On March 5, 2024 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 fourth quarter and full year ended December 31, 2023 (Press release, Purple Biotech, MAR 5, 2024, View Source [SID1234640789]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"Our two lead oncology candidates, CM24 and NT219, designed to overcome tumor immune evasion, made significant clinical progress over the past year in difficult to treat indications, positioning them well as potential second line treatments in pancreatic and head and neck cancer. The acquisition last year of our conditionally activated T cells and NK cell engagers platform strongly positions us with a very promising and differentiated approach to cancer treatment, as multi-specifics have garnered increasing industry attention. We look ahead to key data read outs in 2024, backed by a cash runway to take us well into the first half of 2025," stated Gil Efron, Chief Executive Officer of Purple Biotech.
2023 and Recent Clinical & Corporate Highlights:
● CM24 as 2nd Line Treatment for Pancreatic Ductal Adenocarcinoma (PDAC) Data Upcoming
o Phase 2 PDAC study completed enrollment ahead of schedule in 2023
o Interim data expected H1 2024 and topline data expected H2 2024
o CM24 biomarker data presented at AACR (Free AACR Whitepaper) support PDAC indication
The Company’s Phase 2 study for CM24, a multi-functional immune checkpoint inhibitor, dosed its first PDAC patient in February 2023 and completed enrollment of approximately 60 patients ahead of schedule in December of 2023 through 18 centers in the U.S., Spain and Israel. The Phase 2 study (NCT04731467) is evaluating CM24 in combination with Bristol Myers Squibb’s nivolumab plus chemotherapy in PDAC patients as a second line treatment as compared to standard of care chemotherapy alone.
The primary endpoint is overall survival (OS). Interim data are expected in H1 2024, with topline data expected to follow in H2 2024.
At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on pancreatic cancer, Purple Biotech presented new potential PDAC biomarker data for CM24. The data showed potential association of a high expression of CEACAM1 on tumor infiltrating lymphocytes, CM24’s target, with treatment outcomes and decrease in Neutrophil Extracellular Traps (NETs) marker following treatment with CM24, in PDAC patients. This demonstrated the potential of CM24’s novel mechanism of action (MOA) in treating pancreatic cancer.
● NT219 as 2nd Line Treatment for Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN) Phase 2 is Planned
o R/M SCCHN positive results reported at ESMO (Free ESMO Whitepaper)-TAT Congress 2024 from Phase 1 study demonstrating NT219 activity and safety profile
o Recommended Phase 2 Dose achieved; Phase 2 study is planned to commence in H1 2024
o Preclinical data reported at AACR (Free AACR Whitepaper) supports synergy with checkpoint inhibitors
In a Phase 1 dose escalation study (NCT04474470) of NT219, a first-in-class small molecule dual inhibitor of IRS 1/2 and STAT3, Purple Biotech determined 100mg/kg as the recommended Phase 2 dose for NT219 in combination with Erbitux (cetuximab) in the treatment of R/M SCCHN. Detailed results from the study were presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Targeted Anticancer Therapies (ESMO TAT) Congress 2024 in Paris. Safety profile was well tolerated and manageable. Of the 7 evaluable R/M SCCHN patients treated at the highest doses of 50 and 100mg/kg, the tumor objective response rate (ORR) was 29% and the disease control rate (DCR) was 71%, both highly encouraging results. Median follow-up across all dose levels was 9.4 months as of the cutoff date (95% CI: 3.4-10.0, 8 out of 15 patients remaining in follow up).
A Phase 2 study of NT219 in combination with cetuximab as a second line treatment for R/M SCCHN is planned to commence in H1 2024. The Company is supported by its newly formed Head and Neck Cancer Scientific Advisory Board, which provided us their guidance on clinical studies for NT219 in combination with cetuximab as a second line treatment and potentially in combination with a PD1 inhibitor as a first line treatment.
At the AACR (Free AACR Whitepaper) Annual Meeting 2023 in Orlando, Florida, results presented from a preclinical study demonstrated the potential of NT219 to work synergistically with either anti-PD1 or anti-CTLA4 drugs to reprogram the immune profile in the tumor microenvironment and convert resistant tumors to responders. The study was led by researchers at The University of Texas MD Anderson Cancer Center.
● Tri-Specific Conditionally Activated Immuno-Engagers Oncology Platform Acquired
o First asset expected to be IND ready in approximately two years
o Lead tribody target 5T4 is highly expressed in multiple cancers
o Preclinical data validate cancer cell killing effect
In February 2023, Purple Biotech acquired a platform of conditionally activated T cell and NK cell engagers that selectively activate immune response within the tumor microenvironment. The platform’s lead tribody in development, IM1240, which is expected to be ready for an Investigational New Drug (IND) filing with the U.S. Food and Drug Administration in approximately two years, targets the antigen 5T4 to induce a strong immune system response against cancer cells. 5T4 is highly expressed on certain tumors and correlates with poor prognosis.
Financial Results for the Year Ended December 31, 2023
Research and Development Expenses were $17 million, an increase of $0.7 million, or 4.3%, compared to $16.3 million in 2022. The increase was mainly due to expenses related to the ongoing NT219 and CM24 clinical trials, including chemistry, manufacturing and controls (CMC) expenses.
Selling, General and Administrative Expenses were $5.2 million, compared to $6.3 million in 2022, a decrease of $1.1 million mainly due to a decrease in salary, insurance and share based payment expenses.
Operating Loss was $22.3 million, a decrease of $0.3 million, or 1.3%, compared to $22.6 million 2022. The decrease was mainly due to the decrease in selling, general and administrative expenses offset by the increase in research and development expenses.
Finance income for 2023 was $2.3 million, an increase of $1.5 million, or 188%, compared to $0.8 million in 2022. The increase was mainly due to the change in the fair value valuation of warrants.
On a non-IFRS basis (as reconciled below), adjusted operating loss was $20.4 million, an increase of $0.2 million, compared to $20.2 million in 2022, mainly due to the increased operating loss of $0.3 million offset by decrease in share based payment expenses of $0.5 million.
Net Loss for 2023 was $20 million, or $0.90 per basic and diluted share, compared to a net loss of $21.8 million, or $1.20 per basic and diluted share, in 2022. The decrease in net loss was mainly due to the increase in finance income and decrease in selling, general and administrative expenses. Adjusted net loss for 2023 was $22.1 million, an increase from $19.6 million in the full year of 2022.
As of December 31, 2023, Purple Biotech had cash and cash equivalents and short-term deposits of $15.3 million, compared to $31.7 million on December 31, 2022. This cash position provides a cash runway into the first half of 2025.
During the year ended December 31, 2023, the Company sold, under the Open Market Sale Agreement with Jefferies LLC, approximately 1,044,000 ADSs, at an average price of $1.63 per ADS. Net proceeds to the Company were approximately $1.5 million, net of issuance expenses.
Financial Results for the Three Months Ended December 31, 2023
Research and Development Expenses were $5.2 million, an increase of $0.4 million, or 8.3%, compared to $4.8 million in the same period of 2022. The increase was mainly due to expenses related to the CM24 and NT219 clinical trials.
Selling, General and Administrative Expenses were $1 million, compared to $1.8 million in the same period of 2022, a decrease of $0.8 million, mainly due to salary and share based payment expenses.
Operating Loss was $6.3 million, a decrease of $0.3 million, or 4.5%, compared to $6.6 million in the same period of 2022.
On a non-IFRS basis (as reconciled below), adjusted operating loss was $6.0 million, an increase of $0.2 million, compared to $5.8 million in the same period of 2022, mainly due to an increase in research and development expenses.
Finance income for the three months ended December 31, 2023 was $1.4 million, an increase of $0.8 million, or 133%, compared to $0.6 million in the same period of 2022. The increase was mainly due to the change in the fair value evaluation of warrants.
Net Loss for the three months ended December 31, 2023 was $4.9 million, or $0.19 per basic and diluted share, compared to a net loss of $6.0 million, or $0.33 per basic and diluted, in the three months ended December 31, 2022. The decrease in net loss was mainly due to an increase in financial income from financial instruments.
Adjusted net loss for the three months ended December 31, 2023 was $8.1 million, an increase from $5.4 million in the same period of 2022.