and Director of the Head and Neck Cancer Program at the University of Colorado Anschutz Medical Campus.
The U.S. Patent and Trademark Office issued a patent for NT219 used in combination with EGFR antibodies for treating cancer patients who have acquired resistance to EGFR therapies. This latest U.S. patent completes the geographic patent protection for NT219 used in combination with cetuximab in major markets, such as the United States, Europe, China and Japan. We believe this additional patent positions the Company well for the potential future commercialization of NT219.
● CAPTN-3 Tri-Specific Antibody Platform Preclinical Studies Advance Toward First-in-Human Clinical Trials
o New data presented at EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics
o Research collaboration with Icahn School of Medicine at Mount Sinai
New data on 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. CAPTN-3 demonstrated sustained tumor regression in a triple-negative breast cancer in-vivo model, as well as dose-dependent activity and a synergistic effect of the engager arms in non-small cell lung cancer patient-derived explants. IM1240, Purple’s lead tribody candidate, demonstrated that cytokine release is 5T4-dependent and suppressed by the conditionally activated capping technology, suggesting a potentially beneficial safety profile.
Purple Biotech entered into a Research Collaboration Agreement with the Icahn School of Medicine at Mount Sinai in New York to explore the immunoregulation of NK and T cells within the tumor microenvironment by CAPTN-3 multi-specific engagers, designed with the purpose of enhancing tumor-specific immunity against various cancer types. This collaboration offers an opportunity to deepen the understanding of tumor immune evasion mechanisms that CAPTN-3 uniquely addresses, with the goal of paving the way for effective treatments for many challenging tumor indications. Purple Biotech is working with Principal Investigator Amir Horowitz, PhD, and his team at Mount Sinai to validate the unique aspects of the CAPTN-3 design in a wide screen of patient-derived tumors, potentially providing new insights for overcoming resistance to standard frontline immunotherapies.
Financial Results for the Three Months Ended December 31, 2024
Research and Development Expenses were $0.5 million, a decrease of $4.7 million, or 90.4%, compared to $5.2 million in the same period of 2023, primarily due to reduced clinical trials expenses.
Sales, General and Administrative Expenses were $0.6 million, compared to $1.0 million in the same period of 2023, a decrease of $0.4 million, or 40%, primarily due to a decrease in salary and salary related expenses and share based payment expenses.
Operating Loss was $1 million, a decrease of $5.3 million, or 84.1%, compared to $6.3 million in the same period of 2023, primarily due to the decrease in research and development expenses.
Adjusted Operating Loss (as reconciled below) was $1 million, a decrease of $5 million, compared to $6.0 million in the same period of 2023, primarily due to the decrease in research and development expenses.
Net Loss for the three months ended December 31, 2024, was $0.4 million, or $XX loss per basic ADS and $XX loss per diluted ADS, compared to a net loss of $4.9 million, or $3.8 per basic and diluted ADS, in the same period of 2023. The decrease in net loss was primarily due to the decrease in research and development expenses.
As of December 31, 2024, Purple Biotech had cash and cash equivalents and short-term deposits of $8.2 million, providing the Company a cash runway into mid-2026.
During the three months ended December 31, 2024, the Company raised $2.8 million through a registered direct offering. In addition, during the period the Company sold approximately 298 thousand ADSs, at an average price of $3.5 per ADS, under the Open Market Sale Agreement with Jefferies LLC, resulting in net proceeds to the Company of approximately $1.5 million, net of issuance expenses.
Financial Results for the Twelve Months Ended December 31, 2024
Research and Development Expenses were $7.6 million, a decrease of $9.4 million, or 55.3%, compared to $17 million in the same period of 2023. The decrease was primarily due to reduced clinical trials expenses.
Sales, General and Administrative Expenses were $3.2 million, a decrease of $2.0, or 38.5%, compared to $5.2 million in the same period of 2023, primarily due to a decrease in salary and salary related expenses and share based payment expenses.
Operating Loss was $11 million, a decrease of $11.3 million, or 50.7%, compared to $22.3 million in the same period of 2023, primarily due to the decrease in research and development expenses.
Adjusted Operating Loss (as reconciled below) was $10.4 million, a decrease of $10 million, compared to $20.4 million in the same period of 2023, primarily due to the decrease in research and development expenses.
Net Loss for the year ended December 31, 2024 was $7.3 million, or $4.44 loss per basic ADS and $4.99 loss per diluted ADS, compared to a net loss of $20 million, or $17.96 loss per basic and diluted ADS, in the same period of 2023. The decrease in net loss was primarily due to a $11.3 million decrease in operating expenses and a $1.4 million increase in financial income net.
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. This non-IFRS measure is not based on any standardized methodology prescribed by IFRS and is not necessarily comparable to similar measures presented by other companies. Adjusted operating loss adjusts for non-cash share-based compensation expenses. The Company’s management and board of directors utilize this non-IFRS financial measure to evaluate the Company’s performance. The Company provides this non-IFRS measure of the Company’s performance to investors because management believes that this non-IFRS financial measure, when viewed with the Company’s results under IFRS and the accompanying reconciliations, is useful in identifying underlying trends in ongoing operations. However, this non-IFRS measure is not a measure of financial performance under IFRS and, accordingly, should not be considered as an alternative to IFRS measures as indicators of operating performance. Further, this non-IFRS measure should not be considered a measure 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.