VYNE Therapeutics Inc. Q3 FY2021 earnings call

• VYNE refocused efforts on developing therapies for immuno-inflammatory diseases, with the licensing of the BET Inhibitor Platform in August. - VYN201, a topical pan-Bromodomain BET inhibitor, has its formulation selected and preclinical safety program initiated. - VYN202, an oral BD2-selective BET inhibitor, is in lead optimization with In4Derm. - Formed a Scientific Advisory Board for BETi programs. - FMX114 Phase 1b/2a trial for atopic dermatitis has enrolled the first patient, with top-line results expected early in Q1 2022. - Planned sale of the topical minocycline franchise, with positive patient and provider responses for AMZEEQ and ZILXI which had combined nearly 165,000 prescriptions through September.

Revenues in the third quarter of 2021 totaled $4.1 million. Product sales from AMZEEQ and ZILXI contributed $4 million, and royalty revenue was $21 million. The product sales from AMZEEQ and ZILXI made up the $4 million of product sales, with royalty revenue being the $21 million component.

• Adjusted operating expenses expected to be in the range of $10 to $15 million in Q4 2021 (excluding a one-time $4 million milestone payment for VYN202), and approximately $10 million per quarter in 2022. - Cash position as of September 30th was ~$53 million, sufficient to fund operations through the second quarter of 2022.

• Forward-looking statements involve risks, uncertainties, and assumptions difficult to predict, including those regarding clinical trials, strategic transactions, and future plans. Factors in VYNE's Therapeutics filings with the SEC could cause actual results to differ materially from forward-looking statements.

Q: About VYN201, VYN202 indications and FMX114 data interpretation.

A: Discussed the multimodal mechanism of FMX114, differentiation of BETi platforms, and early thoughts on potential indications for VYN201 and VYN202. For FMX114, explained its multimodal impact on atopic dermatitis including JAK inhibitor and fingolimod components.

Q: Product sales breakdown, FMX114 data interpretation, comparison to JAK inhibitors.

A: Product sales split not disclosed, FMX114's multimodal action was elaborated on, and BETi preclinical data was compared to steroids showing potent anti-inflammatory effects.

Q: Safety of BETi inhibitors, magnitude of preclinical effects, biomarkers.

A: Topical VYN201 reduces systemic exposure through metabolic liability design, VYN202's BD2 selectivity for improved safety, preclinical data showed potent anti-inflammatory effects comparable to steroids and significant impact on multiple cytokines driving Th17 immunology