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TI

TALPHERA, INC. (TLPH)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 EPS of $(0.10) beat Wall Street consensus of $(0.15), aided by lower operating expenses and a gain from change in warrant liability; revenue was $0.03M vs consensus ~$0, a modest positive surprise . Values retrieved from S&P Global.*
  • Cash operating expense guidance for FY 2025 was trimmed to $17–$19M from $18–$19M in Q4, reflecting tighter cost control while funding completion of the NEPHRO CRRT trial by year-end 2025 .
  • FDA approved the Prior Approval Supplement to reduce NEPHRO CRRT study size to 70 patients (from 166), with 6 patients already enrolled by 3/31; management targets PMA submission early 2026 and potential approval in H2 2026 .
  • Financing of up to $14.8M in three tranches (linked to enrollment milestones and a stock-price condition) plus $5.4M cash at 3/31/25 (pro forma $9.8M) should fund completion of the study; enrollment and tranche triggers are key near-term catalysts .

What Went Well and What Went Wrong

  • What Went Well

    • Study execution improved: FDA approved reduced sample size (70 patients, 90% power) and broadened inclusion criteria, accelerating timelines: “We… received approval… requesting a reduction… to 70… [and] two other changes to broaden… inclusion criteria…” .
    • Site strategy gaining traction: “We remain on track… three institutions already activated… five… by mid-year,” with new sites showing higher engagement vs legacy sites . “8 actively screening sites, 4 legacy… and 4 target… 5 additional sites by mid-year” .
    • Cost discipline: Q1 combined R&D+SG&A down to $2.9M from $4.2M YoY (non-GAAP $2.7M vs $3.9M), lowering expected FY25 cash opex to $17–$19M .

  • What Went Wrong

    • Revenue remains de minimis: Q1 revenue of $27k, consistent with development-stage profile; no product revenue ramp yet .
    • Cash balance declined: Cash/investments fell to $5.4M at 3/31/25 (from $8.9M at 12/31/24), underscoring dependence on milestone-based financing; pro forma improves to $9.8M post first tranche .
    • Legacy sites underperforming: Broader criteria increased activity but “has not yet translated into new patients from our legacy sites,” highlighting study execution risk concentrated in new target-profile sites .

Financial Results

MetricQ3 2024Q4 2024Q1 2025
Revenue ($USD Thousands)$0 $0 $27
R&D ($USD Thousands)$2,053 $1,323 $1,169
SG&A ($USD Thousands)$1,696 $1,673 $1,774
Total Operating Expenses ($USD Thousands)$3,749 $2,996 $2,943
Loss from Operations ($USD Thousands)$(3,749) $(2,996) $(2,916)
Other Income, net ($USD Thousands)$396 $1,126 $250
Net Loss from Continuing Ops ($USD Thousands)$(3,353) $(1,870) $(2,666)
Net Loss ($USD Thousands)$(3,353) $(1,870) $(2,593)
Diluted EPS – Continuing Ops ($USD)$(0.13) $(0.07) $(0.10)
Shares Used (Thousands)26,213 26,238 26,268
Cash & Investments ($USD Millions)$11.1 $8.9 $5.4 (pro forma $9.8)
Non-GAAP OpEx (OpEx less SBC) ($USD Thousands)Q3 2024Q4 2024Q1 2025
Non-GAAP Operating Expenses$3,515 $2,766 $2,747
Actual vs ConsensusQ3 2024Q4 2024Q1 2025
EPS (Actual vs Consensus*) ($USD)$(0.13) vs $(0.1967)*$(0.07) vs $(0.16)*$(0.10) vs $(0.15)*
Revenue (Actual vs Consensus*) ($USD Thousands)$0 vs $0*$0 vs $0*$27 vs $0*

Values retrieved from S&P Global.*

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash Operating Expenses (ex SBC)FY 2025$18M–$19M $17M–$19M Lowered low end
NEPHRO CRRT Study CompletionFY 2025Complete by end of 2025 Complete by end of 2025 Maintained
PMA Submission / Potential Approval2026PMA early 2026; potential approval H2 2026 PMA early 2026; potential approval H2 2026 Maintained
Financing Availability2025Up to $14.8M, 3 tranches tied to 17/35 patient milestones and stock price condition First tranche $4.925M gross ($4.4M net) closed 4/2; remaining tranches contingent Executed first tranche; remaining contingent

Earnings Call Themes & Trends

TopicQ3 2024 (Previous Mentions)Q4 2024 (Previous Mentions)Q1 2025 (Current Period)Trend
Site Activation & Enrollment5 sites screening; first patient enrolled; multiple patients completed 2 new sites started screening; 6 more expected H1 2025 8 sites actively screening; 5 more expected by mid-year; legacy sites contributing less Improving site mix; accelerating activity
Regulatory PathRegistrational study underway; breakthrough designation noted FDA agreed to reduce study to 70; broaden inclusion Reinforced regulatory alignment; reduced clinical risk cited De-risking regulatory execution
Supply Chain & Current AlternativesClinician dissatisfaction with heparin/citrate highlighted —Heparin/citrate shortages; inquiries on nafamostat availability Rising interest in alternative anticoagulant
Financing & LiquidityCash $11.1M; no new financing disclosed Announced up to $14.8M private placement First tranche closed; pro forma cash $9.8M; tranches tied to enrollment/stock Financing runway linked to milestones
Compassionate Use——Exploring compassionate use IDE with large institution for specific patients New potential avenue; supports demand narrative

Management Commentary

  • “We remain on track with new study site activation… the new target profile… has proven beneficial… engagement… higher than legacy sites…” — Vince Angotti, CEO .
  • “We now have a total of 8 actively screening sites… 5 additional sites by mid-year… legacy sites are not expected to make a significant contribution…” — Dr. Shakil Aslam, CMO .
  • “We are reducing the lower end of our previously communicated 2025 expected cash operating expense guidance to… $17 million to $19 million.” — Raffi Asadorian, CFO .
  • “FDA agreed… reduce the study size to 70 patients… primary endpoint powered at 90%.” — Vince Angotti, CEO .

Q&A Highlights

  • Enrollment impact of broadened criteria: Management saw increased screening activity but no material enrollment from legacy sites yet; expects improved yield from new target-profile sites .
  • Disclosure cadence: No enrollment updates until the 17-patient milestone (triggers second financing tranche), signaling focus on milestone-based communication .
  • Study population nuance: Legacy sites skewed to surgical/cardiothoracic ICUs where heparin background use is high; new sites in medical ICUs with nephrologist PIs expected to drive eligibility and enrollment .

Estimates Context

  • Q1 2025 EPS beat: Actual $(0.10) vs consensus $(0.15); Q4 2024 also beat: $(0.07) vs $(0.16); Q3 2024 beat: $(0.13) vs $(0.197) . Values retrieved from S&P Global.*
  • Revenue: Actual $27k vs consensus ~$0 in Q1; prior quarters were $0 in line with consensus . Values retrieved from S&P Global.*
  • Coverage depth: 2–3 estimates on EPS and revenue across quarters and years, indicating limited sell-side coverage; FY 2025 EPS consensus $(0.375)* and FY 2025 revenue $27.5k* suggest minimal near-term P&L expectations. Values retrieved from S&P Global.*
  • Potential estimate revisions: Lower opex run-rate and regulatory de-risking could support modest upward adjustments to EPS (less negative) and timeline confidence; revenue remains negligible until commercialization .

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Execution risk narrowed: FDA-approved protocol changes and improved site profile support timely completion of NEPHRO CRRT by year-end 2025; watch for the 17-patient milestone as the next tangible de-risking event .
  • Cost control is working: Non-GAAP op ex fell to $2.75M in Q1; FY25 cash opex guidance lowered to $17–$19M, extending runway toward completion .
  • Financing is milestone-linked: First tranche closed; future tranches hinge on enrollment (17/35 patients) and stock-price conditions — progress updates could be stock catalysts .
  • Demand signals building: Clinician interest and heparin/citrate shortages underpin the nafamostat narrative; compassionate use IDE exploration adds optionality .
  • Limited revenue near term: With $27k revenue and development-stage profile, the investment case hinges on clinical, regulatory, and financing milestones rather than P&L .
  • 2026 inflection: Management targets PMA submission early 2026 and potential approval H2 2026, defining medium-term commercialization timeline .
  • Risk focus: Legacy site underperformance and milestone gating for financing remain watch items; monitor activation of the five additional high-enrolling sites by mid-year .