Quoin Pharmaceuticals — Third Quarter 2026 Earnings Summary

Financial Performance

• Cash, cash equivalents, and marketable securities totaled $33.2 million as of September 30, 2026, compared to $3.8 million in cash and $14.9 million in investments at December 31, 2025.
• Net loss for the quarter ended September 30, 2026, was $4.9 million, an increase from $3.9 million in the same period in 2025.
• Net loss for the nine months ended September 30, 2026, was $15.2 million, compared to $11.5 million for the nine months ended September 30, 2025.
• Total operating expenses for the quarter were $4.9 million, up from $4.0 million in the prior year quarter, driven by Research and Development expenses of $2.7 million (up from $2.3 million) and General and Administrative expenses of $2.3 million (up from $1.7 million).
• Total operating expenses for the nine months ended September 30, 2026, were $15.5 million, compared to $11.8 million in the prior year period.
• Loss per ADS for the quarter was $0.97 (basic and fully-diluted), compared to $6.71 in the prior year quarter.
• Loss per ADS for the nine months ended September 30, 2026, was $4.26, compared to $19.50 in the prior year period.
• Shareholders' equity increased to $28.7 million as of September 30, 2026, from $13.1 million as of December 31, 2025.
• Total liabilities decreased to $6.0 million as of September 30, 2026, from $7.3 million as of December 31, 2025.

Guidance and Future Outlook

• Management expects to complete recruitment of all 20 participants in the Netherton Syndrome Phase 2/3 study by the end of 2026.
• Topline data for the Netherton Syndrome study is expected to be reported in the second quarter of 2027.
• The company plans to initiate the first formal clinical study for Peeling Skin Syndrome (PSS) before the end of 2026.
• The company plans to advance the QRX009 topical rapamycin program toward clinical testing in early 2027.
• An IND submission for an additional QRX009 indication is planned before the end of 2026.
• Management believes the current cash position will fund operations into 2028.

Business Segments and Product Lines

• QRX003 (Netherton Syndrome): Interim data from the Phase 2/3 study (CL-QRX003-004) showed 4 of 6 participants (66.7%) achieved the primary endpoint of a 1-grade or greater improvement in Investigator Global Assessment (p=0.0087). The key secondary endpoint, Global Statistical Test of Global Impression of Change, achieved statistical significance (p=0.0070). All three participants with moderate to severe pruritus achieved a 3-grade or greater improvement in the Worst Itch Numeric Rating Scale. No treatment-related serious adverse events were reported.
• QRX003 (Peeling Skin Syndrome): The FDA cleared the first-ever IND for QRX003 in PSS on July 9, 2026. The FDA granted Rare Pediatric Disease (RPD) designation on September 8, 2026, and Fast Track designation on September 22, 2026. The EMA granted Orphan Drug Designation on October 14, 2026. If approved in the EU, QRX003 will receive 10 years of market exclusivity for PSS.
• QRX009 (Topical Rapamycin Platform): Investigator-led studies are planned for Pachyonychia Congenita, Gorlin Syndrome, and Tuberous Sclerosis Complex.
• Awareness Campaign: The "NETHERTON NOW" video series released a new episode featuring a pediatric critical care physician and her daughter; the series has cumulatively received over 2.8 million views and 28 million impressions.
• Clinical Publication: A peer-reviewed paper on QRX003 was published in Dermatology and Therapy on October 20, 2026, detailing a pediatric case report where the patient's IGA score improved from 4 (severe) to 0 (clear) over 21 months with no treatment-related adverse events.

Market and Competitive Landscape

• QRX003 holds eight regulatory designations from the FDA, EMA, and Japan's MHLW across Netherton Syndrome and PSS.
• There is currently no approved treatment for Peeling Skin Syndrome.
• The company aims to deliver the first approved treatment for Netherton Syndrome.

Risks and Challenges

• Forward-looking statements include risks regarding the ability to obtain regulatory approvals, complete clinical trials on time, and achieve desired results.
• Actual results may differ materially from expectations due to various risks and uncertainties, including regulatory strategy and compliance.
• The company undertakes no obligation to update forward-looking statements except as required by law.

Management Commentary and Tone

• CEO Dr. Michael Myers stated the third quarter "substantially strengthened Quoin's clinical, regulatory and financial foundation for long-term growth."
• Management highlighted the interim results as the "first ever overall positive data set published for this disease" (Netherton Syndrome).
• Dr. Myers noted the successful August private placement provided funding to "fully complete the development of QRX003 for Netherton Syndrome" and enabled selective investment in the pipeline.
• Management expressed confidence in the goal of delivering the first approved treatment for Netherton Syndrome.

Other Key Points

• Private Placement Financing: On August 28, 2026, Quoin announced a private placement for up to $50.0 million in gross proceeds, including $30.8 million in initial upfront funding and up to $19.2 million upon the potential cash exercise of accompanying ordinary warrants.
• Share Count: Ordinary shares issued and outstanding increased to 168,145,655 as of September 30, 2026, from 52,441,360 as of December 31, 2025.
• Regulatory Milestones: QRX003 received the first Fast Track Designation ever granted for a Peeling Skin Syndrome therapy.
• Balance Sheet Changes: Additional paid-in capital increased to $114.9 million from $84.1 million, reflecting the financing activities.
• Investment Income: Realized and accrued interest income for the nine months ended September 30, 2026, was $372,840, compared to $310,383 in the prior year period.