Name: Edesa Biotech, Inc. Q1 2025 Earnings Call
Start: 2025-02-14T00:00:00.000Z

Executive Summary

Edesa reported Q1 FY2025 net loss of $1.6M and diluted EPS of $(0.48), with total operating expenses flat year over year at $1.9M; R&D rose to $1.0M while G&A fell to $0.9M .
Cash and cash equivalents were $1.6M and working capital $0.2M at quarter-end; subsequently, the company raised $15.0M via a private placement, improving liquidity and positioning funding for the vitiligo program .
Management reiterated timelines: EB06 manufacturing data submission to FDA mid-2025, Phase 2 IND pursuit, and topline results potentially 12–18 months after U.S. regulatory clearance; EB05 (paridiprubart) ARDS study is U.S. government-funded, allowing focus on vitiligo .
No Q1 2025 earnings call transcript was available; Wall Street consensus estimates via S&P Global were unavailable for EDSA this quarter (attempted retrieval resulted in errors), so an estimates beat/miss comparison is not provided. Values would normally be retrieved from S&P Global.

What Went Well and What Went Wrong

What Went Well
- Strengthened balance sheet: $15.0M gross proceeds from private placement led by healthcare investors, adding runway to fund EB06 through fiscal 2026; insiders also participated and Velan gained a board seat .
- Clear clinical prioritization: EB05 ARDS work is government-funded, allowing resources to be redeployed to EB06 vitiligo Phase 2 initiation and manufacturing preparatory work .
- Cost discipline: G&A decreased by $0.3M YoY to $0.9M; total operating expenses held flat YoY at $1.9M despite pipeline progress .
What Went Wrong
- Continued operating losses with limited cash at quarter-end ($1.6M) and modest working capital ($0.2M) before the financing, highlighting dependency on external funding and grants .
- R&D expense increased to $1.0M, reflecting manufacturing and development costs (paridiprubart), while topline revenue remains nil due to clinical-stage status .
- Ongoing going-concern risk considerations: management notes reliance on funding sources and material uncertainty without continued access to capital (mitigated post-quarter by financing) .

Metric	Q1 FY2024 (Dec 31, 2023)	Q3 FY2024 (Jun 30, 2024)	Q1 FY2025 (Dec 31, 2024)
Research and Development ($USD)	$704,458	$897,305	$1,019,818
General and Administrative ($USD)	$1,152,971	$1,035,140	$878,871
Total Operating Expenses ($USD)	$(1,857,429)	$(1,932,445)	$(1,898,689)
Reimbursement Grant Income ($USD)	$120,834	$236,226	$301,195
Other Income (Loss) ($USD)	$58,144	$79,303	$(19,759)
Total Other Income ($USD)	$178,978	$315,529	$281,436
Net Loss ($USD)	$(1,678,451)	$(1,668,212)	$(1,617,253)
Diluted EPS ($USD)	$(0.54)	$(0.52)	$(0.48)
Weighted Avg Shares	3,128,024	3,221,806	3,345,135

KPIs and Balance Sheet

Metric	Sep 30, 2024	Jun 30, 2024	Dec 31, 2024
Cash and Equivalents ($USD)	$1,037,320	$2,040,884	$1,563,502
Working Capital ($USD)	$(0.2)M	$0.7M	$0.2M
Total Assets ($USD)	$3,813,982	$5,227,722	$4,164,181
Current Liabilities ($USD)	$1,832,827	$2,360,627	$1,900,219
Shareholders’ Equity ($USD)	$1,981,155	$2,867,095	$2,263,962

Note: No revenue was reported; the company remains clinical-stage .

Metric	Period	Previous Guidance	Current Guidance	Change
EB06 (Vitiligo) manufacturing data submission to FDA	Mid-2025	Preparing IND filing; continuing preparations to file and manufacture; Health Canada Phase 2 approved	Data anticipated to be submitted to FDA mid-2025; pursue U.S. IND for Phase 2	Clarified timing (mid-2025) – raised specificity
EB06 Phase 2 topline results timing	Post-clearance	12–18 months after U.S. regulatory clearance	12–18 months after U.S. FDA clearance	Maintained
EB05 (Paridiprubart) ARDS study funding	Ongoing	Selected for U.S. gov platform study; Edesa supplies product	U.S. government fully funding Phase 2 platform study; Edesa prioritizing EB06	Improved funding clarity
Funding runway for CXCL10 program	Through FY2026	Improved position post FY2024 financing/ATM; runway not specified	$15.0M private placement to fund CXCL10 program through end of FY2026	Raised runway

(No Q1 FY2025 earnings call transcript found.)

Topic	Previous Mentions (Q3 FY2024)	Previous Mentions (FY2024)	Current Period (Q1 FY2025)	Trend
Vitiligo (EB06)	Preparing FDA IND; Canada Phase 2 approved	Manufacture EB06; submit data with IND; topline 12–18 months post clearance	Manufacturing campaign underway; FDA data submission mid-2025; pursue IND	Progressing toward IND and manufacturing
ARDS (EB05)	Selected for U.S. gov platform study; Edesa provides product	Amending Canadian-supported project to align; gov awards validated tech	U.S. government fully funding Phase 2 platform study	Funding clarity improved; resource shift to EB06
Funding/Liquidity	$2.0M cash; $0.7M working capital; steady management	$1.0M cash; negative WC; post-year financing/ATM improved	$1.6M cash & $0.2M WC at Q-end; $15.0M raised post-quarter	Strengthened post-quarter
Cost Discipline	G&A flat YoY quarter	>20% YoY OpEx decrease	G&A down $0.3M YoY; OpEx flat YoY	Continued discipline
Regulatory	Canada Phase 2 approved for EB06	Plans for U.S. IND submission	FDA submission timing specified (mid-2025)	Increased timing precision

CEO: “Our goal is to be in a position to rapidly launch our vitiligo clinical trial following regulatory clearance… A targeted immunotherapy, like EB06… could offer a safe and efficacious treatment.”
CFO: “With a stronger balance sheet, which includes $15.0 million in gross proceeds… we believe we are well positioned to advance our vitiligo program toward topline data and fund Edesa’s current operating plan.”
Prior quarter CFO tone: Commitment to prudent use of working capital and effective financial management to advance the pipeline .

No Q1 FY2025 earnings call transcript found; no Q&A themes available in source documents [ListDocuments returned none].
Press materials emphasize funding runway, program prioritization (EB06), and ARDS platform study sponsorship .

Wall Street consensus (S&P Global) estimates for Q1 FY2025 EPS and revenue were unavailable for EDSA; an attempt to retrieve consensus resulted in tool errors, and coverage appears limited for this micro-cap clinical-stage company. Values would normally be retrieved from S&P Global.

Financing removes near-term liquidity overhang and funds EB06 through FY2026, a potential catalyst to program initiation and data flow .
Increasing specificity on FDA submission timing (mid-2025) strengthens the EB06 execution narrative; 12–18 month topline window post-clearance sets expectations for data catalysts .
Government-funded ARDS platform study reduces cash burn on EB05, enabling focus and capital allocation to vitiligo where Edesa seeks differentiation downstream of JAK inhibitors .
Operating discipline persists: G&A down YoY and OpEx stable YoY despite R&D uptick for manufacturing; net loss modestly improved YoY .
Near-term catalysts: FDA submission package for EB06 mid-2025; initiation of Phase 2 following clearance; conference visibility and investor engagement .
Risk lens: Continued losses without revenue; reliance on external financing and grant reimbursement; execution risk on manufacturing and regulatory timelines .
Trading implications: Expect news-driven volatility around IND/clearance milestones; financing reduces existential risk but dilution remains a consideration given preferred structures and conversion dynamics .