Quoin Pharmaceuticals, Ltd. (QNRX)·Q3 2025 Earnings Summary

Executive Summary

• Q3 2025 was operationally active with clinical, regulatory and financing milestones, but financials remained pre‑revenue with a higher net loss driven by stepped‑up R&D to advance QRX003 into pivotal studies .
• Liquidity as of 9/30/25 was $1.83M cash and $3.58M investments; an October private placement ($16.6M upfront; up to ~$88.7M from warrants) plus $3.3M in warrant exercises extended runway “into 2027” — a material improvement versus Q2’s “into Q1 2026” outlook .
• FDA granted Orphan Drug Designation for QRX003; company reiterated pivotal trial timelines: enrollment start in Q4 2025, completion targeted Q1 2026, top‑line 2H 2026, and NDA submission later in 2026 — a sustained regulatory/path-to-market narrative .
• No earnings call transcript or Wall Street consensus estimates were available for Q3 2025; as a result, no beat/miss can be assessed (S&P Global consensus unavailable) [GetEstimates].

What Went Well and What Went Wrong

• What Went Well

  • Regulatory: FDA Orphan Drug Designation for QRX003, complementing EMA ODD (May 2025), supporting potential market exclusivity and incentives .
  • Financing: Closed an October private placement with $16.6M upfront and additional warrant upside, explicitly intended to fund completion of QRX003 clinical development and progress other programs; runway guided into 2027 .
  • Clinical momentum: Pivotal trial enrollment to commence Q4 2025; pediatric NS investigator study showed sustained whole‑body response at 9 months (IGA 4→0; pruritus 5→0; no AEs) and expansion to three additional pediatric patients .
  • Management quote: “The third quarter of 2025 has been a period of significant momentum and strategic advancement… we closed a private placement financing with the potential to provide up to $105.3 million in capital” — Dr. Michael Myers, CEO .

• What Went Wrong

  • Higher operating spend: Total OpEx rose to $4.02M (+59% y/y) on increased external clinical costs; net loss widened to $3.95M (vs. $2.35M y/y) as the company accelerated development activities .
  • Balance sheet at quarter‑end: Shareholders’ equity was negative ($1.21M) on 9/30/25 before the October financing; Nasdaq compliance remains an ongoing risk factor highlighted in the 10‑Q .
  • Still pre‑revenue and dependent on capital markets; no product revenues to offset spend and the company acknowledges the need for further funding over time despite the improved near‑term runway .

Financial Results

• Drivers: Management attributes the larger net loss primarily to increased R&D (notably external clinical development expenses) as programs move into and toward pivotal execution .

KPIs – R&D Expense Detail (YoY)

Liquidity (quarter-end balances)

• Segment reporting: Single operating segment; no revenue segmentation applicable .

Guidance Changes

Earnings Call Themes & Trends

No earnings call transcript was published for Q3 2025; themes are drawn from 10‑Q and press releases.

Management Commentary

• “The third quarter of 2025 has been a period of significant momentum and strategic advancement… In October, we closed a private placement financing with the potential to provide up to $105.3 million in capital” — Dr. Michael Myers, CEO .
• On topical rapamycin: “We are very pleased to announce this very significant milestone… a rapamycin loading concentration of 4% [lotion] and 5% [patch]… we intend to move forward… to initiate formal clinical development” .
• On ODD: “Receiving Orphan Drug Designation from the FDA is yet another important milestone… could potentially help facilitate the pathway of QRX003 to approval in the US” .

Q&A Highlights

No Q3 2025 earnings call transcript was available; therefore no Q&A disclosures or guidance clarifications could be assessed for this period [ListDocuments (no transcript found)].

Estimates Context

• Wall Street consensus (S&P Global) for revenue and EPS was unavailable for Q3 2025 and FY 2025; as such, we cannot assess beat/miss versus Street expectations (Values checked via S&P Global and not available) [GetEstimates].

Key Takeaways for Investors

• Runway extended into 2027 post October financing and warrant exercises — a key de‑risking step heading into pivotal execution and 2026 readouts .
• Regulatory vector strengthened with FDA Orphan Drug Designation, augmenting potential exclusivity and incentives upon approval; timelines for enrollment completion and top‑line maintained .
• Clinical momentum is tangible (durable pediatric NS responses; pivotal start imminent in Q4) but spend will likely remain elevated as external clinical costs ramp — expect continued OpEx pressure until readouts .
• Platform optionality is increasing (positive PSS signals; topical rapamycin technical milestone with near‑term manufacturing and 2026 clinical starts), broadening medium‑term catalysts beyond QRX003 .
• Equity remained negative at quarter‑end but was addressed by the October raise; Nasdaq compliance remains a disclosed risk to monitor, alongside ongoing capital needs through regulatory milestones .
• Trading implications: near‑term catalysts include (i) pivotal enrollment initiation (Q4 2025), (ii) ongoing pediatric NS investigator data flow, and (iii) rapamycin batch manufacturing; medium‑term focus is on Q1 2026 enrollment completion and 2H 2026 top‑line — events likely to drive estimate formation and rerating given pre‑revenue status .

Appendix: Source Documents Used

• Q3 2025 8‑K and Exhibit 99.1 press release; 10‑Q including financial statements, MD&A, risk factors; and Q3‑period press releases (ODD; pediatric NS update; rapamycin program): .
• Prior quarters’ financial PRs for trend analysis: Q2 2025 PR and tables ; Q1 2025 PR and tables .

Notes:

• Company remains pre‑revenue across reported periods .
• Single operating segment; no segment revenue breakdown .
• No earnings call transcript available for Q3 2025 [ListDocuments (none returned)].