Quoin Pharmaceuticals Provides Corporate Update and Reports Fourth Quarter and Full-Year 2024 Financial Results
Quoin Pharmaceuticals (NASDAQ: QNRX) reported significant progress in 2024, particularly with its lead product QRX003 for Netherton Syndrome. Clinical trials showed promising results, including dramatic reduction in disease severity and skin healing. The company recently received FDA clearance for a 'whole-body' clinical study.
Key developments include filing patent applications for novel topical rapamycin formulations, launching the 'NETHERTON NOW' awareness campaign, and completing a $6.8 million public offering. Positive clinical data showed treatment effectiveness with QRX003, with improvements reversing after discontinuation, supporting the need for chronic treatment.
Financial results show cash position of $14.1 million as of December 31, 2024, expected to fund operations into Q2 2026. Net loss for Q4 2024 was $2.3 million, compared to $2.0 million in Q4 2023, while full-year 2024 net loss was $9.0 million versus $8.7 million in 2023.
Quoin Pharmaceuticals (NASDAQ: QNRX) ha riportato progressi significativi nel 2024, in particolare con il suo prodotto di punta QRX003 per la Sindrome di Netherton. Gli studi clinici hanno mostrato risultati promettenti, inclusa una riduzione drammatica della gravità della malattia e una guarigione della pelle. L'azienda ha recentemente ricevuto l'approvazione della FDA per uno studio clinico 'a corpo intero'.
Tra i principali sviluppi ci sono la presentazione di domande di brevetto per nuove formulazioni topiche di rapamicina, il lancio della campagna di sensibilizzazione 'NETHERTON NOW' e il completamento di un offerta pubblica di $6.8 milioni. Dati clinici positivi hanno mostrato l'efficacia del trattamento con QRX003, con miglioramenti che si sono invertiti dopo l'interruzione, supportando la necessità di un trattamento cronico.
I risultati finanziari mostrano una posizione di cassa di $14.1 milioni al 31 dicembre 2024, prevista per finanziare le operazioni fino al secondo trimestre del 2026. La perdita netta per il quarto trimestre del 2024 è stata di $2.3 milioni, rispetto a $2.0 milioni nel quarto trimestre del 2023, mentre la perdita netta per l'intero anno 2024 è stata di $9.0 milioni rispetto a $8.7 milioni nel 2023.
Quoin Pharmaceuticals (NASDAQ: QNRX) reportó avances significativos en 2024, especialmente con su producto principal QRX003 para el Síndrome de Netherton. Los ensayos clínicos mostraron resultados prometedores, incluyendo una reducción dramática en la gravedad de la enfermedad y la curación de la piel. La compañía recibió recientemente la aprobación de la FDA para un estudio clínico 'de cuerpo entero'.
Los desarrollos clave incluyen la presentación de solicitudes de patente para nuevas formulaciones tópicas de rapamicina, el lanzamiento de la campaña de concienciación 'NETHERTON NOW' y la finalización de una oferta pública de $6.8 millones. Los datos clínicos positivos mostraron la efectividad del tratamiento con QRX003, con mejoras que se revertían tras la interrupción, apoyando la necesidad de un tratamiento crónico.
Los resultados financieros indican una posición de efectivo de $14.1 millones al 31 de diciembre de 2024, que se espera financie las operaciones hasta el segundo trimestre de 2026. La pérdida neta para el cuarto trimestre de 2024 fue de $2.3 millones, en comparación con $2.0 millones en el cuarto trimestre de 2023, mientras que la pérdida neta del año completo 2024 fue de $9.0 millones frente a $8.7 millones en 2023.
퀘인 제약 (NASDAQ: QNRX)는 2024년에 특히 네더튼 증후군을 위한 주요 제품 QRX003과 관련하여 중요한 진전을 보고했습니다. 임상 시험은 질병의 심각성을 극적으로 줄이고 피부 치유를 포함하는 유망한 결과를 보여주었습니다. 회사는 최근 '전신' 임상 연구에 대한 FDA 승인을 받았습니다.
주요 개발 사항으로는 새로운 국소 라파마이신 제형에 대한 특허 출원, 'NETHERTON NOW' 인식 캠페인 시작, 및 680만 달러의 공모 완료가 있습니다. 긍정적인 임상 데이터는 QRX003 치료의 효과를 보여주었으며, 중단 후 개선 사항이 되돌아가 만성 치료의 필요성을 뒷받침했습니다.
재무 결과는 2024년 12월 31일 기준으로 1410만 달러의 현금 보유액을 보여주며, 이는 2026년 2분기까지 운영 자금을 지원할 것으로 예상됩니다. 2024년 4분기 순손실은 230만 달러로, 2023년 4분기 200만 달러와 비교되며, 2024년 전체 연도 순손실은 900만 달러로 2023년의 870만 달러와 대조됩니다.
Quoin Pharmaceuticals (NASDAQ: QNRX) a signalé des progrès significatifs en 2024, en particulier avec son produit phare QRX003 pour le syndrome de Netherton. Les essais cliniques ont montré des résultats prometteurs, y compris une réduction dramatique de la gravité de la maladie et la guérison de la peau. L'entreprise a récemment obtenu l'autorisation de la FDA pour une étude clinique 'corps entier'.
Les développements clés incluent le dépôt de demandes de brevet pour de nouvelles formulations topiques de rapamycine, le lancement de la campagne de sensibilisation 'NETHERTON NOW' et l'achèvement d'une offre publique de 6,8 millions de dollars. Des données cliniques positives ont montré l'efficacité du traitement avec QRX003, avec des améliorations qui se sont inversées après l'arrêt, soutenant la nécessité d'un traitement chronique.
Les résultats financiers montrent une position de trésorerie de 14,1 millions de dollars au 31 décembre 2024, prévue pour financer les opérations jusqu'au deuxième trimestre 2026. La perte nette pour le quatrième trimestre 2024 était de 2,3 millions de dollars, contre 2,0 millions de dollars au quatrième trimestre 2023, tandis que la perte nette pour l'année entière 2024 était de 9,0 millions de dollars contre 8,7 millions de dollars en 2023.
Quoin Pharmaceuticals (NASDAQ: QNRX) berichtete über bedeutende Fortschritte im Jahr 2024, insbesondere mit seinem Hauptprodukt QRX003 für das Netherton-Syndrom. Klinische Studien zeigten vielversprechende Ergebnisse, einschließlich einer dramatischen Reduzierung der Schwere der Krankheit und der Hautheilung. Das Unternehmen erhielt kürzlich die Genehmigung der FDA für eine 'Ganzkörper'-Studie.
Zu den wichtigsten Entwicklungen gehören die Einreichung von Patentanträgen für neuartige topische Rapamycin-Formulierungen, der Start der Aufklärungskampagne 'NETHERTON NOW' und der Abschluss eines Öffentlichen Angebots in Höhe von 6,8 Millionen Dollar. Positive klinische Daten zeigten die Wirksamkeit der Behandlung mit QRX003, wobei sich die Verbesserungen nach Abbruch umkehrten, was die Notwendigkeit einer chronischen Behandlung unterstützt.
Die finanziellen Ergebnisse zeigen eine Barmittelposition von 14,1 Millionen Dollar zum 31. Dezember 2024, die voraussichtlich die Betriebe bis zum zweiten Quartal 2026 finanzieren wird. Der Nettoverlust für das vierte Quartal 2024 betrug 2,3 Millionen Dollar, verglichen mit 2,0 Millionen Dollar im vierten Quartal 2023, während der Nettoverlust für das Gesamtjahr 2024 9,0 Millionen Dollar betrug, gegenüber 8,7 Millionen Dollar im Jahr 2023.
- Strong clinical efficacy data for QRX003 in Netherton Syndrome trials
- FDA clearance received for whole-body clinical study
- New patent applications filed expanding potential treatment pipeline
- Successful completion of $6.8M public offering
- $14.1M cash runway extending into Q2 2026
- Increased net loss in Q4 2024 ($2.3M vs $2.0M in Q4 2023)
- Higher full-year net loss ($9.0M in 2024 vs $8.7M in 2023)
- QRX003 requires chronic treatment as benefits reverse upon discontinuation
Insights
Quoin Pharmaceuticals' latest report signals substantial clinical progress in its lead program for Netherton Syndrome, despite widening financial losses. The standout development is the positive clinical data from QRX003 trials, particularly the transformational improvement in a pediatric patient receiving whole-body application, who was able to discontinue all previously required medications after just two weeks of treatment.
The FDA clearance for a new whole-body clinical study represents a significant regulatory milestone that could expedite the path to approval. This study design, covering 80% of body surface area, creates a more robust data package that better mimics real-world treatment scenarios – a important consideration for rare disease therapies.
The company's financial position includes $14.1 million in cash and equivalents, projected to fund operations into Q2 2026, bolstered by a $6.8 million public offering completed in December. However, net losses increased to $9.0 million for 2024 compared to $8.7 million in 2023.
Pipeline expansion through patent filings for novel topical rapamycin formulations targeting additional rare dermatological conditions demonstrates strategic diversification beyond their lead asset. The proprietary Invisicare® delivery technology appears to be a versatile platform that could generate multiple development candidates.
What's particularly compelling is the evidence of QRX003's mechanism of action, shown by complete symptom reversal following treatment discontinuation – validating both the product's effectiveness and the need for chronic administration.
Quoin's financial position presents a nuanced picture for investors tracking this rare disease play. The $14.1 million cash position provides a runway into Q2 2026, offering reasonable operational certainty during a critical clinical development period. However, investors should note the steadily increasing net losses – $9.0 million for 2024 versus $8.7 million for 2023 – reflecting the resource-intensive nature of late-stage clinical development.
The $6.8 million public offering completed in December came with a noteworthy aspect: significant participation by the entire executive team, demonstrating internal confidence in the company's prospects. For a microcap biotech with a $2.39 million market capitalization, maintaining sufficient funding without excessive dilution represents a key challenge going forward.
The current market valuation appears disconnected from Quoin's clinical progress and potential first-mover advantage in Netherton Syndrome treatment. With positive data accumulating across multiple studies and expanded regulatory pathways, the company's current $0.297 share price seemingly undervalues its pipeline potential.
From a burn rate perspective, Quoin is consuming approximately $2.3 million quarterly. This controlled expense management, coupled with the recent capital raise, has meaningfully extended the company's operational runway. Investors should monitor upcoming clinical milestones, particularly the whole-body study results, as key value inflection points that could trigger partnership interest or licensing opportunities in this orphan disease space.
ASHBURN, Va., March 13, 2025 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the "Company" or "Quoin"), a late clinical-stage specialty pharmaceutical company focused on rare and orphan diseases, today announced recent corporate accomplishments and provided an update on its fourth quarter and full-year 2024 progress.
Quoin CEO Michael Myers said, "2024 was without a doubt the most significant year in Quoin’s history as our team delivered tremendous progress in clinical, regulatory and manufacturing settings. This progress was particularly exemplified in the clinical development of QRX003, our product candidate for Netherton Syndrome, and we are encouraged by the positive data our ongoing studies are generating. The significant improvements observed across multiple clinical endpoints, including a dramatic reduction in disease severity, tangible skin healing and barrier restoration as well as highly positive patient-reported outcomes, have provided further evidence of QRX003’s potential to address the underlying pathology of Netherton Syndrome.
Our recently announced FDA-cleared ‘whole-body’ clinical study will represent the most extensive evaluation of QRX003 to date, and we believe will generate a very robust and comprehensive safety and efficacy data set that will become a central component of our regulatory approval submission. As a company, we remain steadfast in our mission to develop the first FDA-approved treatment for Netherton Syndrome, a disease with no approved therapies and a profound impact on patients and families.
Additionally, our recent patent filings for novel topical rapamycin formulations mark an important step in expanding our pipeline to address additional rare dermatological diseases. With multiple clinical trials underway, and continued pipeline expansion, 2025 is already shaping up to become a highly pivotal year for Quoin.”
Recent Accomplishments
On March 4, 2025, Quoin announced it had filed U.S. and international patent applications for novel topical rapamycin formulations targeting microcystic lymphatic malformations, venous malformations and angiofibromas. The products are being developed using Quoin’s in-licensed proprietary Invisicare® delivery technology, further expanding Quoin’s rare disease pipeline.
A week earlier, Quoin announced highly positive whole body clinical data from its ongoing pediatric Netherton Syndrome study. The first patient to receive whole-body application of QRX003 showed transformational improvement after just two weeks, with clear visual evidence of skin healing. Crucially also, the patient was able to fully discontinue previously required medications, including all antihistamines, glucocorticoids, antivirals, and has not needed any antibiotic treatment. Furthermore, the patient is experiencing zero nightly sleep disturbances for the first time in her life. No adverse events were reported.
Earlier in February, Quoin launched its ‘NETHERTON NOW’ awareness campaign, a multi-channel initiative designed to raise awareness of Netherton Syndrome and its impact on patients and families. The company introduced a dedicated website, providing educational resources and support for the Netherton community.
In January, Quoin released further clinical evidence from its open label study supporting QRX003’s effectiveness. Data showed that within four weeks of discontinuation of treatment all positive clinical improvements observed after 12 weeks of treatment were completely reversed, reinforcing QRX003’s mechanism of action as a competitive broad spectrum serine protease inhibitor and the need for ongoing chronic treatment to maintain therapeutic benefits.
Earlier in January, Quoin announced additional positive clinical data from its ongoing open-label Netherton Syndrome study. The first subject to complete 12 weeks of twice-daily dosing with QRX003 demonstrated sustained clinical improvement across all measured endpoints. No adverse events were reported throughout the study. Photographic evidence clearly showing direct evidence of skin healing may be accessed on Quoin’s website.
Fourth Quarter 2024 Highlights
On Dec. 20, 2024, Quoin announced the successful completion of a
A day prior, Quoin received FDA clearance to initiate a new whole-body clinical study for QRX003. This groundbreaking study, which will be led by Dr. Amy Paller at Northwestern University, will evaluate the safety and efficacy of twice-daily application of QRX003 to more than
On Dec. 18, 2024, Quoin announced positive interim data from two of its ongoing Netherton Syndrome clinical studies. The first subject dosed twice daily for six weeks in the company’s open-label study demonstrated a significant clinical response across multiple endpoints. In addition, data from Quoin’s ongoing pediatric study showed a rapid improvement in skin appearance within 12 days of treatment, with no adverse events reported.
Financial Highlights
- Quoin had approximately
$14.1 million in cash, cash equivalents and marketable securities as of December 31, 2024. This is expected to fund the Company’s operations into the second quarter of 2026. - Net loss for the quarter ended December 31, 2024 was approximately
$2.3 million compared to approximately$2.0 million for the quarter ended December 31, 2023. Net loss for the twelve months ended December 31, 2024 was$9.0 million compared to$8.7 million for the twelve months ended December 31, 2023. - Investors are encouraged to read the Company’s Annual Report on Form 10-K when it is filed with the Securities and Exchange Commission (the “SEC”), which will contain additional details about Quoin’s financial results as of and for the period ended December 31, 2024.
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, Palmoplantar Keratoderma, Scleroderma, Epidermolysis Bullosa, microcystic lymphatic malformations, venous malformations and others. For more information, go to: www.quoinpharma.com.
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’s potential to address the underlying pathology of Netherton Syndrome; whole-body’ clinical study generating a robust and comprehensive safety and efficacy data set that will become a central component of the Company’s regulatory approval submission; the Company developing the first FDA-approved treatment for Netherton Syndrome; the Company’s new U.S. and International patent applications for novel topical rapamycin (sirolimus) formulations as potential treatments for a number of rare diseases including microcystic lymphatic malformations, venous malformations and angiofibromas; the progress or success of Quoin’s ongoing clinical trials; 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, Palmoplantar Keratoderma, Scleroderma, Epidermolysis Bullosa, microcystic lymphatic malformations, venous malformations 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 clinical studies may not generate the results anticipated; the Company ability to recruit additional subjects; the clinical studies not generating data which is sufficiently robust and comprehensive to support an NDA filing; the Company’s ability to obtain regulatory approvals; the Company’s ability to protect its assets with the new patent applications; the Company’s ability to obtain regulatory approvals for the commercialization of its product candidates or to comply with ongoing regulatory requirements; the Company’s ability to deliver a safe and effective treatment for Netherton Syndrome; the Company may be unable to submit applications and initiate clinical development as and when planned; and other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 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
| QUOIN PHARMACEUTICALS, LTD. | ||||||||||||
| Consolidated Balance Sheets | ||||||||||||
| December 31, | December 31, | |||||||||||
| 2024 | 2023 | |||||||||||
| ASSETS | ||||||||||||
| Current assets: | ||||||||||||
| Cash and cash equivalents | $ | 3,623,343 | $ | 2,401,198 | ||||||||
| Investments | 10,433,535 | 8,293,663 | ||||||||||
| Prepaid expenses and other current assets | 869,126 | 591,034 | ||||||||||
| Total current assets | 14,926,004 | 11,285,895 | ||||||||||
| Prepaid expenses - long term | 300,000 | 300,000 | ||||||||||
| Intangible assets, net | 483,334 | 583,334 | ||||||||||
| Total assets | $ | 15,709,338 | $ | 12,169,229 | ||||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||||||
| Current liabilities: | ||||||||||||
| Accounts payable | $ | 905,704 | $ | 526,523 | ||||||||
| Accrued expenses | 1,528,977 | 1,308,706 | ||||||||||
| Accrued interest and financing expense | 1,146,251 | 1,146,251 | ||||||||||
| Due to officers - short term | 600,000 | 600,000 | ||||||||||
| Total current liabilities | 4,180,932 | 3,581,480 | ||||||||||
| Due to officers - long term | 2,323,733 | 2,923,733 | ||||||||||
| Total liabilities | $ | 6,504,665 | $ | 6,505,213 | ||||||||
| Commitments and contingencies | ||||||||||||
| Shareholders' equity: | ||||||||||||
| Ordinary shares, no par value per share, 100,000,000 authorized at December 31, 2024 and 2024, respectively - 8,948,164 (8,948,164 ADS's) ordinary shares issued and outstanding at December 31, 2024 and 987,220 (987,220 ADS's) at December 31, 2023 | $ | - | $ | - | ||||||||
| Additional paid in capital | 64,370,465 | 51,867,336 | ||||||||||
| Accumulated deficit | (55,165,792 | ) | (46,203,320 | ) | ||||||||
| Total shareholders' equity | 9,204,673 | 5,664,016 | ||||||||||
| Total liabilities and shareholders' equity | $ | 15,709,338 | $ | 12,169,229 | ||||||||
| QUOIN PHARMACEUTICALS, LTD. | ||||||||||||||||||
| Consolidated Statements of Operations | ||||||||||||||||||
| Years Ended December 31, | Three months ended December 31, | |||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||||
| (Audited) | (Audited) | (Unaudited) | (Unaudited) | |||||||||||||||
| Operating expenses | ||||||||||||||||||
| General and administrative | $ | 5,925,833 | $ | 6,070,517 | $ | 1,410,717 | $ | 1,385,276 | ||||||||||
| Research and development | 3,602,632 | 3,307,987 | 994,344 | 832,391 | ||||||||||||||
| Total operating expenses | 9,528,465 | 9,378,504 | 2,405,061 | 2,217,667 | ||||||||||||||
| Other (income) and expenses | ||||||||||||||||||
| Unrealized (gain) loss | (7,502 | ) | 2,683 | 15,541 | (9,243 | ) | ||||||||||||
| Realized and accrued interest income | (558,491 | ) | (694,614 | ) | (109,328 | ) | (158,546 | ) | ||||||||||
| Total other (income) expense | (565,993 | ) | (691,931 | ) | (93,787 | ) | (167,789 | ) | ||||||||||
| Net loss | $ | (8,962,472 | ) | $ | (8,686,573 | ) | $ | (2,311,274 | ) | $ | (2,049,878 | ) | ||||||
| Loss per ADS | ||||||||||||||||||
| Basic | $ | (1.91 | ) | $ | (9.64 | ) | $ | (0.35 | ) | $ | (2.08 | ) | ||||||
| Fully-diluted | $ | (1.91 | ) | $ | (9.64 | ) | $ | (0.35 | ) | $ | (2.08 | ) | ||||||
| Weighted average number of ADS's outstanding | ||||||||||||||||||
| Basic | 4,688,723 | 900,919 | 6,527,981 | 987,220 | ||||||||||||||
| Fully-diluted | 4,688,723 | 900,919 | 6,527,981 | 987,220 | ||||||||||||||
FAQ
What were the key clinical results for QNRX's QRX003 in Netherton Syndrome trials?
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