Quoin Pharmaceuticals Provides Corporate Update and Announces First Quarter 2025 Financial Results
The company demonstrated compelling clinical data showing almost complete skin healing and reduction/elimination of pruritus in both adult and pediatric patients. Notably, pediatric patients were able to discontinue previously required medications. The studies confirmed QRX003's mechanism of action as a broad-spectrum serine protease inhibitor.
Financial highlights show a cash position of $11.6 million as of March 31, 2025, expected to fund operations into Q1 2026. The company reported a net loss of $3.8 million for Q1 2025, compared to $2.3 million in Q1 2024.
Quoin expanded its patent portfolio and launched NETHERTON NOW, a community awareness initiative. The company is preparing for additional international clinical sites and a new FDA-cleared study at Northwestern University evaluating whole-body QRX003 application in 8-12 patients.
L'azienda ha mostrato dati clinici convincenti con quasi completa guarigione della pelle e riduzione/eliminazione del prurito sia nei pazienti adulti che pediatrici. In particolare, i pazienti pediatrici hanno potuto sospendere i farmaci precedentemente necessari. Gli studi hanno confermato il meccanismo d'azione di QRX003 come inibitore a spettro ampio delle proteasi seriniche.
I dati finanziari evidenziano una posizione di cassa di 11,6 milioni di dollari al 31 marzo 2025, sufficiente a finanziare le operazioni fino al primo trimestre 2026. L'azienda ha registrato una perdita netta di 3,8 milioni di dollari nel primo trimestre 2025, rispetto a 2,3 milioni nel primo trimestre 2024.
Quoin ha ampliato il portafoglio brevetti e lanciato NETHERTON NOW, un'iniziativa per sensibilizzare la comunità. L'azienda si sta preparando ad aprire ulteriori siti clinici internazionali e a uno studio approvato dalla FDA presso la Northwestern University per valutare l'applicazione totale di QRX003 in 8-12 pazienti.
La compañía mostró datos clínicos convincentes que evidencian casi una curación completa de la piel y reducción/eliminación del prurito en pacientes adultos y pediátricos. Notablemente, los pacientes pediátricos pudieron suspender los medicamentos que antes requerían. Los estudios confirmaron el mecanismo de acción de QRX003 como un inhibidor de serina proteasa de amplio espectro.
Los aspectos financieros resaltan una posición de efectivo de 11,6 millones de dólares al 31 de marzo de 2025, que se espera financie las operaciones hasta el primer trimestre de 2026. La compañía reportó una pérdida neta de 3,8 millones de dólares en el primer trimestre de 2025, en comparación con 2,3 millones en el primer trimestre de 2024.
Quoin amplió su cartera de patentes y lanzó NETHERTON NOW, una iniciativa de concienciación comunitaria. La empresa se está preparando para abrir más sitios clínicos internacionales y un nuevo estudio aprobado por la FDA en la Universidad Northwestern para evaluar la aplicación de QRX003 en todo el cuerpo en 8-12 pacientes.
회사는 성인 및 소아 환자 모두에서 거의 완전한 피부 치유와 가려움증 감소/제거를 보여주는 설득력 있는 임상 데이터를 제시했습니다. 특히 소아 환자들은 이전에 필요했던 약물 복용을 중단할 수 있었습니다. 연구는 QRX003가 광범위한 세린 프로테아제 억제제임을 확인했습니다.
재무 하이라이트로는 2025년 3월 31일 기준 현금 보유액 1,160만 달러를 기록했으며, 이는 2026년 1분기까지 운영 자금을 지원할 것으로 예상됩니다. 회사는 2025년 1분기에 순손실 380만 달러를 보고했으며, 이는 2024년 1분기의 230만 달러에 비해 증가한 수치입니다.
Quoin은 특허 포트폴리오를 확장하고 커뮤니티 인식 프로그램인 NETHERTON NOW를 시작했습니다. 회사는 추가 국제 임상 사이트 준비와 Northwestern 대학에서 FDA 승인을 받은 전신 QRX003 적용 연구(8-12명 대상)를 준비 중입니다.
L'entreprise a présenté des données cliniques convaincantes montrant une guérison quasi complète de la peau et une réduction/élimination du prurit chez les patients adultes et pédiatriques. Notamment, les patients pédiatriques ont pu arrêter les médicaments auparavant nécessaires. Les études ont confirmé le mécanisme d'action de QRX003 en tant qu'inhibiteur à large spectre des sérine protéases.
Les points financiers montrent une trésorerie de 11,6 millions de dollars au 31 mars 2025, suffisante pour financer les opérations jusqu'au 1er trimestre 2026. La société a enregistré une perte nette de 3,8 millions de dollars au 1er trimestre 2025, contre 2,3 millions au 1er trimestre 2024.
Quoin a élargi son portefeuille de brevets et lancé NETHERTON NOW, une initiative de sensibilisation communautaire. L'entreprise se prépare à ouvrir des sites cliniques internationaux supplémentaires et à lancer une nouvelle étude approuvée par la FDA à l'Université Northwestern, évaluant l'application de QRX003 sur tout le corps chez 8 à 12 patients.
Das Unternehmen präsentierte überzeugende klinische Daten, die nahezu vollständige Hautheilung und Reduktion/Eliminierung von Juckreiz bei erwachsenen und pädiatrischen Patienten zeigen. Besonders bemerkenswert ist, dass pädiatrische Patienten zuvor benötigte Medikamente absetzen konnten. Die Studien bestätigten den Wirkmechanismus von QRX003 als Breitband-Serinprotease-Inhibitor.
Finanzielle Highlights zeigen eine Barkasse von 11,6 Millionen US-Dollar zum 31. März 2025, die voraussichtlich den Betrieb bis zum ersten Quartal 2026 finanziert. Das Unternehmen meldete einen Nettoverlust von 3,8 Millionen US-Dollar im ersten Quartal 2025, verglichen mit 2,3 Millionen im ersten Quartal 2024.
Quoin erweiterte sein Patentportfolio und startete NETHERTON NOW, eine Initiative zur Gemeinschaftsaufklärung. Das Unternehmen bereitet zusätzliche internationale Studienzentren sowie eine neue von der FDA genehmigte Studie an der Northwestern University vor, die die Ganzkörperanwendung von QRX003 bei 8-12 Patienten untersucht.
- Positive clinical results showing almost complete skin healing in Netherton Syndrome patients
- Clear demonstration of QRX003's mechanism of action through reversal study
- Pediatric patients able to discontinue multiple previously required medications
- Patent portfolio expansion potentially extending protection through 2045
- Strong cash position of $11.6M supporting operations into Q1 2026
- FDA clearance for new whole-body application study at Northwestern University
- Increased net loss to $3.8M in Q1 2025 from $2.3M in Q1 2024
- Clinical benefits completely reverse upon treatment discontinuation, indicating need for chronic treatment
Insights
Quoin's QRX003 for Netherton Syndrome shows promising clinical data with clear mechanism validation, despite widening losses.
Quoin's press release reveals significant clinical progress for their lead candidate QRX003 in Netherton Syndrome (NS), a rare genetic skin disorder. The clinical data presented is particularly compelling, showing almost complete skin healing in multiple patients and the elimination of pruritus (itching) - a crucial quality-of-life improvement allowing patients to sleep undisturbed for potentially the first time.
What's mechanistically significant is the observed complete reversal of benefits after treatment discontinuation. This provides clear validation of QRX003's mechanism as a serine protease inhibitor that effectively substitutes for the missing LEKTI protein in NS patients. This protein deficiency disrupts the natural balance between skin cell production and shedding, and QRX003 appears to successfully restore this equilibrium.
The pediatric trial results are particularly noteworthy, with improvement from "Severe" to "Mild" on the Investigator's Global Assessment (IGA) scale within just six weeks. More impressively, whole-body application enabled discontinuation of multiple supportive medications including antibiotics, antihistamines, antivirals, and glucocorticoids - suggesting QRX003 addresses multiple disease manifestations simultaneously.
The newly FDA-cleared study at Northwestern University represents a strategic advancement, as it will evaluate whole-body application in 8-12 patients - potentially creating the largest clinical dataset ever compiled for this ultra-rare condition. This approach simulates real-world usage patterns and strengthens Quoin's regulatory position.
While the clinical data is encouraging, investors should note the company's widening net loss of
Quoin's patent activity during Q1 2025 represents a strategic expansion beyond their core Netherton Syndrome focus, potentially creating significant long-term value. The company filed patents for topical rapamycin formulations targeting multiple rare skin diseases, and secured additional IP covering novel QRX003 formulations with protection potentially extending to 2045.
This intellectual property strategy accomplishes several critical objectives. First, it creates a barrier to competition for QRX003 by extending exclusivity well beyond the drug's initial patent life. Second, it supports pipeline diversification into adjacent rare dermatological conditions like microcystic lymphatic malformations, venous malformations, and angiofibromas - leveraging their expertise while minimizing development risk.
The rapamycin formulation patents are particularly strategic. Rapamycin (sirolimus) is a known mTOR inhibitor with established efficacy in various conditions, but topical delivery presents significant formulation challenges. If Quoin has developed proprietary delivery technology, this could be applied across multiple indications, creating a valuable technology platform rather than a single-product company.
The timing of these filings suggests Quoin is preparing for commercial success with QRX003 while simultaneously building a broader rare dermatology franchise. This dual approach mitigates risk for investors and potentially positions the company as an attractive acquisition target for larger pharmaceutical companies seeking to bolster their rare disease portfolios.
While patents don't guarantee commercial success, they provide essential protection for small biotechs developing treatments for ultra-rare conditions where market exclusivity is vital for recouping development costs. Quoin's expanded patent portfolio significantly enhances its long-term value proposition beyond the immediate clinical results of QRX003.
Continued Progress in Ongoing Late-Stage Netherton Syndrome Studies
Announced Positive Clinical Data for Adult and Pediatric Netherton Patients
Provided Clear Visual Evidence of QRX003 Mechanism of Action
Patent Portfolio Expanded to Support Pipeline Growth
Launch of NETHERTON NOW Advocacy Initiative
ASHBURN, Va., May 13, 2025 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or “Quoin”), a late clinical-stage, specialty pharmaceutical company focused on developing and commercializing novel treatments for rare and orphan diseases, today provides a business update and announces financial results for the quarter ended March 31, 2025.
Quoin CEO Dr. Michael Myers said, “The first quarter of 2025 has seen continued momentum across all aspects of our business. We reported compelling data from multiple QRX003 studies in Netherton Syndrome, including clear visual evidence of almost complete skin healing and reduction or, in some cases, the elimination of pruritus allowing the patient to experience zero nightly sleep disturbance for the first time in their life. Whole-body treatment with QRX003 has also enabled the pediatric patient to discontinue previously required medications including antibiotics, antihistamines, antivirals and glucocorticoids. We also announced positive data from our open-label study that demonstrated clear visual evidence of almost complete skin healing compared to baseline. Importantly, we also reported that a full and rapid reversal of all clinical benefits from QRX003 treatment occurs following discontinuation of treatment. This result provides clear support that QRX003 acts as a broad-spectrum serine protease inhibitor targeting the skin kallikreins and performs the function of the missing LEKTI protein by restoring the natural balance of skin replenishment and skin shedding. Alongside this clinical progress, we expanded our patent portfolio with new filings covering novel formulations targeting several rare skin diseases, including our new development programs for microcystic lymphatic malformations, venous malformations and angiofibromas. We also launched NETHERTON NOW, our multi-faceted awareness initiative to support and engage with the Netherton community, advocacy groups, treating physicians, and policy and lawmakers. In short, this has been a busy but highly productive start to 2025, and we are very excited by our continued progress and remain focused on delivering the first approved treatment for this devastating disease”
Q1 2025 Corporate Highlights
Over the past three months, Quoin achieved a number of significant corporate milestones and highlights:
Jan. 6, 2025
Quoin announced 12-week data from the first adult subject dosed twice daily with QRX003 in the open-label study, showing improvement across all endpoints and sustained benefit with no safety concerns.
Jan. 14, 2025
Interim results from the pediatric Investigator Study showed the subject improved from “Severe” to “Mild” on the Investigator’s Global Assessment (IGA) after six weeks of treatment, prompting a transition to whole-body dosing.
Jan. 23, 2025
Post-treatment follow-up data showed complete reversal of clinical gains four weeks after QRX003 was discontinued, supporting the need for chronic treatment and affirming the drug’s mechanism of action.
Feb. 4, 2025
Quoin launched its NETHERTON NOW awareness campaign, including a stand-alone website and patient-focused media hub to raise visibility around NS and support the community.
Feb. 27, 2025
Groundbreaking results from the first pediatric subject to receive whole-body QRX003 dosing revealed rapid and profound clinical benefit within two weeks, including the elimination of pruritus and discontinuation of prior medications.
March 4, 2025
U.S. and international patents were filed for topical rapamycin formulations targeting a number of rare skin diseases.
March 25, 2025
Quoin filed a new U.S. patent application for novel formulations of QRX003 and related compounds, potentially extending IP protection through 2045 across multiple rare disease indications.
Financial Highlights
Cash Position:
Quoin had approximately
Net Loss:
For the quarter ended March 31, 2025, Quoin reported a net loss of approximately
Looking Ahead
Quoin continues to advance its active clinical studies of QRX003 in NS, with additional pediatric and adult sites preparing to launch internationally. A newly FDA-cleared study, led by Dr. Amy Paller at Northwestern University, will evaluate whole-body application of QRX003 in up to eight to twelve patients. Designed to simulate real-world use of QRX003 once approved, this study will generate what will potentially be the most extensive clinical data set ever compiled for Netherton Syndrome.
About Quoin Pharmaceuticals Ltd.
Quoin Pharmaceuticals Ltd. is a late clinical-stage specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases. We are committed to addressing unmet medical needs for patients, their families, communities and care teams. Quoin’s innovative pipeline comprises four products in development that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, SAM Syndrome, Palmoplantar Keratoderma, Scleroderma, Epidermolysis Bullosa, Microcystic Lymphatic Malformations, Venous Malformations, Angiofibroma and others. For more information, visit www.quoinpharma.com or LinkedIn for updates.
Cautionary Note Regarding Forward Looking Statements
The Company cautions that statements in this press release that are not descriptions of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances, such as “expect,” “intend,” “hope,” “plan,” “potential,” “anticipate,” “look forward,” “believe,” “may,” and “will,” among others. All statements that reflect the Company’s expectations, assumptions, projections, beliefs, or opinions about the future, other than statements of historical fact, are forward-looking statements, including, without limitation, statements relating to: QRX003 acting as a broad-spectrum serine protease inhibitor targeting the skin kallikreins and performing the function of the missing LEKTI protein by restoring the natural balance of skin replenishment and skin shedding, delivering the first approved treatment for Netherton Syndrome, the Company’s capital supporting operations into the first quarter of 2026, continuing to advance active clinical studies of QRX003 in NS, with additional pediatric and adult sites preparing to launch internationally, evaluating whole-body application of QRX003 in up to eight- twelve patients in a newly FDA-cleared study, led by Dr. Amy Paller at Northwestern University, the study generating what will potentially be the most extensive clinical data set ever compiled for Netherton Syndrome and Quoin’s products in development collectively having the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, SAM Syndrome, Palmoplantar Keratoderma, Scleroderma, Epidermolysis Bullosa, Microcystic Lymphatic Malformations, Venous Malformations, Angiofibroma and others. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon the Company’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties including, but not limited to, the Company’s ability to deliver a safe and effective treatment for Netherton Syndrome; whether the Company’s studies successfully generate data that is sufficiently robust and comprehensive to support an NDA filing for QRX003 as an approved treatment for Netherton Syndrome; and other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 and in other filings the Company has made and may make with the SEC in the future. One should not place undue reliance on these forward-looking statements, which speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law.
For further information, contact:
Quoin Pharmaceuticals Ltd.
Michael Myers, Ph.D., CEO
mmyers@quoinpharma.com
Investor Relations
PCG Advisory
Jeff Ramson
jramson@pcgadvisory.com
(646) 863-6341
-Tables to follow-
| QUOIN PHARMACEUTICALS, LTD. | |||||||||||
| Consolidated Balance Sheets | |||||||||||
| March 31, | December 31, | ||||||||||
| 2025 | 2024 | ||||||||||
| (unaudited) | |||||||||||
| ASSETS | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | 3,822,122 | $ | 3,623,343 | |||||||
| Investments | 7,730,598 | 10,433,535 | |||||||||
| Prepaid expenses and other current assets | 944,099 | 869,126 | |||||||||
| Total current assets | 12,496,819 | 14,926,004 | |||||||||
| Prepaid expenses - long term | - | 300,000 | |||||||||
| Intangible assets, net | 458,334 | 483,334 | |||||||||
| Total assets | $ | 12,955,153 | $ | 15,709,338 | |||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | $ | 644,057 | $ | 905,704 | |||||||
| Accrued expenses | 2,465,303 | 1,528,977 | |||||||||
| Accrued interest and financing expense | 1,146,251 | 1,146,251 | |||||||||
| Due to officers - short term | 600,000 | 600,000 | |||||||||
| Total current liabilities | 4,855,611 | 4,180,932 | |||||||||
| Due to officers - long term | 2,173,733 | 2,323,733 | |||||||||
| Total liabilities | $ | 7,029,344 | $ | 6,504,665 | |||||||
| Commitments and contingencies | |||||||||||
| Shareholders' equity: | |||||||||||
| Ordinary shares, no par value per share, 100,000,000 authorized at March 31, 2025 and December 31, 2024, respectively - 20,585,830 (588,166 ADS’s) ordinary shares issued and outstanding at March 31, 2025 and 8,948,164 (255,661 ADS’s) ordinary shares issued and outstanding at December 31, 2024 | $ | - | $ | - | |||||||
| Additional paid in capital | 64,903,780 | 64,370,465 | |||||||||
| Accumulated deficit | (58,977,971 | ) | (55,165,792 | ) | |||||||
| Total shareholders' equity | 5,925,809 | 9,204,673 | |||||||||
| Total liabilities and shareholders' equity | $ | 12,955,153 | $ | 15,709,338 | |||||||
| QUOIN PHARMACEUTICALS, LTD. | ||||||||||||
| Consolidated Statements of Operations (Unaudited) | ||||||||||||
| Three months ended March 31, | ||||||||||||
| 2025 | 2024 | |||||||||||
| Revenue | ||||||||||||
| (Unaudited) | (Unaudited) | |||||||||||
| Operating expenses | ||||||||||||
| General and administrative | $ | 1,583,038 | $ | 1,572,986 | ||||||||
| Research and development | 2,374,139 | 885,298 | ||||||||||
| Total operating expenses | 3,957,177 | 2,458,284 | ||||||||||
| Other (income) and expenses | ||||||||||||
| Unrealized (gain) loss | (126 | ) | 6,509 | |||||||||
| Realized and accrued interest income | (144,872 | ) | (137,513 | ) | ||||||||
| Total other income | (144,998 | ) | (131,004 | ) | ||||||||
| Net loss | $ | (3,812,179 | ) | $ | (2,327,280 | ) | ||||||
| Loss per ADS | ||||||||||||
| Basic | $ | (6.50 | ) | $ | (38.73 | ) | ||||||
| Fully-diluted | $ | (6.50 | ) | $ | (38.73 | ) | ||||||
| Weighted average number of ADS's outstanding | ||||||||||||
| Basic | 586,331 | 60,094 | ||||||||||
| Fully-diluted | 586,331 | 60,094 | ||||||||||
FAQ
What were QNRX's key clinical results for QRX003 in Q1 2025?
What is Quoin Pharmaceuticals' (QNRX) current cash position and burn rate?
How does QNRX's QRX003 drug work for Netherton Syndrome?
What new clinical trials is QNRX planning for QRX003?
What intellectual property developments did QNRX announce in Q1 2025?
