From New Mechanisms to New Standards of Care - Corporate Presentation
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From New Mechanisms to New Standards of Care Corporate Presentation
Forward-Looking Statements Statements in this presentation, other than statements of historical fact, constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding the expected closing of Summit’s recently announced private placement of American Depositary Shares, Summit’s clinical trials supporting the safety and efficacy of its product candidates and the potential novelty of such product candidates as treatments for disease, plans and objectives for clinical trials, product development and regulatory filings, Summit’s collaboration with Eurofarma Laboratorios SA, Summit’s award from BARDA, Summit’s Discuva Platform, strategies, future performance, expectations, assumptions, financial condition, liquidity and capital resources. These forward-looking statements may be preceded by, followed by or otherwise include the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions. Actual results or events may differ materially from those expressed or implied in any forward-looking statements due to various factors, including the risks and uncertainties inherent in clinical trials and product development and commercialization, such as the uncertainty in results of clinical trials for product candidates, the uncertainty of whether the preliminary results from a clinical trial will be predictive of final results of that trial or whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, the risk of failure of the third parties upon whom Summit relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk that any third-party collaborator, including Eurofarma, terminates or fails to meet its obligations to Summit, the risk of the ability of BARDA to terminate our contract for convenience at any time, the risk that Summit’s discovery and development platform may not identify new potential drug development candidates, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials and the timing, cost and design of future clinical trials and research activities, the timing of expected filings with the FDA or other regulatory agencies; and the other risks and uncertainties described in Summit’s public filings with the Securities and Exchange Commission. Summit may not actually achieve the plans, intentions or expectations disclosed in its forward-looking statements, and you should not place undue reliance on its forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Summit disclaims any intent or obligation to revise or update these forward-looking statements, except as required by applicable law. 2 Company presentation January 2019
Creating a Different Antibiotic Company
NEW SCIENCE NEW PHILOSOPHY NEW OPPORTUNITY
New bacterial targets The right drug for the Beat standard of care
right bug
New drugs against them Economic and clinical
Real unmet needs data to support
premium price
Innovative development
plans
3
Company presentation
January 2019
Past Commercial Success Associated with Innovation
Macrolides
Glycopeptides, Nitroimidazoles, Streptogramins
Cycloserine, Novobiocin
Pleuromutilins Rifamycins
Trimethoprim
Cephalosporins
Quinolones
Polymyxins, Phenicols
Fosfomycin
Nitrofurans Mupirocin
Tetracyclines
Carbapenems
Aminoglycosides, Bacitracin
Oxazolidinones
Monobactams
Sulfonamides
Penicillin Lipopeptides
1920s 1930s 1940s 1950s 1960s 1970s 1980s 1990s 2000s 2010s
YEAR ANTIBIOTIC CLASS DISCOVERED
1920s-1980s Since 1990
• Multiple novel mechanisms & classes • No new mechanisms; only
• Multiple examples of significant commercial incremental benefits
success • Niche market positioning with
• Ciprofloxacin; azithromycin; ceftriaxone low commercial return
• Resistance not clinical issue • Resistance is a clinical issue
4
Company presentation
January 2019
Adapted from ReAct Group 2015
Only Two Late Stage Antibiotics are Novel Drug name Company Phase Drug Class Ceftobiprole Basilea 3/ Marketed (ex-US) Cephalosporin Plazomicin Achaogen Marketed (US) Aminoglycoside Eravacycline Tetraphase Marketed (US) Tetracycline Omadacycline Paratek Approved (US) Tetracycline Lefamulin Nabriva NDA submitted Pleuromutilin Iclaprim Motif Bio NDA submitted 2,4 diaminopyrimidine Cefiderocol Shionogi 3 Cephalosporin Cefilavancin Theravance 3 Glycopeptide beta lactam Imipenem & relebactam Merck 3 Carbapenem/BLI Cefepime & tazobactam Wockhardt 3 Cephalosporin/BLI Murepavadin Polyphor 3 Novel; P. aeruginosa specific Ridinilazole Summit 3-ready Novel; C. difficile specific 5 Company presentation January 2019
Stewardship and Commercial Success Aligned
Stewardship ultimately about upfront use of
the correct drug Vancomycin for CDI and
• Novel mechanism agents address specific
ceftriaxone for gonorrhoea
used front-line
indications and unmet needs
do not equate to
• Their use improves clinical outcomes and
stewardship
reduces healthcare costs
Summit’s approach aligns with stewardship
and could result in commercial success
• Development programs designed to meet needs Ridinilazole for CDI and
of patients, providers and payors SMT-571 for gonorrhoea
• Data from these programs promote market used front-line
uptake of agents into front-line settings do equate to stewardship
• Acceptable pricing achieved through clear and
demonstrable package of benefits
6
Company presentation
January 2019
Our New Mechanism Antibiotic Pipeline
Discovery Preclinical Phase 1 Phase 2 Phase 3 Funding source
CDI
BARDA
(ridinilazole)1
Gonorrhea
(SMT-571)1
Roche
Collaboration2
Gonorrhea
(Target #2)1
ESKAPE
Program1
Discuva Platform
(1) We own worldwide rights to ridinilazole, outside of certain Latin American countries and Caribbean
islands, and own worldwide rights to our gonorrhea and ESKAPE programs
7
Company presentation (2) Roche holds worldwide development and commercialization rights to these compounds and Summit is
January 2019 entitled to specified development, commercialization and sales milestone payments from Roche.New Science Discovering new mechanism antibiotics with our Discuva Platform
Discuva Platform: Enabling Optimized Candidate Selection
From discovery through candidate selection,
our Discuva Platform delivers optimized antibiotics with:
New Low Targeted
mechanisms propensities for spectrums of
of action resistance activity
We advance those new mechanism candidates where a major commercial opportunity exists and
we can show significant advantages over the current standard of care
9
Company presentation
January 2019Proprietary Libraries Cover Major Unmet Needs, Enable
Potential Pipeline Expansion
K. pneumoniae
CDC Urgent / CDC Serious
WHO Critical Threats /
Threats Other ESKAPE
Pathogens
N. gonorrhoeae
E. faecalis
E. coli
E. faecium
P. aeruginosa
S. aureus
A. baumannii
S. pneumoniae
Gram negative Gram positive
10
Company presentation
January 2019Discuva Platform: Rapid Screening to Identify
New Bacterial Targets
Through the process of creating hundreds of thousands of mutant bacteria of a single species, genes essential
for the survival of that species can be identified as those which have no insertions
Library of mutant Next-generation Genome map of
engineered bacteria sequencing mutation insertions
11
Company presentation
January 2019Discuva Platform: Elucidate Mechanism of Action and
Optimize Against Resistance
• Our libraries of mutant bacteria allow us to have exquisite control over gene expression in a given species
• These mutants have increased, decreased or disrupted gene expression levels
• In the presence of an antibiotic, the mutant libraries can help us to rapidly elucidate mechanisms of action and
optimize against potential resistance mechanisms
-drug of interest +drug of interest Next-generation
+gene manipulation sequencing
Which genes are involved in MOA?
Are there any resistance liabilities?
12
Company presentation
January 2019Ridinilazole Our Phase 3-ready precision antibiotic in development for front-line treatment of C. difficile infection
About C. difficile Infection (CDI)
>1.0m cases Initial treatment Failure likely
per year in US fails to cure or connected to
and EU1, 29,000 sustain cures in microbiome
deaths per year around a third impact of standard
in the US2 of cases of care
14
Company presentation 1. Decision Resources, 2015
2. New England Journal of Medicine, 2015
January 2019Ridinilazole: Potent, Oral & Narrow Spectrum
NEW SCIENCE NEW PHILOSOPHY NEW OPPORTUNITY
Phase 2 clinical trial Replace front-line broad Front-line treatment for CDI
demonstrated superiority spectrum generics and reduction of rCDI
over standard of care
Differentiated label Expect to file NDA in 2022,
Highly selective antibiotic if Phase 3 results positive
preserved microbiome Provide clinical and
economic evidence at Potential ~$700M global
Activity restricted to gut launch peak sales
Well-tolerated in Phase 1 Exclusivity expected
and 2 clinical trials through 2034 in US, Europe
and Japan
15
Company presentation
January 2019Ridinilazole Highly Preserving of Microbiome of CDI
Patients Compared to Vancomycin
Cladograms Showing Changes in Relative Abundancy of Microbiome Following 10 Days Dosing
RIDINILAZOLE VANCOMYCIN
Reduced relative abundancy Increased relative abundancy
16
Company presentation Source: Thorpe et al., PLOS ONE, 2018
January 2019Ridinilazole: Statistical Superiority Over Vancomycin in
Phase 2 CoDIFy Trial in SCR
Cure at End of Treatment Sustained Clinical Response (SCR)
Ridinilazole 77.8% 100
Vancomycin 69.7%
75
Δ 24.3
0 25 50 75 100
66.7%
50
Recurrence 30 Days Post Treatment
42.4%
25
Ridinilazole 14.3%
Vancomycin 34.8%
0
Vancomycin Ridinilazole
0 25 50 75 100
(90% CI 3.1–39.1)
17
Company presentation Source: Vickers et al, Lancet ID, 2017
January 2019Phase 3: Plan to Deliver Clinical and
Economic Evidence at Launch
Two randomized, double-blind clinical trials Group Design
Group N Agent Regimen
Primary endpoint:
1 340 Ridinilazole 200mg BID for 10 days
SCR to 30 days post end of treatment
2 340 Vancomycin 125mg QID for 10 days
• Test for superiority (>95% power)
Secondary and exploratory endpoints:
Clinical cure at EOT
• Test for non-inferiority (90% power)
SCR rates to 60 and 90 days post EOT
Impact on microbiome/metabolome
Safety and tolerability
Health economic outcomes endpoints:
Include: readmission rates, length of hospital stay
18
Company presentation
January 2019Potential Path to Regulatory Approvals for Ridinilazole
Planned Milestones
Q1 2019
Phase 3
clinical trials
initiation
H2 2021
Phase 3 clinical
trials top-line
data
2022
File NDA
with the FDA
19
Company presentation
January 2019Ridinilazole: Commercialization Strategy Delivering clinical and economic evidence, at launch, to position ridinilazole as front-line agent. Done by achieving the following goals: Differentiated label • Demonstrating superiority over current standard of care (vancomycin) on a clinically meaningful endpoint (SCR) that assesses the unmet medical need of reducing CDI recurrence • Could result in regulatory approval for: “Treatment of CDI and reducing the recurrence of CDI” Demonstrating economic benefits of reduced recurrence • Justifies premium price for ridinilazole over current standard of care Capitalizing on a favorable environment • Quality metrics requiring healthcare facilities to minimize readmissions • Increasing awareness of the importance of the microbiome • Stewardship: CDI specific therapy replacing inappropriate vancomycin use 20 Company presentation January 2019
Potential Opportunity for Broad Use Across CDI Disease
Spectrum
>1M cases
(US & EU)
Initial Episode Recurrent Disease
~75% ~ 25%
Initial + mild-moderate Initial + severe
~50% ~ 25%
Patient Initial mild-moderate Initial mild-moderate
Segment Community Hospital
~ 25% ~ 25%
Vancomycin
Current
Treatments Metronidazole, Vancomycin Vancomycin Fidaxomicin,
Bezlotoxumab, FMT
Opportunity RDZ RDZ RDZ RDZ
21
Company presentation
January 2019About Gonorrhea
1.4m cases in N. Gonorrhoeae We are using the
US & EU has consistently last CDC
78m worldwide1 developed recommended
resistance to treatment option;
known classes no new treatment
of antibiotics options available
22
Company presentation 1. World Health Organization, July 2017 press release
January 2019Gonorrhea: Opportunity to Develop New Standards of Care
NEW SCIENCE NEW PHILOSOPHY NEW OPPORTUNITY
Two novel targets from Be adopted onto Resistance to
Discuva Platform WHO guidelines recommended treatment
growing, no approved
New series against each Develop compounds which antibiotics available to
are oral, single dose, narrow replace it
Potent against clinical spectrum, target three
isolates, including multi-drug sites of infection Become new standard of
resistant strains care in treatment of
gonorrhea
SMT-571 has shown in vivo
preclinical activity and oral 1.4m cases in US & EU,
bioavailability 78m worldwide
23
Company presentation
January 2019SMT-571: Potent New Mechanism Gonorrhea Antibiotic in
IND-Enabling Studies
Target: cell division
• Potent in vitro activity across gonorrhea clinical isolates and WHO
Strain MIC (μg/mL)
reference panel, including multi-drug resistant strains
FA1090 0.08
WHO-M 0.09
WHO-L 0.09
WHO-N 0.09
WHO-O 0.09
WHO-G 0.09
WHO-F 0.09
WHO-K 0.09
WHO-P 0.09
WHO-X 0.09
24
Company presentation
January 2019Potential Path to Proof of Concept for SMT-571
Planned Milestones
H2 2019
Phase 1 clinical
trial initiation
H2 2020
Phase 1 clinical
trial top-line data;
Phase 2 clinical
trial initiation
H2 2022
Phase 2 clinical
trial top-line data
25
Company presentation
January 2019Planned Upcoming Milestones
Q1 2019 H2 2021 2022
Phase 3 Phase 3 File NDA for
initiation top-line data FDA approval
CDI
Ridinilazole
2019 2020 2021 2022
Gonorrhea
SMT-571
H2 2019 H2 2020 H2 2021
Phase 1 Phase 1 Phase 2
initiation top-line data top-line data
Phase 2
initiation
26
Company presentation
January 2019Antibiotic Experience at Summit
David Roblin, MD, President of R&D
Previous antibiotic experience at Pfizer and Bayer
Richard Vickers, PhD,CSO
Discovered ridinilazole
Dave Powell, PhD, SVP, Research Brought
Previous antibiotic experience at GSK 8 antibiotics
to market
Nawaz Khan, VP, Anti-infectives Discovery
Discovered SMT-571
Clive Mason, Senior Director, Platform Discovery
Discovered SMT-571
Frank Armstrong, MD, Chairman
Previous antibiotic experience at Astrazeneca and Bayer
27
Company presentation
January 2019Summary Financials
Key Items Amount
Nasdaq Share Price (Jan. 2, 2019): $1.20
SYMBOL: SMMT
Issued Share Capital O/S(1): 32.1M
Market Cap (based on Jan. 2, 2019, share price)(2): $39M
Cash Balance (Oct. 31, 2018)(3): $16.7M
Pro-Forma Cash Balance (Oct. 31, 2018)(4): $41.3M SYMBOL: SUMM
Debt (Oct. 31, 2018): $0
(1) Based on total Ordinary Shares outstanding; Ordinary Shares outstanding as of Dec. 17, 2018,
were 82.3 million; an additional 78.1 million shares are expected to be admitted on or about Jan. 8,
28 2019; one ADS is equivalent to five Ordinary Shares
Company presentation (2) Assumes 32.1 million ADS share count post expected admission mentioned in footnote (1) above
January 2019 (3) Assumes an exchange rate of $1. 2779 to £1.00
(4) Pro forma figure includes net proceeds of approximately $24.6 million relating to Summit’s private
placement, which is expected to close on or about Jan. 8, 2019Contact Details investors@summitplc.com Twitter: @summitplc 136a Eastern Avenue Milton Park Oxfordshire UK One Broadway Cambridge Massachusetts US 29 Company presentation January 2019
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