EX-99.1 2 exhibit_99-1.htm EXHIBIT 99.1

Exhibit 99.1


     Microbiome-Empowered Therapeutics                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            © 2022 Biomica LTD. All rights reserved.  Dr. Elran Haber, CEO  January 2022                     
 

  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 forward-looking 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.”    Forward-looking statement   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.    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 any other entity, 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. The trademarks included herein are the property of the ownersthereof and are used for reference purposes only. Such use should not be construed as an endorsement of the products or services of Evogene.  
 

 An emerging biopharmaceutical company with cutting edge computational capabilities to develop the most optimized microbiome-based therapeutics.  Rooted in excellence  We are Biomica    Drug candidates identified and designed with PRISM – a proprietary computational platform combining AI capabilities with big data.  Optimized discovery, design & development, resulting in best-in-class pharmaceuticals.Precise & efficient – from concept to clinical trials in only 3 years.  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  Spearheading the future   
 

 Our Mission  Current programs:  Gastrointestinal (GI) related disorders  Antimicrobial resistance (AMR)  Showing promise in immune-mediated & infectious diseases  Immuno-oncology  To discover & develop novel therapies formicrobiome-related human disorders. We utilize computational predictive biology to provide new therapeutic modalities for high-value, unmet medical needs. 
 

 10  14  microbesin thehuman body  Trillions of microorganisms live in & on our bodiesPlay an essential role in various daily bodily functionsMicrobiome diversity is associated with health & wellbeing  Harnessing the human microbiome 
 

 Right field, right time  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/   Industry  Big pharma  Most candidates are still in the discovery & preclinical stages; Increasing number advancing to clinical stage (Ph. II/III)  Areas of focus  Multi $Bn market opportunityMore than $4Bn invested in microbiome companies since 2014 Record high investmentsIn microbiome companies  Prominent VCs  Active companies  Dermatology (8%)CNS (7%)Other (6%)GI-related disorders (44%)Cancer & Immune-mediated Diseases (35%)            Key Players  6%  7%  8%  35%  44%  70%  CAGR  2024  2018 
 

 The microbiomeis flourishing  Right field, right time  A clinical promisecomes true  Positive phase 3 clinical data shows strong validation of microbiome therapeutics.  Aug 10, 2020  June 19, 2020  11 September 2020  17 June, 2021  26 January, 2021  2 July, 2021  30 November, 2020 
 

 Fecal Microbiota Transplantation (FMT)                    Single-strain method                    Multi-strain rationally-designed Live biotherapeutic products (LBPs)                                  ** Better safety due to fewer & carefully selected entities  * Higher efficacy due to multiple carefully selected MoAs   Limitations of common approaches                          Number of microbial entities  QC  Scalability  Druggability  Patentability  COGS  Targeted multiple functions composition  Potency*  Safety**   Fully addressed Partial addressed Not addressed       
 

 Finding the optimal combinationof microbes is complex  To develop best-in-class drugs, one must find, select, and combineonly the most suitable microbes from the thousands of strains in our bodies.  Each method has its own set of challenges  Biological method:Healing the sick by comparing them to the healthy  Computational method:Using AI to findthe key microbes  Slow & exhaustingLimited by small data Like finding needle in the hay  Lack of proper tools & datasetsPoor ability to gain valuable insights 
 

       Computational, targeted& function-based drug design  Modulatinga patient’s microbiome  Computational predictive biology platform  Function-baseddrug design process  The approach:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              2  1  3 
 

   Modulatinga patient’s microbiome    1      Immuno-oncology or GI disorders  Infections caused by multi-drug resistant bacteria  Reduced diversityLoss of beneficial microbesOpportunist’s expansion  EliminationSelective targeting via small molecules, peptide(s)  SupplementationAdding beneficial bacteria                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Initial state:Dysbiosis  Desired state:Homeostasis(balance) 
 

     Computational predictive biology platform  Proprietary computational algorithms utilized to mine data  Big data  $$$tens of millions of dollars invested  Validationthrough collaborations with industrial leaders & internal results  Proven, robust data integration, analysis & prediction  Databases generated via data integration capabilities  Biology  AI      2    20 yearsof experience 
 

     Analysis, integration&prioritization      Computational & researcher-guided selection of candidate microbes    Computational predictive biology platform  2    Patients’ microbiome:Identifies the strains present & the functions they perform  Strain identifierFunction finderStrain-functionallocator  Patients’ genetic & clinical data:Examining the patient’s clinical data & genomic data  Clinical dataHuman genomicsConsolidator    Drug      Holistically determining the best strains for the patient                                                               
 

     Function based drug design process  3    An emphasis on microbial function  The optimal combination  PRISM allows high resolution analysis to rationally design therapeutics based on microbial functions*.This differentiates Biomica from current practices.  Up to 4 bacterial strains are carefully-selected, based on their functions, which may work across several complementary mechanisms.  *  Functions:Genetic elements (e.g. genes, operons, pathway, plasmids) and/or their biosynthetic products (e.g. metabolites, proteins, enzymes)  Current practices  Biomica  Name: DX13756Functional profile:Fully mappedContribution to functions of interest 9/10Modes of actions affected: 5/5Overall score: 9.75  Name: DX13756Functional profile:Fully mappedContribution to functions of interest 9/10Modes of actions affected: 5/5Overall score:                  Minimum no. of microbial strainsMaximumrelevant & complementary functionsOptimal therapeutic impact                         
 

    Fully addressed Partial addressed Not addressed     Fully addressed Partial addressed Not addressed    Fecal Microbiota Transplantation (FMT)                    Single-strain method                    Multi-strain rationally-designed LBPs                    Biomica’s rationally-designed LBPs                    ** Better safety due to fewer & carefully selected entities  * Higher efficacy due to multiple carefully selected MoAs   Biomica’s optimal therapeutic outcome                          Number of microbial entities  QC  Scalability  Druggability  Patentability  COGS  Targeted multiple functions composition  Potency*  Safety**                   
 

                   Immuno-oncology  BMC128  Combination Therapywith ICI* for Solid Tumors            GI-related disorders  BMC333  IBD              BMC426  IBS            Antimicrobial resistance (AMR(  BMC202  C. difficile Infection               TBD**  MRSA Infection             * Immune checkpoint inhibitors **Biomica in collaboration with Nobel Prize Laureate Prof. Ada Yonath at Weizmann Institute of Science to develop a selective treatment for MRSA infection.  The pipeline    Live biotherapeutics Small-molecule        Program  Indication / Target  Discovery  Preclinical  Phase 1 /POC  Phase 2  Approach           
 

 Cancer immunotherapy  1  Response to immunotherapy through specific bacterial functions   * Based on Biomica’s computational analysis  Responders  Non-responders  SCFA productionInflammation Mucin turnover Innate immunity APC activityCD8+/CD4+ activityMethanogenesis      Induction  Suppression 
 

       POC in humans  1  Modulating gut microbiome improves cancer treatment  www.sciencemag.org/news/2019/04/fecal-transplants-could-help-patients-cancer-immunotherapy-drugs    Cancer immunotherapy  …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…  “  “ 
 

 www.science.org/doi/10.1126/science.abf3363  POC in humans  1  Modulating gut microbiome improves cancer treatment  www.science.org/doi/10.1126/science.abb5920  Cancer immunotherapy  Reports  Clinical Trials 
 

   1  Cancer immunotherapy  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.  Next gen. optimized consortiaA new combination providing the selected microbial functions& presenting higher likelihood for survival in GI.    Consortium  Micro-organism  Microbial component / function          Host response          Interactions with other micro-organisms        Cell envelope component  SCFA production  Lactate production  Flagella  Mucin degradation  Dendritic cell activation and TH1 response  CD4/8 activation  NF-k8 activation  TLR activation  Gut health  Consortium members  General gut residents  BMC127  BMCS111                            BMCS114                            BMCS115                            BMCS117                            Consortium  Micro-organism  Microbial component / function          Host response            Interactions with other micro-organisms        Cell envelope component  SCFA production  Lactate production  Flagella  Mucin degradation  Dendritic cell activation and TH1 response  CD4/8 activation  NF-k8 activation  TLR activation  TNFa  Gut health  Consortium members  General gut residents  BMC121  BMCS111                              BMCS114                              BMCS115                              BMCS117                                BMC128 
 

   1  Cancer immunotherapy  Control  The study indicates that pre-treatment with BMC128 conditions the immune system & primes it for an efficient anti-tumor response.  BMC128 administered prior to and in combination with anti-PD1  significantly improved anti-tumor activity   * BMC 128 - Comprised of 4 live bacterial strains derived from BMC121 and BMC127    8 September, 2020  Anti-PD1  BMC-128+ Anti-PD1  Pre-tx BMC-128 + Anti-PD1  100%  0%  50%  Sacrificed during the studySurvived the study      Pre-tx BMC-128 + Anti-PD1  Anti-PD1  100%  0%  50%  PDSD      CRPR      ORR (CR+PR): 23.5% vs 34.8%   48% increase in responders  Recist  Survival Rate 
 

   1  Cancer immunotherapy  These results demonstrate the potential applicability of BMC128 and its relevance to treating multiple types of solid tumors.  BMC128 demonstrating  efficacy against melanoma    13 April, 2021  BMC-128 + Anti-PD1  Control (untreated)  100%  0%  50%  PDSD      CRPR      Recist  Anti-PD1  BMC128 significantly enhanced anti-tumor activity, resulting in an increased response of melanoma tumors to anti-PD1  3  0  2  1  Tumor volume  Day (post tumor inoculation)  Control (untreated)Anti-PD1BMC128 + Anti-PD1        BMC128 demonstrates increased Objective Response Rate (ORR)No response in the Anti-PD1 group        ***  ***  * 
 

   1  Cancer immunotherapy  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.    13 October, 2020  Biomica completed large-scale GMP-production of BMC128 to support its first-in-human proof of concept clinical study, expected in early 2022 
 

   GI-related disorders  2  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).  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.    PatientsEst.  43M  IBS (40M)IBS-D (16M)IBS-C (14M)IBS-M (9M)  IBD (3M)Crohn's disease (2M)Ulcerative colitis (1M)Pouchitis (150K)  IBS ($1.5Bn)  IBD ($19.2Bn)    20.7Bn  USD  https://www.grandviewresearch.com/industry-analysis/irritable-bowel-syndrome-ibs-treatment-market  https://www.grandviewresearch.com/industry-analysis/inflammatory-bowel-disease-ibd-treatment-market  *In collaboration with The University of North Carolina (UNC) at Chapel Hill 
 

   2  GI-related disorders  Established role for microbiome in IBD etiology  Drug comprised of 4 bacterial strains, detected through Biomica’s proprietary computational functional genomic analysis platform.  A state of inflammation is associated with reduced richness of microbial taxa and functions  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.  BMC333  Aimed to reduce inflammation for treating IBD      pubmed.ncbi.nlm.nih.gov/27769810/pubmed.ncbi.nlm.nih.gov/25595930/  Optimized drug candidate derived from Biomica’s drug candidates BMC321 and BMC322 
 

 2  GI-related disorders  reduce inflammation in a DSS-treated mouse model*  BMC321 & BMC322 indicate to  Severe inflammation (% of total number of mice): Control - 43% VS. BMC322- 10%  DSS only  100%  0%  50%  SevereMild-moderate      Inflammation statusDay 7 of DSS treatment  DSS + BMC322  3000  0  2000  1000  Lipocalin (ng/g stool)  Days  UntreatedDSS only      DSS + BMC321DSS + BMC322      1  4  6  7  Gut inflammation level During DSS treatment  %mice  * Preliminary results  Days  7  14  21  0          AB  DSS  END                C57bl/6J(SPF)  BMC321 / BMC322; 3XW dosing   
 

 2  GI-related disorders  BMC333 reduce tissue damage due to inflammation  Study design for testing the anti-inflammatory effect of BMC333 in DSS-induced colitis murine model.  Disease severity along study evaluated by Disease Activity Index (DAI) combined score following DSS administration in BMC333-treated and untreated groups.  Mean histological score  2  0  1.5  0.5  1  2  0  1.5  0.5  1  8  0  6  2  4  Erosions  Crypt_loss  Sum_Score  Histological evaluation from H&E staining of mice colon sections after DSS administration in BMC333-treated and untreated groups.  WT mice (SPF)  8  14  15  1          End  BMC3333XW  DSS2%  control (naïve)    DSS only      BMC333  Combined score  control (naïve)    DSS only      1  6  11  15  4  8  13  10  0  7.5  5  2.5  BMC333  BMC333x3/wk  DSS2%  p-value (day 15) <0.05    ***  ***  **        * 
 

   Antimicrobial resistance (AMR)  3  Targeting multi-drug resistant bacterium while preserving healthy gut microbiome  C. difficile infection (CDI)  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  MRSA infection  $3.9Bn  MRSA market in 2025 (est.)  $5.4Bn  Due mostly to hospitalization, the economic cost of CDI (est.)  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.  * Desai et al. BMC Infectious Diseases (2016) 16:303; Toxins 2016, 8, 134  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.  * 
 

 Upcoming advancements  The potential for future drugs  Predictions for patients’ response to ICI    Responder          Non-responder  Responder  Responder  Responder      Non-responder 
 

 Elran Haber, PhD, MBACEOPreviously 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 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.  An experienced management team  Prof. Yehuda RingelCSOChief 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, PhDVP of Research & DevelopmentPreviously 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.  Eyal PartukVP Finance10 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  Ofer HavivChairmanMr. Ofer Haviv serves as Evogene’s (Nasdaq: EVGN) President and CEO since of late 2004.  Doron Ben AmiDirectorMr. Doron Ben Ami is a highly experienced executive with a successful track record of more than 20 years of in the Pharma industry.  Kinneret Savitsky, PhDDirectorDr. Kinneret Livnat-Savitzky is the CEO and board member of FutuRx Ltd (OrbiMed, J&J Innovation and Takeda’s accelerator), Kinneret has over 25 years of experience in senior leadership positions in the biopharmaceutical industry. 
 

 Prof. Yehuda RingelChief 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 VosProfessor and Chair of Microbiology at Wageningen University, the Netherlands and Professor of Human Microbiomics at the University of Helsinki, Finland.  Prof. R. Balfour SartorServes 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 VersalovicPathologist-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 RubinSection 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 StraussmanPrinciple investigator of the Tumor microenvironment, tumor microbiome and resistance to anti-cancer therapy lab at the Weizmann Institute of Science, Israel.  World-class scientific advisory board & advisors 
 

 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).  are to explore efficacy variables in response to combined treatment with BMC128 and anti PD-1.  Exploratory objectives  POC first-in-human clinical trial to be initiated early 2022  expected to be enrolled in this phase I trial.  12-15 Patients   of the BMC128 and anti PD-1 combination will be investigated as primary objective.  Safety & tolerability  is the expected start of this study, in a leading medical center in Israel.  Q1 2022  
 

 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, immuno-oncology and microbiome-related gastrointestinal (GI) disorders.  Experienced management team, board of directors& world-class scientific advisory board.  Summary 
 

 Thank you!                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            info@biomica.com