FOSTER CITY, Calif., April 12, 2024 (GLOBE NEWSWIRE) — Notable Labs, Ltd. (Nasdaq: NTBL) (“Notable” or the “Company”) is a clinical-stage precision oncology company. We are developing new cancer treatments. The company's Predictive Precision Medicine Platform (PPMP) reported financial results for the year ended December 31, 2023, providing an update on its business.
“Last year was a big year for Notable. We built a strong clinical validation dataset, starting with a poster presented at the American Association for Cancer Research (AACR 2023). We completed the reverse merger and became a publicly traded company. We also reported successful PPMP clinical data from our Phase 2 fociclopirox trial and our platform's ability to accurately predict patient outcomes for certain treatments. ,” said Thomas Bock, MD, Notable's chief executive officer. “Thanks to the performance of our platform in accurately predicting the outcome of the fociclopirox trial, we are pleased to announce that our lead product candidate, volasertib, in development for patients with relapsed/refractory acute myeloid leukemia (r/r AML) We were able to enhance our clinical trial design. Future Phase 2 trials will utilize this platform to enrich study enrollment of patients predicted to respond to volasertib, allowing for faster We believe this will enable enrollment, reduce the time to efficacy data, and ultimately increase the probability of success.”
Dr. Bock further commented: “Looking to the future, we plan to significantly advance our volasertib clinical program in 2024 and further validate the potential of PPMP as a precision medicine tool. Abstracts related to this program will be presented this week at AACR 2024. We are pleased with the results and look forward to providing additional data in the coming months.”
Dr. Joseph Wagner, Notable's chief scientific officer, added: Our study will incorporate key findings from previous studies conducted by Boehringer Ingelheim, the originator of volasertib, and that the standardization of best supportive care and the introduction of dosing based on body surface area will improve patient response. This suggests that it is likely to improve tolerability. We plan to include and evaluate these improvements in a small-scale all-comer dose optimization implementation before enrolling predicted responders in the PPMP. The open-label design of our Phase 2 study allows us to provide ongoing updates and enable us to begin our next Phase 3 study as early as possible. ”
Recent and upcoming milestones:
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Two poster presentations at AACR2024: April 8 and 9, 2024
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Volasertib: Starting with a dose optimization prelude and advancing the Phase 2 program
Financial results for the fiscal year ending December 2023
Total cash and cash equivalents (cash) As of April 1, 2024, Notable had cash and cash equivalents of $8.2 million. Based on our current cash position and our planned expense performance rates, we believe our current cash balances are sufficient to support our planned expenses, obligations and capital expenditure requirements through the fourth quarter of 2024.
total net revenue Includes revenue from diagnostic services performed exclusively as an outsourced provider. Total net revenue for the year ended December 31, 2023 was $300,000.
Total cost of service Concerns the cost of processing diagnostic tests on clinical samples. Total service costs for the year ended December 31, 2023 were $0.2 million.
Research and development expenses Revenues for the year ended December 31, 2023 were $4.7 million, compared to $7.8 million in 2022, due to lower engineering costs required to support the PPMP platform and the Reflects lower testing costs for volasertib.
General and administrative expenses Full-year 2023 sales were $10.1 million compared to $5.2 million in 2022. This primarily reflects increased third-party costs related to the merger, which closed in October 2023, and increased costs associated with being a public company, including directors and officers insurance (D&O). ) and stock-based compensation.
Other income (expenses), net Other income for the full year 2023 increased to $3.4 million net from an expense of $1.5 million in 2022. This increase was primarily due to losses on conversion of Series D SAFEs and increases in the derivative fair value of Series D SAFEs. Series C SAFE and Redeemable Convertible Preferred Stock Warrant Liability.
Net loss in 2023 Net loss for the year ended December 31, 2023 was ($14.4 million), or a net loss of ($14.4 million), or a loss of (3.41) per share on an underlying and diluted basis, or a loss of (1,130) per share. million dollars). (21.97) per share on an basic and diluted basis for the year ended December 31, 2022.
Number of issued shares As of April 1, 2024, there were approximately 9 million people.
About volasertib
Volasertib is a PLK-1 inhibitor with demonstrated activity in AML and other tumor types, including solid tumors, where there is significant unmet medical need. Based on volasertib's performance in PPMP, which is an important and unique step in Notable's targeted implementation strategy and decision-making, Notable is leveraging PPMP to predict volasertib-responsive patients prior to treatment and improve predicted volasertib responsiveness. The goal is to selectively enroll and treat patients who have Increase the number of responders, increase response rates and overall patient outcomes for volasertib, and fast-track the remaining clinical development of volasertib in this patient population. Volasertib was originally developed and manufactured by Boehringer Ingelheim and previously received breakthrough therapy designation by the FDA. Notable volasertib was introduced and received exclusive worldwide development and commercialization rights, except for certain rare childhood cancers.
About Notable Labs Inc.
Notable Labs, Ltd. is a clinical-stage platform therapeutics company developing predictive precision medicine for cancer patients. Through his proprietary Predictive Precision Medicines Platform (PPMP), Notable aims to predict whether a patient is likely to respond to a particular treatment. PPMP is designed to identify and select clinically responsive patients prior to treatment, allowing rapid clinical development. By continually advancing and expanding the scope of his PPMP across diseases and predicted medical outcomes, Notable is becoming a leader in predictive precision medicine and changing the way patients seek and receive the treatments that are best for them. We aim to start a revolution.
Notable believes that it has developed a targeted, risk-free introduction strategy to deliver the medical efficacy and commercial value of its products faster and with an increased likelihood of success than traditional drug development. . Notable aims to have a dramatic positive impact on patients and the medical community by transforming historic standards of care. Notable is headquartered in Foster City, California. For more information, please visit our website and follow @notablelabs.
Forward-looking statements
This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. This includes, but is not limited to, statements, express or implied, regarding Notable's future business and goals. the potential benefits of Notable's therapeutic candidates or platform technology; the timing of clinical milestones for Notable's therapeutic candidate; The company's cash runway. Other statements that are not historical facts. All statements other than statements of historical fact contained in this communication are forward-looking statements. These forward-looking statements are made as of the date they are first issued and are based on current expectations, estimates, projections, projections and management's beliefs and assumptions. Forward-looking statements involve a number of risks and uncertainties, many of which involve factors and circumstances beyond Notable's control. Notable's actual results may be affected by forward-looking statements due to a number of factors, including, but not limited to: (i) uncertainties associated with Notable's platform technology and risks associated with clinical development and regulatory approval; Results may differ materially from those stated or implied. product candidate information, including potential delays in the initiation, enrollment and completion of clinical trials; (ii) risks related to Notable's inability to obtain sufficient additional capital to continue advancing these product candidates and preclinical programs; (iii) uncertainties in achieving successful clinical results for our product candidates and unanticipated costs that may arise therefrom; (iv) risks associated with the inability to realize value from product candidates and preclinical programs under development and anticipated to be developed, given the inherent risks and difficulties associated with bringing product candidates to market; (v) risks related to Notable's future financial and operating results, including its ability to achieve profitability; (vi) Notable's ability to retain key personnel; (vii) Notable's ability to manage its requirements as a public company; (viii) uncertainty regarding the Israel-Hamas war; (ix) Noble's ability to obtain orphan drug designation for its drug candidates, and the benefits associated therewith; (x) Notable's inability to obtain regulatory approval for any of its drug candidates; (xi) changes or additions to international, federal, state, or local legal requirements, including changes or additions to tax laws or rates, drug regulations, and other regulations; As a result of these risks and uncertainties, actual results or the timing of events may differ materially from those anticipated in the forward-looking statements. These and other risks and uncertainties are described in more detail in our periodic filings with the Securities and Exchange Commission (the “SEC”). This includes the factors listed in the section titled “Risk Factors” in the renowned institute's annual report on Form 10-K. , Ltd. for the year ended December 31, 2023 and other subsequent filings with the SEC. You should not place undue reliance on these forward-looking statements, which are made only as of the date hereof or as of the date indicated in the forward-looking statements. Notable disclaims any forward-looking statements contained herein to reflect changes in its expectations regarding the forward-looking statements contained herein or to reflect changes in events, conditions or circumstances on which such statements are based. We expressly disclaim any obligation or undertaking to publish any updates or corrections to any statement regarding.
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