On March 13, 2018 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company delivering innovative anti-infective therapies for difficult-to-treat and often life-threatening infections, reported financial results for the year ended December 31, 2017, and provided an update on recent operational and clinical developments (Press release, Scynexis, MAR 13, 2018, View Source [SID1234524738]).
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"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 8th 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.