SCYNEXIS Reports Third Quarter 2018 Financial Results and Provides Company Update
JERSEY CITY, N.J., Nov. 13, 2018 /PRNewswire/ -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company delivering innovative therapies for difficult-to-treat and often life-threatening infections, today reported financial results for the quarter ended September 30, 2018, and provided an update on recent clinical and operational developments.
Key Messages:
-- Women suffering from vaginal yeast infections (vulvovaginal candidiasis
or VVC) have only one approved oral treatment option. With SCYNEXIS's
U.S. Food and Drug Administration (FDA)-endorsed Phase 3 registration
program for VVC on track to begin by year-end, and with a potential New
Drug Application (NDA) filing planned for 2020, ibrexafungerp may become
the much-needed oral alternative for the millions of women who are not
well-served by fluconazole.
-- Despite existing therapies, mortality associated with invasive
aspergillosis remains as high as 50%. Based on positive pre-clinical
data, an ibrexafungerp combination regimen has the potential to show
superiority to the current standard of care. SCYNEXIS has initiated a
Phase 2 study as a proof of concept in this indication.
-- Patients with no therapeutic options for invasive fungal infections
continue to enroll in SCYNEXIS's ibrexafungerp programs designed for
such refractory infections, including infections caused by Candida
auris, a multidrug-resistant pathogen that is the subject of recent
warnings by the Centers for Disease Control and Prevention (CDC) and
other health authorities.
-- As of September 30, 2018, SCYNEXIS has $49.5 million in cash and cash
equivalents and short-term investments, adequate to fund activities into
2020.
"With our successful End-of-Phase 2 Meeting with the FDA, we continue to advance toward our goal of bringing ibrexafungerp to patients in need," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "Following FDA's agreement with our proposed overall design of the Phase 3 registration program for VVC, we anticipate that results showing superiority of ibrexafungerp over placebo would lead to filing an NDA in 2020 for the treatment of VVC, followed by a supplemental NDA in 2021 for the prevention of recurrent VVC."
Dr. Taglietti continued: "In parallel, we are advancing the development of ibrexafungerp for severe, invasive indications. We continue to enroll patients in our FURI study for the treatment of refractory infections; we recently dosed the first patient in our CARES study for the treatment of high-mortality Candida auris infections and we initiated our Phase 2 combination study for the treatment of invasive aspergillosis. We remain committed to maximizing the clinical utility of ibrexafungerp, a first-in-class therapy that combines the broad-spectrum antifungal activity and safety profile of the echinocandin class with the oral convenience of the azole class. With a cash runway into 2020, we are well-funded to progress all ongoing programs."
Ibrexafungerp (formerly SCY-078) Update
-- VVC Phase 3 Registration Program on Track for Initiation by End of 2018,
with Potential NDA Filing in 2020.
-- In October 2018, SCYNEXIS announced the successful completion of an
End-of-Phase 2 Meeting with the FDA for VVC. The FDA has agreed with
the SCYNEXIS's proposed design of the Phase 3 registration program
to support approval of oral ibrexafungerp for the treatment of VVC
and the prevention of recurrent VVC. SCYNEXIS anticipates initiating
the program by the end of 2018.
-- If approved, ibrexafungerp would provide a much-needed oral option
for the millions of women who are currently not well-served by
existing VVC therapies. Fluconazole, approved over 25 years ago, is
the only oral treatment available and fails to adequately address
several patient segments: fluconazole-failure patients, management
of VVC during pregnancy, moderate-to-severe VVC, recurrent VVC and
VVC caused by fluconazole-resistant Candida spp.
-- Continued Progress on SCYNEXIS's Strategy to Expand the Use of
Ibrexafungerp in Severe Invasive Fungal Infections.
-- In October 2018, SCYNEXIS dosed the first patient in the CARES
study, a Phase 3, multi-center (U.S. and India), open-label,
single-arm study evaluating the efficacy, safety and tolerability of
oral ibrexafungerp for the treatment of Candida auris infections. C.
auris is an emerging life-threatening and multidrug-resistant fungal
pathogen, with a mortality rate of up to 60%.
-- The FURI study, evaluating oral ibrexafungerp for the treatment of
fungal infections refractory or resistant to standard of care, is
ongoing with a preliminary data review planned by the end of the
year.
-- SCYNEXIS recently initiated a Phase 2 combination study of oral
ibrexafungerp in invasive aspergillosis. An animal model of
pulmonary aspergillosis showed improved outcomes and survival rates,
supporting the potential superiority of ibrexafungerp in combination
with azole therapy versus the standard of care.
-- Ibrexafungerp is well-positioned to address significant unmet needs
in patients suffering from severe invasive fungal infections. It is
a first-in-class therapy, with broad-spectrum activity (including
against multidrug-resistant strains), fungicidal activity versus
Candida, high tissue penetration and a favorable safety profile.
These features, available in the convenience of an oral formulation,
differentiate ibrexafungerp from available alternatives, and, if
approved, would make it an attractive option for the treatment of
severe invasive fungal infections.
-- Presentation at the 2018 ESCMID/ASM Conference on Drug Development. In
September 2018, SCYNEXIS presented a poster at the 2018 European Society
of Clinical Microbiology and Infectious Diseases (ESCMID)/American
Society for Microbiology (ASM) Conference on Drug Development to Meet
the Challenge of Antimicrobial Resistance. The poster, titled
"Ibrexafungerp (formerly SCY-078) Displays Potent In Vitro Activity
Against C. Glabrata Isolates with Mutations in fks Genes," describes the
results of several pre-clinical studies designed to evaluate the in
vitro activity of ibrexafungerp in Candida glabrata strains with fks
mutations, which are often contributory in the development of
echinocandin resistance. C. glabrata is the second-most common fungal
species isolated from blood in the US and one of the most common fungal
pathogens worldwide.
Third Quarter 2018 Financial Results
Cash, cash equivalents and short-term investments totaled $49.5 million as of September 30, 2018, with net working capital of $39.1 million.
Research and development expenses decreased to $3.9 million in the third quarter of 2018, compared to $4.5 million in the third quarter of 2017. The decrease of $0.5 million, or 12%, for the three months ended September 30, 2018, was primarily driven by a decrease of $0.8 million in preclinical development expense and a decrease of $0.2 million in consulting expense and was offset in part by an increase of $0.5 million in chemistry, manufacturing, and controls.
Selling, general and administrative expenses increased to $2.4 million in the third quarter of 2018, compared with $2.0 million in the third quarter of 2017. The increase of $0.4 million, or 21%, for the three months ended September 30, 2018, was primarily driven by a $0.2 million charge for deferred offering costs recognized during the three months ended September 30, 2018.
Total other income increased to $6.7 million in the third quarter of 2018 due to a $6.9 million non-cash gain recorded on the fair value adjustment of the warrant liabilities.
Net income for the third quarter of 2018 was $0.4 million, or $0.01 per share. This compares with a net loss for the third quarter of 2017 of $8.4 million, or $0.31 per share.
About Ibrexafungerp (formerly SCY-078)
Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an investigational antifungal agent and the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and IV formulations. Ibrexafungerp is currently in development for the treatment of fungal infections caused primarily by Candida (including C. auris) and Aspergillus species. It has demonstrated broad spectrum antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. The FDA has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the formulations of ibrexafungerp for the indications of IC (including candidemia), IA and VVC, and has granted Orphan Drug Designation for the IC and IA indications.
About SCYNEXIS
SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company committed to positively impacting the lives of patients suffering from difficult-to-treat and often life-threatening infections by developing innovative therapies. The SCYNEXIS team has extensive experience in the life sciences industry, discovering and developing more than 30 innovative medicines over a broad range of therapeutic areas. SCYNEXIS's lead product candidate, ibrexafungerp (formerly SCY-078), is a novel oral/IV antifungal agent in Phase 2 clinical and pre-clinical development for the treatment of multiple serious and life-threatening invasive fungal infections caused by Candida and Aspergillus species. For more information, visit www.scynexis.com.
Forward Looking Statement
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 without limitation, statements regarding: expectations for the timing of initiation of, and dosing in, clinical trials; timing of planned NDA filings and preliminary reviews of data, and the adequacy of resources to fund activities into 2020. 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 SCYNEXIS's ability to successfully develop and obtain FDA approval for ibrexafungerp; the expected costs of studies and when they might begin or be concluded; and SCYNEXIS's reliance on third parties to conduct SCYNEXIS's clinical studies and to manufacture product supplies. These and other risks are described more fully in SCYNEXIS's filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K under the caption "Risk Factors" and other documents subsequently filed with or furnished to the Securities and Exchange Commission. 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
Natalie Wildenradt
Argot Partners
Tel: 212-600-1902
natalie@argotpartners.com
Media Relations
George E. MacDougall
MacDougall Biomedical Communications
Tel: 781-235-3093
george@macbiocom.com
SCYNEXIS, INC.
UNAUDITED CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
Three Months Ended September 30,
2018 2017
Revenue $
64 $
64
Operating expenses:
Research and development, net 3,933 4,459
Selling, general and administrative 2,433 2,004
Total operating expenses 6,366 6,463
Loss from operations (6,302) (6,399)
Other (income) expense:
Amortization of debt discount 103 100
Interest income (260) (109)
Interest expense 435 373
Warrant liabilities fair value adjustment (6,931) 1,638
Total other (income) expense (6,653) 2,002
Net income (loss) $351 $(8,401)
Net income (loss) per share attributable to common stakeholders - basic
Net income (loss) per share - basic $0.01 $(0.31)
Net income (loss) per share attributable to common stockholders - diluted
Net income (loss) per share - diluted $0.01 $(0.31)
Weighted average common shares outstanding
Basic 46,988,844 27,091,061
Diluted 47,025,503 27,091,061
SCYNEXIS, INC.
UNAUDITED CONDENSED BALANCE SHEETS
(in thousands)
September 30, December 31,
2018 2017
Cash and cash
equivalents $
16,080 $
11,469
Short-term
investments 33,408 32,424
Total current
assets 50,235 44,960
Total assets 51,650 45,850
Loan payable, current portion 7,349 4,349
Warrant liability 174
Total current
liabilities 11,086 10,144
Warrant liabilities 5,068 3,872
Loan payable, long
term 7,617 10,303
Total liabilities 23,771 24,440
Total
stockholders'
equity 27,879 21,410
Total liabilities
and stockholders'
equity $
51,650 $
45,850
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SOURCE SCYNEXIS, Inc.
