Cyclacel Pharmaceuticals, Inc. (CYCC)·Q2 2024 Earnings Summary

Executive Summary

• Q2 2024 was an operationally disciplined quarter with reduced R&D spend and stable G&A, while cash rose to $6.0M following financing; net loss narrowed to $3.3M from $5.5M YoY .
• Precision medicine Phase II (065-101) is “enrolling well”; initial data from CDKN2A/CDKN2B-altered cohort targeted for Q4 2024, with T‑cell lymphoma cohort now open; success criteria defined as ≥2 responses in first 12–14 patients before expansion .
• Company reiterated cash runway into Q4 2024 and lowered operating cash burn versus prior year-to-date; UK R&D tax credits were $0.4M in Q2 vs $0.6M YoY, reflecting lower qualifying R&D spend .
• Near-term stock catalysts: interim Phase II readout (Q4 2024), clarity on enrollment pace and response threshold achievement, and continued precision medicine narrative; plus IP reinforcement via EPO’s notice of intention to grant a plogosertib patent (exclusivity to Aug 2040) .

What Went Well and What Went Wrong

What Went Well

• Phase II 065‑101 enrollment progressing well; initial clinical activity readout targeted for Q4 2024. “We are on track to report in the fourth quarter of 2024 initial data from the precision medicine cohort of 065‑101” .
• Defined PoC success bar and confidence on patient identification: “Stage 1 is…approximately 12 to 14 patients, where you need to see more than 2 responses…then move on” .
• Operating discipline: R&D fell to $2.0M from $4.7M YoY; net loss narrowed to $3.3M from $5.5M; cash increased to $6.0M supported by ~$6.3M financing proceeds .

What Went Wrong

• Minimal revenue ($4k) highlights continued dependence on external financing and non-dilutive credits; UK R&D tax credits declined to $0.4M from $0.6M YoY .
• Cash runway only into Q4 2024, keeping financing risk elevated pending clinical catalysts .
• Plogosertib program activity moderated; while IP strengthened, clinical work awaits formulation switch with prior commentary indicating pauses and refocus on biomarker-driven strategies (update from earlier quarters) .

Financial Results

Segment R&D allocation (program view):

KPIs and liquidity:

Estimate comparison:

Note: Wall Street consensus via S&P Global was unavailable for CYCC (no mapping/coverage), so estimate comparisons cannot be provided.

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “We are on track to report in the fourth quarter of 2024 initial data from the precision medicine cohort of 065‑101 with our CDK2/9 inhibitor as monotherapy in patients with advanced solid tumors and later on in patients with T‑cell lymphoma.” — Spiro Rombotis, CEO .
• “We are pleased with strong investigator interest and are nearing completion of recruitment in the precision medicine cohort… There are no approved medicines for patients with CDKN2A/CDKN2B alterations.” — Brian Schwartz, M.D., interim CMO .
• “As of June 2024, cash equivalents totaled $6 million… Net loss for the 3 months of June 30, 2024, was $3.3 million… The company estimates that its current cash resources will fund planned programs into the fourth quarter of 2024.” — Paul McBarron, CFO/COO .
• “Stage 1 is…approximately 12 to 14 patients, where you need to see more than 2 responses. And then you would move on to the next phase of the study.” — Brian Schwartz .

Q&A Highlights

• PoC success threshold and design: Stage 1 targets 12–14 patients, requiring >2 responses to proceed; expansion confirms responses in a larger cohort .
• Enrollment cadence and disclosure timing: Expect around a dozen patients’ response data by year-end; scans every two months drive data readouts cadence .
• Biomarker sensitivity exploration: Management aims to parse which specific CDKN2A/CDKN2B alterations may be more sensitive to fadraciclib based on >20–25 patients treated across datasets .

Estimates Context

• Wall Street consensus via S&P Global was unavailable for CYCC for Q2 2024 due to missing company mapping/coverage in SPGI systems, so estimate comparisons (revenue/EPS beats/misses) cannot be determined. This likely reflects limited analyst coverage for a micro-cap, clinical-stage biotech [GetEstimates error noted].
• Given the lack of sell-side estimates, investor focus should center on clinical milestones, cash runway, and operating discipline rather than quarterly “beats/misses”.

Key Takeaways for Investors

• Operational discipline continued: R&D down to $2.0M (from $4.7M YoY) and G&A flat; net loss narrowed to $3.3M YoY, supporting extended runway into Q4 2024 .
• Precision medicine PoC is the main 2H catalyst: initial data targeted for Q4 2024 in CDKN2A/CDKN2B-altered tumors; T‑cell lymphoma cohort is open and progressing .
• Explicit PoC success bar (≥2 responses in 12–14 patients) offers a clear framework for near-term value inflection and readthrough to larger cohort expansion .
• Cash bolstered by ~$6.3M financing; cash rose to $6.0M. Financing risk remains post-Q4 without further capital or partnering, making the Q4 readout pivotal .
• IP strengthening around plogosertib (EPO notice to grant; exclusivity to Aug 2040) provides optionality for biomarker-driven development once formulation work completes .
• Q4 2024 stock reaction likely driven by whether interim PoC meets or exceeds the defined response threshold; strong signals could enable partnering or financing on improved terms .
• Absent consensus estimates, frame near-term trading around enrollment updates, scan cadence (every two months), and timing confirmations for data disclosure by year-end .