Quoin Pharmaceuticals, Ltd. Q3 FY2022 earnings call

• Successfully completed a $16.8 million public offering, oversubscribed, funding the company into 2024. • Initiated a clinical trial for QRX003 in Netherton Syndrome patients, a randomized, double-blinded vehicle-control study with 18 patients over 12 weeks. • Launched a dedicated website for the Netherton Syndrome clinical trial. • Plan to initiate a second clinical trial for Netherton patients on off-label systemic therapy, open label, 10 patients, with protocol submitted to FDA. • Progress in research projects at QUT, hopeful for clinical testing next year. • Expanded international distribution partners for QRX003 to 60 countries, including Canada via agreement with Endo Ventures Limited.

Research and development expenses for the third quarter were $750,000, primarily attributable to clinical trial and associated manufacturing costs, as well as research projects with QUT. General and administrative expenses were $1.6 million. No specific revenue contribution percentages for product segments were provided as the focus was on QRX003 and related initiatives.

• Funding from the public offering ensures operations into 2024. • Key inflection points in 2023 expected from Netherton clinical trials, with first study readout in first half 2023 and second study around the same time. • Plan to make a go/no-go decision on 004 RDEB for RDEB by middle of 2023.

• Risks associated with forward-looking statements, where actual results may differ materially from expectations. • Uncertainties in clinical trial outcomes, including patient recruitment and study readouts. • Regulatory uncertainties in obtaining approvals for QRX003 and other products. • Manufacturing and commercialization challenges for products.

Q: Could you walk through inflection points in 2023?

A: The two key inflection points will be from the Netherton clinical trials, with the first study anticipated to read out first half of 2023 and the second study around the same time.

Q: How is recruitment for the trials going?

A: Systematic process with initial lag but recruitment picking up, with interest high including patients traveling long distances. Adults are currently the focus, with children to follow.

Q: Envision filing NDA for combinations?

A: It's a maybe; currently expecting QRX003 to be frontline therapy, and discussing combination possibilities.

Q: Timelines for publications of QRX003 findings?

A: Will embark on publication strategy once clinical data reads out, will publish and make data freely available then.

Q: Explain liability to officers?

A: Liabilities to officers are repayments for working without pay before funding, repaid at $50,000 per month to two officers.

Q: Proportion of patients on off-label systemic therapy?

A: Guessed less than 10%, with patients on biologics like dupixent and Taltz.

Q: Impact of other RDEB space movements on 004 RDEB?

A: No one-size-fits-all, but plan to make go/no-go decision on 004 RDEB by middle of 2023, with product being patient-friendly topical lotion.