SCYNEXIS Reports Full Year 2016 Financial Results and Provides Company Update
March 13 2017 - 4:30PM
SCYNEXIS, Inc. (NASDAQ:SCYX), a drug development company committed
to the development and commercialization of novel anti-infectives
to address significant unmet therapeutic needs, today reported
financial results for the year ended December 31, 2016, and
provided an update on recent operational and clinical developments.
"2016 was rich in achievements for SCYNEXIS, and we
accomplished many corporate and clinical development
milestones in a short period of time," said Marco Taglietti, M.D.,
President and Chief Executive Officer of SCYNEXIS. "We’ve continued
to make progress in developing SCY-078, a novel antifungal
triterpenoid class, for the treatment of invasive, often
life-threatening and drug-resistant fungal infections that are
rapidly becoming a global health crisis. We also strengthened our
financial position in 2016 to focus on the continued advancement of
SCY-078, our lead program.”
2016 Corporate Accomplishments
- Successfully completed an underwritten public offering raising
gross proceeds of $22.5 million and the closing of a term loan
raising an additional $15 million in gross proceeds. These
transactions have strengthened our financial position, which we
expect will extend our cash runway into early 2019.
- Received designation as a Small and Medium Sized Enterprise
(SME) by the European Medicines Agency (EMA), making us eligible to
receive financial incentives, reduced regulatory fees and waivers,
and scientific advice and other assistance from EMA personnel
through the clinical development process.
2016 SCY-078 Update Development Progress
- Completed two Phase 2 studies of oral SCY-078 in separate
patient populations with Candida spp. infections that provided
evidence of overall anti-candida activity and a promising safety
profile:- In a Phase 2 study evaluating oral SCY-078 in patients
with vulvovaginal candidiasis (VVC), we observed numerically higher
clinical cure rates at test-of-cure and fewer recurrences of VVC at
the four-month follow-up when compared to the standard of care
(oral fluconazole).- In a Phase 2 study evaluating the
pharmacokinetics, safety and tolerability of oral SCY-078 as an
oral step-down treatment in patients with invasive candidiasis, we
identified the daily oral SCY-078 dose that achieves the intended
plasma exposure for efficacy and was well-tolerated.
- On March 2, 2017, the U.S. Food and Drug Administration (FDA)
informed us to hold the initiation of any new clinical studies with
the intravenous (IV) formulation of SCY-078. Ongoing and future
clinical development using the oral formulation of SCY-078 are
unaffected by this regulatory action. We are working closely
with the FDA to review the pre-clinical and clinical data
supporting the use of a suitable IV formulation and dose regimen of
SCY-078 to test in subsequent studies. The upcoming meeting with
the FDA is scheduled for the second quarter of 2017.
- Completed two additional Drug-Drug Interaction (DDI) studies,
demonstrating the low potential of SCY-078 to cause clinically
relevant DDIs, an attribute that differentiates this novel agent
from azoles.
- Completed three-month toxicology studies that support the
longer duration of oral treatment (up to 90 days) in our subsequent
studies.
- The FDA granted Orphan Drug Designation (ODD) to SCY-078 for
the treatment of both invasive Aspergillus and Candida infections,
as well as Fast Track and Qualified Infectious Disease Product
(QIDP) designations for the IV formulation of SCY-078 for the
treatment of invasive candidiasis and invasive aspergillosis.
Fast Track and QIDP designations for the oral formulation of
SCY-078 were previously granted.
SCY-078 and Recent Corporate Updates
- Opened sites in the U.S. to evaluate SCY-078 in patients with
invasive FUngal infections that are
Refractory to, or are Intolerant
of, standard therapies (the FURI study), for
which SCY-078 has the potential to provide a differentiated
treatment option. We expect enrollment for patients receiving the
oral administration of SCY-078 to commence in the first half of
2017.
- In February 2017, preclinical research done at Case Western
Reserve School of Medicine showed that SCY-078 was effective in
vitro against Candida auris, a life-threatening and
multidrug-resistant fungus. These findings were published
online and in an upcoming issue of Antimicrobial Agents and
Chemotherapy. Researchers evaluated the activity of SCY-078 against
16 different C. auris isolates and results showed potent activity
of SCY-078 against all strains at concentrations indicative of
potential clinically-relevant effect.
- Submitted SCY-078 data presentations and publications at
multiple medical meetings throughout the course of the year,
including the European Congress of Clinical Microbiology and
Infectious Diseases 2017 (ECCMID), ASM Microbe 2017 and ID Week
2017.
- Strengthened our commercial, strategy, operations and business
development experience with the addition of industry veteran Marion
McCourt, former Chief Operating Officer of Medivation, to the
SCYNEXIS Board of Directors.
Full Year 2016 Financial Results
Cash and cash equivalents and short-term investments totaled
$58.6 million as of December 31, 2016.
Research and development expenses increased to $20.1 million in
2016, compared to $16.4 million in 2015. The increase of $3.7
million, or 23%, was primarily the result of the expansion of our
development programs for SCY-078 in 2016 including the completion
of two Phase 2 studies, extension of the Phase 1 IV program, and
the completion of three-month toxicology studies and two DDI
studies.
Selling, general and administrative expenses decreased to $8.0
million from $12.2 million for the year ended December 31, 2015.
The decrease of $4.2 million, or 34%, was primarily the result of
the decrease in severance, retention and stock compensation expense
recognized during the year ended December 31, 2015.
Loss from operations in 2016 was $27.8 million, compared to a
loss from operations of $28.3 million in 2015. The $0.5 million
decrease in the loss from operations between the two periods was
due to a $3.7 million increase in research and development expense,
offset by a decrease in selling, general and administrative expense
of $4.2 million.
Total other expense (income) increased to $2.2 million in 2016
due to a $1.9 million non-cash loss recorded on the adjustment in
the fair value of the warrant liability.
Net loss attributable to common stockholders in 2016 was $30.0
million, or $1.58 per share. This compares to net loss attributable
to common stockholders in 2015 of $32.6 million, or $2.68 per
share.
About SCYNEXIS, Inc.
SCYNEXIS is a drug development company committed to the
development and commercialization of novel anti-infectives to
address significant unmet therapeutic needs. We are developing our
lead product candidate, SCY-078, as an oral and IV drug for the
treatment of several fungal infections, including serious and
life-threatening invasive fungal infections. For more information,
visit www.scynexis.com.
Forward Looking Statement
Statements contained in this press release, including but not
limited to the statements, regarding Company’s future cash position
and the timing of the next meeting with the FDA to discuss the data
and agree on subsequent studies, 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' ability to successfully develop SCY-078,
including SCYNEXIS' ability to resolve the FDA’s concerns to lift
the clinical hold and obtain FDA approval for SCY-078; the expected
costs of studies and when they might begin or be concluded; and
SCYNEXIS' reliance on third parties to conduct SCYNEXIS' clinical
studies. 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 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.
|
SCYNEXIS, INC. |
STATEMENTS OF OPERATIONS |
(in thousands, except share and per share
data) |
|
|
|
Years Ended December 31, |
|
2016 |
|
2015 |
Revenue |
$ |
257 |
|
|
$ |
257 |
|
Operating
expenses: |
|
|
|
|
Research
and development, net |
20,076 |
|
|
16,440 |
|
Selling,
general and administrative |
7,998 |
|
|
12,166 |
|
Total
operating expenses |
28,074 |
|
|
28,606 |
|
Loss from
operations |
(27,817 |
) |
|
(28,349 |
) |
Other expense
(income): |
|
|
|
|
Amortization of deferred financing costs and debt discount |
100 |
|
|
— |
|
Interest
income |
(185 |
) |
|
— |
|
Interest
expense |
351 |
|
|
(11 |
) |
Warrant
liability fair value adjustment |
1,906 |
|
|
— |
|
Total other expense
(income) |
2,172 |
|
|
(11 |
) |
Loss from continuing
operations before taxes |
(29,989 |
) |
|
(28,338 |
) |
Income
tax benefit |
— |
|
|
— |
|
Loss from continuing
operations |
(29,989 |
) |
|
(28,338 |
) |
Loss from discontinued
operations, net of tax |
|
— |
|
|
|
(4,285 |
) |
Net
loss |
$ |
(29,989 |
) |
|
$ |
(32,623 |
) |
|
|
|
|
|
Loss per share
attributable to common stockholders - basic and diluted |
|
|
|
|
Continuing operations |
$ |
(1.58 |
) |
|
$ |
(2.33 |
) |
Discontinued operations |
— |
|
|
(0.35 |
) |
Net loss
per share - basic and diluted |
$ |
(1.58 |
) |
|
$ |
(2.68 |
) |
Weighted average common
shares outstanding: |
|
|
|
|
Basic and
diluted |
19,035,299 |
|
|
12,163,559 |
|
|
|
|
|
|
|
SCYNEXIS, INC. |
BALANCE SHEETS |
(in thousands) |
|
|
|
|
|
December 31, 2016 |
|
December 31, 2015 |
Cash and cash
equivalents |
$ |
35,656 |
|
|
$ |
46,985 |
|
Short-term
investments |
22,930 |
|
|
— |
|
Total current
assets |
59,327 |
|
|
48,437 |
|
Total assets |
|
59,792 |
|
|
|
49,273 |
|
Total current
liabilities |
3,717 |
|
|
6,664 |
|
Total liabilities |
24,973 |
|
|
7,324 |
|
Total stockholders’
equity |
34,819 |
|
|
41,949 |
|
Total liabilities and
stockholders’ equity |
$ |
59,792 |
|
|
$ |
49,273 |
|
|
|
|
|
|
|
|
|
CONTACTS:
Media Relations
Cammy Duong
MacDougall Biomedical Communications
781-591-3443
cduong@macbiocom.com
Investor Relations
Susan Kim
Argot Partners
Tel: 212-203-4433
susan@argotpartners.com
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