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KALA BIO, Inc. (KALA)·Q2 2025 Earnings Summary

Executive Summary

  • Cash runway remained intact at $31.9M as of June 30, 2025, with management reiterating funding into 1Q 2026; operating loss widened YoY on higher R&D as KPI-012 advanced toward the CHASE Phase 2b topline readout .
  • EPS beat on S&P Global Primary EPS versus consensus: actual -$1.32 vs estimate -$1.70, reflecting lower normalized loss and modest other income; GAAP EPS was -$1.71, wider sequentially vs Q1’s -$1.41 * *.
  • Clinical execution was the quarter’s catalyst: CHASE Phase 2b enrollment completed (79 randomized across 37 sites) with topline data guided for end of September 2025; management believes the trial could serve as pivotal for a potential BLA, contingent on positive results .
  • Balance sheet actions included a $2.5M principal/fee prepayment on debt, reducing long-term debt to $18.8M; working capital decreased to $17.6M as trial costs ramped .

What Went Well and What Went Wrong

What Went Well

  • Completion of CHASE Phase 2b enrollment and tightened topline timing (“end of September 2025”), increasing visibility to a near-term clinical catalyst .
  • Clear strategic framing of KPI-012’s multifactorial mechanism and potential to treat all PCED etiologies; “We are well-positioned heading into our key readout… which we believe has the potential to serve as a pivotal trial required to support a BLA” — Todd Bazemore, Interim CEO .
  • Continued non-dilutive support via grant income ($0.55M in Q2) and disciplined G&A growth (+$0.3M YoY) while prioritizing R&D for KPI-012 .

What Went Wrong

  • Loss widened YoY: operating loss -$11.0M vs -$9.6M; net loss -$11.2M vs -$9.6M, reflecting higher R&D and lower grant income YoY .
  • Sequential degradation vs Q1: GAAP EPS -$1.71 vs -$1.41; grant income fell to $0.55M vs $2.35M in Q1, increasing net loss despite steady Opex .
  • Working capital declined ($17.6M vs $22.7M in Q1) as cash decreased due to operations and debt prepayment, compressing liquidity buffer into the key data readout .

Financial Results

GAAP P&L and Balance Sheet (Oldest → Newest)

MetricQ4 2024Q1 2025Q2 2025
Cash and Cash Equivalents ($MM)$51.2 $42.2 $31.9
Working Capital ($MM)$35.8 $22.7 $17.6
Long-term Debt, net ($MM)$20.1 $15.1 $18.8
G&A Expense ($MM)$4.2 $4.6 $4.6
R&D Expense ($MM)$5.3 $6.1 $6.2
Total Operating Expenses ($MM)$9.5 $10.7 $11.0
Operating Loss ($MM)-$9.5 -$10.7 -$11.0
Interest Income ($MM)$0.48 $0.46 $0.41
Interest Expense ($MM)-$1.39 -$1.09 -$1.08
Grant Income ($MM)$2.20 $2.35 $0.55
Net Loss ($MM)-$8.18 -$8.95 -$11.16
GAAP EPS-$1.74 -$1.41 -$1.71
Weighted Avg Shares (MM)4.69 6.35 6.51

Notes: Company reports no revenue line items; margins not meaningful for development-stage period .

Estimates vs Actuals (Q2 2025)

MetricConsensusActualSurprise
Primary EPS (S&P)-$1.70*-$1.32*+$0.38*
Revenue ($MM) (S&P)$0.00*N/A (no revenue reported) N/A

Values retrieved from S&P Global. GAAP EPS for Q2 2025 was -$1.71 .

KPIs and Trial Execution (Oldest → Newest)

KPIQ4 2024Q1 2025Q2 2025
CHASE Phase 2b Randomized Patients87 Ongoing enrollment; LATAM sites activated 79 verified for primary analysis
Sites Activatedn/aLATAM sites activated 37 U.S. & LATAM
Topline Data Timing3Q 2025 3Q 2025 End of September 2025
Cash Runway GuidanceInto 1Q 2026 Into 1Q 2026 Into 1Q 2026

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
CHASE Phase 2b Topline Timing3Q 2025“3Q 2025” “End of September 2025” Narrowed window
Cash RunwayThrough early 2026“Into 1Q 2026” “Into 1Q 2026” Maintained
Debt Principal PrepaymentQ2 2025n/a$2.5M prepayment of principal/fees Balance sheet de-risking

No revenue, margin, tax, or dividend guidance provided; company is development-stage .

Earnings Call Themes & Trends

No Q2 2025 earnings call transcript was available in the document set; themes reflect management commentary across press releases.

TopicPrevious Mentions (Q4 2024 & Q1 2025)Current Period (Q2 2025)Trend
R&D execution (KPI-012 in PCED)Enrollment progressing; targeting 3Q topline; LATAM activation Enrollment completed; 79 randomized; topline end of September Positive progress; milestone achieved
Regulatory pathPotential first of two pivotal trials for BLA Potential pivotal trial for BLA contingent on positive results Maintained confidence; clarity increasing
KOL and market educationBuilding KOL engagement KOL event underscored unmet need and mechanism Strengthening narrative
Balance sheet/runwayRunway into 1Q 2026 Runway into 1Q 2026; $2.5M debt prepayment Stable runway; reduced debt
Platform expansion (KPI-014)Preclinical retinal programs described Continued preclinical positioning; neuroprotective rationale Ongoing

Management Commentary

  • “We are well-positioned heading into our key readout of the CHASE trial, which we believe has the potential to serve as a pivotal trial required to support a BLA… remain on track to report topline results at the end of September” — Todd Bazemore, Interim CEO .
  • “KOLs… underscored the high unmet need for patients with PCED and highlighted the potential of KPI-012’s multifactorial mechanism of action to address all underlying etiologies” — Todd Bazemore .
  • “The completion of enrollment in the CHASE trial is a significant milestone… we believe KPI-012 could be a significant advance for the treatment of… 100,000 people with PCED in the United States” — Kim Brazzell, Ph.D., CMO .

Q&A Highlights

  • No earnings call transcript or Q&A was found for Q2 2025 in the available documents [ListDocuments returned none].

Estimates Context

  • S&P Global Primary EPS consensus for Q2 2025 was -$1.70 with 3 estimates; S&P actual Primary EPS was -$1.32, a beat of +$0.38. GAAP EPS reported by KALA was -$1.71, indicating differences between normalized “Primary EPS” and GAAP net loss per share [GetEstimates]* .
  • Revenue consensus was $0.00 with 3 estimates; company reported no revenue, consistent with development-stage status [GetEstimates]* .
    Values retrieved from S&P Global.

Key Takeaways for Investors

  • Near-term catalyst: CHASE Phase 2b topline at end of September 2025; management views trial as potentially pivotal for BLA if positive, a decisive stock driver .
  • EPS beat on S&P normalized basis despite GAAP loss widening sequentially; grant income variability and R&D timing will continue to drive quarterly EPS volatility *.
  • Liquidity remains adequate into 1Q 2026; debt prepayment ($2.5M) supports balance sheet de-risking ahead of data .
  • If topline is positive, expect rapid engagement with FDA and potential clarity on registrational path; KOL support and unmet need narrative strengthen commercial prospects in PCED .
  • Execution risk remains elevated given single-asset concentration; watch for magnitude of efficacy (complete healing endpoint) and safety in the 3U/mL vs 1U/mL dosing arms .
  • Estimate revisions likely: Analysts may tighten EPS trajectories post-data and update probability-weighted timelines for commercialization and funding needs [GetEstimates]*.
  • Trading lens: Data readout timing and press cycle (KOLs, conferences) are key for sentiment; downside risk if efficacy misses or if regulatory view requires additional trials beyond CHASE .