SCYNEXIS Reports Full Year 2024 Financial Results and Provides Corporate Update

Rhea-AI Summary

SCYNEXIS (NASDAQ: SCYX) reported its full year 2024 financial results, highlighting key developments in its antifungal pipeline. The company's Phase 1 trial of SCY-247, initiated in December 2024, is progressing with results expected in Q3 2025. The company reported a net loss of $21.3 million ($0.44 per basic share) for 2024, compared to a net income of $67.0 million in 2023.

Financial highlights include revenue of $3.7 million from the GSK license agreement and a $10 million milestone payment from GSK. R&D expenses decreased by 14.6% to $26.4 million, while SG&A expenses reduced by 30.9% to $14.5 million. The company ended 2024 with cash, cash equivalents and investments of $75.1 million, projecting runway into Q3 2026.

SCYNEXIS anticipates restarting its Phase 3 MARIO study in invasive candidiasis in Q2 2025, pending FDA's lifting of the clinical hold.

Positive

• Strong cash position of $75.1M providing runway into Q3 2026
• Received $10M milestone payment from GSK partnership
• 14.6% reduction in R&D expenses to $26.4M
• 30.9% decrease in SG&A expenses to $14.5M

Negative

• Net loss of $21.3M in 2024
• Revenue declined significantly to $3.7M from $130.1M in 2023
• Phase 3 MARIO study remains on clinical hold
• Cash position decreased from $98.0M in 2023 to $75.1M in 2024

Insights

Financial Analyst

SCYNEXIS's 2024 annual results reveal a company focused on clinical advancement with a stable financial foundation. The $21.3 million net loss ($0.44 per share) contrasts with 2023's $67.0 million net income, which was largely attributable to a one-time $130.1 million license payment from GSK. The company's $75.1 million cash position provides a substantial runway into Q3 2026, covering upcoming milestones including the expected Phase 1 results of SCY-247.

Cash burn appears well-managed, with R&D expenses reduced by 14.6% to $26.4 million and SG&A costs cut by 30.9% to $14.5 million. The $10 million milestone payment from GSK in 2024 demonstrates continued partnership value, though regular revenue remains at $3.7 million.

The FDA clinical hold on the Phase 3 MARIO study for ibrexafungerp represents a key regulatory hurdle, though management's projection for resolution in Q2 2025 suggests confidence in addressing regulatory concerns. With approximately 15 months of operational runway following the expected SCY-247 Phase 1 results, SCYNEXIS has sufficient financial flexibility to navigate near-term clinical development without immediate financing pressure.

Pharmaceutical R&D Expert

SCYNEXIS's antifungal pipeline is progressing along two strategic paths. SCY-247, their second-generation triterpenoid antifungal, has initiated dosing in Phase 1 trials with results expected in Q3 2025. The compound's preclinical data, presented at multiple scientific conferences throughout 2024, demonstrated promising activity against resistant fungal pathogens - a critical unmet need in infectious disease treatment.

The ongoing clinical hold for the Phase 3 MARIO study represents a temporary setback, though management's projection for FDA resolution in Q2 2025 suggests the company has made progress in addressing regulatory concerns. This timing indicates confidence in resuming this pivotal trial for ibrexafungerp in invasive candidiasis within months.

The acceptance of four SCY-247 presentations at the upcoming ESCMID Global congress reflects continued scientific interest in the compound's mechanism and potential. The development of novel antifungals is particularly significant given the rising incidence of drug-resistant fungal infections and the pipeline of new therapeutic options industrywide.

The completed FURI and CARES studies for ibrexafungerp, with data to be presented at ESCMID, should provide additional insights into the compound's efficacy profile. Resolving the clinical hold will be critical for advancing the company's lead asset toward potential commercialization in the invasive candidiasis indication.

• The Phase 1 trial of the second-generation triterpenoid antifungal SCY-247, initiated in December of 2024, continues and results are expected in Q3 of 2025.
  
• Four presentations for SCY-247 were accepted by the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global) congress, April 11-15, 2025 in Vienna, Austria.
  
• SCYNEXIS continues to make progress towards the restart of the Phase 3 MARIO study in invasive candidiasis. The Company anticipates the restart, pending the FDA’s lifting of the clinical hold, in the second quarter of 2025.
  
• SCYNEXIS ended 2024 with cash, cash equivalents and investments of $75.1 million, and projects a cash runway into Q3 2026.
  

JERSEY CITY, N.J., March 12, 2025 (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, 2024.

“In 2024, we achieved a key milestone with the initiation of a Phase 1 trial of our second-generation fungerp, SCY-247,” said David Angulo, M.D., President and Chief Executive Officer. “In preclinical studies, SCY-247 has consistently demonstrated highly encouraging results in a broad range of invasive fungal infections, highlighting its potential for clinical success. We believe SCY-247 has significant potential to become the next therapeutic to fight resistant fungal pathogens and look forward to completion of the trial later this year. We are also making progress towards restarting the MARIO trial, pending the lift of the clinical hold issued by the Food and Drug Administration (FDA), anticipated in the second quarter of this year.”

SCY-247 Development Program

• Dosing was initiated in a Phase 1 single and multiple ascending dose study of SCY-247, the Company’s second-generation triterpenoid antifungal in development for the treatment of severe invasive fungal infections. The company expects to release single ascending and multiple ascending dose data in Q3 of 2025.
  
• Preclinical data from studies of SCY-247 were presented at multiple medical meetings throughout 2024, including at IDWeek, the Mycoses Study Group Education & Research Consortium (MSGERC) Biennial Meeting, the Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) and the 11th Advances Against Aspergillosis and Mucormycosis (AAAM) Conference. Presentations highlighted encouraging preclinical efficacy and pharmacokinetic data of SCY-247 in multiple models of invasive fungal infections.
  
• Four presentations are planned for this year’s European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global) congress, April 11-15 2025 in Vienna, Austria.
  

Ibrexafungerp Clinical Updates

• The final activities to restart the Phase 3 MARIO study in invasive candidiasis are underway. SCYNEXIS anticipates the FDA’s clinical hold to be lifted in the second quarter of 2025.
  
• SCYNEXIS received a $10 million milestone payment from partner GSK in 2024, triggered by the delivery of final study reports from the completed FURI, CARES and NATURE studies. The data from FURI and CARES will be presented at the ESCMID Global congress, April 11-15 2025 in Vienna, Austria. For more information on the trials, please visit ClinicalTrials.gov (CARES: NCT03363841; FURI: NCT03059992).
  

Full Year 2024 Financial Results

For the full year ended December 31, 2024, revenue primarily consisted of $3.7 million in license agreement revenue associated with the GSK license agreement. For the year ended December 31, 2023, revenue primarily consisted of the $130.1 million recognized upon the transfer of the license associated with the GSK License Agreement in May 2023.

Research and development expense for the full year ended December 31, 2024 decreased to $26.4 million compared to $30.9 million for the same period in 2023. The decrease of $4.5 million, or 14.6%, was primarily driven by a decrease of $7.4 million in clinical expense, a decrease of $1.3 million in salary expense primarily associated with medical affairs, and a net decrease in other research and development expense of $0.4 million, offset in part by an increase of $3.9 million in chemistry, manufacturing, and controls (CMC) expense, and an increase of $0.7 million in preclinical expense.

SG&A expense for the full year ended December 31, 2024 decreased to $14.5 million from $20.9 million for the same period in 2023. The decrease of $6.5 million, or 30.9%, was primarily driven by a decrease of $5.8 million in professional fees and a decrease of $0.9 million in commercial expense due to the costs incurred in the prior period associated with BREXAFEMME, offset by a net increase of $0.2 million in other selling, general, and administrative expense.

Total other income was $16.0 million for the full year ended December 31, 2024, versus total other expense of $5.5 million for the same period in 2023. The variance is mainly due to the fair value adjustment related to the warrant liabilities. For the years ended December 31, 2024 and 2023, we recognized a gain of $13.8 million and a loss of $3.2 million, respectively, for the fair value adjustment for warrant liabilities primarily due to the decrease and increase in our stock price during the periods, respectively.

Net loss for the full year ended December 31, 2024, was $21.3 million, or $0.44 basic loss per share, compared to a net income of $67.0 million, or $1.40 basic earnings per share and $1.39 diluted earnings per share for the same period in 2023.

Cash Balance

Cash, cash equivalents and investments totaled $75.1 million on December 31, 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 into Q3 2026.

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 clinical, pre- clinical and discovery phases, 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 into Q3 2026; the expectation to release single ascending and multiple ascending dose data from the SCY-247 Phase 1 study in Q3 of 2025; the clinical and commercial potential for SCY-247; and the anticipated lifting of the clinical hold of the Phase 3 MARIO study in Q2 of 2025. 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 12, 2025, 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,
		2024				2023
Revenue:
Product revenue, net		$	—			$	1,044
License agreement revenue			3,746				139,097
Total revenue			3,746				140,141
Operating expenses:
Cost of product revenue			—				15,624
Research and development			26,405				30,928
Selling, general and administrative			14,458				20,920
Total operating expenses			40,863				67,472
(Loss) income from operations			(37,117	)			72,669
Other expense (income):
Amortization of debt issuance costs and discount			1,726				2,994
Interest income			(4,291	)			(3,954	)
Interest expense			828				3,130
Other income			(235	)			—
Warrant liabilities fair value adjustment			(13,812	)			3,166
Derivative liability fair value adjustment			(196	)			154
Total other (income) expense			(15,980	)			5,490
(Loss) income before taxes			(21,137	)			67,179
Income tax (expense)			(151	)			(138	)
Net (loss) income		$	(21,288	)		$	67,041
Net (loss) income per share attributable to common stockholders – basic
Net (loss) income per share – basic		$	(0.44	)		$	1.40
Net (loss) income per share attributable to common stockholders – diluted
Net (loss) income per share – diluted		$	(0.44	)		$	1.39
Weighted average common shares outstanding – basic and diluted
Basic			48,513,073				47,852,833
Diluted			48,513,073				48,390,582

SCYNEXIS, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
		December 31, 2024				December 31, 2023
Assets
Current assets:
Cash and cash equivalents		$	16,051			$	34,050
Short-term investments			43,249				40,312
Prepaid expenses and other current assets			2,184				5,548
License agreement receivable			753				2,463
License agreement contract asset			9,509				19,363
Restricted cash			435				380
Total current assets			72,181				102,116
Investments			15,846				23,594
Deferred offering costs			417				175
Restricted cash			109				163
Operating lease right-of-use asset			2,090				2,364
Total assets		$	90,643			$	128,412
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable		$	4,569			$	7,149
Accrued expenses			3,793				7,495
Deferred revenue, current portion			1,642				1,189
Operating lease liability, current portion			407				340
Warrant liabilities			—				130
Convertible debt and derivative liability			13,688				—
Total current liabilities			24,099				16,303
Deferred revenue			1,294				2,727
Warrant liabilities			7,998				21,680
Convertible debt and derivative liability			—				12,159
Operating lease liability			2,175				2,581
Total liabilities			35,566				55,450
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $0.001 par value, authorized 5,000,000 shares as of December 31, 2024 and December 31, 2023; 0 shares issued and outstanding as of December 31, 2024 and December 31, 2023			—				—
Common stock, $0.001 par value, 150,000,000 shares authorized as of December 31, 2024 and 2023; 37,973,991 and 37,207,799 shares issued and outstanding as of December 31, 2024, and December 31, 2023, respectively			41				40
Additional paid-in capital			431,571				428,169
Accumulated deficit			(376,535	)			(355,247	)
Total stockholders’ equity			55,077				72,962
Total liabilities and stockholders’ equity		$	90,643			$	128,412

FAQ

What are the key financial results for SCYX in 2024?

SCYNEXIS reported $3.7M in revenue, $21.3M net loss ($0.44 per share), with $75.1M in cash and investments as of December 31, 2024.

When will SCYX's Phase 1 trial results for SCY-247 be available?

Results from the SCY-247 Phase 1 trial are expected in Q3 2025.

What is the cash runway projection for SCYNEXIS (SCYX)?

SCYNEXIS projects its current cash position of $75.1M will provide runway into Q3 2026.

When is SCYX expecting to restart the Phase 3 MARIO study?

SCYNEXIS anticipates restarting the Phase 3 MARIO study in Q2 2025, pending FDA's lifting of the clinical hold.

How much did SCYX receive in milestone payment from GSK in 2024?

SCYNEXIS received a $10 million milestone payment from GSK in 2024.