Ibrexafungerp First Representative of a Novel Oral/IV Antifungal Portfolio Corporate Presentation - September 2021 - cloudfront.net
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® Ibrexafungerp First Representative of a Novel Oral/IV Antifungal Portfolio Corporate Presentation – September 2021
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: BREXAFEMME may not be accepted by physicians and patients at the rate SCYNEXIS expects; risks inherent in SCYNEXIS’
ability to successfully develop and obtain FDA approval for ibrexafungerp for additional indications; unexpected delays may occur in the
timing of acceptance by the FDA of an NDA submission; the expected costs of commercializing BREXAFEMME or of clinical studies and
when they might begin or be concluded; SCYNEXIS’ need for additional capital resources; and SCYNEXIS’ reliance on third parties to
conduct SCYNEXIS’ clinical studies and commercialize its products. The use of words such as “anticipates,” “expects,” “intends,” “plans,”
“could,” “should,” “would,” “may,” “will,” “believes,” “estimates,” “potential,” or “continue” and variations or similar expressions are intended to
identify forward-looking statements, but not all forward-looking statements may be so identified. 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, 2020 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.
© 2021 SCYNEXIS, Inc. All Rights Reserved. 2
Summary: Investment Highlights
Ibrexafungerp: 1st member of the ‘fungerp’ family – a potential solution for the fungal infection crisis
Novel IV/oral, potent, broad-spectrum antifungal with significant potential ranging from vaginal
yeast infections in the community setting to hospital, life-threatening, invasive fungal infections
U.S. Commercial launch of BREXAFEMME in August 2021 for treatment of VVC, a large market
with only one oral FDA-approved product and >17 million Rx/year: Estimated U.S. peak sales of
$400-$600MM in VVC
10 years of U.S. regulatory exclusivity until 2031 plus composition-of-matter patent up to 2035,
with additional applications pending, for at least 14 years of exclusivity in the U.S.
Potential to monetize world-wide rights and recently partnered with Hansoh Pharma for research,
development and commercialization of ibrexafungerp in Greater China
Experienced clinical and commercial teams & over $112MM current cash balance
Significant near-term catalyst potential in the hospital setting with recent positive data readouts
for the hospital-based program in refractory invasive fungal infections and Candida auris | IV
Phase 1 ongoing
© 2021 SCYNEXIS, Inc. All Rights Reserved. 3
Our Focus
SCYNEXIS is building a broad antifungal franchise that
has the potential to be a transformative agent in severe
hospital infections and women’s health
Ibrexafungerp is a valuable weapon in the fight against
big threats (C. auris, multi-drug resistant fungi)
© 2021 SCYNEXIS, Inc. All Rights Reserved. 4
Experienced Leadership Team in Place to Execute this
Vision
Leadership has impressive track record for successful new drug development and commercialization
Marco Taglietti, M.D. David Angulo, M.D. Christine Coyne Eric Francois Scott Sukenick
President and Chief Chief Medical Officer Chief Commercial Chief Financial Officer General Counsel
Executive Officer Officer
© 2021 SCYNEXIS, Inc. All Rights Reserved. 5
Ibrexafungerp Clinical Program Designed to Yield Broad,
Strong Product Label
Ibrexafungerp is an innovative, powerful and versatile solution intended to address significant unmet needs in
multiple fungal infections 2020 2021 2022
®
Treatment of
NDA Approved
Vulvovaginal Accepted Jun. 2021
Outpatient
Candidiasis (VVC) 1 P3 (VANISH- Positive Data Dec. 2020
306) Complete Apr. 2020
Launched
Aug. 2021
Prevention of 1 P3 (CANDLE) – SPA agreement Potential
Approval
Recurrent VVC Ongoing
H2:2022
Data sNDA
H1:22 H1:22
Data
1 P2 study (SCYNERGIA) Ongoing
Invasive Aspergillosis H2:21
(Combination Therapy) Positive Prelim. Data
Positive Prelim Data
(Jan. ‘20) (Mar. ‘21)
Inpatient
FURI Study (open-label, refractory IFIs)
Refractory Invasive
Ongoing
Fungal Infections
(Designed for LPAD
CARES Study (open-label, Candida auris)
eligibility)
Ongoing
P1 Liposomal IV (double-blind,
IV Formulation placebo-controlled, dose ranging)
Ongoing
Key Milestones
Other potential oral indications: Prophylaxis, Chronic Fungal Infections
© 2021 SCYNEXIS, Inc. All Rights Reserved. 6
Ibrexafungerp Clinical Program Designed to Yield Broad,
Strong Product Label
Ibrexafungerp First new antifungal class in 20 years
2021 (a novel class with strong and first new ORAL antifungal class in
potential and broad appeal) over 40 years ®
2010
Echinocandins 3 key products
2000 (limited to IV only, Peak sales from ~$370M to $680M
hospital use)
1990
Azoles
1980 (IV and Oral, hospital 4 key products
Peak sales from ~$720M to >$1B
and community uses)
1970
Polyenes
1960 (limited to IV only, 2 key products
hospital use) Peak sales from ~$500M
Numbers represent WW peak sales of each product. Sources: 10K filings and www.pharmaceuticalonline.com/doc/pfizer-warner-lambert-agree-to-90-billion-mer-0001
© 2021 SCYNEXIS, Inc. All Rights Reserved. 7
Balance Sheet is Strong
Cash runway into 2023
Cash and cash equivalents of $112M as of June 30, 2021; and $30M of debt drawn
in Q2
Up to an additional $30M of non-dilutive debt financing
Eligible to receive up to $112M in development and commercial milestones, plus low
double-digit royalties on net product sales from partner Hansoh in Greater China
Potential for additional ex-US business development opportunities
© 2021 SCYNEXIS, Inc. All Rights Reserved. 8
BREXAFEMME® (ibrexafungerp tablets)
VVC: Our First Indication
© 2021 SCYNEXIS, Inc. All Rights Reserved. 9
BREXAFEMME® – A “Modern-Day” Treatment for
HCPs & Patients
Triterpenoid; novel class
Fungicidal vs Candida spp.
Half-life ~20 hours
Convenient 1 day dosing, with/without food
Safety & Efficacy
Durable and complete resolution of signs
Resolution of Signs and Symptoms
and symptoms
In vitro activity vs. resistant strains and broad-
Activity vs. resistant & other Candida strains
spectrum anti-Candida activity
Favorable safety profile: no evidence of QTc
Safety profile
prolongation or hepatoxicity
BREXAFEMME® is indicated for the treatment of post-menarchal females with VVC
BREXAFEMME® is contraindicated in pregnancy
© 2021 SCYNEXIS, Inc. All Rights Reserved. 10VVC Prescription Market Historically Large and Growing
~17M TRxs Annually
Terconazole & Other 1.0M 15.9M Fluconazole
Source: IQVIA Xponent TRx Monthly Data May 2020 - April 2021
© 2021 SCYNEXIS, Inc. All Rights Reserved. 11Most Patients Suffer from Multiple VVC Episodes
20% 45% 29% 6%
1 Episode 2–5 Episodes 6–20 Episodes >20 Episodes
*Based on a study conducted in ~ 2,000 women in the United States and 5 European countries.
Reference: Johnson SR, Griffiths H, Humberstone FJ et al. Attitudes and experience of women to common vaginal infections….
VVC: Vulvovaginal Candidiasis
© 2021 SCYNEXIS, Inc. All Rights Reserved. 12BREXAFEMME – Addresses an Underserved and Unmet
Need
Approximately 45% of patients fail fluconazole2
The first-ever oral alternative to fluconazole HCP Patient
Novel Mechanism of Action
• Fungicidal1 – Kills Candida spp. Frustration
Activity against multiple species of Candida1
Sustained Outcomes at 25 days1
One-day treatment course
Patient friendly, less frustration and anxiety
Most common adverse reactions observed in clinical trials (incidence ≥2%) were diarrhea, nausea,
abdominal pain, dizziness, and vomiting
1. BREXAFEMME Prescribing Information. 2. Fluconazole Prescribing Information, and SCYNEXIS Market Research (data on file).
© 2021 SCYNEXIS, Inc. All Rights Reserved. 13FDA Approval of First New Treatment in 20+ years
Garnered Significant Media Coverage
© 2021 SCYNEXIS, Inc. All Rights Reserved. 14Majority of VVC Patients Are Commercially Insured
Medicare
Medicaid
15%
19%
Payer Engagement: Strong Progress to Date
Cash • Customer meetings with payers underway
3%
covering 70% of Commercial Lives
• More than 15 Payer P&T Reviews
Scheduled
63% • Contracting Process Started for Multiple
Target Accounts
Commercial
Source: IQVIA Xponent Weekly Data 5/3/2019 – 4/30/2021; Rx only market
© 2021 SCYNEXIS, Inc. All Rights Reserved. 15Sales Team in Action Driving Awareness and Utilization
VVC Market
Efficient Deployment
Geographically Concentrated
• Primary call points are OB/GYN, NP/PA,
and PCP
• Cover 89% of the market potential
• Conducting in-person and virtual sales
calls
• Growth rate continues strengthening
week over week
© 2021 SCYNEXIS, Inc. All Rights Reserved. 16VVC is Only the Beginning
• Treatment of VVC is the first of
multiple indications being
studied for ibrexafungerp
• Solution for community AND
hospital fungal infections
• More than 14 years of patent
protection to build a long-
lasting anti-fungal franchise
© 2021 SCYNEXIS, Inc. All Rights Reserved. 17Hospital:
Invasive Fungal Infections
“Invasive fungal infections will not go away any time soon. Therefore,
we need to circumvent resistance to treatment by continued
discovery and development of new antifungal agents and strategies.”
Dr. John Perfect
Nature Reviews/Drug Discoveries (2017)
scynexis.comHospital Fungal Infections: Intensifying Public Health Threat
1 2 3
The Clinical Problems The Medical Needs The Emerging Concerns
• Rising Invasive Fungal • Few systemic drugs (3 classes • Antifungal resistance & new
Infections with mortality in the available, only one oral class) alarming fungal species
20-50% range • Lack of oral options effective
against multidrug-resistant
pathogens
July 23, 2021
© 2021 SCYNEXIS, Inc. All Rights Reserved. 19Hospital Fungal Infections Can Be Deadly to Vulnerable
Populations
High-risk population is growing: ~3% of U.S. adults are immunocompromised
Invasive Historical Typical Treatment Options / Ibrexafungerp Potential
Fungal Disease Mortality Rate Tx Durations Opportunity
Invasive • Step-down option for azole-
• Echinocandins (5-7 days)
candidiasis resistant (suspected or
~ 20-40% • Fluconazole as step-down
confirmed)
• 2-6 weeks
• Single IV-Oral agent
Pulmonary • Combination with azoles to
• Voriconazole / Isavuconazole
aspergillosis improve survival
30-50% • Amphotericin B
• Option for azole-resistant
• 6 to 12 weeks
disease
Refractory fungal • Amphotericin B
• Stand alone or combination
infections • Combination therapy
40-50% therapy for refractory fungal
• Azoles
disease
• 4-12 weeks
Prophylaxis • Alternative with fewer DDI
N/A • Azoles
concerns
© 2021 SCYNEXIS, Inc. All Rights Reserved. 20Hospital Utilization is a Second Potential Value Driver
Based on the unique attributes of ibrexafungerp and the limitations of existing treatment
options, ibrexafungerp may be used in multiple settings
Ibrexafungerp Potential Hospital
Ibrexafungerp Key Attributes
Market Opportunity
• Broad spectrum covers Candida, Aspergillus, • Salvage use in patients failing other antifungals
Pneumocystis and dimorphic fungi
• Oral step-down after IV echinocandins for
• Fungicidal vs. Candida (kills the pathogen) patients with azole-resistant Candida spp.
• Validated MoA but low cross resistance with • Empirically for patients with a suspected fungal
echinocandins pathogen
• Active against resistant strains across all • Prophylactically for patients at risk of fungal
classes (incl. MDR C. auris) infections
• Non-azole oral therapy • Combination treatment with an azole for
• High tissue distribution – allows to treat deep- invasive aspergillosis
seated infections (incl. abscess and bone) • Chronic candidiasis patients
• No safety signals
© 2021 SCYNEXIS, Inc. All Rights Reserved. 21Label Expansion Focused on Hospital Setting
FURI CARES SCYNERGIA
• Phase 3, open label, • Phase 3, open label, • Phase 2, randomized, double-
uncontrolled, global uncontrolled, global blind, global, ibrexafungerp in
• Subjects with invasive fungal combination with
• Subjects with Candida auris Voriconazole (ongoing)
infections or severe infections (including
mucocutaneous refractory to • Subjects with Invasive
candidemia)
or intolerant of SoC or when Aspergillosis
oral antifungal options are not • Sites: South Asia and Africa
adequate for continued therapy • Top-line data expected in
after initial IV standard of care • Multiple in vitro and in vivo H2:2021
antifungal evidence of activity
• Sites: US, Germany, UK, Spain, • 1 positive interim analysis
Austria, Netherlands reported
• 3 positive interim analyses
reported
© 2021 SCYNEXIS, Inc. All Rights Reserved. 22Summary: Investment Highlights
Ibrexafungerp: 1st member of the ‘fungerp’ family – a potential solution for the fungal infection crisis
Novel IV/oral, potent, broad-spectrum antifungal with significant potential ranging from vaginal
yeast infections in the community setting to hospital, life-threatening, invasive fungal infections
U.S. Commercial launch of BREXAFEMME in August 2021 for treatment of VVC, a large market
with only one oral FDA-approved product and >17 million Rx/year: Estimated U.S. peak sales of
$400-$600MM in VVC
10 years of U.S. regulatory exclusivity until 2031 plus composition-of-matter patent up to 2035,
with additional applications pending, for at least 14 years of exclusivity in the U.S.
Potential to monetize world-wide rights and recently partnered with Hansoh Pharma for research,
development and commercialization of ibrexafungerp in Greater China
Experienced clinical and commercial teams & over $112MM current cash balance
Significant near-term catalyst potential in the hospital setting with recent positive data readouts
for the hospital-based program in refractory invasive fungal infections and Candida auris | IV
Phase 1 ongoing
© 2021 SCYNEXIS, Inc. All Rights Reserved. 23Thank You
© 2021 SCYNEXIS, Inc. All Rights Reserved. 24You can also read
