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BREXAFEMME^® (ibrexafungerp tablets), launched in September 2021 for the treatment of vulvovaginal candidiasis (VVC), achieved almost 4,000 prescriptions with net revenues of $0.7 million in Q1 2022. Expansion of the labeling to include prevention of recurrent VVC is anticipated by end of 2022.

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As of May 2022, BREXAFEMME was covered by commercial insurance plans representing 93 million, or 55% of commercially insured lives.

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SCYNEXIS initiated MARIO, a global Phase 3 study to evaluate ibrexafungerp as an oral step-down treatment for invasive candidiasis (IC) in the hospital setting and anticipates enrolling the first patient by the end of Q2 2022.

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Reported positive results from new interim analyses of the FURI and CARES trials highlighting oral ibrexafungerp’s potency against severe fungal infections, with 83.2% of combined patients demonstrating a clinical response to oral ibrexafungerp.

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Based on a cash balance of $95.2 million at March 31, 2022, and a $45 million public offering ($42 million net) in April, SCYNEXIS has a projected cash runway into Q1 2024.

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SCYNEXIS will host a conference call today, May 12 at 8:30 a.m. EDT

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BREXAFEMME delivered $0.7 million in net sales in first quarter 2022. According to IQVIA data, there were approximately 4,000 total prescriptions for BREXAFEMME written in Q1 2022. Total prescriptions have continued to grow in 2022 with 1,070 in January, 1,328 in February and 1,579 in March.

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BREXAFEMME was prescribed by over 1,800 unique healthcare professionals (HCPs) in the first quarter, and 55% of these doctors expanded their use and prescribed the treatment to multiple patients during this period, up from 40% last quarter.

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Commercial insurance coverage of BREXAFEMME continues to expand. As of April 2022, BREXAFEMME was covered by plans representing more than 93 million or 55% of commercially-insured lives.

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Reported positive results from the fourth interim analysis of the FURI and CARES trials highlighting oral ibrexafungerp’s potency against severe fungal infections. The recent interim analyses included 39 new cases from FURI and eight new cases from CARES who completed treatment during the 12 months since the prior interim analyses. In the combined analysis of 131 patients, 83.2% of patients demonstrated a clinical response to oral ibrexafungerp. Of the 131 FURI and CARES study cases analyzed to date, 61.1% achieved a complete or partial response, or clinical improvement; and 22.1% achieved stable disease, which is a favorable outcome in patients with severe progressive fungal infections.

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Reported positive results from the pivotal Phase 3 CANDLE study of oral ibrexafungerp for prevention of rVVC. In this international trial of 260 patients with rVVC, defined as three or more episodes of vulvovaginal candidiasis (VVC) in the previous 12 months, patients initially received a three day regimen of fluconazole to treat their current infection, and responders were randomized in the prevention phase to receive either 300 mg ibrexafungerp BID or matching placebo one day a month, for six months. The study showed that 65.4% of patients receiving ibrexafungerp achieved clinical success by having no recurrence at all, either culture-proven, presumed or suspected, through Week 24 compared to 53.1% of placebo-treated patients (p=0.02). The advantage of ibrexafungerp over placebo was sustained over the three-month follow-up period and remained statistically significant (p=0.034). Ibrexafungerp was generally safe and well-tolerated. There were no serious drug-related adverse events, and no patients treated with ibrexafungerp discontinued therapy due to adverse events. The most commonly reported events were headaches and gastrointestinal events, which were mostly mild and generally consistent with the current BREXAFEMME label. SCYNEXIS plans to submit the results in a supplemental NDA to the U.S. Food and Drug Administration (FDA) in the second quarter of 2022 and anticipates receiving approval by year-end.

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SCYNEXIS initiated MARIO, a global Phase 3 study to evaluate ibrexafungerp as an oral step-down treatment for invasive candidiasis (IC) in the hospital setting. Company anticipates enrolling the first patient by the end of Q2 2022.

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Following the positive Phase 1 data with the IV formulation reported previously, SCYNEXIS has begun to scale up manufacturing to enable additional IV trials.

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Presented several posters highlighting details from interim analyses of data from its ongoing Phase 3 FURI and CARES studies investigating the potential of ibrexafungerp as a treatment for invasive candidiasis (IC) and candidemia, including infections caused by Candida auris (C. auris). The posters were presented at the 32nd Annual European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) held in Lisbon, Portugal April 23-26, 2022. Posters included:

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An interim analysis of the CARES study of 18 enrolled patients with candidemia and other infections caused by Candida auris (C. auris) treated for a mean duration of 18 days, 78% of patients showed complete or partial response and 11% had stable disease.

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An interim analysis with combined data of 49 patients with invasive candidiasis and candidemia from the ongoing Phase 3 FURI (n=39) and CARES (n=10) studies. Aggregate data from the two studies showed that of the patients treated with ibrexafungerp, 68% had complete or partial response and 14% had stable disease.

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Data presented from an in vivo mouse model of mucormycosis found that ibrexafungerp monotherapy demonstrated in vivo efficacy in treating both Rhizopus delemar and Mucor circinelloides infections in mice, consistent with other antifungals currently used against mucormycosis. Additionally, the study found that when ibrexafungerp was combined with liposomal amphotericin B (LAMB) or posaconazole (POSA), synergistic benefits were observed with a significant enhancement in median survival time and overall survival when compared to any one therapy alone (p<0.05).

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Reported new positive outcomes in patients with refractory vulvovaginal candidiasis (VVC) treated with oral ibrexafungerp from the ongoing Phase 3 FURI study. The new interim analysis was presented during the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical & Scientific Meeting held in San Diego May 6-8, 2022. Ibrexafungerp showed positive results in difficult-to-treat VVC patients with severe fungal infections who were either intolerant to standard antifungal therapy or experienced refractory infections despite treatment. Of the 14 patients in the FURI study with refractory or relapsed cases of VVC treated with ibrexafungerp, 10 (71.4%) had successful clinical outcomes as judged by an independent Data Review Committee. Patients with VVC received 750 mg of oral ibrexafungerp (375 mg twice a day) every 72 hours for a total of three dosing days (Day 1, Day 4 and Day 7). In the study, ibrexafungerp was generally safe and well-tolerated with findings consistent with the existing product label.

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SCYNEXIS raised gross proceeds of $45 million gross ($42 million net) in an April 2022 public offering of common stock, pre-funded warrants, and warrants.

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SCYNEXIS received $4.7 million in non-dilutive proceeds in February 2022 from the sale of New Jersey State net operating losses to a third party.

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SCYNEXIS received an additional $5.0 million in non-dilutive proceeds in March 2022 from the third tranche of the previously reported Term Loan Agreement with Hercules Capital/SVB upon achieving positive results from the Phase 3 CANDLE study of ibrexafungerp for the prevention of recurrent yeast infections.