PLUS THERAPEUTICS, INC. (PSTV)·Q4 2024 Earnings Summary

Executive Summary

• Q4 revenue of $1.412M beat consensus by ~40% (estimate $1.007M); EPS of $(0.49) was slightly better than consensus $(0.497) as non-cash warrant mark-to-market and grant revenue recognition supported results in a low-revenue, clinical-stage profile *.
• Secured $15M equity financing and a $2M CPRIT grant advance, restoring Nasdaq equity compliance and extending cash runway into mid-2026; management guided 2025 grant revenue to $6–$8M .
• LM program: Phase 1 single-dose completed; recommended Phase 2 dose at 44 mCi, plan for end-of-Phase 1 FDA meeting and initiation of multiple-dose trial; GBM Phase 2 completion targeted for 2025; CNSide full commercial launch on track for 2025 .
• Near-term catalysts: CNSide commercialization milestones, LM regulatory interactions, LM multi-dose enrollment, GBM Phase 2 enrollment completion, and pediatric IND submission—each potentially re-rating prospects for de-risking and future revenue .

What Went Well and What Went Wrong

What Went Well

• Completed LM Phase 1 single-dose trial with RP2D at 44 mCi; management expects an expedited path via single-dose expansion and future registrational design discussions: “We think … a single dose of 44 millicuries warrants further evaluation for FDA approval…” .
• Strengthened liquidity and runway: $15M financing; regained Nasdaq equity compliance; CPRIT $2M advance; guided 2025 grant revenue to $6–$8M .
• Built supply chain redundancy with SpectronRx and extended Telix IsoTherapeutics agreement to secure cGMP Re-186 for late-stage trials and commercialization .

What Went Wrong

• Operating loss widened YoY to $14.7M (2024) amid increased ReSPECT-LM spend; net loss was $13.0M, reflecting financing expense ($3.545M) partially offset by positive warrant FV change ($5.654M) .
• Cash and investments fell to $3.6M at year-end 2024 vs. $8.6M prior year, highlighting dependence on equity/grants until commercial revenue ramps .
• Accounts payable and accrued expenses rose to $11.3M from $6.6M YoY, and stockholders’ equity remained negative, underscoring near-term balance sheet pressure absent continued non-dilutive funding and disciplined OpEx .

Financial Results

Quarterly P&L comparisons (oldest → newest)

KPIs and balance sheet indicators

Note: Revenue primarily reflects grant revenue recognition aligned to CPRIT share of REYOBIQ development costs; quarterly operating loss tracks increased LM trial spend .

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “The year 2025 has the potential to be transformational … transitioning to an operational revenue generating company with the launch of CNSide.” — Marc H. Hedrick, CEO .
• “We think … a single dose of 44 millicuries warrants further evaluation for FDA approval for LM …” — Marc H. Hedrick on LM strategy .
• CFO: “We expect 2025 grant revenue to be in the range of $6 million to $8 million” and reviewed $15M financing, CPRIT advances, DoD and NIH grant support .
• CNSide market: “Best reasonable case is 0.5 million tests a year in the U.S.” and a focused KOL-first sales approach to capture 80% share at NCI centers .

Q&A Highlights

• CNSide go-to-market: niche, KOL-centered approach at ~30 NCI centers initially; partnering optionality preserved for U.S./ex-U.S. .
• GBM Phase 2 powering and design: comparator arms show ~8-month median OS; FDA openness to real-world-controlled Phase 3 could reduce active-arm size to ~100 patients .
• LM Phase II design: proposal to segment HER2-positive/negative breast LM; CNSide could serve as primary/co-primary endpoint given correlation with survival .
• Multi-dose LM study: move forward with Phase II/Phase Ib while collecting multiple-dose PK/PD and efficacy data; compassionate-use experience supports safety/benefit .
• CNSide scale: operational capacity scalable to hundreds of thousands of tests; sequencing (ISH/ICC/NGS) to expand menu later in 2025 .

Estimates Context

Results vs. S&P Global consensus show consistent beats across 2024 quarters.

* Values retrieved from S&P Global.

Implication: Revenues, driven by grant recognition timing, and EPS aided by favorable warrant FV changes, have outpaced low expectations; 2025 estimates may need upward revision for grant revenue and reduced dilution risk if CNSide launches on time .

Key Takeaways for Investors

• Liquidity de-risking: $15M equity financing plus CPRIT/DoD/NIH grants extend runway into mid-2026, reducing near-term financing overhang .
• Regulatory path for LM: completion of Phase 1 and RP2D supports potential expedited single-dose expansion and registrational planning; watch for EOP1 FDA meeting and multiple-dose data in 2025 .
• CNSide commercialization: targeted KOL-first launch in 2025 is a tangible revenue catalyst ahead of drug approvals; reimbursement and state licensures are key milestones .
• GBM momentum: Nature Communications publication enhances credibility; Phase 2 completion targeted 2025 with real-world control design under FDA dialogue .
• P&L dynamics: quarterly “beats” largely reflect grant revenue timing and non-cash warrant FV gains; monitor OpEx discipline and accounts payable trajectory .
• Supply chain redundancy: SpectronRx and Telix IsoTherapeutics secure Re-186 supply for late-stage trials and commercialization, mitigating manufacturing risk .
• Trading setup: Near-term catalysts—LM FDA meeting, LM multi-dose initiation, CNSide launch milestones and GBM enrollment completion—can drive sentiment and estimate revisions.

Sources: Q4 2024 8-K and press release ; Q4 earnings call transcript ; Q3 materials ; Q2 materials ; Q4 press releases .