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PLUS THERAPEUTICS, INC. (PSTV)·Q1 2024 Earnings Summary

Executive Summary

  • Q1 2024 showed improving operating leverage driven by higher CPRIT grant revenue and lower losses: grant revenue rose to $1.68M vs $0.51M YoY and net loss narrowed to $3.26M (EPS $(0.75)) from $4.81M (EPS $(2.07)) YoY; cash ended at $2.90M, down from $8.55M at 12/31/23 as the company awaited mid-year CPRIT draws .
  • Funding visibility improved post-quarter via a $19.25M private placement ($7.25M upfront ≈ 12 months’ incremental runway) plus scheduled CPRIT advances of ~$6.9M in 2024 and ~$1M DoD pediatric funding starting late Q3/Q4; management guided 2024 grant revenue to $6–$7M .
  • Clinical momentum: LM Phase 1 single-dose dose-escalation advanced through Cohort 5 (66.1 mCi), with 12 of 18 patients alive as of March; FDA Type C meeting scheduled (June 10) for a multi-dose expansion; GBM Phase 2 continues with encouraging OS signal (13 months reported Nov-2023 vs ~8 months SOC) .
  • Potential stock catalysts: FDA feedback (LM multi-dose, pediatric IND in 2H24), LM Phase 1 completion and pivotal trial design, GBM Phase 2 data update later in 2024, and CNSide diagnostic commercialization plan (as soon as Q4 2024) .

What Went Well and What Went Wrong

  • What Went Well

    • Accelerating LM program and clearer regulatory path: “we believe multiple doses of rhenium obisbemeda will be the optimal therapeutic approach” with a Type C FDA meeting scheduled and goal to complete LM Phase 1 enrollment in 2024; 12/18 patients remained alive as of March data cut .
    • Strengthened funding roadmap and runway: $7.25M gross from private placement closed May 9 (part of up to $19.25M), specific CPRIT cash advance timing (~$3.4M late Q2/early Q3 and ~$3.5M late Q4), and ~$1M DoD pediatric grant expected in 2024; CFO guided 2024 grant revenue to $6–$7M .
    • Strategic expansion via CNSide diagnostic assets and management hires; validation of CNSide CSF tumor cell assay implemented as an exploratory endpoint in ReSPECT-LM, with plans for commercial launch as soon as Q4 2024 and a >0.5M tests TAM discussed by management .

  • What Went Wrong

    • Cash burn remained significant ahead of CPRIT advances: cash fell to $2.90M at 3/31/24 (from $8.55M at 12/31/23), driven by $(4.51)M operating cash outflows in Q1 despite higher grant revenue .
    • No commercial revenue and continuing losses: Q1 operating loss was $(3.30)M, net loss $(3.26)M (EPS $(0.75)); while improved YoY, sequential improvement is dependent on grant timing and continued cost control .
    • Estimates context unavailable: Wall Street consensus (S&P Global) could not be retrieved for Q1 2024; beat/miss vs expectations cannot be assessed this quarter (see Estimates Context) .

Financial Results

Q1 2024 vs Q1 2023 (YoY)

MetricQ1 2023Q1 2024
Grant Revenue ($USD Millions)$0.506 $1.677
Total Operating Expenses ($USD Millions)$5.228 $4.976
Operating Loss ($USD Millions)$(4.722) $(3.299)
Net Loss ($USD Millions)$(4.805) $(3.261)
Diluted EPS ($)$(2.07) $(0.75)
Net Loss Margin (%)(950.6%) (194.4%)
Note: Net Loss Margin calculated as Net Loss ÷ Grant Revenue using cited figures.

Sequential snapshot

MetricQ3 2023Q1 2024
Grant Revenue ($USD Millions)$1.240 $1.677
Total Operating Expenses ($USD Millions)$4.491 $4.976
Operating Loss ($USD Millions)$(3.251) $(3.299)
Net Loss ($USD Millions)$(3.219) $(3.261)
Diluted EPS ($)$(1.00) $(0.75)
Net Loss Margin (%)(259.6%) (194.4%)

Liquidity

Metric9/30/202312/31/20233/31/2024
Cash & Cash Equivalents ($USD Millions)$11.006 $8.554 $2.901
  • Segment breakdown: No commercial revenue; reported grant revenue only .
  • KPIs (clinical-operational)
    • LM trial: “enrollment of the 3 required patients for dosing in Cohort 5…66.1 millicuries”; 12/18 patients dosed remained alive as of March 2024 .
    • Trial footprint: added 5 LM sites to support current and follow-on trials .
    • GBM signal: Phase 2 OS 13 months as of Nov 2023 vs ~8 months SoC (context from Q4 disclosures reiterated in Q1 call) .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Grant Revenue ($)FY 2024“Grant revenue will continue to increase during 2024” (qualitative) $6–$7M grant revenue expected for 2024 Increased specificity
CPRIT Cash Advances ($)FY 2024~$6.9M expected in 2024; $3.3M 1H24, $3.6M by YE ~$6.9M total; ~$3.4M late Q2/early Q3 and ~$3.5M late Q4 Timing refined
DoD Pediatric Grant ($)2024–2026Not previously quantified by period~$1M in 2024; 3-year $3M total begins late Q3/Q4 New detail
Runway (qualitative)Multi-periodRunway into 2H 2025 on cash + grants +$7.25M upfront from $19.25M financing ≈ 12 months incremental runway Strengthened
LM Program Milestones2024Complete LM Phase 1 enrollment; FDA engagement on pivotal FDA Type C meeting (June 10) for multi-dose; aim to complete Phase 1 enrollment 2024 and define RP2D Clarified plan
CNSide Commercialization2024Assess viability; implement as exploratory endpoint Commercial launch as soon as Q4 2024; business evaluation and reimbursement strategy underway Upgraded path

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3–Q4 2023)Current Period (Q1 2024)Trend
Funding & RunwayCash $8.6M (12/31/23); ~$6.9M CPRIT in 2024; runway into 2H25; continued grant strategy $7.25M upfront from $19.25M raise; ~$6.9M CPRIT timing detailed; ~$1M DoD in 2024; 2024 grant revenue $6–$7M Visibility improving
LM program (design, pace)Cohort 4 completed; aim to complete Phase 1 in 2024; plan pivotal Phase 2/3 in 1H25 Cohort 5 enrolled; FDA Type C for multi-dose; 12/18 alive as of March; plan to complete Phase 1 in 2024 Accelerating
GBM programPhase 2 OS 13 months vs ~8 months SOC; site expansion Add new sites; aim to complete Phase 2 enrollment 2024/early 2025; update later in 2024 Execution focus
CNSide diagnosticImplementation as exploratory endpoint; viability assessment Acquisition closed; validate CSF01; TAM >0.5M tests; target commercial launch as soon as Q4 2024 Commercial path forming
Manufacturing/supplyBuild redundancy; add GMP capacity; radiation services Selecting third GMP partner; expanding radiation services network; secure supply for pivotal/commercial Scaling for pivotal
Pediatric programPlan pediatric IND in 2024 DoD $3M award recommended; IND approval anticipated 2024; first site Lurie; possible enrollment early 2025 Funded start
Device (RNL-BAM)FDA classified as device; design work underway Working on device quality system, design requirements, IP expansion Steady progress

Management Commentary

  • “We have made substantial business progress thus far in 2024… focus on moving lead programs to pivotal trials, key data readouts, building out a commercial ready supply chain, and leveraging the new opportunities provided by the recent CNSide acquisition.” — Marc Hedrick, CEO .
  • “We expect 2024 grant revenue to be in the range of $6 million to $7 million… [CPRIT] advances totaling $6.9 million in 2024… $7.25 million received at closing represents approximately 12 months of incremental runway.” — Andrew Sims, CFO .
  • “Ultimately, we believe multiple doses of rhenium obisbemeda will be the optimal therapeutic approach to suppress and potentially cure LM.” — Marc Hedrick .
  • “Given the safety profile and the unprecedented amount of radiation we can deliver to the CNS using our technology, we believe there is a tremendous potential for improving upon the standard of care in GBM.” — Marc Hedrick .

Q&A Highlights

  • Development timelines: Management now sees LM potentially reaching approval before GBM, citing larger patient pool, lack of approved LM therapies, and potential Phase 2/3 pivotal design for LM; GBM remains active with site expansion and Phase 2 enrollment targeted into late 2024/early 2025 .
  • Data cadence: SNMMI in June will reiterate LM data (with one additional cohort) for nuclear medicine audiences; SNO/ASCO in August to update enrollment/safety; SNO in November targeted for more definitive LM data; GBM update later in 2024 .
  • Pediatric funding: DoD grant expected to cover Phase 1 costs, with prospects for additional funding to accelerate sites/Phase 2 after preliminary data .
  • Key clinical questions: For solid CNS tumors (GBM), focus is on delivery/dose planning and software to optimize CED; for CSF disease (LM), focus is on dose and fractionation over time to suppress/cure LM .

Estimates Context

  • Consensus estimates: S&P Global (Capital IQ) consensus for PSTV’s Q1 2024 revenue/EPS was unavailable at the time of analysis due to data access limitations; therefore, we cannot assess beat/miss vs Wall Street expectations this quarter. We will update when S&P Global data becomes accessible.

Key Takeaways for Investors

  • Near-term catalysts: FDA Type C (LM multi-dose) feedback (June); SNO/ASCO (Aug) LM enrollment/safety update and FORESEE CNSide data; SNO (Nov) potential full LM Phase 1 data; GBM Phase 2 update later in 2024; CNSide commercialization plan for as soon as Q4 2024 .
  • Funding de-risking: Private placement ($7.25M upfront) plus predictable CPRIT advances ($6.9M in 2024) and DoD pediatric grant ($1M in 2024) support continued execution amid non-commercial stage; watch for warrant exercises (~$12M potential) as additional upside .
  • Execution watchpoints: Complete LM Phase 1 and define RP2D; secure FDA alignment on LM pivotal and pediatric IND; expand manufacturing/radiation capacity to ensure pivotal readiness .
  • Clinical inflection potential: LM pivotal (breast cancer LM) could start as early as early 2025 if multi-dose plan and Phase 1 completion align; GBM continues to show promising OS vs SOC with broader site ramp in 2H24 .
  • Risk factors: Low cash at quarter-end ahead of grant receipts, ongoing operating losses without commercial revenue, regulatory timing risks, manufacturing scale-up dependencies, and the need to sustain non-dilutive funding .
  • Diagnostic adjacency: CNSide could expand LM addressable market and provide near-term revenue optionality; management is evaluating commercialization and reimbursement to launch as soon as Q4 2024 .

Supporting Sources:

  • Q1 2024 8-K and press release (financials, milestones) .
  • Q1 2024 earnings call transcript (clinical updates, guidance, funding detail, quotes) .
  • Q4 2023 8-K and call (baseline guidance and 2023 financials) .
  • Q3 2023 8-K (quarterly comps) .
  • Post-quarter press release (CPRIT advance and CNSide leadership) .