SCYNEXIS Reports First Quarter 2025 Financial Results and Provides Corporate Update

Rhea-AI Summary

SCYNEXIS (NASDAQ: SCYX) reported Q1 2025 financial results and key developments. The FDA lifted the clinical hold on ibrexafungerp, but SCYNEXIS faces a disagreement with GSK regarding the restart of the Phase 3 MARIO study for invasive candidiasis treatment. GSK maintains commitment to Brexafemme commercialization. In China, Hansoh received NMPA approval for ibrexafungerp in acute VVC treatment, triggering future milestone payments and ~10% royalties. The company presented positive preclinical data for SCY-247, its second-generation fungerp candidate, with Phase 1 results expected in Q3 2025. Financial highlights include: Q1 net loss of $5.4 million ($0.11 per share), revenue of $0.3 million, and cash position of $53.8 million providing runway into Q3 2026.

Positive

• FDA lifted clinical hold on ibrexafungerp, allowing Phase 3 MARIO study to resume
• Hansoh received Chinese NMPA approval for ibrexafungerp in VVC treatment, leading to milestone payment and 10% royalties
• Positive preclinical data for SCY-247 showing potent antifungal activity against multi drug-resistant fungi
• Strong cash position of $53.8M providing runway into Q3 2026
• 29% decrease in R&D expenses from $7.2M to $5.1M year-over-year

Negative

• Disagreement with GSK over MARIO study termination could impact partnership
• Revenue decreased significantly from $1.4M in Q1 2024 to $0.3M in Q1 2025
• Net loss of $5.4M in Q1 2025 compared to net income of $0.4M in Q1 2024
• Cash position decreased from $75.1M to $53.8M quarter-over-quarter

Insights

Biotech Financial Analyst

FDA lifting ibrexafungerp's clinical hold is positive, but GSK dispute over MARIO study creates uncertainty despite strong cash position.

SCYNEXIS's Q1 2025 results contain several significant developments that paint a mixed picture for investors. The FDA lifting the clinical hold on ibrexafungerp marks a crucial regulatory milestone and removes a major barrier to the company's lead program. However, the subsequent disagreement with GSK over the continuation of the Phase 3 MARIO study introduces significant uncertainty. While GSK has expressed continued commitment to commercializing Brexafemme for VVC indications, this dispute raises questions about the partnership's stability.

On the positive side, Hansoh's approval in China for ibrexafungerp in acute VVC will trigger milestone payments and approximately 10% royalties on sales, creating a new revenue stream. The SCY-247 program is advancing with positive preclinical data and Phase 1 results expected in Q3 2025, potentially expanding SCYNEXIS's antifungal portfolio.

Financially, SCYNEXIS has a cash position of $53.8 million, providing runway into Q3 2026 after repaying $14 million in convertible notes. The 29% reduction in R&D expenses (from $7.2 million to $5.1 million) reflects tighter cost controls. However, revenue dropped significantly from $1.4 million to $0.3 million, and the company reported a net loss of $5.4 million compared to net income of $0.4 million in the same period last year.

The WHO's recognition of invasive candidiasis as an area of unmet need with limited treatment options validates SCYNEXIS's strategic focus, but the GSK dispute creates near-term execution risk for the MARIO study that investors should monitor closely.

Pharmaceutical Industry Expert

FDA clinical hold removal is promising, but GSK partnership strain and weak revenue offset by solid pipeline progress.

The resolution of the FDA clinical hold on ibrexafungerp represents an important regulatory clearance for SCYNEXIS, particularly in the context of developing treatments for invasive candidiasis, an area highlighted by the WHO as having significant unmet needs. The removal of this regulatory barrier should enable the resumption of the MARIO Phase 3 trial, a crucial program for expanding ibrexafungerp's potential market.

However, the disagreement with GSK regarding the continuation of the MARIO study is concerning. While GSK has reiterated commitment to commercializing Brexafemme for VVC and rVVC indications, this dispute signals potential partnership strain. The language suggesting SCYNEXIS is "seeking to resolve this disagreement" while simultaneously "resuming the MARIO study" indicates a complex situation that could impact development timelines and costs.

The approval from China's NMPA for Hansoh to commercialize ibrexafungerp for acute VVC represents a validation of the drug's potential and opens access to the large Chinese market. The 10% royalty structure provides SCYNEXIS with meaningful economics without commercial infrastructure investment in China.

On the pipeline front, SCY-247 is showing promise as a second-generation fungerp with potent activity against multi-drug resistant fungi, a growing global health concern. The Phase 1 trial progression demonstrates SCYNEXIS's commitment to building a broader antifungal portfolio despite challenges with their lead asset.

The company's financial discipline is evident in the 29% reduction in R&D expenses, though the significant drop in revenue related to the GSK agreement (from $1.4 million to $0.3 million) raises questions about the health of this key partnership. The $53.8 million cash position provides sufficient runway to navigate current challenges while advancing key programs.

• Ibrexafungerp clinical hold lifted by the FDA. SCYNEXIS working to resolve a disagreement with GSK involving the restart of the MARIO study. GSK remains committed to the commercialization of Brexafemme.
  
  
• Hansoh recently received Chinese (NMPA) approval for ibrexafungerp in the treatment of acute VVC. SCYNEXIS will receive a milestone payment from Hansoh upon commercialization as well as royalties of approximately 10% on China sales.
  
  
• Presented positive preclinical data for its second-generation fungerp candidate, SCY-247, at the European Society of Clinical Microbiology and Infectious Disease (ESCMID) meeting; Company expects to report initial Phase 1 data for SCY-247 in Q3 2025.   
  
  
• SCYNEXIS ended Q1 2025 with cash, cash equivalents and investments of $53.8 million and projects a cash runway into Q3 2026.
  
  

JERSEY CITY, N.J., May 15, 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 first quarter ended March 31, 2025.

“The lifting of the clinical hold for ibrexafungerp was an important achievement for our company. While seeking to resolve the disagreement with GSK, we are moving forward with the Phase 3 MARIO study. Our second-generation fungerp candidate, SCY-247, continues to progress, with Phase 1 study results expected in the upcoming months,” said David Angulo, M.D., President and Chief Executive Officer.

“SCYNEXIS remains committed to developing novel antifungal solutions to the rising threat of deadly fungal infections including invasive candidiasis for which there are limited treatment options and significant concerns for emergence of resistances, as highlighted by the WHO in their call to industry and other parties for research, development and public health action in this area of unmet need,” he added.  

Ibrexafungerp / GSK Developments

• In late April, the FDA notified SCYNEXIS that the clinical hold on ibrexafungerp had been lifted and concluded that the Phase 3 MARIO study could resume. The MARIO study is a Phase 3 trial evaluating ibrexafungerp for the treatment of invasive candidiasis. Subsequently GSK notified SCYNEXIS of their intention to immediately terminate the study. SCYNEXIS does not believe that GSK currently has the right to unilaterally terminate the MARIO study under the license agreement with GSK (GSK License Agreement) and is seeking to resolve this disagreement. Meanwhile, SCYNEXIS is resuming the MARIO study with the goal of having subjects enrolled in the coming weeks. While at this time it is too early to say how this disagreement regarding the MARIO study may be resolved, GSK has reiterated its commitment to continued collaboration regarding other aspects of the GSK License Agreement, including with respect to the commercialization of BREXAFEMME for the VVC and rVVC indications.
  

SCY-247 Development Program

• Presented positive preclinical efficacy data on its second-generation fungerp candidate SCY-247 at the ESCMID meeting, which took place in Vienna, Austria from April 11-15, 2025. Data from the four presentations continues to build upon SCY-247’s positive profile illustrating its unique attributes in the fight against difficult-to-treat fungal infections, including its potent antifungal activity against multi drug-resistant fungi.
• In December 2024, the Company initiated a randomized, double-blind, placebo-controlled Phase 1 study of single and multiple ascending doses of oral SCY-247 in approximately 100 healthy subjects. The primary endpoint is safety and tolerability, and the secondary endpoint is pharmacokinetics. Single ascending and multiple ascending dose data are expected in Q3 2025.

First Quarter 2025 Financial Results

For the three months ended March 31, 2025 and 2024, revenue primarily consists of $0.3 million and $1.4 million, respectively, in license agreement revenue associated with the GSK License Agreement.

Research and development expense for the three months ended March 31, 2025, was $5.1 million compared to $7.2 million for the same period in 2024. The decrease of $2.1 million, or 29%, for the three months ended March 31, 2025, was primarily driven by a decrease of $1.6 million in chemistry, manufacturing, and controls expense, a decrease of $0.8 million in clinical expense, and a net decrease in other research and development expense of $0.1 million, offset in part by an increase of $0.4 million in preclinical expense.

SG&A expense for the three months ended March 31, 2025, remained consistent with the prior comparable period at $3.7 million.

Total other income was $3.2 million for the three months ended March 31, 2025, versus total other income of $10.5 million for the same period in 2024. The variance is mainly due to the fair value adjustment related to the warrant liabilities. For the three months ended March 31, 2025 and 2024, we recognized gains of $2.9 million and $9.6 million, respectively, on the 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 March 31, 2025 was $5.4 million, or $(0.11) basic loss per share, compared to net income of $0.4 million, or $0.01 basic income per share for the same period in 2024.

Cash Balance

Cash, cash equivalents and investments totaled $53.8 million on March 31, 2025, compared to $75.1 million on December 31, 2024. The Company repaid $14.0 million of March 2019 convertible notes due in March 2025 in the first quarter. 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 2025; the plans and expectations regarding the MARIO study and outcome of discussions with GSK; and the clinical and commercial potential for SCY-247. 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.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
	Three Months Ended March 31,
		2025				2024
License agreement revenue	$	257			$	1,373
Operating expenses:
Research and development		5,141				7,212
Selling, general and administrative		3,726				3,669
Total operating expenses		8,867				10,881
Loss from operations		(8,610	)			(9,508	)
Other (income) expense:
Amortization of debt issuance costs and discount		312				401
Interest income		(776	)			(1,280	)
Interest expense		173				205
Warrant liability fair value adjustment		(2,928	)			(9,608	)
Derivative liability fair value adjustment		—				(168	)
Total other income		(3,219	)			(10,450	)
(Loss) income before taxes		(5,391	)			942
Income tax expense		—				(531	)
Net (loss) income	$	(5,391	)		$	411
Net (loss) income per share attributable to common stockholders – basic
Net (loss) income per share – basic	$	(0.11	)		$	0.01
Net (loss) income per share attributable to common stockholders – diluted
Net (loss) income per share – diluted	$	(0.11	)		$	0.01
Weighted average common shares outstanding – basic and diluted
Basic		49,435,500				48,245,559
Diluted		49,435,500				48,565,051

SCYNEXIS, INC.
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
	March 31, 2025				December 31, 2024
Assets
Current assets:
Cash and cash equivalents	$	6,942			$	16,051
Short-term investments		33,665				43,249
Prepaid expenses and other current assets		1,454				2,184
License agreement receivable		216				753
License agreement contract asset		9,509				9,509
Restricted cash		435				435
Total current assets		52,221				72,181
Investments		13,155				15,846
Deferred offering costs		417				417
Restricted cash		109				109
Operating lease right-of-use asset		2,013				2,090
Total assets	$	67,915			$	90,643
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	4,260			$	4,569
Accrued expenses		2,630				3,793
Deferred revenue, current portion		1,642				1,642
Operating lease liability, current portion		425				407
Convertible debt		—				13,688
Total current liabilities		8,957				24,099
Deferred revenue		1,294				1,294
Warrant liability		5,070				7,998
Operating lease liability		2,062				2,175
Total liabilities		17,383				35,566
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $0.001 par value, authorized 5,000,000 shares as of March 31, 2025 and December 31, 2024; 0 shares issued and outstanding as of March 31, 2025 and December 31, 2024		—				—
Common stock, $0.001 par value, 150,000,000 shares authorized as of March 31, 2025 and December 31, 2024; 39,020,274 and 37,973,991 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively		42				41
Additional paid-in capital		432,416				431,571
Accumulated deficit		(381,926	)			(376,535	)
Total stockholders’ equity		50,532				55,077
Total liabilities and stockholders’ equity	$	67,915			$	90,643

FAQ

What caused the FDA to lift the clinical hold on SCYX's ibrexafungerp?

The FDA lifted the clinical hold on ibrexafungerp in late April 2025, concluding that the Phase 3 MARIO study could resume. The specific reasons for lifting the hold were not detailed in the press release.

What is the current cash position of SCYNEXIS (SCYX) and how long will it last?

SCYNEXIS had $53.8 million in cash, cash equivalents and investments as of March 31, 2025, which is expected to provide runway into Q3 2026.

What is the dispute between SCYNEXIS and GSK regarding the MARIO study?

After the FDA lifted the clinical hold, GSK notified SCYNEXIS of their intention to immediately terminate the MARIO study. SCYNEXIS disputes GSK's right to unilaterally terminate the study under their license agreement and is seeking to resolve this disagreement.

What are the financial results of SCYNEXIS (SCYX) for Q1 2025?

SCYNEXIS reported Q1 2025 revenue of $0.3 million, R&D expenses of $5.1 million, SG&A expenses of $3.7 million, and a net loss of $5.4 million ($0.11 per share).

What progress has SCYNEXIS made with SCY-247 development?

SCYNEXIS presented positive preclinical efficacy data for SCY-247 at ESCMID, showing potent antifungal activity against multi drug-resistant fungi. A Phase 1 study is ongoing with results expected in Q3 2025.