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EB

Edesa Biotech, Inc. (EDSA)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 FY2025: Net loss of $1.75M and diluted EPS of $(0.25); operating expenses were $1.90M, essentially flat YoY. Other income declined to $0.15M, reflecting lower SIF reimbursement and interest income. Cash was $12.36M with working capital of $12.1M at quarter-end .
  • EB06 vitiligo program advanced toward IND—management anticipates submitting drug manufacturing data to the FDA by end of calendar 2025; EB05 (paridiprubart) saw the first randomizations in the U.S. government “Just Breathe” ARDS platform study .
  • Liquidity improved via February financing; management expects existing cash plus grants to fund the vitiligo program through end of fiscal 2026, a key de-risking for near-term execution .
  • No earnings call transcript was available for Q3; Wall Street consensus EPS and revenue estimates from S&P Global were unavailable for EDSA this quarter, so estimate comparisons cannot be made (S&P Global data unavailable) .

What Went Well and What Went Wrong

What Went Well

  • EB06 manufacturing and regulatory preparation progressed, with CEO reiterating confidence in safety profile and mechanism: “We’re energized by the opportunity to bring an innovative immunotherapy like EB06... favorable safety profile... target the immune system mechanisms impacting both lesional and non-lesional skin” .
  • EB05 ARDS program gained momentum; the U.S. government announced first randomizations on the platform trial—offsetting EB05 spend while advancing clinical validation .
  • Strengthened balance sheet and runway: cash $12.36M and working capital $12.1M at June 30, 2025; management expects funding through end of fiscal 2026 for vitiligo program .

What Went Wrong

  • Other income decreased by $110K YoY to $154K on lower SIF reimbursement and interest income; nine-month other income fell $0.3M YoY to $0.5M .
  • Continued operating losses reflecting clinical-stage status: operating loss $1.90M; net loss $1.75M; no product revenue while spending on development .
  • Going concern disclosure underscores dependence on external financing and grants to advance pipeline (material uncertainty if funding access is constrained) .

Financial Results

Income Statement Key Metrics (oldest → newest)

Metric ($USD)Q3 2024Q2 2025Q3 2025
Research and Development$897,305 $484,306 $939,067
General and Administrative$1,035,140 $1,154,580 $964,676
Total Operating Expenses$1,932,445 $1,638,886 $1,903,743
Total Other Income$264,233 $49,000 $154,279
Net Loss$(1,668,212) $(1,590,448) $(1,749,464)
Diluted EPS$(0.52) $(0.30) $(0.25)
Weighted Avg Shares3,221,806 5,305,763 7,022,678

Notes:

  • Edesa did not report product revenues; other income comprises grant income, interest and FX .

Program-Specific R&D Spend

Program R&D ($USD)Q3 2024Q3 2025
EB06$0 $226,118
EB05$640,030 $396,993
Other Dev/Discovery$22,866 $40,370
Unallocated Internal Costs$234,409 $275,586
Total R&D$897,305 $939,067

KPIs and Liquidity

KPI ($USD)Q3 2024Q2 2025Q3 2025
Cash & Cash EquivalentsN/A$13,896,650 $12,361,690
Working CapitalN/A$13.5M $12.1M
Grant Income (quarter)$236,226 $52,268 $183,281

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
EB06: Submit manufacturing data to FDA for INDCalendar 2025“Second half of calendar 2025” (Q2 update) “By end of calendar 2025” (Q3 update) Clarified/tightened window
EB06: Topline results timing post-FDA clearancePost-IND12–18 months after clearance (Q2) Reiterated timeline (no change in Q3 doc) Maintained
Funding runway for vitiligo programThrough FY2026Not disclosed priorManagement expects runway through end of fiscal 2026 New disclosure

Earnings Call Themes & Trends

No Q3 FY2025 earnings call transcript was available. Themes below reflect press releases and 10‑Q commentary.

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3)Trend
EB06 manufacturing/INDManufacturing campaign initiated; IND submission targeted for H2 2025 Submit manufacturing data by end of calendar 2025; continued regulatory prep Steady progress; timeline clarified
EB05 ARDS platform trialFully funded U.S. government study; pivoting resources to EB06 First randomizations completed on platform study Execution milestone achieved
Funding & capital$15M private placement; cash $13.9M (Q2) Cash $12.36M; runway through FY2026 Liquidity outlook improved
SIF grant incomeGrant income supporting EB05 program Quarterly grant income $0.18M; YoY lower Lower pace vs prior year
Regulatory/legalHealth Canada approval for Phase 2 vitiligo study Ongoing FDA engagement (IND preparation) Continued regulatory prep

Management Commentary

  • CEO (Par Nijhawan, MD): “We’re energized by the opportunity to bring an innovative immunotherapy like EB06 into an area of high unmet need... favorable safety profile... has the potential to make it a preferable option for vitiligo patients” .
  • CFO (Peter Weiler): “We are channeling our operational efforts into regulatory preparation and drug manufacturing of our EB06 candidate with the goal of being in a position to move rapidly into clinical testing” .
  • CFO (Peter Weiler): Financial results in line with expectations, reflecting refocus to vitiligo; EB06 expenditures offset by decreased EB05 expenses due to the fully funded “Just Breathe” study .

Q&A Highlights

No Q3 FY2025 earnings call transcript was available; therefore, Q&A themes and any guidance clarifications from analysts cannot be assessed for this quarter [Search attempt returned none].

Estimates Context

  • Wall Street consensus EPS and revenue estimates from S&P Global were unavailable for EDSA for Q1–Q3 FY2025, so we cannot assess beats/misses versus Street expectations this quarter (S&P Global data unavailable).

Key Takeaways for Investors

  • EB06 vitiligo program remains the core value driver; clarified IND timing (“by end of calendar 2025”) should act as a near-term catalyst as manufacturing data are submitted .
  • EB05 ARDS program progress under U.S. government sponsorship reduces company-funded spend and provides external clinical validation; first randomizations are a meaningful milestone .
  • Liquidity and runway: cash of $12.36M and management’s expectation to fund the vitiligo program through FY2026 reduce near-term financing risk; monitor continued grant receipts and any ATM usage .
  • Operating losses will persist absent revenue; investors should focus on regulatory milestones (IND acceptance, Phase 2 initiation) and clinical readouts (12–18 months post-FDA clearance) as the main value inflection points .
  • Program spend mix is shifting: EB06 costs up while EB05 costs down—consistent with the strategy to prioritize vitiligo; watch for EB06 partnering or additional regulatory updates .
  • SIF grant income support continues but at a lower cadence YoY; this, plus interest trends, explains lower other income—monitor future claims and FX impacts .
  • Absence of consensus estimates and an earnings call limits near-term sentiment drivers; execution on disclosed timelines and conference participation may serve as communication catalysts .