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PLUS THERAPEUTICS, INC. (PSTV)·Q2 2024 Earnings Summary

Executive Summary

  • Q2 2024 was execution-heavy: LM program data continued to look encouraging (median OS 12 months; no DLTs through Cohort 4), CNSide met its primary endpoint and showed >2x sensitivity vs cytology, and funding visibility improved via CPRIT, DoD, and potential warrant proceeds .
  • Financially, grant revenue declined year over year ($1.28M vs $1.85M) and sequentially ($1.28M vs $1.68M), while operating expenses rose on LM trial spend; net loss improved YoY due to favorable non-cash warrant revaluation partially offset by financing expense . Management reiterated 2024 grant revenue guidance of $6–$7M and outlined ~$22M of incremental potential liquidity from grants and warrants .
  • Guidance catalysts: complete LM Phase 1 single-dose, initiate multi-dose LM Phase 1, GBM Phase 2 data updates, CLIA certification for CNSide LDT, and further CPRIT/DoD cash advances in 2H24 .
  • Stock drivers near term: SNO (Nov) LM update, CNS (late Sep/early Oct) GBM update, FDA feedback on LM multi-dose protocol, and execution on grant milestones/funding advances .

What Went Well and What Went Wrong

  • What Went Well

    • LM (ReSPECT-LM) safety/efficacy: No DLTs through Cohort 4; median OS 12 months with 8/16 alive; high therapeutic window dosimetry (≈156–160 Gy to subarachnoid/ventricles vs ≈1 Gy spleen) .
    • CNSide diagnostic: FORESEE met primary endpoint; influenced treatment decisions in >90% of cases; 80% sensitivity vs 29% for cytology; informed therapy selection in 24% of decisions .
    • Funding visibility: Received $3.3M CPRIT advance in June; management expects 2024 grant revenue of $6–$7M; outlined incremental access to ~$22M (CPRIT/DoD ~$10M + warrants up to $12M) .

  • What Went Wrong

    • Top-line contraction: Grant revenue decreased YoY and QoQ (Q2 2024: $1.279M vs $1.854M in Q2 2023; $1.279M vs $1.677M in Q1 2024), while LM trial spending increased operating loss .
    • Balance sheet pressure: Stockholders’ deficit widened to $(7.6)M; current liabilities exceeded total assets (warrant liability, new line of credit), highlighting sensitivity to financing cadence and grant timing .
    • Non-cash P&L volatility: Large non-cash items (warrant FV change +$4.694M; financing expense $(3.545)M$; issuance costs $(0.432)M$) complicate period comparability and EPS interpretation .

Financial Results

Metric (USD)Q2 2023Q1 2024Q2 2024
Grant Revenue ($000)$1,854 $1,677 $1,279
R&D Expense ($000)$1,420 $2,763 $2,773
G&A Expense ($000)$1,924 $2,213 $2,203
Total OpEx ($000)$3,344 $4,976 $4,976
Loss from Operations ($000)$(1,490) $(3,299) $(3,697)
Other Income (Expense), net ($000)$8 $38 $757
Net Loss ($000)$(1,482) $(3,261) $(2,940)
EPS Basic ($)$(0.59) $(0.75) $(0.45)
Basic Shares (000)2,509 4,322 6,501

Notes: Q2 2024 other income includes change in fair value of warrants (+$4.694M), financing expense ($(3.545)M), and issuance costs ($(0.432)M) .

Balance Sheet Snapshot

Metric (USD $000)Dec 31, 2023Jun 30, 2024
Cash & Cash Equivalents$8,554 $4,912
Investments— $3,523
Total Current Assets$9,834 $9,380
Total Assets$11,388 $11,212
Accounts Payable & Accrued$6,631 $6,946
Warrant Liability— $6,160
Line of Credit— $3,292
Total Liabilities$12,736 $18,837
Stockholders’ (Deficit)$(1,348) $(7,625)

Cash Flow (First Half)

Metric (USD $000)H1 2023H1 2024
Net Cash Used in Operating Activities$(8,571) $(5,663)
Net Cash Used in Investing Activities$(108) $(4,166)
Net Cash Provided by Financing Activities$1,454 $6,187

OpEx Breakdown (Quarterly)

OpEx Detail ($000)Q2 2023Q1 2024Q2 2024
Research & Development$1,420 $2,763 $2,773
General & Administrative$1,924 $2,213 $2,203

KPIs and Program Data (selected)

KPIQ4 2023Q1 2024Q2 2024
LM median OS (single-dose Phase 1)10 months (Cohorts 1–3) —12 months (Cohorts 1–4; 8/16 alive)
LM safety (DLTs)No DLTs to Cohort 3 Cohort 5 initiated No DLTs to Cohort 4; MTD not reached
CNSide utility—Implementation into ReSPECT-LM; validation complete FORESEE met primary endpoint; >90% decisions impacted; 80% vs 29% sensitivity vs cytology
GBM Phase 2 OS (as of Nov 2023)13 months vs ~8 months SOC Sites expansion plan Additional sites onboarding; fall update planned

Estimates vs Actuals

MetricQ2 2024 ConsensusActual Q2 2024
Revenue/Grant Revenue ($M)N/A (S&P Global consensus unavailable)$1.279
EPS (Basic)N/A (S&P Global consensus unavailable)$(0.45)

S&P Global consensus was not available for PSTV in Q2 2024 after attempted retrieval [GetEstimates error].

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Grant RevenueFY 2024—$6–$7M expectedNew (initial)
CPRIT Cash Advances2H 2024~$3.4–$3.6M discussed in Q1~$3.7M expected mid/late Q4 2024Slightly raised/clarified
CPRIT Cash Advances2025—~$3.7M expectedNew (visibility)
DoD Pediatric GrantFY 2024—~$1M of $3M over 3 years expected to commence in Sep 2024New (timing)
NIH GBM Trial Coverage2024~90% of trial costs~90% of trial costsMaintained
Liquidity (Warrants+Grants)Multi-year—Incremental access to ~$22M ($10M grants + $12M warrant exercise potential)New framing

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4’23, Q1’24)Current Period (Q2’24)Trend
LM efficacy/safety10-mo OS (C1–3); no DLTs; expanding sites 12-mo OS (C1–4); no DLTs; MTD not reached; Cohort 5 dosing; multi-dose protocol submitted Improving efficacy signal; progressing to multi-dose
CNSide diagnosticsRe-implementation into trial; assessing commercialization FORESEE met endpoints; >90% utility; >2x sensitivity vs cytology; CLIA LDT process underway; lab director hired Strong validation; building toward potential launch
GBM programPhase 2 OS 13 months vs ~8 SOC; plan for pivotal design New sites onboarding; CNS (Sept/Oct) update planned; enrollment completion likely 1H’25 Progressing sites/visibility; timeline modestly extended
Funding & runwayCPRIT advances cadence; non-dilutive focus $3.3M CPRIT advance received; $3.7M expected Q4; DoD pediatric funding starting Sep; NIH covers ~90% GBM; ~$22M potential liquidity incl. warrants Improved visibility; diversified sources
Manufacturing/supply chainBuilding redundancy; additional GMP manufacturer sought “Building in redundancy and commercial readiness” updates forthcoming Continued de-risking ahead of pivots
RegulatoryPlan FDA interactions LM/GBM; pediatric IND path Anticipate FDA approval for LM multi-dose Phase 1; pediatric IND later 2024 Advancing filings

Management Commentary

  • “Rhenium (186Re) Obisbemeda continues to show safety and promising signs of efficacy after a single administration in patients with LM… on track to complete the single administration ReSPECT-LM Phase 1 trial soon, expand to multiple doses, and move to Phase 2 funded by our existing CPRIT award.” — CEO Marc Hedrick .
  • “FORESEE met its primary endpoint… CNSide influencing treatment decisions in over 90% of clinical decisions… [and] showed a detection rate of tumor cells of 80% versus 29% for cytology.” — CEO Marc Hedrick .
  • “We expect 2024 grant revenue to be in the range of $6 million to $7 million… This provides incremental access to cash of $22 million: $10 million from CPRIT and DoD and $12 million from the exercise of A and B warrants.” — CFO Andrew Sims .
  • “We anticipate [LM multi-dose Phase 1] to begin enrolling later in 2024 at the current 7 trial sites, with a number of new sites to be added.” — CEO Marc Hedrick .

Q&A Highlights

  • CNSide clinical utility: Management detailed three decision types guided by CNSide—diagnosis confirmation, biomarker-driven therapy selection, and potential treatment discontinuation when CTCs drop to zero .
  • LM multi-dose timing: IND amendments in process; leveraging existing IND and current sites to accelerate start; expects trial to initiate later in 2024 with data accruing faster than single-dose due to fewer DSMB gating delays .
  • Commercialization prep for CNSide: Technology transfer completed; hiring of Medical Director; in-house microfluidic chip manufacturing to remove supply constraints; evaluating commercial opportunity and required investment .
  • Grants seasonality and cadence: CPRIT has semiannual cycles and ~6-month review/award timeline; NIH/DoD more sporadic and RFP-driven .

Estimates Context

  • S&P Global consensus estimates for Q2 2024 (revenue/EPS) were unavailable for PSTV at the time of analysis despite attempted retrieval; as a result, no formal “beat/miss” versus Street is presented this quarter. This is consistent with micro-cap/clinical-stage coverage gaps [GetEstimates error].

Key Takeaways for Investors

  • Clinical momentum: LM efficacy signal strengthened (12-mo OS; no DLTs through Cohort 4), while CNSide demonstrated high clinical utility—together enhancing the LM therapeutic/diagnostic thesis .
  • Funding visibility improved: 2024 grant revenue guided to $6–$7M; CPRIT/DoD cash advances expected in 2H24; NIH continues to defray GBM trial costs; warrants provide additional optionality .
  • Financials reflect investment phase: Lower grant revenue and higher LM spend widened operating loss; P&L volatility from non-cash warrant/financing items complicates EPS optics near term .
  • Near-term catalysts: LM multi-dose trial initiation (regulatory feedback pending), SNO LM update (Nov), CNS GBM update (late Sep/early Oct), and CLIA certification progress for CNSide LDT .
  • Strategic optionality: Building manufacturing redundancy and site expansion positions programs for prospective pivotal starts in 2025, with CNSide potentially broadening LM market and creating a nearer-term revenue adjacency .
  • Risk factors: Negative equity position and reliance on grant timing/warrant exercises highlight financing sensitivity; continued execution on non-dilutive funding and clinical timelines is key .
  • Trading implications: Event-driven setup into SNO/CNS conferences and FDA feedback; data quality/scale and funding milestones likely to drive volatility.

Additional Relevant Press Releases (Q2 timeframe)

  • Aug 13, 2024: FORESEE trial results—CNSide met primary and secondary endpoints; >90% decision impact; >2x sensitivity vs cytology .
  • Aug 12, 2024: LM Cohort 1–4 update—no DLTs; mean absorbed dose ≈156 Gy subarachnoid/ventricles; median OS 12 months .
  • Jul 25, 2024 and Aug 8, 2024: Conference participation and earnings call logistics .

Sources: Q2 2024 8-K and press release, financial statements and call transcript . For prior-quarter context: Q1 2024 8-K and transcript; Q4 2023 8-K and transcript .