JERSEY CITY, N.J., March 14, 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 year
ended December 31, 2018, and provided
an update on recent operational and clinical developments.
"We ended 2018 having accomplished meaningful progress across
our ibrexafungerp clinical development programs, including positive
results from our Phase 2b DOVE study
evaluating the oral formulation of ibrexafungerp in the lead
indication of vulvovaginal candidiasis," said Marco Taglietti, M.D., President and Chief
Executive Officer of SCYNEXIS. "We fully intend to carry the
momentum of 2018 throughout this year as we conduct our Phase 3
VANISH trials, where we anticipate top-line data in the first half
of 2020 with a planned New Drug Application (NDA) submission in the
second half of 2020."
Dr. Taglietti continued: "Progress also continues on the
development of oral ibrexafungerp across multiple additional
indications in severe, difficult-to-treat, hospital-based
infections to address a significant unmet need for patients
fighting life-threatening and often drug-resistant
pathogens. Recently, we disclosed the positive results
obtained with oral ibrexafungerp in a group of patients with fungal
infections refractory to currently available treatments and we
initiated the Phase 2 study in invasive aspergillosis. We remain
focused on maximizing the broad clinical utility of ibrexafungerp
and realizing the full potential of this first member of a new
antifungal class."
Ibrexafungerp (formerly SCY-078), the first representative of a
novel antifungal family referred to as triterpenoids, is being
developed for oral and intravenous (IV) 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 Development Update
- Currently enrolling patients in the VANISH Phase 3
registration program evaluating the safety and efficacy of
ibrexafungerp in patients with acute VVC. On track to initiate a
planned Phase 3 trial of ibrexafungerp for the prevention of
recurrent VVC in the first half of 2019.
-
- In January 2019, SCYNEXIS
announced the initiation of the Phase 3 VANISH registration program
following a positive end-of-phase 2 meeting with the U.S. Food and
Drug Administration (FDA). The VANISH program is comprised of two
Phase 3 clinical trials (approximately 350 patients each) designed
to evaluate the efficacy of a one-day 600mg oral dose of
ibrexafungerp versus placebo for the treatment of VVC. Top-line
results from the study are anticipated in the first half of 2020.
Pending successful completion of these two trials, SCYNEXIS plans
to submit an initial NDA for oral ibrexafungerp for the treatment
of VVC in the second half of 2020.
- SCYNEXIS is on track to initiate a third Phase 3 clinical trial
(approximately 350 patients) evaluating the safety and efficacy of
oral 600mg ibrexafungerp, given once-a-month for six months, versus
placebo for the prevention of recurrent VVC. Patients with a
diagnosis of VVC and a history of at least three episodes of VVC in
the past 12 months (including the current episode) will first
receive standard-of-care (SoC) treatment for their active
infection. Patients whose active infection has been successfully
treated will be randomized to ibrexafungerp or placebo in a 1:1
ratio for the prevention phase of the trial.
- These Phase 3 programs are designed to build on the positive
top-line data reported from the Phase 2b DOVE study. This study demonstrated that the
one-day 600mg ibrexafungerp oral dose selected for Phase 3 clinical
evaluation was well-tolerated, with strong clinical and mycological
activity, and showed potential for improved sustained effect versus
fluconazole, the current SoC for VVC.
- In May 2018, the FDA granted both
Qualified Infectious Disease Product (QIDP) and Fast Track
designations for the oral formulation of ibrexafungerp for the
treatment of VVC and the prevention of recurrent VVC, which
includes priority review and five years of additional
exclusivity.
- Progress continues on SCYNEXIS's strategy to expand the use
of ibrexafungerp in severe, difficult-to-treat, fungal
infections.
-
- In January 2019, SCYNEXIS
announced interim results from the first 20 patients enrolled in
the FURI study, a global, open-label study evaluating oral
ibrexafungerp as a salvage treatment in patients with
difficult-to-treat refractory or resistant invasive 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. Oral ibrexafungerp was well-tolerated, with the most
common treatment-related adverse events being gastrointestinal.
There were no deaths due to progressive fungal disease and no
safety signals warranting changes in the study. These
preliminary results support continued patient enrollment in the
FURI study to build toward a future NDA submission and potential
approval through the Limited Population Pathway for Antibacterial
and Antifungal Drugs (LPAD). Enrollment in the study continues to
progress, with 32 sites now active in the U.S. and Europe.
- In October 2018, SCYNEXIS dosed
the first patient in the 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
(CARES study). C. auris has been classified by the Centers
for Disease Control and Prevention (CDC) as a serious global health
threat, as it can be multidrug-resistant, with a mortality rate of
up to 60%. Enrollment is ongoing with several patients
currently enrolled.
- In the fourth quarter of 2018, SCYNEXIS initiated a Phase 2
study (SCYNERGIA study) of oral ibrexafungerp in combination with
voriconazole for the treatment of invasive aspergillosis. This
study was initiated following improved outcomes and survival rates
observed in preclinical models of pulmonary aspergillosis using the
combination of oral ibrexafungerp with azole therapy.
- SCYNEXIS continues to explore development of IV formulation
of ibrexafungerp. While oral ibrexafungerp is progressing as a
potential valuable option to treat hospital-based invasive fungal
infections, as recently shown in the preliminary results from the
FURI study, the company continues with the development of the
intravenous liposomal formulation of ibrexafungerp and will provide
further updates on this program in the future.
- Presentation of new preclinical data in support of
prophylactic use of oral ibrexafungerp. In February 2019, SCYNEXIS announced the
presentation of a poster at the upcoming Superbugs and Superdrugs
2019 conference. The poster, titled "Activity of oral ibrexafungerp
in murine models of Pneumocystis pneumonia (PCP),"
highlights the results from multiple preclinical studies that
evaluated oral ibrexafungerp versus trimethoprim/sulfamethoxazole,
the current SoC for PCP. Oral ibrexafungerp demonstrated strong
activity against PCP in these models, as determined by a reduction
in organism burden and improved survival. These results warrant
further investigation of ibrexafungerp for both the prevention and
treatment of PCP, a potentially life-threatening infection that
occurs in vulnerable immunocompromised individuals, including those
undergoing solid organ and stem cell transplants.
Corporate Update
- In March 2019, SCYNEXIS
completed the sale of a $16.0 million
convertible unsecured senior note in a private placement to
Puissance Capital. The sale of the convertible note provides
desired funds in a less dilutive manner than typical equity
offerings. SCYNEXIS used the proceeds to retire in full the
previous term loan, strengthening near-term cash flows and
extending the Company's cash runway past an anticipated NDA
submission in the second half of 2020.
- United States Adopted Names (USAN) Council selected
"Ibrexafungerp" as non-proprietary name for SCY-078. In
February 2019, the USAN Council, in
consultation with the World Health Organization's (WHO)
International Nonproprietary Names (INN) Expert Committee, selected
ibrexafungerp as the non-proprietary name for SCY-078. The
USAN Council, by working closely with the INN Programme of the WHO
and various national nomenclature groups, aims for global
standardization and unification of drug nomenclature to ensure that
drug information is communicated accurately and unambiguously. In
July 2018, the WHO INN group created
the new stem, "-fungerp," indicating that ibrexafungerp is
different and unique to any previously-approved antifungal drug,
and the first member of a new triterpenoid drug class.
Ibrexafungerp has the potential to be the first new antifungal
class approved in the last 20 years.
- In January 2019, SCYNEXIS
announced the appointment of Armando
Anido to its Board of Directors. Mr. Anido
currently serves as Chairman and Chief Executive Officer of Zynerba
Pharmaceuticals (NASDAQ: ZYNE), a role he has held since
October 2014, and has more than 30 years of executive
leadership experience in the biopharmaceutical industry. The
addition of Mr. Anido to an experienced Board provides invaluable
operational and commercial expertise as SCYNEXIS prepares to
potentially submit an NDA in the second half of 2020.
- In January 2019, SCYNEXIS
completed the sale of a portion of its Net Operating Losses (NOLs)
and received a cash receipt of $6.7
million. This sale was structured through the New Jersey
Technology Business Tax Certificate Transfer (NOL) Program, which
allows eligible companies to sell their New Jersey NOLs and
research and development tax credits up to a maximum lifetime
benefit of $15 million per
company. This transaction resulted in a pro forma cash balance
of $51 million as of January 3, 2019.
Full Year 2018 Financial Results
Cash, cash equivalents and short-term investments totaled
$44.2 million as of December 31, 2018.
Research and development expenses increased to $21.6 million for the year ended December 31, 2018, compared to $18.3 million for the year ended December 31, 2017. The increase of $3.2 million, or 17.6%, was primarily driven by
an increase of $2.9 million in
clinical development, an increase of $1.3
million in chemistry, manufacturing, and controls (CMC), and
an increase of $0.8 million in salary
and personnel related costs, offset in part by a decrease of
$1.5 million in consulting fees and a
net decrease of $0.3 million in other
research and development expenses.
Selling, general and administrative expenses increased to
$8.7 million in 2018, compared with
$8.3 million in 2017. The increase of
$0.4 million, or 5.2%, in 2018, was
primarily driven by the $0.2 million
charge for deferred offering costs recognized during the year ended
December 31, 2018.
Total other income was $10.8
million in 2018, compared to other income of $1.3 million in 2017 due to a $11.9 million non-cash gain recorded on the
adjustment in the fair value of the warrant liabilities.
Income tax benefit increased to $6.7
million in 2018, compared to zero in 2017, due to the
$6.7 million sale of a portion of
SCYNEXIS's NOLs through the New Jersey Technology Business Tax
Certificate Transfer (NOL) Program.
Net loss for 2018 was $12.5
million, or $0.28 per share.
This compares with a net loss for 2017 of $25.1 million, or $0.94 per share.
About Ibrexafungerp
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 intravenous (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 invasive
candidiasis (IC) (including candidemia), invasive aspergillosis
(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 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. 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 Biomedical Communications
Tel: 781-235-3093
george@macbiocom.com
SCYNEXIS,
INC.
|
STATEMENTS OF
OPERATIONS
|
(in thousands,
except share and per share data)
|
|
|
|
|
|
|
|
|
|
Years Ended
December 31,
|
|
2018
|
|
2017
|
|
Revenue
|
$
|
257
|
|
|
$
|
257
|
|
Operating
expenses:
|
|
|
|
|
Research and
development, net
|
21,560
|
|
|
18,326
|
|
Selling, general and
administrative
|
8,680
|
|
|
8,251
|
|
Total operating
expenses
|
30,240
|
|
|
26,577
|
|
Loss from
operations
|
(29,983)
|
|
|
(26,320)
|
|
Other expense
(income):
|
|
|
|
|
Amortization of debt
discount
|
428
|
|
|
400
|
|
Interest
income
|
(967)
|
|
|
(386)
|
|
Interest
expense
|
1,626
|
|
|
1,455
|
|
Warrant liabilities
fair value adjustment
|
(11,866)
|
|
|
(2,729)
|
|
Total other
income:
|
(10,779)
|
|
|
(1,260)
|
|
Loss before
taxes
|
|
(19,204)
|
|
|
|
(25,060)
|
|
Income tax
benefit
|
|
6,736
|
|
|
|
−
|
|
Net
loss
|
$
(12,468)
|
|
|
$
(25,060)
|
|
Net loss per share –
basic and diluted
|
$
(0.28)
|
|
|
$
(0.94)
|
|
Weighted average
common shares outstanding – basic and diluted
|
43,883,995
|
|
26,746,322
|
|
|
SCYNEXIS,
INC.
|
|
|
BALANCE
SHEETS
|
|
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
2018
|
|
December 31,
2017
|
Cash and cash
equivalents
|
|
$
|
11,439
|
|
$
|
11,469
|
Short-term
investments
|
|
32,718
|
|
32,424
|
Total current
assets
|
|
51,463
|
|
44,960
|
Total
assets
|
|
|
53,170
|
|
|
45,850
|
Loan payable, current
portion
|
|
|
−
|
|
|
4,349
|
Total current
liabilities
|
|
5,877
|
|
10,144
|
Loan payable expected
to be refinanced
|
|
15,082
|
|
10,303
|
Total
liabilities
|
|
21,945
|
|
24,440
|
Total stockholders'
equity
|
|
31,225
|
|
21,410
|
Total liabilities and
stockholders' equity
|
|
$
|
53,170
|
|
$
|
45,850
|
|
|
|
|
|
|
|
|
|
|
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SOURCE SCYNEXIS, Inc.