Leveraging Genomics for Completely New Modes of Action with More Targeted Pest Control

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1 Pipeline Leveraging Genomics for Completely New Modes of Action with More Targeted Pest Control uses RNAi: A natural mechanism to control the expression of a gene BIODIRECT: R&D DEVELOPMENT PIPELINE DISCOVER Y: INITIAL SCREENING Sequence genome related to product concept, identify key sequence and selection of lead actives SELECTION OF LEAD ACTIVES PHASE 1: PROOF OF CONCEPT Define prototype formulation and test for desired performance Glyphosate Resistant Weed Control Virus Control - Tospovirus Insect Control Canola Flea Beetle Arrows reflect phase advancement PHASE 2: EARLY DEVELOPMENT Finalize formulation and field testing to confirm performance consistency Insect Control Colorado Potato Beetle Technology - Bee Health PHASE 3: ADVANCED DEVELOPMENT Data generation for regulatory submissions and commercial preparation PATH TO MARKET PHASE 4: PRE- LAUNCH Final regulatory approvals and manufactu ring scale up for commercia l launch HIGHLIGHTS: PIPELINE FOCUS: Drive for the most valuable product concepts Continue to drive efficacy and delivery efforts to unlock the broader portfolio opportunity Continue focused effort on unlocking plant and insect responses more broadly PROJECT UPDATE: Bee Health advancing to Phase 2, expected to be first product to launch commercially from the Pipeline Canola Flea Beetle advancing to Phase 1, targets the #1 pest in canola, estimated annual damages in North America >$300M 1 1

2 # of MITES/100 BEES Technology Bee Health Research Significant Improvements in Bee Hive Survival Achieved With New Biologicals PROJECT: Technology - Bee Health STATUS: ADVANCEMENT Phase 2 PROJECT HIGHLIGHTS: KEY REGIONS: GLOBAL MARKET OPPORTUNITY Bees play a vital role in agriculture as pollinators Varroa mites infestation is the greatest threat to bee health and most significant contributor to hive collapse New technology targeting Varroa is expected to replace non-selective miticides Next Steps: Expanded Varroa control field testing and field validation of antiviral technology Expected to be first product to launch from the platform MONSANTO VARROA CONTROL TESTING 2015 REHOVOT, ISRAEL (In Progress) Reduced Varroa populations demonstrated in the field by targeting Varroa mites Automated image analysis to assess hive strength Bee infested with Varroa # OF WEEKS BIODIRECT NON-TREATED Selective Varroa Suppression: At week 11, varroa mite count reduced by more than 1.8X with treatment vs untreated hives 2

3 Technology Treated % INSECT VIABILITY Untreated Technology Canola Flea Beetle (CFB) Research Alternative Solution to Neonic Application, Additionally Would Offer Growers an Enhanced Solution to Control Striped Flea Beetles PROJECT: CFB STATUS: ADVANCEMENT Phase 1 PROJECT HIGHLIGHTS: KEY REGIONS: U.S.,CANADA & EUROPE Flea beetles are highly destructive defoliators of canola causing significant economic yield loss Field trials with technology at multiple locations in the U.S. and Canada demonstrate reduction in flea beetle damage on canola Provides alternative solution to neonics and additionally provides enhanced control against striped flea beetles Continue field trial testing for efficacy 2015 MONSANTO FIELD TRIALS JULY 2015 PORTAGE LA PRAIRIE, MANITOBA, CANADA BIODIRECT TECHNOLOGY PROVIDES SIGNIFICANT CONTROL: 12 DAYS POST INFESTATION, INSECT VIABILITY ~20% AS DEMONSTRATED IN LAB RESULTS DAYS POST INFESTATION BIODIRECT TECHNOLOGY NON SPECIFIC TRIGGER 3

4 Regulatory Risk Assessment of RNA is Not New ILSI-CERA Conference Proceedings (EPA, USDA, Academics and Industry): In all of the cases discussed, it was determined that the testing approaches and protocols that have been used to assess currently approved genetically engineered crops can also be used to adequately assess RNAi-engineered crops This information is relevant to phenotype, regardless of the modification method used to develop the genetically engineered plant. 4

5 Regulatory Risk Assessment of RNA is Not New USA EPA has recently evaluated RNA-based insect control (MON 87411) In conclusion, there is a reasonable certainty that no harm will result from aggregate exposure to the U.S. population, including infants and children, to the dsrna transcript This includes all anticipated dietary exposures and all other exposures for which there is reliable information. The potential for off-target and other unintended effects, which were discussed as an uncertainty by the SAP, appears to be unlikely based on the data and other information provided. Results from the soil degradation study indicate that DvSnf7 _968 degraded within approximately 2 days after application to soil, regardless of texture, ph, clay content and other soil differences, as measured by molecular analysis (QuantiGene) and by insecticidal activity (bioassay). 5

6 Key Regulatory Considerations FAMILIARITY: RNA-based suppression is based on natural mechanisms, and has been used in crop protection, biotechnology as a longstanding approach to achieve gene regulation SAFETY: RNA has a history of safe consumption, presence in the environment. SPECIFICITY: RNA offers highly-specific gene suppression that greatly reduces potential impact on non-target organisms NO NEW RISK ASSESSMENT PARADIGM NEEDED The current safety assessment strategy for biotech RNA-based products is based on the same safety assessment paradigm as other (bio)technologyderived crops that have been reviewed and approved globally General principal applies to Existing regulatory paradigm is adequate 6