Quoin Pharmaceuticals, Ltd. (QNRX) SEC Filings & Earnings Calls

Single-patient case report; results may not be generalizable to broader population.

“The authors note that these single-patient observations are consistent with a possible treatment-associated effect, and that ongoing clinical trials will further evaluate the safety and efficacy of QRX003.” · word for word

Phase 2/3 study still recruiting; topline data not expected until Q2 2027.

“Quoin expects to complete recruitment of all 20 participants in CL-QRX003-004 by the end of 2026 and report topline data in the second quarter of 2027.” · word for word

Clinical trial initiation and regulatory approval risks remain; no approved therapies for Peeling Skin Syndrome yet.

“Company on track to initiate first-ever formal clinical study for Peeling Skin Syndrome before year end; forward-looking statements caution about regulatory and clinical uncertainties.”

Dilution risk from warrant exercises

“The issuance of ADSs to the holders of Private Placement Warrants upon any exercise thereof will not affect the rights of the holders of our outstanding ADSs, but such issuances will have a dilutive effect on our existing shareholders, including the voting power and economic rights of existing shareholders.” · word for word

Potential adverse impact on future capital raising if proposal not approved

“Additionally, failure to approve this proposal may be viewed negatively by holders of the Private Placement Warrants and could adversely affect our ability to raise capital on favorable terms in future financing transactions.” · word for word

Clinical and regulatory risk; Phase 2/3 study yet to initiate; small patient population (up to 12); no approved treatment currently exists.

“Phase 2/3 study expected to enroll up to 12 pediatric and adult patients...Quoin is targeting approval of QRX003 as a potential treatment for Peeling Skin Syndrome in 2028.”

Clinical and regulatory risk remains; Phase 2 study not yet initiated; no approved treatments for PSS.

“Quoin Expects to Initiate Phase 2 Study in 2H 2026; Study Plans to Enroll up to 12 Pediatric and Adult Peeling Skin Patients” · word for word

Clinical trial still ongoing; only interim data on 6 of 20 patients

“Interim analysis covers the first six participants to complete the 12-week treatment period.” · word for word

No treatment-related serious adverse events reported

“No treatment-related serious adverse events were reported.” · word for word

Going concern risk

“These factors raise substantial doubt about the Company’s ability to continue as a going concern.” · word for word

Dilution risk from warrants and options

“Outstanding and exercisable at June 30, 2026 9,708,823 warrants and 1,025,618 stock options.”

No revenue or profitability in sight

“To date, no products have been commercialized and no revenue has been generated by the Company.” · word for word

Single source supplier dependency

“The Company is also dependent on several third party suppliers, in some cases a single source supplier including the contract research organization managing both of the Company’s current clinical studies, the supplier of the active pharmaceutical ingredient (API), as well as the contract manufacturer of the drug product for clinical development.” · word for word

Pre-revenue clinical-stage biotech with widening net losses

“Net Income (Loss) ($ in Millions): 2025: (15.8), 2024: (9.0), 2023: (8.7)” · word for word

Significant related-party indebtedness to CEO and COO

“As of December 31, 2025, approximately $1,359,000 and $965,000 of such indebtedness was outstanding to Dr. Myers and Ms. Carter, respectively.” · word for word

No approved treatment for Netherton Syndrome; QRX003 still in clinical development with Phase 3 not yet initiated.

“There is currently no approved treatment for Netherton Syndrome.” · word for word

Going concern risk

“management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern for a period of at least one year from the date of the filing of this Quarterly Report on Form 10-Q.” · word for word

No revenue, no approved products

“To date, no products have been commercialized and no revenue has been generated by the Company.” · word for word

Dependence on single source suppliers

“The Company is also dependent on several third party suppliers, in some cases a single source supplier including the contract research organization managing both of the Company’s current clinical studies, the supplier of the active pharmaceutical ingredient (API), as well as the contract manufacturer of the drug product for clinical development.” · word for word

Clinical and regulatory risk: Phase 3 trial design not yet finalized; FDA openness to alternative design may still require additional data.

“FDA expressed openness to an alternative study design... Quoin will submit clinical data... prior to initiating the Phase 3 pivotal program to gain alignment.”

No revenue or commercialized products

“To date, no products have been commercialized and no revenue has been generated.” · word for word

Clinical trial failure risk

“The FDA may order the temporary or permanent discontinuation of a clinical trial at any time, or impose other sanctions, if it believes that the clinical trial either is not being conducted in accordance with FDA regulations or presents an unacceptable risk to the clinical trial patients.” · word for word

Competition from larger entities

“Some of these entities are larger and better funded than us.” · word for word

Dependence on third-party manufacturers

“Our manufacturing strategy is to contract with third parties to manufacture our clinical and commercial active pharmaceutical ingredient (API) and drug product supplies.” · word for word

Intellectual property uncertainty

“The strength of patents in the biotechnology and pharmaceutical field involves complex legal and scientific questions and can be uncertain.” · word for word

Clinical and regulatory risk: Phase 3 study design and recruitment may face challenges.

“FDA indicated a single Phase 3 study may be sufficient; alternative study design without traditional placebo control.”

Financing risk: Warrants may dilute existing shareholders if exercised.

“Up to $88.0 million upon potential exercise of accompanying warrants.” · word for word

Nasdaq Delisting Risk

“If we fail to comply with the Nasdaq listing requirements and do not regain compliance, our ADSs will be subject to delisting by Nasdaq.” · word for word

Going Concern Risk

“We have incurred net losses every year since inception and we have an accumulated deficit of approximately $66.6 million at September 30, 2025.” · word for word

Financing Risk

“Additional financing will be required to complete the research and development of our product candidates and our other operating requirements, which may not be available at acceptable terms, if at all.” · word for word

Pre-revenue company with increasing net loss and R&D spend; no approved products or revenue.

“Net loss increased to $3.9M in Q3 2025 from $2.3M in Q3 2024; R&D expenses doubled.”

Cash burn rate high; reliance on private placement and warrant exercises for funding into 2027.

“Cash $5.4M at Sep 30, 2025; $16.6M upfront from private placement and $3.3M from warrant exercises in October 2025 extend runway into 2027.”

Clinical and regulatory risk: QRX003 pivotal studies just starting; no guarantee of success.

“QRX003 Pivotal Studies to Commence Enrollment in Q4 2025; pipeline still early stage.”