SCY-247’s IND-enabling activities continue to progress, with initiation of Phase I anticipated in the second half of 2024
Clinical study reports for the FURI, CARES and NATURE trials in refractory invasive fungal infections remain on track for delivery to GSK in mid 2024, which would trigger a $10 million development milestone payment to SCYNEXIS
SCYNEXIS ended Q1 2024 with cash, cash equivalents and investments of $94.2 million and projects a cash runway of more than two years
JERSEY CITY, N.J., May 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 first quarter ended March 31, 2024.
“We continue to be impressed by the highly promising preclinical results of our next generation compound SCY-247,” said David Angulo, M.D., President and Chief Executive Officer. “SCY-247 consistently demonstrates potent activity against a broad range of invasive fungal pathogens, including resistant species for whom there are few or no treatment options. We plan to begin a Phase I trial by year-end. In response to the hold on clinical studies of ibrexafungerp due to possible beta-lactam cross contamination, we have entered into certain new manufacturing agreements with third-party contract manufacturers to begin producing new batches of ibrexafungerp. We believe this new material will allow us to lift the clinical hold and restart the Phase 3 MARIO study evaluating ibrexafungerp in patients with invasive candidiasis."
SCY-247 Preclinical Development Program
Phase I-enabling development activities for SCY-247, the second generation fungerp from SCYNEXIS’ proprietary antifungal platform, continue to progress. A portion of these activities, including assessing SCY-247 efficacy 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.
Presented preclinical efficacy data on SCY-247 at the Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global, formerly ECCMID) in Barcelona, Spain from April 27-30, 2024. An oral presentation presented by Nathan Wiederhold, Ph.D. featured an in vivo study that demonstrated significant fungal burden reduction in the kidneys and lungs of mice with Candida glabrata invasive candidiasis treated with SCY-247. Additional poster presentations highlighted potent in vitro activity of SCY-247 on a broad range of susceptible and multidrug-resistant pathogenic fungi.
Ibrexafungerp Clinical and Regulatory Updates
Final study reports from the completed FURI, CARES, NATURE, SCYNERGIA, and VANQUISH studies are anticipated to be delivered to partner GSK in mid 2024, delivery of the first three of which would trigger a $10 million development milestone payment to SCYNEXIS. Data analysis for the FURI study is ongoing, and top line data from the CARES study are positive and consistent with previously disclosed results from interim analyses.
First Quarter 2024 Financial Results
For the three months ended March 31, 2024, revenue consists of the $1.4 million in license agreement revenue associated with the license agreement with GSK. For the three months ended March 31, 2023, revenue consisted of $1.1 million product sales of BREXAFEMME.
Research and development expense for the quarter ended March 31, 2024 was $7.2 million compared to $6.8 million for the same period in 2023. The increase of $0.4 million, or 6%, for the three months ended March 31, 2024, was primarily driven by an increase of $1.6 million in chemistry, manufacturing, and controls (CMC) expense and a $0.3 million increase in preclinical expense, offset in part by a $0.8 million decrease in clinical expense and a decrease of $0.5 million in salaries primarily associated with medical affairs.
SG&A expense for the quarter ended March 31, 2024 decreased to $3.7 million from $4.8 million for the same period in 2023. The decrease of $1.2 million, or 24%, for the three months ended March 31, 2024, was primarily driven by a decrease of $0.8 million in professional fees and a decrease of $0.4 million in commercial expense due to the costs incurred in the prior comparable period associated with BREXAFEMME.
Total other income was $10.5 million for the quarter ended March 31, 2024, versus total other expense of $23.2 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 March 31, 2024 and 2023, we recognized a gain of $9.6 million and a loss of $21.7 million, respectively, on fair value adjustment for warrant liabilities primarily due to the decrease and increase in our stock price during the periods, respectively.
Net income for the quarter ended March 31, 2024, was $0.4 million, or $0.01 basic income per share, compared to a net loss of $33.9 million, or $0.71 basic loss per share for the same period in 2023.
Cash Balance
Cash, cash equivalents and investments totaled $94.2 million on March 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 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 .
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 28, 2024, and form 10-Q for the quarter ending March 31, 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 March 31,
2024
2023
Revenue:
Product revenue, net
$
—
$
1,130
License agreement revenue
1,373
—
Total revenue
1,373
1,130
Operating expenses:
Cost of product revenue
—
137
Research and development
7,212
6,835
Selling, general and administrative
3,669
4,840
Total operating expenses
10,881
11,812
Loss from operations
(9,508
)
(10,682
)
Other (income) expense:
Amortization of debt issuance costs and discount
401
255
Interest income
(1,280
)
(587
)
Interest expense
205
1,447
Warrant liabilities fair value adjustment
(9,608
)
21,673
Derivative liabilities fair value adjustment
(168
)
406
Total other (income) expense
(10,450
)
23,194
Income (loss) before taxes
942
(33,876
)
Income tax expense
(531
)
—
Net income (loss)
$
411
$
(33,876
)
Net income (loss) per share attributable to common stockholders – basic
Net income (loss) per share – basic
$
0.01
$
(0.71
)
Net income (loss) per share attributable to common stockholders – diluted
Net income (loss) per share – diluted
$
0.01
$
(0.71
)
Weighted average common shares outstanding – basic and diluted
Basic
48,245,559
47,757,246
Diluted
48,565,051
47,757,246
SCYNEXIS, INC.
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
March 31, 2024
December 31, 2023
Assets
Current assets:
Cash and cash equivalents
$
35,482
$
34,050
Short-term investments
44,762
40,312
Prepaid expenses and other current assets
1,583
5,548
License agreement receivable
—
2,463
License agreement contract asset
19,466
19,363
Restricted cash
380
380
Total current assets
101,673
102,116
Investments
13,943
23,594
Deferred offering costs
175
175
Restricted cash
163
163
Operating lease right-of-use asset
2,300
2,364
Total assets
$
118,254
$
128,412
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable
$
8,918
$
7,149
Accrued expenses
4,601
7,495
Deferred revenue, current portion
1,083
1,189
Operating lease liability, current portion
356
340
Warrant liabilities
—
130
Convertible debt and derivative liability
12,391
—
Total current liabilities
27,349
16,303
Deferred revenue
2,111
2,727
Warrant liabilities
12,202
21,680
Convertible debt and derivative liability
—
12,159
Operating lease liability
2,487
2,581
Total liabilities
44,149
55,450
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $0.001 par value, authorized 5,000,000 shares as of March 31, 2024 and December 31, 2023; 0 shares issued and outstanding as of March 31, 2024 and December 31, 2023
—
—
Common stock, $0.001 par value, 150,000,000 shares authorized as of March 31, 2024 and December 31, 2023; 37,779,796 and 37,207,799 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively
41
40
Additional paid-in capital
428,900
428,169
Accumulated deficit
(354,836
)
(355,247
)
Total stockholders’ equity
74,105
72,962
Total liabilities and stockholders’ equity
$
118,254
$
128,412
