SCYNEXIS Reports First Quarter 2017 Financial Results and Provides Update on IV Formulation Development Status
May 08 2017 - 3:20PM
SCYNEXIS, Inc. (NASDAQ:SCYX), a biotechnology company delivering
innovative anti-infective therapies for difficult-to-treat and
often life-threatening infections, today reported financial results
for the quarter ended March 31, 2017, and provided an update on
recent operational and clinical developments.
SCY-078 Update
Clinical Development Status of IV Formulation of
SCY-078
- We recently met with the FDA to discuss the requirements needed
to lift the clinical hold on the intravenous (IV) formulation of
SCY-078. Based on the feedback from this meeting, we plan to submit
to the FDA a comprehensive analysis of data from preclinical and
clinical studies, including recently completed and planned
preclinical studies. Upon lifting of the clinical hold, we
plan to test the intended IV dose regimen first in healthy
volunteers and then expect to initiate our planned Phase 2 study
for the treatment of patients with invasive Candida
infections. As a result, we now anticipate the commencement
of this Phase 2 study to occur in 2018.
Clinical Development Program with Oral Formulation of
SCY-078 On Track
- Clinical development of the oral formulation of SCY-078 is
progressing as planned. We have opened sites in the U.S. for the
open-label study of oral SCY-078 for the treatment of invasive
fungal infections that are refractory to or intolerant of standard
antifungal agents (FURI study). We expect enrollment in this
study to commence in the second quarter of 2017.
Eight SCY-078 Data Presentations at ECCMID
- In April 2017, we had several clinical and non-clinical
presentations at the 27th European Congress of Clinical
Microbiology and Infectious Diseases (ECCMID) that supported the
broad spectrum activity of SCY-078 against fungal infections in
multiple settings and indications. Key conclusions presented
include:- Synergy of SCY-078 in combination with other antifungals
against Aspergillus- Antifungal activity of SCY-078 against
emerging drug-resistant Candida auris- Activity of SCY-078
against Candida biofilms- Clinical efficacy in two Phase 2a
studies in patients with invasive candidiasis and patients with
vulvovaginal candidiasis (VVC)
SCY-078 In Vitro Activity Against Candida auris
Reported
- In March 2017, preclinical research showing SCY-078 to be
active in vitro against Candida auris, a life-threatening and
multidrug-resistant fungus that has been called a major global
health threat by the Centers for Disease Control, was published in
Antimicrobial Agents and Chemotherapy. This Case Western Reserve
School of Medicine study evaluated the activity of SCY-078 against
16 different Candida auris isolates. Results showed potent activity
of SCY-078 against all strains tested at concentrations indicative
of potential clinically-relevant effect.
Additional SCY-078 Target Indications Under
Consideration
- We are also pursuing other indications with the oral
formulation of SCY-078, including VVC.
"In the first quarter of 2017, we continued to advance the
development program for the oral formulation of SCY-078, our lead
development program and the first representative of a novel
triterpenoid antifungal family," said Marco Taglietti, M.D.,
President and Chief Executive Officer of SCYNEXIS. “Although the
recent regulatory action is causing some delay in the development
of our intravenous formulation, we are progressing our oral
development program as planned while we address the clinical hold
on the IV formulation. We remain committed to advancing SCY-078 as
a treatment for increasingly urgent global health threats. As
recently presented at ECCMID, there is a growing body of SCY-078
clinical and nonclinical research highlighting the potential
versatility of this compound against multiple invasive,
drug-resistant and difficult-to-treat fungal infections,
including Candida auris.”
First Quarter 2017 Financial ResultsCash and
cash equivalents and short-term investments totaled $54.9 million
as of March 31, 2017, with net working capital of $52.2
million.
Research and development, net expenses decreased to $4.0 million
in the first quarter of 2017, compared to $4.7 million in the first
quarter of 2016. The decrease of $0.7 million, or 15%, for the
three months ended March 31, 2017 was primarily driven by a
decrease of $0.6 million in clinical development expenses and a
decrease of $0.7 million in chemistry, manufacturing and controls
(CMC) expenses, offset in part by a $0.3 million increase in
preclinical development and a $0.3 million increase in professional
services.
Selling, general and administrative expenses decreased to $2.1
million in the first quarter of 2017, compared to $2.5 million in
the first quarter of 2016. The decrease of $0.5 million, or 19%,
was primarily the result of a decrease of $0.6 million in
consulting and professional services.
Total other income increased to $1.1 million in the first
quarter of 2017 due to a $1.5 million non-cash gain recorded on the
adjustment in the fair value of the warrant liability, offset in
part by a $0.3 million increase in interest expense.
Net loss for the first quarter of 2017 was $4.9 million, or
$0.19 per share. This compares to a net loss for the first
quarter of 2016 of $7.2 million, or $0.52 per share.
About SCYNEXIS, Inc.SCYNEXIS, Inc. is a
biotechnology company committed to positively impacting the
lives of patients suffering from difficult-to-treat and often
life-threatening infections by delivering innovative anti-infective
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. The
Company's lead product candidate, SCY-078, is the first
representative of a novel intravenous and oral triterpenoid
antifungal family and is in Phase 2 clinical development 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 maybe, "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 on the IV formulation of SCY-078 on a timely
basis, if at all, 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. |
UNAUDITED CONDENSED STATEMENTS OF
OPERATIONS |
(in thousands, except share and per share
data) |
|
|
|
Three Months Ended March 31, |
|
|
2017 |
|
2016 |
Revenue |
|
$ |
64 |
|
|
$ |
64 |
|
Operating
expenses: |
|
|
|
|
|
Research
and development, net |
|
|
4,020 |
|
|
|
4,743 |
|
Selling,
general and administrative |
|
|
2,060 |
|
|
|
2,533 |
|
Total
operating expenses |
|
|
6,080 |
|
|
|
7,276 |
|
Loss from
operations |
|
|
(6,016 |
) |
|
|
(7,212 |
) |
Other (income)
expense: |
|
|
|
|
|
Amortization of debt discount |
|
|
100 |
|
|
|
— |
|
Interest
income |
|
|
(69 |
) |
|
|
(28 |
) |
Interest
expense |
|
|
345 |
|
|
|
— |
|
Warrant
liability fair value adjustment |
|
|
(1,523 |
) |
|
|
— |
|
Total other income |
|
|
(1,147 |
) |
|
|
(28 |
) |
Net
loss |
|
$ |
(4,869 |
) |
|
$ |
(7,184 |
) |
Warrant
liability fair value adjustment |
|
|
(1,523 |
) |
|
|
— |
|
Net loss
attributable to common stockholders – diluted |
|
$ |
(6,392 |
) |
|
$ |
(7,184 |
) |
Net loss per share
attributable to common stockholders – basic |
|
|
|
|
|
|
|
Net loss
per share – basic |
|
$ |
(0.19 |
) |
|
$ |
(0.52 |
) |
Loss per share
attributable to common stockholders – diluted |
|
|
|
|
|
Net loss
per share – diluted |
|
$ |
(0.25 |
) |
|
$ |
(0.52 |
) |
Weighted average common
shares outstanding: |
|
|
|
|
|
Basic |
|
|
25,364,429 |
|
|
|
13,905,613 |
|
Diluted |
|
|
25,562,027 |
|
|
|
13,905,613 |
|
|
|
|
|
|
|
|
|
|
SCYNEXIS, INC. |
UNAUDITED CONDENSED BALANCE SHEETS |
(in thousands) |
|
|
|
|
|
|
|
March 31, 2017 |
|
December 31, 2016 |
Cash and cash
equivalents |
|
$ |
19,908 |
|
|
$ |
35,656 |
|
Short-term
investments |
|
34,991 |
|
|
22,930 |
|
Total current
assets |
|
55,590 |
|
|
59,327 |
|
Total
assets |
|
|
56,655 |
|
|
|
59,792 |
|
Total current
liabilities |
|
3,358 |
|
|
3,717 |
|
Loan payable,
long term |
|
14,352 |
|
|
14,252 |
|
Total
liabilities |
|
23,122 |
|
|
24,973 |
|
Total
stockholders’ equity |
|
33,533 |
|
|
34,819 |
|
Total
liabilities and stockholders’ equity |
|
$ |
56,655 |
|
|
$ |
59,792 |
|
|
|
|
|
|
|
|
|
|
CONTACTS
Investor Relations
Susan Kim
Argot Partners
Tel: 212-203-4433
susan@argotpartners.com
Media Relations
Cammy Duong
MacDougall Biomedical Communications
Tel: 781-591-3443
cduong@macbiocom.com
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