Quoin Pharmaceuticals, Ltd. Q3 FY2023 earnings call

• QRX003 clinical data: Positive data released from ongoing open-label trial in Netherton Syndrome; planned protocol amendments to optimize clinical plans, including eliminating lower dose, modifying dosing frequency to twice daily, and increasing study subjects.
• Commercial partnerships: Entered ninth commercial partnership for QRX003 with FarmaMondo for Singapore, now have 61 countries in partnerships; in late-stage discussions for Southeast Asia and Latin America.
• M&A strategy: Narrowed down to three rare disease products for potential acquisition/licensing, but will only close deals if funds are available for clinical development.
• CMO progress: Contract manufacturer successfully developed and scaled up GMP manufacturing process for QRX003 active ingredient, exclusively available to Quoin.
• Netherton Syndrome clinical study: Quoin remains the only company actively conducting studies under open IND; other companies' timelines for Netherton Syndrome studies are delayed or abandoned.

No specific product segment financial performance with absolute revenue and contribution % provided in the transcript.

• Working towards closing at least one M&A transaction expeditiously but with consideration of market conditions and funding for clinical development of acquired assets.
• Clinical timelines for QRX003: Protocol amendments expected to result in more robust data set and potentially faster approval; no material change to overall timelines but potential for speedier approval.
• Funds usage: Current funds primarily to advance QRX003 and other pipeline products; additional products need new capital for development.

• Market conditions: Unfavorable current market conditions impacting M&A transactions, as external factors can affect transaction consummation.
• Funding risks: Need to ensure ability to fund clinical development of acquired assets; risk of acquiring assets that can't be funded for development.
• Clinical trial risks: External factors and timelines for other companies' Netherton Syndrome studies being delayed or abandoned.

Q: How do the changes to the Phase 2/3 trial affect the timeline for filing and approval?

A: Gordon Dunn states no material change to timelines, but data release pace affected positively, potentially speeding up approval.

Q: Timing of M&A transaction and required funds?

A: Gordon Dunn says ideal to close prior to end of year, but market conditions and external factors involved; need funds for clinical development of acquired assets.

Q: Updates on other early stage programs like QRX004, QRX007, QRX008?

A: QRX004 on hold evaluating commercial opportunity; QRX007 and QRX008 making progress with Australia partnership, but at different pace than QRX003.

Q: Will clinical data accelerate conversations with distribution partners?

A: Michael Myers says potentially, as there's inbound interest and it will increase interest in unpartnered countries.

Q: Total addressable market and price point for NS product?

A: Michael Myers estimates 7,000-8,000 patients in U.S. and Europe, 10,000-15,000 in partnered countries; TAM potentially over $500 million, but exact price point not specified.

Q: M&A interest given company's stock price?

A: Michael Myers says can't provide details but people are looking at the company, focused on current work and Board to address offers.