JERSEY CITY, N.J., May 8, 2019 /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 March 31, 2019, and provided an
update on recent clinical developments.
"We are encouraged by the positive interim results and patient
cases from our ongoing studies evaluating oral ibrexafungerp in
severe and difficult-to-treat fungal infections," said Marco Taglietti, M.D., President and Chief
Executive Officer of SCYNEXIS. "We also continue to advance oral
ibrexafungerp in our ongoing Phase 3 VANISH study in patients with
VVC, with the goal of sharing top-line data in the first half of
2020. In parallel, with the positive results seen in our complete
reproductive and developmental toxicology package, we are moving
closer to a potential New Drug Application (NDA) submission for VVC
in the second half of 2020."
Ibrexafungerp (formerly SCY-078), the first representative of a
novel family of compounds referred to as triterpenoids, is being
developed for oral and intravenous administration and is in
clinical development for the treatment of several serious fungal
infections, including vulvovaginal candidiasis (VVC), invasive
candidiasis (IC), invasive aspergillosis (IA) and refractory
invasive fungal infections. If approved, ibrexafungerp would be the
only oral alternative to azoles for the treatment of VVC and
prevention of recurrent VVC.
Ibrexafungerp Update
- Data presented at the 2019 American College of Obstetrics
and Gynecology Annual Clinical and Scientific Meeting (ACOG)
support a future NDA submission of oral ibrexafungerp for the
treatment of VVC and highlight potential differentiation versus VVC
standard-of-care.
-
- Pre-clinical studies, conducted as part of a full reproductive
and developmental toxicity package, showed that ibrexafungerp did
not cause reproductive harm to adult animals or developmental harm
to offspring. These findings are extremely meaningful for women
with VVC, often of child-bearing age, and can differentiate oral
ibrexafungerp against fluconazole, which has a warning for
potential risks of spontaneous abortion and congenital
abnormalities in its prescribing information.
- Additional data presented further support the utility of
ibrexafungerp as a treatment for VVC, including clinical results
from a prior Phase 2b dose-finding
study of oral ibrexafungerp in patients with VVC and preclinical
data demonstrating in vitro activity against
fluconazole-resistant Candida spp.
- All ACOG 2019 posters and presentations can be found on the
SCYNEXIS website.
- SCYNEXIS is currently enrolling patients in the VANISH Phase
3 registration program evaluating the safety and efficacy of oral
ibrexafungerp in patients with acute VVC and is on track to
initiate a planned Phase 3 trial for the prevention of recurrent
VVC (the CANDLE study) in the second quarter of 2019.
- New data from six presentations at the 29th
European Congress of Clinical Microbiology and Infectious Diseases
(ECCMID) shows favorable clinical activity in difficult-to-treat
fungal infections, including Candida auris.
-
- An oral presentation showcased results from the first interim
analysis of 20 patients with various Candida infections from
the FURI study, an open-label trial of oral ibrexafungerp in
patients with refractory fungal infections. Oral ibrexafungerp
demonstrated a clinical benefit in 17 of the 20 patients, with 11
patients achieving a complete or partial response and six patients
achieving a stable disease response. Enrollment in the study
continues to progress in the U.S. and Europe.
- A poster presentation highlighted clinical findings for two
patients with Candida auris candidemia enrolled in the CARES
study, who were successfully treated with oral ibrexafungerp.
Candida auris is a pathogen defined by the Centers for
Disease Control and Prevention (CDC) as "an emerging fungus that
presents a serious global health threat."
- Preliminary results from the FURI and CARES studies build
toward a potential future NDA submission through the Limited
Population Pathway for Antibacterial and Antifungal Drugs
(LPAD).
- All ECCMID 2019 posters and presentations can be found on the
SCYNEXIS website.
First Quarter 2019 Financial Results
Cash, cash equivalents and short-term investments totaled
$39.1 million as of March 31, 2019, with net working capital of
$35.4 million.
Research and development expenses increased to $9.7 million for the quarter ended March 31, 2019, compared to $5.3 million in the first quarter of 2018. The
increase of $4.4 million, or 82%, was
primarily driven by a milestone payment made during the quarter
upon initiation of the Phase 3 VVC registration study, an increase
of $1.1 million in clinical
development, and a net increase of $0.5 million in other research and
development expenses, offset in part by a decrease of $0.5 million in chemistry, manufacturing, and
controls (CMC) and a decrease of $0.7
million in preclinical development expense.
Selling, general and administrative expenses in the first
quarter of 2019 increased to $2.2
million, compared with $2.0
million in the first quarter of 2018.
Total other expense was $11.0
million in the first quarter of 2019, compared to total
other income of $3.2 million in the
first quarter of 2018. The increase in other expense is
attributable to the non-cash losses recognized during the first
quarter of 2019 of $6.5 million and
$3.4 million associated with the fair
value adjustments for warrant liabilities and derivative liability,
respectively. Additionally, during the first quarter of 2019, we
recognized a loss on extinguishment of debt of $0.8 million.
Net loss for the first quarter of 2019 was $22.9 million, or $0.46 per share. This compares with a net loss
for the first quarter of 2018 of $4.0 million, or $0.12 per share.
About Ibrexafungerp
Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an
investigational antifungal agent and the first representative of a
novel family of compounds referred to as "fungerps" (antifungal
triterpenoids). This agent combines the well-established activity
of glucan synthase inhibitors with the potential flexibility of
having oral and intravenous formulations. Ibrexafungerp has
demonstrated broad spectrum antifungal activity, in vitro
and in vivo, against multidrug-resistant pathogens,
including azole- and echinocandin-resistant strains. Ibrexafungerp
is currently in development for the treatment of fungal infections
caused primarily by Candida (including C. auris) and
Aspergillus species, and is being evaluated in multiple
clinical programs: the VANISH registration program for the
treatment of VVC is enrolling, the Phase 3 trial for the prevention
of recurrent VVC is being initiated in the second quarter of 2019,
the SCYNERGIA Phase 2 trial for invasive aspergillosis (IA) and the
FURI and CARES Phase 3 trials for the treatment of patients with
refractory infections are ongoing. The FDA has granted
Qualified Infectious Disease Product (QIDP) and Fast Track
designations for the formulations of ibrexafungerp for the
indications of invasive candidiasis (IC) (including candidemia), IA
and VVC, and has granted Orphan Drug Designation for the IC and IA
indications. Ibrexafungerp is formerly known as SCY-078.
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, having discovered and developed more than 30 innovative
medicines over a broad range of therapeutic areas. SCYNEXIS's
lead product candidate, ibrexafungerp (formerly known as SCY-078),
is a novel IV/oral antifungal agent in Phase 3 clinical and
preclinical development for the treatment of multiple serious and
life-threatening invasive fungal infections caused by
Candida, Aspergillus and Pneumocystis 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. 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; whether
the positive results from the FURI trial to date will continue to
be achieved as the study continues; uncertainties about the
regulatory standards for approval through LPAD; and SCYNEXIS's
reliance on third parties to conduct SCYNEXIS's clinical studies.
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
Heather Savelle
Argot Partners
Tel: 212-600-1902
heather@argotpartners.com
Media Relations
George E.
MacDougall
MacDougall
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
March 31,
|
|
2019
|
|
2018
|
|
Revenue
|
$
|
64
|
|
|
$
|
64
|
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
9,684
|
|
|
5,326
|
|
Selling, general and
administrative
|
2,241
|
|
|
1,971
|
|
Total operating
expenses
|
11,925
|
|
|
7,297
|
|
Loss from
operations
|
(11,861)
|
|
|
(7,233)
|
|
Other expense
(income):
|
|
|
|
|
Loss on
extinguishment of debt
|
|
814
|
|
|
|
−
|
|
Amortization of debt
issuance costs and discount
|
200
|
|
|
111
|
|
Interest
income
|
(281)
|
|
|
(167)
|
|
Interest
expense
|
367
|
|
|
379
|
|
Warrant liabilities
fair value adjustment
|
6,522
|
|
|
(3,554)
|
|
Derivative liability
fair value adjustment
|
|
3,425
|
|
|
|
−
|
|
Total other expense
(income):
|
11,047
|
|
|
(3,231)
|
|
Net
loss
|
$
|
(22,908)
|
|
|
$
|
(4,002)
|
|
Net loss per share –
basic and diluted
|
$
|
(0.46)
|
|
|
$
|
(0.12)
|
|
Weighted average
common shares outstanding – basic and
diluted
|
49,317,575
|
|
|
33,579,025
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SCYNEXIS,
INC.
|
UNAUDITED
CONDENSED BALANCE SHEETS
|
(in thousands,
except share and per share data)
|
|
|
|
|
|
|
|
|
|
March 31,
2019
|
|
December 31,
2018
|
Cash and cash
equivalents
|
$
|
12,950
|
|
|
$
|
11,439
|
|
Short-term
investments
|
26,110
|
|
|
32,718
|
|
Total current
assets
|
40,073
|
|
|
51,463
|
|
Operating lease
right-of-use asset
|
|
3,317
|
|
|
|
−
|
|
Total
assets
|
|
45,067
|
|
|
|
53,170
|
|
Total current
liabilities
|
4,638
|
|
|
5,877
|
|
Warrant
liabilities
|
|
7,508
|
|
|
|
986
|
|
Loan payable expected
to be refinanced
|
−
|
|
|
15,082
|
|
Convertible debt and
derivative liability
|
|
18,296
|
|
|
|
−
|
|
Operating lease
liability
|
|
3,295
|
|
|
|
−
|
|
Total
liabilities
|
33,737
|
|
|
21,945
|
|
Total stockholders'
equity
|
11,330
|
|
|
31,225
|
|
Total liabilities and
stockholders' equity
|
$
|
45,067
|
|
|
$
|
53,170
|
|
View original
content:http://www.prnewswire.com/news-releases/scynexis-reports-first-quarter-2019-financial-results-and-provides-company-update-300846618.html
SOURCE SCYNEXIS, Inc.