Executive Summary

Q3 2025 delivered regulatory progress (EMA SAWP confirmed eligibility for EU conditional marketing authorization for iopofosine I‑131 in post‑BTKi WM) and pipeline execution (CLR‑125 Phase 1b initiated), alongside disciplined spending that reduced operating expenses and net loss; cash runway extended into Q3 2026 .
EPS beat vs S&P consensus: Q3 actual EPS of −$1.41 vs −$2.53 consensus (+$1.12 surprise); beats also in Q1 and Q2, with revenue expected at $0 given pre‑commercial stage operations (S&P Global) *.
Management reiterated U.S. accelerated approval strategy contingent on initiating the confirmatory Phase 3 (≈$10M to start, ≈$15M to reach initial enrollment, ≈$28M to full enrollment, ≈$40M total), while advancing EU CMA filing targeted for early/mid‑2026 and potential 2027 launch .
Near‑term catalysts: EU CMA submission prep, CLR‑125 TNBC patient dosing and early dosimetry data in 1H 2026, partnering discussions across U.S./EU regions, and potential U.S. NDA submission upon Phase 3 initiation; EMA/FDA statistics cited by management imply high approval odds (EU CMA ≈80%; FDA BTD AA ≈79%) .

What Went Well and What Went Wrong

What Went Well

EMA SAWP advised CMA submission would be acceptable for iopofosine I‑131 in post‑BTKi WM; “we received confirmation of our eligibility to file for conditional marketing approval in the EU” .
Balance sheet strengthened: raised ≈$12.7M in financings and subsequent warrant exercises; CFO: runway “adequate to fund budgeted operations into the third quarter of 2026” .
Pipeline milestones: initiated Phase 1b for CLR‑125 in TNBC; secured Actinium‑225 supply via ITM for CLR‑225 and advanced IND‑enabling work; RPDD for pediatric high‑grade glioma .

What Went Wrong

U.S. confirmatory Phase 3 remains funding‑gated; management detailed cost milestones (≈$10M to initiate, ≈$15M to reach regulatory‑acceptable “ongoing” enrollment, ≈$28M full enrollment, ≈$40M total) .
CLR‑225 Phase 1 pancreatic study is “phase‑one ready” but gating item is financing; trial start awaits capital despite supply/logistics readiness .
Pre‑revenue profile persists; net loss still −$4.44M though improved YoY; reliance on warrant/financing activity introduces dilution concerns for investors .

Financial Results

Metric	Q1 2025	Q2 2025	Q3 2025
Research & Development ($USD Millions)	$3.43	$2.39	$2.52
General & Administrative ($USD Millions)	$2.97	$3.65	$2.33
Total Operating Expenses ($USD Millions)	$6.40	$6.04	$4.85
Loss from Operations ($USD Millions)	$(6.40)	$(6.04)	$(4.85)
Net Loss ($USD Millions)	$(6.60)	$(5.45)	$(4.44)
EPS (Basic, $USD)	$(0.14)	$(3.39)	$(1.41)
Cash & Equivalents ($USD Millions)	$13.90	$11.00	$12.60

Notes:

Company reported no product revenue; operating performance driven by R&D/G&A and other non‑cash items (warrant valuation/issuance) .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
EU CMA filing for iopofosine I‑131 (post‑BTKi WM)	2026	Decision to submit expected late Q3/early Q4 2025	SAWP advised CMA submission acceptable; submit early/mid‑2026; potential 2027 EU launch	Raised (eligibility confirmed; timeline set)
U.S. NDA (accelerated approval)	Upon Phase 3 initiation	Plan to pursue AA NDA once confirmatory trial underway; contingent on funding	Reaffirmed; ≈$10M to initiate, ≈$15M to initial enrollment, ≈$28M full enrollment, ≈$40M total	Maintained with quantified cost milestones
Phase 3 design (WM)	18–24 months enrollment	Comparator RCT, ≈100 pts per arm	Reiterated comparator design, ≈100 pts/arm	Maintained
CLR‑125 (TNBC) Phase 1b	Start/Dosing	Planned late 2025/early 2026	Initiated Phase 1b; dosimetry/three dose arms; dosing imminent	Raised (trial initiation)
CLR‑225 (Pancreatic) Phase 1	Start	Phase‑1 ready; contingent on funding	Financing remains gating item; ITM supply secured; IND‑enabling complete	Maintained (operational readiness improved)
Cash runway	Liquidity	Into Q2 2026	Into Q3 2026	Raised

Earnings Call Themes & Trends

Topic	Previous Mentions (Q1 2025 and Q2 2025)	Current Period (Q3 2025)	Trend
Regulatory strategy (EU/U.S.)	Q1: Pursuing EMA conditional approval; exploring strategic alternatives . Q2: FDA Breakthrough; plan AA NDA upon Phase 3 initiation .	EMA SAWP eligibility for CMA confirmed; U.S. AA plan reaffirmed with specific cost/enrollment thresholds .	Improving regulatory clarity
Partnering	Q1: Engaged Oppenheimer to explore alternatives . Q2: Active discussions with partners .	Management “slow‑played” until EU clarity; now multiple parties advanced in diligence across U.S./EU/global .	Accelerating
Financing & runway	Q1: Cash into Q4 2025 . Q2: Cash into Q2 2026 .	Raised ≈$12.7M; runway into Q3 2026 .	Strengthening
R&D execution (CLR‑125/CLR‑225)	Q2: CLR‑125 protocol submitted; CLR‑225 phase‑1 ready .	CLR‑125 Phase 1b initiated; CLR‑225 ready pending financing; Actinium‑225 supply secured .	Advancing
Supply chain (isotopes)	Q2: Multi‑isotope supply agreement with Nusano .	ITM Actinium‑225 supply agreement for CLR‑225 .	Diversifying/secured
Pricing/HTA context	—	MFN/global price strategies; HTA comparator requirements in EU; EU prices often 50% of U.S. .	Building commercial groundwork
Clinical efficacy narrative (WM)	Q1: MRR 59% in BTKi‑treated subset . Q2: 12‑month follow‑up completed; independent review committee .	PFS last disclosed 11.4 months (at 8‑month follow‑up); 12‑month follow‑up complete but not updated to avoid promotional risk pre‑submission .	Stable; withholding new PFS until filing

Management Commentary

“We received confirmation of our eligibility to file for conditional marketing approval in the EU…a major milestone that could bring iopofosine to patients as early as 2027.” — Jim Caruso .
“We ended the quarter with cash and cash equivalents of $12.6 million…now expect that our cash on hand is adequate to fund budgeted operations into the third quarter of 2026.” — CFO Chad Kolean .
“To initiate the study itself…approximately about $10 million…about $15 million to the point at which we would have sufficient enrollment for the agency to act…$28 million to get the full enrollment and then $40 million to see out the rest of the study.” — Jarrod Longcor .
“We have initiated the phase 1b study for CLR 125 in triple negative breast cancer…we expect to start dosing patients imminently.” — Jarrod Longcor .
“We have…entered into a supply agreement with ITM…to help support our alpha‑labeled phospholipid ether radiopharmaceutical candidates.” — Jarrod Longcor .

Q&A Highlights

EMA scope and line of therapy: SAWP focused on post‑BTKi WM; in EU, BTKi typically second/third line; company has robust post‑BTKi data supporting CMA filing .
U.S. Phase 3 cost and timing: ≈$10M to initiate, ≈$15M to reach 10–25% enrollment deemed “ongoing,” ≈$28M full enrollment, ≈$40M total; BTD/fast track could enable ~6‑month review post submission .
Pricing strategy/HTA: Management highlighted MFN/global pricing trends and EU HTA comparator research requirements; indicated EU prices can be 50% of U.S. in some cases .
Partnering cadence: Discussions advanced post EU regulatory clarity; multiple parties completed/nearly completed diligence across U.S./EU/global scopes .
CLR‑225 gating: Financing remains the gating factor; CRO/sites/submissions ready; Actinium‑225 supply secured to avoid future delays .
PFS disclosure: Most recent public PFS was 11.4 months at 8‑month follow‑up; 12‑month follow‑up complete, but company will avoid updating PFS pre‑NDA to prevent promotional concerns .

Estimates Context

Metric	Q1 2025	Q2 2025	Q3 2025
Primary EPS Consensus Mean ($)	−4.90*	−3.70*	−2.53*
Actual EPS ($)	−0.14	−3.39	−1.41
EPS Surprise ($)	+0.70	+0.31	+1.12
Primary EPS – # of Estimates	3*	3*	4*
Revenue Consensus Mean ($USD Millions)	0.00*	0.00*	0.00*

Values with asterisk () retrieved from S&P Global.
Interpretation: CLRB delivered EPS beats in all three quarters, with the largest in Q3 (+$1.12), while revenue remained at $0 given the pre‑commercial stage (S&P Global; actuals consistent with company’s non‑revenue profile) .

Key Takeaways for Investors

Regulatory de‑risking: EMA SAWP eligibility for EU CMA (post‑BTKi WM) and FDA Breakthrough for WM underpin a credible path to approvals; management cited ~80% EU CMA and ~79% U.S. BTD AA success rates as context .
Near‑term execution priorities: Fund and initiate U.S. Phase 3 to enable AA NDA; prepare EU CMA submission for early/mid‑2026; partner(s) could provide non‑dilutive capital and commercial capabilities .
Pipeline momentum: CLR‑125 Phase 1b TNBC trial initiated with dosimetry‑driven dosing; initial patient dosing expected imminently and data through 2026; CLR‑225 ready pending financing with Actinium‑225 supply secured .
Financial trajectory: Operating expenses and net loss trending down; cash runway to Q3 2026 following ~$12.7M raised and $5.8M warrant exercises .
EPS performance: Q3 delivered a significant EPS beat vs consensus; sustained beats in Q1–Q3 suggest estimates may need to adjust for lower opex and non‑cash warrant effects (S&P Global) *.
Commercial/pricing groundwork: EU HTA comparator requirement and MFN dynamics point to disciplined global pricing strategy; EU price often below U.S. (management indicated up to ~50% in some cases) .
Trading lens: Upcoming EU CMA submission milestones, any U.S. Phase 3 funding/partnering announcements, and CLR‑125 early dosimetry data are likely stock catalysts; headline risk remains around financing timing and partner structure .

Additional Data Exhibits

Q3 2025 Press Release Highlights (Operating data)

R&D $2.52M; G&A $2.33M; Net Loss $4.44M; EPS −$1.41; Cash $12.60M .

Prior Quarters (for trend)

Q2 2025: R&D $2.39M; G&A $3.65M; Net Loss $5.45M; EPS −$3.39; Cash $11.00M .
Q1 2025: R&D $3.43M; G&A $2.97M; Net Loss $6.60M; EPS −$0.14; Cash $13.90M .

Strategic/Regulatory Milestones

EMA SAWP advised CMA acceptable; EU launch potential in 2027 .
FDA BTD for WM; AA NDA planned once Phase 3 underway .
CLR‑125 Phase 1b initiated (TNBC); ITM Actinium‑225 supply secured (CLR‑225) .

Cellectar Biosciences, Inc. (CLRB)·Q3 2025 Earnings Summary