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Epitomee Medical Ltd. — Investor Presentation 2021
Nov 29, 2021
6780_rns_2021-11-29_5d025a77-70aa-4588-af9c-6d7de90e556e.pdf
Investor Presentation
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Ingestible therapeutic platform
Investor Presentation
Tel-Aviv | November 2021
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 many 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

Dr. Ruthie Amir, MD. Chief Medical & Regulatory Officer
Global VP Regulatory Syneron, Sofwave medical.

Maya Gabrieli, CPA Financial controller Plastopil Hazorea LTD, KPMG

Mission Statement
Epitomee Medical has developed ingestible technology platform that enables the creation of swallowable medical devices aimed to act along the GI tract to achieve therapeutic outcomes in highly prevalent diseases

Epitomee in a nutshell
| Our Technology Platform |
Self ingested device platform for targeted deployment and delivery of therapies along the GI tract |
|---|---|
| Disruptive technology addressing 2 Huge Markets |
Weight management market opportunity > \$200 b Biologics market opportunity > \$300 b |
| Strategic Partnership with Nestle |
Global commercialization and marketing by Nestle Deal provides immediate and mid term cash to complete the entire US Clin/Regulatory |
| Market Launch By Nestle H2/23 |
Cleared in Europe, Cleared in Israel, 510(k) FDA trial is ongoing in the US Scaling up manufacturing process development toward market launch |
| Portfolio Of 42* Patents |
30 Granted patents, 12 Pending patents |
| Strong Shareholders | Shimon Eckhouse & XT Holdings |
* Updated 18.11.21

The Epitomee platform
Device-based solutions acting along the GI tract, utilizing self-ingested, transient, shapeshifting platforms

ORAL ADMINISTRATION
Packed in a swallowable standard size capsule for easy daily use

TRANSIENT OPERATION
Set duration of interaction, followed by dissolvement and eviction through natural bowel movements

TARGETED DEPLOYMENT
Controlled activation along the stomach, duodenum and Small intestine through pH sensitive trigger mechanism

SAFE FUNCTION
Produced from approved Excipients, food additives and food contact materials Weight management device Active in the stomach.
Device for oral delivery of biologics Active in the small intestine.
Epitomee weight management capsule
Its impact is transitory as It dissolves completely and leaves the body naturally within several hours

x2 Taken twice a day, before meals
Early sensation of fullness
Resulting in a lower daily caloric intake
Subsequent weight loss
The Capsule expands in the stomach into a semi rigid scaffold creating a natural sense of fullness
15-20 Minutes

How Epitomee Works

SHAPESHIFTING 02
Expanding into a semi rigid triangular shape as a reaction to stomach's pH levels


Interacting with stomach's mechanical sensors, inducing early satiety and modified gastric emptying


After several hours in the stomach, the device disintegrates in the intestine within minutes


Mechanosensory stimulation
The applied local pressure activates key pathways involved in the regulation of food intake both in the brain and the stomach



|
The stunning rise of overweight & Obesity in the US
73% of all US adults are overweight
1 out of 3 kids

Sources: see list on page 33
Overweight = body mass index (BMI) of 25.0–29.9 kg/m2 Obesity = BMI at or above 30.0 kg/m2 Severe Obesity = BMI at or above 40.0 kg/m2

Multi billion Growing market

Sources: see list on page 33

Clinical trial data shows safety and efficacy WEIGHT-LOSS


Clinical trial data shows additional clinical value



Reasons to use the Epitomee weight management solution

The Nestle – Epitomee Strategic Deal ( Closed Aug 2020)
Exclusive global license to use the Epitomee product in the weight loss market
Agreement to develop and commercialize a novel weight loss and metabolic health product
Market launch planned for H2 2023
Deal provides immediate and mid-term cash and long-term visibility on revenue stream Nestle Health Science is responsible for commercialization Epitomee is responsible for manufacturing

The Nestle – Epitomee Deal | High Level Payments Scheme


GROWING ROYALTIES Up to 10%
Cost Plus Markup ON PRODUCT
*Up to now \$17 M of the \$64 M were paid

Business Case Example
For demonstration only. Constitutes a "forward-looking statements" as defined in the Securities Law


Example of the meaning of going to the market with Nestle
For demonstration only. Constitutes a "forward-looking statements" as defined in the Securities Law


Revenues outside Europe
Nestle Development Milestones Revenues 2022-2023 (47 m\$)
Nestle Sales Milestones Revenues (60 m\$)
Revenues from New
*US & EU5 Market

Global Regulatory

EU market, CE mark

Israel – Cleared by the ministry of health since October 2021
USA – FDA preparation for H1 2023
In preparation for H2 2023 market launch Nestle and Epitomee regulatory teams are working towards regulatory clearances in the following territories:

Epitomee 510(k) US study design Nonsignificant risk study
The effect of Epitomee Capsule on Body Weight in Patients with Overweight and Obesity with/without Prediabetes

Study Design

Sample size
Double-blind, Placebo Controlled, Randomized, Multicenter, Adaptive Design Study.

Main patient population
- Adults, BMI 27-40 kg/m2 2. Normoglycemic and Prediabetic subjects

-
Average weight loss from baselinebetter than control
-
Proportion of subjects who have lost at least 5% of their baseline weight > 35%

Competitive Landscape
| Gelesis/ Plenity (medical device) |
Novonordisk Wegovy (drug) |
Noom (mobile application) |
Allurion Ellipse (medical device) |
||
|---|---|---|---|---|---|
| consumer price range (monthly) |
\$80-\$120 | \$100 | \$1200 | \$59 | \$1,000-1,500 |
| Administration | 1 pill per meal | 3 pills per meal | By injection | Mobile app only |
Inflate at the clinic then X ray |
| Requires a Prescription | |||||
| Drug free | |||||
| Slow gastric emptying | unknown | Unknown | |||
| Self administered |

Timeline to market


Disruption of the Biologics Market with a novel oral delivery device

Most oral solution attempts involve manipulation on the drug itself – Complicated, requires new drug regulatory pathway for every application.

- Biologics delivery is typically delivered by painful and burdensome injections
- Oral administration is not possible for most biologics
Source: see on page 33
Current Future by EPITOMEE
Epitomee offers a novel approach Using an ingestible device for the delivery of biologics
|
Disruptive solution for the biologics market

With its new approach Epitomee could disrupt the biologics market
The platform allows:

Drug-device combination regulation

Saving painful injections for patients

Saving long and expensive development trials for the industry
Targeting: Cancer, Diabetes, Autoimmune~30% of all pharma. Biologics are typically delivered by injections
Sources: see list on page 33
Potential combination with multiple blockbuster biologics

Sources: see list on page 34
|

biologics Development milestones - Delivery device


Very active M&A and investment market with significant value
| Value \$0.67b |
Gelesis, valued \$0.67b, November 2021, to be listed Q4/21 Gelesis is competing with Epitomee/Nestlé with a swallowable transient device for weight management. |
|---|---|
| Value \$3.7b |
Noom, raised \$540m, at a value of 3.7b, plans to go public during 2022 Noom is a mobile app offering lifestyle advice and weight loss programs. |
| Value \$1.35b |
Novo Nordisk Acquired Emisphere Technologies for \$1.35b, November 2020. Emisphere is a drug delivery company with proprietary technologies that enable oral formulations of therapeutics. |
| Multi billions strategics |
Novo Nordisk teams with CVS Health on obesity support program ahead of Wegovy Direct to consumer launch, October 2021 |
| Value Multi billions strategics \$1.35b |
Eli Lilly compete with Novo Nordisk with a new weight loss drug named Tirzepatide, reported March 2021 |
| Multi billions strategics |
Boehringer Ingelheim Launches Weight-Loss Trials, april 2021 |
| Value \$1.3b |
Rani therapeutics, went public on Aug 2021, raised \$73m, now valued at ~\$1.3b, Nasdaq: RANI Rani is competing head-to-head with Epitomee in the field of devices for oral delivery of biologics, and in similar stage as Epitomee. |


Multiple patent families,
Updated 18.11.21

Epitomee in a nutshell
| Our Technology Platform |
Self ingested device platform for targeted deployment and delivery of therapies along the GI tract |
|---|---|
| Disruptive technology addressing 2 Huge Markets |
Weight management market opportunity > \$200 b Biologics market opportunity > \$300 b |
| Strategic Partnership with Nestle |
Global commercialization and marketing by Nestle Deal provides immediate and mid term cash to complete the entire US Clin/Regulatory |
| Market Launch By Nestle H2/23 |
Cleared in Europe, Cleared in Israel, 510(k) FDA trial is ongoing in the US Scaling up manufacturing process development toward market launch |
| Portfolio Of 42* Patents |
30 Granted patents, 12 Pending patents |
| Strong Shareholders | Shimon Eckhouse & XT Holdings |
* Updated 18.11.21


Thank you

References
Slide No. 11
- https://www.cdc.gov/nchs/data/hestat/obesity-adult-17-18/obesity-adult.htm
- https://www.childhealthdata.org/browse/survey/results?q=8029&r=1
Slide No. 12
- https://www.globenewswire.com/news-release/2020/12/17/2147220/0/en/Global-Weight-Management-Industry.html
- https://www.alliedmarketresearch.com/weight-loss-management-diet-market
- https://www.marketinsightsreports.com/reports/07163079345/global-weight-loss-and-weight-management-market-size-status-and-forecast-2021-2027
- https://www.reportsanddata.com/report-detail/obesity-treatment-market
- https://www.360researchreports.com/global-obesity-treatment-market-18329373
- https://www.marketresearch.com/GlobalInfoResearch-v4117/Global-Obesity-Treatment-Company-Regions-14363795/
Slide No. 25
• https://www.statista.com/statistics/1118421/biologic-medicines-share-of-total-pharmaceutical-sales-in-oecd-countries/
Slide No. 26
- https://www.prnewswire.com/news-releases/global-biologics-market-opportunities-and-strategies-report-2020-covid-19-impact-and-recovery---forecast-to-2023-2025--2030- 301223015.html
- https://www.globenewswire.com/news-release/2020/04/03/2011472/0/en/Global-Biologics-Market-to-surpass-US-456-83-8-Billion-by-2027-Says-CMI.html
- https://www.verifiedmarketresearch.com/product/biologics-market/
- https://www.coherentmarketinsights.com/market-insight/oral-biologics-market-989
- https://marketresearch.biz/report/oral-biologics-market/
- https://manometcurrent.com/exclusive-report-on-oral-biologics-market-analysis-report-2021-and-forecast-to-2029-with-different-segments-key-players/
References
Slide No. 27
- https://www.grandviewresearch.com/industry-analysis/glp-1-receptor-agonist-market
- https://www.businesswire.com/news/home/20210325005642/en/Global-TNF-Alpha-Inhibitors-Market-Report-2020-2030-COVID-19-Growth-and-Change---Market-is-Expectedto-Decline-from-40.66-Billion-in-2019-to-39.01-Billion-in-2020---ResearchAndMarkets.com
- Basal Insulin (Long-Acting Insulin) Market Projections to 2024 with Company Profiles & Share Analysis ResearchAndMarkets.com | Business Wire
- Human Growth Hormone (HGH) Market | 2021 26 | Industry Share, Size, Growth Mordor Intelligence
- Global Parathyroid Hormone Market Data And Industry Growth Analysis (thebusinessresearchcompany.com)
- Interferon Beta Drugs Market Size, Trends, Shares, Insights, Forecast Coherent Market Insights
