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,
2018
|
|
December 31,
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.