SCYNEXIS Reports Second Quarter 2024 Financial Results and Provides Corporate Update

Rhea-AI Summary

SCYNEXIS (NASDAQ: SCYX) reported Q2 2024 financial results and provided a corporate update. Key highlights include:

1. Delivery of clinical study reports for FURI, CARES, and NATURE trials to GSK, triggering a $10 million milestone payment.

2. Progress on SCY-247's IND-enabling activities, with Phase 1 study planned for Q4 2024.

3. Q2 2024 ended with $83.7 million in cash, projecting a runway of over two years.

4. Q2 2024 financial results: $0.7 million revenue, $6.8 million R&D expense, $3.2 million SG&A expense, and a net loss of $14.5 million ($0.30 per share).

5. Ongoing work to restart the Phase 3 MARIO study in invasive candidiasis.

Positive

• $10 million milestone payment from GSK expected in Q3 2024
• Cash runway projected for more than two years
• Progress in SCY-247 development with Phase 1 study planned for Q4 2024
• Decrease in R&D and SG&A expenses compared to Q2 2023

Negative

• Net loss of $14.5 million in Q2 2024
• Significant decrease in revenue from $130.1 million in Q2 2023 to $0.7 million in Q2 2024
• Loss of $5.8 million on fair value adjustment for warrant liabilities

Insights

Financial Analyst

SCYNEXIS's Q2 2024 results reveal a mixed financial picture. The company's revenue dropped significantly from $130.1 million in Q2 2023 to just $0.7 million in Q2 2024, primarily due to the one-time license agreement revenue with GSK in the previous year. However, the company's cost management efforts are evident, with R&D expenses slightly decreasing and SG&A expenses dropping by 58%.

The cash position remains strong at $83.7 million, with an additional $10 million milestone payment expected in Q3. This, combined with reduced expenses, supports the company's projection of a cash runway beyond two years, providing financial stability for ongoing research and development efforts.

The net loss of $14.5 million in Q2 2024, compared to a net income of $122.3 million in Q2 2023, reflects the impact of the one-time revenue event last year and highlights the importance of milestone payments and potential future commercialization for the company's long-term financial health.

Medical Research Analyst

SCYNEXIS's clinical progress is encouraging, particularly with the completion of FURI, CARES and NATURE studies for ibrexafungerp in refractory or resistant invasive fungal infections. The positive top-line results, consistent with previous interim analyses, suggest potential efficacy in this challenging therapeutic area.

The company's pipeline development is progressing well. The advancement of SCY-247, their next-generation fungerp, shows promise with robust preclinical results against a broad range of invasive fungal pathogens. The planned Phase 1 study initiation in Q4 2024 indicates steady progress in bringing this potential new treatment to clinical trials.

However, the delay in the Phase 3 MARIO study for invasive candidiasis due to manufacturing issues is a setback. The company's efforts to reestablish the clinical supply chain are important for maintaining momentum in this important late-stage trial. Overall, SCYNEXIS's research pipeline appears solid, with potential to address significant unmet needs in antifungal therapy.

• 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. (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 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. (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; 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
ikoffler@lifesciadvisors.com

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

FAQ

What milestone did SCYNEXIS (SCYX) achieve in Q2 2024?

SCYNEXIS delivered clinical study reports for the FURI, CARES, and NATURE trials to GSK, triggering a $10 million development milestone payment expected in Q3 2024.

When is SCYNEXIS (SCYX) planning to initiate the Phase 1 study for SCY-247?

SCYNEXIS plans to initiate the Phase 1 study for SCY-247 in Q4 2024.

What was SCYNEXIS's (SCYX) cash position at the end of Q2 2024?

SCYNEXIS ended Q2 2024 with $83.7 million in cash, cash equivalents, and investments.

What was SCYNEXIS's (SCYX) net loss for Q2 2024?

SCYNEXIS reported a net loss of $14.5 million, or $0.30 basic loss per share, for Q2 2024.