Society of Hematologic Oncology (SOHO) session to highlight volasertib program Phase 2 volasertib AML program expected to begin in the coming months FOSTER CITY, Calif., Aug. 29, 2024 (GLOBE NEWSWIRE) -- Notable Labs, Ltd. (Nasdaq: NTBL) ("Notable", "Notable Labs" or the "Company"), a clinical-stage precision oncology company developing new cancer therapies identified by its Predictive Medicine Platform (PMP), announced that the Company will present an overview of the Phase 2 program and additional data fro ...

Thomas Bock, MD resigns as CEO; Joseph Wagner, PhD, CSO, appointed interim CEO Company affirms plan to initiate volasertib Phase 2 program in the coming months FOSTER CITY, Calif., Aug. 26, 2024 (GLOBE NEWSWIRE) -- Notable Labs, Ltd. (Nasdaq: NTBL) ("Notable", "Notable Labs" or the "Company"), a clinical-stage precision oncology company developing new cancer therapies identified by its Predictive Medicine Platform (PMP), announced that Thomas A. Bock, MD has resigned from his positions as Chief Executive Of ...

"We are pleased to report positive progress in our clinical development program to evaluate the use of volasertib, in combination with decitabine, for patients with R/R AML. Receiving FDA's clearance and agreement on a Phase 2 dosing plan positions us to move forward to activate study sites," said Thomas Bock, M.D., Chief Executive Officer of Notable. "AML remains a devastating and life-threatening unmet need, especially for patients whose disease has progressed after first-line treatment, and especially in ...

Shares of Notable Labs (NTBL) have been struggling lately and have lost 22.1% over the past week. However, a hammer chart pattern was formed in its last trading session, which could mean that the stock found support with bulls being able to counteract the bears. So, it could witness a trend reversal down the road. While the formation of a hammer pattern is a technical indication of nearing a bottom with potential exhaustion of selling pressure, rising optimism among Wall Street analysts about the future ear ...

Clinical Development - Notable's Predictive Precision Medicines Platform (PPMP) achieved a clinical response prediction accuracy of 83-100% in four independent trials[81]. - The company plans to initiate a Phase 2 trial for its lead asset Volasertib in adult acute myeloid leukemia (AML) in Q2 2024, with results expected in Q4 2024[84]. - Notable anticipates significant increases in research and development expenses as it prepares for late-stage clinical studies and regulatory approvals for Volasertib and Fosciclopirox[94]. - The company does not expect to generate product revenue until regulatory approval for Volasertib or Fosciclopirox is obtained[109]. - The company anticipates significant and increasing operating losses in 2024 as it advances clinical development efforts[109]. Financial Performance - For the three months ended March 31, 2024, Notable reported services revenue of $1 thousand, an increase from $0 in the same period of 2023[99]. - Research and development expenses for the three months ended March 31, 2024, were $1.55 million, a decrease of $46 thousand compared to $1.60 million in the same period of 2023[100]. - General and administrative expenses decreased by $1.63 million to $2.29 million for the three months ended March 31, 2024, compared to $3.92 million in the same period of 2023[98]. - The net loss for the three months ended March 31, 2024, was $3.77 million, a reduction of $2.51 million from a net loss of $6.27 million in the same period of 2023[98]. - Net loss decreased to $3.8 million from $6.3 million, a decrease of $2.5 million or 40.0% for the three months ended March 31, 2024 compared to the same period in 2023[106]. - Other income increased to $0.1 million from a net expense of $0.7 million, an increase of $0.8 million or 109.6% for the three months ended March 31, 2024 compared to the same period in 2023[105]. - Cash used in operating activities was $3.6 million for the three months ended March 31, 2024, an increase of approximately 21.8% from $2.9 million in the same period in 2023[117]. - The company has an accumulated deficit of $86.1 million as of March 31, 2024, primarily due to development efforts[107]. - Net cash used in financing activities was $0 million for the three months ended March 31, 2024, a decrease of $4.3 million from $4.3 million provided in the same period in 2023[119]. Funding and Financial Strategy - Following the merger on October 16, 2023, former Notable Labs, Inc. equity holders owned approximately 71.9% of the outstanding equity of the company[86]. - The merger was treated as a reverse recapitalization, with Notable Labs, Inc. being the accounting acquirer[87]. - The company plans to seek additional funding through public or private offerings, debt financing, or collaborations to meet operational needs[111]. - As of May 9, 2024, the company has cash and cash equivalents of $6.8 million, which is expected to finance operations through September 2024[108]. Revenue Recognition - Notable recognizes revenue from diagnostic services based on a five-step revenue recognition model[131]. - As of March 31, 2024, and December 31, 2023, Notable has not recorded any deferred revenue or contract assets[131]. - Notable has not received any advance payments for which there are remaining performance obligations[131]. - Material costs of services revenue are recorded as costs of sales, while immaterial costs are recorded in operating expenses[131]. - Revenue is recognized when performance obligations are satisfied by transferring promised goods or services to customers[132].

Financial Results - Notable Labs, Ltd. announced its financial results for the year ended December 31, 2023, on April 12, 2024[5] - Specific financial metrics and performance indicators were detailed in the press release, which is attached as Exhibit 99.1[6] Business Update - The company provided a business update alongside its financial results, indicating ongoing strategic initiatives[5]

Merger and Corporate Structure - Notable Labs completed a merger with Notable Labs, Inc. on October 16, 2023, continuing as a wholly owned subsidiary[17]. - On October 16, 2023, Notable Labs, Inc. merged with Merger Sub, resulting in former Notable Labs, Inc. equity holders owning approximately 71.9% of the outstanding equity of the Company on a fully diluted basis[137]. Predictive Precision Medicines Platform (PPMP) - The Predictive Precision Medicines Platform (PPMP) has achieved a predictive precision of 83-100% in identifying clinically responding patients across four independent clinical validation trials[25]. - The PPMP has a growing data repository of over 190 billion lines of data, derived from patient tissue and blood samples, enhancing its predictive capabilities[30]. - In a study on high-risk myelodysplastic syndromes (MDS), the PPMP demonstrated a positive predictive value (PPV) of 100% for predicting treatment response[35]. - In adult AML studies, the PPMP showed a PPV of 83% for predicting responses to the combination treatment of venetoclax and decitabine[36]. - For pediatric AML, the PPMP achieved a PPV of 100% for predicting minimal residual disease negativity and a PPV of 90% for 1-year relapse-free survival[40]. - The PPMP allows for the identification of patients expected to respond to treatments before initiation, potentially accelerating therapeutic development[19]. - Notable aims to revolutionize predictive precision medicine by expanding the PPMP's reach across various patient segments and diseases[22]. - Notable plans to expand its platform across liquid and solid tumors, focusing on identifying patient populations with high unmet medical needs, where less than 30% respond to standard treatments[41][42]. Drug Development and Clinical Trials - Notable's lead asset, Volasertib, is expected to enter a Phase 2 trial for adult acute myeloid leukemia (AML) in Q2 2024, with results from the first six patients anticipated in Q4 2024[21]. - Volasertib, a PLK-1 inhibitor, has shown clinical activity in approximately 10-30% of patients, with Notable obtaining worldwide rights for its development and commercialization[44][45]. - In a Phase 2 study, Volasertib combined with low-dose cytarabine (V+LDAC) achieved a complete response plus complete response with incomplete blood count recovery rate of 31.0%, compared to 13.3% for LDAC alone[46]. - A follow-up Phase 3 study indicated an overall response rate of 27.7% for V+LDAC versus 17.1% for placebo plus LDAC, suggesting a potential benefit from Volasertib[48]. - Notable plans to initiate a Phase 2 study in relapse/refractory AML in 2024, with a subsequent registrational Phase 3 study contingent on successful outcomes[56][57]. - The company anticipates filing an IND in Q1 2024 and enrolling the first PPMP-selected patient in Q4 2024[57]. - Notable's development strategy for Volasertib includes tailored dosing and improved infection control to enhance clinical tolerability and response rates[51][53]. - In a Phase 1b/2a clinical trial of Fosciclopirox for relapsed or refractory AML, 18 heavily pre-treated patients were enrolled, with 9 evaluable for response assessment; none achieved a complete response, but stable disease was observed in 2 patients[72]. - The PPMP predicted that all patients in the trial would be non-responsive to Fosciclopirox, which was confirmed by actual patient responses, indicating a potential bias in patient selection[73]. Financial Condition and Funding - Notable has incurred significant losses since inception and anticipates continuing to incur substantial losses for the foreseeable future, raising doubts about its ability to continue as a going concern[145]. - The company has generated only limited revenue since inception and does not anticipate significant revenues from product sales for the foreseeable future[152]. - Notable's financial condition and operating results are expected to fluctuate significantly due to various factors, including the transition from research and development to commercial activities[144]. - The company must develop and commercialize drug candidates with significant market potential to achieve profitability, which involves completing clinical trials and obtaining marketing approvals[148]. - Notable's existing cash and capital resources are insufficient to fund all planned efforts, necessitating further funding through various means[159]. - The company expects to incur significant expenses as it continues its research and development efforts, including preclinical and clinical development of its product candidates[146]. - Notable anticipates significant increases in research and development expenses as it advances its product candidates, Volasertib and Fosciclopirox, through clinical trials[160]. - The company expects to require additional capital to support its operations, which may not be available on acceptable terms, potentially impacting its financial condition[159]. - Future sales of Notable's shares could result in dilution for existing shareholders, impacting share price and capital raising efforts[165]. Regulatory Environment - The FDA approval process for new drugs involves extensive regulation and can take many years, requiring substantial data on quality, safety, and efficacy[79]. - Clinical trials are conducted in three phases, with Phase 3 trials designed to provide data necessary for demonstrating product effectiveness and safety[83]. - Post-approval trials may be mandated by the FDA to gather additional safety data after initial marketing approval[84]. - The cost of preparing and submitting a New Drug Application (NDA) is substantial, including application user fees and annual program fees for eligible products[86]. - The FDA aims to complete standard reviews of drug products within ten months and priority reviews within six months[1]. - Upon NDA approval of a new chemical entity, the drug receives five years of marketing exclusivity, preventing the FDA from receiving any ANDA for a generic version during this period[92]. - The FDA may approve a drug under accelerated approval regulations based on a surrogate endpoint that predicts clinical benefit, with rigorous post-marketing compliance requirements[97]. - The centralized procedure for drug approval in the EU has a maximum evaluation timeframe of 210 days, which can be reduced to 150 days under accelerated assessment[105][106]. - Notable's laboratory received its initial CLIA certification in 2018 and was certified by CAP in 2021, ensuring compliance with regulatory standards[110]. - The FDA may require a risk evaluation and mitigation strategy (REMS) as a condition of NDA approval, which can significantly impact the drug's market potential[90]. - The FDA's review process may be extended by three additional months to consider late-submitted information[1]. - The total patent term after extension may not exceed 14 years from approval, with a maximum of five years for a single patent extension[93]. - The Fast Track program allows for more frequent interactions with the FDA and may enable rolling reviews of drug applications[95][96]. - Notable plans to maintain CLIA compliance and certification to ensure eligibility for billing Medicare and Medicaid beneficiaries[111]. - The FDA has not required laboratories that furnish only laboratory developed tests (LDTs) to comply with medical device regulations, but this could change in the future[112]. Market and Competitive Landscape - The pharmaceutical industry presents intense competition, with Notable facing challenges from larger companies with greater resources in research, development, and marketing[65]. - Notable's success is contingent on obtaining and maintaining proprietary protection for its product candidates and preventing infringement by others[74]. - Notable's prospects are heavily reliant on its ability to develop and commercialize drug candidates, which may take several years[171]. - The historical failure rate for drug candidates in the biotechnology industry is high, and Notable has not yet obtained final regulatory approval for any drug candidate[181]. - Notable's drug candidates may not receive marketing approval due to various reasons, including insufficient clinical trial results or failure to meet safety and efficacy standards[179]. - Market acceptance of Notable's drugs is critical for funding future operations, including development and marketing efforts[211]. - Orphan drug designation may provide financial incentives but does not guarantee marketing exclusivity or commercial advantages[212]. - Even with orphan drug designation, Notable may not secure exclusivity if competitors obtain approval first[213]. - The FDA's requirement for demonstrating clinical superiority for orphan drug exclusivity could impact Notable's future approvals[214]. Compliance and Legal Risks - Notable is subject to various healthcare laws and regulations, including the Anti-Kickback Statute and the Stark Law, which could constrain its business operations[120][121]. - The federal False Claims Act imposes civil penalties for presenting false claims, which could apply to Notable even if it does not submit claims directly[123]. - Compliance with data privacy regulations, such as HIPAA and the California Consumer Privacy Act, is essential for Notable's operations and may require significant resources[127][128]. - State and foreign fraud and abuse laws may also apply to Notable's sales and marketing arrangements, adding complexity to compliance efforts[129]. - Non-compliance with regulations could harm Notable's reputation and financial results, necessitating significant resources for compliance efforts[196]. Challenges in Drug Development - Delays in clinical trials can result in increased costs and hinder Notable's ability to generate revenue from its drug candidates[184]. - The company may face challenges in enrolling patients with specific genomic or biomarker signatures necessary for its clinical trials, affecting its research and development efforts[183]. - Notable relies on Contract Research Organizations (CROs) and clinical trial sites for conducting trials, which may not perform as required[187]. - The results of early clinical trials may not predict outcomes in later trials, leading to potential variability in safety and efficacy results[191]. - Any delays in clinical trials could significantly harm Notable's business, financial condition, and prospects[190]. - Notable's drug candidates may face undesirable side effects that could delay or prevent regulatory approval, impacting their commercial profile and leading to significant negative consequences[192]. - If undesirable side effects are identified post-approval, Notable could face market acceptance issues, potential recalls, and increased regulatory restrictions[193]. - Notable is utilizing the PPMP for oncology drug development, but the innovative approach is in early stages, making cost and time predictions challenging[194]. - The PPMP may fail to yield commercially viable drug candidates, affecting Notable's ability to generate future product revenues[195].

Revenue and Income - The company generated cumulative revenues of approximately $17.4 million, primarily from an exclusive license agreement with NanoCarrier Co., Ltd., which has now been terminated [85]. - Revenues for the three months ended September 30, 2023, were $0, a decrease from $0.5 million in the same period in 2022, due to the termination of the NanoCarrier license agreement [99]. - The company has not generated taxable income since inception, with carry forward tax losses of $250.5 million as of December 31, 2022 [96]. Expenses and Financial Performance - Research and development expenses have decreased significantly since the termination of the OVAL study and ofra-vec program [87]. - Research and development expenses, net, for the three months ended September 30, 2023, were approximately $5.9 million, a decrease of approximately $6.6 million from $(0.7) million in the same period in 2022, mainly due to the termination of clinical trials and workforce reductions [103]. - General and administrative expenses for the nine months ended September 30, 2023, were $7.0 million, down from $9.8 million in the same period in 2022, primarily due to a reversal of share-based compensation and reduced commercialization activity [106]. - Operating loss for the nine months ended September 30, 2023, was $4.6 million, compared to a loss of $29.0 million in the same period in 2022, reflecting a significant reduction in expenses [118]. Cash Flow and Financing - As of October 31, 2023, the post-Merger Company had cash and cash equivalents of $14.3 million, with expectations of continued operational losses in the foreseeable future [113]. - Net cash used in operating activities for the nine months ended September 30, 2023, was approximately $7.6 million, primarily due to a net loss of $4.6 million and a net increase in working capital of $3.3 million [118]. - Cash provided by investing activities for the nine months ended September 30, 2023, was approximately $10.0 million, mainly from the maturation of short-term bank deposits and proceeds from the sale of long-term assets [120]. - The company expects to finance future cash needs through equity offerings, debt financings, collaborations, and licensing arrangements, with no committed external sources of funds currently available [115]. Asset Transactions - The company recorded a capital gain of approximately $0.2 million from the sale of its former Modi'in manufacturing facility, completed on March 9, 2023 [81]. - The company completed the sale of the VB-601 Asset to Immunewalk Therapeutics Inc. for total cash consideration of $250,000 plus up to $4.75 million in milestone payments and royalties [83]. - The company plans to monetize the VB-601 asset rather than pursue internal clinical development [75]. Mergers and Corporate Structure - The merger with Notable Labs, Inc. was completed on October 16, 2023, with former Notable securityholders owning approximately 75.2% of the combined entity on a fully diluted basis [77]. - The company executed a 1-for-35 reverse share split as part of the merger agreement, resulting in 34,285,714 authorized Ordinary Shares [78]. Compliance and Regulatory Matters - The company received a deficiency letter from Nasdaq regarding the minimum bid price requirement, but has since demonstrated compliance with listing requirements [84]. - The company has received a total of $38.4 million in grants from the Israeli Innovation Authority, which are subject to repayment through future royalties [89].

Revenue and Financial Performance - The company generated cumulative revenues of approximately $17.4 million, primarily from an exclusive license agreement with NanoCarrier Co., Ltd., which has now been terminated [77]. - No revenues were recorded for the three and six months ended June 30, 2023, compared to $0.1 million and $0.2 million for the same periods in 2022, respectively, due to the termination of the NanoCarrier license agreement [91][93]. - The company recorded a gain on the sale of its former Modi'in manufacturing facility of approximately $0.4 million during the six months ended June 30, 2023 [72]. - Cash used in operating activities was approximately $4.1 million for the six months ended June 30, 2023, compared to $18.1 million for the same period in 2022, indicating a significant reduction in cash burn [111][112]. - As of June 30, 2023, the company had cash and cash equivalents totaling $24.3 million and working capital of $19.2 million, which is expected to be sufficient to fund operations for at least 12 months [107]. Expenses and Cost Management - Research and development expenses are expected to be significantly less than prior periods due to the closure of the ofra-vec program and the early stage of the VB-601 program [84]. - Research and development expenses, net, decreased by approximately $8.3 million for the three months ended June 30, 2023, and by approximately $15.7 million for the six months ended June 30, 2023, primarily due to the termination of clinical trials and workforce reductions [95][96]. - General and administrative expenses are expected to decrease due to a significant reduction in workforce, although legal and administrative fees related to the merger are anticipated to increase [85]. - General and administrative expenses decreased by $1.1 million for the three months ended June 30, 2023, and by $1.0 million for the six months ended June 30, 2023, mainly due to reversals of share-based compensation and reduced payroll expenses [97][98]. - Operating loss for the three months ended June 30, 2023, was $0.9 million, compared to an operating loss of $9.6 million for the same period in 2022, reflecting a decrease of $8.7 million [90]. - Impairment loss for the three and six months ended June 30, 2023, was $0.3 million, attributed to the write-down of remaining fixed assets in preparation for a merger [99][100]. Mergers and Acquisitions - The proposed sale of the VB-601 asset includes total cash consideration of up to $5 million plus royalties, with an upfront cash payment of $250,000 upon closing [73]. - The merger with Notable Labs, Inc. is expected to result in former Notable securityholders owning approximately 76% of the ordinary shares on a fully diluted basis [69]. - The merger is intended to qualify as a tax-free reorganization for U.S. federal income tax purposes [68]. - The company plans to use proceeds from the asset sale to meet the $15.0 million minimum net cash closing condition required by the merger agreement [72]. Funding and Grants - The company has received a total of $38.4 million in grants from the Israeli Innovation Authority, which are subject to repayment through future royalty payments [82]. - The company raised an aggregate of $328.5 million since inception, including $29.4 million from IIA grants and $2.6 million from the EIC [106]. - The company anticipates needing additional capital to obtain regulatory approval for product candidates and may pursue various financing options, including equity offerings and collaborations [108]. Compliance and Regulatory Matters - The company has a compliance period until August 28, 2023, to regain compliance with Nasdaq's minimum bid price requirement [74]. - Financial expenses, net, were approximately $0.01 million for the three months ended June 30, 2023, compared to $0.2 million of income for the same period in 2022, primarily due to changes in exchange rates [104].

Financial Performance - Revenues for the three months ended March 31, 2023, were $0, a decrease of $113,000 compared to $113,000 in the same period in 2022, due to the termination of the NanoCarrier license agreement[87]. - The company reported a net loss of $2.6 million for Q1 2023, with non-cash charges totaling $0.5 million[99]. - Financial income, net, for the three months ended March 31, 2023, was approximately $0.05 million, down from $0.1 million in the same period in 2022, due to unfavorable exchange rates[93]. Research and Development - Research and development expenses, net, for the three months ended March 31, 2023, were approximately $0.1 million, a decrease of approximately $7.4 million from $7.5 million in the same period in 2022, primarily due to the termination of clinical trials and workforce reductions[90]. - The company anticipates a significant decrease in ongoing research and development expenses due to the closure of the ofra-vec program and the early stage of the VB-601 program[80]. Cash and Capital Resources - As of March 31, 2023, the company had cash and cash equivalents totaling $26.5 million and working capital of $19.2 million[95]. - The company expects its current cash resources to be sufficient to fund estimated operating expenses and capital expenditures for at least 12 months from the filing date of the financial statements[95]. - The company raised an aggregate of $327.0 million since inception, including $29.4 million from IIA grants and $1.1 million from the EIC[94]. - Net cash used in operating activities for Q1 2023 was approximately $1.7 million, compared to $8.3 million in Q1 2022[99][100]. - Net cash provided by investing activities for Q1 2023 was approximately $10.1 million, primarily due to the maturation of short-term bank deposits and the sale of a long-term asset[101]. - The company may seek additional capital through equity offerings, debt financing, collaborations, and licensing arrangements, which could dilute existing shareholders' interests[96]. - The company may need to delay or limit product development if unable to raise additional funds when needed[96]. Merger and Corporate Actions - The proposed Merger with Notable Labs, Inc. is expected to result in former Notable securityholders owning approximately 76% of the combined company on a fully diluted basis[66]. - The Merger is intended to qualify as a tax-free reorganization for U.S. federal income tax purposes[65]. - The company completed the sale of its rights to the former Modi'in manufacturing facility for $7.1 million on March 9, 2023, to meet the $15.0 million minimum Net Cash closing condition for the proposed Merger[71]. Tax and Financial Position - As of March 31, 2023, the company had carry forward tax losses of $250.5 million and does not expect to pay taxes in Israel until taxable income is generated[84]. - General and administrative expenses for the three months ended March 31, 2023, were $3.2 million, slightly up from $3.2 million in the same period in 2022, mainly due to increased legal costs[91]. - The company anticipates that its losses may fluctuate significantly based on clinical trial timings and collaboration agreements[95]. - The company had no financing activities in Q1 2023 or the parallel period[102].