Expert Perspectives on VVC Introduction July 14, 2020 1 Ibrexafungerp (” ibrexa ” or ”IBX”) is an investigational drug.
Forward-Looking Statements Certain statements regarding SCYNEXIS, Inc. (the “Company”) made in this presentation constitute forward -looking statements, including, but not limited to, statements regarding our business strategies and goals, plans and prospects, market size, adoption rate, potential revenue, clinical validity and utility, growth opportunities, future products and product pipeline. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. 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. Forward-looking statements may be identified by the use of the words “anticipates,” “expects,” “intends,” “plans,” “could,” “should,” “would,” “may,” “will,” “believes,” “estima tes ,” “potential,” or “continue” and variations or similar expressions. These statements are based upon the current expectations and beliefs of man agement and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward- looking statements. These risks and uncertainties include, but are not limited to, risks and uncertainties discussed in the Company's most recent reports filed with the Securities and Exchange Commission ("SEC"), including under the caption “Risk Factors” in the C omp any’s annual report on Form 10- K for the year ended December 31, 2019 and in the Company’s subsequent quarterly reports on Form 10 -Q, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. The Company undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this presentation, or to reflect actual outcomes. 2
Agenda 10:00 10:10 10:45 11:00 11:15 11:45 Ibrexa VVC Disease VVC Market Closing Introduction Overview & Q&A Session State Opportunity Remarks Progress Dr. Marco KOLs: Dr. Nkechi Azie Jim Maffezzoli Open to all Dr. Marco Taglietti Barbara Dehn, VP of Clinical VP of Marketing Taglietti CEO NP & Development & & Sales CEO Dr. Caroline Medical Affairs Mitchell 3 Ibrexafungerp (” ibrexa ” or ”IBX”) is an investigational drug.
Innovation Creates Value Value for VVC patients With limited treatment options and poor quality of life who want to feel “normal” Value for Health Care Providers Who need an alternative mode-of-action therapy and seek to reduce frustration of patients and improve their satisfaction Value for Public Health Agencies Who seek to promote innovative anti-infective agents to guard against future pathogens Value for Strategic Partners To complement existing portfolios in underserved disease areas Value for Savvy Investors & Loyal Shareholders Who recognize true innovation 4 Ibrexafungerp (” ibrexa ” or ”IBX”) is an investigational drug.
Ibrexafungerp: Most Clinically Advanced Innovation in Antifungals A new antifungal, in a novel class Innovation in Innovation in Innovation in Women’s Health Drug Development Hospital Setting • • • Potential to introduce Potential to be the Active against the FIRST new first new oral, non- multidrug-resistant antifungal class in azole, product for fungi, including over 20 years… emerging Candida treatment of VVC auris • … and more than 40 • In development for years after the prevention of introduction of oral recurrent VVC for azoles which nothing is approved 5 Ibrexafungerp (” ibrexa ” or ”IBX”) is an investigational drug.
The Im Impact of VVC Barbara Dehn NP scynexis.com
290,000 NPs in US Nurse 75% provide Primary Care Practit itio ioners Over 1 billion patient visits/year
Private practices Urgent Care Walk in Clinics Reproductive Centers Planned Parenthood Emergency Rooms Hospitals Examine, Dia iagnose, Prescribe
Usual Pathway to Relief 1. Hope it goes away 2. Online research 3. OTC remedy 4. “Natural” remedies 5. Hope it goes away 6. Office visit
Shrouded in Shame Not well understood Under reported Under appreciated
Vulvovaginal Candidiasis, VVC : A fungal infection of the lower female reproductive tract 12
VVC Afflicts 75% of women at least once in their lifetime 9 million women in the US Yearly 138 million women worldwide 50% of women will have a recurrence 8% will have 3+ episodes in a year = recurrent rVVC Not Associated with STI’s
Treatments: Oft ften repeated 1 cla class: AZOLEs • Over the Counter Creams • Clotrim azole • Micon azole • Tiocon azole • Oral medication • Flucon azole • Prescription Intravaginal Creams • Butocon azole • Tercon azole • Other agents • Boric Acid • Nystatin
VVC Risk Factors Prior use of Antibiotics Diabetes Obesity Use of Corticosteroids Pregnancy Immunocompromised
Recurrent VVC • 3-4 times/year • Pain with sex • Inflammation and Rash • Cracks, fissures in skin Impacts • Work • Self esteem • Relationship • Energy level • Physical functioning
Why doesn’t this go away? Why are you giving me the same thing….Again?
Vulvovaginal candidiasis Caroline Mitchell, MD, MPH Associate Professor, Obstetrics & Gynecology Massachusetts General Hospital & Harvard Medical School
Who am I?
Why should you care about VVC?
Vulvovaginal 75% candidiasis is common
Oral Topical Current treatments Miconazole Fluconazole Terconazole (Itraconazole) Clotrimazole (Voriconazole) Tioconazole Butaconazole
Cure at 1 month ranges from 50-80%, depending on the definition of “cure” 100 Why does the 80 field need a Percent cured new 60 medication? 40 20 0 SS < 2 SS = 0 Mycologic Zhou Mycoses 2016 (PMID 27073145); Sobel AJOG 2001; Nyirjesy JL LGTD 2019; Li Med Mycol 2015
High blood pressure 11 Many medical conditions Diabetes (oral) 5 have multiple types of Blood thinners 3 treatment options VVC 1
Pro Con Topical azoles Easy Irritating Messy Current azole Fluconazole Easy Can’t use in pregnancy therapies Incomplete efficacy have Medication interactions limitations Itraconazole, Familiar Not in guidelines Voriconazole Potential liver toxicity Less efficacy
OTC and alternative options
OTC and alternative options
50 % with recurrent VVC Probiotics are 40 ineffective to 30 prevent 20 recurrence Probiotic 10 Placebo 0 Czaja Pirotta Witt Kovachev Adapted from van de Wijgert BJOG 2019
The other options have significant limitations Flucytosine & Amphotericin $1400 $18-30
Pregnancy Recurrence Fluconazole-resistant C. albicans Non-albicans species Special cases Kennedy Curr Infect Dis Rep; Ameen Jl Mycol Med 2017; Goncalves Crit Rev Microbiol
Pregnancy Recurrence Fluconazole-resistant C. albicans Non-albicans species Special cases Candida species % cases (US) % cases (world) C. albicans 70-89% 35-90% C. glabrata 3-15% 3-50% C. tropicalis 1% 0.2 – 18% C. parapsilosis 4-8.9% 0.5 - 10% C. kruseii 0.1% 0.1 – 6% Kennedy Curr Infect Dis Rep; Ameen Jl Mycol Med 2017; Goncalves Crit Rev Microbiol
Risk of miscarriage between 2 7-23 weeks Hazard Ratio Denmark Fluconazole is 1 1.4 million contraindicated pregnancies in pregnancy Increased risk for miscarriage 0 Fluconazole Molgaard-Nielsen JAMA 2016 32
Between 5-9% of women have rVVC at any one time After 6 months weekly fluconazole suppression , 50-60% of women have a recurrence Recurrent VVC Among 191 women with rVVC, the median duration of fluconazole suppressive therapy was 16 months during 3 years of follow-up By age 50, 25% of women in the US report experiencing rVVC (lasting 1-4 years) Goncalves Crit Rev Microbiol 2017; Denning Lancet ID 2018; Collins Jl LGTD 2020; Sobel AJOG 2016
Boric acid Higher-dose Fluconazole Fluconazole- Itraconazole or Ketoconazole resistance Topical azole or Vaginal nystatin Non-albicans Vaginal Gentian violet Compounded vaginal flucytosine 17%/Amphotericin B 3% Sobel & Sobel Expert Opinion Pharmacotherapy 2018
A patient story
Ibrexafungerp Overview First Representative of a Novel Oral Antifungal for the Treatment of VVC Nkechi Azie, MD, MBA, FIDSA Pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections 36 Ibrexafungerp (” ibrexa ” or ”IBX”) is an investigational drug.
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