SCYNEXIS Reports Full Year 2017 Financial Results and Provides Company Update
SCYNEXIS Reports Full Year 2017 Financial Results and Provides Company Update
Robust enrollment continues in Phase 2b VVC trial with top-line data expected in mid-2018
IV SCY-078 program advancing, with liposomal IV formulation to be tested in a Phase 1 study in the third quarter of 2018
Completion of recent $30.0 million equity offering strengthens Company's cash position
JERSEY CITY, N.J., March 13, 2018 /PRNewswire/ -- 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 year ended December 31, 2017, and provided an update on recent operational and clinical developments.
"In 2017, we made meaningful progress in advancing our lead product candidate, SCY-078, across a range of indications, most notably with the initiation and continued progression of our Phase 2b DOVE study evaluating oral SCY-078 for the treatment of vulvovaginal candidiasis (VVC)," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "Additionally, we now have a path forward with our IV SCY-078 program and plan to start Phase 1 testing of our new liposomal IV formulation in the third quarter of 2018. Overall, we continued to expand the body of evidence showing SCY-078's potential as a potent therapy for the treatment of multiple fungal infections associated with significant unmet medical needs. Following the completion of our recent $30 million equity offering, we are well-positioned to advance the SCY-078 platform in 2018 and beyond."
Advancement of Oral SCY-078 Programs
-- Initiated Phase 2b dose-finding study in lead indication of VVC
-- DOVE Study. Dosing is ongoing in the Phase 2b, dose-finding trial
designed to evaluate the safety and efficacy of oral SCY-078
compared to oral fluconazole (the standard of care) for the
treatment of VVC, our most advanced indication. The study continues
to enroll rapidly, and SCYNEXIS expects to report top-line results
in mid-2018.
-- If successful, following completion of the DOVE study and following
an End-of-Phase 2 meeting with the U.S. Food and Drug Administration
(FDA), SCYNEXIS anticipates initiating a Phase 3 VVC study in the
fourth quarter of 2018, with the objective of filing the New Drug
Application (NDA) for acute VVC in 2020.
-- Two studies for the treatment of refractory invasive fungal infections
opened for enrollment.
-- FURI Study. Commenced patient dosing in a global, open-label study,
designed to evaluate oral SCY-078 for the treatment of fungal
infections that are refractory to or intolerant of standard therapy.
A total of 24 locations throughout the U.S. and Europe are now
active, and enrollment continues to progress.
-- CARES Study. The global, open-label study, designed to evaluate oral
SCY-078 for the treatment of Candida auris infections, an often
multidrug-resistant pathogen associated with high mortality
infections, opened for enrollment in the fourth quarter of 2017. The
CARES study is intended to provide rapid access to oral SCY-078 for
patients suffering from this life-threatening infection.
-- Potential for streamlined development pathway for both studies.
SCYNEXIS believes that compelling data from the FURI and/or CARES
studies could allow oral SCY-078 to become eligible for the
regulatory Limited Population Pathway for Antibacterial and
Antifungal Drugs (LPAD), potentially resulting in an initial NDA
based on streamlined development. SCYNEXIS plans to conduct a
preliminary data review in the fourth quarter of 2018.
-- Promising pre-clinical data generated to support "Combination Study
Design" for treatment of invasive aspergillosis. Based on promising data
of SCY-078 in combination with an azole agent in pre-clinical models of
invasive aspergillosis, SCYNEXIS plans to initiate a randomized,
double-blind, Phase 2 study of oral SCY-078 in combination with azole
therapy, the standard of care, for this indication. SCYNEXIS is
finalizing the trial design and expects to initiate this study in the
third quarter of 2018.
Advancement of IV SCY-078 Program with Liposomal IV Formulation
-- Pre-clinical work on the liposomal IV formulation of SCY-078 continues,
and SCYNEXIS remains on track to initiate a Phase 1 trial evaluating the
safety and tolerability of this formulation in healthy volunteers in the
third quarter of 2018.
-- If successful, following completion of the Phase 1 study and pending FDA
review, SCYNEXIS plans to initiate a Phase 2b IV-oral step-down study of
SCY-078 in invasive candidiasis patients with the liposomal IV and oral
formulations of SCY-078 in the fourth quarter of 2018.
Pre-Clinical Data Support Continued Development of SCY-078
-- In February 2018, at the 8(th) Advances Against Aspergillosis (AAA),
SCYNEXIS presented new, pre-clinical data demonstrating synergistic
activity and improved outcomes of SCY-078 in combination with
isavuconazole for the treatment of invasive pulmonary aspergillosis.
-- In October 2017, at IDWeek 2017, SCYNEXIS presented results from three
studies supporting the potent and broad antifungal activity of SCY-078
against Candida and Aspergillus species. These results showed SCY-078's
potent activity against wild-type (WT) and azole-resistant strains of A.
fumigatus, as well as against WT, azole-resistant and
echinocandin-resistant strains of C. parapsilosis. In addition, SCY-078
showed clinically-meaningful penetration into tissues relevant for the
targeted indications, including lung, vaginal mucosa and kidney,
following oral and IV administration in rats and mice.
-- In August 2017, at the IDSOG Annual Meeting, SCYNEXIS presented results
showing SCY-078's high penetration into vaginal tissue after oral
administration and its potent anti-Candida activity in acidic pH
conditions, characteristic of the vaginal setting, supporting the use of
SCY-078 as a novel treatment of VVC.
Corporate Update
-- On March 6, 2018, SCYNEXIS raised $30.0 million in gross proceeds by
issuing 17,751,500 shares of the Company's common stock and two series
of warrants to purchase up to an aggregate of 21,301,800 shares of the
Company's common stock. The offering resulted in approximately $27.8
million of net proceeds after deducting the underwriting discount and
estimated offering expenses.
-- In November 2017, SCYNEXIS announced the appointment of Scott Sukenick,
J.D., as General Counsel. With more than ten years of legal experience
in life sciences, Mr. Sukenick joined SCYNEXIS most recently from Cooley
LLP, where he focused on life sciences litigation and strategic
intellectual property management.
Full Year 2017 Financial Results
Cash, cash equivalents and short-term investments totaled $43.9 million as of December 31, 2017.
Based upon its existing operating plan and the net proceeds from the March 6, 2018 offering, SCYNEXIS believes that its existing cash, cash equivalents and short-term investments will enable the Company to fund its operating requirements into 2020.
Research and development expenses decreased to $18.3 million in 2017, compared to $20.1 million in 2016. The decrease of $1.8 million, or 8.7%, was primarily driven by a decrease of $1.7 million in clinical development, a decrease of $1.3 million in chemistry, manufacturing, and controls (CMC), a decrease of $0.6 million in consulting fees; offset by an increase of $0.9 million in salary and personnel related costs and an increase of $0.9 million in other research and development expenses.
Selling, general and administrative expenses increased to $8.3 million in 2017, compared to $8.0 million in 2016. The increase of $0.3 million, or 3.2%, was primarily driven by an increase of $0.6 million in business development related activities, a $0.3 million increase in stock-based compensation, and a net increase of $0.2 million in other selling, general and administrative expenses; offset by a decrease of $0.4 million in both professional and consulting expenses.
Loss from operations in 2017 was $26.3 million, compared to a loss from operations of $27.8 million in 2016. The $1.5 million decrease in the loss from operations between the two periods was due to $1.8 million decrease in research and development expense, offset by an increase in selling, general and administrative expense of $0.3 million.
Total other income was $1.3 million in 2017, compared to other expense of $2.2 million in 2016 due to a $2.7 million non-cash gain recorded on the adjustment in the fair value of the warrant liability offset by an increase in interest expense of $1.1 million.
Net loss in 2017 was $25.1 million, or $0.94 per share. This compares to a net loss in 2016 of $30.0 million, or $1.58 per share.
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 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 a novel oral/IV antifungal agent in clinical development for the treatment of several 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, including but not limited to the Company's plans to start Phase 1 testing of its new liposomal IV formulation in the third quarter of 2018 and other expectations regarding clinical developments, 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 SCY-078; 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. 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
Susan Kim
Argot Partners
Tel: 212-203-4433
susan@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,
2017 2016
---- ----
Revenue $257 $257
Operating expenses:
Research and development, net 18,326 20,076
Selling, general and administrative 8,251 7,998
----- -----
Total operating expenses 26,577 28,074
Loss from operations (26,320) (27,817)
Other expense (income):
Amortization of debt discount 400 100
Interest income (386) (185)
Interest expense 1,455 351
Warrant liability fair value
adjustment (2,729) 1,906
------ -----
Total other (income) expense (1,260) 2,172
------ -----
Net loss $(25,060) $(29,989)
======== ========
Net loss per share - basic and
diluted $(0.94) $(1.58)
====== ======
Weighted average common shares
outstanding - basic and diluted 26,746,322 19,035,299
========== ==========
SCYNEXIS, INC.
CONDENSED BALANCE SHEETS
(in thousands)
December 31, December 31,
2017 2016
Cash and cash equivalents $11,469 $35,656
Short-term investments 32,424 22,930
Total current assets 44,960 59,327
Total assets 45,850 59,792
Loan payable, current portion 4,349 -
Total current liabilities 10,144 3,717
Loan payable, long term 10,303 14,252
Total liabilities 24,440 24,973
Total stockholders' equity 21,410 34,819
Total liabilities and stockholders'
equity $45,850 $59,792
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SOURCE SCYNEXIS, Inc.
