Executive Summary

Q1 2025 results showed a narrower loss and lower OpEx: net loss improved to $19.7M ($0.51) vs $30.5M ($1.31) in Q1 2024 as R&D fell to $16.1M and G&A to $9.0M; revenue remained de minimis at $0.07M from collaborations . Versus S&P Global consensus, EPS beat by ~$0.23 (actual -$0.51 vs -$0.738*) and revenue modestly topped ($0.065M vs $0.010M*) as the business remains pre-commercial. Values retrieved from S&P Global.
Regulatory timeline intact: device DV testing for CELLECTRA is underway and expected to complete 1H25, with rolling BLA for INO-3107 planned to begin mid-2025; management is targeting FDA file acceptance by year-end 2025 and, if priority review is granted, a potential mid-2026 PDUFA date .
Cash runway remains into Q1 2026 with estimated Q2 2025 net cash burn of ~$22M (sequentially lower vs ~$27M projected for Q1 2025), supporting execution through BLA submission and confirmatory trial start .
Thesis catalysts: completion of DV testing and BLA rolling start, initiation of U.S. confirmatory trial (>20 sites), continued physician/KOL engagement (COSM and other conferences), and visibility on EU/UK pathways; early DMAb PoC data provides optionality beyond 3107 .

What Went Well and What Went Wrong

What Went Well
- Regulatory progress and timeline clarity: “We remain on track to submit our BLA for INO-3107… begin rolling submission in mid-2025… receive file acceptance by the end of this year… If we receive priority review, it could allow for a PDUFA date in mid-2026” (CEO) .
- Cost discipline and loss improvement: Total OpEx fell 20% YoY to $25.1M (from $31.5M) on lower INO-3107 manufacturing/immunology, legal, and stock comp; net loss improved to $19.7M vs $30.5M YoY .
- Strengthening clinical narrative: durability (year 2–3) and immunology data highlighted at major venues (e.g., Nature Communications; COSM) underpin the surgery-reduction benefit and commercial readiness efforts .
What Went Wrong
- Still pre-revenue with minimal top line ($0.07M collaborations); commercial inflection hinges on approval and launch timing .
- Balance sheet draw: cash and ST investments declined to $68.4M from $94.1M QoQ as the company advances 3107/device activities .
- Competitive and regulatory uncertainties: Q&A flagged competitor timing in RRP and label constructs (e.g., “surgery-sparing” claim) as outstanding discussions with FDA; ex-U.S. regulators expect placebo-controlled data .

Financial Results

Actuals trend (oldest → newest)

Metric	Q1 2024	Q4 2024	Q1 2025
Revenue ($USD Millions)	$0.00	$0.12	$0.07
Total Operating Expenses ($USD Millions)	$31.49	$20.50	$25.12
Net Loss ($USD Millions)	$30.47	$19.40	$19.69
Diluted EPS ($)	$(1.31)	$(0.65)	$(0.51)
R&D Expense ($USD Millions)	$20.91	$12.90	$16.09
G&A Expense ($USD Millions)	$10.57	$7.60	$9.02

Q1 2025 vs S&P Global consensus

Metric	Q1 2025 Actual	Q1 2025 Consensus
Revenue ($USD Millions)	$0.07	$0.01*
EPS ($)	$(0.51)	$(0.738)*

Values retrieved from S&P Global.

Revenue breakdown (Q1 2025)

Revenue Component	Q1 2025 ($USD Millions)
Collaborative arrangements	$0.07

Liquidity and share metrics (context)

Metric	Q3 2024	Q4 2024	Q1 2025
Cash + ST Investments (period-end, $USD Millions)	$84.8	$94.1	$68.4
Common Shares Outstanding (period-end, Millions)	26.1	36.1	36.7

Notes: Q1 2025 other non-operating items included change in fair value of warrant liability (+$3.71M) and interest income ($0.81M) .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash runway	Company-level	Into Q1 2026	Into Q1 2026	Maintained
Net cash burn	Q1 2025 vs Q2 2025	Q1’25 ≈ $27M	Q2’25 ≈ $22M	Lowered (improved)
Device DV testing (CELLECTRA)	1H 2025	DV testing to complete enabling BLA modules	DV testing underway; anticipated complete 1H25	Maintained/timing reiterated
BLA rolling submission (INO-3107)	2025	Begin mid-2025; complete 2H25; request priority review	Begin mid-2025; complete 2H25; seek priority review; target FDA acceptance by YE25	Maintained/clarified acceptance goal
Potential PDUFA (if priority review)	Mid-2026	Mid-2026 potential	Mid-2026 potential	Maintained

Earnings Call Themes & Trends

Topic	Previous Mentions (Q-2 and Q-1)	Current Period (Q1 2025)	Trend
INO-3107 BLA timeline	Target mid-2025 rolling BLA; non-device modules drafted; DV testing to enable submission	On track: DV testing initiated; start rolling mid-2025; aim file acceptance by YE25; potential mid-2026 PDUFA if priority	On track/clarified milestones
Device DV testing	Resolved single-use array issue; DV step next	DV testing “underway,” significant for device-related BLA modules	Executing
Confirmatory trial	Planning; FDA alignment ex-US evolving	Placebo-controlled, 2:1 randomization; >20 U.S. sites; IND update after DV; ~100 patients targeted	Advancing design/operational prep
Market size/epi	RRP ~14k U.S. prevalent cited historically	Company research suggests 14k underestimates; no diagnostic code complicates sizing; incidence ~1.8/100k/yr	Larger TAM possible; ongoing research
Competitive landscape	Noted need for preferred product, durability, tolerability	Priority review rationale vs competitor (neutralizing Ab/microenvironment issues may limit competitor efficacy)	Confident differentiation narrative
Pricing/access	Commercial readiness planning underway	Payers open to rare-disease pricing analog (Ogsiveo $360k/yr) for initial 4-dose regimen; redosing TBD	Early payer receptivity
Ex-U.S. strategy	EMA CAT certification; UK ILAP designation	EU/UK expect placebo-controlled data for approval	Pathway defined; trial evidence required
Field/KOL engagement	Building CCO org; conference presence	MSL deployment planned; active at National HPV, ELS, COSM, ASGCT	Increasing physician outreach
Platform optionality (DMAb)	Interim PoC durability (72 weeks), no ADA; partner funding	Reiterated durability and tolerability; not pursuing COVID DMAb; broader protein/ERT potential	Positive optionality maintained

Management Commentary

“We remain on track to submit our BLA for INO-3107… begin rolling submission in mid-2025… receive file acceptance by the end of this year. This would allow for a PDUFA date in mid-2026 if we receive priority review.” – CEO Jacqueline Shea .
“We have begun manufacturing the updated commercial-grade arrays and initiated DV testing… significant component of the device-related BLA modules… all non-device modules [are drafted].” – CMO Michael Sumner .
“Operating expenses dropped from $31.5M in Q1 2024 to $25.1M in Q1 2025… net loss was $19.7M or $0.51 per share… cash, cash equivalents and short-term investments were $68.4M… runway into Q1 2026.” – CFO Peter Kies .
“After reviewing our data, many laryngologists commented that ~8 out of 10 patients achieved a 50%–100% reduction in surgeries… patient-centric regimen… administered in physician’s office.” – CCO Steve Egge .

Q&A Highlights

Label/claim: FDA recognizes the clinical benefit is reduction in surgeries; too early to predict “surgery-sparing” label language, but all paths point to surgery reduction being central .
Epidemiology/TAM: 14k U.S. prevalent is likely an underestimate; no diagnostic code complicates counts; continued research; incidence ~1.8/100k/year .
Priority review vs competitor: Management believes unique patient populations and competitor vulnerabilities (neutralizing antibodies, papilloma microenvironment) support accelerated pathway rationale for 3107 .
Ex-U.S. pathway: EU/UK expect placebo-controlled data; confirmatory trial designed with 2:1 randomization and ≥2 surgeries prior year criteria .
Pricing and access: Payer work suggests rare disease analog pricing (SpringWorks’ Ogsiveo $360k/yr) is appropriate for initial 4 doses; redosing pricing not yet guided .

Estimates Context

Q1 2025 delivered a meaningful EPS beat: actual $(0.51) vs S&P Global consensus $(0.738); revenue was immaterial but exceeded consensus ($0.065M vs $0.010M). Given minimal revenue, estimate revisions should focus on OpEx cadence and cash burn trajectory into the BLA and confirmatory trial. Values retrieved from S&P Global.

Key Takeaways for Investors

Regulatory path intact with near-term DV completion and mid-2025 rolling BLA start; YE25 file acceptance target frames the approval/launch setup for 2026 (priority review case) .
Cost control continues to narrow losses; Q1 OpEx down 20% YoY and EPS improved to $(0.51); cash runway into Q1 2026 supports execution through key catalysts .
Clinical durability and immunology evidence (years 2–3, Nature Communications publication) reinforce the core value proposition (surgery reduction) aiding payer/provider adoption prep .
Commercial groundwork is advancing (MSLs, KOL conferences); early payer feedback aligns with rare-disease pricing analogs, supporting initial regimen economics .
Competitive dynamics understood; management articulates a clear differentiation thesis for 3107 and is preparing confirmatory trial to support broader claims and ex-U.S. approvals .
Watch for sequential burn improvement ($22M guided for Q2 vs $27M guided prior) and financing optionality given pre-commercial status .
Near-term catalysts for trading: DV testing completion, rolling BLA initiation, confirmatory trial start/IND update, ongoing conference disclosures (e.g., COSM durability, ASGCT data) .