On May 11, 2020 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug resistant infections, reported financial results for the quarter ended on March 31, 2020 and provided an update on recent clinical and corporate developments (Press release, Scynexis, MAY 11, 2020, View Source [SID1234557524]).
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"The past several months have seen major accomplishments by SCYNEXIS, as we continued to generate positive clinical data from both our vaginal yeast infection and hospital-based programs, while also enhancing both our current cash position and our financial flexibility going forward," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "With the successful completion of our Phase 3 VANISH program, we remain on track to submit an NDA for ibrexafungerp as a treatment for vaginal yeast infections in the second half of this year, as we continue SCYNEXIS’s transition to a fully-integrated research and commercial entity. If approved, ibrexafungerp could represent the first new class of antifungals in over 20 years – a particularly significant achievement at a time when the need for novel anti-infectives has become devastatingly clear."
Ibrexafungerp Update
Completed the Phase 3 VANISH program with announcement of positive top-line results for the VANISH-306 study investigating the safety and efficacy of oral ibrexafungerp as a treatment for women with VVC (vaginal yeast infections). In the VANISH-306 study, ibrexafungerp achieved superiority over placebo with high statistical significance (p≤0.01) for the key endpoints required to support the New Drug Application (NDA) filing for this indication. The VANISH-306 study results were consistent with the prior positive efficacy findings observed in the VANISH-303 and the Phase 2b DOVE studies. Additionally, ibrexafungerp had a favorable tolerability profile throughout its Phase 3 program in VVC.
Enrollment is ongoing in the Phase 3 CANDLE study, investigating the safety and efficacy of oral ibrexafungerp for the prevention of recurrent VVC, for which there is no approved therapies in the U.S.. Pending successful completion of this trial, SCYNEXIS anticipates top-line results and the submission of a supplemental NDA for this indication in the second half of 2021.
Announced positive results from the second interim analysis of the ongoing Phase 3 open-label FURI study, evaluating oral ibrexafungerp as a salvage treatment in patients with difficult-to-treat mucocutaneous and invasive fungal infections. In the 41 patients analyzed to date, oral ibrexafungerp showed clinical benefits in 83% of patients, with 56% of patients achieving a complete or partial response and 27% a stable disease response. Of the 41 treated patients, only six did not respond to ibrexafungerp treatment and one patient was considered indeterminate. The protocol was amended to include a larger group of patients with diverse complex fungal infections and to extend the treatment duration beyond 90 days.
Enrollment is ongoing in the Phase 2 SCYNERGIA study for patients with invasive aspergillosis and activities are also ongoing in the development of a liposomal intravenous formulation for ibrexafungerp.
Data presentations. SCYNEXIS continues to educate the scientific community about ibrexafungerp’s clinical potential against a number of pathogens. In February 2020, SCYNEXIS presented in vitro data of ibrexafungerp that showed synergistic activity against Aspergillus isolates from lung transplant recipients at the Advances Against Aspergillosis and Mucormycosis Conference. SCYNEXIS also presented on the Candida auris landscape at the Superbugs and Superdrugs conference in March. Finally, in May 2020, SCYNEXIS announced the publication of six abstracts highlighting the potential clinical utility of ibrexafungerp in the 30th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) abstract book, now available online.
Corporate Developments Subsequent to March 31, 2020
On April 9, 2020, SCYNEXIS entered into a Senior Convertible Note Purchase Agreement with Puissance Life Science Opportunities Fund VI and issued and sold to Puissance $10 million of 6.0% Senior Convertible Notes due 2026.
On April 10, 2020, SCYNEXIS entered into a Common Stock Purchase Agreement with Aspire Capital Fund, LLC, pursuant to which it may sell to Aspire Capital up to $20.0 million in shares of its common stock over the next 30 months.
In April 2020, SCYNEXIS received a cash receipt of $3.1 million from the sale of a portion of its unused Net Operating Losses (NOLs) and R&D credits.
First Quarter Financial Results
Cash, cash equivalents and short-term investments totaled $34.5 million as of March 31, 2020, compared to $48.4 million in cash, cash equivalents, and short-term investments at December 31, 2019.
Research and development expenses for the quarter ended March 31, 2020 increased to $9.9 million from $9.7 million for the quarter ended March 31, 2019. The increase of $0.2 million, or 2%, was primarily driven by an increase of $2.1 million in clinical development costs, an increase of $1.6 million in chemistry, manufacturing, and controls (CMC) costs, and a net increase in other research and development expenses of $0.5 million, mostly offset by a milestone payment made to Merck during the three months ended March 31, 2019.
Selling, general and administrative expenses for the quarter ended March 31, 2020 increased to $2.6 million from $2.2 million for the quarter ended March 31, 2019. The increase of $0.4 million, or 17%, was primarily driven by a $0.3 million increase in professional fees and commercial related expenses.
Total other income increased to $5.5 million for the quarter ended March 31, 2020, compared to total other expense of $11.0 million for the quarter ended March 31, 2019. The increase in other income is primarily attributable to a $4.8 million non-cash gain recorded on the fair value adjustment of the warrant liabilities during the quarter ended March 31, 2020 in comparison to $6.5 million and $3.4 million non-cash losses recognized during the quarter ended March 31, 2019 on the fair value adjustments of the warrants liabilities and derivative liability, respectively.
Net loss for the quarter ended March 31, 2020 was $7.0 million, or ($0.07) net loss per basic and diluted share, compared to a net loss of $22.9 million, or ($0.46) net loss per basic and diluted share, for the quarter ended March 31, 2019.
COVID-19 Update
COVID-19, a novel strain of coronavirus, was first identified in December 2019, and subsequently declared a global pandemic by the World Health Organization on March 11, 2020. SCYNEXIS has been monitoring the COVID-19 pandemic closely and has not identified any significant adverse impacts of COVID-19 to SCYNEXIS’s operations or estimated timelines for the development efforts of ibrexafungerp, including the expected NDA submission for the treatment of vaginal yeast infection in the second half of 2020. The ultimate impact of the COVID-19 health pandemic is highly uncertain and subject to change and SCYNEXIS will continue to monitor the COVID-19 situation closely.
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, the ‘fungerps’. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and 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 vulvovaginal candidiasis (VVC) and has granted Orphan Drug Designation for the IC and IA indications. Ibrexafungerp is formerly known as SCY-078.