On August 14, 2023 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, reported financial results for the second quarter ended June 30, 2023 (Press release, Scynexis, AUG 14, 2023, View Source [SID1234634400]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In the second quarter, we continued to execute on our key priorities, by maximizing ibrexafungerp’s value and by advancing our ground-breaking class of antifungals to fight serious global health threats," said David Angulo, M.D., President and Chief Executive Officer of SCYNEXIS. "We were pleased to achieve the first development milestone under our exclusive licensing agreement with GSK based on the progress of the Phase 3 ibrexafeungerp MARIO study and to report the successful NDA filing of ibrexafungerp for VVC in China. Our innovative triterpenoid antifungal platform is poised to provide significant value and we are rapidly advancing the next generation fungerp SCY-247 and anticipate filing an IND in 2024. With our current cash balance and modest projected spending over the next years, we are well-positioned to support the entire clinical development of SCY-247 and continue the fight against life-threatening fungal infections."

Corporate Developments

On June 21, 2023, SCYNEXIS announced the achievement of a $25 million performance-based development milestone under its exclusive license agreement with GSK for ibrexafungerp. The milestone payment follows the achievement of a development goal for the Phase 3 MARIO study for ibrexafungerp in invasive candidiasis.
Ibrexafungerp Clinical and Regulatory Updates

SCYNEXIS and partner Hansoh Pharmaceutical Group Company Limited (3692.HK) announced that China’s NMPA has accepted for review an NDA for oral ibrexafungerp tablets for the treatment of adult and post-menarchal pediatric females with vulvovaginal candidiasis (VVC) in the Chinese mainland. The application, submitted by Hansoh Pharma, is based on positive results from Phase 3 studies in which ibrexafungerp successfully achieved statistically significant superiority over placebo for the primary and key secondary study endpoints.
Ibrexafungerp Scientific Presentations and Publications

Presented an overview of the innovative study design of the ongoing Phase 3 MARIO trial investigating oral ibrexafungerp as a step-down therapy for invasive candidiasis and shared interim data analyses from its ongoing Phase 3 FURI and CARES studies at the 33rd Annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) held in Copenhagen, Denmark, April 15-18, 2023.
SCY-247 Preclinical Development Program

IND-enabling development activities for SCY-247 continue to progress. SCY-247 is a broad-spectrum antifungal with potential oral and IV systemic therapeutic formulations for multiple drug-resistant pathogens. A portion of these activities, including assessing the activity against Candida auris and Mucorales, are being supported by NIH grants. IND filing for this compound is anticipated in the second half of 2024.
Second Quarter 2023 Financial Results

We recognized $131.5 million in total revenue for Q2 2023 compared with $1.3 million in Q2 2022. The increase in revenue was associated primarily with the recognition of $131.0 million in licensing agreement revenues from GSK.

Research and development expense for Q2 2023 was $7.0 million, compared to $7.1 million for Q2 2022.

Selling, general & administrative (SG&A) expense for Q2 2023 decreased to $7.5 million from $15.8 million for Q2 2022. The decrease of $8.3 million, or 53%, for Q2 2023, was primarily driven by a decrease of $9.0 million in commercial expense due to the costs incurred in the prior comparable period associated with the active promotion of BREXAFEMME which ceased in the fourth quarter of 2022, a decrease of $1.1 million in salary related expense primarily driven by the workforce reduction in the fourth quarter of 2022 concentrated in the commercial and medical affairs functions, a decrease of $0.5 million in other medical affairs related expense, and a net decrease in other selling, general, and administrative expense of $0.6 million, offset in part by an increase in professional fees of $2.9 million. The $2.9 million increase in professional fees is primarily due to a $3.1 million expense incurred during the current period for business development associated with the License Agreement with GSK.

Total other income was $5.7 million for Q2 2023, versus total other income of $8.4 million for Q2 2022. During Q2 2023 and Q2 2022, SCYNEXIS recognized a non-cash gain of $8.2 million and a non-cash gain of $9.7 million, respectively, on the fair value adjustment of the warrant liabilities.

Net income for Q2 2023 was $122.3 million, or $2.56 basic income per share and $2.46 diluted income per share, compared to a net loss of $13.3 million, or $0.31 basic and diluted loss per share for Q2 2022.

Cash Balance

Cash, cash equivalents and investments totaled $91.9 million on June 30, 2023, compared to $73.5 million on December 31, 2022, The June 30, 2023 cash balance is after deduction of the approximately $36 million Hercules Capital and Silicon Valley Bridge Bank loan which was repaid in full in the second quarter and does not include the $25 million development milestone recognized in the second quarter. Based upon its current operating plan which assumes modest spending in 2024 and receipt of the $25 million development milestone payment from partner GSK, SCYNEXIS believes that its existing cash, cash equivalents and investments will provide a cash runway beyond two years.

About Triterpenoid Antifungals

Triterpenoid antifungals (also known as "fungerps") are a novel class of structurally-distinct glucan synthase inhibitors that combine the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. They have demonstrated broad-spectrum antifungal activity against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. Ibrexafungerp is the first representative of this novel class of antifungal agents. Ibrexafungerp, formerly known as SCY-078, is currently approved in the U.S. for the treatment of vulvovaginal candidiasis and is in late-stage of development for invasive candidiasis and other indications. SCY-247 is a next generation fungerp in pre-clinical development for the treatment of life-threatening and often multi-drug resistant fungal diseases including Candida auris infections.