Quoin Pharmaceuticals, Ltd. (QNRX): Business Model Canvas [Dec-2025 Updated]

You're looking at a late-stage biotech, and honestly, the current business model for Quoin Pharmaceuticals, Ltd. (QNRX) isn't about product sales-it's a pure play on regulatory milestones for a rare disease. As of September 30, 2025, they were running lean with only $5.4 million in cash after spending $6.7 million on R&D for the first nine months, but they just bought crucial runway by pulling in $16.6 million in upfront financing in October 2025. Their whole game hinges on QRX003 becoming the first approved therapy for Netherton Syndrome to secure up to a decade of market exclusivity, so you need to see how their nine strategic commercial agreements and proprietary drug delivery system are positioned to convert that potential into revenue post-NDA filing, which they anticipate in late 2026.

Quoin Pharmaceuticals, Ltd. (QNRX) - Canvas Business Model: Key Partnerships

You're looking at the external relationships Quoin Pharmaceuticals, Ltd. (QNRX) relies on to get its rare and orphan disease treatments to market, which is crucial given their late-stage clinical focus. Here's the breakdown of their key partnerships as of late 2025, grounded in the latest figures we have.

Commercial Reach and Distribution Alliances

Quoin Pharmaceuticals, Ltd. (QNRX) has established a broad international footprint through strategic commercial agreements, which is a major component of their go-to-market strategy outside of the planned US and EU internal sales infrastructure. This network is designed to handle distribution in territories where they do not plan to build their own sales force.

• The company has entered into nine separate strategic commercial agreements spanning 61 countries.
• These countries include Canada, Australia, New Zealand, the Middle East, China, Hong Kong, Taiwan, Central and Eastern Europe, the Baltic States, and several countries in Latin America.

For context on their financial capacity to support these operations and pipeline advancement, Quoin Pharmaceuticals, Ltd. closed a private placement financing in October 2025 with the potential to provide up to $105.3 million in capital. As of September 30, 2025, the cash position was $5.4 million, and the recent financing is expected to support operations into 2027.

Academic Research Collaborations

The pipeline development is heavily supported by specific research partnerships with academic institutions, focusing on novel drug delivery and new indications. The agreement terms often involve funding research with an option to license, avoiding upfront fees.

The table below summarizes the key academic research partnerships mentioned in the outline:

Clinical and Trial Execution Support

To execute pivotal trials, Quoin Pharmaceuticals, Ltd. (QNRX) relies on external expertise, though specific financial arrangements are not detailed in the public updates.

• Key Opinion Leaders (KOLs): The company reports having Strong KOL support for clinical and advocacy efforts.
• Contract Research Organizations (CROs): Quoin Pharmaceuticals, Ltd. (QNRX) is preparing to commence pivotal studies for QRX003 in the fourth quarter of 2025, which necessitates the use of CROs for execution, though specific contract values or numbers of CROs are not publicly itemized.

Quoin Pharmaceuticals, Ltd. (QNRX) - Canvas Business Model: Key Activities

You're looking at the core engine driving Quoin Pharmaceuticals, Ltd. (QNRX) right now-the activities they must execute flawlessly to move from late-stage development to a commercial entity. It's all about execution on QRX003 and building the foundation for market entry.

Late-stage clinical development of lead asset QRX003

The primary activity centers on advancing QRX003, particularly for Netherton Syndrome (NS). Quoin Pharmaceuticals announced positive 6-month clinical data from its pediatric NS study, showing significant skin improvements and reduced itching with no adverse events reported. The FDA cleared a second pivotal study (CL-QRX003-002) for NS, with enrollment expected to conclude by the end of Q1 2026. The company anticipates an NDA (New Drug Application) filing later in 2026. Also, initial positive data emerged from an investigator-led Pediatric Peeling Skin Syndrome (PSS) study, which is also being advanced.

Regulatory filings for Orphan Drug and Rare Pediatric Disease designations

Securing regulatory advantages is a critical, ongoing activity. Quoin Pharmaceuticals achieved several key designations that streamline development and offer market protection. These include:

• Obtaining Rare Pediatric Disease Designation from the U.S. FDA for QRX003 in Netherton Syndrome, enabling potential Priority Review Voucher eligibility upon approval.
• Receiving Orphan Drug Designation from the European Medicines Agency (EMA), which grants 10 years of market exclusivity in Europe upon approval.
• The FDA also granted Orphan Drug Designation for QRX003 in Netherton Syndrome.

These designations help accelerate development and secure future revenue streams. If onboarding takes 14+ days, churn risk rises-similarly, regulatory delays can severely impact a small biotech's runway.

Global rare disease awareness campaigns (NETHERTON NOW)

Actively building a patient community and disease awareness is a core activity, largely executed through the NETHERTON NOW campaign. As of November 2025, the campaign videos achieved over 1.5 million views in the six months since launch. Earlier, in August 2025, the campaign had surpassed one million video views and over 14 million impressions. This campaign amplifies patient stories and provides educational content, which is vital for rare disease market access and physician education.

Expanding and maintaining a robust Intellectual Property (IP) portfolio

Protecting the innovation behind QRX003 and future pipeline assets is paramount. Quoin Pharmaceuticals expanded its patent portfolio with new filings covering novel formulations. Specifically, in March 2025, the company filed U.S. and international patent applications for novel topical rapamycin formulations, potentially extending IP protection through 2045 across multiple rare disease indications. The clinical data showing a full and rapid reversal of benefits upon discontinuation provides clear support for the mechanism of action, which is also protected.

Building internal commercial infrastructure for US, EU, and Japan

Preparing for potential commercial launch is evidenced by key operational hires and financial positioning. Quoin Pharmaceuticals appointed Sally Lawlor as Chief Financial Officer to support commercialization and financial operations. The company is using proceeds from a financing event to fund general corporate purposes, which may include operating expenses and advancing clinical development toward potential approval.

Here's the quick math on the capital supporting these activities as of late 2025:

What this estimate hides is the burn rate post-pivotal study enrollment, but the runway into 2027 provides a solid base for the next 18 months of key activities. Finance: draft 13-week cash view by Friday.

Quoin Pharmaceuticals, Ltd. (QNRX) - Canvas Business Model: Key Resources

You're looking at the core assets Quoin Pharmaceuticals, Ltd. (QNRX) relies on to drive its specialty pharma business as of late 2025. These aren't just line items; they are the tangible and intangible foundations supporting their rare disease pipeline.

The most immediate resource is the balance sheet strength as of the last reported quarter. Honestly, for a late-stage clinical company, liquidity is king. Here's the quick math on their cash position before factoring in recent financing events.

The lead asset, QRX003, is definitely the most critical resource. This lotion, formulated at a 4% concentration for Netherton Syndrome (NS), is currently being evaluated in two pivotal registrational clinical studies. Recruitment for both studies is targeted to conclude in the first quarter of 2026. You should watch for top-line data, which is anticipated in the second half of 2026, with an NDA submission planned later that year.

Regulatory designations are powerful intangible assets that de-risk the development pathway and enhance commercial potential. Quoin Pharmaceuticals, Ltd. has secured several key ones for QRX003:

• FDA Rare Pediatric Disease Designation (RPDD) granted on June 24, 2025.
• FDA Orphan Drug Designation (ODD) granted on October 21, 2025.
• EMA Orphan Drug Designation granted in May 2025.

The FDA ODD is important because, if approved, it provides seven years of market exclusivity in the US. Also, the RPDD makes the asset eligible for a potential Priority Review Voucher (PRV) upon marketing approval, which is a highly valuable tradable asset.

Finally, the proprietary Invisicare polymer drug delivery system is a core technology. This patented innovation is what powers the QRX003 formulation. It is designed to enhance the efficacy and controlled release of active pharmaceutical ingredients when applied to the skin. The technology is protected by patents, patent applications, and trade secrets, and it is central to Quoin Pharmaceuticals, Ltd.'s ability to create its topical products.

Finance: draft 13-week cash view by Friday.

Quoin Pharmaceuticals, Ltd. (QNRX) - Canvas Business Model: Value Propositions

The core value proposition for Quoin Pharmaceuticals, Ltd. (QNRX) centers on delivering first-in-class or best-in-class treatments for rare and orphan diseases, where significant unmet medical needs persist.

First potential approved therapy for Netherton Syndrome

QRX003 is on track to potentially become the first approved treatment for Netherton Syndrome (NS), a devastating, life-altering disease for which there are currently no approved therapies. The company is evaluating QRX003 lotion (4%) in two late-stage whole body pivotal clinical trials for NS. Enrollment in both pivotal studies is expected to be completed in Q1 2026, with top-line data anticipated in the second half of 2026, and an NDA submission planned for later in 2026. The increased research and development expenditure, approximately $2.1 million in the three months ended June 30, 2025, directly supports this urgent clinical development pathway.

7 years of market exclusivity in the U.S. post-approval (FDA ODD)

The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to QRX003 for NS. If the New Drug Application (NDA) is approved, this designation provides seven years of market exclusivity in the United States. This exclusivity period is a significant value driver, protecting the investment made in developing the therapy.

10 years of market exclusivity in Europe post-approval (EMA ODD)

The European Medicines Agency (EMA) granted Orphan Drug Designation for QRX003 in May 2025. This regulatory achievement affords Quoin Pharmaceuticals, Ltd. (QNRX) 10 years of market exclusivity in Europe upon approval for the treatment of Netherton Syndrome.

Clinically validated, durable improvement for rare skin diseases

Clinical observations support the potential for durable improvement from QRX003. Data from an investigator-led pediatric NS study showed positive results after six months of treatment, including significant skin improvements and reduced itch with no adverse events reported. Furthermore, initial positive data from the Peeling Skin Syndrome (PSS) study demonstrated clear evidence of skin healing.

The quantitative improvements observed in the PSS study after 12 weeks of treatment with QRX003 are detailed below:

This data reflects a clinically meaningful two-grade improvement in the Investigator's Global assessment.

Pipeline targeting multiple rare dermatological and vascular conditions

Quoin Pharmaceuticals, Ltd. (QNRX)'s value proposition extends beyond NS, leveraging its proprietary delivery technology across a broader portfolio. The pipeline collectively has the potential to target several rare and orphan indications:

• Netherton Syndrome (NS)
• Peeling Skin Syndrome (PSS)
• Palmoplantar Keratoderma
• Scleroderma
• Epidermolysis Bullosa
• Microcystic Lymphatic Malformations
• Venous Malformations
• Angiofibroma

The company is actively expanding its pipeline studies. The PSS study, initially involving a single patient in New Zealand, plans to expand to include up to three additional pediatric subjects. Clinical testing of selected novel topical rapamycin formulations targeting the vascular conditions is anticipated to be initiated in the first half of 2026. The company reported approximately $7.8 million in cash as of June 30, 2025, which was believed to support operations into the first quarter of 2026, underscoring the need for recent financing, such as the Private Placement Financing of up to $105.3 million closed in October 2025, to fund this pipeline expansion.

Quoin Pharmaceuticals, Ltd. (QNRX) - Canvas Business Model: Customer Relationships

You're focused on building a company that truly serves the rare disease community, and for Quoin Pharmaceuticals, Ltd., that means deep, direct engagement across the board. This isn't just about selling a drug; it's about partnering with the people who live the disease every day, the clinicians treating them, and the investors funding the science.

High-touch engagement with patient advocacy groups and families

Quoin Pharmaceuticals, Ltd. treats patient advocacy as a core relationship, not an afterthought. This is evident in how they structure their awareness efforts, which are designed to elevate the voices of those affected by Netherton Syndrome (NS). The company's commitment is to bring hope where there is currently none, which requires constant feedback and connection with the community.

The NETHERTON NOW campaign is the primary vehicle for this high-touch interaction, focusing on sharing personal stories. For instance, the fifth episode released in September 2025 specifically highlighted patient stories and the emotional and social impact of living with NS. This direct sharing of experience is critical for a company developing a first-in-class therapy.

• Amplifies voices of patients, families, caregivers, and advocates.
• Highlights the painful realities of Netherton Syndrome.
• Focuses on the emotional and social impact of the disease.

Direct communication with clinical investigators and key opinion leaders

For a late clinical-stage company, investigator relationships are everything; they drive the science forward. Quoin Pharmaceuticals, Ltd. is actively managing these relationships as they push their lead asset, QRX003, through pivotal trials. You can see this focus in their clinical progression updates.

Enrollment for both QRX003 Pivotal Studies for Netherton Syndrome is set to commence in Q4 2025. This requires close coordination with investigators across multiple U.S. and international sites. Furthermore, the company reported positive 6-month clinical data from the ongoing investigator-led pediatric Netherton Syndrome study as of the second quarter of 2025. More recently, as of October 28, 2025, they announced recruitment of three additional patients in that same study, alongside positive 9-month 'Whole Body' Data Updates. To further cement these relationships, Quoin Pharmaceuticals, Ltd. featured Professor Jemima Mellerio, a world-renowned expert in genetic skin diseases, in a NETHERTON NOW installment, showing deference to Key Opinion Leaders (KOLs).

Dedicated Investor Relations (IR) to manage capital market stakeholders

Managing capital market stakeholders requires transparency, especially when cash burn is high due to late-stage development. Quoin Pharmaceuticals, Ltd. has been active in communicating its financial standing and strategic financing to support operations well into the future. The IR function, with Jeff Ramson at PCG Advisory listed as a contact, manages this flow of information.

Here's the quick math on their financial fortification efforts as of late 2025, which directly impacts stakeholder confidence:

The company's total asset tally is roughly $11.39M with equity at around $5.44M. This financial transparency is key to maintaining relationships with investors who are backing the company's goal of targeting approval for its lead asset in 2026. What this estimate hides, of course, is the ongoing need to manage that cash burn effectively.

Educational content via the NETHERTON NOW video series

The NETHERTON NOW video series is a deliberate strategy to educate the broader public and clinical community, moving beyond simple awareness. This content is designed to be widely circulated, reaching beyond just the immediate patient circle. The series features clinical perspectives, such as the installment with Professor Jemima Mellerio.

The engagement metrics for this educational push are substantial. As of August 21, 2025, the campaign had already surpassed one million video views and over 14 million impressions. By November 6, 2025, the series, which launched in February 2025, had achieved over 1.5 million views in just 6 months since its major push. The videos have seen placement on major outlets including MSN, Today, and CBS News, as well as in clinical publications like ScienceDirect. This defintely shows a broad reach for their educational messaging.

• Total Video Views (as of Nov 2025): Over 1.5 million.
• Total Impressions (as of Aug 2025): Over 14 million.
• Number of Episodes (as of Sept 2025): Five.
• Distribution Channels include MSN, Today, and CBS News.

Finance: draft 13-week cash view by Friday.

Quoin Pharmaceuticals, Ltd. (QNRX) - Canvas Business Model: Channels

You're looking at how Quoin Pharmaceuticals, Ltd. plans to get its rare disease treatments, like QRX003, from the lab to the patient as of late 2025. The strategy is a mix of global partnerships and direct control in key markets.

Global network of clinical trial sites for pivotal studies

The channel for product development relies heavily on a geographically diverse clinical trial network to support regulatory filings.

• Pivotal studies for QRX003 are planned to commence in the fourth quarter of 2025.
• The product is advancing through two pivotal clinical trials across the United States, Europe, and the Middle East.
• Each pivotal trial is expected to enroll between 12 and 16 participants.
• Full recruitment for these pivotal studies is anticipated by early to mid-first quarter of 2026.
• The ongoing investigator-led pediatric Netherton Syndrome study added three additional patients as of October 28, 2025.
• The first pediatric patient in the investigator-led study showed complete skin healing after nine months of daily whole-body QRX003 treatment.

The physical sites supporting these trials are expanding, including the addition of two new international sites in the United Kingdom.

Strategic commercial partners for distribution in 61 international markets

Commercial reach outside of core direct markets is being established through a network of established partners.

Quoin Pharmaceuticals, Ltd. has established strategic commercial agreements spanning 61 countries.

Planned internal sales force for direct commercialization in US, EU, and Japan

For the most significant potential markets, Quoin Pharmaceuticals, Ltd. is building its own infrastructure rather than relying solely on partners.

The company plans to establish a sales infrastructure for direct commercialization in the following territories:

• United States
• Europe (specifically Western Europe is often implied for direct focus)
• Japan

Direct-to-patient digital and social media platforms

Awareness and patient engagement are being driven through targeted digital campaigns.

The NETHERTON NOW awareness campaign has generated significant digital reach:

• Campaign series passed one million video views.
• The campaign achieved 14 million impressions.
• The campaign has achieved over 1.5 million views overall.

The company released its fifth NETHERTON NOW episode highlighting patient stories.

Quoin Pharmaceuticals, Ltd. (QNRX) - Canvas Business Model: Customer Segments

You're looking at the core audience for Quoin Pharmaceuticals, Ltd. (QNRX) as of late 2025. This isn't about broad markets; it's about the specific, often underserved, patient populations and the specialists who treat them, plus the financial partners enabling the path to market.

Patients with Netherton Syndrome (pediatric and adult)

This group represents the primary target for QRX003, which has received both FDA Rare Pediatric Disease Designation and European Medicines Agency Orphan Drug Designation for Netherton Syndrome (NS). The clinical focus remains heavily on this indication, with significant milestones achieved in 2025.

• Second pivotal study (CL-QRX003-002) is set to enroll 12-15 subjects.
• Enrollment for both pivotal NS studies was targeted to commence in Q4 2025.
• Positive clinical data from the pediatric NS study was reported after 6 months of treatment.
• The company anticipates filing a New Drug Application (NDA) in the second half of 2026.
• The NETHERTON NOW awareness campaign videos surpassed 1.5 million views in the six months leading up to Q3 2025.

Patients with other rare skin diseases (e.g., Peeling Skin Syndrome)

Quoin Pharmaceuticals, Ltd. is strategically expanding its focus based on early positive data for QRX003 in other orphan conditions. Peeling Skin Syndrome (PSS) is the most immediate secondary focus.

Specialty dermatologists and genetic disease specialists

These are the prescribers and key opinion leaders. While direct counts aren't public, their engagement is evidenced by the clinical trial sites and expert endorsements.

• The NS pivotal studies are being conducted at sites across the U.S., Europe, and the Middle East.
• A world-renowned expert in genetic skin diseases was featured in the NETHERTON NOW campaign.

Global pharmaceutical companies for regional licensing/M&A

This segment is less about direct patient volume and more about the financial validation and potential commercialization partners. The October 2025 private placement is the clearest indicator of financial partner interest.

Here's the quick math on the recent financing that supports future business development activities, including potential M&A or licensing outlays:

What this estimate hides is the specific valuation placed on regional rights, but the $105.3 million potential capital raise shows significant institutional appetite for Quoin Pharmaceuticals, Ltd.'s platform.

Finance: draft 13-week cash view by Friday.

Quoin Pharmaceuticals, Ltd. (QNRX) - Canvas Business Model: Cost Structure

You're looking at the financial engine driving Quoin Pharmaceuticals, Ltd. (QNRX) as it pushes its rare disease pipeline forward. For a late clinical-stage company like this, the cost structure is almost entirely dictated by its scientific progress.

Dominant cost is Research and Development (R&D). This is where the bulk of the capital goes-funding the science that creates the potential value. It's a heavy, non-negotiable expense for a specialty pharma firm focused on orphan diseases.

The R&D burn rate is substantial. Specifically, R&D expenses totaled $6.7 million for the nine months ended Sept 30, 2025. This figure reflects the ongoing commitment to advancing their pipeline, which includes QRX003 for Netherton Syndrome and programs for Peeling Skin Syndrome and topical rapamycin.

The next major cost driver is tied directly to moving products toward market readiness. This involves:

• Costs for pivotal clinical trials and regulatory submissions.
• Advancing clinical development for multiple rare indications.
• Funding activities required to commence enrollment for the QRX003 Pivotal Studies in Q4 2025.

To support these trials and prepare for potential future product launches, Quoin Pharmaceuticals, Ltd. incurs significant overhead. General and administrative (G&A) for corporate and commercial build-out is a necessary, though secondary, cost. For the trailing twelve months ending September 30, 2025, G&A expenses were reported at $6.42 million. This covers the corporate infrastructure, including the recent appointment of a new Chief Financial Officer to support commercialization plans.

Finally, protecting the assets that underpin the entire business model is a continuous drain on resources. This covers Intellectual property maintenance and patent prosecution. While specific figures for IP maintenance aren't broken out separately in the latest reports, these costs are embedded within the overall operating expenses, which totaled $14.18 million for the TTM ending September 30, 2025.

Here's a quick look at the key expense and cash components as of late 2025:

The company is clearly structured around high fixed costs related to R&D, which is typical. Honestly, the cash position of $5.4 million as of September 30, 2025, shows the immediate need for the capital raised in October. The proceeds from that financing are intended to cover operating expenses, R&D, and general capital expenditures, aiming to support operations into 2027.

The key cost components driving the burn rate are:

• Funding clinical execution for QRX003 pivotal studies.
• Advancing the Peeling Skin Syndrome program.
• Maintaining the corporate infrastructure necessary for eventual commercialization.

Finance: draft 13-week cash view by Friday.

Quoin Pharmaceuticals, Ltd. (QNRX) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Quoin Pharmaceuticals, Ltd. (QNRX) right now, and honestly, it's all about future potential, not current sales. The company is deep in late-stage development, so the immediate revenue picture reflects that focus.

Currently $0.0 in product revenue (Q2 2025)

For the second quarter of 2025, Quoin Pharmaceuticals, Ltd. reported exactly $0.0 in GAAP revenue. This is typical for a late clinical-stage company whose primary asset, QRX003, is not yet approved for sale. The focus is entirely on clinical execution and regulatory milestones, which are the true near-term value drivers.

Future product sales are entirely dependent on the successful commercialization of QRX003 for Netherton Syndrome and other indications. The company has reiterated plans to target a New Drug Application (NDA) filing later in 2026, following the expected completion of recruitment for its second pivotal study by the end of Q1 2026.

Financing Proceeds as an Immediate Revenue Stream

The most concrete financial inflow recently comes from equity financing. In October 2025, Quoin Pharmaceuticals, Ltd. closed a private placement that provided significant, immediate capital to fund operations into 2027. Here's the quick math on that capital raise:

The company believes the $16.6 million upfront funding, combined with $3.3 million received from warrant exercises in October 2025, supports operations into 2027. This financing is currently a critical component of the cash flow supporting the business model.

Potential Milestone Payments and Royalties

While the 61-country commercial agreements are in place, the search results detail specific potential payments tied to the licensing of the technology underlying QRX003. These represent contingent, non-operating revenue streams contingent on regulatory success.

• Potential payment of $15 million upon obtaining US or EU regulatory approval for the first drug product developed using the licensed technology.
• Potential payment of $7.5 million upon achieving defined development milestones.
• A $5 million payment due to Skinvisible upon receiving approval in the U.S. or the European Union, whichever occurs first.
• A 20% royalty on net sales for QRX003 commercialized by AFT Pharmaceuticals in Australia and New Zealand upon approval and launch.

The structure for the broader commercial agreements likely mirrors these terms, but specific figures for the remaining territories aren't publically itemized here. Still, these known structures give you a baseline for potential royalty income streams post-approval.

Potential Sale of a Priority Review Voucher (PRV)

The FDA granted QRX003 Rare Pediatric Disease Designation for Netherton Syndrome. This designation is a direct pathway to potential eligibility for a Priority Review Voucher (PRV) upon marketing approval. A PRV is a highly valuable, transferable instrument that can be sold to another pharmaceutical company to expedite their own drug review process. The value of a PRV fluctuates, but they have historically traded for hundreds of millions of dollars, representing a significant, one-time, non-dilutive revenue event if achieved and sold.