StemGELA TMJ Regenerative Therapy

Millie C Embree, MS DMD PhD

PI, TMJ Biology and Regenerative Medicine Lab

Mo Chen, PhD MBA

CEO, Wnt Scientific, LLC

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10 million Americans

$4 billion healthcare burden

Women of child bearing ages

Cartilage degeneration

Jaw bone defects

Symptoms

Pain and inflammation

Limited jaw movements

Dental malocclusion

Temporomandibular Joint Osteoarthritis (TMJ OA)

Chouinard et al, Oral Maxillofacial Surg Clin N Am 2018 2

Sclerostin (SOST)

• Inhibits Wnt pathway

• Regenerates TMJ

Hyaluronic acid (HA)

• FDA approved for osteoarthritis

• Lubricant

• Anti-inflammatory

• Anti-nociceptive

TMJ is critical for eating, speaking and dental occlusion

StemGEL activates local stem cells in the TMJ to regenerate cartilage

The Solution: StemGEL-TMJ

An injectable, local TMJ regenerative therapy that alleviates pain and restores function.

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B) Sclerostin Regenerates

Cartilage& Ameliorates TMJ OA

StemGEL-TMJ Regenerates Cartilage

SOST PBS0

2

4

6

8

10 p=0.0008

Macro

scopic

OA

RS

I S

core

+PBS control+Sclerostin

3 mm 3 mm

n=8

25 mm 50 mm

3 mm

H&E

ACAN/FCSCs

50 mm

50 mm

50 mm

Stem cells

4 mm

A) Fibrocartilage stem Cells

Regenerate Cartilage

Stem Cell

Sclerostin Release Curve

0 5 10 15 20 25 30 35 40 450

10

20

30

40

50

60

70

80

90

100

Scle

rostin R

ele

ase (

%)

Days

Embree et al, Nature Communications 2016

C) StemGEL Induces

Cartilage Regeneration

0

5

10

15

20

25

********

Col2a1 F

old

Change

StemGELSclerostinControl

4

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StemGEL-TMJ Advantage:

The First Non-Surgical Regenerative TMJ therapy

1. Administered in a dental office

chairside with no down time

2. Delivered locally to alleviate

pain and restore jaw function

3. Reduce inflammation and

stimulate regeneration

Palliative

ice packs, soft foods, OTC meds, oral appliances, steroid injections, hyaluronic acid (Euflexxa, Gel-one, Hyalgan)

Procedures/Surgery

arthroscopy, orthognathic surgery, TMJ replacement

Do not prevent disease or promote regeneration

Invasive, multiple surgeries, high failure rates

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“I’m in so much pain but I don’t want surgery.”

-Kolia, patient

“I’m 23 years old and cannot eat… feel hopeless.”

-Carol, patient

“I am 53 years old and had five jaw surgeries.”

-Diane, patient

Patients

Insurance

Companies

Providers

Non-surgical

Low CostsRegenerative

Pain ReliefSimple

Application

The StemGEL-TMJ Advantage

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Market Size

StemGEL Market

2.6 Million Patients

Surgical

0.3 MIL

Palliative

0.3 MIL

Palliative +

Procedures

2 MIL

TMD

10 Million Patients

Surgical

1.6 MIL

Palliative

1.6 MIL

Palliative +

Procedures

6.8 MIL

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StemGEL-TMJ Progress

$1.2 Million NIH Grant for target identification

Publish in Nature Communications, Osteoarthritis & Cartilage (7 in total)

2015

2016

2018

$225,000 NIH STTR Phase I Grant for product formulation

Collaboration agreement between Wnt Scientific & Columbia University

Patent filed by Columbia University

Wnt Scientific & Columbia sign exclusive option

Columbia BiomedX Award2019

Edward Puzas, PhD

Professor, University of Rochester

Past President Orthopaedic Research Society

Alia Koch, DDS MD

Program Director

Oral and Maxillofacial Surgery

Columbia University Medical Center

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Our Team

Millie Embree, MS DMD PhD

Director, TMJ Biology Lab

Dr. Edwin S Robinson Assistant Professor

Columbia University Medical Center

Mo Chen, MBA PhD

CEO, Wnt Scientific

Hanying Bai, PhD

VP for Research, Wnt Scientific

Janet S Lee, PhD

President, Subito Science

Clinical/Science Lead Business/Science Lead

Medical AdvisorScientific Advisor

Regulatory Advisor Scientific Advisor

Advisory BoardInventors

Traction & Path to Market

Phase I/II

Trial

Strategic Partnership/Venture CapitalInternal/Federal Grants

FDA

review

Market

EntrySubmit

IND

2022

IND Studies

GLP Toxicology

pK

Immunogenesis

CMC

Target Identification

& Formulation

Discovery

Cells

Fluid

Tissue

2014

Pre-Clinical

Validation

Validation

Assays

2019

Phase III Trial

Submit

NDA/BLA

2028

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THANK YOU