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Applied Therapeutics, Inc. (APLT)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 EPS of $−0.13 beat Wall Street consensus of $−0.14*, while revenue of $1.00m (license) beat consensus of $0.25m*; YoY net loss narrowed materially to $19.0m from $68.6m on lower OpEx .
  • License revenue recognition drove the top-line surprise; R&D services revenue was $0 in the quarter, versus $0.122m in Q3 2024 .
  • Regulatory update: FDA Type C minutes for CMT‑SORD identified open issues (surrogate endpoint, primary endpoint, carcinogenicity), and the company intends to request another Type C meeting to discuss Phase 3 design; FDA meeting for Classic Galactosemia is scheduled in Q4 2025 .
  • Liquidity declined to $11.9m cash at quarter-end; leadership transition announced (Executive Chairman resigned), which could influence near‑term sentiment and governance narrative .

What Went Well and What Went Wrong

What Went Well

  • EPS and revenue beat: $−0.13 vs $−0.14* EPS and $1.00m vs $0.25m* revenue, driven by license revenue recognition, with YoY OpEx lower (R&D: $9.6m vs $14.8m; G&A: $8.2m vs $15.0m) .
  • Constructive FDA dialogue for CMT‑SORD; company plans an additional Type C meeting to refine Phase 3 design. Quote: “We completed a meeting with the FDA… we commenced constructive discussions as we continue to refine our regulatory strategy” — Les Funtleyder .
  • Positive PMM2‑CDG single‑patient data: well tolerated, dose‑dependent sorbitol decrease, and NPCRS improved by 9 points (46%), supporting future development .

What Went Wrong

  • Cash burn accelerated: cash fell to $11.9m (Sep 30, 2025) from $30.4m (Jun 30, 2025) and $50.8m (Mar 31, 2025), raising financing risk .
  • CMT‑SORD regulatory uncertainties persist: FDA cited open issues on pathophysiology, surrogate endpoint (sorbitol), Phase 3 primary endpoint selection, and carcinogenicity testing .
  • Galactosemia program remains under CRL; despite an FDA meeting scheduled in Q4 2025, approval timing and remediation path are unresolved .

Financial Results

Consolidated Performance vs Prior Periods and YoY

MetricQ3 2024Q1 2025Q2 2025Q3 2025
Total Revenue ($USD Millions)$0.12 $0.00 $0.00 $1.00
License Revenue ($USD Millions)$0.00 $0.00 $0.00 $1.00
R&D Services Revenue ($USD Millions)$0.12 $0.00 $0.14 $0.00
R&D Expense ($USD Millions)$14.83 $7.84 $9.92 $9.60
G&A Expense ($USD Millions)$15.04 $17.69 $13.18 $8.16
Net Loss ($USD Millions)$68.59 $21.83 $21.33 $18.99
Diluted EPS ($USD)$−0.48 $−0.15 $−0.15 $−0.13
Cash & Cash Equivalents ($USD Millions)N/A$50.76 $30.42 $11.95

Revenue Composition

MetricQ3 2024Q1 2025Q2 2025Q3 2025
License Revenue ($USD Millions)$0.00 $0.00 $0.00 $1.00
R&D Services Revenue ($USD Millions)$0.12 $0.00 $0.14 $0.00

KPIs

KPIQ3 2024Q1 2025Q2 2025Q3 2025
Cash & Cash Equivalents ($USD Millions)N/A$50.76 $30.42 $11.95
Weighted-Average Shares (Basic)144.35m 144.79m 145.09m 145.56m
Total Operating Expenses ($USD Millions)$29.87 $25.53 $23.10 $17.76

Results vs S&P Global Consensus

MetricQ1 2025Q2 2025Q3 2025
Primary EPS Consensus Mean ($)−0.193*−0.160*−0.140*
Primary EPS Actual ($)−0.15 −0.15 −0.13
Revenue Consensus Mean ($USD Millions)5.63*0.31*0.25*
Revenue Actual ($USD Millions)0.00 0.00 1.00

Values retrieved from S&P Global.*

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Financial guidance (Revenue/EPS/OpEx)FY/Q4 2025None providedNone providedMaintained (none)
CMT‑SORD regulatory pathwayOngoingPlanning NDA/discussion; pathway undeterminedAdditional Type C meeting request planned to discuss Phase 3 designMaintained momentum; pathway remains under discussion
Classic Galactosemia (govorestat)Q4 2025Under CRL; ongoing reviewFDA meeting scheduled in Q4 2025Process progressing; timetable set
PMM2‑CDG development2H 2025Ongoing expanded accessPositive single‑patient data published/presented; continued evaluationNarrative strengthened

Earnings Call Themes & Trends

Note: No Q3 2025 earnings call transcript was available; themes are derived from press releases.

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3 2025)Trend
CMT‑SORD regulatory strategyWorking with FDA; meeting scheduled Q3 2025 Type C minutes received; open issues identified; additional Type C meeting planned Advancing but unresolved
Classic GalactosemiaUnder CRL; review and planning for FDA engagement FDA meeting scheduled in Q4 2025 Progressing (process milestone)
PMM2‑CDG clinical dataUpcoming ASHG presentation Positive single‑patient outcomes (tolerability, sorbitol decrease, NPCRS +9 points) Strengthening
Corporate/governanceLeadership appointments (CMO, EVP) Executive Chairman resignation (no disagreement) Transition
Commercialization/partneringOut-licensing AT‑001 to Biossil No new commercial deals disclosedStable

Management Commentary

  • “We completed a meeting with the FDA to discuss a potential NDA submission for govorestat for the treatment of CMT‑SORD… We expect to submit another meeting request with the FDA to further discuss the design of a potential Phase 3 trial” — Les Funtleyder, interim CEO & CFO .
  • “We are scheduled to meet with the FDA in the fourth quarter to review govorestat for the treatment of classic galactosemia… new data from a single patient with PMM2‑CDG… further support the potential for continued clinical development” — Les Funtleyder .
  • Board leadership transition was announced; resignation was for personal reasons and not due to disagreement .

Q&A Highlights

  • No Q3 2025 earnings call transcript found in the document catalog; therefore, no Q&A themes or clarifications available [SearchDocuments: none; ListDocuments: no transcript].

Estimates Context

  • Q3 2025 results beat consensus on EPS ($−0.13 vs $−0.14*) and revenue ($1.00m vs $0.25m*), primarily due to license revenue recognition and lower total operating expenses vs prior year .
  • Prior quarters: Q2 2025 EPS matched consensus ($−0.15 vs $−0.16* modest beat), but revenue was in line at $0 vs $0.31m*; Q1 2025 materially missed on revenue ($0 vs $5.63m*) while EPS beat ($−0.15 vs $−0.19*) .
    Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Near‑term catalysts center on FDA interactions: additional Type C meeting for CMT‑SORD Phase 3 design and Q4 2025 FDA meeting for Classic Galactosemia; headline risk and momentum will hinge on regulatory feedback .
  • Cash runway tightened materially to $11.9m; expect financing or partnering actions to be a key overhang unless non‑dilutive inflows materialize .
  • Clinical narrative strengthened by PMM2‑CDG data, supporting optionality in pipeline prioritization and future trials .
  • Earnings quality: revenue beat came from license revenue; durability of top‑line remains uncertain absent recurring revenue sources .
  • Governance watch: Executive Chairman resignation introduces leadership transition risk but was disclosed as non‑disagreement; monitor board/management stability .
  • Trading setup: stock likely sensitive to regulatory headlines; positive FDA feedback could re‑rate, while requests for additional studies (e.g., carcinogenicity) could delay timelines .
  • Medium‑term thesis: execution on CMT‑SORD Phase 3 design, addressing Galactosemia CRL, and securing capital are pivotal to value realization; PMM2‑CDG progress adds strategic optionality .