NON-CONFIDENTIAL

Driving Value from Lead to Clinic

TSRL, Inc. Technology Accelerator

Drew Hertig, MBABusiness Development

ahertig@tsrlinc.com

A New Model for Preclinical Drug Development

1bd@tsrlinc.com 734-663-3607 www.tsrlinc.com

NON-CONFIDENTIAL

The Challenge

Many therapeutic assets are struggling to find funding to move past the “Valley of Death”

Inception Pre-lead Lead IND NDA

3-5 years 1 year 2 years 5 yearsV

alu

e o

f O

pp

ort

un

ity

Development Timeline“Valley of Death”

Value Infection

Drug Discovery10k-30k

Lead Selection

30-60

PreclinicalDevelopment

10-20

Phase I5-10

Phase II2-5

Phase III2

Approval1

©2015 TSRL, Inc.

2

NON-CONFIDENTIAL

The Opportunity

Academic life science drug products require…

• Collaboration: Strong interdisciplinary science & business acumen

• Visibility: Industry is increasingly looking for academia for new products

• Relationships: NIH is emerging as a strong player in translational medicine

Funding climate for early stage assets changing

• VC funds have moved to later stage assets

• Government and foundations are increasingly stepping in with funding

• Commercial potential is not sufficiently analyzed

• Comprehensive data package demonstrating drug product potential is lacking

3

NON-CONFIDENTIAL

TSRL, Inc. Accelerator Model:A hybrid model leveraging minimally-dilutive funding and experienced

pharma management to “de-risk” and drive projects to IND

4

NON-CONFIDENTIAL

Our Accelerator Strategy…

• Builds on our proven track record of designing and developing oral and targeted drugs, with an initial focus on infectious diseases

• Develops drug assets in-house or in-licensed from academic and industry organizations

• Selects potential drug assets against a set of criteria established to maximize the potential for commercialization success

• Provides infrastructure, laboratory, scientific and business resources, as well as in-kind services to drive projects to IND

5

NON-CONFIDENTIAL

Incubator vs Accelerator: What’s the Difference?

Working Space: Business incubators typically provide office and/or wet-lab space, with the opportunity for entrepreneurs to mingle with each other

• Commercialization strategy assistance

• Access to high-level networks

• Flexibility to expand as company grows

JLabs, Janssen Labs innovation center, an incubator

“Nesting” Company: Accelerators offer additional services, i.e. human capital and seed funding:

• All of the above services, plus

• Equipment/comprehensive preclinical research services

• Seed funding in exchange for an equity stake in a future NewCo

http://www.oxbridgebiotech.com/review/business-development/incubator-vs-accelerator-whats-difference/ 6

NON-CONFIDENTIAL

TSRL TA Value-Add Model

• Develop plan/budget

• Generate data and drive project to IND or POC

• Nourish partnerships and collaborations

• GOAL: Obtain total data package and refined commplan for next inflection point

1) The Idea

• Inventor/Entrepreneur

• Drug Therapy Concepts

• Intellectual Property

2) Screening

• Devise/evaluate concepts for technical do-ability

• Analyze & uncover commercial potential

• GOAL: Submit SBIR grant with high likelihood of success

4) Development

5) Decision

• No-go decision results in feedback, development plan, data package

• Go decision results in TSRL Inc. partnership, NewCo, external investment, acquisition or out-license

• GOAL: Obtain ROI of 5-10x per asset

Value of Project

Re

sou

rces

Re

qu

ire

d

Pipeline Discovery

Preclinical Development

3) Go/No-Go

©2015 TSRL, Inc.

7

NON-CONFIDENTIAL

9 Grants/Yr.

Pipeline Discovery

Technology Disclosure• Source from referrals, internal projects,

conferences, inbound and outbound websites, through Accelerator RFPs

Technology Assessment & Rubric• Prepare with Commercial Assessment (CA) and

Project Summary Document (PSD)

SBIR Grant Selection• Select the best projects from a combination of

“fundability” and adherence to core portfolio

120 Disclosures/Yr.

15 Assessments/Yr.

8

NON-CONFIDENTIAL

Consultants

Infrastructure & Expertise

9

Wet LabsAnimal Labs

Grant WritingFundraising

Drug Development Project Management

Oral Drug DeliveryProdrug Science

Strategic Partners NIH / FDA

CROs

TSRL TA Team & Collaborators

NON-CONFIDENTIAL

Technology Accelerator

Project C

Project B

Project A

Funding• Prior funding• Stage/level of funding

Science• Expertise-fit• Development risk• Feasibility

Intellectual Property• Strength of IP• Prior art• Scope

Commercial Potential• Market size• Reimbursement• Development costs• Competitive landscape

Business Structure• Licensing (inventor

equity)• Risk-adjusted portfolio• Business formation

Commercial Assessment

People• Inventor credibility,

network, and business acumen

• Management skill and track record

Product• Clinical path• Time to market• Manufacturing

10

NON-CONFIDENTIAL

We Are Looking to Collaborate With…

• Life science entrepreneurs seeking to commercialize their early stage drug therapy concepts

• In need of support for:

• Drug development expertise – drug delivery and PK/PD core

• Minimally dilutive funding

• Commercialization assessment

• Infrastructure capabilities for generating crucial preliminary data

• Admin/business operations support

….and who are time-constrained and welcome a collaborative partner to expedite their drug product development

11

NON-CONFIDENTIAL

Consideration in Return

• Collaborative Research and Development Agreement as your first industry partner

• ≥50% of grant-specific aims performed at TSRL, Inc. laboratories or within our network

• Equity consideration upon exit

• First right-of-refusal

• Non-royalty/sublicense consideration

Our TA team works as collaborators on your project—as a result, we have a vested interest in your success

12

NON-CONFIDENTIAL

Summary

• TSRL Inc. Technology Accelerator provides life science entrepreneurs with:

• Infrastructure » office & bench space, AAALAC-accredited animal facilities, BSL-2, radiation safety license, controlled substance license

• Laboratory services » equipment, SOPs, QC

• Scientific resources » in-kind services, development/research strategy support

• Business resources » administrative, commercialization plan support, business development, marketing

• Experience » analytical chemistry, animal models, PK/ADME, drug delivery, regulatory (FDA/Pre-IND), industry management experience

• Network » collaborators, partners, consultants, relationships (NIH)

Our mission is to provide investigators with means to bridge the “Valley of Death” and to advance potentially life-saving drug products

13

NON-CONFIDENTIAL

Questions?

Thank You!

14