JERSEY CITY, N.J., Nov. 13, 2023 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today reported financial results for the third quarter ended September 30, 2023.
“We faced unexpected challenges associated with the recent BREXAFEMME® recall and the clinical hold placed on the MARIO trial this quarter,” said David Angulo, M.D., President and Chief Executive Officer of SCYNEXIS. “While options for resolution of these issues are being evaluated we continue making progress towards data analysis for recently completed clinical studies (FURI, CARES, SCYNERGIA and VANQUISH). Our solid cash position has allowed us to advance the development of our next generation triterpenoid antifungal ‘SCY-247’ and continue to seek to maximize shareholder value while avoiding the volatile capital markets."
Ibrexafungerp Clinical and Regulatory Updates
Scientific Presentations and Publications
SCY-247 Preclinical Development Program
Third Quarter 2023 Financial Results
SCYNEXIS recognized a loss of ($0.6) million in product revenue for Q3 2023 compared with product revenue of $1.6 million in Q3 2022. The ($0.6) million loss in product revenue for Q3 2023 was primarily due to a $3.5 million reserve recognized for the product recall in September 2023. The Company ceased all promotion of BREXAFEMME® in Q4 2022.
Research and development expense for Q3 2023 was $6.5 million, compared to $6.4 million for Q3 2022.
Selling, general & administrative (SG&A) expense for Q3 2023 decreased to $5.0 million from $16.7 million for Q3 2022. The decrease was primarily driven by decreased commercial costs and salary expense associated with BREXAFEMME® commercialization.
Total other income was $8.3 million for Q3 2023, versus total other expense of $7.8 million for Q3 2022. During Q3 2023 and Q3 2022, SCYNEXIS recognized a non-cash gain of $7.5 million and a non-cash loss of $6.5 million, respectively, on the fair value adjustment of the warrant liabilities.
Net loss for Q3 2023 was $1.8 million, or $0.04 basic loss per share compared to a net loss of $29.6 million, or $0.62 basic loss per share for Q3 2022.
Cash Balance
Cash, cash equivalents and investments totaled $105.2 million on September 30, 2023, compared to $73.5 million on December 31, 2022. Based upon the company’s current operating plan, SCYNEXIS believes that its existing cash, cash equivalents and investments provides a cash runway beyond two years.
SCYNEXIS filed a shelf registration statement with the Securities and Exchange Commission today to replace its current shelf registration statement, which will be expiring in December 2023, as well as a registration statement for the issuance of shares pursuant to outstanding warrants as a result of expiring or expired shelf registration statements for the issuance of those shares.
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. (NASDAQ: 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 its proprietary triterpenoid antifungal compounds as broad-spectrum, systemic, antifungal agents for multiple fungal indications. The U.S. Food and Drug Administration (FDA) approved the first representative of this antifungal class 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 is ongoing. Additional assets in the novel “fungerp” class of antifungals are currently in the 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. 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 31, 2023, and form 10-Q for the quarter ending September 30th, 2023, 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
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| SCYNEXIS, INC. | ||||||||
| UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| (in thousands, except share and per share data) | ||||||||
| September 30, 2023 | December 31, 2022 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 44,071 | $ | 45,814 | ||||
| Short-term investments | 44,001 | 27,689 | ||||||
| Prepaid expenses and other current assets | 3,172 | 2,503 | ||||||
| License agreement receivable | 2,349 | — | ||||||
| License agreement contract asset | 19,309 | — | ||||||
| Accounts receivable, net | 2,245 | 2,101 | ||||||
| Inventory, net | 13,114 | 899 | ||||||
| Restricted cash | 380 | 55 | ||||||
| Total current assets | 128,641 | 79,061 | ||||||
| Investments | 17,115 | — | ||||||
| Other assets | 25 | 5,511 | ||||||
| Deferred offering costs | 73 | 73 | ||||||
| Restricted cash | 164 | 163 | ||||||
| Intangible assets, net | 103 | 408 | ||||||
| Operating lease right-of-use asset (See Note 8) | 2,425 | 2,594 | ||||||
| Total assets | $ | 148,546 | $ | 87,810 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,490 | $ | 5,937 | ||||
| Accrued expenses | 9,543 | 5,628 | ||||||
| Deferred revenue, current portion | 2,435 | — | ||||||
| Other liabilities, current portion (See Note 7) | — | 5,771 | ||||||
| Operating lease liability, current portion (See Note 8) | 325 | 282 | ||||||
| Warrant liabilities | 997 | — | ||||||
| Total current liabilities | 16,790 | 17,618 | ||||||
| Deferred revenue | 1,646 | — | ||||||
| Warrant liabilities | 23,638 | 18,644 | ||||||
| Convertible debt and derivative liability (See Note 7) | 11,808 | 11,001 | ||||||
| Loan payable | — | 34,393 | ||||||
| Operating lease liability (See Note 8) | 2,673 | 2,921 | ||||||
| Total liabilities | 56,555 | 84,577 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, $0.001 par value, authorized 5,000,000 shares as of September 30, 2023 and December 31, 2022; 0 shares issued and outstanding as of September 30, 2023 and December 31, 2022 | — | — | ||||||
| Common stock, $0.001 par value, 150,000,000 shares authorized as of September 30, 2023 and December 31, 2022; 37,175,815 and 32,682,342 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively | 40 | 36 | ||||||
| Additional paid-in capital | 427,612 | 425,485 | ||||||
| Accumulated deficit | (335,661 | ) | (422,288 | ) | ||||
| Total stockholders’ equity | 91,991 | 3,233 | ||||||
| Total liabilities and stockholders’ equity | $ | 148,546 | $ | 87,810 | ||||
| SCYNEXIS, INC. | ||||||||
| UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
| (in thousands, except share and per share data) | ||||||||
| Three Months Ended September 30, | ||||||||
| 2023 | 2022 | |||||||
| Revenue: | ||||||||
| Product (loss) revenue, net | $ | (614 | ) | $ | 1,557 | |||
| License agreement revenue | 2,375 | — | ||||||
| Total revenue | 1,761 | 1,557 | ||||||
| Operating expenses: | ||||||||
| Cost of product revenue | 379 | 189 | ||||||
| Research and development | 6,466 | 6,430 | ||||||
| Selling, general and administrative | 5,014 | 16,739 | ||||||
| Total operating expenses | 11,859 | 23,358 | ||||||
| (Loss) income from operations | (10,098 | ) | (21,801 | ) | ||||
| Other (income) expense: | ||||||||
| Amortization of debt issuance costs and discount | 360 | 396 | ||||||
| Interest income | (1,263 | ) | (531 | ) | ||||
| Interest expense | 212 | 1,379 | ||||||
| Warrant liabilities fair value adjustment | (7,468 | ) | 6,497 | |||||
| Derivative liabilities fair value adjustment | (182 | ) | 42 | |||||
| Total other (income) expense | (8,341 | ) | 7,783 | |||||
| (Loss) income before taxes | (1,757 | ) | (29,584 | ) | ||||
| Income tax benefit | — | — | ||||||
| Net (loss) income | $ | (1,757 | ) | $ | (29,584 | ) | ||
| Net (loss) income per share attributable to common stockholders – basic | ||||||||
| Net (loss) income per share – basic | $ | (0.04 | ) | $ | (0.62 | ) | ||
| Net (loss) income per share attributable to common stockholders – diluted | ||||||||
| Net (loss) income per share – diluted | $ | (0.04 | ) | $ | (0.62 | ) | ||
| Weighted average common shares outstanding – basic and diluted | ||||||||
| Basic | 47,891,996 | 47,503,821 | ||||||
| Diluted | 47,891,996 | 47,503,821 | ||||||
| Last Trade: | US$1.23 |
| Daily Change: | -0.08 -6.11 |
| Daily Volume: | 198,687 |
| Market Cap: | US$46.670M |
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