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4M

4D Molecular Therapeutics, Inc. (FDMT)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 results were operationally strong with Phase 3 initiation (4FRONT-1) and RMAT designation for 4D-150 in DME; financially, collaboration revenue was de minimis ($14K) and net loss widened to $47.972M as R&D ramped for Phase 3 .
  • EPS of -$0.86 was essentially in line with S&P Global consensus (-$0.862*), while revenue materially missed consensus ($0.446M* vs $0.014M actual); the miss reflects limited near-term revenue as a development-stage biotech focusing on internally owned programs .
  • Cash, cash equivalents and marketable securities were $458.441M, extending runway into 2028; the cash runway extension is a key positive versus prior guidance (H1 2027 previously) and supports execution through Phase 3 toplines in H2 2027 .
  • Catalysts: Phase 3 enrollment progress in wet AMD, FDA RMAT designation in DME, and pending SPECTRA 52-week DME interim data (Q3 2025) are near-term narrative drivers; topline wet AMD Phase 3 data expected in H2 2027 .

Values with asterisks (*) are retrieved from S&P Global.

What Went Well and What Went Wrong

What Went Well

  • Initiated the first Phase 3 trial (4FRONT-1) for 4D-150 in wet AMD; “historic moment for 4DMT as we become a Phase 3 company” demonstrating execution against pivotal timelines .
  • RMAT designation for 4D-150 in DME, with FDA alignment that a single Phase 3 trial combined with wet AMD Phase 3 data would be acceptable for a BLA—streamlining registrational path .
  • Management focus and pipeline prioritization (4D-150 and 4D-710) extended cash runway into 2028; “our strong balance sheet provides us an expected operational runway into 2028” .

What Went Wrong

  • Revenue ($14K) missed Street consensus materially as expected for a company without commercial products, highlighting near-zero collaboration/license revenue this quarter .
  • Net loss increased to $47.972M YoY (from $32.401M) driven by higher R&D tied to Phase 3 initiation, reflecting burn escalation ahead of pivotal programs .
  • No earnings call transcript available in the document set for Q1 2025, limiting visibility into Q&A color and any nuanced guidance or operational clarifications typically provided during the call. Searches of earnings-call-transcript returned no results in the catalog [SearchDocuments none], and no transcript was found among Q1 2025 documents listed [ListDocuments results above].

Financial Results

Quarterly Comparison vs Prior Periods

Metric (USD)Q3 2024Q4 2024Q1 2025
Revenue ($ Thousands)$3 $1,000*$14
Net Loss ($ Thousands)$43,843 $49,671*$47,972
Net Loss per Share (EPS)-$0.79 -$0.90*-$0.86
Total Operating Expenses ($ Thousands)$51,135 $56,118*$53,635
R&D Expense ($ Thousands)$38,484 $—$40,699
G&A Expense ($ Thousands)$12,651 $—$12,936
Cash, Cash Equivalents & Marketable Securities ($ Thousands)$550,671 $505,460 $458,441

Values with asterisks (*) are retrieved from S&P Global.

Notes:

  • Q4 2024 quarterly EPS and revenue are not provided in the FY press release; the starred values are from S&P Global consensus data services consistent with GetFinancials outputs. Values retrieved from S&P Global.

Year-over-Year (Q1 2025 vs Q1 2024)

Metric (USD)Q1 2024Q1 2025YoY Change
Revenue ($ Thousands)$28 $14 -50.0%
Net Loss ($ Thousands)$32,401 $47,972 +48.1%
Net Loss per Share (EPS)-$0.66 -$0.86 -$0.20

Actual vs Wall Street Consensus (Q1 2025)

MetricConsensusActualSurprise
EPS-$0.862*-$0.86 +$0.002 (inline)
Revenue ($ Millions)$0.446*$0.014 -$0.432 (material miss)

Values retrieved from S&P Global.

KPIs and Operating Drivers

KPIQ3 2024Q4 2024Q1 2025
Phase 3 wet AMD program status4FRONT-1 initiation expected Q1 2025 4FRONT-1 expected March; 4FRONT-2 Q3 2025 4FRONT-1 initiated; >50 sites open
DME regulatory pathPhase 3 planning update expected early Jan 2025 FDA alignment single Phase 3 acceptable with wet AMD data RMAT designation; single Phase 3 acceptable; 52-week interim in Q3 2025
Cash runway guidanceAt least into H1 2027 Into 2028 Into 2028

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayMulti-year“At least into H1 2027” (Q3 2024) “Into 2028” (FY 2024 and Q1 2025) Raised runway
4FRONT-1 initiation (wet AMD)Q1 2025“Expected Q1 2025” “Initiated; first patients enrolled” (Mar 2025) Achieved milestone
4FRONT-2 initiation (wet AMD)Q3 2025“Expected Q3 2025” “Expected Q3 2025” Maintained
Wet AMD Phase 3 topline timingH2 2027“Expected H2 2027 (both trials)” “Expected H2 2027” Maintained
DME registrational path2025+“Single Phase 3 acceptable with wet AMD Phase 3 data” RMAT designation; proceed to single Phase 3; 52-week interim update Q3 2025 Enhanced regulatory position
SPECTRA DME interim updateQ3 2025“Expected mid-2025/Q3 2025” “Expected Q3 2025” Maintained

Earnings Call Themes & Trends

Note: No Q1 2025 earnings call transcript was available in the document set; themes below reflect company communications across prior quarters and Q1 press releases.

TopicPrevious Mentions (Q-2: Q3 2024; Q-1: Q4 2024)Current Period (Q1 2025)Trend
Product performance (wet AMD)Robust reduction in injection burden; stable anatomy; tolerability in PRISM Reinforced PRISM 52-week results; Phase 3 dose 3E10 vg/eye; >50 sites open Strengthening with Phase 3 execution
Regulatory/legal (DME)FDA alignment on single Phase 3 acceptable RMAT designation; plan to proceed to single Phase 3 Improving regulatory clarity
R&D execution & timelinesPhase 3 wet AMD expected Q1/Q3 2025; topline H2 2027 4FRONT-1 initiated; 4FRONT-2 expected Q3 2025; topline H2 2027 On track/achieved
Pulmonology (4D-710 CF)Cohorts completed; extension ongoing; interim data H2 2025 expected Interim AEROW data/program update H2 2025 expected Stable
Cash runway/macroCash sufficient into H1 2027 Runway into 2028 post pipeline focus Positive shift
Supply chain/tariffs/AINot discussed Not discussed No change

Management Commentary

  • “The first quarter of 2025 marked a pivotal moment for 4DMT… initiated our first 4D-150 Phase 3 clinical trial 4FRONT-1 in wet AMD… Our strong balance sheet provides us an expected operational runway into 2028” — David Kirn, M.D., CEO .
  • “This is a historic moment for 4DMT as we become a Phase 3 company… 4D-150 has the clear potential to address the greatest unmet needs… multi-year relief from frequent and burdensome injections” — David Kirn, M.D., CEO .
  • “The RMAT designation… underscores the potential of 4D-150 to sustain visual acuity improvements while dramatically reducing treatment burden for patients… first investigational medicine to be granted the designation in both indications” — David Kirn, M.D., CEO .
  • “4D-150 represents a potentially transformative new therapeutic option… designed to allow for seamless adoption into retina clinic practices” — Company commentary on target product profile .

Q&A Highlights

  • No Q1 2025 earnings call transcript was found in the available corpus; therefore, Q&A themes, guidance clarifications, and tone shifts from analyst questions cannot be assessed this quarter. Searches for “earnings-call-transcript” for Q1 2025 returned no results for FDMT in the document catalog [ListDocuments earnings-call-transcript results above; SearchDocuments none].

Estimates Context

  • EPS: Actual -$0.86 vs S&P Global consensus -$0.862* (inline). Revenue: Actual $0.014M vs S&P Global consensus $0.446M* (material miss). The revenue gap reflects minimal collaboration/license revenue while the company advances wholly owned programs without commercial partnerships driving near-term revenue .
  • Estimate implications: R&D intensity (+$12.829M YoY) tied to Phase 3 initiation suggests operating expense baselines trending higher in 2025, which may prompt upward revisions to OpEx expectations; revenue forecasts should reflect limited near-term contribution until potential partnership or commercialization milestones .

Values retrieved from S&P Global.

Key Takeaways for Investors

  • Execution: Phase 3 wet AMD program is underway with 4FRONT-1 enrollment begun; 4FRONT-2 initiation remains on track for Q3 2025—de-risking timeline risk and supporting H2 2027 topline targets .
  • Regulatory momentum: RMAT designation in DME and FDA alignment on a single Phase 3 trial accelerates the registrational path and supports potential pipeline-in-a-product positioning for 4D-150 across retinal indications .
  • Cash runway: Extended into 2028 enables completion of Phase 3 wet AMD trials and continued DME/CF development without near-term dilution assumptions—supportive for medium-term thesis .
  • Near-term catalysts: Q3 2025 52-week interim DME data; continued Phase 3 site activation/enrollment updates; CF AEROW interim data in H2 2025—each can shift narrative and risk perception .
  • Financial profile: Expect low/no revenue and elevated R&D as pivotal programs ramp; EPS/OpEx trends likely dominated by trial execution rather than top-line contributions until partnered milestones or commercial events .
  • Stock drivers: Clinical and regulatory readouts (DME interim, wet AMD enrollment pace), trial design/tolerability durability data, and any partnering announcements are likely to move shares more than quarterly P&L prints .
  • Risk management: Clinical risk in Phase 3 wet AMD; regulatory alignment must translate to robust Phase 3 outcomes; funding path remains strong, but additional capital or partnerships could be pursued for commercialization scaling .