DALLAS - Lantern Pharma Inc. (NASDAQ: LTRN) has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to their investigational drug candidate LP-184, also known as STAR-001, for the treatment of Glioblastoma (GBM), a serious brain cancer. This designation is aimed at expediting the review of new drugs that address unmet medical needs in serious conditions.
LP-184 is currently undergoing a Phase 1A clinical trial to assess its safety and tolerability across a broad range of solid tumors, including GBM. The drug candidate was developed using Lantern Pharma's artificial intelligence platform, RADR®, which includes over 100 billion data points to help identify mechanisms that could be exploited to target difficult-to-treat cancers.
Glioblastoma impacts nearly 13,000 U.S. adults each year and about 300,000 globally. The current standard of care for GBM patients has a median survival time of less than 15 months, with a high mortality rate. LP-184 has been shown in preclinical studies to be effective in GBM models, regardless of the MGMT gene expression status, which is associated with resistance to the current standard GBM treatment, temozolomide.
Lantern Pharma's CEO, Panna Sharma, expressed confidence that LP-184 could meet the critical need for effective GBM treatments and highlighted its potential in addressing challenges in aggressive CNS cancers.
The company plans to progress LP-184 as STAR-001 through its subsidiary, Starlight Therapeutics, targeting GBM and other CNS and brain cancers. A Phase 1b/2a clinical trial for recurrent GBM is planned to start in late 2024 or early 2025, focusing on safety, pharmacokinetics, and preliminary efficacy. Furthermore, the company intends to use RADR® to explore LP-184's suitability in combination with other approved agents for cancer control in various patient subgroups.
Lantern Pharma leverages its proprietary AI platform to accelerate the development of its pipeline of cancer therapies, aiming to transform the cost and pace of oncology drug discovery and development. The company's approach has been to advance drug programs from AI insights to clinical trials within 2-3 years, with a focus on both solid tumors and blood cancers.
The information in this article is based on a press release statement from Lantern Pharma Inc.
In other recent news, Lantern Pharma has received three new rare pediatric disease designations (RPDD) from the U.S. Food and Drug Administration for its investigational drug, LP-184. The designations aim to combat malignant rhabdoid tumors, rhabdomyosarcoma, and hepatoblastoma, supplementing a previous RPDD for atypical teratoid rhabdoid tumors. Lantern Pharma has also made significant strides in cancer therapy, developing a diagnostic tool for LP-184, and confirming PTGR1 as a key biomarker.
The company has also obtained a Japanese patent for its drug candidate LP-284, following a U.S. patent awarded in April 2023. Lantern Pharma received regulatory clearance to conduct Phase 2 clinical trials of its drug LP-300 in Japan and Taiwan, focusing on non-small cell lung cancer in never-smokers.
On the financial front, despite reporting a net loss of $4.2 million for Q4 and $15.96 million for the full year of 2023, Lantern Pharma maintained a strong cash position of approximately $41.3 million. The company's research and development expenses rose to $11.9 million in 2023, driven by increased research and payroll costs. These are some of the recent developments revolving around Lantern Pharma.
InvestingPro Insights
As Lantern Pharma (NASDAQ: LTRN) advances its promising LP-184 drug candidate for Glioblastoma treatment, investors might benefit from a closer look at the company's financial health. According to InvestingPro data, Lantern Pharma's market capitalization stands at $38.21 million, reflecting its current position as a small-cap biopharmaceutical company.
InvestingPro Tips reveal that Lantern Pharma holds more cash than debt on its balance sheet, which could be crucial for funding its ongoing clinical trials and research. This financial cushion may provide some reassurance to investors concerned about the company's ability to support its drug development pipeline.
However, it's important to note that the company is quickly burning through cash, a common characteristic of biotech firms in the development stage. This is further evidenced by the fact that Lantern Pharma is not profitable over the last twelve months, with a negative P/E ratio of -2.15.
The stock's price movements are quite volatile, which is typical for small-cap biotech companies, especially those awaiting critical clinical trial results or regulatory decisions. This volatility is reflected in the company's price performance, with a 1-year price total return of 7.9%, but a 6-month return of -40.54%.
Analysts do not anticipate the company will be profitable this year, which aligns with the nature of early-stage pharmaceutical companies investing heavily in R&D. The next earnings date is set for October 30, 2024, which may provide more insights into the company's financial trajectory and progress with LP-184.
For investors seeking a more comprehensive analysis, InvestingPro offers 10 additional tips for Lantern Pharma, providing a deeper understanding of the company's financial position and market performance.
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