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Epitomee Medical Ltd.

Investor Presentation • Sep 12, 2023

6780_rns_2023-09-12_617c22dc-0513-45f6-b058-c2523640a41a.pdf

Investor Presentation

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Ingestible Therapeutic Platform Treating Chronic Disease through the GI Tract

September 2023

This presentation (the "Presentation") is for informational purposes only and does not constitute or form any part of any offer or solicitation to buy or subscribe for securities of Epitomee Medical Ltd. (the "Company") and should not be regarded as a recommendation or an opinion on such matters. The information included in this Presentation is not comprehensive and does not include all the information with respect to the Company and its business required for any decision concerning an investment in the Company's securities. This Presentation includes forecasts, estimates, assessments, expectations and other information, intent or belief pertaining to future events and/or matters, which constitute "forward-looking statements" as defined in the Securities Law 5728-1968, which is based on current expectations, projections and assumptions about future events. Actual results may differ materially due to variety of factors, some of which the Company has no control over and cannot be reasonably foreseen at this date, including, but not limited to: dependency on third parties engaged by or who contracts the Company and its services, change in the overall economy; the duration and severity of the COVID-19 (coronavirus) pandemic and its impact on the Company and on local and global economy and the Company's ability to manage and develop its business. Such information may not materialize, in whole or in part, or may materialize in a manner significantly different to that forecast. Therefore, actual future results, performances or achievements of the Company may differ materially from what is or may be expressed or implied in this Presentation. Certain information and factual statements (including markets or trends) contained herein are based on or derived from publicly available documents or independent third-party sources the accuracy of such information and the assumptions on which such information is based have not been independently verified. The past performance information contained herein is not indicative of future results and there can be no assurance that the Company will achieve comparable results or that the Company will be able to implement its investment strategy or achieve any investment objective.

Management Team

Shimon Eckhouse, PhD Co-founder and Chairman

Founder of Syneron Nasdaq:ELOS & Lumenis Nasdaq:LMNS, Sofwave Medical TLV: SOFW and others

Dan Hashimshony, PhD Chief Executive Officer

Founder & CEO-Dune Medical Devices Chief Scientist X-technologies, and others

Gal Aharonowitz COO

SHL, VP R&D Lumenis, GM Israel Dune medical

Yael Kenen, PhD VP Clinical Affairs

TEVA, Global Clinical Drug Development Director

Gil Cohen, PhD VP R&D

SCO Dune Medical Devices, Hebrew University of Jerusalem

Maya Gabrieli, CPA VP Finance

Plastopil Hazorea LTD, KPMG

Safi Landskroner VP Business Development

Dexcel Pharma, Mapi Pharma, Chartwell Pharmaceuticals

Dr. Ruthie Amir, MD. Chief Medical & Regulatory Officer

Global VP Regulatory Syneron, Sofwave Medical

Company Highlights

Ingestible, Shapeshifting Platform Breakthrough Tech

  • Creates self-ingested, swallowable devices that act along the GI tract
  • Achieves therapeutic outcomes in prevalent diseases

Market Potential Multi Billion \$ Market

  • Weight management > \$200B (Commercialization stage)
  • Biologics delivery > 300B (Growth engine)

With Global Conglomerates Strategic Alliances

  • Weight management: Global commercialization and marketing with Nestle
  • Biologics: Advancing collaborations with big pharma on biologic oral delivery

Regulatory Progress Global Commercialization Protected Innovation

  • Cleared in: Europe, Israel
  • Completed pivotal study for FDA 510(k) showing great clinical outcomes
  • Targeting FDA clearance & market launch in 2024

  • 30 granted patents
  • 12 pending patents

• Current cash balance ~ \$38M

A Platform Technology with Various Applications

Adaptable in function, duration and location of operation

ORAL ADMINISTRATION Easy ingestion with no clinical procedures

TARGETED DEPLOYMENT

Precise delivery to specific therapeutic location

TRANSIENT ACTIVITY Temporary engagement and complete clearance

SAFE

Designed with patient safety at the forefront

Oral Biologics: drug carrier for 2 delivery in the small intestine

Weight Management: 1 active in the stomach

Strategic Focus

Weight Management

Our Solution:

Drug-free, Ingestible Treatment

  • Imitates solid food intake
  • Daily therapy

Biologics Delivery

Market Potential:

Our Solution:

Protected, Oral Delivery

  • Eliminates the need for injections
  • Improves bioavailability

Weight Management Solution Overview

2.6B People Worldwide are Overweight or Obese

Weight Management Capsule

Creating a sense of fullness:

The capsule expands in the stomach into a semi-rigid triangle, imitating solid food through its interaction with the stomach wall.

Weight Management Capsule – Mechanism of Action

Activating the body's natural mechanisms to regulate food intake

Surging Market Demand Driven by the Rise of GLP-1 Injection

2021 2027 \$16.5B \$24B GLP1 Market Growth Rising Demand for 'Easy Fix' Solutions The market is increasingly seeking effective, convenient treatments. Willingness to Pay Users are demonstrating a readiness to pay out of pocket for solutions that work. Challenges with Current Treatments High costs, side effects and the Opportunity for Alternative Solutions GLP-1 dropouts are primed candidates looking for more sustainable & user-friendly treatment.

injection delivery method result in significant user attrition.

Maintenance treatment with Epitomee- avoiding weight gain.

Epitomee: An Alternative for a Wider Audience

Epitomee Weight Management Capsule – Key Attributes

Epitomee 'RESET' Clinical Trial Design

Randomized Evaluation of Efficacy and Safety of the Epitomee Capsule Trial

The effect of the Epitomee Capsule on Body Weight in Patients with Overweight and Obesity, with/without Prediabetes

Comprehensive Analysis

Multi-Parametric Assessment

The pivotal trial encompasses a broad array of health metrics, examined throughout the trial: Chemistry (Serum Insulin, HOMA-IR, FPG & HBA1C, Triglycerides), Hematology, Coagulation (PT/INR), Urine Analysis

Subcategories of Interest

Detailed analysis enables identifying specific benefits within patient subgroups.

Epitomee Digital Add on Study Platform (by Setpoint health)

Physical Activity Tracker

Weight Scale Study Portal Access to patients and sites teams Study App Access

G Track My Day Edit
( >
1,030 calories consumed
980 calories remaining
3.6 Ibs lost
6.4 Ibs to go
8,829 Walking Steps
12 Exercise Minutes
7.05 Sleep Hours
X Messages
Capsule 1
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SHOAHD		 1월
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G Track My Day Edit
> >
1,030 calories consumed
101) 980 calories remaining
3.6 Ibs lost
6.4 Ibs to go
8,829 Walking Steps
12 Exercise Minutes
7.05 Sleep Hours
X Messages
Capsule 1
(1)
CHWOGHESVO		 ansulo 2
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Shaping Your Health | 17

Primary Endpoint Criteria Achieved

Co-primary Efficacy Endpoints & Success Criteria

1

2

Mean change in body weight (%) is greater, clinically & statistically, in Epitomee arm Vs control arm

Proportion of subjects who lost at least 5% of their baseline weight is greater than the threshold (35%)

Primary Safety Endpoint

Incidence of device-related serious treatment emergent adverse events (SAEs) from the randomization up to 24 weeks post-randomization

Zero Related SAEs

Previous Clinical Trial Results

Efficacy & Safety Demonstrated in Clinical Trials

7 out of 10 Completers experienced weight loss

% Total Body Weight Loss

Waistline Reduction

The entire cohort reduced ~5 cm of their waist circumference on average

Clinical Trial Data Reveals Additional Clinical Value

Prediabetic participants

experienced significant reduction

PREDIABETES IMPROVEMENT CARDIOVASCULAR RISK FACTOR REDUCTION

21 of the 35 participants

with high blood pressure reported

  • in HbA1c and/or glucose levels Systolic BP: Reduced by an average of 13mmHg
    • Diastolic BP: Reduced by an average of 10mmHg

Strategic Partnership: Nestle & Epitomee (Aug 2020)

Exclusive License

Global commercialization rights for Epitomee's weight loss product

Joint Market Development

Expand and optimize market reach and accessibility

Launch Horizon Market launch planned for 2024

Responsibilities

Nestle heads global commercialization; Joint global registration activities; Epitomee responsible for manufacturing

Financial Stability

Immediate and mid-term cash injection, with a visible, long-term revenue outlook

High Level Payment Scheme

Additional potential in Development & Sales Milestones

Advancing Manufacturing

Epitomee Advances Global Registration

Market-specific registration

Biologics Delivery Solution Overview

Transforming Biologic Delivery: A Multibillion-Dollar Opportunity Capitalizing on a \$300 Billion Market Seeking Oral Solutions

The Current Situation

  • Biologics are administered via painful injections
  • Low adherence to treatment protocols due to discomfort of the patient

The Unmet Need

• Pharma companies are actively seeking oral delivery alternatives to improve patient compliance

Epitomee's Solution

• An innovative platform for the oral delivery of biologics

Biologics Delivery Capsule

Enabling effective delivery:

Once in the small intestine, the capsule expands into a scaffold that carries a biological payload on its outer shell. The expanding scaffold affixes to the intestinal wall, maximizing payload proximity to achieve optimal absorption.

Biologics Delivery Capsule – Mechanism of Action

Achieving effective bioavailability through direct contact

exits the body

Clearing out

04

Epitomee: Improving Adherence for Millions

By achieving direct, a-traumatic contact with the intestinal wall, the delivery device ensures effective bioavailability, offering patients a non-invasive treatment method that enhances adherence.

Development Strategy: Generating Revenue Ahead of Product Commercialization

Transforming Biologic Treatments to Achieve Blockbuster Impact

Thank you

Contact Dan Hashimshony PhD, CEO [email protected]

References

More from Epitomee Medical Ltd.

Investor Presentation 2023
Nov 30
Share Issue/Capital Change 2023
Nov 30
Registration Form 2023
Sep 12
Regulatory Filings 2022
Mar 29
Regulatory Filings 2022
Feb 17
Regulatory Filings 2021
Dec 21
Regulatory Filings 2021
Dec 14
Regulatory Filings 2021
Dec 14
Regulatory Filings 2021
Dec 13
Pre-Annual General Meeting Information 2021
Nov 29
View all filings →

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