Purple Biotech Ltd.

Purple Biotech Ltd, formerly Kitov Pharma Ltd, is an Israeli clinical-stage startup that creates medications to relieve pain and circumvent immune evasion and tumour growth. NT-219 and CM-24 are the company's main products. A bi-specific inhibitor of two important cancer resistance pathways, NT-219 is a tiny chemical and CM-24 is a monoclonal antibody blockin. Consensi, a fixed-dose combination of celecoxib and amlodipine besylate for the concurrent treatment of osteoarthritis pain and hypertension, is another product owned by the company.

Key Recent Business Updates

• Reports Biomarker Data from CM24 Phase 1 Dose Escalation Study (March 16, 2023): New findings from exploratory analyses carried out as part of a Phase 1 dosage escalation trial that evaluated the safety and tolerability of CM24 with nivolumab were presented by Purple Biotech Ltd. 14 patients with advanced malignancies were recruited in the trial, including 11 with pancreatic adenocarcinoma (PDAC), 2 with colorectal adenocarcinoma (CRC), and 1 with papillary thyroid cancer. The analyses performed in eight evaluable PDAC patients show that therapy with CM24 with nivolumab, both immediately and 15 days after the initial injection, results in clinically significant and long-lasting decreases in serum myeloperoxidase, a biomarker for NETs. Moreover, investigations of tumour samples taken from evaluable PDAC patients reveal that greater levels of CEACAM1+ tumor-infiltrating cells in the TME may be favourably correlated with patient survival.
• Announces First Patient Dosed in Open Label, Randomized Part of CM24 Phase 2 Clinical Trial (February 14, 2023): In the randomized portion of the open-label Phase 2 clinical study examining CM24 for the treatment of advanced metastatic pancreatic cancer, Purple Biotech Ltd. reported that the first patient had received a dosage. CM24, a brand-new, first-in-class monoclonal antibody that targets CEACAM1, which encourages tumor immune evasion, is being studied in the current Phase 2 experiment. The study's randomized comparison of standard of care (SoC) chemotherapy with SoC chemotherapy for second-line PDAC patients using CM24, the PD-1 immune checkpoint inhibitor nivolumab, and SoC chemotherapy. In this randomized Phase 2 research, which is now enrolling its first patient, Purple Biotech is treating about 30 patients in the experimental cohort and an additional 30 patients in the control group.
• Reported Full-Year 2022 Financial Results (February 08, 2023):

1. As a comparison to USD 11.8 million in the same time of 2021, research and development costs increased by USD 4.5 million, or 38.1%, to USD 16.3 million. The increase was primarily brought on by costs associated with the current clinical studies NT219 and CM24, including CMC costs.
2. Selling, General, and Administrative Costs increased by USD 0.2 million to USD 6.3 million from USD 6.1 million in the same quarter of 2021.
3. Operational Loss increased by USD 4.7 million or 26.3% to USD 22.6 million from USD 17.9 million in the same quarter of 2021. The cost of research and development increased, which was the major cause of the increase.
4. In comparison to a net loss of USD 18.5 million, or USD 1.01 per basic and diluted share, in 2021, the net loss for 2022 was USD 21.8 million, or USD 1.20 per basic and diluted share. The rise in operational costs, which totaled USD 4.5 million, was somewhat offset by a decrease in loss from discontinued operations of USD 0.6 million and an increase in finance income of USD 0.5 million.
5. Purple Biotech had USD 31.7 million in cash and cash equivalents, short- and long-term deposits as of December 31, 2022, down from USD 47.4 million on that date. The second half of 2024 can be funded using the funds in this position.
6. In accordance with the Open Market Selling Agreement with Jefferies LLC, the Company sold around 543 thousand ADSs during the year ended December 31, 2022, with an average price of USD 2.65 per ADS. After deducting issuing costs, the Company received about USD 1.3 million in net proceeds.

• Expanded Pipeline of First-in-Class Therapeutics with Acquisition of Immunorizon (February 02, 2023): The purchase of Immunorizon Ltd., a private firm creating potential multi-specific T and NK cell engager cancer medicines, was announced by Purple Biotech Ltd. Via the purchase, Purple Biotech will have access to a larger selection of experimental tri-specific antibody molecules that target many different antigens and have the potential to be expanded to more targets. The cleavable capping technology of the drug candidates Purple Biotech is acquiring distinguishes them from other multi-specific cell therapies that target 5T4+ tumors and restricts the compound's therapeutic activity to the local tumor microenvironment, potentially expanding the anticipated therapeutic window in patients. Via this technological platform, the acquisition will also provide Purple Biotech access to other preclinical assets that target different TAAs.

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