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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
The earnings report shows positive signs such as reduced R&D expenses, net loss, and increased cash position. However, risks like limited cash resources beyond Q4 2024, decreased UK R&D tax credits, and competitive pressures balance these positives. The Q&A session revealed unclear management responses, adding to uncertainties. Given these mixed signals, the stock price is expected to remain neutral in the short term.
Cash Equivalents $6 million (up from $3.4 million as of December 31, 2023) - Increase due to improved cash position.
Net Cash Used in Operating Activities $3.6 million for the six months ended June 30, 2024 (down from $8.2 million for the same period in 2023) - Decrease attributed to reduced operational expenditures.
Net Cash Provided by Financing Activities $6.3 million for the six months ended June 30, 2024 - Resulted from the issuance of common stock and warrants under a securities purchase agreement.
Research and Development Expenses $2 million for the three months ended June 30, 2024 (down from $4.7 million for the same period in 2023) - Decrease due to reduced clinical trial and non-clinical expenditures.
R&D Expenses for Fadra $1.5 million for the three months ended June 30, 2024 (down from $3 million for the same period in 2023) - Decrease due to lower clinical trial costs.
R&D Expenses for Plogosertib $0.5 million for the three months ended June 30, 2024 (down from $1.4 million for the same period in 2023) - Decrease due to reduced manufacturing costs.
General and Administrative Expenses Approximately $1.6 million for each of the three months ended June 30, 2024 and 2023 - Remained flat.
Net Loss $3.3 million for the three months ended June 30, 2024 (down from $5.5 million for the same period in 2023) - Decrease attributed to lower operational costs.
UK R&D Tax Credits $0.4 million for the three months ended June 30, 2024 (down from $6 million for the same period in 2023) - Decrease directly correlated to qualifying R&D expenditure.
Fadraciclib (Fadra) Progress: Cyclacel is advancing its precision medicine strategy for Fadraciclib, an oral CDK29 inhibitor, with ongoing recruitment in the Phase 2 proof-of-concept study.
Clinical Activity Reporting: Initial clinical activity from the Phase 2 study is expected to be reported starting in Q4 2024.
T-cell Lymphoma Cohort: A second cohort for T-cell lymphoma patients has been opened based on promising Phase 1 results.
Market Need: There is a significant unmet medical need in patients with CDKN2A and/or CDKN2B chromosomal abnormalities.
Cash Position: As of June 30, 2024, cash equivalents totaled $6 million, up from $3.4 million at the end of 2023.
R&D Expenses: R&D expenses decreased to $2 million for Q2 2024 from $4.7 million in Q2 2023.
Net Cash from Financing: Net cash provided by financing activities was $6.3 million for the six months ended June 30, 2024.
Clinical Strategy: The company is focusing on specific cancer types with CDKN2A/B abnormalities for its clinical trials.
Cash Resources: As of June 30, 2024, cash equivalents totaled $6 million, which may limit the company's ability to fund planned programs beyond the fourth quarter of 2024.
R&D Tax Credits: The UK research and development tax credits decreased significantly to $0.4 million from $6 million in the previous year, indicating a potential risk in funding future R&D activities.
Net Loss: The net loss for the three months ended June 30, 2024, was $3.3 million, which reflects ongoing financial challenges.
Competitive Pressures: The company is focusing on a precision medicine strategy for Fadra, which may face competitive pressures from other therapies targeting similar patient populations.
Clinical Trial Risks: The Phase 2 proof-of-concept study's success is uncertain, as it relies on the recruitment of specific patient cohorts and the efficacy of Fadra in those populations.
Adverse Events: Treatment-related adverse events reported during clinical trials, including hyperglycemia and accidental overdose, pose risks to patient safety and may impact the study's outcomes.
Economic Factors: The overall economic environment may affect funding opportunities and investor interest, impacting the company's financial stability.
Fadraciclib (Fadra) Strategy: Cyclacel is advancing its precision medicine strategy for Fadraciclib, an oral CDK29 inhibitor, with ongoing recruitment in the Phase 2 proof-of-concept study targeting patients with CDKN2A and/or CDKN2B chromosomal abnormalities.
Clinical Trials: The company is evaluating Fadra as a monotherapy in various tumor types, with initial clinical activity results expected in Q4 2024.
Patient Recruitment: Recruitment in the enriched cohort of the Phase 2 study is progressing well, with initial results anticipated from around a dozen patients by the end of 2024.
Cash Resources: As of June 30, 2024, Cyclacel has $6 million in cash equivalents, which is expected to fund planned programs into Q4 2024.
R&D Expenses: R&D expenses for Fadra were $1.5 million for Q2 2024, down from $3 million in Q2 2023, indicating a decrease in clinical trial costs.
Net Loss: The net loss for Q2 2024 was $3.3 million, a reduction from $5.5 million in Q2 2023, reflecting improved financial management.
Net cash provided by financing activities: $6.3 million for the six months ended June 30, 2024, as a result of receiving approximately $6.3 million net of expenses from the issue of common stock and warrants under securities purchase agreement.
The earnings report shows positive signs such as reduced R&D expenses, net loss, and increased cash position. However, risks like limited cash resources beyond Q4 2024, decreased UK R&D tax credits, and competitive pressures balance these positives. The Q&A session revealed unclear management responses, adding to uncertainties. Given these mixed signals, the stock price is expected to remain neutral in the short term.
The earnings call highlights financial sustainability risks with limited cash runway, potential enrollment challenges, and paused studies indicating strategic or resource issues. Despite some positive elements like reduced losses and upcoming data presentations, the financial instability and dependency on uncertain clinical outcomes weigh heavily. Analysts' questions revealed no management evasiveness, but the lack of strong positive catalysts or partnerships, combined with financial and operational risks, suggests a negative sentiment, likely resulting in a stock price decline of -2% to -8%.
The earnings call reveals significant financial and operational challenges, including a limited cash runway, clinical program delays, and increased net loss. The Q&A section highlights management's lack of clarity on funding strategies and operational timelines, adding to uncertainties. Despite some positive developments, such as upcoming biomarker data disclosure, the overall sentiment remains negative due to these substantial risks and uncertainties.
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