- Clinical study reports for the FURI, CARES and NATURE trials in refractory or resistant invasive fungal infections were delivered to GSK, triggering a $10 million development milestone payment to SCYNEXIS which we expect to receive in Q3 2024.
- SCY-247’s IND-enabling activities continue to progress. Pre-clinical in vitro and in vivo studies, presented at several medical conferences, have shown potent and broad antifungal activity. Phase 1 study initiation is planned for Q4 2024.
- SCYNEXIS ended Q2 2024 with cash, cash equivalents and investments of $83.7 million, not including the recently earned $10 million development milestone, and projects a cash runway of more than two years.
JERSEY CITY, N.J., Aug. 08, 2024 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. ( SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today reported financial results for the second quarter ended June 30, 2024.
“Successful completion of the FURI, CARES, and NATURE studies is an important achievement for the future development of ibrexafungerp for refractory or resistant invasive fungal infections,” said David Angulo, M.D., President and Chief Executive Officer. “Positive top-line results from the studies are consistent with previously disclosed results from interim analyses, and delivery of the final study reports to GSK triggered a $10 million milestone payment to SCYNEXIS. Work continues to reestablish the clinical supply chain of ibrexafungerp, and we look forward to restarting the Phase 3 MARIO study in invasive candidiasis. We are also continuing to make progress with SCY-247, our next generation fungerp. SCY-247 continues to yield robust preclinical results, highlighting its promising therapeutic potential against a broad range of invasive fungal pathogens. We plan to present these data at upcoming medical meetings, and a planned Phase 1 study is on track to begin in Q4 of 2024.”
SCY-247 Preclinical Development Program
- Preclinical data from studies of SCY-247, the second generation fungerp from SCYNEXIS’ proprietary antifungal platform, are planned to be presented at multiple upcoming medical meetings, including the Mycoses Study Group Education & Research Consortium (MSGERC) Biennial Meeting in September 2024 and ID Week in October 2024. Phase I initiation continues to be anticipated in Q4 2024.
Ibrexafungerp Clinical Updates
- Final study reports from the completed FURI, CARES and NATURE studies were delivered to our partner, GSK. Delivery of these reports triggered a $10 million development milestone payment to SCYNEXIS which we expect to receive in Q3 2024. Results from the FURI and CARES studies are planned to be presented at a future medical meeting. For more information on the trials, please visit ClinicalTrials.gov (CARES: NCT03363841; FURI: NCT03059992).
- Third-party manufacturing of new batches of ibrexafungerp for use in clinical trials is in progress, and SCYNEXIS looks forward to restarting the Phase 3 MARIO study in invasive candidiasis.
Second Quarter 2024 Financial Results
For the three months ended June 30, 2024, revenue consists of the $0.7 million in license agreement revenue associated with the license agreement with GSK. For the three months ended June 30, 2023, revenue primarily consisted of the $130.1 million recognized upon the transfer of the license associated with the License Agreement with GSK in May 2023.
Research and development expense for the three months ended June 30, 2024 was $6.8 million compared to $7.0 million for the same period in 2023. The decrease of $0.2 million, or 3%, for the three months ended June 30, 2024, was primarily driven by a decrease of $1.1 million in clinical expense and a decrease of $0.3 million in salaries primarily associated with medical affairs, offset in part by a $0.7 million increase in chemistry, manufacturing, and controls (CMC) expense and an increase of $0.5 million in preclinical expense.
SG&A expense for the three months ended June 30, 2024 decreased to $3.2 million from $7.5 million for the same period in 2023. The decrease of $4.3 million, or 58%, for the three months ended June 30, 2024, was primarily driven by a decrease of $3.5 million in professional fees and a decrease of $0.3 million in commercial expense due to the costs incurred in the prior comparable period associated with BREXAFEMME.
Total other expense was $5.2 million for the three months ended June 30, 2024, versus total other income of $5.7 million for the same period in 2023. The variance is mainly due to the fair value adjustment related to the warrant liabilities. For the three months ended June 30, 2024 and 2023, we recognized a loss of $5.8 million and a gain of $8.2 million, respectively, on fair value adjustment for warrant liabilities primarily due to the changes in our stock price during the periods.
Net loss for the three months ended June 30, 2024, was $14.5 million, or $0.30 basic loss per share, compared to a net income of $122.3 million, or $2.56 basic income per share.
Cash Balance
Cash, cash equivalents and investments totaled $83.7 million on June 30, 2024, compared to $98.0 million on December 31, 2023. Based upon the company’s current operating plan, SCYNEXIS believes that its existing cash, cash equivalents and investments 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.
About SCYNEXIS
SCYNEXIS, Inc. ( SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. SCYNEXIS is developing the company’s proprietary antifungal platform “fungerps.” Ibrexafungerp, the first representative of this novel class, has been licensed to GSK. The U.S. Food and Drug Administration (FDA) approved BREXAFEMME® (ibrexafungerp tablets) in June 2021, for its first indication in vulvovaginal candidiasis (VVC), followed by a second indication in November 2022, for reduction in the incidence of recurrent VVC. Late-stage clinical investigation of ibrexafungerp for the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. Additional antifungal assets from this novel class are currently in pre-clinical and discovery phase, including the compound SCY-247. For more information, visit www.scynexis.com.
Forward-Looking Statements
Statements contained in this press release regarding expected future events or results are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements regarding: SCYNEXIS’s expectation that it will have a cash runway of more than two years; anticipated initiation of Phase I clinical studies of SCY-247 in Q4 of 2024; and the resumption of the Phase 3 MARIO study. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks inherent in regulatory and other costs in developing products. These and other risks are described more fully in SCYNEXIS' filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K filed on March 28, 2024, and form 10-Q for the quarter ending June 30, 2024, including under the caption "Risk Factors." All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
CONTACT:
Investor Relations
Irina Koffler
LifeSci Advisors
Tel: (646) 970-4681
[email protected]
| SCYNEXIS, INC. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data) | |||||||||
| Three Months Ended June 30, | |||||||||
| 2024 | 2023 | ||||||||
| Revenue: | |||||||||
| Product revenue, net | $ | — | $ | 468 | |||||
| License agreement revenue | 736 | 130,986 | |||||||
| Total revenue | 736 | 131,454 | |||||||
| Operating expenses: | |||||||||
| Cost of product revenue | — | 426 | |||||||
| Research and development | 6,807 | 7,040 | |||||||
| Selling, general and administrative | 3,166 | 7,474 | |||||||
| Total operating expenses | 9,973 | 14,940 | |||||||
| (Loss) income from operations | (9,237 | ) | 116,514 | ||||||
| Other (income) expense: | |||||||||
| Amortization of debt issuance costs and discount | 421 | 1,998 | |||||||
| Interest income | (1,130 | ) | (737 | ) | |||||
| Interest expense | 197 | 1,249 | |||||||
| Warrant liabilities fair value adjustment | 5,761 | (8,214 | ) | ||||||
| Derivative liabilities fair value adjustment | (28 | ) | (42 | ) | |||||
| Total other expense (income) | 5,221 | (5,746 | ) | ||||||
| (Loss) income before taxes | (14,458 | ) | 122,260 | ||||||
| Income tax expense | — | — | |||||||
| Net (loss) income | $ | (14,458 | ) | $ | 122,260 | ||||
| Net (loss) income per share attributable to common stockholders – basic | |||||||||
| Net (loss) income per share – basic | $ | (0.30 | ) | $ | 2.56 | ||||
| Net (loss) income per share attributable to common stockholders – diluted | |||||||||
| Net (loss) income per share – diluted | $ | (0.30 | ) | $ | 2.46 | ||||
| Weighted average common shares outstanding – basic and diluted | |||||||||
| Basic | 48,511,656 | 47,837,393 | |||||||
| Diluted | 48,511,656 | 49,923,361 | |||||||
| SCYNEXIS, INC. UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except share and per share data) | ||||||||
| June 30, 2024 | December 31, 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 25,994 | $ | 34,050 | ||||
| Short-term investments | 47,044 | 40,312 | ||||||
| Prepaid expenses and other current assets | 1,418 | 5,548 | ||||||
| License agreement receivable | 233 | 2,463 | ||||||
| License agreement contract asset | 19,509 | 19,363 | ||||||
| Restricted cash | 380 | 380 | ||||||
| Total current assets | 94,578 | 102,116 | ||||||
| Investments | 10,657 | 23,594 | ||||||
| Deferred offering costs | 175 | 175 | ||||||
| Restricted cash | 163 | 163 | ||||||
| Operating lease right-of-use asset (See Note 7) | 2,233 | 2,364 | ||||||
| Total assets | $ | 107,806 | $ | 128,412 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 5,350 | $ | 7,149 | ||||
| Accrued expenses | 5,498 | 7,495 | ||||||
| Deferred revenue, current portion | 1,229 | 1,189 | ||||||
| Operating lease liability, current portion (See Note 7) | 372 | 340 | ||||||
| Warrant liabilities | — | 130 | ||||||
| Convertible debt and derivative liability (See Note 6) | 12,784 | — | ||||||
| Total current liabilities | 25,233 | 16,303 | ||||||
| Deferred revenue | 1,817 | 2,727 | ||||||
| Warrant liabilities | 17,962 | 21,680 | ||||||
| Convertible debt and derivative liability (See Note 6) | — | 12,159 | ||||||
| Operating lease liability (See Note 7) | 2,388 | 2,581 | ||||||
| Total liabilities | 47,400 | 55,450 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, $0.001 par value, authorized 5,000,000 shares as of June 30, 2024 and December 31, 2023; 0 shares issued and outstanding as of June 30, 2024 and December 31, 2023 | — | — | ||||||
| Common stock, $0.001 par value, 150,000,000 shares authorized as of June 30, 2024 and December 31, 2023; 37,856,463 and 37,207,799 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively | 41 | 40 | ||||||
| Additional paid-in capital | 429,659 | 428,169 | ||||||
| Accumulated deficit | (369,294 | ) | (355,247 | ) | ||||
| Total stockholders’ equity | 60,406 | 72,962 | ||||||
| Total liabilities and stockholders’ equity | $ | 107,806 | $ | 128,412 | ||||
