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Ibrexafungerp (”ibrexa” or ”IBX”) is an investigational drug.
Expert Perspectives on VVC
July 14, 2020
Introduction
Expert Perspectives on VVC Introduction July 14, 2020 1 - - PowerPoint PPT Presentation
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
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Ibrexafungerp (”ibrexa” or ”IBX”) is an investigational drug.
July 14, 2020
Introduction
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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,” “estimates,” “potential,” or “continue” and variations or similar expressions. These statements are based upon the current expectations and beliefs of management 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 Company’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
after the date of this presentation, or to reflect actual outcomes.
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Ibrexafungerp (”ibrexa” or ”IBX”) is an investigational drug.
Introduction
Taglietti CEO 10:00
VVC Disease State
KOLs: Barbara Dehn, NP &
Mitchell 10:10
Ibrexa Overview & Progress
VP of Clinical Development & Medical Affairs 10:45
VVC Market Opportunity
Jim Maffezzoli VP of Marketing & Sales 11:00
Q&A Session
Open to all 11:15
Closing Remarks
Taglietti CEO 11:45
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Ibrexafungerp (”ibrexa” or ”IBX”) is an investigational drug.
Value for Public Health Agencies Who seek to promote innovative anti-infective agents to guard against future pathogens
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 Savvy Investors & Loyal Shareholders
Who recognize true innovation
Value for Strategic Partners
To complement existing portfolios in underserved disease areas
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Ibrexafungerp (”ibrexa” or ”IBX”) is an investigational drug.
A new antifungal, in a novel class Innovation in Drug Development Innovation in Women’s Health Innovation in Hospital Setting
the FIRST new antifungal class in
years after the introduction of oral azoles
first new oral, non- azole, product for treatment of VVC
prevention of recurrent VVC for which nothing is approved
multidrug-resistant fungi, including emerging Candida auris
scynexis.com
Barbara Dehn NP
Nurse Practit itio ioners 290,000 NPs in US 75% provide Primary Care Over 1 billion patient visits/year
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A fungal infection of the lower female reproductive tract
Afflicts 75% of women at least once in their lifetime
Yearly
9 million women in the US 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
Prior use of Antibiotics Diabetes Obesity Use of Corticosteroids Pregnancy Immunocompromised
Why doesn’t this go away? Why are you giving me the same thing….Again?
Caroline Mitchell, MD, MPH Associate Professor, Obstetrics & Gynecology Massachusetts General Hospital & Harvard Medical School
Topical Oral
Miconazole Terconazole Clotrimazole Tioconazole Butaconazole Fluconazole (Itraconazole) (Voriconazole)
Zhou Mycoses 2016 (PMID 27073145); Sobel AJOG 2001; Nyirjesy JL LGTD 2019; Li Med Mycol 2015
SS < 2 SS = 0 Mycologic 20 40 60 80 100 Percent cured
Cure at 1 month ranges from 50-80%, depending on the definition of “cure”
1 3 5 11 VVC Blood thinners Diabetes (oral) High blood pressure
Pro Con Topical azoles Easy Irritating Messy Fluconazole Easy Can’t use in pregnancy Incomplete efficacy Medication interactions Itraconazole, Voriconazole Familiar Not in guidelines Potential liver toxicity Less efficacy
Czaja Pirotta Witt Kovachev 10 20 30 40 50
% with recurrent VVC
Probiotic Placebo
Adapted from van de Wijgert BJOG 2019
Flucytosine & Amphotericin
Pregnancy Recurrence Fluconazole-resistant C. albicans Non-albicans species
Kennedy Curr Infect Dis Rep; Ameen Jl Mycol Med 2017; Goncalves Crit Rev Microbiol
Pregnancy Recurrence Fluconazole-resistant C. albicans Non-albicans species
Candida species % cases (US) % cases (world)
70-89% 35-90%
3-15% 3-50%
1% 0.2 – 18%
4-8.9% 0.5 - 10%
0.1% 0.1 – 6%
Kennedy Curr Infect Dis Rep; Ameen Jl Mycol Med 2017; Goncalves Crit Rev Microbiol
Denmark 1.4 million pregnancies Increased risk for miscarriage
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1 2 Hazard Ratio
Molgaard-Nielsen JAMA 2016
Risk of miscarriage between 7-23 weeks
Fluconazole
Between 5-9% of women have rVVC at any one time After 6 months weekly fluconazole suppression , 50-60% of women have a recurrence 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 Itraconazole or Ketoconazole Topical azole Vaginal nystatin Vaginal Gentian violet Compounded vaginal flucytosine 17%/Amphotericin B 3%
Sobel & Sobel Expert Opinion Pharmacotherapy 2018
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Ibrexafungerp (”ibrexa” or ”IBX”) is an investigational drug.
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
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Ibrexafungerp (”ibrexa” or ”IBX”) is an investigational drug.
Diseases, Women’s Health, CNS, Immunology and Gastro-Intestinal Disease.
– Medicines Company – Senior Vice President Medical Affairs – Astellas – Senior Medical Director Clinical Development and Medical Affairs – Pfizer – Medical Director Clinical Development – Pharmacia- Associate Medical Director – Eli Lily – Research Fellow – Indiana University Medical Center – Infectious disease specialist Physician
Dame and a Medical degree from the University of Nigeria.
Pharmacology.
Vice President Clinical Development and Medical Affairs
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Ibrexafungerp (”ibrexa” or ”IBX”) is an investigational drug.
No Safety Signals Phase 3 Program Successfully Completed Broad- spectrum of Activity Different From the Start Kills Candida
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Ibrexafungerp (”ibrexa” or ”IBX”) is an investigational drug.
Ibrexafungerp: First Oral Glucan Synthase Inhibitor Glucan Synthase Inhibitor Echinocandins (e.g., Caspofungin)
CASPOFUGIN
Structurally distinct: Allowing oral delivery
IBREXAFUNGERP
Available only in Intravenous Formulation, not available orally
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Ibrexafungerp (”ibrexa” or ”IBX”) is an investigational drug.
Validated MoA Differentiated binding vs. echinocandins
Fungal Cell
Nucleus Cell Wall β-(1,6)-glutan Mannoproteins Chitin Phospholipid bilayer
Ergosterol
(Polyenes siteErgosterol Synthesis Pathway
(Azoles site of interaction)β-(1,3)-glucan synthase
(SCY-078 and echinocandins site of interaction)Depletion of β-(1,3)-glucans in cell wall
Larkin E., et al. The Emerging Pathogen Candida auris: Growth Phenotype, Virulence Factors, Activity of Antifungals, and Effect of SCY-078, a Novel Glucan Synthesis Inhibitor, on Growth Morphology and Biofilm Formation. Antimicrob Agents Chemother. 2017 May; 61(5)
Cell Membrane and Cell Wall
β-(1,3)-glucan
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Ibrexafungerp (”ibrexa” or ”IBX”) is an investigational drug.
The First Non-azole Treatment for VVC
Novel Class Triterpenoid Active Against Azole-resistant Candida No Cross Resistance with Azoles Exclusive Fungal Target Fungicidal Against Candida Proven Gold Standard MoA vs. Candida All prescription VVC drugs are Azoles
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Ibrexafungerp (”ibrexa” or ”IBX”) is an investigational drug.
In Vitro Activity is Not Impaired at Vaginal pH Take With Or Without Food Plasma to Genital Tissue Ratio: Ibrexafungerp –1: 9 Fluconazole – 1: 0.7 - 1.0
Oral 1-Day Treatment 20-hour Half-Life
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Ibrexafungerp (”ibrexa” or ”IBX”) is an investigational drug.
Pre-clinical
No end organ toxicity No fetal toxicity
Clinical
Well Tolerated > 1200 dosed Majority of AEs were GI-related: mild and transient
No Hepatotoxicity No Renal Toxicity No QTC effect Minimal DDIs
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Ibrexafungerp (”ibrexa” or ”IBX”) is an investigational drug.
Key Milestones
DOVE P2b
(Jul 2018) 1 P3 (VANISH-303) Complete
1 P3 (CANDLE) – SPA agreement Ongoing
NDA H2:20 sNDA H2:21 1 P3 (VANISH-306) Complete Positive Data Nov 2019 Positive Data Apr 20‘20 Potential Approval Mid-2021
2018 2019 2020 2021
Treatment of VVC (VANISH) Prevention of Recurrent VVC (CANDLE)
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Ibrexafungerp (”ibrexa” or ”IBX”) is an investigational drug.
Efficacy at Day-10 TOC and Day-25 FU (mITT) Ibrexafungerp VVC Phase 3 Program VANISH-306
IBX 300mg BID (n=188)
VANISH-303
IBX 300mg BID (n=188)
Clinical Cure (0 S&S) at TOC 63.3%* 50.5%** Mycological Eradication at TOC 58.5%** 49.5%** Clinical Improvement (0 or 1 S&S) at TOC 72.3%* 64.4%** Complete Symptom Resolution at FU 73.9%** 59.6%*
* p value ≤ 0.01 ** p value ≤ 0.001
Ibrexafungerp met its endpoints and achieved highly statistically significant superiority vs. placebo in two well-controlled studies
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Ibrexafungerp (”ibrexa” or ”IBX”) is an investigational drug.
63% 74% 51% 60% 52% 70% 58% 50%
0% 20% 40% 60% 80% TOC (Day-10) FU (Day-25) TOC (Day-10) FU (Day-25) TOC (Day-10) FU (Day-25) TOC (Day-10) FU (Day-25)
Fluconazole
Clinical Cure (0 S&S)
VANISH-306 IBX 300mg BID (n=188)
DOVE Phase 2 Study VANISH Phase 3 Studies
VANISH-303 IBX 300mg BID (n=188) DOVE P2 Study IBX 300mg BID (n=27) DOVE P2 Study FLU 150mg (n=24)
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Ibrexafungerp (”ibrexa” or ”IBX”) is an investigational drug.
programs includes more than 850 patients enrolled, with 575 ibrexafungerp-treated patients (one-day 300mg BID dose)
to study drug
group were gastrointestinal in nature
diarrhea/loose stool, nausea, abdominal pain
Safety Set VANISH + DOVE IBX 300mg BID (n=575) Diarrhea/ Loose Stool 16.7%
76% mild
Nausea 11.8%
87% mild
Abdominal Pain 4.5%
92% mild
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Ibrexafungerp (”ibrexa” or ”IBX”) is an investigational drug.
Ibrexafungerp Fluconazole
Mechanism of Action beta-(1,3)-D-glucan synthase inhibitor 14α-demethylase inhibitor Cidal/Static vs. Candida Fungicidal Fungistatic Active vs. azole-resistant Candida Yes No Activity Impacted at low vaginal pH Yes No Vaginal tissue/Plasma ratio 9:1 1:1 Evidence of Fetal Toxicity (pre- clinical) No Yes Evidence of QTC prolongation No Yes Evidence of Liver Toxicity No Yes One-day Oral dose Yes Yes
The Vaginal Yeast Infection market only has treatments from one class (azoles) and no treatment options with a different MoA
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Ibrexafungerp (”ibrexa” or ”IBX”) is an investigational drug.
July 14, 2020
Jim Maffezzoli
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Ibrexafungerp (”ibrexa” or ”IBX”) is an investigational drug.
marketing and commercialization, most recently as the Senior Vice President of Marketing at women’s health company Viveve Medical.
leadership roles in Urology and Women’s Health at Allergan plc, Exeltis USA, Inc. (a division of the global pharmaceutical group Insud Pharma) and Pfizer Inc.
and P&L leadership roles for Nabisco and Kraft Inc.
Graduate School of Management at Northwestern University, and a B.A. in Political Economy from Princeton University.
Vice President of Marketing and Sales
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Ibrexafungerp (”ibrexa” or ”IBX”) is an investigational drug.
US Market Opportunity Overview
Ibrexafungerp Peak U.S. Net Sales Potential $400 - $600M
(does not include conversion of any of the 18M annual OTC units) Total Rx/year (14.2M Oral Flu + 1.2M Topical) Assumed WAC Price Value of Total Addressable Market (in billions)
✓ Large oral market (5-yr CAGR: 3%) ✓ Only one-class of products (azoles) ✓ No new product in over 25 years ✓ No Branded Product ✓ No Promotion in over 15 years
92% 8%
Oral Topical
Majority of women prefer an Oral Rx treatment vs a Rx cream
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Ibrexafungerp (”ibrexa” or ”IBX”) is an investigational drug.
Market Stakeholders Launch Framework Brand Objectives
Access
Payer
Access
Provider
Availability
Demand
Prescriber
Adoption
Patient
Acquisition & Adherence Launch Strategy Adoption Propensity Analysis
Value Realization
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Ibrexafungerp (”ibrexa” or ”IBX”) is an investigational drug.
✓ Convenient dosing (Oral) ✓ First-in-Class MoA (fungicidal vs. fungistatic) ✓ Broad-spectrum activity (including resistance) ✓ No safety signals
mainly for 2nd or 3rd or subsequent episodes of VVC
✓ Several HCPs also want to try it on a proportion of 1st episode patients particularly those who have comorbidities
Really like it – after 20 years finally something new I’d use it for all my patients No safety signals or DDIs concerns It’s fungicidal
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Ibrexafungerp (”ibrexa” or ”IBX”) is an investigational drug.
29% 48% 59% 59% First Episode Third Episode 4+ Episode 8.3M Second Episode 4.5M 1.7M 900K Unadjusted Preference Shares
“Recurrent”
Total VVC Rx/year 15.4M
Treatment
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Ibrexafungerp (”ibrexa” or ”IBX”) is an investigational drug.
Putting strategies in place minimizes insurance restrictions
✓ Develop key access strategies
✓ Hire highly experienced “A plus” level Account Directors to deliver value message to payers ✓ Pre-approval Information Exchange and Awareness Build
the limitations of fluconazole
Key Initiatives:
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Ibrexafungerp (”ibrexa” or ”IBX”) is an investigational drug.
Adoption
– Network algorithms and machine learning (50 variables, 2,900 products) – Multilevel regression analysis and health system overlay
generate and nurture leads
HCP adoption changes
Increased productivity and uptake
Propensity to Prescribe Access Favorability
Launch Customers
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Ibrexafungerp (”ibrexa” or ”IBX”) is an investigational drug.
– Pain, disruption, and impact on QoL are generally not acknowledged
– Many are ashamed, see it as something to live with and blame themselves
– Confusion, fear, limited education – Limited Effective Treatments
84% 16%
HCP would prescribe if patient requested HCP would not prescribe if patient requested
HCP Willingness to Grant an Ibrexafungerp Request
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Ibrexafungerp (”ibrexa” or ”IBX”) is an investigational drug.
Superior Insights
Better Informed and Relevant Content and Placement Strategies More Targeted and Effective Infrastructure
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Ibrexafungerp (”ibrexa” or ”IBX”) is an investigational drug.
Yeast Infection Menopause Breast Cancer Ovarian Cancer Menstrual Cramps Urinary Incontinence
1.1M
363K 343K8 238K 174K 46K
Yeast Infection
A lead topic in women’s health search velocity Digital is their source for information and conversation High educational need Search analysis shows the market to be larger than expected
Top Search Questions Monthly Volume
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Ibrexafungerp (”ibrexa” or ”IBX”) is an investigational drug.
6MM+
total searches per month
45k+
specific questions covered
40+
causes / risk factors asked about
30+
potential treatments explored
…but few medication brand options
A lead topic in women’s health search velocity Digital is their source for information and conversation High educational need Search analysis shows the market to be larger than expected
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Ibrexafungerp (”ibrexa” or ”IBX”) is an investigational drug.
Information Action Evaluation Next Step
Problem Identification
Solution Exploration
Solution Evaluation
effects?
Solution Decision
Solution Execution
Solution Effect Monitoring
fluconazole to work?
Solution Modification
to do?
itching?
Episode Conclusion & Forward Management
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Ibrexafungerp (”ibrexa” or ”IBX”) is an investigational drug.
Highest Priority High Priority
Total Market
100% of total searches
True Market – Core
Complicated Cases … Rx
True Market – Relevant
OTC / Other Medications
Where To Compete
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Ibrexafungerp (”ibrexa” or ”IBX”) is an investigational drug.
Highest Priority High Priority
Total Market
100% of total searches
True Market – Core
Complicated Cases … Rx
True Market – Relevant
OTC / Other Medications
Where To Compete What To Say
Queries & Competitive Review Content Unmet Needs (Gaps) Content Roadmap
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Ibrexafungerp (”ibrexa” or ”IBX”) is an investigational drug.
VVC is a large underserved market that has not seen either a new product in over 25 years or promotion in over 15 years Ibrexafungerp has a well-liked product profile that prescribers want to use across a broad range of patients SCYNEXIS’ multi-stakeholder integrated launch strategies provide a path to cost effective launch that will maximize the value of Ibrexafungerp in VVC
scynexis.com