TALPHERA, INC. (TLPH)·Q2 2025 Earnings Summary

Executive Summary

• Accelerating clinical execution: NEPHRO CRRT enrollment reached 15 patients, with 90% from newly profiled nephrology-led medical ICU sites; management targets completing the 70-patient study by year-end 2025 and a PMA submission in Q1 2026, framing 2026 approval as the goal .
• Expense discipline: 2025 cash operating expense (non-GAAP) guidance cut to $16–17M from $17–19M in Q1 (and $18–19M in Q4), implying a leaner burn while still funding study completion; CFO expects 2H OpEx to bump as enrollment ramps .
• Results vs consensus: Q2 EPS of -$0.10 beat the S&P Global consensus of -$0.13; revenue was $0 and in line with $0 consensus. Coverage remains thin (1–2 estimates), limiting signal strength. Values retrieved from S&P Global.*
• Funding pathway: $14.8M three-tranche financing structured on 17/35 patient enrollment milestones and a $0.7325 stock price condition (waivable by investors), with Q2-end cash of $6.8M; management believes committed tranches plus current cash support study completion .
• Potential stock catalysts: hitting the 17-patient milestone, execution on site activations to 13 by end Q3, compassionate use IDE traction, and reiterated 2025 completion timeline .

What Went Well and What Went Wrong

• What Went Well

  • Enrollment momentum from new target-profile sites (nephrologist PIs, medical ICUs) doubled total patients since May; 15 enrolled with 90% from new sites, validating the protocol/site pivot .
  • Clearer path and confidence: CEO emphasized clinical/regulatory/commercial risk viewed as low, citing 30+ years of nafamostat use in Asia, FDA Breakthrough designation, and disadvantages of heparin/citrate in CRRT .
  • Expense execution and guidance cut: Q2 combined R&D+SG&A fell to $3.7M from $4.3M YoY; 2025 cash OpEx guidance lowered to $16–17M .

• What Went Wrong

  • No revenue base: Q2 revenue was $0, highlighting continued reliance on financing and expense control in the absence of commercial sales .
  • Continued financing overhang: tranches tied to enrollment milestones and a stock price condition; while waivable, equity condition adds execution/market dependency risk .
  • Operational lift ahead: CFO cautioned OpEx will rise in 2H as enrollment accelerates; near-term burn will increase with site activations and patient accrual .

Financial Results

Quarterly trend (oldest → newest)

Q2 YoY comparison

Q2 2025 actual vs S&P Global consensus

• Estimate coverage: EPS est. count = 1; Revenue est. count = 2.*
• Values retrieved from S&P Global.*

KPIs and operating drivers (oldest → newest)

Segment breakdown: Not applicable (no commercial revenue segments) .

Guidance Changes

CFO also noted 2H OpEx to step up with enrollment acceleration .

Earnings Call Themes & Trends

Management Commentary

• “We have enrolled 15 patients in the NEPHRO clinical study… we expect to complete the study by the end of the year… add six new clinical sites by the end of the third quarter, bringing the total number of sites up to 13” — CEO Vince Angotti .
• “These new [target-profile] sites have enrolled over ninety percent of the 15 patients to date… nine patients over the last six weeks” — CMO Shakil Aslam .
• “If approved, [Niyad] would become the only FDA approved regional anticoagulant for use during CRRT” — CEO .
• “We are reducing the previously communicated 2025 expected cash operating expense guidance to… $16–17 million… a reduction from the $17–19 million range provided last quarter” — CFO Raffi Asadorian .
• “We’re very excited… goal of completing [the] trial this year in 2025 with an FDA approval of [Niyad] in 2026” — CEO closing .

Q&A Highlights

• Enrollment trajectory: With nine additional target-profile sites coming online for ~four months (Sep–Dec), management calculates ~1.5 patients/site/month needed to reach 70; recent per-site run-rate is at/above this, making the target feasible if activations proceed as planned .
• Compassionate use IDE scope: Focus on oncology patients with thrombocytopenia and sepsis/liver dysfunction where heparin/citrate are contraindicated; safety data would be included in the broader safety package and support future publications/commercial uptake .
• Heparin/citrate availability: Episodic heparin supply challenges and citrate shortages noted; users remain “on edge” about predictable supply, supporting interest in nafamostat .
• Financing tranche conditions: Investors emphasized the 17-patient milestone more than the stock price condition and can waive the price trigger if needed; discussions expected upon reaching milestones .
• Expense cadence: Expect OpEx to “bump up” in 2H due to accelerated enrollment and site activations .

Estimates Context

• Q2 2025 EPS: Actual -$0.10 vs consensus -$0.13 (beat). Revenue: $0 vs consensus $0 (in line). Estimate counts: EPS=1, Revenue=2.*
• Q1 2025 EPS: Actual -$0.11 vs consensus -$0.15 (beat). Revenue: $27k vs consensus $0 (above). Estimate counts: EPS=2, Revenue=2.*
• Q2 2024 EPS: Actual -$0.15 vs consensus -$0.21 (beat). Estimate counts: EPS=3, Revenue=3.*
  Values retrieved from S&P Global.*

Key Takeaways for Investors

• Execution turning the corner: Enrollment has clearly inflected on the back of site/PI re-profile; completion by year-end is increasingly credible if site activations remain on schedule .
• Risk-balanced path: FDA Breakthrough designation, reduced sample size (70; 90% power), and long-standing ex-US nafamostat experience underpin management’s view of lower clinical/regulatory risk .
• Leaner burn, near-term step-up: 2025 cash OpEx guidance cut to $16–17M, but CFO flagged 2H enrollment-driven increases; expect quarterly OpEx to trend higher near term .
• Funding catalysts: 17-patient milestone could unlock the second tranche (or investor waiver); cash plus tranches seen as sufficient to fund study completion .
• Strategic optionality: Compassionate use IDE could seed safety data, physician experience, and publications in high-need subpopulations, aiding commercialization if approved .
• Macro tailwinds: Heparin/citrate supply issues and off-label citrate use support provider interest in a labeled regional CRRT anticoagulant if Niyad is approved .
• Trading setup: Near-term stock drivers include 17-patient disclosure, site activation cadence to 13 by end Q3, and any updates on compassionate use IDE progress .

Notes:  
* S&P Global estimates used for consensus and estimate counts.  

Sources: Q2 2025 press release and financial tables ; 8-K furnishing Q2 results ; Q2 2025 earnings call transcript ; Q1 2025 press release ; Q4 2024 press release ; FDA agreement and financing announcement .