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Notable Labs, Ltd. (NTBL)·Q1 2024 Earnings Summary
Executive Summary
- Q1 2024 was a funding-constrained quarter with minimal services revenue ($0.001M) and reduced OpEx; net loss narrowed to $(3.766)M and diluted EPS to $(0.42) as legal/professional costs from 2023 merger subsided .
- Cash and equivalents declined to $8.171M; management now guides runway “through September 2024,” below the prior “into Q4 2024” outlook, highlighting near-term financing risk .
- Volasertib Phase 2 program remains the key catalyst: IND (Q1 2024), initiation (Q2 2024), dose-optimization readout (Q4 2024), and first PPMP-selected patient enrollment (Q4 2024) are reiterated as on-track .
- No Q1 2024 earnings call transcript was filed; qualitative updates came via the FY23 press release and the 10‑Q; S&P Global consensus estimates were unavailable for NTBL, so beat/miss cannot be assessed.
What Went Well and What Went Wrong
What Went Well
- Management reaffirmed the PPMP-guided Volasertib Phase 2 timeline, with body surface area dosing and standardized best supportive care expected to enhance tolerability and responses: “We… include and evaluate these refinements in a small all-comers dose optimization prelude… prior to enrolling PPMP-predicted responders” (Joseph Wagner, Ph.D.) .
- Operating discipline: G&A fell to $2.289M from $3.923M YoY as merger-related and public company setup costs normalized .
- Strategic clarity: CEO emphasized PPMP’s role to “enrich the study’s enrollment with patients predicted to respond… increased probability of success,” reinforcing the selective-enrollment model (Thomas Bock, M.D.) .
What Went Wrong
- Cash runway shortened versus prior guidance (from “into Q4 2024” to “through September 2024”), increasing near-term financing risk and potential dilution .
- Minimal operating revenue ($0.001M) underscores lack of near-term product monetization; quarterly CFO usage increased to $(3.561)M from $(2.923)M YoY .
- Fosciclopirox Phase 2a results (reported Dec 2023) showed no complete responses among evaluable patients; PPMP correctly predicted non-responsiveness, but outcome emphasizes the need for PPMP-driven responder enrichment in future programs .
Financial Results
Note: NTBL reported Q1 2024 on a post-merger basis. Q3 2023 pre-merger VBL data are included for limited sequential context and are not strictly comparable.
Sequential context (limited comparability; Q3 2023 reflects pre-merger VBL):
Segment and KPIs:
- Reportable segments: Single operating segment (precision oncology platform therapeutics) .
- Shares outstanding: 9,018,261 as of May 6, 2024 .
Guidance Changes
No numerical revenue, margin, OpEx, OI&E, or tax rate guidance was provided in Q1 materials.
Earnings Call Themes & Trends
No Q1 2024 earnings call transcript was filed. Narrative below draws on Q3 2023 10‑Q, FY23 10‑K, and Q1 2024 10‑Q/press releases.
Management Commentary
- “The performance of our platform… has enabled us to enhance the clinical trial plan for our lead product candidate, volasertib… utilizing the platform to enrich enrollment with patients predicted to respond…” — Thomas Bock, M.D., CEO (Apr 12, 2024) .
- “PPMP’s recently reported, 100% accurate prediction of fosciclopirox’s clinical trial outcome has allowed us to eliminate an entire 30-patient cohort from the planned volasertib program…” — Thomas Bock, M.D. (Feb 22, 2024) .
- “We… introduce body surface area-based dosing [and] standardizing best supportive care… likely to enhance patient responses and tolerability.” — Joseph Wagner, Ph.D., CSO (Feb 22, 2024) .
Q&A Highlights
No Q1 2024 earnings call transcript was filed; no Q&A highlights are available from company transcripts for the quarter [ListDocuments returned 0 for earnings-call-transcript].
Estimates Context
- S&P Global (Capital IQ) consensus estimates for NTBL were unavailable in our system, preventing assessment of beats/misses versus Street on revenue/EPS/EBITDA and target price. This limits conclusions on near-term estimate revisions or surprises (GetEstimates returned CIQ mapping error for NTBL).
Key Takeaways for Investors
- Near-term catalyst path remains intact: Volasertib Phase 2 start (Q2), dose-optimization data (Q4), and first PPMP-selected patient (Q4) could be stock-moving milestones if safety/tolerability and early response quality align with PPMP predictions .
- Financing overhang: runway now to September 2024, shorter than prior guide; expect equity/debt or partnership activity—monitor dilution risk and timing .
- Execution in PPMP-enriched trials is critical: Fosciclopirox reinforced PPMP’s predictive utility; success hinges on translating prediction into superior clinical outcomes for Volasertib .
- Operating discipline evident (lower G&A), but cash burn increased YoY; absent revenue, continued reliance on external capital likely in 2024 .
- No call/consensus prints: Trade setup will hinge on clinical updates and financing headlines rather than estimate beats/misses; consider event-driven positioning into Q4 readouts .
Supporting Data Details
- Balance sheet snapshot (quarter-end): Cash & equivalents $8.171M; total assets $15.598M; equity $11.545M .
- P&L snapshot (Q1 2024): Revenue $0.001M; R&D $1.550M; G&A $2.289M; operating loss $(3.838)M; net loss $(3.766)M; diluted EPS $(0.42) .
- Cash flows (Q1 2024): CFO $(3.561)M; investing $(0.006)M; financing $(0.019)M .
- Segment: Single reportable operating segment .
Citations:
- Q1 2024 10‑Q (filed May 15, 2024): financial statements, MD&A, liquidity and guidance .
- 8‑K 2.02 press release (Apr 12, 2024): FY23 update, cash runway comment, strategic remarks .
- 8‑K press release (Feb 22, 2024): Volasertib Phase 2 program milestones and PPMP strategy .
- Q3 2023 10‑Q: pre‑merger sequential context .
- FY23 10‑K: PPMP validation data; Fosciclopirox trial outcome context .