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 investorrelations@scynexis.com. (last updated 06/24/2019)


Regulatory and Exclusivity

Generating Antibiotic Incentives Now (GAIN) was passed in 2012 as part of the Food and Drug Administration Safety and Innovation Act (FDASIA) to address the public health threat of antimicrobial drug resistance by stimulating the development and approval of new antibacterial and antifungal drugs. The GAIN Act provides potential for an extended exclusivity period of five years, fast track designation and eligibility for priority review to novel antibiotics designated as Qualified Infectious Disease Product (QIDP) by FDA.

For more information: https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM595188.pdf

Yes. Ibrexafungerp has received QIDP status for invasive candidiasis and aspergillosis (oral 2014 and IV 2016) and for vulvovaginal candidiasis in 2018. Therefore, 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 ($2.6 million for 2019) will be waived for the first NDA filing as a small company.

LPAD (Limited Population Pathway for Antibacterial and Antifungal Drugs) is intended as an accelerated regulatory path 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.

For more information: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM610498.pdf

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 we believe could qualify for approval under the LPAD regulatory pathway.

The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product (“drug”) to treat a rare disease or condition upon request of a sponsor and it provides waiver of PDUFA fees and 7 additional years of exclusivity for the orphan indication. 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.

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.

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.

Clinical Development – Vulvovaginal Candidiasis (VVC)

SCYNEXIS will perform 3 studies: 2 studies in acute VVC (VANISH) and 1 study in recurrent VVC. The 2 studies in acute VVC have been initiated while the study in recurrent VVC is planned to start in the second quarter of 2019.

The VANISH Phase 3 program comprises 2 Phase 3 trials (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: https://clinicaltrials.gov/ct2/show/NCT03734991

SCYNEXIS plans to initiate a third Phase 3 trial (approximately 350 patients) evaluating oral ibrexafungerp vs. placebo in recurrent VVC in the second 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.

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 with potential for priority review. A supplemental NDA for the prevention of recurrent VVC is anticipated for 2021.

Clinical Development – 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.

For more information: Combination Therapy with SCY-078 and Isavuconazole for Treatment of Experimental Invasive Pulmonary Aspergillosis

The Phase 2 trial (SCYNERGIA) designed to evaluate the safety and efficacy of oral ibrexafungerp in combination with standard-of-care voriconazole in patients with invasive pulmonary aspergillosis. An animal model of pulmonary aspergillosis demonstrated improved outcomes and survival rates, supporting the potential superiority of ibrexafungerp in combination with azole therapy versus standard of care alone in this high-mortality indication.

The SCYNERGIA study is a multicenter, randomized, double-blind, two-arm study to evaluate the safety, tolerability, efficacy and PK of the combination therapy of ibrexafungerp plus voriconazole compared to those of voriconazole monotherapy in subjects 18 years of age and older with a hematological malignancy (HM) or a myelodysplastic syndrome or aplastic anemia or hematopoietic cell transplantation (HCT) and a probable or proven invasive pulmonary aspergillosis. The study will accrue approximately 60 patients and is expected to take 2 years to complete.

For more information: https://clinicaltrials.gov/ct2/show/NCT03672292

Clinical Development – Refractory Fungal Infections

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.

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

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.

Financials

Increasing the number of authorized shares for future issuance at an annual shareholder meeting is a common business practice when the total number of available issuable shares becomes relatively low. The number of authorized shares of SCYNEXIS common stock at the time of IPO in 2014 was 125 million.  In the last five years, a majority of these initially authorized shares have been either issued in past equity offerings or are potentially issuable assuming exercise of outstanding options, warrants and/or conversion of convertible debt.  Requesting an increase in authorized shares does not mean that the company is issuing common stock nor that it has any plans, arrangements or understandings, to issue any of the common stock that will be newly authorized following the approval of this proposal by our stockholders. For further information, please see our preliminary proxy statement dated 04/26/19.

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.

For more information: https://en.wikipedia.org/wiki/Convertible_bond

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://ir.scynexis.com/press-releases/detail/171/scynexis-is-retiring-existing-term-loan-through-a

As of December 31, 2018, SCYNEXIS had cash, cash equivalents and short-term investments of approximately $44.2 million.

In January 2019, SCYNEXIS completed the sale of a portion of its NOLs and received a cash receipt of $6.7 million, resulting in a pro forma cash balance of $51 million as of January 3, 2019. In March 2019, SCYNEXIS also completed the sale of a $16.0 million convertible unsecured senior note in a private placement. SCYNEXIS used the proceeds of the convertible debt to retire in full the previous term loan, strengthening near-term cash flows and extending the Company's cash runway past an anticipated NDA submission in the second half of 2020.

As of Mach1, 2019 (per the last filed 10-K), the number of basic shares outstanding was 50.1 million and the number of fully diluted shares was 81.7 million.

In January 2019, SCYNEXIS completed the sale of a portion of its Net Operating Losses (NOLs) and received a cash receipt of $6.7 million. This sale was structured through the New Jersey Technology Business Tax Certificate Transfer (NOL) Program, which allows eligible companies to sell their New Jersey NOLs and research and development tax credits up to a maximum lifetime benefit of $15 million per company.

For more information: https://www.njeda.com/technology_lifesciences/Technology-Business-Tax-Certificate-Transfer-(NOL)

Investment Bank

Analyst

Rating

Price Target

Brookline Capital Markets

Kumar Raj PhD

BUY

$10.00

Canaccord Genuity

Dewey Steadman, CFA

BUY

$4.00

Guggenheim Securities

Adnan Butt

BUY

$5.00

Ladenburg Thalmann Financial Services

Michael Higgins

BUY

$6.00

HC Wainwright

Oren Livnat, CFA

BUY

$4.50

Maxim Group

Jason McCarthy, PhD

BUY

$4.00

Needham & Co.

Alan Carr, PhD

BUY

$5.00

Opus National Capital Markets

Jonathan Aschoff, PhD

BUY

$6.00

Roth Capital Partners

in transition

BUY

---

WBB Securities

Steve Brozak

BUY

$8.00

For more information: https://ir.scynexis.com/analyst-coverage

Miscellaneous

Oral Presentations

Title: Ibrexafungerp (SCY-078) 
Presenter: David Angulo, MD

Ibrexafungerp will be highlighted during this special session, "Antifungals New and Near." The session is designed to identify novel antifungal targets and agents in the early discovery phase as well as an update on novel antifungals in late clinical development.

Title: Efficacy of Ibrexafungerp (Formerly SCY-078) in a Murine Therapeutic Model of Pneumocystis Pneumonia 
Presenter: Stephen Barat, PhD

The presentation will highlight results demonstrating that ibrexafungerp shows significant activity in a murine treatment model of Pneumocystis pneumonia (PCP). PCP is an opportunistic fungal infection that affects immunocompromised patients, including those infected with HIV, undergoing organ transplants or receiving chemo- or immune-therapy as a cancer treatment. Current therapies to treat PCP have limitations related to efficacy and toxicity. In previously conducted studies, ibrexafungerp showed significant activity in a murine prophylaxis model of PCP. Taken together, these results indicate that ibrexafungerp could potentially be a viable option for managing PCP in immunocompromised patients.

Poster Presentations

Title: Efficacy of Ibrexafungerp (Formerly SCY-078) in the Treatment of Candida auris Cutaneous Infection in a Guinea Pig Model 
Presenter: Mahmoud Ghannoum, PhD

The poster will present in vivo results showing that treatment with ibrexafungerp reduced the fungal burden in skin infected with Candida auris, when compared to the untreated control, thus suggesting efficacy in the treatment of cutaneous infections and the potential role of ibrexafungerp in C. auris skin decolonization.

Title: Efficacy of Oral Ibrexafungerp (Formerly SCY-078) in the Treatment of Candida auris Infection in a Murine Model 
Presenter: Mahmoud Ghannoum, PhD

In this study, data will be presented showing the potent antifungal activity of ibrexafungerp against C. auris strains in a murine mouse model measuring kidney fungal burden and survival rates. Tissue burdens were lower than vehicle controls in all treatment groups, with the highest reduction in tissue burden observed in the 30 mg/kg dosing group. The 14-day survival rate was comparable across groups, with animals in the 10, 20 and 30 mg/kg groups having survival rates of 60, 70 and 60%, respectively, compared to the vehicle group which had a survival rate of 20%.

Title: Preclinical Safety Evaluation of the Novel Antifungal Ibrexafungerp (formerly SCY-078) Supports Long-Term Dosing 
Presenter: Stephen Barat, PhD

Results from in vivo studies evaluating the safety of ibrexafungerp will be presented. In these ibrexafungerp studies, genetic toxicity, end organ toxicity from chronic daily dosing (in rats up to 6 months and in dogs up to 9 months) and developmental and reproductive toxicity in rats and/or rabbits from conception to sexual development of the offspring were evaluated. Ibrexafungerp was well-tolerated in both rats and dogs, with end organ toxicity consisting mainly of phospholipidosis. The no-observed-adverse-effect-levels (NOAELs) for end organ toxicity are equivalent to 7-fold and 3-fold multiples (in rats and dogs, respectively) relative to the targeted efficacious human clinical exposures based on data from in vivo murine models of candidiasis and aspergillosis. Results from this preclinical package suggest that ibrexafungerp has a favorable preclinical safety profile and supports the potential for long-term dosing in patients suffering from invasive fungal infections.

Title: Penetration of Ibrexafungerp (formerly SCY-078) versus Micafungin at the Site of Infection in an Intra-Abdominal Candidiasis Mouse Model 
Presenter: Yanan Zhao, PhD

The poster will feature results from a study designed to test ibrexafungerp's penetration in a mouse model of intra-abdominal candidiasis (IAC), a common invasive fungal infection with high mortality. Echinocandins, the current standard of care for the treatment of invasive candidiasis, are not ideal treatment options for IAC given their poor penetration into intra-abdominal tissue and abscesses. In this study, ibrexafungerp penetrated significantly better into intra-abdominal abscesses as compared to micafungin. These data demonstrate that ibrexafungerp holds promise as a potential therapeutic option for IAC patients.

Title: Activity of a Novel 1,3-beta-D-Glucan Inhibitor, Ibrexafungerp (Formerly SCY-078), against Candida glabrata 
Presenter: Mahmoud Ghannoum, PhD

This study tested the in vitro activity of ibrexafungerp against C. glabrata clinical isolates (18 wild-type and 22 echinocandin-resistant strains), as well as the in vivo activity against wild-type and echinocandin-resistant C. glabrata strains. The ibrexafungerp MIC range against 40 C. glabrata clinical isolates was 0.5-4.0 µg/mL, with an MIC90 of 1.0 µg/mL. Time-kill studies showed that ibrexafungerp, at concentrations of 0.25 to 1 µg/mL, produced a 4 to 6 log reduction in growth of the susceptible strain at 24- and 48-hour time points. Mice infected with C. glabrata and treated with ibrexafungerp at doses ≤ 30 mg/kg showed significant reductions in kidney fungal burden for both a susceptible strain (P=≤ 0.01) and a echinocandin-resistant strain (P=≤0.03). In vivo and in vitro assays suggest that ibrexafungerp has promise for the treatment of invasive candidiasis caused by wild-type and echinocandin-resistant C. glabrata.

Title: Efficacy of Ibrexafungerp (Formerly SCY-078) in a Murine Therapeutic Model of Pneumocystis Pneumonia 
Presenter: Stephen Barat, PhD

This poster will highlight results from an in vivo study designed to evaluate the therapeutic activity of oral ibrexafungerp gainst Pneumocystis pneumonia (PCP), a significant risk for immunocompromised patients. Oral ibrexafungerp was evaluated at two dose levels (15mg/kg or 30mg/kg, twice daily), compared to trimethoprim/sulfamethoxazole (50/250mg/kg three times weekly), the current standard of care, and vehicle control. At each dose level, oral ibrexafungerp demonstrated activity against Pneumocystis, as determined by a reduction in organism burden and improved survival, supporting future clinical studies of ibrexafungerp for both treatment of PCP and prophylactic use as a single oral agent in immunocompromised patients.

Title: Interim Analysis of a Phase 3 Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (Formerly SCY-078) in Patients with Refractory or Intolerant Fungal Diseases (FURI) 
Presenter: Luis Ostrosky-Zeichner, MD

This poster will present results from the first interim analysis of 20 patients with various Candida infections from the FURI study, an open-label trial of oral ibrexafungerp in patients with refractory fungal infections. In this analysis, 11 patients (55%) achieved complete or partial response, six patients (30%) maintained stable disease, two patients (10%) experienced progression of disease and one case was considered indeterminate. Of particular interest, the patients enrolled in the FURI study predominantly had non-albicans Candida spp. infections, which are more resistant and difficult-to-treat with current marketed antifungal agents, reflecting the need for new antifungal therapies. 

Oral Presentation

Title: Favorable Response to Oral Ibrexafungerp (formerly SCY-078) in Patients with Refractory Fungal Diseases, Interim Analysis by Pathogen from a Phase 3 Open-label Study (FURI) 

Presenter: Oliver Cornely, MD

The presentation showcases results from the first interim analysis of 20 patients with various Candida infections from the FURI study, an open-label trial of oral ibrexafungerp in patients with refractory fungal infections. 11 patients (55%) achieved complete or partial response, 6 patients (30%) maintained stable disease, 2 patients (10%) experienced progression of disease and one case was considered as indeterminate. Of particular interest, the patients enrolled in the FURI study predominantly had non-albicans Candida spp. infections, which are more resistant and difficult-to-treat with current marketed antifungal agents, reflecting the need for new antifungal therapies.

Poster Presentations

Title: Successful Treatment of Two Patients with Candida auris Candidemia with the Investigational Agent, Oral Ibrexafungerp (formerly SCY-078) from the CARES Study

Presenter: Deven Juneja, MD

The poster presents clinical findings of two patients with Candida auris candidemia enrolled in the CARES study, who were successfully treated with oral ibrexafungerp. Both patients had multiple co-morbidities, were admitted to ICU and were diagnosed with Candida auris in the bloodstream, a pathogen defined by the Center of Disease Control (CDC) as "an emerging fungus that presents a serious global health threat."  Both of these difficult-to-treat candidemia cases responded positively to oral ibrexafungerp, with clearance of the C. auris infection at the end of treatment.  Ibrexafungerp was well-tolerated by both patients.

Title: Favourable Clinical Outcome of Two Patients with Candida spp. Spondylodiscitis Treated with Oral Ibrexafungerp (formerly SCY-078) from the FURI Study

Presenter: Philipp Koehler, MD

The poster presents two patients with Candida spondylodiscitis, a rare and difficult-to-treat infection of the intervertebral disc space and vertebral bone that requires months-long courses of therapy. Both patients were enrolled into the FURI study, with one patient being intolerant to azole therapy and the other patient failing standard therapy. The patients have received >290 days and >100 days of ibrexafungerp therapy, with one patient showing significant improvement and one complete resolution. Long-term treatment with ibrexafungerp has been well tolerated by these patients.

Title: Use of Ibrexafungerp (formerly SCY-078) to Treat Severe Azole-refractory Oesophageal Candidiasis: A Case Report from the FURI Study

Presenter: Jose Vazquez, MD

The poster presents a patient from the FURI study, a 63-year-old male with a 10-year history of painful esophageal constriction and recurrent esophageal candidiasis, requiring a percutaneous gastroenterostomy feeding tube due to his inability to swallow and eat. Multiple courses of antifungals were unsuccessful in treating this fluconazole-resistant C. glabrata infection, and the patient was enrolled in the FURI study with severe esophagitis at baseline. After 54 days of oral ibrexafungerp treatment, the infection fully resolved. The patient remained asymptomatic during the follow-up period and the feeding tube was able to be removed.

Title: Penetration of Ibrexafungerp (formerly SCY-078) versus Micafungin at the Site of Infection in an Intra-abdominal Candidiasis Mouse Model

Presenter: Annie Lee, PhD

The oral E-poster presents results from a study designed to test ibrexafungerp's penetration in a mouse model of intra-abdominal candidiasis (IAC). IAC is a common invasive fungal infection with high mortality. Echinocandins, the current gold standard for treatment for invasive candidiasis, are not ideal treatment options for IAC given their poor penetration into intra-abdominal tissue and abscesses. In this study, Perlin et al., showed that ibrexafungerp penetrates significantly better into intra-abdominal abscesses as compared to micafungin. It holds promise as a potential therapeutic option for IAC patients.

Title: Efficacy of Ibrexafungerp (formerly SCY-078) against Pneumocystis Pneumonia in a Murine Therapeutic Model 

Presenter: Stephen Barat, PhD

The oral E-poster presents results from an in vivo study designed to evaluate the therapeutic activity of oral ibrexafungerp against Pneumocystis pneumonia (PCP), a significant risk for immunocompromised patients. Oral ibrexafungerp was evaluated at two dose levels (15mg/kg or 30mg/kg, twice daily), compared to trimethoprim/sulfamethoxazole 50/250mg/kg three times weekly, the current standard of care, and vehicle control. At each dose level, oral ibrexafungerp demonstrated activity against Pneumocystis, as determined by a reduction in organism burden and improved survival, supporting future clinical studies of ibrexafungerp for both treatment of PCP and prophylactic use as a single oral agent in immunocompromised patients.

Here are the links below:

A Mysterious Infection, Spanning the Globe in a Climate of Secrecy

  • Fungus Immune to Drugs Quietly Sweeps the Globe
  • The rise of Candida auris embodies a serious and growing public health threat: drug-resistant germs.

What You Need to Know About Candida Auris

  • C. auris is a mysterious and dangerous fungal infection that is among a growing number of germs that have evolved defenses against common medicines. Here are some basic facts about it.

Culture of Secrecy Shields Hospitals with Outbreaks of Drug-Resistant Infections

  • The lack of transparency puts patients at risk, some say. Institutions say disclosure could scare some people away from seeking needed medical care.

How a Chicago Woman Fell Victim to Candida Auris, a Drug-Resistant Fungus

  • The mysterious infection has appeared at hospitals around the world, but few institutions or families have discussed their experience.

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.