DALLAS - Lantern Pharma Inc. (NASDAQ:LTRN), a biopharmaceutical company leveraging artificial intelligence (AI) for cancer drug development, has been awarded three rare pediatric disease designations (RPDD) by the U.S. Food and Drug Administration (FDA) for its investigational drug, LP-184. The designations cover malignant rhabdoid tumors (MRT), rhabdomyosarcoma (RMS), and hepatoblastoma, adding to a previous RPDD for atypical teratoid rhabdoid tumors (ATRT).
The RPDD status is granted to drugs that treat serious or life-threatening pediatric diseases affecting fewer than 200,000 children in the U.S. This designation could lead to a Priority Review Voucher (PRV) upon FDA marketing approval, which expedites the review of a subsequent marketing application. PRVs are valuable assets that can be sold; recent sales have exceeded $100 million.
LP-184 has shown promise in preclinical models, demonstrating tumor regression and extended survival in pediatric cancers. These models are part of the Pediatric Preclinical Testing Program supported by the National Cancer Institute (NCI). LP-184 is currently in a Phase 1A clinical trial, with plans to develop future trials for pediatric patients based on findings.
Malignant rhabdoid tumors are aggressive childhood cancers affecting the kidneys and soft tissues, with approximately 35 to 50 new cases diagnosed annually in the U.S. Rhabdomyosarcoma, a cancer arising from skeletal muscle progenitor cells, is the most common soft-tissue sarcoma in children, with 250-300 new cases each year in the U.S. Hepatoblastoma is the predominant liver cancer in young children, with its incidence slowly increasing worldwide.
Lantern Pharma's CEO, Panna Sharma, expressed the company's commitment to advancing pediatric cancer therapies, highlighting the role of AI in expediting drug development. The RPDDs underscore the company's dedication to addressing rare pediatric cancers.
This news is based on a press release statement from Lantern Pharma.
In other recent news, Lantern Pharma has made considerable advancements in cancer therapy. The company has reported significant progress in developing a diagnostic tool for its cancer drug candidate, LP-184, based on qRT-PCR technology. This tool is intended to measure PTGR1 RNA levels in tumor samples, which could predict sensitivity to LP-184. Lantern Pharma has also confirmed PTGR1 as a key biomarker, a crucial step in the development of a companion diagnostic to aid in patient selection for clinical trials.
Lantern has also secured a Japanese patent for its drug candidate LP-284, designed for specific blood cancers. This follows a U.S. patent awarded in April 2023, with the company anticipating similar protections in other regions. Additionally, Lantern received regulatory clearance to conduct Phase 2 clinical trials of its drug LP-300 in Japan and Taiwan, focusing on treating non-small cell lung cancer in never-smokers.
On the financial side, Lantern reported a net loss of $4.2 million for Q4 and $15.96 million for the full year of 2023, despite maintaining a strong cash position of approximately $41.3 million. The company's research and development expenses rose to $11.9 million in 2023 due to increased research and payroll costs. As part of its future plans, Lantern intends to launch clinical trials for Starlight Therapeutics, a development for CNS cancers, in the second half of the year.
InvestingPro Insights
Lantern Pharma Inc. (NASDAQ:LTRN) has been drawing attention with its recent FDA designations, reflecting its dedication to tackling rare pediatric cancers. As the company advances its AI-driven drug development, investors are keeping a keen eye on its financial metrics and market performance. According to InvestingPro data, Lantern Pharma has a market capitalization of $42.95 million and a price-to-book ratio as of Q2 2024 of 1.39, indicating the market's valuation of the company relative to its book value.
Investors might also note the company's significant price volatility, with a six-month price total return showing a steep decline of 62.54%. This level of volatility is echoed in one of the InvestingPro Tips, which highlights that Lantern Pharma's stock price movements have been quite volatile. Another tip for investors to consider is that analysts do not anticipate the company will be profitable this year, a crucial factor when evaluating the potential for long-term investment.
Despite the challenges, Lantern Pharma holds more cash than debt on its balance sheet, which is a positive sign of the company's financial stability and could provide some reassurance to investors concerned about its cash burn and weak gross profit margins. For those interested in a deeper analysis, InvestingPro offers additional tips on Lantern Pharma, which can be found at https://www.investing.com/pro/LTRN.
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