Sign in

You're signed outSign in or to get full access.

IB

Inmune Bio, Inc. (INMB)·Q4 2024 Earnings Summary

Executive Summary

  • INmune Bio delivered a clean year-end update with minimal revenue and a narrower timeline to the AD02 Phase II top-line Alzheimer’s readout, now specified as “June 2025,” positioning data as the near-term stock catalyst .
  • Liquidity remains the key operational risk but improved: $20.9M cash at 12/31/24, $5.4M added via ATM post year-end, and ~3.9M warrants that could raise ~$30M on acceleration tied to positive AD02 data .
  • Q4 EPS beat S&P Global consensus (−$0.40 vs −$0.54), and FY EPS (−$2.11) was better than consensus (−$2.248); revenue remains de minimis and non-core to the investment case (XPro AD02 efficacy/safety is the catalyst) [GetEstimates]* .
  • Strategic progress across platforms: AD02 enrollment at 208 patients with safety reaffirmed; INKmune progressed to Phase II dosing with strong tolerability; CORDStrom BLA targeted for early 2026 with preparations underway, all framing mid-’25 into ’26 as event-heavy .

What Went Well and What Went Wrong

  • What Went Well
    • AD02 on track: “We will provide top-line results in June” with both EMACC and CDR endpoints planned for the initial release; management emphasized robust data quality and endpoint readiness .
    • Financing flexibility: $29.9M raised in 2024 plus ~$5.4M via ATM in 1Q25; ~3.9M warrants could add ~$30M if accelerated on positive AD02 data .
    • Platform breadth: INKmune entered Phase II dosing with excellent safety to date; CORDStrom in-licensed data and orphan/RPD designations support a BLA path, adding a nearer-term potential commercial asset .
  • What Went Wrong
    • Cash burn increased: FY24 net loss widened to ~$42.1M (from ~$30.0M in 2023), driven by R&D ramp to $33.2M; year-end cash fell to $20.9M .
    • Timeline sensitivities: INKmune trial cadence extended—Phase II enrollment expected to complete by end of 2025; regulatory timelines for CORDStrom imply filing in early 2026, delaying revenue optionality .
    • Persistent revenue immateriality: Operating model remains pre-revenue; quarter-to-quarter P&L optics hinge on R&D cadence rather than commercial activity, keeping dependency on external financing high .

Financial Results

Quarterly performance (oldest → newest)

MetricQ2 2024Q3 2024Q4 2024
Revenue ($)$0 $0 $0*
EPS (Basic & Diluted)$(0.50) $(0.60) $(0.40)*
Cash & Cash Equivalents (period end, $)$31.07M $33.55M $20.92M

Full-year comparison

MetricFY 2023FY 2024
Revenue ($)$155k $14k
Net Loss ($)$(30.01)M $(42.08)M
EPS (Basic & Diluted)$(1.67) $(2.11)
R&D Expense ($)$20.27M $33.17M
G&A Expense ($)$9.62M $9.48M
Cash & Cash Equivalents (12/31)$35.85M $20.92M

Consensus vs actuals (S&P Global; asterisk denotes SPGI-sourced)

PeriodRevenue Cons. ($)Revenue Actual ($)EPS Cons. ($)EPS Actual ($)
Q4 2024$0*$0*$(0.54)*$(0.40)*
FY 2024$8.4k*$14k $(2.248)*$(2.11)
  • EPS and revenue from S&P Global marked with “*”. Values retrieved from S&P Global.

KPIs and operating items

KPIQ2 2024Q3 2024FY 2024
R&D Expense ($)$7.05M $10.07M $33.17M
G&A Expense ($)$2.81M $2.22M $9.48M
Shares Outstanding (approx.)19.71M (6/30/24) 22.17M (9/30/24) 22.28M (12/31/24)

Segment breakdown: N/A – company is pre-revenue; no commercial segment disclosure .

Guidance Changes

Metric/ItemPeriodPrevious GuidanceCurrent GuidanceChange
AD02 Top-line (XPro in early AD)Mid-2025“Q2 2025” (prior) “June 2025; EMACC and CDR at top-line” Narrowed timing; clarified endpoints
INKmune CaRe PC progression2025Phase II enrollment by Q2’25 (prior cadence) Complete enrollment “by end of ’25”; data released as available Extended timeline
CORDStrom BLA (RDEB)2025–2026“2025 or early 2026” “File BLA in the first quarter of next year” (as of Mar 27, 2025) → implies Q1’26; manufacturing/CMC build-out ongoing Target coalescing around early 2026

Note: Minor phrasing discrepancies between press release and call; management consistently directs to early 2026 as the likely filing window for CORDStrom given CMC workstreams .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 & Q3 2024)Current Period (Q4 2024 Call)Trend
AD02 Enrollment/EndpointsEnrollment closing; EMACC performing; CDR-powered study 208 patients, 8 countries; top-line in June; EMACC & CDR at top-line; safety clean to date Execution progressing; data window narrowed
Safety (XPro)Positive safety updates; EEG/synapse biomarkers “No deaths; no emergency MRIs; infections on one hand” in elderly cohort Reinforced
INKmune (mCRPC)Completed low-dose; strong tolerability; formulation/manufacturing scale-up Phase II dosing at mid/high cohorts; >30 administrations with no significant AEs/CRS; enrollment through 2025 Building dose/expansion dataset
CORDStrom (RDEB)Program introduced; data positive; regulatory path forming In-licensed Mission EB data; aiming BLA early 2026; open-label planned; orphan/RPD granted Moving toward filing
Financing/RunwayEquity raises; joined Russell 3000; Q3 cash into 2025 $29.9M 2024 raises; $5.4M ATM YTD; runway through Q3 (ex-warrants/REBATES) Adequate near-term, catalyst-dependent
AI/data opsN/AOmniScience “Vivo” genAI control tower to support AD02 data ops New operational capability

Management Commentary

  • “We will provide top-line results for the [AD02] trial in June… [with] a robust package of cognitive, clinical and functional data.” – RJ Tesi .
  • “As of today, there have been no unscheduled neuroimaging studies… no deaths… [XPro] has shown to be safe” in ~73-year-old early AD patients. – RJ Tesi .
  • “During 2024, we raised $29.9 million… [and] warrants… may be accelerated with positive AD02 data… potentially raise approximately $30 million.” – David Moss .
  • “We expect to complete enrollment [INKmune] as it’s currently designed by the end of ’25 and data… later this year.” – David Moss .
  • “We… expect to file a BLA for CORDStrom… in the first quarter of next year.” – David Moss (as of Mar 27, 2025; implying Q1’26) .

Q&A Highlights

  • Endpoint release: Both EMACC (primary) and CDR will be part of the top-line package in June; management emphasized data cleaning/analysis readiness .
  • EMACC and FDA: Team believes they have followed the FDA “playbook”; acceptance depends on data; CDR provides additional validation path .
  • AD02 screening/dropouts: Screen failures ~72% (in line with AD trials); inflammatory biomarker exclusion <10%; no safety-related dropout signal .
  • CORDStrom regulatory: In-licensed data viewed as BLA-supportive; open-label extension to refine dosing; MHRA and FDA discussions ongoing; CMC focus through year-end .
  • Commercial approach: Likely to partner near launch for distribution/marketing; prepared to go alone if needed; similar stance for XPro pending data .

Estimates Context

  • Q4 2024: EPS beat consensus (−$0.40 actual vs −$0.54 est); revenue in-line at $0. Result changes to FY are immaterial given revenue baseline; expense cadence drove optics [GetEstimates]*.
  • FY 2024: EPS (−$2.11) better than consensus (−$2.248); revenue $14k vs $8.4k est. Estimates will likely re-center around June top-line binary for AD02; valuation sensitivity remains dominated by clinical outcome probability rather than P&L [GetEstimates]* .
  • Upcoming revisions: Expect analysts to hold limited near-term revenue assumptions and flex opex/cash runway scenarios contingent on AD02 readout timing and warrant exercise assumptions .
  • Values retrieved from S&P Global.

Key Takeaways for Investors

  • The setup is catalyst-driven: June 2025 AD02 top-line readout with both EMACC and CDR disclosed at top-line is the primary stock driver; safety profile to date is supportive of broader risk-reward .
  • A positive read could unlock capital (warrant acceleration) and partnership optionality; management explicitly structured financing to lever a good clinical outcome .
  • Non-AD platforms add depth: INKmune’s strong tolerability and ongoing Phase II dosing plus CORDStrom’s BLA path into early 2026 create a multi-asset cadence through 2025–26 .
  • Cash runway into Q3 (ex-warrants/rebates) is adequate to reach AD02 data; but equity sensitivity remains if data disappoints—position sizing and hedging warranted around event risk .
  • Focus diligence on EMACC-CDR alignment and the breadth of top-line “cognitive, clinical, functional” evidence; management’s plan to release both endpoints at top-line reduces ambiguity risk .
  • Any incremental safety signals at top-line would be disproportionately impactful given the elderly AD population; current commentary remains clean .
  • Secondary 2025 updates from INKmune (mid/high dose) and CORDStrom regulatory progress can inform mid-term optionality even if AD02 is mixed .

Additional Relevant Disclosures and Prior Quarters

  • Q3 2024 results and operational updates (completed enrollment, EMACC performance, INKmune low-dose cohort data, financing) .
  • Q2 2024 results (interim blinded analysis supported EMACC performance; XPro stability and biomarker data; financing and cash visibility) .
  • Q4 2024 press release and financials (Year-end 2024) including detailed DN-TNF/INKmune/CORDStrom highlights and FY financial statements .
  • OmniScience partnership (Dec 4, 2024): Vivo genAI control tower deployed to centralize/analyze AD02 trial data at speed .

Footnote: Asterisked (“*”) values sourced from S&P Global consensus and actuals via GetEstimates. Values retrieved from S&P Global.