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TI

TALPHERA, INC. (TLPH)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 showed disciplined cost control and strengthened liquidity, offset by a push-out of NEPHRO CRRT enrollment completion to H1 2026. Cash and investments were $21.3M at quarter-end, aided by a $17M first-tranche financing led by CorMedix; management believes conditional tranches provide runway through a potential Niyad PMA approval in late 2026 .
  • EPS was roughly in line with consensus: GAAP diluted EPS from continuing operations was $(0.11) vs S&P consensus of $(0.11); revenue was de minimis at $1K vs $0K consensus, consistent with a pre-commercial profile .
  • Operating expenses fell YoY (non-GAAP OpEx ex-SBC: $3.27M vs $3.52M), and FY25 cash OpEx guidance was cut to $14–$15M (from $16–$17M in Q2 and $17–$19M in Q1), with deferred spend moving to H1 2026; the cut was driven by pacing of site activation/enrollment .
  • Key catalyst path: continued site activations/enrollment updates (≥17 patients achieved in August) and potential business development optionality given CorMedix’s right-of-first-negotiation following Phase 3 topline; delays in activating several high-volume sites were the primary headwind this quarter .

What Went Well and What Went Wrong

  • What Went Well

    • Liquidity and funding visibility improved: “The financing closed in September…is expected to provide us sufficient capital through at least a Niyad PMA approval anticipated in 2026,” with $21.3M cash/investments at 9/30 .
    • Cost discipline: Combined R&D+SG&A fell to $3.4M vs $3.7M YoY; non-GAAP OpEx ex-SBC $3.27M vs $3.52M YoY .
    • Clinical engagement: Management cited investigator “eagerness for nafamostat” and reiterated if approved, Niyad would be the only FDA‑approved regional anticoagulant for CRRT; sites report nafamostat would be a preferred option given limitations of heparin/citrate .

  • What Went Wrong

    • Enrollment timeline pushed: Activation of several target-profile sites slipped; study completion moved from end-2025 to H1 2026 .
    • Higher net loss YoY: Net loss from continuing ops widened to $(4.44)M vs $(3.35)M, largely due to a negative warrant liability fair value change, despite lower operating expenses .
    • Execution friction: A VA site faced internal staffing cuts that delayed timelines by ~3–4 months; other institutions changed internal approval processes, elongating activation despite contracting .

Financial Results

Quarterly P&L snapshot (USD Thousands unless noted)

MetricQ3 2024Q1 2025Q2 2025Q3 2025
Revenue ($)$0 $27 $0 $1
Research & Development ($)$2,053 $1,169 $1,500 $1,803
Selling, General & Administrative ($)$1,696 $1,774 $2,193 $1,620
Total Operating Expenses ($)$3,749 $2,943 $3,693 $3,423
Net Loss from Continuing Ops ($)$(3,353) $(2,666) $(3,489) $(4,436)
Diluted EPS – Continuing Ops ($)$(0.13) $(0.10) $(0.10) $(0.11)
Shares Used (thousands)26,213 26,268 34,530 41,454
Non-GAAP OpEx (ex-SBC) ($)$3,515 $2,747 $3,527 $3,271

Balance sheet and liquidity

MetricDec 31, 2024Mar 31, 2025Jun 30, 2025Sep 30, 2025
Cash, Cash Equivalents & Investments ($)$8,863 $5,388 $6,791 $21,289

Estimates vs Actuals (Q3 2025)

MetricQ3 2025 ActualQ3 2025 Consensus*# of Estimates*
Revenue ($USD Thousands)$1 $0.0*2*
Diluted EPS – Continuing Ops ($)$(0.11) $(0.11)*1*
Target Price (Longer-term) ($)—$3.25*—

Values with asterisks were retrieved from S&P Global.

KPIs and operating execution

KPIQ1 2025Q2 2025Q3 2025
NEPHRO patients enrolled (cumulative)— (update expected at 17 milestone) 15 (as of Q2 PR) 17 achieved Aug 25 (≥25% of 70)
Active target-profile sites3 new sites activated and screening; 5 additional expected by mid-year (target 13 total) 7 screening (4 legacy, 3 new) with 6 more target sites expected in Q3 5 of 9 target-profile sites activated; 4 more expected in Q4
Study completion timingEnd of 2025 (plan) End of 2025 (plan) Shifted to H1 2026

Notes: Segment revenue/margins not applicable (pre-commercial).

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash OpEx (R&D+SG&A, ex-SBC)FY 2025$17–$19M (Q1) → $16–$17M (Q2) $14–$15M (Q3) Lowered twice
NEPHRO study completionEnrollment timelineBy end of 2025 H1 2026 Pushed out
Cash runwayThrough developmentExpected to fund to study completion by end-2025 (Q2) Sufficient cash (with conditional tranches) through potential PMA approval in late 2026 Extended runway expectation
PMA timelineApproval expectationPMA submission planned Q1 2026 (Q2 PR) Potential PMA approval late 2026 Clarified end-point (approval)

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 2025, Q2 2025)Current Period (Q3 2025)Trend
Study enrollment/activationQ1: FDA allowed reduction from 166→70 patients; new site profile; plan to complete by YE25 . Q2: 15 patients enrolled; 6 additional target sites expected in Q3; strong acceleration from new sites .Activation of several large sites delayed; 5 of 9 target-profile sites active; completion pushed to H1 2026 .Slower activation → timeline slip
Financing/runwayQ1: $4.9M tranche structure, tied to 17 and 35 patient milestones . Q2: $6.8M cash; tranches could fund to YE25 study completion .$17M first tranche led by CorMedix; conditional tranches extend runway to potential approval in late 2026 .Visibility improved
Regulatory pathQ1: PAS approval to shrink sample size; broader inclusion criteria . Q2: FDA-agreed design; breakthrough designation; clear path .Continued breakthrough engagement; considering further eligibility tweaks to accelerate enrollment .Constructive, iterative
Commercial interest/marketQ2: Physician interest; heparin/citrate shortages noted .PIs eager for nafamostat; reaffirmed disadvantages of heparin/citrate; Niyad would be only FDA‑approved regional anticoagulant if approved .Stable to positive
Compassionate useQ2: Preparing compassionate use IDE for specific high-need subpopulation .Advancing compassionate use IDE with large Southeast institution; first such submission at site .Advancing
Corporate/BD optionality—CorMedix received right-of-first-negotiation post-Phase 3 topline; appointed CEO Joseph Todisco to TLPH board .New strategic angle

Management Commentary

  • “The financing…is expected to provide us sufficient capital through at least a Niyad PMA approval anticipated in 2026…[and] validates the attractiveness of the Niyad market opportunity.” – Vince Angotti, CEO .
  • “We have received consistent feedback from the principal investigators conveying eagerness for nafamostat to be available as their preferred alternative to current CRRT anticoagulants.” – Vince Angotti, CEO .
  • “Due to the delays in the activation of these new sites, we now anticipate study completion in the first half of 2026.” – Dr. Shakil Aslam, CMO .
  • “The three critical risk elements—clinical, regulatory, and commercial—for the nafamostat program are low…trial design agreed with FDA…breakthrough designation…disadvantages of current products.” – Vince Angotti, CEO .

Q&A Highlights

  • Enrollment pace and site activation: Management affirmed new target sites are enrolling at similar per-site rates; acceleration requires layering on additional sites; delays at several institutions drove the timeline shift to H1 2026 .
  • Operational friction at VA site: A VA center had staffing cuts, adding ~3–4 months to its activation timeline; not yet enrolling but expected to join before year-end .
  • Financing tranche conditions: Investors can waive stock-price conditions; discussions indicated primary focus on the 17-patient milestone, which has been achieved (Aug 25) .
  • Compassionate use: Data from compassionate use would contribute to safety submissions and external publications highlighting high-need subpopulations unsuitable for heparin/citrate .

Estimates Context

  • Q3 2025: EPS $(0.11) actual vs $(0.11) consensus*; revenue $1K actual vs $0K consensus*. Given minimal reported revenue and pre-commercial status, estimate dispersion remains low (1–2 estimates), and the focus remains on OpEx control and clinical/regulatory milestones .
  • Target price consensus remains $3.25*, indicating longer-term optionality around successful NEPHRO completion/PMA and strategic alternatives; however, near-term estimate revisions may reflect the push-out of study completion into H1 2026.
    Values with asterisks were retrieved from S&P Global.

Key Takeaways for Investors

  • Liquidity extended: $21.3M cash/investments plus conditional tranches are expected to fund through a potential PMA approval in late 2026, reducing near-term financing overhang .
  • Expense discipline intact: FY25 cash OpEx guidance cut to $14–$15M, with deferred spend sliding to H1 2026 alongside the updated clinical timeline .
  • Execution is the swing factor: The principal risk is timely activation/enrollment at high-volume sites; management is pursuing eligibility refinements to accelerate enrollment .
  • Strategic optionality: CorMedix’s right-of-first-negotiation post-Phase 3 topline and board representation introduce a credible BD path contingent on study outcomes .
  • Near-term catalysts: Site activation updates, crossing 35-patient threshold, potential compassionate use visibility, and any FDA feedback on protocol eligibility adjustments .
  • Trading setup: With EPS/revenue largely non-catalytic, shares are likely to trade on clinical execution, financing cadence, and BD headlines; the guidance cut with runway extension shifts focus to H1 2026 enrollment completion and late-2026 approval timing .

Sources

  • Q3 2025 8-K and Exhibit 99.1 Press Release: results, OpEx, EPS, liquidity, financing, guidance .
  • Q3 2025 Earnings Call Transcript: timeline shift, site activation details, risk framing, Q&A .
  • Other press releases (Q1–Q2 2025) for trend and milestones: Q1 results ; Q2 results ; 17-patient enrollment milestone .
  • S&P Global consensus data for estimates (values with asterisks retrieved from S&P Global).