PLUS THERAPEUTICS, INC. (PSTV)·Q3 2024 Earnings Summary

Executive Summary

• Q3 results were consistent with a clinical-stage profile: grant revenue was $1.46M, operating loss was $3.80M, and net loss was $2.87M (basic EPS $(0.37)); cash and investments were $4.8M at quarter-end, with $0.9M received in October and a $3.9M CPRIT advance expected within ~90 days of the release .
• Strategically, Plus secured FDA agreement to initiate a Phase 1 multi-dose LM study, expects to complete the single-dose LM Phase 1 and determine MTD/RP2D by year-end, and expanded manufacturing via SpectronRx to support late-stage/commercial-scale needs .
• Timelines shifted modestly: LM multi-dose enrollment is now targeted for Q1 2025 (previously “later in 2024”); CNSide LDT commercial re-introduction is slated for early 2025, pending CLIA compliance in Q1 2025 .
• CFO reiterated 2024 grant revenue guidance of $6–$7M and quantified approximate liquidity runway of ~$27M when including cash/investments, warrant proceeds (if fully exercised), and committed grant funding, highlighting reliance on non-dilutive sources .

What Went Well and What Went Wrong

What Went Well

• FDA advancement: “Securing agreement from the FDA to initiate a Phase 1 multiple dose administration trial is a key next step” in LM; enrollment expected to begin Q1 2025 at seven U.S. sites .
• Clinical momentum: LM single-dose Phase 1 remains on track to complete by year-end with MTD/RP2D determination, while GBM data presented at CNS showed favorable safety and dose–response signals (mean Phase 2 absorbed dose 300 Gy; 89% ≥100 Gy) and new site expansion (North Shore, Ohio State) .
• Manufacturing de-risking: SpectronRx partnership adds GMP redundancy and scalability to meet late-stage clinical and commercial forecasts, supporting up to ~15,000 doses/year capacity over time, per call commentary on scale-up objectives .

What Went Wrong

• Liquidity tight at quarter-end: cash was $1.22M and total current liabilities were $12.1M; while mitigated by $3.57M in investments and expected grant advances, the balance sheet showed a stockholders’ deficit of $(5.17)M, underscoring financing risk .
• Timeline push-outs: LM multi-dose trial start moved from “later in 2024” to Q1 2025; CNSide LDT commercial re-introduction guided to early 2025 pending CLIA compliance—both delays modestly extend catalysts .
• Continued operating losses: Q3 operating loss of $3.80M and YTD operating loss of $10.80M reflect ongoing R&D and G&A spend increases (R&D +14.6% YoY; G&A +20.0% YoY in Q3), though partially offset by grant revenue .

Financial Results

Income Statement and EPS (Quarterly)

Notes: Q3 grant revenue increased vs Q2 and vs Q3 2023 ($1.24M) on a small base; operating expenses rose YoY, reflecting LM trial spend .

Balance Sheet Liquidity (Quarterly)

Additional context: $0.9M DoD grant payment received in October and next CPRIT advance of $3.9M expected within ~90 days of Nov 14 release .

Segment/KPI

• Revenue is solely grant revenue; no commercial product revenue or segment reporting. KPIs are clinical/operational milestones (LM and GBM trial progress, CNSide launch and reimbursement steps) rather than commercial metrics .

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “Securing agreement from the FDA to initiate a Phase 1 multiple dose administration trial is a key next step in our integrated development plan for [RNL] for patients with LM… on track to complete both Phase 1 LM trials and move to later stage trials in 2025.” – Marc Hedrick, CEO .
• On therapeutic index in LM: “about 50-plus… and a preview of Cohort 5… greater than 100:1… bone marrow ticked up in Cohort 5… DSMB cut back Cohort 6 dose… Cohort 4 dose will be the recommended Phase II dose” .
• CFO on liquidity: “We received the first DoD advance in October… on track for next CPRIT advance of $3.9M… Taking into [account] cash on hand, [if] financing warrants… fully exercised and committed… and contractual grant revenue is approximately $27 million” .
• GBM: Phase 2 average absorbed tumor dose ~300 Gy; high delivery parameters achieved; new sites activated to support completion and potential pivotal .

Q&A Highlights

• Grant landscape: Management remains constructive on CPRIT opportunities despite macro/political uncertainty; CPRIT may deploy additional capital to well-executing companies .
• LM multi-dose dosing rationale: Selected ~13 mCi fractionated dose based on safety/response at Cohort 4 (~44 mCi) and FDA comfort with dose fractionation; compassionate-use re-dosing experiences informed approach .
• CNSide timeline and reimbursement: Commercial re-introduction targeted for early 2025; prioritizing CLIA compliance in Q1 2025, payer Z-Code, and PLA code; negotiating lab services agreements with ~10 institutions; will guide on pricing/ramp after reimbursement progress .
• Therapeutic ratio: LM therapeutic target:off-target ratio ~50+:1 through Cohort 4, >100:1 in Cohort 5; supports dose escalation but informed DSMB caution for Cohort 6 .
• Integrated LM plan: Potential to take both a high single-dose and a lower multi-dose regimen toward market; more details at SNO and in early 2025 .

Estimates Context

• Wall Street consensus (S&P Global) for Q3 2024 EPS and revenue could not be retrieved at this time; therefore, a vs-estimates analysis is unavailable. We will update when S&P Global consensus is accessible.
• As a clinical-stage company recognizing grant revenue (no commercial product revenue), Street estimates are often sparse; management reiterated 2024 grant revenue guidance of $6–$7M on the call .

Key Takeaways for Investors

• Near-term catalysts are primarily clinical and regulatory: completion of LM single-dose Phase 1 with MTD/RP2D, SNO updates, and LM multi-dose trial initiation in Q1 2025; GBM Phase 2 readout path into 2H 2025 remains supportive with new site adds .
• Liquidity hinges on timely non-dilutive inflows (CPRIT advances, DoD) and potential warrant exercises; quarter-end cash was low, but management highlighted ~$27M in combined runway sources including grants and warrants .
• Manufacturing risk reduced via SpectronRx; supply chain now better aligned with late-stage and commercial ambitions, which can be critical for partner diligence and eventual launch readiness .
• CNSide LDT launch is a 2025 event; reimbursement groundwork (CLIA compliance, Z-Code, PLA) is underway; FORESEE data supports clinical utility and could aid adoption once commercialized .
• Strategy suggests two potential LM paths (high single-dose and multi-dose), offering optionality for efficacy/safety optimization and regulatory positioning; watch for detailed development plan updates at SNO/early 2025 .
• With no commercial revenue, stock moves will likely track clinical/regulatory newsflow and funding milestones rather than quarterly P&L beats; continued grant execution and milestone delivery are key to sustaining investor confidence .

Supporting Press Releases and Context (Q3 2024 and recent)

• Q3 financials and milestones: Plus Therapeutics Reports Third Quarter 2024 Financial Results; cash+investments $4.8M; LM multi-dose FDA agreement; expected CPRIT advance .
• SpectronRx manufacturing agreement to scale RNL supply for late-stage/commercial demand .
• CNS Meeting GBM update: mean Phase 2 absorbed dose 300 Gy; >100 Gy threshold associated with control; additional clinical sites .
• SNO schedule and symposium highlighting LM therapeutic/diagnostic programs .