News & Events zu Quoin Pharmaceuticals Ltd (QNRX)QNRXQuoin Pharmaceuticals Ltd

Quoin Pharmaceuticals Reports Positive Interim Results for QRX003 Phase 2/3 Study

Quoin Pharmaceuticals announced positive interim results from CL-QRX003-004, its ongoing Phase 2/3 study of QRX003 4% lotion in patients with Netherton Syndrome. The primary endpoint of 1-grade improvement or greater for IGA on all of the treatment area met the pre-specified alpha-adjustment for interim analysis with statistical significance. Four of six participants achieved the target 1-grade or greater improvement across all of the treatment area in Investigator Global Assessment from baseline at Week 12, or 66.67% against a pre-specified alpha of 0.0215. Two of those four participants achieved a 2-grade or greater IGA improvement across all of the treatment area. Key secondary endpoint, a Global Statistical Test of Global Impression of Change, achieved statistical significance at week 12 with a mean change of -1.5. All three participants with moderate to severe pruritus at baseline achieved a clinically meaningful greater than 3-grade improvement in Worst Itch Numeric Rating Scale at Week 12. One participant had a greater than 6-grade improvement. For the Ichthyosis Area and Severity Index, improvements ranging from 31-87% reduction in severity from baseline were recorded after 12 weeks of treatment with QRX003. These results mirrored those for the IGA with the same 4 participants recording clinically meaningful improvements for both endpoints. No treatment-related serious adverse events were reported. No clinically significant ECG, laboratory, or vital sign abnormalities were identified. 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. If approved, QRX003 could become the first FDA-approved treatment for Netherton Syndrome.

Quoin Pharmaceuticals Enters Agreement to Raise $50M

Quoin Pharmaceuticals announced that it has entered into a securities purchase agreement with new and existing healthcare-focused institutional investors to raise up to approximately $50M in gross proceeds, including initial upfront funding of approximately $30.8M and up to an additional approximately $19.2M upon the potential cash exercise of accompanying ordinary warrants at the election of the investors. The financing includes participation from healthcare-focused investors, including Sirenia Capital Management LP, Sphera Healthcare, AIGH Capital Management, Nantahala Capital, StemPoint Capital LP, and Stonepine Capital Management, among others, as well as members of the Company's management team and Board of Directors. Leerink Partners is acting as lead placement agent for the private placement. BTIG and Lake Street Capital Markets are acting as co-placement agents for the private placement. Pursuant to the terms of the securities purchase agreement, Quoin will issue an aggregate of 6,305,300 American Depositary Shares and accompanying ordinary warrants to purchase up to an aggregate of 3,152,650 ADSs, as described below, at a combined purchase price of $4.88 per ADS and accompanying ordinary warrant, in accordance with the "Minimum Price" requirement as defined in the Nasdaq rules. The accompanying ordinary warrants will have an exercise price of $6.10 per ADS for an aggregate exercise price of up to approximately $19.2M. The accompanying ordinary warrants will be immediately exercisable and will expire on the earlier of (i) five years from the closing date of the private placement or (ii) 30 days after the company's public announcement that the primary endpoint has been met in the company's clinical trial CL-QRX003-004, evaluating QRX003 for the treatment of Netherton Syndrome. In lieu of ADSs, certain investors are purchasing pre-funded warrants at a combined purchase price of $4.8799 per pre-funded warrant and accompanying ordinary warrant, which equals the purchase price per ADS and accompanying ordinary warrant less $0.0001, which is in turn equal to the exercise price of each pre-funded warrant. The private placement is expected to close on or about August 31, subject to the satisfaction of customary closing conditions.

Quoin Pharmaceuticals Receives FDA Approval for QRX003 Clinical Study

Quoin Pharmaceuticals announced that the FDA has cleared the company's investigational new drug, or IND, application for QRX003 for the treatment of Peeling Skin Syndrome, enabling initiation of its planned Phase 2 clinical study. Quoin expects to initiate the study in the second half of 2026. Potential clinical sites, clinical investigators and study participants have already been identified.