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Item 1. Business

2026-03-26 compared with 2025-03-13 · 197 added, 161 removed, 301 unchanged (54% of the section changed)

Company Overview

We are a late-stage clinical specialty pharmaceutical company focused on the development and commercialization of therapeutic products that treat rare and orphan diseases for which there are currently very limited or no approved treatments or cures.

Our initial focus is on the development of products, using our proprietary owned and in-licensed drug delivery technologies, that could help address rare genetic diseases.

Our lead product, QRX003, is under clinical development as a potential treatment for Netherton Syndrome (“NS”), a rare hereditary genetic disease.

QRX003 is currently being tested in three regulatory clinical studies under an open Investigational New Drug (“IND”) application with the Food and Drug Administration (“FDA”).

We have opened five clinical sites in the United States (“US”) and intend to open a sixth clinical site at Northwestern University.

We are expanding our trials internationally into the Middle East, the United Kingdom and additional countries in Europe, including Spain and Germany.

QRX003 is currently being tested in a pediatric NS patient at the Children’s Hospital in Dublin, Ireland and we intend to expand this study to include additional children with NS in Spain, the United Kingdom and potentially other countries.

QRX003 is entering pivotal registrational clinical testing under an open Investigational New Drug (“IND”) application with the Food and Drug Administration (“FDA”).

We have opened six clinical sites in the United States (“U.S.”) along with international sites that are being opened in the UK, Spain, France and the Netherlands.

QRX003 is currently being tested in seven pediatric NS patients in investigator-initiated studies in Ireland, Austria, the Netherlands and New Zealand.

QRX003 is also being developed as a potential treatment for Peeling Skin Syndrome with the first subject being treated in New Zealand.

In addition, we entered into two separate Research Agreements with the Queensland University of Technology (“QUT”), under which we have obtained an option for global licenses to QRX007 for the potential treatment of NS and QRX008 for the potential treatment of scleroderma, as well as a Research Agreement with the University College Cork (“UCC”) for the development of novel topical formulations of rapamycin (sirolimus) as potential treatments for a number of rare and orphan diseases.

We are also initiating the development of novel topical formulations of rapamycin using our in-licensed technology as potential treatments for microcystic lymphatic malformations, venous malformations and angifibromas.

Other development products in our pipeline include QRX004 as a potential treatment for Recessive Dystrophic Epidermolysis Bullosa (“RDEB”).

We are in the process of expanding this study to include up to an additional five pediatric subjects.

We entered into a Research Agreement with the Queensland University of Technology (“QUT”) in Australia, under which we have obtained an option for a global license to QRX008 for the potential treatment of scleroderma, as well as a Research Agreement with The School of Pharmacy at University College Cork (“UCC”) for the development of novel topical formulations of rapamycin (sirolimus) as potential treatments for a number of rare and orphan diseases for which there are either limited or no approved therapies or cures, including microcystic lymphatic malformations, venous malformations and angiofibromas among others.

We have also entered into 9 commercial partnerships for QRX003 spanning 61 countries outside of our core commercial territories of the U.S., Western Europe and Japan.

These partnership countries include Canada, Australia, New Zealand, the Middle East, China, Taiwan, Hong Kong Singapore, Israel, Central and Eastern Europe, Turkey as well as several countries in Latin America.

Our mission is to develop and commercialize proprietary therapeutic drug products that treat rare and orphan diseases, particularly for those diseases where no approved treatment currently exists.

To achieve this, we plan to:

● complete the late-stage clinical testing of QRX003 in NS and, if successful, submit for marketing approval in the United States, Europe, Japan and the other territories for which we have commercial agreements in place;

● prepare to commercialize QRX003 by (i) establishing our own sales infrastructure in the U.S., Europe and Japan and (ii) work with our distribution partners to commercialize the product in Canada, Australia/New Zealand, the Middle East, China, Hong Kong, Taiwan, Latin America, Central and Eastern Europe, Turkey and Singapore;

● continue the development of QRX003 for Peeling Skin Syndrome and related rare, genetic skin diseases;

● commence clinical testing of one or more selected formulations of topical rapamycin;

● pursue business development activities by seeking partnering, licensing, merger and acquisition opportunities or other transactions to further expand our pipeline and drug-development capabilities.

To date, no products have been commercialized and no revenue has been generated.

Our Product Candidates

QRX003 is a topical lotion being developed for the treatment of NS.

QRX003 is a topical lotion being developed for the treatment of a number of rare genetic skin diseases.

Our most advanced program is for NS.

The active ingredient in QRX003 is a broad-spectrum serine protease inhibitor whose mechanism of action is to target the kallikreins responsible for the process of skin shedding.

Due to the genetic mutation of the SPINK5 gene, which results in the absence of the kallikrein regulating LEKTI protein, these kallikreins go unregulated and become hyperactive resulting in the uncontrolled desquamation that leads to the highly defective skin barrier in NS patients.

When applied to the skin, QRX003 is designed to perform the function of the missing LEKTI protein and down regulate, but not completely stop, the activity of kallikreins, leading to a more normalized skin shedding process and the formation of a stronger and more effective skin barrier.

Due to the genetic mutation of the SPINK5 gene, which results in the absence of the kallikreins that regulate Lympho-epithelial Kazal-type-related inhibitor (“LEKTI”) protein, a large, 15-domain serine protease inhibitor expressed in epithelial tissues, crucial for regulating skin barrier function and desquamation, these kallikreins go unregulated and become hyperactive resulting in the uncontrolled desquamation that leads to the highly defective skin barrier in NS patients.

When applied to the skin, QRX003 is designed to perform the function of the missing LEKTI protein and down regulate, but not completely

stop, the activity of kallikreins, leading to a more normalized skin shedding process and the formation of a stronger and more effective skin barrier.

While several other companies are pursuing the development of products to treat NS, we believe, to date we are the only company that is actively dosing subjects in multiple NS clinical studies under an open IND with the FDA.

QRX003 was developed using Invisicare® polymer delivery technology licensed from Skinvisible Pharmaceuticals, Inc.

(“Skinvisible”).

See “—Intellectual Property—License Agreement with Skinvisible.” The Invisicare® polymer delivery technology is an optimized topical delivery system that moisturizes the skin whilst simultaneously providing a protective barrier against allergens, toxins and other environmental agents.

QRX004 contains two active ingredients as a potential treatment for RDEB.

One active ingredient induces a read-through of nonsense mutations and leads to creation of robust and sustained type VII collagen, which is designed to improve wound closure, reduce blistering and stronger skin.

This product is being developed using Invisicare® delivery technology in-licensed from Skinvisible.

See “—Intellectual Property—License Agreement with Skinvisible.”

QRX007 and QRX008

In November 2021, we entered into the Research Agreement with QUT, pursuant to which we have an option for up to six months after the project completion to in-license the QRX007 product.

QRX007 is a bi-functional protein designed to be highly selective and potent inhibitor of the KLK5 and KLK7 kallikreins as a potential treatment for NS.

QRX007 is in pre-clinical testing for NS.

2022, we entered into another Research Agreement with QUT, pursuant to which we have an option for up to six months after the project completion to in-license a small molecule VLA - 4 inhibitor, the QRX008 product.

In light of the expected near-term completion of the QRX003 clinical program for NS, in July 2025 Quoin announced that it has discontinued the development of QRX007 for NS.

QRX007 was being developed through Quoin’s research agreement with QUT.

QRX003 is also being developed as a potential treatment for Peeling Skin Syndrome, a rare genetic skin disease for which there is no approved treatment or cure.

In addition, we are planning to pursue the development of QRX003 as a potential treatment for a number of Ichthyosis related disorders and SAM Syndrome potentially putting the product in position to become the first approved for four genetic skin diseases.

In May 2022, we entered into a Research Agreement with QUT, pursuant to which we have an option for up to six months after the project completion to in-license a small molecule VLA - 4 inhibitor, the QRX008 product.

QRX008 is a potential treatment for scleroderma, a rare autoimmune disease for which there is currently no approved treatment, and it is under early-stage development by QUT.

Quoin is planning to schedule a meeting with QUT to discuss the future direction of both research programs.

Research Agreement with University College Cork

On June 10, 2024 we signed a research agreement with The School of Pharmacy at University College Cork (UCC).

We are planning to schedule a meeting with QUT to discuss the future direction of the research program.

On June 10, 2024 we signed a research agreement with UCC.

The scope of the agreement encompasses the development of novel topical formulations of rapamycin (sirolimus) as potential treatments for a number of rare and orphan diseases for which there are currently very limited or no approved therapies or cures.

UCC will apply its proprietary dissolvable microneedle delivery technology along with other formulation approaches to optimize the local delivery of rapamycin and potentially enhance its therapeutic effectiveness as a potential treatment for several pre-identified clinical targets.

Under the terms of the agreement, we will fund a research program at UCC over an anticipated 2-1/2 year period to investigate the development of a number of topical rapamycin formulations for future development as potential treatments for several rare and orphan diseases, where it is believed that the drug’s mechanism of action may provide for clinical efficacy in these settings.

The research agreement provides that UCC will apply its proprietary dissolvable microneedle delivery technology along with other formulation approaches to optimize the local delivery of rapamycin and potentially enhance its therapeutic effectiveness as a potential treatment for several pre-identified clinical targets.

Under the terms of the agreement, we are funding a research program at UCC over an anticipated 2-1/2 year period to investigate the development of a number of topical rapamycin formulations for future development as potential treatments for several rare and orphan diseases, where it is believed that the drug’s mechanism of action may provide for clinical efficacy in these settings.

Following completion of the research program, we will have the option to advance the clinical development of rapamycin formulations developed by UCC.

The terms of the agreement do not require us to pay any upfront license or milestone fees or any royalties based on future product sales.

On November 11, 2025 we announced that the target loading concentrations for two topical rapamycin delivery technologies have been successfully achieved.

Specifically, a rapamycin loading concentration of 4% w/w has been achieved for our proprietary topical formulation while an even higher rapamycin concentration of 5% w/w has been formulated in a proprietary dermal patch system.

We plan to move forward with the manufacture of clinical trial and stability batches from at least one of the delivery technologies with a view to commencing clinical testing in the second half of 2026.

Our Current Product Pipeline

Netherton Syndrome

NS is a rare autosomal recessive genetic disease affecting approximately 6,000 – 8,000 patients combined in the U.S.

and Europe which is caused by a mutation in the SPINK5 gene and has an incidence of approximately 1/200,000 births.

The SPINK5 gene encodes a protein, called lympho-epithelial kazal type related inhibitor (“LEKTI”) that serves as a brake system on the activity of certain proteases (enzymes that digest proteins) in the skin called Kallikreins.

The absence of the LEKTI protein, as a result of the genetic defect that

causes NS, leads to unregulated protease activity in the skin by the Kallikreins, resulting in too few layers of the outer skin (stratum corneum), thereby leading to a highly defective and compromised skin barrier.

As a result, patients with NS suffer from a variety of medical issues including regular, severe infections, skin cancer, chronic pruritis, asthma, and allergies among others.

NS is a rare autosomal recessive genetic disease affecting an estimated 6,000 – 8,000 patients combined in the U.S.

NS is caused by a mutation in the SPINK5 gene and has an incidence of approximately 1/200,000 births.

Under normal circumstances, the SPINK5 gene encodes a protein, called lympho-epithelial kazal type related inhibitor (“LEKTI”) that serves as a brake system on the activity of certain proteases (enzymes that digest proteins) in the skin called Kallikreins.

The absence of the LEKTI protein, as a result of the genetic defect that causes NS, leads to unregulated protease activity in the skin by the Kallikreins, resulting in too few layers of the outer skin (stratum corneum), thereby leading to a highly defective and compromised skin barrier.

As a result, patients with NS suffer from a variety of medical issues including regular, severe infections, skin cancer, chronic pruritus, asthma, and allergies among others.

Newborns with NS have reddened skin (erythroderma) and sometimes a thick parchment-like covering of skin (collodion membrane).

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Use of topical keratolytic agents, such as urea or lactic acid derivatives, may be limited by skin irritation and is generally reserved for older children or adults.

Base line treatment may also include oral antihistamines, which can help to control the itchy, eczematous component, and topical or systemic antibiotics as needed.

Base line treatment may

also include oral antihistamines, which can help to control the itchy, eczematous component, and topical or systemic antibiotics as needed.

Oral and topical steroids and systemic biologics may be beneficial in reducing inflammation and the eczematous component of the disease.

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There is a critical need for a new and effective treatment for NS.

Regulatory Status of QRX003 for the Treatment of NS

Clinical and Regulatory Status of QRX003 for the Treatment of NS

Our lead asset, QRX003, is currently in late-stage clinical development in the U.S.

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We submitted an IND in March 2022 to the FDA to initiate a clinical study of QRX003 in adult NS patients.

We received a ‘Study May Proceed’ notification from the FDA on June 13, 2022, which cleared us to initiate clinical testing of QRX003 in NS patients.

This study is fully up and running and five clinical sites in the U.S.

have been opened and are actively recruiting and dosing patients.

This study originally was designed as a randomized, double blinded assessment of two different doses of QRX003 (4% and 2%) versus a placebo vehicle in 18 adult NS patients.

Initially, the test materials were applied once daily, over a twelve-week period, to pre-selected areas of the patient’s body, primarily the arms and lower legs.

Based on discussions with the FDA, a number of different clinical endpoints are being assessed in the study, including but not limited to, an Investigators Global Assessment (IGA), Patient’s Global Assessment (PaGA), Modified Ichthyosis Area Severity Index (M-IASI) and Pruritus.

In March 2022, we submitted a briefing document to the European Medicines Agency (“EMA”) seeking guidance regarding the clinical and regulatory development of QRX003 for the European Union (“EU”), to which we received comprehensive and constructive feedback.

We also intend to apply for Orphan Drug status in the U.S.

and Europe as well as Rare Pediatric Disease designation in the U.S.

In November 2022, we submitted a protocol for our second clinical study in NS patients to the FDA under our open IND (the “Open Label Study”).

This study was cleared by the FDA to initiate clinical testing in December 2022.

This study originally was designed to be conducted in ten adult NS patients who are currently receiving, and will continue to do so throughout the study, off-label systemic therapy, primarily systemic biologic therapy.

This is an open-label study with no placebo control in which all enrolled subjects receive QRX003.

Both of these NS clinical studies are running concurrently and utilize the same clinical trial sites and investigators in the US.

On October 24, 2023, we released positive initial clinical results obtained from the first six evaluable subjects in the Open Label Study.

Five of the six subjects reported absence of or negligible pruritiu, with one subject reporting no change;

three subjects demonstrated improvement with respect to skin appearance on completion of the study and three showing such improvements during the study though not necessarily on completion of the study.

In addition, all six subjects reported a favorable impression of QRX003 across a number of key metrics, including:

ease of use, time to start working, overall satisfaction, lack of side effects.

As a result of this positive initial data and the absence of any adverse events from both studies, on November 8, 2023 we submitted a number of protocol amendments to the FDA, under our open IND, with a view to optimizing both studies and potentially leading to

even better clinical outcomes and a more rapid regulatory approval.

These protocol amendments included eliminating the lower 2% dose from the double-blinded study, modifying the dosing frequency from once-daily to twice-daily and increasing the number of subjects from 18 to 30.

For the Open Label Study, the number of subjects was increased from 10 to 20 and dosing was modified from once-daily to twice-daily.

On December 13, 2023, we announced that we were cleared by the FDA to implement these protocol amendments.

In February 2024 we submitted a further protocol amendment to the FDA requesting permission to lower the age of eligibility for participation in both studies to 14 years and older from 18 years and older.

On March 4, 2024 we announced that we were cleared to implement this protocol amendment.

All protocol amendments have now been implemented and going forward participants in both regulatory studies will be dosed twice-daily with those enrolled in the blinded study receiving either a 4% dose of QRX003 or a placebo, while subjects in the Open Label Study will receive a 4% dose of QRX003 only.

On June 27, 2024 we announced that we will expand our ongoing Netherton Syndrome clinical studies to include international sites.

The first international site will be opened at a research hospital in Saudi Arabia.

This hospital is currently treating a number of NS patients who will now become eligible for recruitment into our studies.

An experienced Clinical Research Organization has been engaged to manage the study locally.

On August 6, 2024, we announced the planned initiation of an investigator-led clinical study in New Zealand for QRX003 in pediatric patients with Peeling Skin Syndrome.

This rare genetic condition currently has no approved treatments or cures.

The first clinical site has been opened and dosing of the patient has commenced Quoin is actively evaluating additional clinical sites in other countries.

On October 22, 2024 we announced the further expansion of our ongoing Netherton Syndrome clinical studies to include two additional international sites in the United Kingdom (UK).

Both of these sites, Great Ormond Street Hospital and St.

Thomas’ Hospital, which are located in London, are highly qualified centers of excellence for treating Netherton Syndrome patients in the UK.

Both sites have available cohorts of patients potentially eligible to participate in Quoin’s studies.

A globally recognized expert in the treatment of NS patients has been appointed as Principal Investigator for the UK studies and a Clinical Research Organization has been engaged.

The UK and Saudi Arabia sites will operate under the auspices of Quoin’s open IND application with the FDA.

Quoin is also in advanced stage of preparation for the opening of additional sites in several other Western European countries, including Spain and Germany, and is concluding a feasibility study in multiple Eastern European countries with both territories having available cohorts of patients with Netherton Syndrome.

On November 5, 2024, we announced that QRX003 is being tested in a pediatric NS patient at the Children’s Hospital in Dublin, Ireland and that we intend to expand this study to include up to three additional pediatric patients with NS in Spain and up to six additional pediatric patients in the UK.

On December 19, 2024, we announced FDA clearance to initiate a new additional Netherton Syndrome (NS) clinical study for QRX003.

The study will be conducted by Dr.

Amy Paller, of Northwestern University.

It is planned that up to eight subjects will be enrolled into the study and will have QRX003 applied twice daily to greater than 80% of their entire body surface area (BSA) over a 12-week period.

By comparison, in Quoin’s ongoing open-label and double-blinded clinical studies, QRX003 is applied to approximately 20% of the subject’s BSA, typically the arms and lower leg.

This new study, designed to mimic how NS patients will use QRX003 if approved, represents the most extensive use of QRX003 in a clinical setting to date.

It is anticipated that the data generated from this study will be used to supplement the data package to support the potential regulatory approval of QRX003 as a treatment for NS.

In December 2024 and January 2025, we provided data from the first subject dosed twice daily in our ongoing open label study.

On December 18, 2024, we announced positive data after 6-weeks of dosing with QRX003, marking the midpoint of testing.

On January 6, 2025 we shared clinical data for that subject upon completion of testing which showed clear improvements from baseline through 12 weeks of twice-daily dosing with QRX003 across all measured clinical endpoints.

In addition, the patient satisfaction scores across multiple assessed metrics which were highly positive after 6 weeks of testing demonstrated even further improvement after 12 weeks.

No adverse events were reported for the subject during this testing period.

On January 23, 2025, we issued data on that same subject four weeks post-discontinuation of treatment with QRX003 which should showed that all of the positive clinical benefits observed after 12 weeks of testing with QRX003 were completely reversed by 4 weeks after discontinuation of treatment resulting in the subject’s disease state reverting to the baseline status observed prior to QRX003 treatment.

The following table sets forth the first patient data from the open label study dosed twice daily with QRX003.

We received a ‘Study May Proceed’ notification from the FDA on June 13, 2022, for Study CL-QRX003-001.

Table 1 lists all completed, current and planned clinical studies for QRX003 in NS.

Study CL-QRX003-001 is a randomized vehicle controlled study.

In Part A of the study, which recruited 11 subjects, two doses of QRX003 were tested against a vehicle control.

In this part of the study a low potency cosmetic grade of the active ingredient was used.

The test articles were applied once-daily to approximately 20% of the subject’s body surface area (“BSA”) over a 12 week period.

In Part B of the study, which recruited 2 subjects, participants either received QRX003 containing 4% GMP grade DPHP or a vehicle control.

The test articles were applied twice-daily to approximately 20% of BSA.

Recruitment into this study has been completed and the data has not been unblinded as of yet.

In November 2022, we submitted a protocol for Study CL-QRX003-002 in NS patients to the FDA under our open IND and the study initiated in December 2022.

In Part A of this study, which recruited 7 subjects, all participants received the low potency cosmetic grade DPHP once daily on approximately 20% BSA.

All participants in this study had been receiving off-label systemic therapy prior to entry into the study and remained on that treatment throughout the duration of the study.

Endpoints evaluated in Part A at Week 12 included change from baseline on the Investigator’s Global Assessment (“IGA”) scale (0-5), change from baseline on the Worst Itch-

Numeric Rating Scale (“WI-NRS”), a scale for the evaluation of pruritus or itch (0-10) and change from baseline on the Modified Ichthyosis Area Severity Index (“M-IASI”), which assesses the severity and extent of skin symptoms associated with ichthyosis (0-48).

The following Figure 1 outlines initial clinical data obtained from the first seven evaluable subjects from Part A of this study

Despite being treated once daily with low potency cosmetic grade DPHP, two of the 7 subjects achieved a one grade improvement from baseline for the IGA (scale of 0-4) at Week 12.

In addition, five of the 7 subjects had a two-grade improvement from baseline for the WI-NRS (scale of 0-10) at Week 12.

Although not powered for statistical significance, this result was nominally statistically significant with a p-value of 0.001.

Furthermore, of the 5 subjects, whose WI-NRS was 4 or higher at baseline, three achieved a 4-grade improvement at Week 12 with 12 weeks once-daily application of cosmetic grade DPHP with a nominal p-value of 0.0579.

The mean change in WI-NRS from baseline was -2.89, which was also nominally statistically significant.

In Part B of Study CL-QRX003-002, a single subject was tested with QRX003 containing 4% GMP grade DPHP twice-daily over a 12-week period on 20% BSA.

The endpoints for Part B of the study were the same as those in Part A.

The clinical data from this portion of the study are outlined in Table 2.

(Treatment period midpoint)

(End of treatment period)

1 (Almost Clear)

At baseline, the subject had an IGA of 3 (moderate) which improved to 1 (almost clear) following twice daily treatment with QRX003, while the subject’s WI-NRS improved significantly a highly intrusive score of 7 to a very tolerable score of 2.

Furthermore, for the M-IASI, the baseline score of 18 had significantly improved to 3 after 12 weeks of QRX003 treatment.

The subject returned to

the clinical site at week 16 for final evaluation after treatment with QRX003 had been discontinued for 4 weeks.

As outlined in Table 3, all assessed endpoints had returned to, or were worse than, baseline levels after treatment with QRX003 had been removed for 4 weeks.

(Treatment period midpoint)

(End of treatment period)

discontinuation of

Modified Ichthyosis Area of Severity Index, a score used to assess the severity and extent of skin symptoms associated with ichthyosis.

Lower scores indicate improvement.

Worst Itch Numeric Rating Scale, which measures the severity of itch on an 11-point scale (0 = no itch, 10 = worst imaginable itch).

Investigator’s Global Assessment, which uses descriptive categories (e.g., clear, mild, moderate, severe) to evaluate the overall severity of Netherton Syndrome symptoms.

In December 2024 and January 2025 we also provided data on our ongoing pediatric Netherton Syndrome study.

On December 18, 2024, we announced positive data from the initial 12 days of dosing in our ongoing 12-week Investigator Pediatric Study, namely that a significant improvement was observed in the skin area treated with QRX003 versus the non-treated area.

Specifically, at baseline prior to dosing with QRX003, the IGA assessment of the subject’s skin was classified as “severe.” After 12 days of treatment with QRX003, this was improved to “mild-moderate,” representing a very rapid improvement in skin appearance.

On January 14, 2025, we announced that after six weeks of dosing, the IGA assessment of the subject’s skin was classified as “mild.” As a result of these positive results, we further announced on January 14, 2024, that the subject was being transitioned to having QRX003 applied to their whole body surface area (BSA) as opposed to the approximately 20% of their BSA that was tested for the initial six weeks.

In addition, there were no adverse events reported for the subject during this initial six week testing period.

On February 27, 2025, we announced positive clinical data from our ongoing Investigator Pediatric Netherton Syndrome (NS) study.

Both key clinical endpoints, Investigator’s Global Assessment (IGA) and Pruritus or itch, demonstrated highly significant clinical improvements from baseline after two weeks of treatment with QRX003 on patient’s whole body as set forth in the table below.

No adverse events have been reported to date.

Results for First Pediatric Patient Receiving QRX003 ‘Whole-Body’ Application

(1) Almost Clear

Following review of these clinical data, Study CL-QRX003-002 was converted to a ‘whole-body’ protocol Phase 2 study (Part C) where QRX003 is applied twice-daily over a 12-week period to approximately 80% BSA.

This portion of the study is currently recruiting up to 8 evaluable subjects, and no data has been reported yet.

Study CL-QRX003-003 is a Phase 2 study that is being conducted by Dr.

Amy Paller at Northwestern University.

This study will recruit up to 8 evaluable subjects who will be treated twice-daily over a 12-week period with QRX003 on greater than 80% BSA.

Unlike Study CL-QRX003-002, a majority of subjects in this study will not receive ongoing concurrent off-label systemic therapy.

This study is currently recruiting and no data has been reported yet.

Study CL-QRX003-004 is also a Phase 2 open-label study that will recruit up to 8 evaluable subjects, all of whom will fully wash out of any ongoing off-label systemic therapy prior to participation in the study.

Participants will receive QRX003 twice-daily on greater than 80% BSA over a twelve-week period.

Subjects are currently being screened for participation in the study and dosing has not been initiated as of yet.

Studies CL-QRX003-005 and CL-QRX003-006 are planned Phase 3 and 12-month Long Term Extension studies, respectively, which have not started yet.

In addition to the above studies, we are conducting an investigator-initiated clinical study of QRX003 in pediatric NS patients.

The study is being conducted in Ireland, Austria, the Netherlands and New Zealand.

Seven pediatric NS patients are currently being treated in the study.

Table 4 outlines results for the one pediatric subject for which data are currently available.

Investigator Global Assessment

*Both IGA and Pruritus scores based on a 0-10 scale.

* IGA scale 0-4, Pruritus scale 0-10.

After 12 months of treatment with QRX003, the subject’s skin was adjudicated to be clear by the clinical assessor and their pruritus was rated as “no itch”, with both endpoints being scored at 0.

In addition, the subject is experiencing zero nightly sleep disturbance and

has not required antibiotic, antiviral, antihistamine or glucocorticoid medication.

Baseline and 12 month photos of the subject’s skin are illustrated in Figure 2 below.

The subject continues to be treated with QRX003 and has experienced no treatment related adverse events.

We have received Orphan Drug Designation from the European Medicines Agency for QRX003, which would result in 10 years of market exclusivity in Europe upon approval.

This designation offers benefits like scientific advice on study protocols and fee reductions.

The FDA has granted Rare Pediatric Disease Designation to QRX003 for the treatment of Netherton Syndrome, enabling potential Priority Review Voucher eligibility upon marketing approval for the treatment of NS.

The FDA has also granted Orphan Drug Designation to QRX003 for the treatment of Netherton Syndrome.

Furthermore, the FDA has granted Fast Track Designation to QRX003 for the treatment of NS.

On January 20, 2026, we announced that we had filed an application for Breakthrough Medicine Designation with the Saudi Food and Drug Authority (“SFDA”) for QRX003.

The SFDA’s Breakthrough Medicine Designation program is designed to expedite the development, review, and potential availability of medicines that address serious or life-threatening conditions with high unmet medical need and which meet SFDA eligibility requirements.

If granted, the designation will allow for accelerated regulatory review and could enable earlier patient access in Saudi Arabia.

On January 27, 2026, we announced that we had submitted an application to the Japanese Ministry of Health, Labour and Welfare (“MHLW”) for Orphan Drug Designation (“ODD”) for QRX003 for the treatment of Netherton Syndrome.

The MHLW’s Orphan Drug Designation program provides orphan status to therapies intended for the treatment, diagnosis, or prevention of rare diseases that affect fewer than 50,000 people in Japan.

This designation provides certain benefits, including R&D subsidies, tax credits for qualified clinical testing, reduction of MHLW application fees, priority review and ten years of market exclusivity, if approved.

On March 25, 2026, we provided a clinical and regulatory update from our constructive Type C meeting with U.S.

FDA for QRX003 in NS.

We reported that the FDA indicated that a single Phase 3 study may be sufficient to support marketing approval in the US and expressed openness to an alternative study design for Phase 3 that would likely not include a traditional upfront vehicle or placebo control (the “March Type C Meeting Minutes”).

See Part II, Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Recent Developments – Public and Private Offerings – October 2025 Private Placement” for a description of

the March Type C Meeting Minutes’ affect on the exercise period of the Series H Warrants issued in connection with the Company’s October 2025 private placement transaction.

Clinical and Regulatory Status of QRX003 for the Treatment of Peeling Skin Syndrome

On August 6, 2024, we announced the planned initiation of an investigator-led clinical study in New Zealand for QRX003 in pediatric patients with Peeling Skin Syndrome.

This rare genetic condition currently has no approved treatments or cures.

The first clinical site opened in and dosing of the patient commenced in December 2024.

Quoin is actively evaluating additional clinical sites in other countries.

Table 5 below outlines clinical results for the first pediatric patient for whom data is available

After 12 weeks of treatment with QRX003, improvement was observed across all evaluated endpoints.

The subject has now been treated with QRX003 for over one-year with continued improvement in skin appearance and texture.

In addition, the subject’s pruritus has diminished significantly leading to markedly improved sleep function.

Quoin is actively working to recruit up to an additional 5 pediatric subjects into this study.

Clinical and Regulatory Status of QRX009

Quoin is targeting submitting a pre-IND meeting request to the FDA for QRX009 before the end of Q2 of 2026 and to initiate clinical testing in one or more Proof of Concept (“POC”) studies before the end of 2026.

The initial target indications for those POC clinical studies will be selected from Microcystic Lymphatic Malformations, Venous Malformations, Gorlin Syndrome, Epidermolysis Bullosa and Pachyonychia Congenita In addition, Quoin is planning to initiate a pharmacokinetic study for QRX009 in healthy volunteers in Q2 of 2026.

Commercial Strategy

QRX003 has the potential to become the first approved treatment for NS to reach the market both in the U.S.

and Europe and may therefore likely be used in a large proportion of patients.

QRX003 has the potential to become the first approved treatment for NS globally to reach the market and may therefore capture significant market share based on our own commercial infrastructure which we plan to establish in the U.S., Western Europe and Japan as well as from our commercial partnerships.

We currently anticipate that QRX003, if approved, would be applied once or twice daily over the patient’s entire body.

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We intend to self-commercialize QRX003, and other rare disease products the company may develop, if approved, in both the U.S.

Because of the very low number of patients and the fact that diagnosis and treatment are generally provided by a relatively small number of board-certified dermatologists in major urban areas, this concentration of care will enable us to market QRX003 with a small, dedicated salesforce to target patients and caregivers in the U.S.

Outside of the U.S., we have currently established nine separate marketing partnerships for QRX003 that cover 61 different countries including Australia, New Zealand, the Middle East, Central and Eastern Europe, Turkey, Canada, China, Taiwan, Hong Kong, Singapore and the major countries in Latin America.

Once the commercial infrastructure has been established for QRX003 for NS, the subsequent approval and addition of new rare disease indications or products will not result in a significant increase in the size of that infrastructure.

In particular, we believe it is highly likely that physicians who treat patients with NS would also treat patients with Peeling Skin Syndrome, SAM Syndrome,

Palmoplantar Keratoderma and Epidermolysis Bullosa, enabling our sales personnel to discuss several products, once approved, with each treating physician.

We are also in the process of initiating the establishment of a Japanese subsidiary to facilitate the self-commercialization of QRX003 in Japan.

Because of the very low number of patients and the fact that diagnosis and treatment are generally provided by a relatively small number of board-certified dermatologists in major urban areas, we believe this concentration of care will enable us to market QRX003 with a small, dedicated salesforce to target patients and caregivers in the U.S, Europe and Japan.

Outside of these territories, we have currently established nine separate marketing partnerships for QRX003 that cover 61 different countries including Australia, New Zealand, the Middle East, Central and Eastern Europe, Turkey, Canada, China, Taiwan, Hong Kong, Singapore and the major countries in Latin America.

Once the commercial infrastructure has been established for QRX003 for NS, the subsequent approval and addition of new rare disease indications or products is not expected to result in a significant increase in the size of that infrastructure.

In particular, we believe it is highly likely that physicians who treat patients with NS would also treat patients with Peeling Skin Syndrome, SAM Syndrome and other Ichthyosis related disorders, enabling our sales personnel to discuss several products, once approved, with each treating physician.

A key element of our commercial strategy will be to add new products to our portfolio beyond those which we develop ourselves.

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While it is intended that these products will treat rare and orphan diseases, we may widen our scope of interest beyond rare skin diseases as we believe this will not add significant incremental burden to an already established commercial infrastructure.

We have not conducted a formal pricing analysis of QRX003 in NS.

We have not concluded a formal pricing analysis of QRX003 in NS.

We anticipate that pricing at launch may be influenced by the product label negotiated with the FDA, by pharmacoeconomic data developed to support pricing and the potential for greater sales under negotiated government contracts.

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Currently, there are no approved products to treat NS.

However, to our knowledge, there are a number of therapeutic products at various stages of development for the treatment of NS, including candidates from LifeMax Laboratories, Inc., Krystal Biotech, Inc., Sixera Pharmaceuticals, ResVita Bio, BioCryst and Azitra Inc.

As of now, to the best of our knowledge, only Azitra is actively dosing subjects in clinical studies on NS patients under an open IND.

However, to our knowledge, there are a number of therapeutic products at various stages of development for the treatment of NS, including candidates from LifeMax Laboratories, Inc., Sixera Pharmaceuticals, ResVita Bio, BioCryst and Azitra Inc.

As of now, to the best of our knowledge, only Azitra and BioCryst are actively dosing subjects in clinical studies of NS patients under an open IND.

Manufacturing

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The following table lists patents and trademarks that we use in our business.

8,318,818 (exp.

July 10, 2025) directed to Invisicare® technology licensed from Skinvisible.

Patent applications directed to adjunctive therapy for NS with QRX003 filed by Quoin Pharmaceuticals Inc.

in the U.S., Australia, Canada, China, Europe, Japan, Korea, and Mexico.

Trademark Registration No.

6918421 for word mark “RARE DISEASES ARE ONLY RARE IF YOU DON’T LIVE WITH ONE” filed by Quoin Pharmaceuticals, Inc.

and PCT patent applications directed to adjunctive therapy for NS with QRX003 filed by Quoin Pharmaceuticals Inc.

patent application for high purity active ingredient for QRX003.

Trademark Registration No.

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98/850,671 for word mark “NETHERTON NOW” filed by Quoin Pharmaceuticals, Inc.

PCT Application directed to adjunctive therapy for NS with QRX003 filed by Quoin Pharmaceuticals Inc.

License Agreement with Skinvisible

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FDA Approval Process

To obtain approval of our product candidates from the FDA, we must, among other requirements, demonstrate in preclinical studies and well-controlled clinical trials that the product is safe and effective for its intended use and that the manufacturing facilities, processes and controls are adequate to preserve the drug’s identity, strength, quality and purity.

To obtain approval of our product candidates from the FDA, we must, among other requirements, demonstrate in pre - clinical studies and well-controlled clinical trials that the product is safe and effective for its intended use and that the manufacturing facilities,

processes and controls are adequate to preserve the drug’s identity, strength, quality and purity.

The drug approval process generally includes:

● preclinical laboratory tests, in vitro and in vivo preclinical studies and formulation and stability studies;

● pre - clinical laboratory tests, in vitro and in vivo pre - clinical studies and formulation and stability studies;

● the submission to the FDA of an application for human clinical testing, which is known as an IND application;

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● the approval by the FDA of an NDA.

Preclinical tests include laboratory evaluations of product chemistry, toxicity and formulation, as well as animal studies.

Preclinical trials must also be conducted in accordance with FDA and comparable foreign authorities’ legal requirements, regulations or guidelines, including Good Laboratory Practice.

Pre - clinical tests include laboratory evaluations of product chemistry, toxicity and formulation, as well as animal studies.

Pre - clinical trials must also be conducted in accordance with FDA and comparable foreign authorities’ legal requirements, regulations or guidelines, including Good Laboratory Practice.

Violations of these regulations can, in some cases, lead to invalidation of the studies, requiring them to be replicated.

Before human clinical testing can begin, a sponsor must submit the results of the preclinical tests, together with manufacturing information and analytical data, to the FDA as part of the IND, a request for authorization from the FDA to administer an investigational new drug product to humans.

Before human clinical testing can begin, a sponsor must submit the results of the pre - clinical tests, together with manufacturing information and analytical data, to the FDA as part of the IND, a request for authorization from the FDA to administer an investigational new drug product to humans.

A 30-day waiting period after the submission of each IND is required prior to the commencement of clinical testing in humans.

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Phase 3 trials further evaluate efficacy and safety in an expanded patient population, generally at geographically dispersed clinical study sites.

These clinical trials are intended to establish the overall risk-benefit ratio of the product candidate and provide, if appropriate, an adequate basis for product labeling.

In most cases, the FDA requires two adequate and well-controlled Phase 3 clinical trials to demonstrate the safety and efficacy of the drug.

In rare instances, a single Phase 3 trial may be sufficient when either (1) the trial is a large, multicenter trial demonstrating internal consistency and a statistically very persuasive finding of a clinically meaningful effect on mortality, irreversible morbidity or prevention of a disease with a

potentially serious outcome and confirmation of the result in a second trial would be practically or ethically impossible or (2) the single trial is supported by other confirmatory evidence.

Post-approval studies , sometimes referred to as Phase 4 studies, may be conducted after initial marketing approval.

These clinical trials are intended to establish the overall risk-benefit ratio of the product candidate

and provide, if appropriate, an adequate basis for product labeling.

In many cases, particularly for prevalent diseases, the FDA requires two adequate and well-controlled Phase 3 clinical trials to demonstrate the safety and efficacy of the drug.

In many other diseases, such as rare diseases, a single Phase 3 trial may be sufficient when supported by confirmatory evidence In other cases, though less common, a single Phase 3 trial may be sufficient when the trial is a large, multicenter trial demonstrating internal consistency and a statistically very persuasive finding of a clinically meaningful effect on mortality, irreversible morbidity or prevention of a disease with a potentially serious outcome and confirmation of the result in a second trial would be practically or ethically impossible.

Post-approval studies:

sometimes referred to as Phase 4 studies, may be conducted after initial marketing approval.

These studies are used to gather additional information about a product’s safety and/or efficacy in patients affected by the therapeutic indication.

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FDA approval of the NDA is required before marketing and distribution of the product may begin in the United States.

The NDA must include the results of all preclinical, clinical, and other testing and a compilation of data relating to the product’s pharmacology, chemistry, manufacture, and controls.

The NDA must include the results of all pre-clinical, clinical, and other testing and a compilation of data relating to the product’s pharmacology, chemistry, manufacture, and controls.

The submission of most NDAs is subject to the payment of a substantial application user fee.

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In this event, the NDA must be resubmitted with the additional information.

The resubmitted application also is subject to review before the FDA accepts it for filing.

The resubmitted application also is subject to review before the FDA files it.

The FDA may also refer applications for novel pharmaceutical products, as well as pharmaceutical products that present difficult questions of safety or efficacy, to be reviewed by an advisory committee, typically a panel that includes clinicians, statisticians and other experts, for review, evaluation, and a recommendation as to whether the NDA should be approved.

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The FDA is required to facilitate the development, and expedite the review, of drug products that are intended for the treatment of a serious or life-threatening disease or condition for which there is no effective treatment and which demonstrate the potential to address unmet medical needs for the condition.

Fast track designation may be granted for products that are intended to treat a serious or life-threatening disease or condition for which there is no effective treatment and preclinical or clinical data demonstrate the potential to address unmet medical needs for the condition.

Fast track designation may be granted for products that are intended to treat a serious or life-threatening disease or condition for which there is no effective treatment and pre - clinical or clinical data demonstrate the potential to address unmet medical needs for the condition.

Fast track designation applies to both the product and the specific indication for which it is being studied.

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The FDA must take action on an NDA or BLA under priority review within six months of receipt of the NDA or BLA.

The Rare Pediatric Disease Priority Review Voucher program was reauthorized in the Creating Hope Reauthorization Act in December 2020.

Under the current statutory sunset provisions, after December 20, 2024, the FDA may only award a priority review voucher for an approved rare pediatric disease application if the sponsor has rare pediatric disease designation for the drug that is the subject of such application, and that designation was granted by December 20, 2024.

After September 30, 2026, the FDA may not award any rare pediatric disease priority review vouchers, unless the program is extended.

Although legislation to extend the rare pediatric disease priority review voucher program has been proposed, Congress has not yet, and may never, pass a bill to reauthorize the program and extend the sunset dates.

The Rare Pediatric Disease Priority Review Voucher program was reauthorized in February 2026.

Under the current statutory sunset provisions, the FDA may only award a priority review voucher for a rare pediatric disease application approved by September 30, 2029 unless the program is extended.

Post-Marketing Obligations

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These studies or trials may involve continued testing of a product and development of data, including clinical data, about the product’s effects in various populations and any side-effects associated with long-term use.

The FDA may require post-marketing studies or trials to investigate known serious risks or signals of serious risks or identify unexpected serious risks and may require periodic status reports if new safety information develops.

The FDA may require post-marketing studies or trials

to investigate known serious risks or signals of serious risks or identify unexpected serious risks and may require periodic status reports if new safety information develops.

Failure to conduct these studies in a timely manner may result in substantial civil fines.

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The failure to comply with these current and future laws could result in significant penalties and reputational harm and could have a material adverse effect on our business and results of operations.

Commercial Product Pricing

In the United States and some foreign jurisdictions, many of the markets in which we may do business in the future, the prices of pharmaceutical products are subject to direct price controls (by law) and to drug reimbursement programs with varying price control mechanisms.

In the United States, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, or Medicare Modernization Act, changed the way Medicare covers and pays for pharmaceutical products.

The legislation expanded Medicare coverage for drug purchases by the elderly and introduced a new reimbursement methodology based on average sales prices for physician administered drugs.

In addition, this legislation provided authority for limiting the number of drugs that will be covered in any therapeutic class in certain cases.

Cost reduction initiatives and other provisions of this and other more recent legislation could decrease the coverage and reimbursement that is provided for any approved products.

While the Medicare Modernization Act applies only to drug benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and payment limitations in setting their own reimbursement rates.

Therefore, any reduction in reimbursement that results from the Medicare Modernization Act or other more recent legislation may result in a similar reduction in payments from private payors.

Pricing and Reimbursement

In both the United States and foreign markets, the ability to successfully commercialize product candidates that have obtained regulatory approval by the FDA or other governmental authorities depends in significant part on the availability of adequate financial coverage and reimbursement from third party payors, including, in the U.S., governmental payors such as Medicare and Medicaid, managed care organizations, and private commercial health insurers.

There is significant uncertainty related to the insurance coverage and reimbursement of newly approved products.

In the United States, the principal decisions about reimbursement for new products are typically made by the Centers for Medicare & Medicaid Services (“CMS”).

Private payors tend to follow CMS to a substantial degree.

However, no uniform or consistent policy of coverage and reimbursement for drug products exists among third-party payors.

Therefore, coverage and reimbursement for drug products can differ significantly from payor to payor as well as from state to state.

Consequently, the coverage determination process is often a time-consuming and costly process that must be played out across many jurisdictions and different entities.

Further, a payor’s decision to provide coverage for a drug product does not imply that an adequate reimbursement rate will be approved.

In addition, direct or indirect governmental price regulation may affect the prices that we may charge for product candidates.

For example, in the United States and some foreign jurisdictions, the prices of pharmaceutical products are subject to direct price controls (by law) and to drug reimbursement programs with varying price control mechanisms.

There have been, and we expect there will continue to be, legislative and regulatory proposals to change the healthcare system in ways that could significantly affect the pharmaceutical industry, including the Patient Protection and Affordable Care Act of 2010 and the Inflation Reduction Act of 2022.

We anticipate that in the U.S., Congress, state legislatures, and private sector entities will continue to consider and may adopt healthcare policies intended to curb rising healthcare costs.

Healthcare Reform

In the United States, there have been, and continue to be, proposals by the federal government, state governments, regulators and third-party payors to control or manage the increased costs of health care and, more generally, to reform the U.S.

healthcare system.

Healthcare reforms that have been adopted, and that may be adopted in the future, could result in further reductions in coverage and levels of reimbursement for pharmaceutical products, increases in rebates payable under U.S.

government rebate programs and additional downward pressure on pharmaceutical product prices.

Recently, healthcare reform initiatives culminated in the enactment of the Inflation Reduction Act (“IRA”) in August 2022, which will, among other things, allow U.S.

Department of Health and Human Services (“HHS”) to negotiate the selling price of certain drugs and biologics that the Centers for Medicare & Medicaid Services (“CMS”) reimburses under Medicare Part B and Part D, although only high-expenditure single-source drugs that have been approved for at least 7 years (11 years for biologics) can be selected by CMS for negotiation, with the negotiated price taking effect two years after the selection year.

The negotiated prices, which will first become effective in 2026, will be capped at a statutory ceiling price.

Beginning in October 2023, the IRA will also penalize drug manufacturers that increase prices of Medicare Part B and Part D drugs at a rate greater than the rate of inflation.

There has been increasing legislative and enforcement interest in the United States with respect to drug pricing practices.

For example, several healthcare reform initiatives culminated in the enactment of the Inflation Reduction Act (“IRA”) in August 2022, which, among other things, requires the U.S.

Department of Health and Human Services (“HHS”) to directly negotiate the selling price of a statutorily specified number of drugs and biologics each year that CMS reimburses under Medicare Part B and Part D.

The negotiated price may not exceed a statutory ceiling price.

Only high-expenditure single-source drugs that have been approved for at least 7 years (11 years for single-source biologics) are eligible to be selected by CMS for negotiation, with the negotiated price taking effect two years after the selection year.

For 2026, the first year in which negotiated prices become effective, CMS selected 10 high-cost Medicare Part D products in 2023, negotiations began in 2024, and the negotiated maximum fair price for each product has been announced.

In addition, CMS selected and announced the negotiated maximum fair price for 15 additional Medicare Part D drugs, which will become effective in 2027.

For 2028, CMS has selected an additional 15 drugs, comprised of drugs covered under Medicare Part D and, for the first time, drugs payable under Medicare Part B.

For 2029 and subsequent years, 20 Part B or D drugs will be selected.

The negotiated prices have represented, and will continue to represent, a significant discount from average prices to wholesalers and direct purchasers.

Currently, a drug or biological product that has an orphan drug designation for only one rare disease or condition will be excluded from the IRA’s price negotiation requirements, but loses that exclusion if it has designations for more than one rare disease or condition, or if is approved for an indication that is not within that single designated rare disease or condition, unless such additional designation or such disqualifying approvals are withdrawn by the time CMS evaluates the drug for selection for negotiation.

However, as a result of a statutory amendment enacted in July 2025, beginning with the 2028 negotiated price applicability year, a drug may be designated for more than one rare disease or condition and still be excluded from price negotiation, as long as the only approved indications are for such rare diseases or conditions.

The IRA also imposes rebates on Medicare Part B and Part D drugs whose prices have increased at a rate greater than the rate of inflation and in 2024, CMS finalized regulations for the Medicare Part B and Part D inflation rebates.

The IRA permits the Secretary of HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years.

Manufacturers that fail to comply with the IRA may be subject to various penalties, including civil monetary penalties.

The IRA also extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025.

These provisions will take effect progressively starting in 2023, although they may be subject to legal challenges.

These provisions have been and may continue to be subject to legal challenges.

It is unclear what policies will be advanced with respect to IRA implementation and other drug pricing proposals.

In addition, in May 2025, the administration published an executive order regarding most favored nation (“MFN”) drug pricing, which is sometimes referred to as international reference pricing.

This executive order directs HHS to communicate MFN price targets to pharmaceutical manufacturers, and if significant progress towards MFN pricing is not delivered, to propose a rule making plan to implement MFN pricing.

Recently, on December 23, 2025, CMS issued proposed regulations to establish, under the Center for Medicare and Medicaid Innovation, two mandatory MFN demonstration models under Medicare Parts B and D, respectively.

If these rules or other MFN pricing rules are finalized, they are likely to mandate reduced prices of at least some drugs in the United States, if they are also sold in comparator countries.

At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access, and marketing cost disclosure and transparency measures, and in some cases, designed to encourage importation from other countries and bulk purchasing.

It is unclear to what extent additional statutory, regulatory, and administrative initiatives will be enacted and implemented.

European Regulatory Authorities

Regulatory Authorities Outside the United States

In the European Union, governments influence the price of pharmaceutical products through their pricing and reimbursement rules and control of national healthcare systems that fund a large part of the cost of such products to consumers.

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Human Capital

As of December 31, 2024, we had three full-time employees and two part-time employees.

As of December 31, 2025, we had four full-time employees and two part-time employees.

Our employees are not represented by any collective bargaining agreements, and we have never experienced an organized work stoppage.

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surviving as a wholly-owned subsidiary of Cellect (the “Merger”).

Immediately after completion of the Merger, Cellect changed its name to “Quoin Pharmaceuticals Ltd.” In addition, on October 28, 2021, Cellect sold the entire share capital of its subsidiary, Cellect Biotherapeutics Ltd., which essentially included all of Cellect’s then existing net assets, to EnCellX Inc.

(“EnCellX”), a newly formed U.S.

privately held company.

We have no interests in EnCellX subsequent to the closing of the Merger.

Immediately after completion of the Merger, Cellect changed its name to “Quoin Pharmaceuticals Ltd.”

Prior to January 1, 2023, we qualified as a “foreign private issuer” as such term is defined in Rule 405 under the Securities Act.

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We are subject to the informational requirements of the Exchange Act and in accordance therewith, we file reports, proxy and information statements and other information with the SEC.

You can read our SEC filings over the Internet at the SEC’s website at www.sec.gov.Our filings with the SEC are also available free of charge on the investors section of our website at www.quoinpharma.com.

You can read our SEC filings over the Internet at the SEC’s website at www.sec.gov.

Our filings with the SEC are also available free of charge on the investors section of our website at www.quoinpharma.com.

Our filings are available free of charge as soon as reasonably practicable after we electronically file them with, or furnish them to, the SEC.

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We are a “smaller reporting company” as defined in the Securities Exchange Act of 1934, as amended (the “Exchange Act”).

As a result, we may take advantage of certain reduced disclosure obligations available to smaller reporting companies, including the exemption from compliance with the auditor attestation requirements pursuant to the Sarbanes-Oxley Act of 2022, reduced disclosure about our executive compensation arrangements and the requirements to provide only two years of audited financial statements in our annual reports and registration statements.

We will continue to be a “smaller reporting company” as long as (1) we have a public float (i.e., the market value of our ADSs held by non-affiliates) less than $250 million calculated as of the last business day of our most recently completed second fiscal quarter, or (2) our annual revenues are less than $100 million for our previous fiscal year and we have either no public float or a public float of less than $700 million as of the end of that fiscal year’s second fiscal quarter.

As a result, we may take advantage of certain reduced disclosure obligations available to smaller reporting companies, including reduced disclosure about our executive compensation arrangements and the requirements to provide only two years of audited financial statements in our annual reports and registration statements.

day of our most recently completed second fiscal quarter, or (2) our annual revenues are less than $100 million for our previous fiscal year and we have either no public float or a public float of less than $700 million as of the end of that fiscal year’s second fiscal quarter.

Decreased disclosures in our SEC filings due to our status as a “smaller reporting company” may make it harder for investors to analyze our results of operations and financial prospects.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business