PR Newswire
JERSEY CITY, N.J., March 14, 2019
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
Corporate Update
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 Werbung Mehr Nachrichten zur Scynexis Aktie kostenlos abonnieren
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