This section provides a list of FAQs that SCYNEXIS has accumulated from investors, as a quick reference. The information provided in this page is also available publicly on our web site, our SEC filings or in the public domain and it is subject to our Forward Looking Statement Disclaimer. If you have additional questions, please, submit them to firstname.lastname@example.org. (last updated 10/16/2019)
Trending TopicsWho are the members of SCYNEXIS management team? What is ibrexafungerp? When does SCYNEXIS plan to file the NEW Drug Applications (NDA) for acute VVC? What is Candida auris? What is the CARES study?
SCYNEXIS at a Glance
When was SCYNEXIS founded?
SCYNEXIS was founded in 1999.
When did SCYNEXIS become a public company?
SCYNEXIS went public in May 2014.
Who are the members of SCYNEXIS management team?
You can view our management team by visiting the Leadership page on our website.
Who are the members of SCYNEXIS Board of Directors?
You can view our Board of Directors by visiting the Board of Directors page on our website.
What is convertible debt? What is the benefit of the convertible debt for SCYNEXIS?
Convertible debt (or convertible bond / note) is a type of bond that the holder can convert into a predetermined number of shares of common stock in the issuing company during the bond's life, usually at the discretion of the bond holder. It is a hybrid security with debt- and equity-like features.
The current convertible debt offering completed by SCYNEXIS allowed the Company to retire in full its existing $15 million loan, that was set to be repaid by the end of the third quarter 2020. As a result, the Company was able to lower its interest expenses and to push out near-term principal payment obligations. In addition, upon conversion, stock will be issued at a premium price, resulting in less dilution for shareholders versus typical equity offerings.
For more information: https://en.wikipedia.org/wiki/Convertible_bond
Which Wall Street research analysts follow the SCYNEXIS stock?
For a list of research analyst that follow SCYX click here.
What are the current SCYNEXIS’ partnerships?
Information about SCYNEXIS’ partnerships can be found here.
What is ibrexafungerp?
Ibrexafungerp (formerly known as SCY-078), is a novel IV/oral antifungal agent in development for the treatment of multiple serious and life-threatening invasive fungal infections caused by Candida, Aspergillus and Pneumocystis species. For more information, click here.
What is ibrexafungerp regulatory status?
Ibrexafungerp has received Qualified Infectious Disease Product (QIDP) status for invasive candidiasis and aspergillosis (oral 2014 and IV 2016) and for vulvovaginal candidiasis in 2018. Ibrexafungerp is eligible to receive five extra years of exclusivity, fast track status and priority review (6 months review rather than a standard review of 10 months) for these indications. Additionally, the Prescription Drug User Fee Act (PDUFA) payment ($2.9 million for 2020) will be waived for the first NDA filing as a small company.
Ibrexafungerp has been granted orphan drug status for invasive candidiasis in 2016 and for invasive aspergillosis 2017. Approval under QIDP and approval for an Orphan indication could result in a total of 12 years of marketing exclusivity for the indication.
For more information on QIDP Status:
For more information on Orphan Drug Status:
What is the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD)? Are the FURI and CARES studies eligible for LPAD?
LPAD (Limited Population Pathway for Antibacterial and Antifungal Drugs) is intended as an accelerated regulatory pathway for products treating serious or life-threatening infections in a limited patient population with unmet needs. FDA will accept greater uncertainty and higher risk for products that qualify for the pathway, but the labelling will include statements to convey to the health care community that the drug has been shown to be safe and effective only for use in a limited population.
The FURI and CARES protocols have been designed to treat patients suffering from fungal infections with organisms resistant to other products or who cannot tolerate other products. Success against these life-threatening infections would address an unmet medical need and could qualify for approval under the LPAD regulatory pathway when meeting FDA requirements for substantial evidence of effectiveness in the limited population (see under Refractory Fungal Infections).
What is ibrexafungerp patent protection? When will expire?
Ibrexafungerp is covered by a composition of matter patent (i.e., a patent covering the ibrexafungerp compound itself). The 2030 expiration date for this patent is expected to be extended until 2035, pursuant to the patent term extension provisions of U.S. law. We are also pursuing patent coverage beyond the composition of matter, including formulations and methods of treatment, which may provide limited patent protection beyond 2035.
What is the clinical development plan for ibrexafungerp? When does SCYNEXIS expect to file the first NDA for Ibrexafungerp?
You can view our development status and plan by visiting the Pipeline page on our website.
Where can I find scientific data and presentations on Ibrexafungerp?
All ibrexafungerp's publications and presentations can be found here.
What is the status of the ibrexafungerp IV formulation?
In January 2018, we announced encouraging pre-clinical results for the prototype liposomal IV formulation of ibrexafungerp, showing improved local tolerability profile at the infusion site in head-to-head pre-clinical evaluations with the cyclodextrin-based IV formulation. As part of our development plans, the process for the liposomal formulation was transferred for scale-up purposes at a manufacturing site intended to provide clinical supplies. Additional preclinical evaluations were performed with the scaled-up formulation, which unexpectedly revealed differences in tolerability at the injection site, delaying advancement of the IV product into human trials. As it is generally recognized that changes to manufacturing processes and/or scale-up can impact the characteristics of drug products, particularly for more technically complex formulations such as liposomal products, SCYNEXIS is currently working with our vendors and CMC experts to enable us to resume the IND-enabling pre-clinical activities for the IV formulation of ibrexafungerp. SCYNEXIS will provide updates on the IV formulation studies as they become available.
IBREXAFUNGERP Clinical Development – Vulvovaginal Candidiasis (VVC)
What is the development plan to obtain regulatory approval for VVC?
You can view our VVC development plan here.
SCYNEXIS is conducting 3 registration studies: 2 studies in acute VVC (VANISH) and 1 study in recurrent VVC (CANDLE).
The VANISH Phase 3 program comprises 2 Phase 3 trials (enrolling-approximately 350 patients each) designed to evaluate the safety and efficacy of one-day oral ibrexafungerp versus placebo for the treatment of acute VVC in female patients 12 years and older. The study will randomize in a 2:1 randomization, oral ibrexafungerp 300 mg BID for one day vs. placebo BID for one day. The primary efficacy endpoint of the study is the percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the Test-of-Cure Visit (Day10).
Pending successful completion of the VANISH program, SCYNEXIS plans to submit an initial NDA for oral ibrexafungerp for the treatment of VVC in the second half of 2020 utilizing the QIDP designation of ibrexafungerp.
For more information:
SCYNEXIS initiated a third Phase 3 trial (approximately 350 patients) evaluating oral ibrexafungerp vs. placebo in recurrent VVC in the third quarter of 2019, an indication with no product currently approved. Pending successful completion of this Phase 3 study, SCYNEXIS plans to submit a supplemental NDA for oral ibrexafungerp for the prevention of recurrent VVC in 2021. SCYNEXIS reached an agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) on the design, trial population, endpoints and statistical analysis of its pivotal Phase 3 clinical trial (the CANDLE study) of oral ibrexafungerp for the prevention of recurrent vulvovaginal candidiasis (VVC).
When does SCYNEXIS plan to file the NEW Drug Applications (NDA) for acute VVC?
SCYNEXIS plans to submit an initial NDA for oral ibrexafungerp for the treatment of VVC utilizing the QIDP designation of ibrexafungerp and an MAA to EMEA in the second half of 2020.
IBREXAFUNGERP Clinical Development – Invasive Aspergillosis
What is the evidence suggesting that ibrexafungerp in combination may be superior to azoles alone (current standard of care) in Invasive Aspergillosis?
Invasive aspergillosis is a severe, hospital-based, infection with high mortality rates despite the latest available agents (azole class).
A neutropenic rabbit model has shown that ibrexafungerp given in combination with isavuconazole provided significantly better outcomes and improved survival rates versus isavuconazole alone. Moreover, a large clinical study (published by Marr et al. in 2015) showed that glucan synthase inhibitors (like ibrexafungerp) when given in combination with azoles may provide clinical benefits over standard of care alone.
What are the key aspects of the Phase 2 Study in Invasive Aspergillosis (SCYNERGIA Study)?
For information about SCYNERGIA click here.
IBREXAFUNGERP Clinical Development – Refractory Fungal Infections
What is the FURI study?
The FURI study is a multicenter, open-label, non-comparator, single arm study to evaluate the safety and efficacy of ibrexafungerp in patients > 18 years of age with a documented invasive and/or severe mucocutaneous fungal disease that has been intolerant or refractory (rIFI) to standard of care (SoC) antifungal treatment or a continued IV antifungal therapy is not desirable or feasible.
Enrolled patients receive an initial loading dose of 750mg BID (twice a day) of oral ibrexafungerp during the first two days of treatment and subsequent oral doses of 750mg QD (once a day) for up to 90 days.
Data from the FURI study will be analyzed periodically.
For more information: https://clinicaltrials.gov/ct2/show/NCT03059992.
What is Candida auris? What is the CARES study?
Candida auris has been classified by the Centers for Disease Control and Prevention (CDC) as a serious public health threat, as it is multidrug-resistant, has resulted in high mortality rates (up to 60%) and can be spread from patients (and surfaces) to patients, resulting in hospital outbreaks. The CDC is concerned about C. auris for several reasons:
It causes serious infections. C. auris can cause bloodstream infections and even death, particularly in hospital and nursing home patients with serious medical problems. More than 1 in 3 patients with invasive C. auris infections (for example, an infection that affects the blood, heart, or brain) die.
It's often resistant to medicines. Antifungal medicines commonly used to treat Candida infections often don't work for Candida auris. Some C. auris infections have been resistant to all three types of antifungal medicines.
It's becoming more common. Although C. auris was just discovered in 2009, it has spread quickly and caused infections in more than a dozen countries.
It's difficult to identify. C. auris can be misidentified as other types of fungi unless specialized laboratory technology is used. This misidentification might lead to a patient getting the wrong treatment.
It can spread in hospitals and nursing homes. C. auris can spread through contact with affected patients and contaminated surfaces or equipment and, as a result, has caused outbreaks in healthcare facilities. Good hand hygiene and cleaning in healthcare facilities is important because C. auris can live on surfaces for several weeks.
For more information: https://www.cdc.gov/fungal/candida-auris/c-auris-drug-resistant.html
The CARES study is a multi-center (U.S. and India), open-label, single-arm study designed to evaluate the efficacy, safety and tolerability of oral ibrexafungerp in subjects with documented C. auris infections. Similar to the FURI study, subjects receive an initial loading dose of oral ibrexafungerp 750 mg twice a day (BID) during the first 2 days and then subsequent oral ibrexafungerp 750 mg once a day (QD) for up to 90 days.
The study expects to enroll 30 patients.
For more information: https://clinicaltrials.gov/ct2/show/NCT03363841
When would SCYNEXIS file FURI or CARES data for a potential LPAD approval?
Both FURI and CARES studies have been designed to be eligible for the LPAD process. Since filing for an LPAD is dependent on the data that is collected from the studies, we have not provided any guidance when a filing will occur. We will continue to review data on a regular basis from the two studies and make a determination, in consultation with FDA, on the feasibility of a submission under the LPAD guidance using data from FURI and/or CARES studies.
IBREXAFUNGERP Market Opportunity
What is the market opportunity for ibrexafungerp in VVC (or outpatient setting)?
Information about ibrexafungerp’s market opportunity in VVC can be found here.