AI assistant
Evogene Ltd. — Investor Presentation 2022
Jan 10, 2022
6785_rns_2022-01-10_36179907-793b-4d64-aa40-163b3bfc28e9.pdf
Investor Presentation
Open in viewerOpens in your device viewer
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 OF THE SECURITIES EXCHANGE ACT OF 1934
For the month of January 2022
Commission File Number: 001-36187
EVOGENE LTD.
(Translation of Registrant's Name into English)
13 Gad Feinstein Street, Park Rehovot, Rehovot P.O.B 4173, Ness Ziona, 7414002, Israel (Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____
CONTENTS
Attached hereto and incorporated by reference herein is the following exhibit:
99.1Biomica Investor Presentation.
Signature
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
EVOGENE LTD. (Registrant)
Date: January 10, 2022
By: /s/ Dorit Kreiner Dorit Kreiner Chief Financial Officer

BIOMICA
Microbiome-Empowered Therapeutics
Dr. Elran Haber, CEO . January 2022
22 BiomicaLTD' All rights reserved
Forward-looking statement

This presentation contains "forward-looking statements" relating to future events, and we may from time to time make other statements, regarding our outlook or expectations for future financial or operating results
and/or other matters regarding or affecting Evogene Ltd. or its subsidiaries, including Biomica Ltd. ("Biomica") (collectively, "Evogene" or "we"), that are considered "forward-looking statements" as defined in the U.S. Private Securities Litigation Reform Act of 1995 (the "PSLRA") and other securities laws. Such forward-looking statements may be identified by the use of such words as "believe," "expect," "anticipate," "should," "planned," "estimated," "intend" and "potential" or words of similar meaning. For these statements, Biomica claims the protection of the safe harbor for forward-looking statements contained in the PSLRA and other securities laws.

Such statements are based on current expectations, estimates, projections and assumptions, describe opinions about future events, involve certain risks and uncertainties which are difficult to predict and are not guarantees of
future performance. Therefore, actual future results, performance or achievements, and trends in the future of Biomica and Evogene may differ materially from what is expressed or implied by such forwardlooking statements due to a variety of factors, many of which are beyond Biomica's and Evogene's control, including, without limitation, those described in greater detail in Evogene's Annual Report on Form 20-F and in other information it files and furnishes with the Israel Securities Authority and the U.S. Securities and Exchange Commission, including those factors under the heading "Risk Factors."


All written and oral forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirely by the previous statements. Except for any obligations to disclose information as required by applicable
securities laws, Biomica and Evogene disclaim any obligation or commitment to update any information contained in this presentation or to publicly release the results of any revisions to any statements that may be made to reflect future events or developments or changes in expectations, estimates, projections and assumptions.

We are Biomica
An emerging biopharmaceutical company with cutting edge computational capabilities to develop the most optimized microbiome-based therapeutics.

Rooted in excellence
Subsidiary of Evogene Ltd. (NASDAQ, TASE: EVGN), a pioneer in the field of applied computational predictive biology, creating next-generation life sciences products.

Breakthrough platform
Drug candidates identified and designed with PRISM-a proprietary computational platform combining Al capabilities with big data.

Spearheading the future
Optimized discovery, design & development, resulting in best-inclass pharmaceuticals.
Precise & efficient-from concept to clinical trials in only 3 years.
Our Mission
To discover & develop novel therapies for microbiome-related human disorders.
We utilize computational predictive biology to provide new therapeutic modalities for high-value, unmet medical needs.

Showing promise in immune-mediated & infectious diseases
Current programs:

Immuno-oncology

Gastrointestinal (GI) related disorders

Antimicrobial resistance (AMR)

Right field, right time

Right field, right time
A clinical promise
comes true
The microbiome is flourishing

Limitations of common approaches
| Number of microbial entities |
QC | Scalability | Druggability | Patentability | COGS | Targeted multiple functions composition |
Potency* | Safety ** | |
|---|---|---|---|---|---|---|---|---|---|
| Fecal Microbiota Transplantation (FMT) |
1 | V | V | V | V | V | |||
| Single-strain method |
VV | VV | VV | VV | V | VV | V | VV | |
| Multi-strain rationally - designed Live biotherapeutic products (LBPs) |
V | VV | V | VV | V | VV | V |

* Higher efficacy due to multiple carefully selected MoAs ** Better safety due to fewer & carefully selected entities
VV Fully addressed V Partial addressed - Not addressed
Finding the optimal combination of microbes is complex
To develop best-in-class drugs, one must find, select, and combine only the most suitable microbes from the thousands of strains in our bodies.
Each method has its own set of challenges


Computational, targeted & function-based drug design




2
13
Holistically determining the best strains for the patient



Function based drug design process
14
An emphasis on microbial function
PRISM allows high resolution analysis to rationally design therapeutics based on microbial functions *.
This differentiates Biomica from current practices.

* Functions: Genetic elements (e.g. genes, operons, pathway, plasmids) and/or their biosynthetic products [e.g. metabolites, proteins, enzymes]
The optimal combination
Up to 4 bacterial strains are carefullyselected, based on their functions, which may work across several complementary mechanisms.

Minimum no. of microbial strains

+
Maximum relevant & complementary functions
Optimal therapeutic impact
Biomica's optimal therapeutic outcome
| Biomica's rationally - designed LBPs |
VV | VV | VV | VV | VV | VV | VV | VV | VV |
|---|---|---|---|---|---|---|---|---|---|
| Multi-strain rationally - designed LBPs |
V | VV | V | VV | V | VV | V | ||
| Single-strain method |
VV | VV | VV | VV | V | VV | V | VV | |
| Fecal Microbiota Transplantation (FMT) |
Carolla | 0.000 | V | V | V | 40000 | V | V | |
| Number of microbial entities |
QC | Scalability | Druggability | Patentability | COGS | Targeted multiple functions composition |
Potency* | Safety ** |
The pipeline
| Program | Indication / Target |
Discovery | Preclinical | Phase 1 / POC |
Phase 2 | Approach | |
|---|---|---|---|---|---|---|---|
| Immuno- oncology |
BMC128 | Combination Therapy with ICI* for Solid Tumors |
త్రి | ||||
| GI-related disorders |
BMC333 | IBD | త్రా | ||||
| BMC426 | IBS | త్రా | |||||
| Antimicrobial resistance (AMR) |
BMC202 | C. difficile Infection | 彩三 | ||||
| TBD ** | MRSA Infection | 彩三 |

* Immune checkpoint inhibitors
ു
ලිවූ Live biotherapeutics
Response to immunotherapy through specific bacterial functions

POC in humans
Modulating gut microbiome improves cancer treatment
Science
NEWS | HEALTH
Fecal transplants could help patients on cancer immunotherapy drugs
Early results hint that benefits seen in mice could extend to people
5 APR 2019 · BY JOCELYN KAISER
g.org/news/2019/04/fe
18
4 ... Now, another potential therapy is being tested
in clinical studies: fecal transplants. Early results from two groups described at the annual meeting of the American Association for Cancer Research (AACR) here this week suggest some patients who initially did not benefit from immunotherapy drugs saw their tumors stop growing or even shrink after receiving a stool sample from patients for whom the drugs worked ...
... One unresolved question is exactly which microbes help ramp up the desired immune activity ... ■
POC in humans
Modulating gut microbiome improves cancer treatment

Adler", Daniela Dick-Necula", Stephen Raskints, Naamah Bloch", Daniil Rotin", Llat Anafi", Camila Avivi", Jenny Melnichenko', Yael Steinberg-Silman', Ronac Mamtanii', Hagit Harati', Nethanel Asher', Ronnie Shapira-Frommer', Tal Brosh-Nissimove, Yael Eshet+AS), Shira Ben-Simon®, Oren Ziv0, Md Abdul Wadud Khan'4, Moran Amit14, Nadim J. Ajami14, Iris Barshack16, Jacob Schachteri4, Jennifer A. Wargo145, Omry Koren10, Gal Markel1,2,17++, Ben Boursi4,18,19+
Science
Clinical Trials
Davar et al., Science 371, 595-602 (2021) 5 February 2021
Fecal microbiota transplant overcomes resistance to anti-PD-1 therapy in melanoma patients
Diwakar Davar *, Amiran K. Dzutsev2*, John A. McCulloch2, Richard R. Rodrigues23, Joe-Marc Chauvin', Robert M. Morrison', Richelle N. Deblasio', Carmine Menna', Quanquan Ding', Ornella Pagliano2, Bochra Zidi2, Shuowen Zhang+, Jonathan H. Badger2, Marie Vetizou2, Alicia M. Cole2, Miriam R. Fernandes2, Stephanie Prescott2, Raquel G. F. Costa2, Ascharya K. Balaji2,
www.soience.org/doi/10.1126/science.abb5920
WWW.science.org/doi/10.1126/science.abf3363
Combination therapy
Initial focus on solid tumors: Lung cancer (NSCLC), renal cell carcinoma (RCC), and melanoma. Biomica aims to improve clinical response to ICI through immunomodulating combination therapy.

BMC128 administered prior to and in combination with anti-PD1 significantly improved anti-tumor activity

BMC128 demonstrating efficacy against melanoma

Advancing into the clinical phase

BMC128 consists of 4 live bacterial strains.
Results demonstrated a significant reduction of tumor volume, and increased animal survival compared to anti-PD1 therapy alone.
MoA is immune mediated - Increased tumor inflammation & infiltration of T lymphocytes and NK cells.

Potential applicability in the treatment various types of solid tumors.
CISION
13 October, 2020
Biomica Announces Initiation of Large-Scale Production of Live Bacterial Product (LBP) Candidate Consortium in its Immuno-Oncology Program
USA · English ·
The company is advancing to scale-up and GMP batch production, to support anticipated first-in-man proof-of-concept clinical trials next

Biomica completed large-scale GMP-production of BMC 128 to support its firstin-human proof of concept clinical study, expected in early 2022

GI-related disorders
IBS & IBD
Irritable bowel syndrome (IBS)*
A common intestinal functional disorder, group of symptoms: Abdominal pain, constipation or diarrhea, bloating, gas & diarrhea.

Inflammatory bowel disease (IBD)
A group of inflammatory conditions of the colon and small intestine (Crohn's disease, ulcerative colitis & pouchitis).

* In collaboration with The University of North Carolina (UNC) at Chapel Hill
Both clearly related to the microbiome
Biomica pushes the barriers posed by existing therapies by addressing the underlying cause of the disorder, rather than the symptoms.
https://www.grandviewresearch.com/industryanalysis/irritable-bowel-syndrome-ibs-treatment-market
https://www.grandviewresearch.com/industryanalysis/inflammatory-bowel-disease-ibd-treatment-market IBS (40M) IBS-D (16M) IBS-C (14M) IBS-M (9M)
IBD (3M) Crohn's disease (2M) Ulcerative colitis (IM) Pouchitis (150K)
43M
Patients
20.7 Bn
USD
IBS (\$1.5Bn)
IBD (\$19.2Bn)
GI-related disorders
Established role for microbiome in IBD etiology
A state of inflammation is associated with reduced richness of microbial taxa and functions
Gastroenterology, 2017 Feb;152(2):327-339.e4, doi: 10.1053/j.gastro.2016.10.012. Epub 2016 Oct 18.
Roles for Intestinal Bacteria, Viruses, and Fungi in Pathogenesis of Inflammatory Bowel Diseases and Therapeutic Approaches
R Balfour Sartor 1, Gary D Wu 2
Affiliations
1 Departments of Medicine. Microbiology and Immunology. University of North Carolina at Chapel Hill, Chapel Hill, North Carolina. Electronic address: [email protected].
Division of Gastroenterology, Perelman School of Medicine, the University of Pennsylvania, Philadelphia, Pennsylvania. Electronic address: [email protected].
PMID: 27769810 PMCID: PMC5511756 DOI: 10.1053/j.gastro.2016.10.012
BMC333
Optimized drug candidate derived from Biomica's drug candidates BMC321 and BMC322
Aimed to reduce inflammation for treating IBD
> Curr Treat Options Gastroenterol. 2015 Mar;13(1):105-20. doi: 10.1007/s11938-014-0042-7.
Therapeutic Manipulation of the Microbiome in IBD: Current Results and Future Approaches
Jonathan J Hansen 1, R Balfour Sartor
Affiliation
1 Department of Medicine, University of North Carolina at Chapel Hill, CB 7032, Chapel Hill, NC, 27599, USA, [email protected].
PMID: 25595930 PMCID: PMC4364996 DOI: 10.1007/s11938-014-0042-7

Drug comprised of 4 bacterial strains, detected through Biomica's proprietary computational functional genomic analysis platform.


Strains selected for their anti-inflammatory functions, complement each other and target both immunocytes and intestinal mucosal cells.

Each strain supports growth and metabolism of other strains, along with favorable gut resident bacteria.
- pubmed.ncbi.nlm.nih.gov/27769810/ 2. pubmed.nobi.nlm.nih.gov/25595930/
BMC321 & BMC322 indicate to reduce inflammation in a DSS-treated mouse model*

2
GI-related disorders
2
BMC333 reduce tissue damage due to inflammation

3
Antimicrobial resistance (AMR)
Targeting multi-drug resistant bacterium while preserving healthy gut microbiome
C. difficile infection (CDI)

Most common hospital-acquired infections (Over 600,000 a year).

Increasing cause of morbidity and mortality.

Developing a selective anti-bacterial agent designed to inhibit the C. difficile toxin.
Due mostly to hospitalization, \$5.4BN

MRSA infection
A collaboration between Biomica and the Nobel Prize Laureate Prof. Ada Yonath at the Weizmann Institute of Science.
In-licensed IP and knowhow generated by Prof. Ada Yonath.
Cause to tens of thousands of annual cases of mortality in the US.
MRSA market SS. 9BN
lobal-methicillin-resista staphylococcus-aureus-mrsa-drugs reach-over-us-39-billion-b rge-in-the-consumption-of antibiotics-across-the-globe-to-fuelh-observes-trans rice +-research-676949593.html

Upcoming advancements
Predictions for patients' response to ICI
The potential for future drugs

An experienced management team

Elran Haber, PhD, MBA CEO
Previously served as the CEO of Therapix Biosciences (Nasdaq, TASE: TRPX), leading the company to a successful IPO on Nasdag and advancing the Company's programs to clinical stage. Spent more than 10 years as Chairman and board member of several privately held, and publicly traded companies. Served in senior executive roles in various life science companies and a private investment firm. Holds a PhD in Pharmaceutical Science and an MBA in Finance & Financial Engineering both from The Hebrew University of Jerusalem, Israel.

Prof. Yehuda Ringel CSO
Chief of the Gastroenterology and Hepatology Division of the Meir Medical Center in Israel; Professor of Medicine at Chapel Hill, North Carolina and is affiliated with University of North Carolina Hospitals.
Has more than 30 years of diverse experiences, especially in Gastroenterology and translational research, and is an expert on IBS and functional motility disorders: Recipient of several prestigious awards. MD from Technion Institute of Technology, Israel.

Shiri Meshner, PhD VP of Research & Development
Previously served as the head & principal investigator of the Dead Sea microbiology lab in the Dead Sea-Arava science Center.
Spent over 5 years working in the pharma industry both in the US and in Israel | OSI pharmaceuticals and Teva pharmaceuticals). Holds a PhD in systems microbiology from the Department of Physics of Complex Systems at The Weizmann Institute.

10 years experience in corporate finance, public and private companies. Spent the last years as the CFO of a start-up company - involvement in over \$200M private fundraising. Certificated CPA - Hebrew University of Jerusalem. Ernst & Young alumnus.
Board of directors


Mr. Ofer Haviv serves as Evogene's (Nasdaq: EVGN) President and CEO since of late 2004.
Ofer Haviv
Chairman


Mr. Doron Ben Ami is a highly experienced executive with a suppessful track record
of more than 20 years of in
the Pharma industry.
Lundbeck 7 3 MSD
Kinneret Savitsky, PhD Director
Dr. Kinneret Livnat-Savitzky is the CEO and board member of FutuRx Ltd (OrbiMed, J&J Innovation and Takeda's accelerator). Kinneret has over 25 vears of experience in senior leadership positions in the biopharmaceutical industry.



World-class scientific advisory board & advisors

Prof. Yehuda Ringel
Chief Division of Gastroenterology and Hepatology at Meir Medical Center, Israel. Professor of Medicine at Chapel Hill, North Carolina and is affiliated with University of North Carolina Hospitals.

Prof. Willem M De Vos
Professor and Chair of Microbiology at Wageningen University, the Netherlands and Professor of Human Microbiomics at the University of Helsinki, Finland.

Prof. R. Balfour Sartor
Serves as the Midget Distinguished Professor of Medicine, Microbiology and Immunology and Director of the Multidisciplinary IBD Center at the University of North Carolina, Chapel Hill.


Prof. James Versalovic
Pathologist-In-Chief at Texas Children's Hospital and Director of Texas Children's Microbiome Center, Professor and Vice Chair of Pathology & Immunology at Baylor College of Medicine.

Prof. David Rubin
Section chief of gastroenterology, hepatology, and nutrition at University of Chicago Medicine. Chair-elect of the National Scientific Advisory Committee of the Crohn's and Colitis Foundation.

Dr. Ravid Straussman
Principle in vestigator of the Tumor microenvironment, tumor microbiome and resistance to anti-cancer therapy lab at the Weizmann Institute of Science, Israel.
POC first-in-human clinical trial to be initiated early 2022
A phase 1 , open-label study to evaluate the safety and tolerability of BMC128 in combination with anti-PD-1 in patients with non-small cell lung cancer (NSCLC), melanoma or renal cell carcinoma (RCC).
Q1 2022
32
is the expected start of this study, in a leading medical center in Israel.
12-15 Patients
expected to be enrolled in this phase I trial.

Safety & tolerability
of the BMC 128 and anti PD-1 combination will be investigated as primary objective.
Exploratory objectives
প্রকৃতি
are to explore efficacy variables in response to combined treatment with BMC128 and antiPD-1.
Summary

Human microbiome-based therapeutics is a rapidly growing space, and represents a multi \$Bn market opportunity.

Biomica develops innovative microbiome-based therapeutics utilizing dedicated computational predictive biology tools.

Biomica's computational tools and unique approach provide a significant differentiation.

First-in-human POC study in cancer slated early 2022.


Focus on high-value clinical programs for the development of therapies for antibiotic resistant bacteria, immunooncology and microbiome-related gastrointestinal (GI) disorders.

Experienced management team, board of directors & world-class scientific advisory board.
