FOSTER CITY, Calif. - Notable Labs, Ltd. (NASDAQ: NTBL), a precision oncology company, has announced the FDA's clearance to proceed with a Phase 2 clinical trial of volasertib for patients with relapsed refractory acute myeloid leukemia (R/R AML). The trial, which began startup activities earlier this year, is set to commence enrollment in the coming months following the recent agreement on the dosing plan.
The Phase 2 study of volasertib, in combination with decitabine, aims to address the unmet needs of patients with R/R AML, particularly those who have not responded to first-line treatments, including venetoclax-based therapies. Thomas Bock, M.D., CEO of Notable, expressed optimism about the trial's potential to improve patient outcomes and tolerability.
Informed by clinical validation trials at prestigious institutions and data from the drug's originator, Boehringer Ingelheim, Notable's study design incorporates a dose optimization lead-in, body-surface area dosing, and prophylactic antibiotics. The trial will selectively enroll patients predicted to respond to treatment based on Notable's Predictive Medicine Platform (PMP).
The company expects to initiate dosing of the first subjects soon and anticipates initial data from the dose optimization phase by the fourth quarter of 2024. Subsequent selective enrollment of PMP-predicted responders will follow, with initial efficacy results expected in the first half of 2025.
Volasertib, a PLK-1 inhibitor, has shown activity in AML and other tumor types. Notable has obtained exclusive worldwide development and commercialization rights for volasertib, with the exception of certain rare pediatric cancers. The company's PMP is central to its targeted in-licensing strategy, aiming to predict patient responses to therapies and fast-track clinical development.
InvestingPro Insights
As Notable Labs, Ltd. (NASDAQ: NTBL) gears up for a crucial Phase 2 clinical trial for volasertib, the financial health and market sentiment surrounding the company provide additional context for investors. According to InvestingPro data, Notable Labs holds a market cap of 6.31 million USD, reflecting the size and scale of the company in the biotech landscape.
One of the key metrics that stands out is the company's Price / Book ratio for the last twelve months as of Q1 2024, which is 0.55. This suggests that the stock may be undervalued relative to the company's book value, potentially offering an attractive entry point for value investors. Additionally, the Revenue Growth for the same period is an impressive 3787.5%, indicating a significant increase that may be a positive sign for the company's future prospects.
However, it is essential to note that Notable Labs is currently not profitable, as reflected in the P/E Ratio (Adjusted) of -0.72 for the last twelve months as of Q1 2024. This aligns with one of the InvestingPro Tips which highlights that the company has not been profitable over the last twelve months. Moreover, despite the company's liquid assets exceeding short-term obligations, another tip points out that Notable Labs is quickly burning through cash, which could raise concerns about its long-term financial sustainability without successful product development and commercialization.
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