Exhibit 99.3
BIOMICAMicrobiome-Empowered Therapeutics April 2021
Forward Looking Statement This presentation contains "forward-looking statements" relating to future events, and Biomica Ltd (the “Company”) and its parent, Evogene Ltd. (“Evogene”), 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 us 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. We are using forward-looking statements in this presentation when we discuss our value drivers, commercialization efforts and timing, product development and launches, estimated market sizes and milestones, as well as the capabilities of Evogene’s and our technology. 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 may differ materially from what is expressed or implied by such forward-looking statements due to a variety of factors, many of which are beyond our control, including, without limitation, those described in greater detail in Evogene's Annual Report on Form 20-F and in other information Evogene files and furnishes with the Israel Securities Authority and the U.S. Securities and Exchange Commission, including those factors under the heading “Risk Factors”. Except as required by applicable securities laws, we 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. The information contained herein does not constitute a prospectus or other offering document, nor does it constitute or form part of any invitation or offer to sell, or any solicitation of any invitation or offer to purchase or subscribe for, any securities of Evogene or the Company, nor shall the information or any part of it or the fact of its distribution form the basis of, or be relied on in connection with, any action, contract, commitment or relating thereto or to the securities of Evogene or the Company.The trademarks included herein are the property of the owners thereof and are used for reference purposes only. Such use should not be construed as an endorsement of our products or services.
PipelineEnabled by a unique computational predictive biology platform(combining ‘Big-Data’ & Artificial Intelligence technologies) Founded Israel, 2017 Subsidiary of Evogene Ltd. (NASDAQ, TASE: EVGN)A pioneer in the field of applied computational predictive biologyHolds Approx. 90% HIGHLIGHTS MissionDeveloping innovative microbiome-based therapeutics Emerging biopharmaceutical company FocusTreatment of immune-mediated and infectious diseases:Immuno-Oncology Gastrointestinal (GI) related disordersAntimicrobial resistance (AMR)
The Microbiomeand its Functions The human gastrointestinal tract comprises approximately 1014 microbes and amounts to a biomass of approximately 2kg! Trillions of microbes living in & on our bodies, acting as a “Other Genome” For every human gene there are 100 microbial genes Microbes play a critical role in food digestion, protection from diseases and production of nutrients Clinical evidence is accumulating for microbiome’s role in a wide array of illnesses Solving dysbiosis, a state of microbial imbalancein the body, is at thecore of new therapeutic approaches
Market Landscape 70% CAGR Sources: BCC Research (2017) – Human Microbiome-based Drugs and Diagnostics Market SVB – Emerging Healthcare: Microbiome Investment Trends Aug 2017)https://www.microbiometimes.com/the-microbiome-biotech-landscape-an-analysis-of-the-pharmaceutical-pipeline/ 2018 Rapid growing industry Multi $Bn Active companies Big Pharma Prominent VCs Key Drivers market opportunity > $4Bn invested in microbiome companies since 2014 2024 A record in Microbiome investment levels are set in 2017 & 2018, and growing Most candidates are still in thediscovery & preclinical stages;few are in clinical stage (Ph. II/III) Current areas of focus 44% GI related disorders 35% Cancer & Immune-mediated Diseases 8% Other 7% 6% CNS Dermatology
Biomica’s Mission and Focus Discovery and development of novel therapiesfor microbiome-related human disorders using computational predictive biology
The Challenge Microbiome space is Big-Data driven Multi-OMICS big-data & clinical meta-data needed for addressing specific biological questions How to cope with enormous amount of information? The common practice:The biological (trial and error) approach A needlein a haystack… Guessing the lottery numbers It has 2 disadvantages:
The Competitive Edge Our computational technologies enable data integration, analysis & prediction + Databases generated via data integration capabilities Proprietary computational algorithms (AI) utilized to mine data BIG DATA BIOLOGY AI – Computational Predictive Biology Developed over two decades at an investment of tens of millions of dollars and validated through collaborations with industrial leaders & internal results
Scientific Approach Dysbiosis:Reduced diversity;Loss of beneficial microbes;Opportunist’s expansion Initial State Homeostasis(balance) Desired State Supplementation of Beneficial Bacteria Intervention Proprietary platform, enables highly accurate digital representation of the human microbiome (taxonomy & functional analysis) Analysis platform Selective targeting via S. Molecules, Peptide/s Intervention Analysis platform Immuno-Oncology / GI Disorders Infections Caused by Multi-Drug Resistant Bacteria A virtual screening platform, enables to identify and design small molecular agents with specific activity towards microbes/targets
Human Genomics PRISM - Platform Capabilities StrainIdentifier FunctionFinder Strain-Function allocator Accurate digital representation of microbiome strains Comprehensive digital representation of microbiome function Clinical Data Consolidator Comparative analysistools
Biomica’s Edge Our computational platform is capable of unprecedented high-resolution microbiome analysisPioneers in the field of functional microbiome analysis, leading innovative technology Advantages of our approach Vs. others in the field:Fecal Microbiota Transplant (FMT): Collection of 10,000s entities, no QCSingle-strain method: We bring higher efficiency due to multiple MoAs Other multi-strain rationally-designed LBPs: We optimize a consortium for better efficacy with less adverse effects (due to fewer & carefully selected entities) Minimum Microbial Strains Maximum Relevant FunctionsMaximal Therapeutic Impact
Biomica’s Discovery Pipeline Live Biotherapeutics Small-molecule In the AMR Program, Biomica has a collaboration with Nobel Prize Laureate Prof. Ada Yonath at Weizmann Institute of Science to develop a selective treatment for MRSA *Immune Checkpoint Inhibitors, ** Non-small-cell lung carcinoma (NSCLC), ***Previously this program was referred to as “Multi-drug resistant organisms”
Response to Immunotherapy is ModulatedThrough Specific Bacterial Functions Responders Non- responders SCFA productionInflammationMucin turnoverInnate immunityAPC activityCD8+/CD4+ activityMethanogenesis Induction Suppression *Based on Biomica’s computational analysis
Fecal Microbiota Transplantation (FMT) and re-Induction of anti-PD-1 Therapy in Refractory Patients - POC “…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…” https://www.sciencemag.org/news/2019/04/fecal-transplants-could-help-patients-cancer-immunotherapy-drugs
Modulating gut microbiota to treat cancer
Cancer Immunotherapy - Combination TherapyInitial Focus on Lung Cancer (NSCLC) 1 Biomica aims to improve clinical response of ICI through immunomodulating combination therapy * American Cancer Society: Cancer Facts and Figures 2018. Atlanta, Ga: American Cancer Society, 2018. Non–small cell lung cancer (NSCLC) is the leading cause of cancer-related mortality worldwideCurrent solutions reach only an average of 17%-20%* overall response rate BMC121 & BMC127 Orally administered capsule, comprised of 4 bacterial strains each, detected through Biomica’s proprietary computational functional genomic analysis platformStrains were selected based on specific functional capabilities and their immuno-stimulatory potentialThe combination of 4 different microbial strains in a consortium is aimed to achieve effective immune activation through several underlying and complementary mechanisms Rationally designed consortia aimed to facilitate anti-tumor activity in combination with ICI
BMC121 & BMC127 potentiate the effect of anti-PD1 therapy in vivoMean Tumor Volume and Time To Endpoint significantly improved
Optimizing our IO consortia: BMC128 A new combination providing all microbial functions & presenting higher likelihood for survival in GI. BMC128
Immuno-Oncology program – BMC128 potentiate the effect of anti-PD1 therapy in-vivo BMC128 administered prior to and in combination with anti-PD1 significantly improved anti-tumor activity The study indicates that pre-treatment with BMC128 conditions the immune system and primes it for an efficient anti-tumor response % animals Anti-PD1 Pre-tx BMC-128 + Anti-PD1 ORR (CR+PR): 23.5% vs 34.8%48% increase in responders *BMC 128 - Consist of 4 live bacterial strains derived from BMC121 and BMC127 Sep 8th, 2020
BMC128 Demonstrating Efficacy of in Melanoma These results demonstrate the potential applicability of BMC128 and its relevance to treating multiple types of solid tumors Apr 13th, 2021 BMC128 significantly enhanced anti-tumor activity, resulting in an increased response of melanoma tumors to anti-PD1 Log [Tumor volume]
BMC128 consists of 4 live bacterial strainsResults demonstrated a significant reduction of tumor volume, and increased animal survival compared to anti-PD1 therapy aloneMOA is immune mediated- increased tumor inflammation & infiltration of T lymphocytes and NK cellsPotential applicability in the treatment various types of solid tumors Oct 13th, 2020 First-in-human, proof of concept study expected to initiate later this year
Predictor of Patients’ Response to ICI Utilizing AI and PRISM-generated high-res microbiome profiles ImmunoncologyAI-Predictor Input for model training Input Omic-Data and Clinical Info Immune checkpoint inhibitors BMC121 Responders Non-responders ANALYSIS PROCESSING DATA BMC127
GI Related Disorders IBS & IBD Approximate number of patients: 43M Crohn's disease (2M) Pouchitis (150K) Ulcerative colitis (1M) IBD (3M) IBS-M (9M) IBS-C (14M) IBS-D (16M) IBS (40M) Irritable Bowel Syndrome(IBS)*A common intestinal functional disorder, group of symptoms:Abdominal PainConstipation 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) Approximate market size (USD) IBS ($1.5Bn) IBD ($16Bn) Both clearly related to the microbiome Biomica pushes the barriers posed by existing therapiesby addressing the underlying cause of the disorder, rather than the symptoms In collaboration with The University of North Carolina (UNC) at Chapel Hill 2 *https://www.grandviewresearch.com/industry-analysis/irritable-bowel-syndrome-ibs-treatment-market** https://www.grandviewresearch.com/industry-analysis/inflammatory-bowel-disease-ibd-treatment-market#:~:text=Report%20Overview,4.4%25%20from%202018%20to%202026
A state of inflammation is associated with reduced richness of microbial taxa and functions Established Role for Microbiome in IBD Etiology BMC321 & BMC322 Orally administered capsule, comprised of 4 bacterial strains each, detected through Biomica’s proprietary computational functional genomic analysis platformStrains were selected based on their anti-inflammatory functions targeting both immunocytes and intestinal mucosal cellsThe combination of 4 different microbial strains in a consortium is aimed to effectively attenuate inflammation through several complementary mechanismsSupport growth and metabolism of other consortium members and the growth of additional favorable gut resident bacteria Rationally designed consortia aimed to reduce inflammation for the treatment of IBD Currently undergoing pre-clinical studies
BMC321 & BMC322 indicate to reduce inflammation in a DSS-treated mouse model* Severe inflammation (% of total number of mice):Control - 43% VS. BMC322- 10% Gut Inflammation level, During DSS treatment *Preliminary results
C. difficile Infection (CDI) - Landscape 3 The economic cost of CDI est. as $5.4Bn mostly due to hospitalization Desai et al. BMC Infectious Diseases (2016) 16:303; Toxins 2016, 8, 134 Pathogenicity of C. difficile is mainly mediated by two exotoxinsInfection manifestations:DiarrheaAbdominal cramping and painFeverNausea Gram-positive, anaerobic, spore-forming, toxin-producing bacillus Most common hospital-acquired infections (Over 600,000 a year) Increasing cause of morbidity and mortality (older hospitalized patients) Incidence & associated mortality progressively increasing in W.countries 15%–25% of all cases of antibiotic-associated diarrhea result from CDI Our approach is to utilize BMC202 as a non-antibiotic inhibitor of C. difficile toxin, which is responsible for the symptoms associated with CDI, while preserving healthy gut microbiomeBMC202 is a selective anti-bacterial agent designed to inhibit the glucosyl-transferase domain of the C. difficile toxin (TcdB)The drug candidate has been identified using Biomica’s in silico chemical screening platform, which enables high throughput screening of a database of ~300M molecules. BMC202
A collaboration between Biomica and theWeizmann Institute of Science Biomica develops a selective treatment against antibiotic resistant strains of Staphylococcus aureus (MRSA) infection, in a microbiome focused approach utilizing proprietary computational toolsMRSA is a multi-drug resistant bacterium, responsible for several difficult-to-treat infections, leading to tens of thousands of annual cases of mortality in the USMRSA market in 2016 was approximately $2.9Bn, projected to reach over $3.9Bn by 2025*. The company has in-licensed IP and knowhow generated by the Nobel Prize Laureate Prof. Ada Yonath, who supports Biomica’s work on this program *https://www.prnewswire.com/news-releases/global-methicillin-resistant-staphylococcus-aureus-mrsa-drugs-market-to-reach-over-us-39-billion-by-2025-upsurge-in-the-consumption-of-antibiotics-across-the-globe-to-fuel-market-growth-observes-transparency-market-research-676949593.html
The recent positive Phase 3 clinical data provide strong validation for the utilization of microbiome therapeutics and helps validate Biomica's science and clinical approach, and demonstrates the potential value proposition of Biomica
Management Previously served as the CEO of Therapix Biosciences (Nasdaq, TASE: TRPX), leading the company to a successful IPO on Nasdaq, and advancing the company's programs to clinical stageSpent more than 10 years as Chairman and board member of several privately held, and publicly traded, companiesServed 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 Dr. Elran Haber, CEO 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 HospitalsHas more than 30 years of diverse experiences, especially in Gastroenterology and translational research, and an expert on IBS and functional motility disordersRecipient of several prestigious awards MD from Technion Institute of Technology, Israel Prof. Yehuda Ringel, CSO Previously served as the head & principal investigator of the Dead Sea microbiology lab in the Dead Sea-Arava Science CenterSpent 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 Dr. Shiri Meshner, VP of R&D
Board of Directors A seasoned executive with more than 20 years of management experience in the multinational biotech industryServed as Head of the Eastern Europe and Israel region at Merck (MSD), Managing Director of MSD Israel and previously as the General Manager of Lundbeck in Israel Mr. Doron Ben Ami, Director Prof. Yehuda Ringel, Director A seasoned Biopharma executiveServes as the CEO of FutuRx Ltd., the Israeli Biotechnology accelerator established by OrbiMed, Johnson & Johnson Innovation, JJDC and Takeda Pharmaceutical Currently serves as a Chairperson and Board member at number of privatly held healthcare/pharma companiesServed as the CEO of BioLineRx Ltd. (Nasdaq: BLRX) Dr. Kinneret Savitsky, Director Serves as Evogene’s (Nasdaq: EVGN), President and CEO as of late 2004. Prior to that he held the positions of Evogene’s COO and CFO and was involved in the spin-off from CompugenServed as a Director of Finance and Treasurer at Compugen (NASDAQ: CGEN), includes two private placements and an IPO on NASDAQ Mr. Ofer Haviv, Chairman
Prof. Willem M De Vos Prof. James Versalovic Prof. R. Balfour Sartor Prof. Yehuda Ringel Prof. David Rubin Dr. Ravid Straussman Scientific Advisory Board & Advisors 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. Professor and Chair of Microbiology at Wageningen University, the Netherlands and Professor of Human Microbiomics at the University of Helsinki, Finland. 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. 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. 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. Principle investigator of the Tumor microenvironment, tumor microbiome and resistance to anti-cancer therapy lab at the Weizmann Institute of Science, Israel.
SUMMARY Human Microbiome based therapeutics is a rapidly growing space, represents a multi $Bn market opportunity Biomica develops innovative microbiome-based therapeutics utilizing a dedicated computational predictive biology toolsBiomica's computational tools have been specifically developed to allow the processing of large amounts of data to obtain high-resolution mapping of microbial profiles to deliver optimized drug candidatesFocus on high-value clinical programs for the development of therapies for antibiotic resistant bacteria, Immuno-Oncology and microbiome-related gastrointestinal (GI) disorders.Experienced Management Team, Board of Directors and world class Scientific Advisory Board
www.biomicamed.com 13 Gad Feinstein St., Park Rehovot P.O.B 2100 Rehovot 76121, Israelinfo@biomicamed.comT. +972 8 9311900/1F. +972 8 9466724