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How to Tell Your Company’s Story in Just 15 Slides Who-What-Why

How to Tell Your Company’s Story in Just 15 Slides Who ...€¦ · H2 – 2019. HER2 (human epidermal growth factor receptor 2; Receptor tyrosine-protein kinase erbB-2) Much improved

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How to Tell Your Company’s Story in Just 15 Slides

Who-What-Why

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

CARs“Distinct from natural T cell

receptor” may cause more toxicity – no on/off switch

TAC Advantage:“Designing Safe

and More Effective T-Cell

Therapy”

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

Affimed’s pipeline

37

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

Elevator Pitch

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

[email protected]