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QP

Quoin Pharmaceuticals, Ltd. (QNRX)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 showed advancing clinical momentum but higher losses: net loss was $(3,812,179) on total operating expenses of $3,957,177 as R&D spending ramped for late-stage QRX003 studies .
  • Management highlighted “continued momentum” with transformational pediatric whole‑body data and expanded IP filings; cash, cash equivalents and investments were approximately $11.6M as of March 31, 2025, which the company believes supports operations into Q1 2026 .
  • Guidance proxy (cash runway) was effectively lowered versus Q4’s “into Q2 2026” to “into Q1 2026,” reflecting increased clinical spend pace .
  • No Q1 2025 earnings call transcript or S&P Global consensus estimates were available; investors should anchor on clinical catalysts (FDA‑cleared whole‑body study; additional pediatric/adult sites) and financing runway disclosures for near‑term stock drivers . S&P Global consensus: not available for Q1 2025.*

What Went Well and What Went Wrong

What Went Well

  • Transformational pediatric whole‑body data: after two weeks of whole‑body QRX003, IGA improved from 5 to 1–2 and pruritus from 7 to 1; patient discontinued multiple prior meds and experienced zero nightly sleep disturbance; no adverse events reported .
  • Clear strategic execution and tone: “busy but highly productive start to 2025 … very excited by our continued progress and remain focused on delivering the first approved treatment for this devastating disease” — Dr. Michael Myers (CEO) .
  • IP and pipeline expansion: filed U.S. and international patent applications for topical rapamycin formulations (microcystic lymphatic malformations, venous malformations, angiofibromas); and a new U.S. patent application potentially extending QRX003 protection to 2045 and covering multiple skin disorders .

What Went Wrong

  • Loss widened on clinical ramp: net loss increased to $(3,812,179) vs $(2,327,280) in Q1 2024 on higher external clinical development, payroll and R&D allocations as late-stage programs progressed .
  • Runway optics softened: Q4 2024 press release indicated cash runway into Q2 2026, but Q1 2025 press release indicated into Q1 2026; 10‑Q additionally flagged substantial doubt as a going concern absent additional capital .
  • Share structure/market listing overhangs: company effected a 1‑for‑35 ADS ratio change in April 2025 to regain Nasdaq minimum bid compliance; while resolved, it underscores ongoing listing risk if price weakens again .

Financial Results

P&L and Operating Metrics (oldest → newest)

MetricQ3 2024Q4 2024Q1 2025
RevenueN/A (no revenue reported) N/A (no revenue reported) N/A (no revenue reported)
Total Operating Expenses ($)$2,528,002 $2,405,061 $3,957,177
Research & Development ($)$1,170,287 $994,344 $2,374,139
General & Administrative ($)$1,357,715 $1,410,717 $1,583,038
Net Loss ($)$(1,926,679) $(2,049,878) $(3,812,179)
Loss per ADS (Basic) ($)$(1.95) $(2.08) $(6.50)
Weighted Avg ADS Outstanding987,220 987,220 586,331

Notes: Company is development-stage; no revenue reported in the periods shown .

Liquidity (Balance Sheet excerpts; oldest → newest)

MetricQ3 2024Q4 2024Q1 2025
Cash & Cash Equivalents ($)$3,116,750 $3,623,343 $3,822,122
Investments ($)$7,190,138 $10,433,535 $7,730,598
Cash, Cash Equivalents & Marketable Securities (Mgmt. disclosure)~$10.3M ~$14.1M ~$11.6M

Drivers and context:

  • YoY R&D increased 168% on late-stage studies (external clinical, payroll/SBC, and UCC collaboration) .
  • Q1 2025 cash/investments supported by December 2024 financing and Q1 warrant exercises; ongoing spend tied to expanded clinical plans .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayOperating runway outlookInto Q2 2026 (as of 12/31/24) Into Q1 2026 (as of 3/31/25) Lowered (shorter runway)

No formal numeric guidance (revenue, margins, OpEx) was issued; management did provide qualitative operational plans (FDA‑cleared whole‑body study of 8–12 patients led by Dr. Amy Paller; additional adult and pediatric sites internationally) .

Earnings Call Themes & Trends

Note: No Q1 2025 earnings call transcript was available; themes reflect management communications (press releases, 8‑K, 10‑Q).

TopicPrevious Mentions (Q3 2024 and Q4 2024)Current Period (Q1 2025)Trend
Clinical efficacy (QRX003)Initiated PSS study; positive NS interim data; expanding global sites Pediatric whole‑body: IGA 5 → 1–2; pruritus 7 → 1; medication discontinuation; no AEs Improving (stronger clinical signals)
Whole‑body study designFDA clearance for adult whole‑body study; led by Dr. Paller Confirmed FDA‑cleared study up to 8–12 patients; aims for largest NS dataset Advancing (execution readiness)
International expansionUK sites; plans for Western/Eastern Europe Additional pediatric/adult sites preparing to launch internationally Broadening (more geographies)
Financing/runway~late 2025 runway at Q3; into Q2 2026 at Q4 Into Q1 2026; 10‑Q flags going concern risk without new capital Tightening (higher burn)
IP strategyPipeline breadth communicated Filed U.S. & international rapamycin IP; filed new U.S. application potentially to 2045 Expanding (broader protection)

Management Commentary

  • “The first quarter of 2025 has seen continued momentum across all aspects of our business… clear visual evidence of almost complete skin healing… [and] reduction or… elimination of pruritus… Whole-body treatment… enabled the pediatric patient to discontinue previously required medications… we are very excited by our continued progress and remain focused on delivering the first approved treatment for this devastating disease.” — Dr. Michael Myers, CEO .
  • “After just two weeks of treatment… IGA was at 1… pruritus… dropped to… 1–2… patient… discontinued antihistamines, antivirals, glucocorticoids… no antibiotics since initiation… no adverse events… we believe QRX003 is directly targeting the root cause…” — Dr. Michael Myers, CEO (pediatric whole‑body update) .
  • “We… filed U.S. and international patent applications for novel topical rapamycin (sirolimus) formulations… designed to optimize penetration… and a new U.S. patent application… potentially extending IP protection through 2045.” — Management press releases .

Q&A Highlights

  • The company did not publish a Q1 2025 earnings call transcript; management’s disclosures came via the Q1 press release, 8‑K and 10‑Q .
  • No additional Q&A clarifications were available for this quarter.

Estimates Context

  • No S&P Global consensus estimates for Q1 2025 EPS or revenue were available; comparison to Street was not possible for this micro‑cap, development‑stage profile.*
  • Implication: Sell‑side models (if any) likely need to reflect higher near‑term R&D intensity and revised runway disclosures as clinical execution accelerates .

*Values retrieved from S&P Global.

Key Takeaways for Investors

  • Clinical momentum accelerating: pediatric whole‑body data show rapid efficacy signals, medication discontinuation, and improved sleep with no AEs — a meaningful validation point ahead of broader whole‑body evaluation .
  • Execution catalysts: FDA‑cleared whole‑body study (8–12 patients) led by Dr. Paller and expansion of international pediatric/adult sites are near‑term triggers that can expand the dataset and de‑risk the program .
  • R&D investment inflection: Q1 R&D rose to $2,374,139 with external clinical costs leading, consistent with late‑stage progress; expect continued elevated spend as trials scale .
  • Runway optics narrowed: management updated runway to Q1 2026 (from Q2 2026 in Q4 PR) and the 10‑Q includes a going concern warning — plan for potential financing overhang despite recent compliance with Nasdaq minimum bid .
  • IP moat broadening: new patent applications for rapamycin formulations and potential QRX003 protection through 2045 support longer‑term value capture across multiple rare dermatology indications .
  • No Street estimates and no Q1 call transcript: trading may be more headline/catalyst‑driven (clinical, regulatory, financing) given limited sell‑side coverage and absence of a call .
  • Focus for the next 1–2 quarters: pace and breadth of whole‑body data read‑outs, site activation/enrollment, and financing plans to support trial execution and maintain Nasdaq compliance .