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EB

Edesa Biotech, Inc. (EDSA)·Q2 2025 Earnings Summary

Executive Summary

  • Completed $15.0 million equity financing to accelerate EB06 (anti‑CXCL10) vitiligo program; pivoted resourcing from respiratory to dermatology while EB05 (paridiprubart) advances under fully funded U.S. government study .
  • Q2 FY2025 operating expenses fell to $1.6M vs $2.2M YoY; net loss improved to $1.6M (–$0.30 EPS) vs $1.9M (–$0.58 EPS) YoY, aided by lower R&D tied to paridiprubart manufacturing and tighter cost control .
  • IND timing for EB06 shifted from “mid‑2025” to “second half of calendar 2025”; topline Phase 2 results still expected 12–18 months post‑FDA clearance, making filing progress and slot availability the near‑term catalyst .
  • Liquidity strengthened materially: cash rose to $13.9M; working capital at $13.5M at March 31, 2025, post financing; CFO transition to Peter J. Weiler effective May 1, 2025 to support execution .

What Went Well and What Went Wrong

What Went Well

  • Strengthened balance sheet and prioritized EB06: “We are excited about the potential of a novel immunotherapy like EB06… We believe we can ultimately change the treatment paradigm…” — CEO Par Nijhawan, MD .
  • OpEx down ~$0.6M YoY to $1.6M; R&D down to ~$0.5M as paridiprubart manufacturing costs fell, partially offset by EB06 preparation; G&A up modestly on salaries, offset by lower SBC/pro fees .
  • Government funding offsets for EB05 continue; pivot allows resource redeployment to vitiligo: “We are deploying additional resources to manufacturing and preparatory regulatory activities to speed the launch of our upcoming vitiligo study” — CFO .

What Went Wrong

  • Other income fell to $49k (from $360k YoY) on lower Strategic Innovation Fund reimbursement and interest income, creating a headwind to net results .
  • EB06 IND submission target moved from “mid‑2025” to “second half of calendar 2025” due to manufacturing slot availability at third‑party providers, modestly extending the near‑term timeline .
  • No revenue reported; company remains pre‑commercial with losses driven by R&D and G&A, and estimate coverage from Wall Street appears limited this quarter .

Financial Results

MetricQ2 FY2024 (Mar 31, 2024)Q1 FY2025 (Dec 31, 2024)Q2 FY2025 (Mar 31, 2025)
Total Operating Expenses ($USD Millions)$2.2 $1.9 $1.6
Research & Development ($USD Millions)$1.2 $1.0 $0.5
General & Administrative ($USD Millions)$1.0 $0.9 $1.2
Other Income ($USD Millions)$0.36 $0.281 $0.049
Net Loss ($USD Millions)$1.9 $1.617 $1.590
Diluted EPS ($USD)-$0.58 -$0.48 -$0.30

KPIs (liquidity and capitalization):

MetricFY2024 (Sep 30, 2024)Q1 FY2025 (Dec 31, 2024)Q2 FY2025 (Mar 31, 2025)
Cash & Equivalents ($USD Millions)$1.0 $1.6 $13.9
Working Capital ($USD Millions)-$0.2 $0.2 $13.5
Weighted Avg Shares (Common)3,197,423 3,345,135 5,305,763

Estimate comparison:

MetricQ2 FY2025 ConsensusActual Q2 FY2025
EPS ($USD)*N/A-$0.30
Revenue ($USD)*N/ANot reported

Estimates unavailable via S&P Global.*

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
EB06 IND submission timingCalendar 2025“Middle of 2025” “Second half of calendar 2025” Pushed back (timing extended)
EB06 topline Phase 2 results timingPost‑FDA clearance12–18 months after clearance 12–18 months after clearance Maintained
R&D spend trajectoryFY2025Not specifiedResearch expenditures to track EB06 program activities New qualitative view
Manufacturing capacity constraintH1–H2 2025Not specifiedAvailability of third‑party manufacturing slots guiding timeline New gating factor

Earnings Call Themes & Trends

No earnings call transcript was found for Q2 FY2025. Themes below reflect press releases and 8‑K disclosures.

TopicQ-2 (FY2024)Q-1 (Q1 FY2025)Current Period (Q2 FY2025)Trend
EB06 vitiligo programManufacturing and IND planning subject to funding Manufacturing prep underway; IND targeted mid‑2025 Manufacturing ongoing; IND in H2 2025 Slight timing delay; execution progressing
Funding/LiquidityPost‑FY financing initiatives (CEO‑affiliated and ATM) Subsequent $15.0M gross proceeds cited $15.0M financing completed; cash to $13.9M Liquidity strengthened
Respiratory (EB05)Pivot to U.S. gov‑funded ARDS platform study Fully funded U.S. study; prioritization of EB06 Government funding offsets EB05 costs De‑risked spend on EB05
Manufacturing/supply chainNot highlightedNot highlightedThird‑party manufacturing slot availability drives timing New operational constraint
Management/corporateNo changeNo changeCFO transition to Peter J. Weiler effective May 1, 2025 Leadership change to support strategy

Management Commentary

  • “We are excited about the potential of a novel immunotherapy like EB06… We believe we can ultimately change the treatment paradigm… much the same manner that immunotherapies have transformed other systemic autoimmune diseases like psoriasis.” — Par Nijhawan, MD, CEO .
  • “We are deploying additional resources to manufacturing and preparatory regulatory activities to speed the launch of our upcoming vitiligo study, and we anticipate that related research expenditures will generally track activity in this program.” — Peter Weiler, CFO .
  • Q2 focus shift: Increased EB06 expenditures offset by decreased EB05 costs as EB05 benefits from a fully funded U.S. government study .

Q&A Highlights

No Q2 FY2025 earnings call transcript available; therefore, no Q&A highlights or clarifications to report [ListDocuments: earnings-call-transcript found 0].

Estimates Context

  • Wall Street/S&P Global consensus estimates for EPS and revenue were not available for EDSA for Q2 FY2025; we therefore benchmark results qualitatively rather than quantitatively versus Street.*
  • Given limited coverage and pre‑commercial status, estimate updates (if initiated) would likely focus on OpEx cadence, cash runway, and clinical timeline probabilities rather than revenue/EPS.

Estimates unavailable via S&P Global.*

Key Takeaways for Investors

  • Liquidity materially improved post‑financing; cash of $13.9M and working capital of $13.5M provide runway to advance EB06 manufacturing and IND activities into H2 2025 .
  • Operating efficiency: OpEx cut to $1.6M vs $2.2M YoY, with R&D at ~$0.5M reflecting lower paridiprubart manufacturing costs as EB05 funding shifted to U.S. government programs .
  • Near‑term catalyst path: EB06 IND filing in H2 2025 with topline Phase 2 results 12–18 months post‑clearance, making manufacturing slot timing and FDA interactions key trading events .
  • Program prioritization: Continued pivot to vitiligo (EB06) while EB05 is de‑risked by external funding; this resource allocation could sustain lower net losses vs prior year if funding and discipline persist .
  • Corporate execution: CFO transition to Peter J. Weiler positions finance leadership to manage capital allocation and potential strategic engagement during the IND/Phase 2 ramp .
  • Risk factors: Manufacturing capacity constraints at third‑party providers and variability in government reimbursement/interest income can affect timing and quarterly P&L noise .
  • With limited Street coverage, narrative likely driven by clinical execution milestones (manufacturing data, IND acceptance, site activation, enrollment pace) rather than revenue/EPS beats.

Appendix: Source Documents

  • Q2 FY2025 8‑K 2.02 and press release (full text and financial tables) .
  • Q1 FY2025 press release and 8‑K (prior quarter context) .
  • FY2024 press release (Q‑2 context) .
  • CFO transition press release (corporate development) .

Estimates unavailable via S&P Global.*