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Purple Biotech Ltd. (NASDAQ/TASE: PPBT) is a clinical-stage company based in Rehovot, Israel, dedicated to developing innovative cancer therapies that harness the tumor microenvironment to overcome immune evasion and drug resistance. The company's oncology pipeline includes two main drug candidates, CM24 and NT219, along with a pioneering platform of conditionally-activated tri-specific antibodies.
CM24 is a multi-functional immune checkpoint inhibitor undergoing Phase 2 clinical trials for the treatment of pancreatic ductal adenocarcinoma (PDAC). This study, in collaboration with Bristol Myers Squibb, is evaluating CM24 combined with nivolumab and chemotherapy as a second-line treatment. The primary endpoint is overall survival, with interim results expected by mid-2024 and topline data by the end of the same year.
NT219 is a small molecule dual inhibitor targeting IRS1/2 and STAT3. It has shown promising results in a Phase 1/2 dose escalation study for recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). A Phase 2 study is planned for NT219 in combination with cetuximab, set to begin in the first half of 2024.
Additionally, Purple Biotech’s tri-specific antibody platform aims to conditionally activate T cells and natural killer (NK) cells within the tumor microenvironment. The platform's lead candidate, IM1240, targets 5T4, a tumor-associated antigen, and is designed to induce a localized immune response while minimizing off-tumor side effects.
Recent financial reports indicate that Purple Biotech has a solid cash runway into the first half of 2025, thanks to strategic funding and partnerships. The company’s research and development expenses have seen a slight increase due to ongoing clinical trials, while selling, general, and administrative expenses have decreased.
For more detailed information and the latest updates, visit Purple Biotech’s website.
Purple Biotech (NASDAQ/TASE: PPBT), a clinical-stage oncology company, has received a 180-day extension from Nasdaq to regain compliance with the minimum $1.00 bid price requirement. The company now has until January 21, 2025, to meet this requirement, which involves maintaining a closing bid price of at least $1.00 for its American Depositary Shares (ADSs) for a minimum of 10 consecutive business days. This extension does not immediately affect Purple Biotech's listing on Nasdaq or the Tel Aviv Stock Exchange. The company will monitor its ADS price and consider options to regain compliance within the given timeframe.
Purple Biotech (NASDAQ/TASE: PPBT) will host a virtual event on July 11, 2024, to discuss positive interim results from its Phase 2 study of CM24 in treating second-line metastatic pancreatic ductal adenocarcinoma (PDAC). The event will feature key opinion leaders Dr. Michael Cecchini from Yale School of Medicine and Dr. E. Gabriela Chiorean from the University of Washington School of Medicine. They will present data showing a reduction in the risk of death and disease progression, improved overall survival (OS) and progression-free survival (PFS), higher objective response rate (ORR), and disease control rate (DCR). The study also revealed that baseline serum myeloperoxidase (MPO) might be a predictive biomarker for the treatment's effectiveness. CM24, combined with nivolumab and standard chemotherapy, showed promising results. Management will outline future plans for CM24, followed by a Q&A session.
Purple Biotech announced the closing of an exercise of existing warrants, resulting in gross proceeds of approximately $2 million. The company issued new unregistered Series A-1 and A-2 warrants in consideration for the exercise of the existing ones.
The new warrants are exercisable immediately, with varying terms of twenty-four months to five years, and an exercise price of $0.40 per ADS. Net proceeds will fund oncology therapeutic candidates' development and general corporate purposes.
Purple Biotech announced the exercise of existing warrants, generating approximately $2 million in gross proceeds. The exercised warrants, initially priced between $1.25 to $20.00 per ADS, were reduced to $0.36 per ADS. This exercise involves 5,633,509 ADSs. In return, Purple Biotech will issue new Series A-1 and A-2 warrants, allowing the purchase of an additional 4,979,383 and 6,287,635 ADSs at $0.40 per ADS. The A-1 warrants have a five-year term, and the A-2 warrants have a 24-month term. The proceeds will fund oncology therapeutic development and general corporate purposes. The offering is compliant with regulatory standards, closing expected by July 2, 2024, with H.C. Wainwright & Co. as the exclusive placement agent.
Purple Biotech announced positive interim results from its Phase 2 pancreatic cancer study with CM24, nivolumab, and standard chemotherapy. The data, presented at the 2024 ASCO meeting, showed a 26% reduction in death risk and a 28% reduction in progression or death risk in the CM24 combination arm versus standard chemotherapy alone. Median overall survival (OS) was extended by 2.1 months, and median progression-free survival (PFS) was extended by 1.9 months. Additionally, the study found higher objective response rates (25% vs 7%) and disease control rates (63% vs 40%) in the combination arm. Baseline serum myeloperoxidase (MPO) levels may predict survival improvement. Further results are expected in the second half of 2024, with a KOL event scheduled for July 11, 2024.
Purple Biotech announced interim data from its Phase 2 study of CM24 in combination with nivolumab and standard-of-care (SoC) chemotherapy for second-line metastatic pancreatic cancer (PDAC) at ASCO 2024.
The results show a 26% reduction in the risk of death and a 28% reduction in risk of progression or death. Patients treated with CM24+nivolumab+SoC had a median overall survival of 7.72 months compared to 5.62 months with SoC alone.
Additionally, the combination therapy resulted in a 1.9-month improvement in median progression-free survival. The objective response rate (ORR) and disease control rate (DCR) were also higher in the experimental arm (25% and 63%, respectively) compared to SoC (7% and 40%).
The study enrolled 63 patients across 18 centers in the U.S., Spain, and Israel. The investigational therapy was well-tolerated with manageable side effects. Topline final data is expected by the end of 2024.
Purple Biotech announced its Q1 2024 financial results. Key highlights include interim Phase 2 data for CM24 in pancreatic cancer to be presented at ASCO 2024, suggesting a reduced risk of disease progression and death. Topline data expected in Q4 2024. Positive efficacy data for NT219 in head and neck cancer were presented at ESMO-TAT 2024, with a Phase 2 trial planned for 2024. The company reported a net loss of $3.8 million, down from $4.9 million in Q1 2023, and operating losses decreased to $4.5 million. Purple Biotech's cash position stands at $10.8 million, providing a runway into Q1 2025. Sales, general, and administrative expenses decreased by 37.5% to $1 million.
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