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Sep 30, 2021
Scynexis Q3 2021 Earnings Report
Reported financial results for the third quarter and provided a corporate update.
Key Takeaways
SCYNEXIS reported BREXAFEMME net sales of $0.5 million since August. The company's cash balance was $100 million at the end of September, providing a cash runway into 2023. A Phase 1 trial of IV ibrexafungerp was completed.
BREXAFEMME® net sales of $0.5 million generated since August, with IQVIA reporting 1,006 prescriptions in partial Q3.
BREXAFEMME is now covered by commercial insurance plans representing more than 30% of commercially insured lives, exceeding internal expectations.
Intravenous (IV) ibrexafungerp is ready to advance to the next stage of clinical development following successful Phase 1 trial evaluating safety and tolerability of liposomal IV formulation in healthy patients.
Based on a $100 million cash balance at September 30 and operating plan, SCYNEXIS has a projected cash runway into 2023.
Scynexis
Scynexis
Forward Guidance
SCYNEXIS anticipates several milestones, including reporting top-line data from the Phase 3 CANDLE study by early Q2 of next year and potential approval in late 2022.
Positive Outlook
- New IV formulation of ibrexafungerp will enable the company to further expand the potential range of indications for ibrexafungerp in the hospital setting.
- Phase 3 CANDLE study last-patient/last-visit by the end of 2021 with top-line results by early Q2 2022.
- Supplemental NDA submission is anticipated in Q2 2022.
- Potential approval in late 2022.
- Enrollment in the Phase 2 SCYNERGIA study is expected to accelerate over the next two quarters.
Challenges Ahead
- BREXAFEMME may not be accepted by physicians and patients at the rate SCYNEXIS expects.
- Risks inherent in SCYNEXIS' ability to successfully develop and obtain FDA approval for ibrexafungerp for additional indications, including the IV formulation of ibrexafungerp currently in Phase 1.
- Unexpected delays may occur in the timing of acceptance by the FDA of an NDA submission.
- SCYNEXIS’ need for additional capital resources.
- SCYNEXIS' reliance on third parties to conduct SCYNEXIS' clinical studies and commercialize its products.