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Awaken the body’s power to protect, restore & regenerate Corporate Presentation 2016 1

Corporate Presentation 2016...Corporate Presentation 2016 1 Executive Summary Positioned to dominate & expand large untapped market 2 •Dutch domiciled company (Geleen, NL), established

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Page 1: Corporate Presentation 2016...Corporate Presentation 2016 1 Executive Summary Positioned to dominate & expand large untapped market 2 •Dutch domiciled company (Geleen, NL), established

Awaken the body’s power to protect, restore & regenerate

Corporate Presentation 2016

1

Page 2: Corporate Presentation 2016...Corporate Presentation 2016 1 Executive Summary Positioned to dominate & expand large untapped market 2 •Dutch domiciled company (Geleen, NL), established

Executive Summary Positioned to dominate & expand large untapped market

2

•Dutch domiciled company (Geleen, NL), established in 2015 by current shareholders

•IP: Irrevocable exclusive world-wide license for Evitar™, provisional filed by Temple on 2nd indication;

holds option to license another asset (Acute Kidney)

•Lead entering pivotal studies-first in class drug for adhesion prevention in laparoscopy-significant

growth potential- 90% of the 2.5 billion USD market is untapped

•Pipeline of promising products positioned for reference leadership in other surgery indications (spinal,

ortho, etc.), and renal transplant (orphan and fast track )

•Upcoming milestones for Evitar™

•Q3’16-FDA pre-IND meeting request filed- “Breakthrough Designation” expected for Evitar™

•Q4-2016-Data read out from lead program- Evitar™ for adhesion prevention

•Q4’16-Q3’17-Regional (JP, LATAM, EU & USA) licensing discussions for Evitar™

•Q4’16-FDA IND meeting-start pivotal trials in 2017 for lead in USA and Europe for Evitar™

•Q4’16-Secure term sheets -AKI & Evitar under a build to license-discussions underway

•Q4’16-Prepping for Series B Financing of $20-$25 M following Evitar™ data read out

•Strong team assembled with relevant and breadth of experience in the space

•Leading medical and scientific advisory board members from top institutions leading Temple’s programs

Page 3: Corporate Presentation 2016...Corporate Presentation 2016 1 Executive Summary Positioned to dominate & expand large untapped market 2 •Dutch domiciled company (Geleen, NL), established

Milestones-FDA Clearance for Registration Trial -FDA IND meeting request filed Aug.’16—First in Class Drug, Breakthrough Designation -Prepping for 2nd well controlled study -505(b)2 pathway and breakthrough designation expected for expedited approval -NCE exclusivity also available as molecule as abundant safety data as an approved TPN nutritional support but has never been registered as a drug with clinical evidence

Near Term Inflection Point -One well controlled double blind study in 48 patients completion expected Aug ’16 -Multiple products within surgery poised to enter the clinic off same biology -Reference leadership in space and scale possible Financing -Capital efficient model-privately funded by founding shareholders, includes CEO-<$5 million to date- “skin in the game” -Looking to raise 15-20 million USD for pivotal trials and additional programs to enter the clinic.

Positioned to Dominate & Scale

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Page 4: Corporate Presentation 2016...Corporate Presentation 2016 1 Executive Summary Positioned to dominate & expand large untapped market 2 •Dutch domiciled company (Geleen, NL), established

Market & Product Insight from our scientific, medical advisory board of surgeons

& payer

Mitigate Risk through validation

Quality differentiated products for major

unmet medical need

•Unmet medical need, clinical trial, reimbursement &product design vetted by SAB prior to acquiring IP and initiating development •Breakthrough designation, orphan and/or 505(b)2 provides for rapid clinical development

•Disease modifying based on clinicians’ & payers’ input •Value proposition: Reduce repeat procedures, lower re-admissions rates & length of stays •Reducing complications increases hospital quality rating & improves operating margins

4

Market Driven Product Development Approach We go for standard of care where none exists

Simplicity is the ultimate sophistication… --Albert Einstein

Page 5: Corporate Presentation 2016...Corporate Presentation 2016 1 Executive Summary Positioned to dominate & expand large untapped market 2 •Dutch domiciled company (Geleen, NL), established

5

Common Themed Product Pipeline in Hospital/Acute Care/Out-Patient Markets

Mitochondria

Energy Powerhouse of the Cell

DAMAGE OR INJURY HYPOXIA

Post Operative

Fibrosis

Acute Kidney Injury

Acne Scarring

Abdomino- Pelvic

Spine Ortho Provisional patent filed

Entering Pivotal Trial-2017 Orphan &

Fast Track

Page 6: Corporate Presentation 2016...Corporate Presentation 2016 1 Executive Summary Positioned to dominate & expand large untapped market 2 •Dutch domiciled company (Geleen, NL), established

“There is a significant unmet need in fibrosis, and this novel pharmaceutical

approach has potential,” stated Dr. James Greenberg, Chief of Gynecology at the

Faulkner Hospital and a Vice Chairman of Obstetrics & Gynecology at Brigham &

Women's Hospital, Harvard Medical School, Boston, MA. “I believe the approach and

efficacy shown sets a new standard of care in gynecology pelvic surgeries. For me it is

important that it is not a barrier or medical devices which are not that effective.”

EVITAR™ ADDRESSES MAJOR UNMET MEDICAL NEED

First –in-Class Drug -Standard of Care for Surgeries

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Page 7: Corporate Presentation 2016...Corporate Presentation 2016 1 Executive Summary Positioned to dominate & expand large untapped market 2 •Dutch domiciled company (Geleen, NL), established

What are post operative adhesions? Bands of scar tissue that form after most surgeries and stick to organs causing complications. Now, surgery’s single largest complication, cause of morbidities that lead to repeat surgeries, readmissions & longer length of

stays. (Practical Guide to the prevention of

Surgical Adhesions, CME/CE)

Painful Burden = Opportunity Hospitals’ burden, Surgeons’ nemesis, and patients’ nightmare

7

Risk of Adhesions v.

Infection, Hemorrhage

1:17

v.

1:500

Adhesion Awareness: A National Survey of Surgeons, World J. of Surgery, 2010

Page 8: Corporate Presentation 2016...Corporate Presentation 2016 1 Executive Summary Positioned to dominate & expand large untapped market 2 •Dutch domiciled company (Geleen, NL), established

Post-operative complications Most sensitive surrogate marker for quality* ratings for hospitals

8

* *

*Annals of Surgery, 2011, 254 (6), 907-913

**JAMA Surg. 2016;151(6); Journal of Clinical Anaesthesia, Vo. 22, 2010; American J. of Cosmetic Surgery, Vol 22, 1, 2015

*

**

**

Page 9: Corporate Presentation 2016...Corporate Presentation 2016 1 Executive Summary Positioned to dominate & expand large untapped market 2 •Dutch domiciled company (Geleen, NL), established

Large Untapped Adhesion Prevention Market -Limited or no options for laparoscopic abdominal and

pelvic procedures; the fastest growing surgical segment

“First-in-Class Drug from Novel Biology could be ideal product” –Dr. Greenberg, Harvard Surgeon Adhesion related Adoption Drivers -Surgical complications slash profit margins from 5.8% to 0.1%

(Jama Surgical May 11, 2016)

-30 day re-admission rates wither away hospital quality rating

-Related medico-legal issues spike risk for hospitals and surgeons

(Medico Legal Consequences, Int’l J. of Surgery, 2009)

-7 procedures accounted for 80% of surgeries, 80% of patient fatalities,

79% of complications and 80% of national inpatient costs

(JAMA Surg. 2016;151(6))

Global Market ($2.5B)

Untapped Market

Current Penetration

Large Unmet Medical Need & Untapped Market Evitar™ First-in-Class Drug for Laparoscopic Use

9

0.0% 5.0%

With

Without

Hospital Profit Margin With or Without Complications

Profit Margin

Page 10: Corporate Presentation 2016...Corporate Presentation 2016 1 Executive Summary Positioned to dominate & expand large untapped market 2 •Dutch domiciled company (Geleen, NL), established

No Current Standard of Care Creates unmet medical need

Seprafilm® or Interceed®

Barriers Method

Adept®

Barrier Method using an

instillation

Significant Limitations •Not FDA Approved for laparoscopic surgeries •Seprafilm®: Hard to use & handle-sticky; leaks with anastomosis •Near perfect hemostasis environment required for Interceed® •Adhesions still form

Significant Limitations •Infection & swelling reported in trial •Approved : gynecological laparoscopic adhesiolysis, clean cases •Efficacy is marginal (9.8%) difference from Lactated Ringers solution (FDA Panel Review) •Contraindicated to general surgery •Adhesions still form

A clear need for a product that is easy to use in all procedures, applies quickly and achieves broad coverage that prevents adhesions throughout

Seprafilm , Interceed and Adept are registered trademarks for Sanofi, Johnson & Johnson and Baxter respectively

Page 11: Corporate Presentation 2016...Corporate Presentation 2016 1 Executive Summary Positioned to dominate & expand large untapped market 2 •Dutch domiciled company (Geleen, NL), established

Differentiation

Parameters

Evitar™

GYNECARE

INTERCEED®

(Johnson &

Johnson)

ADEPT ®

(Baxter)

(Sanofi-

Genzyme)

Laparoscopic use Yes administered

laparoscopically in

current trial

Not FDA Approved Yes

FDA Approved with

conditions

Not FDA Approved

Fined by US DOJ for

use

Type Drug

Sterile Aqueous

form

Device

Synthetic fabric

Device

Liquid instillation

Device

Bioresorable Film

Ease of use Easily applied in <1

min through

commonly found

syringes

Education & training

required

Known to extend

procedure time

Easy

Significant volume

1000ml in periitoneal

cavity

Education & training

required

Known to extend

procedure time

Safety Issues No AE’s reported in

current trial

AE’s reported AE’s reported AE’s reported

Currently under a

Petition to FDA to

remove off market

EVITAR™ First-in-Class Drug Easy to use, quick to apply & laparoscopic friendly

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Page 12: Corporate Presentation 2016...Corporate Presentation 2016 1 Executive Summary Positioned to dominate & expand large untapped market 2 •Dutch domiciled company (Geleen, NL), established

1975 Today

Anti-inflammatory & Steroids Aspirin to methylpredinisolone

1990 Barrier Devices

2009

Adhesion Literature Suggests:

Re-alignment of Cellular Metabolism

•Restoring balance at cellular level may be possible within hours of surgery* •Rapidly restoring tissue homeostasis enhances normal resolution* •Shifts the gene signalling pathways activated by prolonged hypoxia and oxidative stress away from adhesion formation*

* Awoniyi O. Awonuga, J. B. Diamond, Michael, et al. (2014). Advances in the Pathogenesis of Adhesion Development: The Role of Oxidative Stress. Reproductive Sciences, 1-14.

EvitarTM Moves Beyond “Barrier” Thinking

First-in-Class Patented Drug could be the ideal product

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Page 13: Corporate Presentation 2016...Corporate Presentation 2016 1 Executive Summary Positioned to dominate & expand large untapped market 2 •Dutch domiciled company (Geleen, NL), established

Drug Indication

Preclinical Phase I

Phase II

N=48 patients

Phase III

N=200 patients

Regulatory 505(b)2 Pathway Potential

Evitar™

Market Launch Expected

2019 Patent Expiry

2031 100% enrolled

•Current trial is a double blind placebo controlled randomized study with both a laparoscopic arm (N=38) and laparotomy (N=10), both randomized 1 to 1 in myomectomies (removal of fibroids) with 6-8 week post-op laparoscopy second look follow-up which is the gold standard for assessing adhesions •Blinded Independent Reviewers (in Progress):

•Togas Tulandi MD, MHCM, Professor & Interim Chair of Obstetrics and Gynecology, and Milton Leong Chair in Reproductive Medicine, McGill University, Interim Chief of Department of Obstetrics and Gynecology, McGill University Health Center •Antonio Rosario Garguilio, MD, Assistant Professor, Harvard Medical School, Infertility and Reproductive Surgery Obstetrics/Gynecology

ACCELERATED CLINICAL PATHWAY Elective surgeries, clear endpoints & small trials

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Page 14: Corporate Presentation 2016...Corporate Presentation 2016 1 Executive Summary Positioned to dominate & expand large untapped market 2 •Dutch domiciled company (Geleen, NL), established

ATTRACTIVE TARGET MARKETS Underserved and limited or no options with room for growth

Market Potential 9 + million procedures in US 30+ million globally

Market Needs Limited or no viable solutions laparoscopic procedures An easy to use, effective and broad coverage would meet the need, accelerate adoption and realize the potential

Adhesions from Abdominal &

Pelvic Surgeries

Market Potential 54 million Americans over 65 Spine industry grown from $300M (1997) to $13B (2012) 1.5+ million procedures in US 3+ million procedures globally

Market Needs CMS MS-DRG codes increased reimbursement by 20% Fibrosis may account for 20-36% of FBSS* & makes reoperations more difficult Reducing fibrosis with a safe and effective product would meet the need

Epidural Fibrosis following Spinal

Surgery

Market Potential 6+ million digestive system 1+ million respiratory system 7+ million CV 700K knee replacements 1.2+ million urinary system

Market Needs Fibrosis complications lead to hospitalizations, re-operations and medico-legal issues Customized product design with input from surgical team could dominate the space

Other surgical procedures (US data)

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Page 15: Corporate Presentation 2016...Corporate Presentation 2016 1 Executive Summary Positioned to dominate & expand large untapped market 2 •Dutch domiciled company (Geleen, NL), established

“DROP IT IN EVERY PROCEDURE”

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Value Propositions Balances customer needs & maintains strong margins

Surgeon

<1 min. application time, no change in habits or training

Easily works equally well in open or

scope procedures

Reduces operation time, potential complications

Hospital

Priced right as a % of total procedure, no capital investment required

One product for many procedures, economies of scale

Saves OR time , reduces

complications and readmissions

Margins

90%+

Price point up to $700 US per procedure possible based on efficacy data

Page 16: Corporate Presentation 2016...Corporate Presentation 2016 1 Executive Summary Positioned to dominate & expand large untapped market 2 •Dutch domiciled company (Geleen, NL), established

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PROVEN TEAM Relevant experience-clinical, regulatory, legal, finance, marketing & sales

Len Smith, MSc., JD Strategic Counsel

Sanj Singh, MBA CEO

Lynne Robertson, MS, PhD

Chief Operating Officer

Over 20 years of industry experience in leadership positions; building top teams & strong strategic relationships, business development and raising capital. Board of Directors, BioteCanada. Formerly of: Co-founder, President & CEO of AdeTherapeutics Inc.

Over 29 years of experience in biomedical and pharmaceutical industries. Concept through commercial launch, including discovery, CMC and clinical development, regulatory and compliance, program management and executive leadership. Experience with medical devices, combos, Rx and OTC drugs in Europe and North America. Formerly of Quintiles, KOS, Schering Plough, Mylan, Wyeth Ayerst and cofounder of Gwen Ryan Solutions pharma consulting.

Over 20 years crafting and carrying out strategies for transactions and operations relating to innovative technologies and products leading to growth and profits Structuring and negotiating technology, financing, and corporate deals (licenses, acquisitions, collaborations, joint ventures, mergers, etc.) and other contracts; board, regulatory compliance, IP strategy. Formerly of Valeant, Medicis & Novo Nordisk

Zahir Lavji, Chairman Previous President of Abbott Japan EVP of Int’l Marketing, Abbott

Bill Densel, CEO CheckCap Previous CEO-Beacon Medical Director Marketing & Sales, Biosurgery, Genzyme

Steven Damon CEO 4P Therapeutics Previous VP of Altea, Durect, Kimberly Clark

Board of Directors

James Hattersely Sr. VP BD, Adherium Previous Nektar, Sun Pharma, Antares, & Abbott

Jason Ding, CPA, CBV Previous Sr. Life science practice leader, Deloitte

Saad Gilani Financier, Sr. Portfolio Advisor, Yorkville Advisors

Guy-Jean Savoir Director Carnot Laboratories Founder, Investor, Diversified Corporate Holdings

Page 17: Corporate Presentation 2016...Corporate Presentation 2016 1 Executive Summary Positioned to dominate & expand large untapped market 2 •Dutch domiciled company (Geleen, NL), established

Awaken the body’s power to protect, restore & regenerate

Corporate Presentation

For more information Sanj Singh, CEO

Email: [email protected] Mobile: +1306 261 5189

Lynne Robertson, COO

Email: [email protected]

Mobile: +1 401 744 2718

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Page 18: Corporate Presentation 2016...Corporate Presentation 2016 1 Executive Summary Positioned to dominate & expand large untapped market 2 •Dutch domiciled company (Geleen, NL), established

References

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