Ibrexafungerp First Representative of a Novel Oral/IV Antifungal Portfolio January 2022 - cloudfront.net
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® Ibrexafungerp First Representative of a Novel Oral/IV Antifungal Portfolio January 2022
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 oral/IV, potent, broad-spectrum antifungal with significant potential, ranging from vaginal
yeast infections (VVC) 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. A second indication in recurrent
VVC in 2022: Estimated U.S. peak sales of $400M+ in VVC
Hospital Program ongoing, with positive data readouts in refractory invasive fungal infections
and Candida auris. Intravenous liposomal formulation in development. Potential approval for
Invasive Candidiasis in 2024 with estimated U.S. peak sales of $300-$400M
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 2021 partnership with Hansoh Pharma for research,
development and commercialization of ibrexafungerp in Greater China
Experienced clinical and commercial teams & over $100M cash balance. Cash runway into 2023.
© 2021 SCYNEXIS, Inc. All Rights Reserved. 3
Building an Antifungal Franchise with Ibrexafungerp
A versatile antifungal addressing a broad range of fungal infections in the community and in the hospital
Community Infections Hospital Infections
Treatment of Vaginal Yeast Infections
Ibrexafungerp for Invasive Fungal Infections
BREXAFEMME® (ibrexafungerp tablets) (Multi-day treatment: 750 mg per day
(One-day treatment: 600 mg total) as long as required)
ibrexafungerp Invasive Candidiasis (IC)
Launched in Q3 2021 Refractory IFI (FURI)
Potential Peak Net Sales of $400M+ Candida auris (CARES)
Aspergillus
Potential Approval in IC in 2024
Potential Peak Net Sales of $300-400M
First in class antifungal
Broad spectrum Also in development:
Oral and IV Intravenous Liposomal Formulation
BREXAFEMME® is indicated for the treatment of post-menarchal females with VVC
BREXAFEMME® is contraindicated in pregnancy and in patients with a history of hypersensitivity to ibrexafungerp
© 2021 SCYNEXIS, Inc. All Rights Reserved. 4
Ibrexafungerp Hospital & Community Clinical Programs Potential
Key Milestones
14 years of exclusivity until 2035 with a stream of potential approvals in several indications
2021 2022 2023 2024 2025
P3 Study #302 (MARIO) Initiating
Invasive Candidiasis (IC) NDA IC FDA IC
and/or Candidemia Filing Approval
Data H1:24 H2:2024
H1:24
Data
Invasive Aspergillosis H2’22
P2 study (SCYNERGIA) Ongoing
(Combination Therapy)
Hospital
Interim Data Interim Data
H1:21 H1:22
FURI Study (open-label, refractory IFIs)
Refractory Invasive NDA Approval
Ongoing Data Filing Other
Fungal Infections Interim Data Interim Data H1:24 H1:24 Indications
(Designed for LPAD H1:21 H1:22 H2:24
eligibility) CARES Study (open-label, Candida auris)
Ongoing Data
H1:24
P1 Liposomal IV (double- NDA Filing FDA IV
IV Formulation blind, placebo-controlled, Clinical Development Liposomal IV Formulation for IV H1:25 Approval
dose ranging) Completed H2:2025
Approved
Treatment of Jun. 2021
Vulvovaginal
Community
®
Candidiasis (VVC) Launched
Q3 2021
Prevention of 1 P3 (CANDLE) sNDA rVVC FDA rVVC
Filing Approval
Recurrent VVC Ongoing H1:22 H2:2022
Data
H1:22 Other potential oral indications: Prophylaxis, Chronic Fungal Infections
© 2021 SCYNEXIS, Inc. All Rights Reserved. 5
Cash Balance is Strong
Cash runway into 2023
Cash and cash equivalents of $100M as of September 2021, with additional $29M
raised in December 2021
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. 6
R&D Catalysts – 2022
• CANDLE topline results – Early Q2 2022
• First patient enrolled, MARIO – Q2 2022
• FURI and CARES interim analysis – Q2 2022
• RVVC sNDA submission – End of Q2 2022
• RVVC potential FDA decision – End of 2022
• SCYNERGIA topline data – H2 2022
© 2021 SCYNEXIS, Inc. All Rights Reserved. 7
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 Scott Sukenick Larry R. Hoffman
President and Chief Chief Medical Officer Chief Commercial General Counsel Interim Chief Financial
Executive Officer Officer Officer
© 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 and in patients with a history of hypersensitivity to ibrexafungerp
© 2021 SCYNEXIS, Inc. All Rights Reserved. 10FDA Approval of First New Treatment in 20+ years Garnered
Significant Media Coverage
© 2021 SCYNEXIS, Inc. All Rights Reserved. 11BREXAFEMME, Safety and Efficacy in VVC
Two clinical trials including 545 patients exposed to BREXAFEMME, 2 doses of 300 mg in 1 day
Efficacy Safety
COMPLETE CLINICAL RESPONSE
80%
• The most frequent adverse reactions (≥ 2%)
70%
reported with BREXAFEMME in clinical trials of
60%
vulvovaginal candidiasis treatment were diarrhea,
50% nausea, abdominal pain, dizziness, and vomiting.
40%
• There were no serious adverse reactions.
30%
20%
10%
0%
Day 8-14 Day 8-14 Day 21-29 Day 21-29
Trial 1 Trial 2 Trial 1 Trial 2
BREXAFEMME PLACEBO
COMPLETE CLINICAL RESPONSE defined as complete resolution of signs and symptoms of VVC.
Please refer to full prescribing information at BREXAFEMME.com
BREXAFEMME vs. Placebo differences were all statistically significant.
© 2021 SCYNEXIS, Inc. All Rights Reserved. 12BREXAFEMME has Significant Potential in VVC
Total Rx Treated Episodes
Large VVC Market (>18M annual Rx)
18.5M Rx in 2020
9.5M patients received 18.5M Rx because
Rx Treated VVC Patients
of re-treatments and multiple doses of the
9.5M Patients
SoC being used per episode
Single Two Three Four +
Patients are often re-treated 2, 3 or 4+ times Episode Episode Episode Episode
Patients Patients Patients Patients
in a year with no alternative options
5.6M 2.0M 0.9M 1.0M
BREXAFEMME’s market share* increases BREXAFEMME Potential Peak Prescription Share
as patients experience more episodes or Range based on the Number of Episodes 25%
are considered as “Clinically Challenging” 10%
U.S. Net Sales Potential for BREXAFEMME BREXAFEMME 2027 U.S. Peak Net Sales Potential
Revenue split: ~80% for treatment / ~20% for prevention*** ~$400M+**
Sources: SCYNEXIS HCPs Quantitative Demand Study (n=300), SCYNEXIS Payer Landscape Assessment, IQVIA Xponent Data.
*Market Share takes into account the potential impact of competitors with a prevention indication
© 2021 SCYNEXIS, Inc. All Rights Reserved. 13
**WAC Price for One-Day Course: $475 ***Assumes regulatory approval for rVVCHospital:
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.comOral Ibrexafungerp Development Path Updated to Address
Multiple Unmet Needs in the Hospital Setting
Invasive Candidiasis Refractory/Resistant Invasive Aspergillosis
CARES FURI SCYNERGIA
Phase 3, open label Phase 3, open label, Phase 2, randomized
Candida auris infections Candida, Aspergillus Invasive Pulmonary Aspergillosis
Ongoing and mucormycosis Ongoing
Ongoing
• 1 positive interim analysis • Top-line data expected in H2
reported • 3 positive interim analyses 2022
reported
MARIO
Phase 3, Randomized
Oral Step-Down
In Invasive Candidiasis
Initiating
© 2021 SCYNEXIS, Inc. All Rights Reserved. 15Oral Ibrexafungerp Will Allow Patients to Step-down to a Potent Oral
“Echinocandin-like” Therapy (Fungicidal Gold Standard for Treatment of
Invasive Candidiasis)
Provides a strong oral step-down Facilitates switch to oral therapy
therapy for prescribing physicians • Greater flexibility for patient management
• Broader spectrum of activity versus
• Earlier hospital discharge
fluconazole, similar coverage as
echinocandins • Reduced risk associated with long-term IV
• Potential safety profile advantage to setting
azoles: No liver toxicity or QT prolongation • Savings on hospital and outpatient setting
cost
© 2021 SCYNEXIS, Inc. All Rights Reserved. 16Ibrexafungerp in Invasive Candidiasis
• Ibrexafungerp has shown activity against most fluconazole-resistant Candida strains
• Fluconazole is generally not a preferred option for many non-albicans Candida species (NAC), due
to the high likelihood of resistance
– Depending on the institution, >40% invasive candidiasis cases are caused by NAC
– In many instances the Candida isolate is not recovered (e.g., azole-susceptibility is unknown)
• Ibrexafungerp has also shown activity against >70% echinocandin-resistant Candida
strains
• Provides additional potential benefit as step-down and salvage
• Ibrexafungerp achieves high concentrations is tissues often involved in invasive
candidiasis (e.g., liver, spleen, kidney, lung, etc.)
© 2021 SCYNEXIS, Inc. All Rights Reserved. 17FURI-CARES – Strong Efficacy Signal from Interim Evaluations
• FURI: Subjects with fungal infections refractory to or intolerant of SoC
• CARES: Subjects with Candida auris infections
The Fungal Diseases treated with ibrexafungerp included:
• Invasive Candidiasis (58.3%) such as candidemia, intra-
Global Response at end of abdominal infections, bone and joint infections and other.
treatment FURI+CARES
(DRC assessment) n=84 (%) • Severe Mucocutaneous Candidiasis (38.1%) such as
esophageal, oropharyngeal, chronic mucocutaneous and
Complete, Partial Response or vulvovaginal candidiasis.
54 (64.3)
Clinical Improvement
• Invasive Pulmonary Aspergillosis (3.6%)
Stable Disease 18 (21.4)
Progression of Disease or Fungal Pathogens included :
5 (6.0)
No Clinical Improvement • Candida glabrata (39.3%), C. albicans (35.7%), C. auris
(11.9%), C. krusei (8.3%), other Candida species (12%) and
Death While on Tx* 2 (2.4)
Aspergillus spp (3.6%).
– Patients may have more than 1 species reported at baseline
Unable to Determine 5 (6.0)
*Both deaths due to underlying condition and deemed unrelated to study drug Oral ibrexafungerp was generally safe and well-tolerated
Dose: 1500 mg for 2 days followed by 750 mg QD • Most common treatment-related AEs were mild to moderate GI
Mean Treatment Duration: 40.9 Days events
© 2021 SCYNEXIS, Inc. All Rights Reserved. 18Invasive Candidiasis/Candidemia is a Significant U.S. Opportunity
with Potential Peak Net Sales Between $300M to $400M
~175,000 U.S. Patients/Year Start Treatment with Echinocandins1
~100,000 U.S. Cases of Invasive Candidiasis/Candidemia2
(~30% mortality)
~30,000 Patients Discharged ~5,000 Refractory Infections
~35,000 Azole-Resistant Cases3
On Oral Fluconazole5 (Salvage as in FURI Study)
~23,000 In-Patient Cases4 ~12,000 Out-Patient Cases4
Treated with Echinocandins Treated with Echinocandins ~2,000 Failed Patients6
75% penetration 80% penetration
65% penetration 80% penetration 25% Penetration
~15,000 Patients ~10,000 Patients ~7,000 Patients ~1,500 Patients ~4,000 Patients
(14 Days of Treatment) (14 Days of Treatment) (14 Days of Treatment) (28 Days of Treatment8) (42 Days of Treatment7)
• Treatment regimen: 750mg ibrexafungerp BID for two days followed by 750mg daily
• Rest of the World (ROW) hospital opportunity is similar to the U.S.
1. IQVIA Prescription Data 5. Pappas et al (2016) Clin Infect Dis 62(4):409 and SCYNEXIS Internal Marketing Research
2. NHDS (National Health Discharge Hospital) report by CDC National Center for Health Statistics 6. Mora-Duarte at al (2002): N Engl J Med 347:2020-2029
3. US Centers for Disease Control and Prevention (CDC) 2019 Report 7. Average duration of treatment for this type of patients in the FURI study © 2021 SCYNEXIS, Inc. All Rights Reserved. 19
4. CMS Outpatient Reimbursement Data of EchinocandinsKey Takeaways/Conclusion
Treatment of VVC is the first of multiple potential indications for ibrexafungerp
Growth opportunity for ibrexafungerp will be maximized by pursuing an innovative
path as an oral step-down therapy in the hospital setting with NDA filing and potential
FDA approval in late 2024
More than 14 years of patent protection for ibrexafungerp to build a long-lasting anti-
fungal franchise
Projected peak sales of $300-$400M for the treatment of invasive candidiasis alone in
the hospital, combined with anticipated $400M+ in peak sales of BREXAFEMME in
VVC, could result in revenues approaching antifungal blockbuster status
Funds and resources to market BREXAFEMME and continue clinical development
with a cash runway into 2023
© 2021 SCYNEXIS, Inc. All Rights Reserved. 20® Ibrexafungerp First Representative of a Novel Oral/IV Antifungal Portfolio January 2022
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