Full Press Release Details
SCYNEXIS Reports Second Quarter 2022 Financial Results
and Provides Corporate Update
JERSEY CITY, N.J., August 15, 2022 - SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today reported financial results for the second quarter ended on June 30, 2022.
"We are pleased to see the improvements to the current sales trajectory, and we are well capitalized with a cash runway into the first quarter of 2024 to execute on the next important steps toward our goal of building a broad, long-lasting antifungal franchise," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "For the remainder of the year we will be focused on preparing for the approval of the recurrent VVC indication, while working to enroll invasive candidiasis patients into our MARIO study."
BREXAFEMME Commercial Update
Ibrexafungerp Clinical Updates
Ibrexafungerp Scientific Presentations and Publications
Corporate Developments
Second Quarter 2022 Financial Results
BREXAFEMME increased its net product revenues from $0.7 million in Q1 2022 to $1.3 million in Q2 2022.
Research and development expense for Q2 2022 increased to $7.1 million from $4.7 million for Q2 2021.
Selling, general & administrative (SG&A) expense for Q2 2022 increased to $15.8 million from $12.8 million for Q2 2021. The increase was primarily driven by an increase in costs recognized to support the ongoing commercialization of BREXAFEMME.
Total other income was $8.4 million for Q2 2022, versus total other income of $15.0 million for Q2 2021. During Q2 2022 and Q2 2021, SCYNEXIS recognized non-cash gains of $9.7 million and $15.3 million, respectively, on the fair value adjustment of the warrant liabilities and non-cash gains of $0.2 million and $0.5 million, respectively, on the fair value adjustment of derivative liabilities.
Net loss for Q2 2022 was $13.3 million, or $0.31 basic loss per share, compared to a net gain of $1.7 million, or $0.06 basic income per share for Q2 2021.
Cash and cash equivalents totaled $118.7 million on June 30, 2022, compared to $104.5 million in cash and cash equivalents on December 31, 2021. Based upon its current operating plan, SCYNEXIS believes that its existing cash and cash equivalents, and the anticipated sales of BREXAFEMME, will enable SCYNEXIS to fund its operating requirements into Q1 2024.
Conference call and webcast details
A conference call to discuss the results will be held today at 8:30 a.m. EDT
Investors (domestic): (877) 704-4453
Investors (international): (201) 389-0920
Conference ID: 13730704
Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an 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 in late-stage development for multiple indications, including life-threatening fungal infections caused primarily by Candida (including C. auris) and Aspergillus species in hospitalized patients. It has demonstrated broad-spectrum antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. The U.S. Food and Drug Administration (FDA) granted ibrexafungerp Qualified Infectious Disease Product (QIDP) and Fast Track designations for the IV and oral formulations of ibrexafungerp for the indications of invasive candidiasis (IC) (including candidemia) and invasive aspergillosis (IA) and has granted Orphan Drug Designation for the IC and IA indications. Ibrexafungerp is formerly known as SCY-078.
SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. SCYNEXIS scientists are developing the company's lead asset, ibrexafungerp (formerly known as SCY-078), as a broad-spectrum, systemic antifungal for multiple fungal indications in both the community and hospital settings. SCYNEXIS has initiated the launch of its first commercial product in the U.S., BREXAFEMME (ibrexafungerp tablets). The U.S. Food and Drug Administration (FDA) approved BREXAFEMME on June 1, 2021. SCYNEXIS filed a supplemental New Drug Application (sNDA) to expand BREXAFEMME's labelling to include the prevention of recurrent vulvovaginal candidiasis, and the FDA assigned a target PDUFA action date of November 30, 2022 for this additional indication. In addition, late-stage clinical investigation of ibrexafungerp for the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. For more information, visit www.scynexis.com.
Forward-Looking Statements
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, including but not limited to statements regarding: SCYNEXIS' goal to build a broad antifungal franchise for ibrexafungerp; SCYNEXIS' anticipation of the MARIO study completion and results, including to enable regulatory filing and potential approval for IC, including candidemia, in 2024; SCYNEXIS' expectations for the VANQUISH and CARES studies; and SCYNEXIS' expectation that its cash runway will be into the first quarter of 2024. 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: BREXAFEMME may not be accepted by physicians and patients at the rate SCYNEXIS expects; risks inherent in SCYNEXIS' ability to successfully develop and obtain FDA approval for ibrexafungerp for additional indications; unexpected delays may occur in the timing of acceptance by the FDA of an NDA submission; the expected costs of studies and when they might begin or be concluded; SCYNEXIS' need for additional capital resources; and SCYNEXIS' reliance on third parties to conduct SCYNEXIS' clinical studies and commercialize its products. 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 and Quarterly Report on Form 10-Q, including in each case under the caption "Risk Factors," and in 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.