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Dermata Therapeutics, Inc. (DRMA)·Q4 2024 Earnings Summary

Executive Summary

  • Dermata entered Q4 2024 pre-revenue, focusing spend on the XYNGARI Phase 3 STAR-1 acne trial; FY 2024 net loss was $12.29M with total operating expenses of $12.51M, reflecting heavier clinical activity .
  • Cash and equivalents ended Q4 at $3.16M, with management extending runway into Q3 2025 after raising $7.8M in 2024 and $2.55M in Jan 2025 PIPE financing .
  • Operationally, XYNGARI STAR-1 enrollment was completed in Nov 2024, and the last patient completed last visit in March 2025; topline data were guided for late March and subsequently met all primary endpoints on Mar 26, 2025 (post-quarter), a major validation catalyst for the program .
  • Strategic progress included a Clinical Trial Collaboration Agreement with Revance to study DMT410 for axillary hyperhidrosis and potential broader indications, improving partnering optics heading into STAR-2 initiation in H2 2025 .

What Went Well and What Went Wrong

What Went Well

  • Phase 3 execution on schedule: “We are excited to unblind the topline data from our XYNGARI™ Phase 3 STAR-1 trial in the coming weeks… we fully expect to deliver on this promise” – CEO Gerry Proehl (Mar 17) . Enrollment completed in Nov 2024; last patient last visit completed in Mar 2025 .
  • Clinical validation: Post-quarter, STAR-1 met all three primary endpoints with highly statistically significant and clinically meaningful improvement; Week 12 IGA treatment success 29.4% vs 15.2% placebo (p<0.001), with significant inflammatory and non-inflammatory lesion reductions (p<0.001) .
  • Strategic partnering momentum: Signed a Clinical Trial Collaboration Agreement with Revance (merged with Crown Labs) to evaluate XYNGARI with DAXXIFY for topical hyperhidrosis; potential for multiple indications (hyperhidrosis, acne, rosacea) .

What Went Wrong

  • Elevated cash burn from clinical activities: FY 2024 R&D rose to $8.20M from $4.07M YoY (+$4.13M) driven by STAR-1 trial costs; total operating expenses increased to $12.51M (vs $8.04M in 2023) .
  • Financing dependence: FY 2024 operations used ~$11.1M cash, offset by ~$6.9M net financing proceeds, with runway extended by a $2.55M PIPE in Jan 2025; cash at YE 2024 fell to $3.16M from $7.44M .
  • Limited visibility on quarterly EPS: Filings did not disclose a separate Q4 EPS figure, complicating quarter-over-quarter EPS analysis; only Q3 per-share loss and FY per-share loss were provided .

Financial Results

Operating P&L (Quarterly)

MetricQ2 2024Q3 2024Q4 2024
R&D Expenses ($USD Millions)$2.00 $2.40 $2.19 (derived from FY $8.204M – 9M $6.011M)
G&A Expenses ($USD Millions)$0.90 $0.82 $1.01 (derived from FY $4.309M – 9M $3.302M)
Total Operating Expenses ($USD Millions)N/A$3.23 $3.20 (derived from FY $12.513M – 9M $9.313M)
Loss from Operations ($USD Millions)N/A$(3.23) $(3.20) (derived)
Interest Income ($USD Millions)N/A$0.05 $0.05 (derived from FY $0.226M – 9M $0.176M)
Net Loss ($USD Millions)N/A$(3.17) $(3.15) (derived from FY $12.287M – 9M $9.137M)
Diluted EPS ($USD)N/A$(2.04) N/A (not disclosed separately)

Notes:

  • Q4 values are derived from the difference between FY 2024 and nine months ended Sep 30, 2024, as reported in filings .

Balance Sheet Liquidity

MetricQ2 2024Q3 2024Q4 2024
Cash and Equivalents ($USD Millions)$4.95 $6.14 $3.16
Total Assets ($USD Millions)$5.24 $6.69 $3.53
Total Liabilities ($USD Millions)$1.92 $1.95 $1.97
Total Equity ($USD Millions)$3.32 $4.74 $1.56

Revenue and Margins

MetricQ2 2024Q3 2024Q4 2024Comment
Revenues ($USD Millions)N/AN/AN/AFilings present operating expenses only; no revenue line items provided .
Net Income Margin %N/AN/AN/ANot meaningful for a pre-revenue biotech quarter .
EBITDA Margin %N/AN/AN/ANot meaningful without revenue .

Clinical KPIs (Program Status)

KPIQ2 2024Q3 2024Q4 2024Post-Quarter Update
STAR-1 Enrollment Progress>50% enrolled Near completion by end-2024 Enrollment completed Nov 2024 Last patient last visit completed; topline expected by end of Mar 2025
STAR-1 Topline Efficacy (Week 12 IGA)N/AN/AN/A29.4% XYNGARI vs 15.2% placebo; p<0.001
Inflammatory Lesion Change (Week 12)N/AN/AN/A−16.8 XYNGARI vs −13.1 placebo; p<0.001
Non-inflammatory Lesion Change (Week 12)N/AN/AN/A−17.3 XYNGARI vs −12.4 placebo; p<0.001

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayAs of Q2 2024Into Q4 2024 Into Q2 2025 (Q3 update) Raised
Cash RunwayAs of Q3 2024Into Q2 2025 Into Q3 2025 (post-Jan 2025 PIPE) Raised
STAR-1 Topline TimingQ2/Q3 20241Q 2025 By end of March 2025 Refined timing
STAR-2 InitiationQ4 2024“Quickly initiate following positive STAR-1” Target 2H 2025 initiation Formalized schedule
DMT410 CollaborationQ2/Q3 2024Ongoing partner discussions Signed Revance collaboration (Jan 2025) Upgraded to executed agreement

No revenue, margin, or tax rate guidance was provided in filings; focus remains on clinical timelines, partnering, and cash runway .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q4)Trend
XYNGARI Phase 3 Execution>50% enrolled; topline expected 1Q25 Enrollment completed; topline by end of Mar 2025 On-schedule; milestone achieved
DMT410 PartneringDiscussions ongoing Signed Revance collaboration Jan 2025 Positive inflection
Funding/RunwayRaised $2.3M in Q2; runway into Q4 2024 Raised $5.1M in Q3; runway into Q2 2025 Extended
Clinical Data ReadoutAnticipated milestone; no topline yet Topline guided late March; achieved post-quarter with all primary endpoints met Validation achieved
Regulatory PathComplete two Phase 3 + extension before NDA STAR-2 planned H2 2025, extension to follow Path clarified

Note: No earnings call transcript was available for Q4 2024; themes are synthesized from press releases and 8-Ks .

Management Commentary

  • “We are excited to unblind the topline data from our XYNGARI™ Phase 3 STAR-1 trial… we fully expect to deliver on this promise” – Gerry Proehl, CEO (Mar 17) .
  • “We believe patients deserve an acne treatment… with a significant 45% reduction in inflammatory lesions after just four applications, as seen in our DMT310 Phase 2b acne study” – Gerry Proehl (Nov 13) .
  • “With the last patient visit behind us, we can focus our efforts on cleaning and locking the database… report topline data by the end of March” – Christopher Nardo, Ph.D., CDO (Mar 4) .
  • “We are incredibly excited… highly statistically significant efficacy data… strengthens our confidence about the upcoming XYNGARI™ Phase 3 STAR-2 trial” – Gerry Proehl (Mar 26, post-quarter) .

Q&A Highlights

  • No Q4 2024 earnings call transcript was found; management communications were via 8-K and press releases . Guidance clarifications centered on topline timing, STAR-2 initiation, and cash runway .

Estimates Context

  • Wall Street consensus EPS and revenue estimates from S&P Global were unavailable at the time of this report due to data access limits; therefore, we cannot present beat/miss vs consensus for Q4 2024 [GetEstimates error].

Key Takeaways for Investors

  • Clinical execution de-risks XYNGARI: post-quarter STAR-1 met all primary endpoints, supporting momentum into STAR-2 in H2 2025 and eventual NDA pathway .
  • Cash runway extends into Q3 2025 following FY 2024 financings and Jan 2025 PIPE; watch for additional financing or partnering to bridge to STAR-2 and extension completion .
  • Operating spend peaked with Phase 3 activities; Q4 OpEx of ~$3.20M and net loss ~$3.15M reflect trial cadence; expect OpEx to remain elevated into STAR-2 .
  • Strategic collaboration with Revance on DMT410 opens optionality beyond acne (hyperhidrosis, rosacea), potentially broadening partnership discussions and value inflection points .
  • Near-term trading catalyst: validation headline already printed post-quarter; next milestones include STAR-2 initiation and potential partnering updates—monitor press flow and capital plans .
  • Estimates unavailable; sell-side adjustments likely to center on clinical timelines rather than P&L—coverage may recalibrate probability of success assumptions post-STAR-1 .
  • Risk factors: financing needs, regulatory timelines, and execution in STAR-2; however, Phase 3 efficacy profile and tolerability support a constructive medium-term thesis if timelines hold .