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Item 1. Business

2025-03-13 compared with 2024-03-14 · 189 added, 85 removed, 273 unchanged (50% of the section changed)

Company Overview

We are a clinical stage specialty pharmaceutical company dedicated to the development and commercialization of therapeutic products that treat rare and orphan diseases.

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 skin diseases, particularly those for which there are currently no approved treatments or cures.

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

The active ingredient in QRX003 is a broad-spectrum serine protease inhibitor and the product is formulated with the proprietary in-licensed Invisicare® technology, QRX003 is currently being tested in two ongoing clinical studies in the United States (“U.S.”) under an open Investigational New Drug (“IND”) application with the Food and Drug Administration (“FDA”).

Both studies are actively recruiting patients in five clinical sites across the US.

The opening of additional clinical sites in Europe and elsewhere is currently under evaluation.

We also intend to pursue the development of QRX003 for additional rare diseases including, among others, Peeling Skin Syndrome, SAM Syndrome and Palmoplantar Keratoderma.

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 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”).

In addition, we entered into Research Agreements with the Queensland University of Technology (“QUT”), under which we have obtained an option for global licenses to QRX007 and QRX008 as potential treatments of NS and scleroderma respectively.

We were incorporated under the laws of the State of Israel in 1986 under the name Montiger Ltd.

Between 1986 and 2021, we underwent several name changes, including the name change to Cellect Biotechnology Ltd.

On October 28, 2021, Cellect completed the business combination with Quoin Pharmaceuticals, Inc., a Delaware corporation (“Quoin Inc.”), in accordance with the terms of the Agreement and Plan of Merger and Reorganization, dated as of March 24, 2021 (the “Merger Agreement”), by and among Cellect, Quoin Inc.

and CellMSC, Inc., a Delaware corporation and wholly-owned subsidiary of Cellect (“Merger Sub”), pursuant to which Merger Sub merged with and into Quoin Inc., with Quoin Inc.

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 retained all of Cellect’s then existing assets, to EnCellX Inc.

(“EnCellX”), a newly formed U.S.

privately held company.

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.

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.

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.

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).

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.

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.

Our Current Product Pipeline

Netherton Syndrome

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

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.

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.

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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

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.

Our Product Candidates

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

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 NS clinical studies under an open IND with the FDA.

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

(“Skinvisible”).

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

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.

In May 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.

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.

Regulatory Status of QRX003 for the Treatment of NS

On November 29, 2019, we submitted a pre-IND meeting request to the FDA regarding the proposed development of QRX003 as a potential treatment for NS.

On January 30, 2020, we received feedback from the FDA, which we believe has provided us with a clear path forward for the development of QRX003 as a potential treatment for NS.

With regard to the proposed clinical program, the agency confirmed that in the case of a rare disease, findings from a single Phase 3 trial along with supportive data could be used to establish efficacy.

In response to our query, the agency stated that QRX003 may be a candidate for one or more expedited regulatory approval pathways.

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

under an open IND application with the FDA.

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

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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 versus a placebo vehicle in 18 adult NS patients.

The test materials are applied once daily, over a twelve-week period, to pre-selected areas of the patient’s body.

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) and Pruritis.

In its communication allowing our

study to proceed, the FDA provided further feedback on our development program providing guidance on this initial study that could better inform future studies.

In November 2022, we submitted a protocol for our second clinical study in NS patients under our currently open IND and we were cleared by the FDA to initiate testing in NS patients in December 2022.

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.

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 and is being conducted at the same clinical sites as ongoing double-blinded study.

On October 24, 2023, we released positive initial clinical results obtained from the first six evaluable subjects in our open-label study.

Upon completion of dosing, five of the six patients reported that their pruritis or itch was either absent or negligible.

In addition, according to the IGA assessment, three of the six subjects demonstrated positive improvement in skin appearance on completion of the study while the other three subjects demonstrated improvements in skin appearance at various points throughout 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.

As a result of this positive initial data and the absence of any safety concerns 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.

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.

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

We submitted a further protocol amendment to the FDA in February 2024 requesting approval to reduce the age of eligibility for enrollment into both of clinical to fourteen years and older from eighteen years and older.

On March 4, 2024, we announced that clearance had been received to implement this protocol amendment also.

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 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.

(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

Investigator Global Assessment

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

Commercial Strategy

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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, 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.

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.

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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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.

The clinical biotechnology industry is a competitive industry characterized by technological innovation and growth.

Our competitors include other biotechnology and pharmaceutical companies, academic institutions, and public and private research institutions.

These entities engage in efforts to research, discover and develop new medicines and treatments for substance use.

These entities also seek patent protection and licensing revenues for their research results and may compete with us in recruiting skilled talent.

Some of these entities are larger and better funded than us.

Our management can make no assurances that we can effectively compete with these competitors.

We also may be unable to keep pace with technological developments and other market factors.

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, and Azitra Inc.

As of now, to the best of our knowledge, none of these companies are actively dosing subject in clinical studies on NS patients under an open IND.

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.

Manufacturing

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8,318,818 (exp.

March 10, 2024) and U.S.

8,318,818 (exp.

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

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

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

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

Trademark Registration No.

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98/184,357 for word mark “QELTIQ” filed by Quoin Pharmaceuticals, Inc.

provisional patent application directed to rapamycin formulation for treatment of particular skin disorders

Trademark Application No.

98/850,670 for word mark “NETHERTON NOW:

BECAUSE EVERYONE DESERVES TO FEEL COMFORTABLE IN THEIR OWN SKIN” filed by Quoin Pharmaceuticals, Inc.

provisional patent application directed to use of QRX003 according to a new dosage and for particular skin disorders.

Trademark Application No.

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

License Agreement with Skinvisible

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Clinical trials must be conducted under the supervision of one or more qualified investigators pursuant to protocols detailing, among other things, the objectives of the trial, dosing procedures, subject selection and exclusion criteria and the safety and effectiveness criteria to be evaluated.

For each institution where a clinical trial will be conducted,

an institutional review board (“IRB”) must review and approve the clinical trial protocol and informed consent form required to be provided to each trial subject or his or her legal representative prior to a clinical trial commencing, and conduct on-going monitoring of the study until completed or termination to assure that appropriate steps are taken to protect the human subjects participating in the research.

For each institution where a clinical trial will be conducted, an institutional review board (“IRB”) must review and approve the clinical trial protocol and informed consent form required to be provided to each trial subject or his or her legal representative prior to a clinical trial commencing, and conduct on-going monitoring of the study until completed or termination to assure that appropriate steps are taken to protect the human subjects participating in the research.

The FDA may order the temporary or permanent discontinuation of a clinical trial at any time, or impose other sanctions, if it believes that the clinical trial either is not being conducted in accordance with FDA regulations or presents an unacceptable risk to the clinical trial patients.

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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.

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.

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The orphan designation of a drug also provides the sponsor with certain financial incentives including tax credits and waiver of PDUFA fees.

The granting of an orphan drug designation does not shorten the duration of, the regulatory review and approval process nor does it guarantee regulatory approval.

The first applicant of a new drug application, or NDA, to receive FDA, approval for a particular active ingredient to treat a particular disease with FDA orphan drug designation is entitled to a seven year exclusive marketing period in the United States for that product for that indication.

Rare Pediatric Disease Priority Review Voucher Program

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

After September 30, 2024, the FDA may only award a voucher for an approved rare pediatric disease product application if the sponsor has rare pediatric disease designation for the drug, and that designation was granted by September 30, 2024.

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.

Post-Marketing Obligations

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We are also subject to various laws and regulations governing laboratory practices and the experimental use of animals.

As of December 31, 2023, we had four full-time employees and no part-time employees.

Human Capital

As of December 31, 2024, we had three 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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federal securities laws, in Israel.

We have been informed by our legal counsel in Israel that it may be difficult to assert claims under U.S.

securities laws in original actions instituted in Israel or obtain a judgment based on the civil liability provisions of U.S.

federal securities laws.

We have been informed by our legal counsel in Israel that it may be difficult to assert U.S.

securities laws claims in original actions instituted in Israel.

Israeli courts may refuse to hear a claim based on a violation of U.S.

securities laws against us or our officers and directors because Israel may not be the most appropriate forum to bring such a claim.

securities laws because Israel is not the most appropriate forum in which to bring such a claim.

In addition, even if an Israeli court agrees to hear a claim, it may determine that Israeli law and not U.S.

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law is found to be applicable, the content of applicable U.S.

law must be proved as a fact, which can be a time-consuming and costly process.

Certain matters of procedure will also be governed by Israeli law.

There is little binding case law in Israel addressing the matters described above.

Israeli courts might not enforce judgments rendered outside Israel, which may make it difficult to collect on judgments rendered against us or our officers and directors.

Moreover, among other reasons, including but not limited to fraud or absence of due process, or the existence of a judgment which is at variance with another judgment that was given in the same matter if a suit in the same matter between the same parties was pending before a court or tribunal in Israel, an Israeli court will not enforce a foreign judgment if it was given in a state whose laws do not provide for the enforcement of judgments of Israeli courts (subject to exceptional cases) or if its enforcement is likely to prejudice the sovereignty or security of the State of Israel.

Available Information

We are subject to the informational requirements of the Exchange Act.

law must be proven as a fact which can be a time-consuming and costly process.

Matters of procedure will also be governed by Israeli law.

We have irrevocably appointed Quoin Pharmaceuticals, Inc., as our agent to receive service of process in any action against us in any U.S.

federal or state court arising out of this offering or any purchase or sale of securities in connection with this offering.

Subject to specified time limitations and legal procedures, Israeli courts may enforce a U.S.

judgment in a civil matter which is non-appealable, including a judgment based upon the civil liability provisions of the Securities Act or the Exchange Act and including a monetary or compensatory judgment in a non-civil matter, provided that, among other things:

● the judgment was rendered by a court of competent jurisdiction, according to the laws of the state in which the judgment is given;

● the judgment is enforceable according to the laws of Israel and according to the law of the foreign state in which the relief was granted;

● the judgment is not contrary to public policy of Israel.

Even if such conditions are met, an Israeli court may not declare a foreign civil judgment enforceable if:

● the prevailing law of the foreign state in which the judgment is rendered does not allow for the enforcement of judgments of Israeli courts (subject to exceptional cases);

● the defendant did not have a reasonable opportunity to be heard and to present his or her evidence, in the opinion of the Israeli court;

● the enforcement of the civil liabilities set forth in the judgment is likely to impair the security or sovereignty of Israel;

● the judgment was obtained by fraud;

● the judgment was rendered by a court not competent to render it according to the rules of private international law prevailing in Israel;

● the judgment conflicts with any other valid judgment in the same matter between the same parties;

● an action between the same parties in the same matter was pending in any Israeli court or tribunal at the time at which the lawsuit was instituted in the foreign court.

If a foreign judgment is enforced by an Israeli court, it generally will be payable in Israeli currency, which can then be converted into non-Israeli currency and transferred out of Israel.

The usual practice in an action before an Israeli court to recover an amount in a non-Israeli currency is for the Israeli court to issue a judgment for the equivalent amount in Israeli currency at the rate of exchange in force on the date of the judgment, but the judgment debtor may make payment in foreign currency.

Pending collection, the amount of the judgment of an Israeli court stated in Israeli currency ordinarily will be linked to the Israeli consumer price index plus interest at the annual statutory rate set by Israeli regulations prevailing at the time.

Judgment creditors must bear the risk of unfavorable exchange rates.

What changed 10-K

Item 1. Business