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Applied Therapeutics, Inc. (APLT)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 EPS came in at $(0.15), a modest beat versus Wall Street consensus of $(0.16); revenue was $0 vs consensus of ~$0.31M, reflecting a pre-revenue profile and limited near-term P&L catalysts *. Values retrieved from S&P Global.
  • Cash and cash equivalents declined to $30.4M as of June 30, 2025 (from $50.8M in Q1 and $79.4M at YE 2024), underscoring financing needs amid continued operating losses .
  • Regulatory momentum: FDA meeting scheduled in Q3 2025 to discuss a potential NDA submission for govorestat in CMT‑SORD; full 12‑month and 18/24‑month INSPIRE data highlighted slowed disease progression on MRI and patient‑reported improvements (CMT‑HI) .
  • Strategic actions: out‑licensed AT‑001 to Biossil (upfront payment, future royalties/milestones), and strengthened leadership (new CMO; EVP for Advocacy/Gov’t Affairs) to support clinical and regulatory execution .
  • Near‑term stock drivers are likely regulatory updates (Type C meeting outcomes), clarity on the CMT‑SORD NDA pathway, and financing plans; the EPS beat is less material given no recognized revenue *. Values retrieved from S&P Global.

What Went Well and What Went Wrong

What Went Well

  • FDA engagement: “meeting… to align on its planned NDA submission strategy for govorestat” for CMT‑SORD in Q3 2025, advancing a key regulatory catalyst .
  • Clinical data durability: INSPIRE 24‑month MRIs showed slowed disease progression; statistically significant improvement in CMT‑HI at 12 months; sustained sorbitol reduction through 24 months .
  • Portfolio and org execution: out‑licensing AT‑001 to Biossil for diabetic cardiomyopathy; promotions of Evan Bailey, MD (CMO) and Dottie Caplan (EVP) bolstering regulatory/clinical and advocacy capabilities .

Quote: “We are positioned for forward momentum as we engage with the FDA… regarding a potential NDA submission for govorestat for the treatment of CMT‑SORD.” – Les Funtleyder, Interim CEO & CFO .

What Went Wrong

  • Pre‑revenue profile persists: Q2 2025 recognized $0 in revenue (vs $0.144M in Q2 2024), limiting P&L leverage and estimate visibility .
  • Cash burn and OpEx: Net loss of $21.3M; G&A rose to $13.2M (+$2.6M YoY), reflecting legal/professional/personnel and data storage costs amid continued losses .
  • Galactosemia setback still unresolved: ongoing review of the Complete Response Letter and next regulatory steps for the Classic Galactosemia program, extending timeline uncertainty .

Financial Results

Core P&L and Cash

MetricQ2 2024Q1 2025Q2 2025
Revenue ($USD Millions)$0.144 $0.190 $0.000
Net Income ($USD Millions)$2.898 $(21.825) $(21.330)
Diluted EPS ($USD)$(0.13) $(0.15) $(0.15)
R&D Expense ($USD Millions)$10.004 $7.837 $9.923
G&A Expense ($USD Millions)$10.580 $17.688 $13.175
Cash & Cash Equivalents ($USD Millions)$79.4 (Dec 31, 2024) $50.8 (Mar 31, 2025) $30.4 (Jun 30, 2025)

Additional Operating Metrics

MetricQ2 2024Q1 2025Q2 2025
Loss from Operations ($USD Millions)$(20.440) $(25.525) $(23.098)
Other Income (Expense), Net ($USD Millions)$23.338 $3.700 $1.768
Change in Fair Value of Warrant Liabilities ($USD Millions)$22.744 $3.104 $1.437

Non-GAAP/Cash Flow Indicators (S&P Global)

MetricQ2 2024Q1 2025Q2 2025
EBITDA ($USD Millions)n/a$(25.525)*$(23.098)*
Cash from Operations ($USD Millions)n/a$(28.636)*$(20.341)*

Values with asterisks were retrieved from S&P Global.

Segment Breakdown

No revenue segments disclosed; revenue recognized relates to R&D services and was $0 in Q2 2025 .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Financial Guidance (Revenue/Margins/OpEx)FY 2025Not providedNot providedMaintained (no guidance)
Regulatory Milestones (CMT‑SORD NDA Pathway)Q3–Q4 2025Ongoing FDA engagementFDA meeting scheduled Q3 2025 to align on NDA strategyRaised visibility (process clarity)
Galactosemia Program2025CRL under reviewOngoing review; potential FDA meeting to evaluate path forwardMaintained (under review)

Note: Company did not issue formal quantitative financial guidance in Q2 2025 materials; commentary emphasized regulatory alignment and pipeline execution .

Earnings Call Themes & Trends

(Transcript not available via our sources; thematic tracking uses company press releases across quarters.)

TopicPrevious Mentions (Q4 2024 and Q1 2025)Current Period (Q2 2025)Trend
Regulatory/legalCRL for Galactosemia; evaluating response and next steps FDA meeting scheduled to discuss CMT‑SORD NDA; ongoing Galactosemia review Increasing regulatory clarity in CMT‑SORD; Galactosemia under continued evaluation
R&D executionOptimizing late‑stage programs; building senior regulatory/quality team INSPIRE 12/18/24‑month results: slowed MRI progression; improved CMT‑HI; sustained sorbitol reduction Strengthening data package and durability signals
Product performanceGovorestat as lead candidate across CMT‑SORD, Galactosemia, PMM2‑CDG Clinical durability and patient‑reported benefit; sorbitol assay launched for patient ID Enhanced clinical narratives; diagnostics support for patient identification
Portfolio strategyLeadership additions; regulatory/quality capabilities AT‑001 out‑licensed to Biossil; new CMO/EVP Advocacy Focused portfolio, monetization of non‑core assets
Cash/financingYE 2024 cash $79.4M Cash $30.4M at Q2; continued losses imply financing need Heightened funding urgency

Management Commentary

  • “We are positioned for forward momentum as we engage with the FDA in the third quarter regarding a potential NDA submission for govorestat for the treatment of CMT‑SORD.” – Les Funtleyder, Interim CEO & CFO .
  • “We are encouraged by the breadth of data supporting govorestat’s ability to significantly lower blood sorbitol levels and positively impact… stability and mobility at up to two years… We have also observed slowing of disease progression at 24 months through MRI scans.” – Evan Bailey, MD (then SVP, later CMO) .
  • “For the first time in any CMT patient population… 24 month MRI data [showed] govorestat slowed the progression of the disease.” – Mary M. Reilly, MD (UCL) .

Q&A Highlights

  • No Q2 2025 call transcript was available via our sources; the company’s IR site provides the Q2 press release but does not link a transcript, and our document catalog yielded no earnings call transcript for Q2 2025 .

Estimates Context

Results vs S&P Global Wall Street consensus for Q2 2025:

MetricActualConsensusSurprise
Primary EPS ($)$(0.15) $(0.16)*+$0.01 – bold: beat
Revenue ($USD Millions)$0.00 $0.313*-$0.313 – bold: miss
EBITDA ($USD Millions)$(23.098)*n/an/a

Values with asterisks were retrieved from S&P Global.

Implications:

  • EPS beat is modest and largely a function of operating line items (e.g., warrant fair‑value changes and lower R&D) rather than revenue strength in a pre‑commercial stage .
  • Revenue miss reflects timing of R&D services recognition; consensus likely needs to reflect ongoing zero revenue until commercialization or BD monetization *. Values retrieved from S&P Global.

Key Takeaways for Investors

  • Regulatory catalysts dominate: Q3 FDA meeting on CMT‑SORD NDA strategy is the primary near‑term driver; Galactosemia remains under review post‑CRL .
  • Clinical durability supports the case: INSPIRE data indicate slowed MRI progression at 24 months and improved CMT‑HI at 12 months, strengthening potential NDA narrative .
  • Cash runway tightening: Cash fell to $30.4M at Q2; expect financing or BD acceleration to bridge to potential regulatory submissions/approvals .
  • P&L optics: EPS beat vs consensus is less meaningful without revenue; focus on OpEx discipline and non‑cash items affecting EPS (e.g., warrant liability changes) .
  • Strategic focus: Out‑licensing AT‑001 and leadership promotions suggest prioritization of govorestat and regulatory execution in rare diseases .
  • Trading lens: Stock likely reacts to regulatory headlines (meeting outcomes, clarity on endpoints/labels) more than quarterly EPS deltas; monitor IR updates and FDA communications .
  • Estimate revisions: Consensus should reflect ongoing zero revenue and negative EBITDA until a regulatory inflection or monetization event; limited scope for near‑term estimate upgrades absent new BD or regulatory milestones *. Values retrieved from S&P Global.

Sources:

  • Q2 2025 8‑K and press release, including full financial statements and program updates .
  • Q1 2025 press release, financials and program review .
  • Q4 2024 press release (year‑end financials and leadership updates) .
  • INSPIRE clinical data press release (12/18/24‑month analyses) .
  • Leadership appointments press release .
  • IR press releases index (availability reference) .