SCYX

• WHO's first list of priority deadly fungal pathogens validates SCYNEXIS' strategy to focus on life-threatening invasive fungal infections with ibrexafungerp.
• The company is refocusing resources to clinical development of oral and intravenous liposomal ibrexafungerp for severe hospital-based indications.
• BREXAFEMME saw an increase in prescribers (nearly 2,500 HCPs in Q3, 11% QoQ growth) and prescriptions (almost 5,800 in Q3, 30% QoQ growth).
• Supplemental NDA for recurrent vulvovaginal candidiasis is on track with a PDUFA date of November 30, 2022.
• Cash balance at end of Q3 2022 was over $96 million, with cash runway extended to Q2 2024.
• Pipeline updates: FURI and CARES studies near completion, SCYNERGIA study closing enrollment in 2023, MARIO study ongoing with data expected in early 2024, and IV formulation Phase 2 trial planned for 2023.

• Cash runway extended to Q2 2024 with existing cash to support hospital programs and regulatory filings in 2024.
• Anticipated NDA submission in 2024 with potential approval for hospital indication by end of 2024.
• IV formulation Phase 2 trial planned for 2023, results expected in 2024, informing Phase 3 trial design.

BREXAFEMME net product revenues in the third quarter of 2022 increased approximately 23% to $1.6 million over the $1.3 million in the second quarter. In Q3, almost 2,500 HCPs prescribed BREXAFEMME, representing an 11% quarter-over-quarter increase, and there were almost 5,800 prescriptions in Q3, a 30% growth over the second quarter. BREXAFEMME revenue contribution isn't explicitly stated as a percentage of total revenue, but its performance in terms of prescribers and prescriptions is highlighted.

• Disruption in BREXAFEMME prescriptions due to ending in-person promotion with Amplity Health.
• Uncertainties in clinical trial outcomes and regulatory approvals for hospital indications.
• Dependence on cash runway and potential business development outcomes for BREXAFEMME.

Q: When do you think we will see an out-licensing and/or partner for BREXAFEMME? And how do you think about valuing this opportunity? And is this year possible after your PDUFA? Or is 2023 more likely?

A: SCYNEXIS is actively pursuing potential partners, expect approval of recurrent VVC by end of November 2022 to create interest, and value BREXAFEMME for its potential in women's healthcare and synergistic products.

Q: How will you succeed in the hospital setting when others have failed?

A: Ibrexafungerp is a unique product in a new class, well-differentiated to address unmet needs, and with efficient development program to get favorable label.

Q: Does the inclusion of ibrexafungerp onto the pathogen list improve the chances for nondilutive funding or global partnerships?

A: WHO list reinforces focus on priority fungal diseases, potentially translating to favorable policymaking and partnerships.

Q: Can you give an update on the number of sites for the MARIO study?

A: MARIO study is ongoing, in process of site set-up, with approvals in different countries, on track to complete enrollment by end of next year.

Q: Any feedback for us on your conversations with the FDA ahead of the November 30 PDUFA?

A: Supplemental NDA for recurrent VVC didn't require late cycle conversations with FDA, all signs positive towards approval at PDUFA date.

Q: Does the increased enrollment in the studies impact your funds in any way going to the added costs? And how do you plan to use the extra patients that are enrolling?

A: Incremental cost minimal, data from FURI and CARES studies will be used for salvage therapy indication comparison against external controls.

Q: Does the FURI study include a basket of indications, and do you see one or few of the indications responding better than the others?

A: FURI study includes various indications, expectation is that gist infections (where glucan synthase inhibitors are gold standard) may respond well, with protocol allowing for mold infections and combination therapy.

Q: What is the time line for the SCYNERGIA study?

A: Planning to close enrollment within 2022 and report data in the first half of 2023.