Executive Summary

Cellectar secured FDA alignment on the accelerated approval pathway for iopofosine I-131 in Waldenström macroglobulinemia, finalizing a randomized confirmatory study (100 pts/arm) with conditional approval based on major response rate (MRR) and full approval upon PFS; total cost $40–$45M, ~$30M to full enrollment .
Management acknowledged a prior regulatory setback that delayed the NDA but emphasized “very productive” March 2025 FDA interactions and is evaluating non‑dilutive licensing deals (including global/regional constructs) to fund the pivotal program .
Balance sheet extended via 2024 warrant proceeds ($44.1M in Jan; $19.4M in Jul) and a 60% headcount reduction targeting ~$7.5M annual savings; cash runway into 4Q25 per management .
No discrete Q4 financials or product revenue were disclosed; the company reported FY24 results (net loss $(44.6)M; basic EPS $(1.22)$) and did not provide revenue guidance. S&P Global consensus EPS/revenue for Q4 was unavailable during this session (access limit), so no beat/miss assessment is possible .

What Went Well and What Went Wrong

What Went Well

FDA agreement on an efficient, two‑stage approval design for iopofosine I‑131 (MRR for accelerated approval; PFS for full approval) with a 100-patient per arm RCT; management expects rapid enrollment and plans to be ready to initiate in 2025 .
Strong Phase 2 CLOVER‑WaM efficacy: ORR 83.6% and MRR 58.2% vs agreed 20% MRR threshold; durable responses with manageable toxicity profile across subgroups, supporting regulatory path and partnering interest .
Capital and cost discipline: $63.5M gross cash inflows from warrant exercises/inducement financing in 2024 and ~60% headcount reduction targeting ~$7.5M annual savings, extending runway into 4Q25 .

“Based upon this regulatory clarity … we continue to evaluate inbound inquiries regarding a range of collaborations for iopofosine I 131, which we view as an attractive, non-dilutive funding approach.” — CEO James Caruso .

What Went Wrong

NDA timing: Management acknowledged a regulatory setback that delayed the intended H2’24/H1’25 NDA and now requires MRR data from a new randomized study for accelerated approval, pushing the pathway to conditional approval post-enrollment .
Listing risk: Company below Nasdaq $1 bid; pursuing 180-day remediation with possible additional 180 days and will seek shareholder approval for a reverse split in June 2025 if needed .
Elevated G&A from commercialization build: FY24 G&A $25.6M vs $11.7M in FY23, necessitating restructuring to reduce burn while maintaining key development milestones .

Financial Results

Annual results (FY)

Metric	FY 2023	FY 2024
Cash and Cash Equivalents ($M)	$9.6	$23.3
Research & Development Expense ($M)	$27.3	$26.1
General & Administrative Expense ($M)	$11.7	$25.6
Net Loss ($M)	$(42.8)	$(44.6)
Net Loss per Share — Basic ($)	$(3.50)	$(1.22)
Net Loss per Share — Diluted ($)	$(3.50)	$(1.40)

Notes: No product revenue disclosed in FY24/23 press materials. Company emphasized cash runway into 4Q25 following financings and restructuring .

Quarterly operating metrics (select)

Metric	Q3 2023	Q2 2024	Q3 2024
R&D Expense ($M)	$7.03	$8.20	$5.49
G&A Expense ($M)	$2.38	$6.40	$7.83
Total Operating Expenses ($M)	—	—	$13.33
Net Loss per Share — Basic ($)	$(1.55)	—	$(0.37)
Net Loss per Share — Diluted ($)	$(1.55)	—	$(0.40)

Footnotes: Q2 2024 press materials disclosed R&D and G&A but did not provide full quarterly EPS/Net Loss; Q4 2024 was reported on a full-year basis without discrete quarterly P&L .

KPIs and program economics

KPI	Value	Source
CLOVER‑WaM ORR	83.6%
CLOVER‑WaM MRR	58.2% (vs 20% threshold)
Confirmatory Study Design	RCT, 100 pts/arm; MRR for AA, PFS for full
Enrollment Timeline	~24 months to full enrollment
AA Timing Milestone	MRR assessment ~30 days after last patient enrolled
Total Study Cost	$40–$45M (≈$30M to full enrollment)
Cash Runway	Into 4Q25 (post restructuring)

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
NDA filing for WM (iopofosine)	2024–2025	Plan to file WM NDA in 4Q24; expect accelerated 6‑month review; prep for 2025 launch	Accelerated approval requires MRR data from new RCT; NDA submission expected post‑enrollment for conditional approval; 100 pts/arm, MRR then PFS	Lowered/Delayed
Regulatory Path (design)	2025	Not finalized	FDA‑aligned RCT design, endpoints, costs and timelines agreed	Established/Clarified
Cash Runway	2025	Into 2Q25	Into 4Q25 with ~$7.5M annual savings from ~60% headcount reduction	Raised/Extended
Pivotal RCT Cost	2025+	Not disclosed	$40–$45M total; ~$30M to full enrollment	New
Phase 1 Starts (alpha/Auger)	1H25	“As conditions allow”	Prepared to initiate in 1H25; IND for CLR121225 1H25; CLR121125 ready for Phase 1b/2a TNBC	Timed/Scoped
Nasdaq Remediation	2025	Not discussed	180‑day remediation (possible +180 days); seeking reverse split authorization at June 2025 AGM if needed	New

Earnings Call Themes & Trends

Topic	Q2 2024 (Prior)	Q3 2024 (Prior)	Q4 2024 (Current)	Trend
Regulatory path for WM	File NDA in 4Q24; target accelerated 6‑mo review	NDA “in coming months” after positive pivotal data	NDA delayed; FDA‑aligned RCT (100/arm); AA on MRR; full on PFS	From imminent NDA → RCT‑first accelerated path
Funding/licensing	—	$19.4M raised; potential extra $73.3M via warrants	Active discussions on global/regional licensing; non‑dilutive preferred	Toward partnership funding
Commercial build vs. costs	Building commercial infra (higher G&A)	G&A elevated for launch prep	60% RIF; ~$7.5M annual savings; runway to 4Q25	Pivot to conserve cash
Nasdaq listing	—	—	Remediation plan; reverse split authorization if needed	New risk disclosed
Pipeline (alpha/Auger)	—	—	IND for CLR121225 1H25; CLR121125 ready for TNBC Phase 1b/2a	Advancing solid tumor programs
Manufacturing/supply	—	Supply/mfg agreements (SpectronRx; NorthStar)	Sole‑source supplier risk listed in forward‑looking statements	De‑risking with agreements; risk remains

Management Commentary

“We have achieved alignment on the design of a Phase 3 study required for market approval…conditional accelerated approval is based upon major response rate…full approval [upon] progression free survival.” — COO Jarrod Longcor .
“Based upon this regulatory clarity…we continue to evaluate inbound inquiries regarding a range of collaborations…an attractive, non‑dilutive funding approach.” — CEO James Caruso .
“We implemented a cost savings strategic restructuring, which reduced headcount by approximately 60%. We expect…savings of approximately $7.5 million annually and to extend our cash runway into the fourth quarter of 2025.” — CFO Chad Kolean .
“Accelerated approval will require data from the additional study as well.” — COO Jarrod Longcor (Q&A) .
Comparator arm clarity: investigator’s choice between two NCCN options; one is rituximab monotherapy (INNOVATE MRR ~22%; PFS ~6 months) .

Q&A Highlights

Accelerated approval requires MRR data from the new RCT, not solely CLOVER‑WaM; timeline: ~24 months to full enrollment, then ~30 days for MRR assessment .
Comparator arms: investigator choice between rituximab monotherapy and one additional rituximab‑based regimen; allocation may be uneven, reflecting real‑world utilization .
Cash runway includes IND filings and initial Phase 1 starts; each Phase 1 estimated at ~$4.5M; licensing structures under consideration range from global to regional with standard upfront/milestones/royalties and partner funding of pivotal study and CMC .
Rationale for pancreatic as alpha‑emitter first: high unmet need and consistently strong preclinical efficacy and uptake across PDAC models .

Estimates Context

S&P Global consensus for Q4 2024 EPS and revenue was unavailable during this session due to access limits, so we cannot assess beats/misses versus Street. The company did not disclose discrete Q4 revenue/EPS in its year‑end release and provides no product revenue guidance at this stage .
Values would normally be retrieved from S&P Global; due to access limitations, consensus was not included here. Values retrieved from S&P Global would be noted with an asterisk and S&P Global disclaimer.

Key Takeaways for Investors

Regulatory de‑risking: FDA‑aligned accelerated/full approval design for iopofosine in WM materially clarifies the path to market; execution risk now centers on RCT enrollment and comparator performance .
Funding path: Active pursuit of non‑dilutive licensing (global/regional) could remove pivotal trial overhang ($40–$45M) and extend runway beyond 4Q25 .
Cost discipline: Post‑restructuring savings (~$7.5M/yr) and prior warrant proceeds improve durability into key 2025–2027 catalysts .
Near‑term catalysts: RCT initiation timing and site activation; potential partnering announcement(s); EMA alignment; Phase 1 initiations/early dosimetry data in TNBC and PDAC .
Risk factors: Nasdaq compliance and possible reverse split, sole‑source isotope supply risk, and the need to execute a 200‑patient RCT in a relatively rare disease .
Narrative shift: From imminent NDA (Q2/Q3) to RCT‑first AA path (Q4 call), but clinical de‑risking remains strong given CLOVER‑WaM efficacy and tolerability profile .
Trading lens: Stock likely most sensitive to partnership terms/timing, RCT start pace, and visible de‑risking in Phase 1 solid tumor programs; negative surprise risk from listing remediation or funding slippage .

Cellectar Biosciences, Inc. (CLRB)·Q4 2024 Earnings Summary