SCYNEXIS Reports Full Year 2023 Financial Results and Provides Corporate Update
- SCYNEXIS ended 2023 with $98.0 million in cash, cash equivalents, and investments.
- SCY-247's Phase I initiation is anticipated in the second half of 2024.
- Positive top-line data from the CARES study aligns with previously disclosed results.
- SCYNEXIS made significant progress in 2023, monetizing BREXAFEMME® and advancing SCY-247 development.
- Physician interest in SCYNEXIS's antifungal treatments is growing, with presentations at medical conferences showcasing promising preclinical data.
- Cost of product revenue increased due to an impairment loss on raw material inventory.
- Total other expense was $5.5 million for 2023.
- Net income for 2023 was $67.0 million, compared to a net loss of $62.8 million in the previous year.
Insights
The financial results of SCYNEXIS, Inc. for the year ended December 31, 2023, show a substantial increase in license agreement revenue from $103 thousand in 2022 to $139 million in 2023. This dramatic increase is primarily attributed to the $130.1 million recognized from the GSK License Agreement. The net product revenue from BREXAFEMME, however, decreased from $5.0 million in 2022 to $1.0 million in 2023, which may be a point of concern for investors. The reported impairment loss of $14.6 million due to potential cross-contamination issues indicates a significant operational setback and could impact investor confidence. On the upside, the company's cash position improved, with $98.0 million at the end of 2023 compared to $73.5 million at the end of 2022, suggesting a solid liquidity status and a runway of over two years. This financial stability is important for supporting ongoing R&D efforts and mitigating the impact of increased R&D expenses, which rose by 14% from the previous year. The anticipated $10 million milestone payment from GSK in the first half of 2024 could further strengthen the company's financial position.
The progress of SCYNEXIS in advancing its antifungal platform, particularly SCY-247, is poised to address a critical need in the treatment of invasive fungal infections. The positive top line data from the CARES study and the ongoing preclinical work supported by NIH grants underscore the potential of SCY-247 to become a significant player in the antifungal market. The upcoming Phase I initiation in the second half of 2024 marks a key milestone in the drug's development pathway. The efficacy of SCY-247 against a broad range of fungal pathogens, including multi-drug resistant strains, positions the compound as a promising candidate in the fight against antimicrobial resistance. The collaboration with GSK, despite the revised deal terms, still represents a strong endorsement and could accelerate the clinical and regulatory progress of ibrexafungerp. The medical community's increasing awareness and enthusiasm for the fungerp class, as evidenced by presentations at medical conferences, could facilitate future adoption and commercial success.
The antifungal drug market is witnessing an increasing demand due to the rise in antimicrobial resistance and the limited number of effective treatments available. SCYNEXIS's strategic focus on this area, particularly its next-generation compound SCY-247, aligns with market needs and could capture significant market share if clinical trials prove successful. The decrease in SG&A expenses by 67% reflects a strategic shift in resource allocation, likely prioritizing R&D over commercialization efforts in the short term. This could position the company for long-term growth, as successful R&D outcomes may lead to lucrative commercial opportunities. Furthermore, the positive scientific reception of SCY-247 at conferences suggests a growing market interest, which could bode well for future commercialization efforts. The partnership with GSK, despite the reduced potential value, still offers substantial financial incentives for SCYNEXIS, including milestone payments and royalties, which can be a catalyst for future stock performance.
- SCY-247’s IND-enabling activities continue to advance with initiation of Phase I anticipated in the second half of 2024
- Data analysis for the FURI study is ongoing; top line data from the CARES study has been received and is positive and consistent with previously disclosed results from interim analyses
- The clinical study reports for FURI, CARES and NATURE in refractory invasive fungal infections are on target for delivery to GSK in the first half of 2024 which would trigger a
$10 million development milestone payment to SCYNEXIS
- SCYNEXIS ended 2023 with cash, cash equivalents and investments of
$98.0 million and projects a cash runway of more than two years
JERSEY CITY, N.J., March 28, 2024 (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 year ended December 31, 2023.
“SCYNEXIS had a year of significant progress in 2023, laying the foundation for future success by monetizing our first antifungal, BREXAFEMME®, and progressing the development of SCY-247, our next generation compound,” said David Angulo, M.D., President and Chief Executive Officer. “SCY-247 continues to demonstrate highly encouraging preclinical results, with potent activity against a broad range of fungal pathogens, including mucormycosis. We look forward to continuing IND-enabling activities, culminating in the initiation of the first Phase I clinical study later this year. We are working diligently toward the resumption of the MARIO Phase III study of ibrexafungerp in invasive candidiasis and, with our strong cash balance, we are well-positioned to continue advancing SCY-247 as the next potential weapon in the fight against deadly fungal infections.”
SCY-247 Preclinical Development Program
- Phase I enabling development activities for SCY-247, the next generation fungerp from SCYNEXIS’ proprietary antifungal platform, continue to progress. A portion of these activities, including assessing the compound’s activity against Candida auris and Mucorales, are being supported by National Institute of Health (NIH) grants. Phase I initiation is anticipated in the second half of 2024.
Ibrexafungerp Clinical and Regulatory Updates
- In March 2023, SCYNEXIS and GSK entered into an exclusive license agreement for the development, manufacturing and commercialization of ibrexafungerp (BREXAFEMME). The agreement was amended in December of 2023 in connection with the delay in the commercialization of BREXAFEMME and further clinical development of ibrexafungerp associated with the potential cross contamination of ibrexafungerp drug substance with a non-antibacterial beta lactam compound. The deal has a total potential value of
$448 million plus royalties (revised from$593 million plus royalties), including development milestone payments of up to$72.35 million , regulatory approval milestone payments of up to$49 million , commercial milestone payments of up to$57.5 million based on the first commercial sale in invasive candidiasis, and sales milestone payments of up to$179.5 million . SCYNEXIS is eligible to receive royalty payments based on cumulative global annual sales of Ibrexafungerp in the mid-single digit to mid-teen range. To date, SCYNEXIS has received an upfront payment of$90 million and a development milestone of$25 million .
- Final study reports from the completed FURI, CARES, SCYNERGIA, NATURE, and VANQUISH studies are anticipated to be delivered to GSK in the first half of 2024, which would trigger a
$10 million development milestone payment to SCYNEXIS. Top line data from the CARES study is positive and consistent with previously disclosed results from interim analyses. It is anticipated that the CARES data will be presented at a future scientific meeting.
Scientific Presentations
Physician awareness and enthusiasm towards the fungerp class addressing critical antimicrobial resistant threats continues to build at medical conferences.
- Presented preclinical efficacy data on SCY-247 for the treatment of mucormycosis at the 11th Advances Against Aspergillosis and Mucormycosis (AAAM) Conference held in Milan, Italy January 25 – 27, 2024. The poster featured results from a study in a highly lethal mouse model of mucormycosis that demonstrated statistically significant improvement in overall survival and reduced fungal burden following treatment with SCY-247 alone and in combination with standard of care liposomal amphotericin B (LAMB) compared to placebo.
- Presented preclinical data on SCY-247 at the 11th Congress on Trends in Medical Mycology (TIMM) held in Athens, Greece October 20-23, 2023. The oral presentation featured a preclinical study that demonstrated potent and broad-spectrum activity of SCY-247 against a range of fungal pathogens, including multi-drug resistant strains, in in vitro and in vivo models.
Full Year 2023 Financial Results
License agreement revenue was
Cost of product revenue was
Research and development expense for the full year 2023 increased to
SG&A expense for the full year 2023 decreased to
Total other expense was
Net income for the full year 2023, was
Cash Balance
Cash, cash equivalents and investments totaled
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 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; delivery of clinical study reports to GSK in the first half of 2024, anticipated initiation of Phase I clinical studies of SCY-247 in the second half of 2024; and the resumption of the 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 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
ikoffler@lifesciadvisors.com
| SCYNEXIS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data) | |||||||
| Years Ended December 31, | |||||||
| 2023 | 2022 | ||||||
| Revenue: | |||||||
| Product revenue, net | $ | 1,044 | $ | 4,988 | |||
| License agreement revenue | 139,097 | 103 | |||||
| Total revenue | 140,141 | 5,091 | |||||
| Operating expenses: | |||||||
| Cost of product revenue | 15,624 | 628 | |||||
| Research and development | 30,928 | 27,259 | |||||
| Selling, general and administrative | 20,920 | 62,961 | |||||
| Total operating expenses | 67,472 | 90,848 | |||||
| Income (loss) from operations | 72,669 | (85,757 | ) | ||||
| Other expense (income): | |||||||
| Amortization of debt issuance costs and discount | 2,994 | 1,589 | |||||
| Interest income | (3,954 | ) | (1,415 | ) | |||
| Interest expense | 3,130 | 5,198 | |||||
| Other income | — | (3 | ) | ||||
| Warrant liabilities fair value adjustment | 3,166 | (22,301 | ) | ||||
| Derivative liability fair value adjustment | 154 | (1,316 | ) | ||||
| Total other expense (income) | 5,490 | (18,248 | ) | ||||
| Income (loss) before taxes | 67,179 | (67,509 | ) | ||||
| Income tax (expense) benefit | (138 | ) | 4,700 | ||||
| Net income (loss) | $ | 67,041 | $ | (62,809 | ) | ||
| Net income (loss) per share attributable to common stockholders – basic | |||||||
| Net income (loss) per share – basic | $ | 1.40 | $ | (1.47 | ) | ||
| Net income (loss) per share attributable to common stockholders – diluted | |||||||
| Net income (loss) per share – diluted | $ | 1.39 | $ | (1.47 | ) | ||
| Weighted average common shares outstanding – basic and diluted | |||||||
| Basic | 47,852,833 | 42,613,510 | |||||
| Diluted | 48,390,582 | 42,613,510 | |||||
| SCYNEXIS, INC. CONSOLIDATED BALANCE SHEETS (in thousands, except share and per share data) | |||||||
| December 31, 2023 | December 31, 2022 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 34,050 | $ | 45,814 | |||
| Short-term investments | 40,312 | 27,689 | |||||
| Prepaid expenses and other current assets | 5,548 | 2,503 | |||||
| License agreement receivable | 2,463 | — | |||||
| License agreement contract asset | 19,363 | — | |||||
| Accounts receivable, net | — | 2,101 | |||||
| Inventory, net | — | 899 | |||||
| Restricted cash | 380 | 55 | |||||
| Total current assets | 102,116 | 79,061 | |||||
| Investments | 23,594 | — | |||||
| Other assets | — | 5,511 | |||||
| Deferred offering costs | 175 | 73 | |||||
| Restricted cash | 163 | 163 | |||||
| Intangible assets, net | — | 408 | |||||
| Operating lease right-of-use asset | 2,364 | 2,594 | |||||
| Total assets | $ | 128,412 | $ | 87,810 | |||
| Liabilities and stockholders’ equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 7,149 | $ | 5,937 | |||
| Accrued expenses | 7,495 | 5,628 | |||||
| Deferred revenue, current portion | 1,189 | — | |||||
| Other liabilities, current portion | — | 5,771 | |||||
| Operating lease liability, current portion | 340 | 282 | |||||
| Warrant liabilities | 130 | — | |||||
| Total current liabilities | 16,303 | 17,618 | |||||
| Deferred revenue | 2,727 | — | |||||
| Warrant liabilities | 21,680 | 18,644 | |||||
| Convertible debt and derivative liability | 12,159 | 11,001 | |||||
| Loan payable | — | 34,393 | |||||
| Operating lease liability | 2,581 | 2,921 | |||||
| Total liabilities | 55,450 | 84,577 | |||||
| Commitments and contingencies | |||||||
| Stockholders’ equity: | |||||||
| Preferred stock, | — | — | |||||
| Common stock, | 40 | 36 | |||||
| Additional paid-in capital | 428,169 | 425,485 | |||||
| Accumulated deficit | (355,247 | ) | (422,288 | ) | |||
| Total stockholders’ equity | 72,962 | 3,233 | |||||
| Total liabilities and stockholders’ equity | $ | 128,412 | $ | 87,810 | |||
FAQ
When is the Phase I initiation for SCY-247 expected?
What was SCYNEXIS's cash balance at the end of 2023?
What milestone payment would trigger a $10 million development payment to SCYNEXIS?
What was the license agreement revenue for SCYNEXIS in 2023?
Where was preclinical efficacy data on SCY-247 presented?
What is the total potential value of the license agreement with GSK for ibrexafungerp?
