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Awaken the body’s power to protect, restore & regenerate
Corporate Presentation 2016
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Executive Summary Positioned to dominate & expand large untapped market
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•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
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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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
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Market Driven Product Development Approach We go for standard of care where none exists
Simplicity is the ultimate sophistication… --Albert Einstein
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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
“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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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
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Risk of Adhesions v.
Infection, Hemorrhage
1:17
v.
1:500
Adhesion Awareness: A National Survey of Surgeons, World J. of Surgery, 2010
Post-operative complications Most sensitive surrogate marker for quality* ratings for hospitals
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* *
*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
*
**
**
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
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0.0% 5.0%
With
Without
Hospital Profit Margin With or Without Complications
Profit Margin
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
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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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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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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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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“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
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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
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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References
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