Executive Summary

Q4 2024 update focused on pipeline and liquidity: cash and cash equivalents were approximately $60.0M at December 31, 2024, while the pivotal Phase 3 PFS primary endpoint readout for Cylembio (IO102-IO103) shifted to Q3 2025 as PFS events accrued more slowly than expected .
Management still targets a 2025 BLA submission (subject to positive data) and a potential U.S. launch in 2026, maintaining the regulatory path despite the PFS timing slide .
Liquidity improved post-quarter via up to €57.5M of EIB debt (8% PIK; three committed tranches plus a €20M uncommitted accordion), extending runway into Q2 2026; warrants accompany each tranche and certain tranches require clinical/financing milestones .
A Nasdaq minimum bid-price deficiency notice in late December introduces listing risk; IOBT has until June 24, 2025 to regain compliance or seek transfer to the Capital Market for an additional period .

What Went Well and What Went Wrong

What Went Well

Pipeline execution: enrollment completed ahead of schedule in the perioperative Phase 2 basket trial (IOB-032/PN‑E40; 95 patients) with initial data expected in H2 2025; SCCHN Phase 2 met ORR primary endpoint and NSCLC showed ~50% without progression at 12 months, with safety consistent with prior studies .
Balance sheet resilience: secured up to €57.5M from the EIB (three committed tranches totaling €37.5M and a €20M accordion), extending cash runway into Q2 2026, supporting pre-commercialization activities .
Strategic clarity and branding: adoption of Cylembio as U.S. brand name for IO102‑IO103; management reiterated intent to submit a BLA in 2025 and prepare for a 2026 launch, pending positive data .
- “Pending positive data, we expect to submit a BLA to the US FDA by the end of the year and a potential launch in the US in 2026.” — CEO Mai‑Britt Zocca .

What Went Wrong

Timing slide on the catalyst: Phase 3 PFS primary endpoint readout moved from 1H 2025 to Q3 2025 due to slower accumulation of PFS events, pushing the major efficacy catalyst into later 2025 .
Listing overhang: Nasdaq notified IOBT on Dec 26, 2024 of non-compliance with the $1.00 minimum bid for 30 consecutive trading days; IOBT has a 180‑day cure period to regain compliance, creating optical and technical risk .
Continued losses pre-commercialization: Q3 2024 net loss of $24.0M (vs. $21.7M in Q3 2023) with R&D $20.2M and G&A $6.3M; Q2 2024 net loss was $20.7M (vs. $21.2M in Q2 2023), underscoring ongoing burn prior to revenue .

Financial Results

Note: For Q4 2024, IOBT provided preliminary cash only; FY 2024 financial statements were not yet finalized/audited as of the March 4, 2025 8-K. No Q4 2024 P&L was furnished .

Cash and liquidity

Metric	Q2 2024	Q3 2024	Q4 2024
Cash and cash equivalents ($M)	$100.7	$80.2	~$60.0

P&L snapshot (quarterly)

Metric	Q2 2023	Q2 2024	Q3 2023	Q3 2024
Net loss ($M)	$(21.2)	$(20.7)	$(21.7)	$(24.0)
R&D expense ($M)	$16.5	$15.8	$17.7	$20.2
G&A expense ($M)	$5.3	$5.7	$5.8	$6.3
Net loss per share (EPS, $)	$(0.74)	$(0.31)	$(0.43)	$(0.36)

Operating commentary (context)

In Q3 2024, operating losses were driven by ongoing Phase 3 and Phase 2 execution; no product revenues were provided in the releases (loss from operations equaled total operating expenses) .
Cash runway: prior expectation “into Q4 2025” (pre‑EIB) was updated to Q2 2026 after EIB debt facility announcement .

KPIs and development milestones (selected)

KPI	Prior Period(s)	Current (Q4 2024)
Phase 3 (IOB‑013/KN‑D18) status	Enrollment completed (407 pts); IDMC interim (Q3’24) recommended continuation without modifications	PFS primary readout now expected in Q3 2025 due to slower PFS event accrual
Perioperative Phase 2 (IOB‑032/PN‑E40)	Enrollment progressing	Enrollment completed ahead of schedule (95 pts); initial data H2 2025
Phase 2 SCCHN (IOB‑022/KN‑D38)	Data accepted for ESMO 2024	Primary endpoint ORR met; encouraging PFS; safety consistent
Phase 2 NSCLC (IOB‑022/KN‑D38)	Plan to share updates in fall 2024	~50% without disease progression at 12 months; safety consistent
Cash runway	Into Q4 2025 (pre‑EIB)	Into Q2 2026 with EIB tranches

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Phase 3 PFS primary readout timing (Cylembio + pembro in advanced melanoma)	Study readout	1H 2025	Q3 2025 (due to slower PFS events)	Lowered (timing slid)
BLA submission timing (Cylembio)	2025	2025, pending positive data	By year‑end 2025, pending positive data	Maintained
U.S. launch timing (Cylembio)	2026	2026, subject to approval	2026, subject to approval	Maintained
Cash runway	N/A	Into Q4 2025 (pre‑EIB)	Into Q2 2026 with EIB facility	Raised (extended)
Financing	N/A	N/A	Up to €57.5M EIB facility (8% PIK; 3 committed tranches + €20M accordion)	New

Why: The PFS timing shift stems from fewer-than-expected PFS events; runway extension is driven by the new EIB debt facility .

Earnings Call Themes & Trends

Note: No Q4 2024 earnings call transcript was available in the document set; themes are based on company filings and press releases.

Topic	Previous Mentions (Q2 2024, Q3 2024)	Current Period (Q4 2024)	Trend
Phase 3 timeline	Interim analysis review planned/complete; PFS readout projected 1H 2025	PFS readout now expected Q3 2025 due to slower event accrual	Timing slide (later)
Regulatory path (BLA)	BLA in 2025 pending positive data	BLA by YE 2025 reiterated	Maintained
Safety/efficacy signals outside melanoma	SCCHN/NSCLC data progressing; ESMO/SITC updates	SCCHN ORR met; NSCLC ~50% no progression at 12 months; safety consistent	Strengthening dataset
Perioperative program	Enrollment ongoing	Enrollment completed; initial data H2 2025	Positive execution
Financing & runway	Runway into Q4 2025	EIB debt up to €57.5M extends runway to Q2 2026	Improved liquidity
Listing status	—	Nasdaq bid‑price deficiency notice (Dec 26, 2024)	New risk

Management Commentary

Strategic focus and timing: “With the primary endpoint readout of our pivotal Phase 3 trial … now expected in the third quarter, we expect 2025 could be an exciting year for IO Biotech. Pending positive data, we expect to submit a BLA to the US FDA by the end of the year and a potential launch in the US in 2026.” — Mai‑Britt Zocca, CEO .
Platform vision: “Our investigational therapeutic cancer vaccines are designed … targeting both immune‑suppressive cells in the TME and cancer cells … demonstrating promising activity when combined with an anti‑PD‑1 therapy.” — CEO .
Perioperative strategy: “Enrollment completed early … exploring the potential … across a range of solid tumors at an earlier stage of disease progression.” — CEO (Jan 9, 2025 PR) .

Q&A Highlights

No Q4 2024 earnings call transcript was available in the document set; no Q&A content to summarize [ListDocuments returned none].

Estimates Context

We attempted to retrieve S&P Global consensus for Q4 2024 and recent quarters, but the data was unavailable due to access limits at the time of analysis; therefore, comparisons to consensus EPS/revenue could not be included. Values from S&P Global were unavailable at time of request.
Historical company materials for Q2/Q3 2024 provided operating expenses and net losses, but no product revenue lines; Q4 2024 financial statements were not yet finalized as of the March 4, 2025 8‑K .

Key Takeaways for Investors

The key 2025 catalyst has moved to Q3: Phase 3 PFS readout is now expected in Q3 2025 due to slower event accrual; this is the dominant stock driver near‑term .
Regulatory path intact: Company reiterates BLA submission by YE 2025 (pending a positive PFS outcome), with potential 2026 U.S. launch; clinical breadth in SCCHN/NSCLC and perioperative melanoma adds optionality .
Liquidity extended but with structure: EIB facility (8% PIK with warrant coverage/milestones) pushes runway into Q2 2026, reducing near‑term financing risk but introducing warrant overhang and milestone dependencies for later tranches .
Technical/listing overhang: Nasdaq bid‑price deficiency notice could weigh on sentiment until cured; a reverse split or transfer to Capital Market remains an available path if needed .
Execution signals outside melanoma: SCCHN ORR met and NSCLC durability signal (12‑month progression-free ~50%) support platform credibility; initial perioperative data in H2 2025 provides a secondary set of catalysts .
Cash cadence still matters: Absent revenue, quarterly losses continue (e.g., Q2/Q3 2024 net losses $20.7M/$24.0M), so development milestones and financing cadence will shape dilution expectations .
Watch for clarity on: Phase 3 operational updates, EIB tranche draws/milestones, any strategic partnerships, and listing compliance steps; all can influence near‑term trading setup .

Supporting documents and filings cited:

Q4 2024 business highlights press release and 8‑K (cash, timing, runway):
EIB debt facility terms and runway impact:
Nasdaq minimum bid‑price notice:
Prior quarters’ financials (Q2/Q3 2024):

IO Biotech, Inc. (IOBT)·Q4 2024 Earnings Summary