Quoin Pharmaceuticals, Ltd. Q2 FY2023 earnings call

• Clinical trials: Open label Netherton Syndrome trial achieved 50% recruitment with additional enrollments; second Netherton trial on track to recruit majority of subjects this month. First patient in open label study completed testing with positive results across endpoints. Plans to initiate additional Netherton trials, including in Middle East and ex-US pediatric subjects. Progress on QRX003 in other indications like Peeling Skin Syndrome, SAM Syndrome, etc.
• Partnerships: Ongoing research programs with Queensland University of Technology (QUT) for Scleroderma and Netherton Syndrome, benefiting from Australian tax rebates and faster clinical testing.
• M&A strategy: Actively pursuing acquisitions/licensing in rare/orphan disease space, with discussions advancing and targeting at least one transaction by year-end.

No specific product segments detailed. As of June 30, cash and marketable securities were approximately $15.4 million (down from $17 million on March 31). Net loss for Q2 was $2.1 million, down from $2.7 million in Q2 2022, primarily due to lower legal and professional fees in 2023.

• Top line data from open label Netherton study expected by end of 2023; double-blinded study top line data expected early 2024.
• Targeting regulatory approval for QRX003 in Netherton Syndrome in early 2025.
• Aim to complete at least one M&A transaction by year-end.

Q: Can you talk more about the onset, cadence, and timing of benefits from the first patient's data?

A: Benefit started to become evident in the second half of the 12-week dosing period, consistent across all measured endpoints.

Q: Has the first patient been followed up, and is there recurrence of symptoms?

A: No follow-up as the patient was only in the 12-week study; likely symptoms reversed after discontinuing QRX003.

Q: Have findings impacted study design, and considerations for full body application?

A: Safety profile allows consideration of dose increase, frequency change; full body dosing is being discussed, including in Middle East study.

Q: Timing for top line data and Phase 3, and expansion outside US?

A: Top line open label data by end of 2023, double-blinded early 2024; regulatory approval early 2025. Global expansion with 8 commercial partners; data generation opens opportunities for early approval in partners' jurisdictions.