On April 12, 2024 Notable Labs, Ltd. (Nasdaq: NTBL) ("Notable" or the "Company"), a clinical-stage precision oncology company developing new cancer therapies identified by its Predictive Precision Medicine Platform (PPMP), reported financial results for the year ended December 31, 2023 and provided a business update (Press release, Notable Labs, APR 12, 2024, View Source [SID1234642037]).
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"The last year has been a time of great accomplishment for Notable. We built a strong clinical validation dataset, starting with a poster presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (AACR 2023); became a publicly listed company, following the closing of a reverse merger in October 2023; and reported successful PPMP clinical data from the Phase 2 fosciclopirox study that showcased the ability of our platform to accurately predict patient outcomes for specific therapeutics," said Thomas Bock, M.D., Chief Executive Officer of Notable. "The performance of our platform in accurately predicting the outcome of the fosciclopirox study has enabled us to enhance the clinical trial plan for our lead product candidate, volasertib, in development for patients with relapsed/refractory acute myeloid leukemia (r/r AML). In our upcoming Phase 2 trial, we will be utilizing the platform to enrich the study’s enrollment with patients predicted to respond to volasertib, which we believe will result in more rapid enrollment, shorter time to efficacy data and, ultimately, increased probability of success."
Dr. Bock commented further, "Looking ahead, we are on track to significantly advance the clinical program for volasertib in 2024 and further validate the potential for PPMP as a precision medicine tool. We are pleased that an abstract related to this program was presented this week at the AACR (Free AACR Whitepaper) 2024 and look forward to providing additional data in the coming months."
Joseph Wagner, Ph.D., Chief Scientific Officer of Notable, added, "We are enthusiastic to initiate the Phase 2 volasertib/PPMP trial in the coming months. Our study will incorporate important learnings from prior studies conducted by volasertib’s originator, Boehringer Ingelheim, which suggest that standardizing best supportive care and introducing body surface area-based dosing are likely to enhance patient responses and tolerability. We plan to include and evaluate these refinements in a small
all-comers dose optimization lead-in, prior to enrolling PPMP-predicted responders. The open label design of our Phase 2 trial will enable us to provide ongoing updates and initiate a subsequent Phase 3 trial at the earliest possibility."
Recent and Upcoming Milestones:
● Presentation of two posters at AACR (Free AACR Whitepaper)2024: April 8 and 9, 2024
● Volasertib: Advance the Phase 2 program, starting with the dose optimization prelude
Year End December 31, 2023 Financial Results
Total cash and cash equivalents (Cash) were $11.8 million as of December 31, 2023. As of April 1, 2024, Notable has cash and cash equivalents of $8.2 million. Based on its current cash position and the Company’s planned expense run rate, the Company believes that its current cash balance is sufficient to support its planned expenses, obligations and capital expenditure requirements into Q4 2024.
Total net revenue includes revenue from diagnostic services performed on a limited basis as an outsourced provider. Total net revenue for the year ended December 31, 2023 was $0.3 million.
Total cost of services relate to the costs of processing diagnostic tests of laboratory samples. Total cost of services for the year ended December 31, 2023 was $0.2 million.
Research and development expenses for the year ended December 31, 2023 were $4.7 million, compared to $7.8 million in 2022, reflecting lower engineering costs necessary to support the PPMP platform, as well as lower laboratory costs for fosciclopirox and volasertib.
General and administrative expenses for the full year 2023 were $10.1 million compared to 5.2 million in 2022, mainly reflecting increased third-party costs related to the merger completed in October 2023, as well as higher costs associated with being a public company, including Directors and Officers Insurance (D&O) and stock-based compensation.
Other Income (Expense), Net for the full year 2023 increased to $3.4 million of other income, net, from an expense of $1.5 million in 2022. The increase was primarily due to the loss on the conversion of the Series D SAFEs, the increase in the derivative fair value of the Series C SAFE and redeemable convertible preferred stock warrant liability.
Net loss for 2023 decreased to $(11.3) million, or a loss of $(3.41) per share on a basic and diluted basis, for the year ended December 31, 2023, versus a net loss of $(14.4) million, or a loss of $(21.97) per share on a basic and diluted basis, for the year ended December 31, 2022.
Outstanding shares as of April 1, 2024 were approximately 9.0 million.
About Volasertib
Volasertib is a PLK-1 inhibitor with demonstrated activity in AML and other tumor types, including solid tumors, with significant unmet medical need. Building on the performance of volasertib on PPMP, an important and proprietary step during Notable’s targeted in-licensing strategy and decision making, Notable will utilize PPMP to predict volasertib-responsive patients prior to their treatment, with the goal of selectively enrolling and treating those predicted responders, increasing volasertib’s response rates and overall patient outcomes, and fast-tracking volasertib’s remaining clinical development in this patient population. Volasertib was originally developed and manufactured by Boehringer Ingelheim and previously granted breakthrough therapy designation by the FDA. Notable in-licensed volasertib and obtained exclusive worldwide development and commercialization rights, except for certain rare pediatric cancers.