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What We Will Cover Today
• Quick sense of who’s in the room
• Review of the 15 Slide Methodology
• Sample slides
• Review methodology for elevator pitch
• Practice your pitch live!
https://www.youtube.com/watch?time_continue=1&v=AclUQu8QgHI
Communicating Respect
Why are you here?
Your goal as a presenter is to suit your audience and be clear on your objectives
Whether small or large company
Credibility At Stake
If complex data or information does not coalesce into a few clear ideas, you’ve promised music but delivered noise.
It is not the chart or graph that they will judge, it’s the information itself.
Conventions are the Form of
Expectation:
It will be harder to remember if
you deviate from convention
The influence of the brain and expectation are far greater than the raw
data
Example Conventions
• Up is good
• Down is bad
• North is up
• South is down
• Red is negative
• Green is positive
• Blue is cold
• Hierarchies move from top down
• Lighter color shades are emptier or lower darker one
Work within Conventions
Story-telling is an Art that Captures Audiences
Transform your data and concepts into memorable stories
Conceptual Data Driven
Focus Ideas Statistics
Goals Simplify, teach Inform, enlighten
Title Slide
Company Name
Tagline
Logo
Speaker Name
Date
Conference Name
WHY?
End with why you’re excited about the
opportunity
Slide 1:Overview
4-5 high-level bullets with key facts about your company
Answer the question, “why” up front to garner interest
Enormous Value Created with CAR T-cells
• Chimeric antigen receptors (CARs), new approach to cancer therapy where immune cells (T cells) are removed from a patient, engineered, and reintroduced into patients to fight cancer
• 2017: two CAR-T cell therapies received FDA approval
• Several CAR T-cell biotechnology companies were funded; listed on NASDAQ; 2 major acquisitions
1
3
$300 million$736 million
$747 million
$616 million$310 million
$9 billion sale to Celgene
$11.9 billion sale to Gilead
$8.5 billion
Executive Summary
Founded: May 2017 RINCH and MBV, LLC
Technology: Novel Microbiome Platform
Indications: NEC, AAD, and Cachexia
Located: Indianapolis, IN/Columbus, OH
IP: Worldwide Exclusive LA from RINCH
Funding: $380k in non-dilutive funding
Raise: Series A Up to $4M
Close: 4/23/18
14
NEC = Necrotizing EnterocolitisAAD = Antibiotic Associated Disorders (e.g. diarrhea)
Capital Investment in the Microbiome
• Since 2010 approximately $1.8 billion of venture investment (Seed round through Series C)
• 60% of the investment ($1.0 billion) in 2016 and 2017 alone
15*Source – Global Engage (http://www.global-engage.com/life-science/investing-microbiome-future/); February 2018
++ in Series B and C funding rounds from 2014 on supports development programs are progressing smoothly
Slide 2:The Agenda
Six Basic Elements
1. Medical Problem & Your Solution
2. Market Opportunity
3. Product Differentiation
4. Leadership Team, Board, Scientific Advisory Board
5. Development, Regulatory & Manufacturing
6. Commercial Strategy
Slide 3:The Problem
Describe the problem
Layman’s terms
Use of infographics
Back up facts
Use of research
Slide 5: The Solution
Description of products and services
Compelling benefits
Barriers to entry
Differentiation
Threats
Opportunities
Validation
Therapeutic Hypothesis “A Damaged, Leaky Gut”
The Problem• Many therapeutic interventions unintentionally deplete
the microbiome (i.e. antibiotics, chemotherapy, radiation)
• A depleted microbiome causes the gut to develop holes in the mucus barrier and leak pathogens into the blood stream – “a damaged, leaky gut”
Our Solution• Induce formation of a biofilm to protect the probiotic
from stomach acid and prime the probiotic for engraftment within the mucus barrier
• SB-121 facilitates the thickening of the mucosal layer to induce lasting beneficial effects of a healthier, intact intestinal lining
• Prevents negative effects from GI insults
Pathogens
Mucus Barrier
Mucus Barrier
- Scioto Biofilm Platform
Slide 5: The Market and Target Product Profile
Clear definition
Size, growth, and share
Key players and strategies: differentiation, commoditization, pricing
Payer distribution: private and public, reimbursement issues
EGFR Single/Double Mutant Inhibitor: 3rd Gen EGFR TKI
• Only 1 approved third generation drug that targets the activating EGFR mutations including the T790M+ mutation (osimertinib) • Tagrisso, AZD9291
• The T790M+ mutation develops in:• Asia – ~50 % of all NSCLC patients• US – ~30% of all NSCLC patients
We believe that there is a need for a second drug that is potent, shows high activity to this mutation and importantly penetrates the blood brain barrier
Proven therapeutic Target
MRC-0152 08MAR1817
51.5
10.7
11
18.7
91.9M adult moderate‐to‐severe acute pain patient visits in medically supervised settings
Emergency department Outpatient surgery
Inpatient/other surgery Other procedures
91.9M
Source: Aggregated Medical Literature review, QuintilesIMS primary market research, QuintilesIMS analysis 2016. ARX-04 and Zalviso US data-December 2016
MRC-0152 08MAR18
MRC-0152 08MAR18
Initial emergency department target of 18M adult patient visits annually receiving IVs exclusively for pain meds
Source: Aggregated Medical Literature review, QuintilesIMS primary market research, Qunitles IMS analysis 201618
112Mpatient visits
51Mpatients visits
33Mpatients visits
18MIV for pain only in ER
Initial Emergency Department Target
Total ER patient visits
Moderate‐to‐ severe acute pain
in EROpioid for pain in
ER
MRC-0152 08MAR18
MRC-0152 08MAR18
DSUVIA outpatient surgery opportunity is estimated at 11M adult patient visits annually
27Mpatients visits
11Mpatients visits
Outpatient procedures
Moderate‐to‐severe acute pain patients
21 Source: Aggregated Medical Literature review, QuintilesIMS primary market research, Qunitles IMS analysis 2016
Outpatient surgery target
MRC-0152 08MAR18
Slide 6: Competitive Positioning(within limitations of data)
Most successful charts show a single salient point so clearly that we feel we understand the
charts meaning without trying
• Shows anti-tumor activity by reducing tumor size in the lung and the brain
• At lowest dose tested
• Highly selective against mutant forms of NSCLC
.
Serial sections on MRI (T2 Flair)
Baseline (pretreatment)
After 6 weeks of indoximod +
radiation (54 Gy)
DIPG scans reviewed by Tina Young-Poussaint, M.D.,Boston Children’s Hospital
Patient 037 classified as:“Significant response”
Encouraging Early Data in DIPGResponse for 9.4-Year-Old Male with Newly Diagnosed DIPG
Patient remains neurologically normal at 6 months from initial treatment
Slide 7:Team
Photographs and background on key members
Establish company’s pedigree
Tell a story about the company’s culture
Scioto Has a Strong and Experienced Scientific and Executive Team
34
Scientific Advisors
Nationwide Children’s Hospital - Scientific Team
Monon Bioventures LLC - Executive Team
• Steven Goodman, PhD - Principle Investigator
• Gail Besner, MD - Chief of Pediatric Surgery
• Michael Bailey, PhD - Principle Investigator
• Lauren Bakaletz, PhD – VP for Basic Science Research
• Joseph Trebley, PhD – Chief Executive Officer
• Jim Schulz – Chief Financial Officer
• Mark Heiman, PhD - Chief Science Officer
• Kevin Meyer – Chief Operating Officer
• Jaswant Gidda, PhD - Preclinical
• Sam Corveleyn – CMC Drug Development
• Graeme Martin, PhD – Business Development
Experienced Management TeamProven track record in biotech, pharma, product development and finance
Adi Hoess, Ph.D., CEO
• AFMD CEO since 2011, joined in 2010 fromJerini/Jenowis
• Led AFMD IPO in2014
• CCO at Jerini, instrumental in IPO and M&A withShire
•GM and VP Molecular Medicine atCarl-Zeiss
• Co-founded MorphoSys; VP Licensing and BD
Wolfgang Fischer, Ph.D, COO, CMO(interim)• Joined AFMD in 2017 from Sandoz
Biopharmaceuticals
• Global Head of Program and Project
Management at Sandoz Biopharmaceuticals
• Regional Medical Director Hematology atNovartis Oncology
• Medical Director Oncology at NovartisSwitzerland
20
Florian Fischer, Ph.D., CFO
• AFMD full-time CFO since 2014,
joined in 2005 from MedVenture
Partners, a company he founded
• Led AFMD IPO in2014
• CFO of Activaero GmbH and of Vivendy
• Deutsche Bankand KPMG (Biotech/Healthcare)
Martin Treder, Ph.D., CSO• Joined AFMD in 2015 from CT Atlantic
AG, a Swiss I/O company he co-
founded
• Co-founder of U3 Pharma (targeted cancertherapeutics)
• Responsible for U3’s innovative anti-
HER3 therapeutic antibodies portfolio
Slide 8/9: Pre-clinical and Clinical Pipeline
Names and descriptions of preclinical compounds, indications, platforms, programs behind the lead compounds
Differentiating features of each
Synergies between programs
Goals
Safety and efficacy
Estimated data timeline
Pipeline: Novel Kinase Inhibitors
SKI-G-801
YH25448 (GNS-1480)
4th Gen EGFR inhibitor
FGFR4
inhibitor
SKI-O-703
2nd Gen SYK inhibitor
Discovery Preclinical Phase 1Product TargetTherapeutic
Area
SYK
FLT3m+
EGFRdm+
EGFRtm+
FGFR4
SYK
Immunology
Oncology
CNS disease
RA, Rheumatoid Arthritis; SLE, Systemic Lupus Erythematosus; ITP, Immune Thrombocytopenia; AIHA, Autoimmune Hemolytic Anemia; IgAN, IgA Nephropathy; AML,Acute Myeloid Leukemia; NSCLC, Non Small Cell Lung Cancer; EGFRdm+, EGFR double mutants; PD, Parkinson’s disease; EGFRtm+, EGFR triple mutants; HCC, Hepatocellular Carcinoma; Gen, Generation; IO, immuno-oncology
Phase 2Indication
ITP, AIHA ,IgAN, RA, SLE
AML
NSCLC
NSCLC
HCC
IO,
Blood cancer
LRRK2 PDSKI-O-1130
38 Oscotec/Genosco©
Target Profile Tumors Clinic Ready
ROR1(Tyrosine-protein kinase transmembrane receptor)
Promise in multiple large solid tumor markets
Lung, breast, colon, gastric, pancreatic, and CNS tumors
H2 – 2019
HER2(human epidermal growth factor receptor 2; Receptor tyrosine-protein kinase erbB-2)
Much improved animal efficacy & safety compared to CAR-Ts
Glioblastoma; osteosarcomas; other HER2 over-expressing tumors
H2 – 2019
Undisclosed Promise in solid tumors Solid tumors, high unmet need 2020 – 2021
BCMA(B-Cell Maturation Antigen)
Best-in-class potential (autologous and/or allogeneic)
Multiple Myeloma 2019 – 2020
CD19(B-Cell Antigen)
Best-in-class safety and efficacy potential DLBCL Early 2019
Platform Development
Off-the-shelf TAC T-cells, complementary chimeric receptors to enhance TAC T-cells, CMC improvements, etc.
3
9
Promising & Diversified Pipeline
B-C
ell
Ma
lig
na
nc
ies
So
lid
Tum
ors
• Successful pre-CTA meeting with Health Canada in December 2016: Agreement on key preclinical, clinical and
manufacturing requirements; Next Pre-CTA update meeting with Health Canada planned for Early Q2-2018
Dis
co
ve
ry
Slide 10: Regulatory Strategy
Discuss geographic strategy
Highlight milestones achieved to date
Provide overview: BLA, SPA, Orphan status, Pediatric voucher, Fast track
Regulatory Strategy
• Timing:• Pre-IND to be filed by end of Q1 2018
• Single dose (nasal gavage) - prophylactic treatment given immediately after birth (likely within 48 hrs)
• Dr. Jaswant Gidda: Supporting
• Focus of registration:• Propose a Phase II interventional trial to investigate the role of a Lr
biofilm on GI maturity and immune response of premature infants
• Indications: • Time to establish full enteral feeds
• Reduction of time/days in the NICU
• Incidence of necrotizing enterocolitis
• Time until full term birth weight
• Inclusion Criteria:• Gestational age 30 - 32 weeks
• Very Low Birth Weight - 1,500g or less (~60,000 patients per year)
42
Slide 11: Manufacturing Strategy
In-house or contract manufacture (and why)
Timing of production
Inventory levels
Special issues
•Processes
•Volume
•Cost
• Current process uses lentivirus and is similar to CAR-T process
• Conducting scale-up of manufacturing process in our lab
• Manufacturing at the Centre of Excellence for Cellular Therapy (CETC)
in Montreal for first-in-man studies
• The CETC facility 37,000 ft2 and is compliant with US, EU and Canadian GMP
• Tech transfer initiated April 2017 after optimization and scale-up
Manufacturing Plans
Slide 12: Commercial Strategy
Out-license or commercialize
Domestic or international partners
Marketing & PR plan
Advocacy Relations
•Processes
•Volume
•Cost
Medical Comms Strategy
KOL Development
Publication and medical meeting strategy
Slide 13: Financial Position
• Balance sheet
• Income statement as appropriate
• Put numbers in context
• Current financial guidance as appropriate
Summary financials
• Shares outstanding
• Insider holdings
• Market capitalization
Market position
Financing
• Current Financing to Date• NCH – Active RO1
• Scioto - $380,000 NIH STTR Award Phase I
• Series A Preferred Stock – Led by BioCrossroads
• Up to $4 million (>$1.7M committed and scheduled to close April 23, 2018)
• Animal health venture - Signed option for poultry rights
• $50,000 payment (100+ chicken study planned)
• Future Potential Financing• NIH - Therapeutic for Rare and Neglected Disease Division (Finalist)
• April 2018 – Submission of New Phase I SBIR ~ $350,000
• September 2018
• Follow on submission of Phase II STTR ~ $2.5 million
• Submission of new Phase I SBIR ~$350,000
48
• Triumvira Immunologics Inc. Ontario corporation incorporated May 2015
• Triumvira Immunologics USA Inc. - wholly owned Delaware incorporated subsidiary
• CA$ 6.4 MM received from Canadian investors
• Founding shareholders - 59%; HNW & Angels - 41%
• 6.75M common shares outstanding
• ±CA$ 6 MM in non-dilutive funding from grants and foundation support for TAC technology
• Genome Canada
• Several Cancer Foundations
• Samuel Family Foundation
Company Finance History
Financial Position
Q1 2018 End Cash and Equivalents $143.9 million
YE 2018 Cash Projected To be updated on Q2 call
Shares Outstanding as of March 31, 2018 37.2 Million
Resources sufficient to support focused clinical development of indoximod
Slide 14: Upcoming Milestones
• Summarize company’s upcoming milestones
Management View of milestone creating value
• Clinical
• Regulatory
• Clinical/medical
• Commercial
• Manufacturing
• Transactions
• Operational
• Management
Upcoming news flow
Future Milestones – 12 to 24 months
52
• Submit Pre-IND meeting request to FDA
• Complete IND efforts and submit to FDA
• Initiate clinical study (Q2/3 2019)
• Finalize contracts for master stocks, manufacturing, analysis and stability
• Formulation and clinical manufacturing process development
• Complete initial partner trials in Q1 2018
• Aggressively seek non-dilutive funding
• Prepare for Series B and/or partner technology
• Identify potential partners for acquisition and licensing opportunities
Clinical and Regulatory
Financing - Partnering
CMC and Preclinical Efforts for IND
NewLink Genetics – Key Takeaways
▪ Indoximod has a differentiated mechanism of action (MOA)
• Reverses the effects of low tryptophan by increasing proliferation of effector T cells
• Drives differentiation into T helper cells vs regulatory T cells
• Downregulates IDO expression in dendritic cells
▪ Promising clinical activity of indoximod in combination with
• Chemotherapy in AML
• Checkpoint blockade in melanoma
• Radiation and chemotherapy in DIPG
▪ Additional indoximod data to be presented at upcoming medical conferences
• Melanoma & Pancreatic Cancer: Final Phase 2 results at ASCO, June 2018
• DIPG: Updated Phase 1b data at ISPNO, July 2018
• AML: Updated Phase 1b data intended 2H 2018
Differentiated MOA demonstrating clinical activity for multiple combinations and indications
Slide 15: Conclusion
Use the company’s brand statement for the title
Use the company’s elevator speech for the text
Capture the essence of the preceding 14 slides
Include a contact name, email address and company website address on the final slide
End with a call to action
Scioto Biosciences, Inc
Contact: Joe TrebleyEmail: [email protected]
Phone: 765-376-1471www.sciotobiosciences.com 55
• Overview• Novel microbiome platform technology
• Multiple billion dollar plus market opportunities
• Strong IP portfolio
• Experienced management and scientific team
• Success in getting non-dilutive funding
• Raising up to $4M in equity financing
• Round lead by Biocrossroads (initial close 4/23)
• Other institutional investors committed
• Target clinical entry in Q2/3 2019
A Great Elevator Pitch Answers:
• Who are we?
• What do we do?
• How do we do it?
• Whom do we do it for?
The Process of Creating a
Great Elevator
Pitch
• Identify answers to the four key questions – write down your answers
• Link them to create a paragraph
• Read the paragraph aloud
• Adapt it to your natural way of speaking
• Shorten it to fewer than 100 words or less than one minute
• Practice it with friends and take their advice seriously
• Memorize key messages so you can adapt and use it anywhere
• Keep your delivery fresh and natural
• Use it often
• Refine it as needed
Example of an
Elevator Pitch
Who are we?
• LaVoieHealthScience is an integrated strategic communications agency
What do we do?
• We help health and science companies engage key audiences to build value for their innovations
How do we do it?
• Through integrated communications covering public relations & investor relations
Whom do we do it for?
• Emerging and established health and science companies throughout the globe
If you have any questions, please contact:
Donna LaVoie
LaVoieHealthScience
One Thompson Square
Boston, MA 02129
617-372-8800 ext. 107