AquAdvantage Salmon Innovation in Aquaculture. R.L. Stotish President & CEO AquaBounty Technologies

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Bruce Blankenship
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1 AquAdvantage Salmon Innovation in Aquaculture R.L. Stotish President & CEO AquaBounty Technologies

2 FARMED ATLANTIC SALMON Global salmon production worth $10 billion Combined the world s salmon farmers produce 2.1 million metric tons of salmon, from just percent of the world s oceans, says new report. IntraFish Media ISFA Report 2015

4 US SALMON IMPORTS 2015 U.S. Atlantic salmon imports, value by selected sources (1,000 U.S. dollars) Product, country code and name Jan-Feb 14 Jan-Feb Chile 771, , , , ,492 1,080,485 1,332, , , Canada 448, , , , , , ,304 61,783 73, Norway 54, , , , , , ,531 39,216 57, United Kingdom 66, , , ,566 88, , ,504 23,513 14, Faroe Islands 14,588 58,588 66,781 97,208 67, , ,219 23,435 8, China (Mainland) 29,394 32,142 32,249 27,629 40,902 58,016 54,409 18,427 3, Denmark 694 6,328 13,146 4, ,415 15,367 4, Other countries 8,533 19,704 26,356 13,213 19,537 19,287 44,806 3,942 10,428 Total 1,393,750 1,385,884 1,438,931 1,520,211 1,606,088 2,075,400 2,356, , ,738 57% 15% 12% Date run: 4/3/ :56:37 AM U.S. Atlantic salmon imports, volume by selected sources (1,000 pounds) Product, country code and name Jan-Feb 14 Jan-Feb Chile 212, ,229 61, , , , ,004 45,620 47, Canada 166, , , , , , ,399 15,087 24, Norway 14,402 60,213 80,643 41,557 31,782 40,591 57,657 7,389 13, United Kingdom 23,376 37,253 34,312 34,970 29,727 27,594 34,060 5,424 3, Faroe Islands 6,540 23,117 20,886 32,926 25,981 33,127 35,606 5,598 2, China (Mainland) 13,530 14,290 14,447 9,631 12,379 17,785 17,046 5,961 1, Denmark 173 1,458 3, ,358 2, Other countries 1,994 4,475 5,366 2,649 4,765 4,387 8, ,261 Total 439, , , , , , ,144 86,676 94,912 52% 19% 11% Date run: 4/3/ :56:31 AM

5 DANISH SALMON DENMARK 2,000 TONS 5

6 AquAdvantage Salmon

7 Weight (g) Gains in Growth Smolts (AAS vs. Nontransgenics) Growth Curves (smolts) 600 AAS Standard AquAdvantage salmon Standard salmon Days (from first feeding)

AquAdvantage Salmon Regulatory sequences from ocean pout AFP gene & coding domain from chinook salmon GH-1 cdna 1989 1992 Microinject P 1 // Promoter ATG GH cdna TAG Terminator // 1994 F 1 TATA

8 AquAdvantage Salmon Regulatory sequences from ocean pout AFP gene & coding domain from chinook salmon GH-1 cdna Microinject P 1 // Promoter ATG GH cdna TAG Terminator // 1994 F 1 TATA AATAA 1996 F F 3 Transgene DNA Microinjection Transgenic Founder F 4 F 5 Milt 2004 F 6 Fertilized Microinjected Eggs Selection Non-transgenic Progeny F 7 F F 12 8

COMMERCIAL PRODUCTION OPERATIONS Production of Triploid, Monosex, Eyed-AAS Eggs ApprovedGrow-Out Harvest Diploid Triploid AAS Broodstock nm XX XX XX XXX XXX Homozygous AquAdvantage

9 COMMERCIAL PRODUCTION OPERATIONS Production of Triploid, Monosex, Eyed-AAS Eggs ApprovedGrow-Out Harvest Diploid Triploid AAS Broodstock nm XX XX XX XXX XXX Homozygous AquAdvantage NeoMale XX XX XXX XXX Sale Confirm Genotype F XX Non-Transgenic Salmon Female PCR Milt Fertilize Induce Triploid y Confirm Triploidy FACS Non-Transgenic Broodstock Processed Salmon 9

10 Post-Approval Approval Environmental Assessment Claims Food Safety Durability Phenotype Integrated Transgene Plasmid Transgene Product Definition

11 FDA FINDINGS RELEVANT TO COMPOSITION AAS meet the standard of identity for Atlantic salmon established by FDA s Reference Fish Encyclopedia No biologically relevant differences were detected in the levels of the gene product, or any endogenous metabolite or substance found in physiological pathways that could be impacted by that hormone AAS contained the expected amounts of nutritionally important omega-3 and omega-6 fatty acids at the appropriate ratio for a fish source No biologically relevant differences were found in the allergenicity of edible products Found no biologically relevant difference between food from AAS and conventional Atlantic salmon Food from AquAdvantage Salmon is as safe to eat as food from other Atlantic salmon tm VMAC Briefing Packet September 20, 2010

12 Phenotypic Characterization VMAC Briefing Packet AquAdvantage Salmon - Page 24 Phenotypic Characterization c. General Observations ABT conducted a controlled, blinded animal safety study at their PEI facility, which examined the effect of the integrated AquAdvantage construct on the health of the GE animals. The study was a careful and well-controlled assessment of the health of the fish and the following sections focus primarily on the information provided in this study. The general health and behavior of all of the fish was assessed by facility personnel and independent veterinary professionals specializing in aquatic species. The study fish were observed at the PEI facility at four separate time points following pre-enrollment qualification of the fish from each study group. Assessments were made for feeding activity, behavior, posture, and position in the water column, coloration, observation of any external lesions, morbidity, mortality, and any other abnormal clinical signs. No health abnormalities were observed and the fish were regarded as in good health and of normal behavior. Conclusion: AquAdvantage Salmon show no general health or behavioral abnormalities relative to comparator fish.

13 Environmental Assessment In sum, the evidence collected and independently evaluated by CVM shows that the creation, production, grow-out and human consumption of AquAdvantage Salmon under the conditions proposed in the Sponsor s NADA and described in this EA will not result in significant adverse effects on the environment. Environmental Assessment for AquAdvantage Salmon New Animal Drug Application Submitted by AquaBounty Technologies, Inc.

14 Evolutionary Applications ISSN (2011) ORIGINAL ARTICLE Reproductive performance of alternative male phenotypes of growth hormone transgenic Atlantic salmon (Salmo salar) Darek T. R. Moreau,1 Corinne Conway2 and Ian A. Fleming1 1 Ocean Sciences Centre, Cognitive and Behavioural Ecology, Memorial University of Newfoundland, St John s, Newfoundland, Canada 2 Ocean Sciences Centre, Memorial University of Newfoundland, St John s, Newfoundland, Canada Transgenic salmon exhibit reduced breeding efficiency (>10X) when compared to anadromous wild type salmon in an artificial mesocosm

16 DAILY FEED INTAKE OF TG SALMON WAS 3 FOLD HIGHER THAN NTG REGARDLESS OF PLOIDY AND DIET Ganga et al, 2015

17 TGC OF TG SALMON WAS 3 FOLD HIGHER THAN NTG REGARDLESS OF PLOIDY AND DIET Ganga et al, 2015

18 FCR (g DM feed/g wet weight gain) FCR WAS SIGNIFICANTLY LOWER (20%) IN TG THAN NTG REGARDLESS OF PLOIDY&DIET 1.2 2N FM 2N PP 3N FM 3N PP 1 bc b c 0.99 b 0.8 a a a TG NTG Ganga et al 2015

19 NRE (%) Higher Protein Retention Efficiencies in TG vs NTG c b c bc bc TG bc NTG bc 40 a FM PP FM PP DIP TRIP Ganga et al, 2015

20 LRE (%) Higher Lipid Retention Efficiencies in TG vs NTG 90 TG NTG d d c c c bc 60 b 50 a FM PP FM PP DIP TRIP Ganga et al, 2015

AquAdvantage Salmon could reduce both the carbon footprint and cost of transportation Oslo Miami New York AquAdvantage Salmon Series 1, A, 0.05 Norwegian Salmon Series 1, N, 1.

22 AquAdvantage Salmon could reduce both the carbon footprint and cost of transportation Oslo Miami New York AquAdvantage Salmon Series 1, A, 0.05 Norwegian Salmon Series 1, N, 1.13 Chilean Salmon Series 1, C, 1.24 Santiago Carbon emissions (CO 2 -equivalent) per lb salmon transported* *Calculation based on transporting salmon by truck and air freight from point to point at representative loading capacities, fuel efficiencies and distances. Salmon are transported approximately an average of 300 miles to Oslo for air freight to New York and 640 miles to Santiago for air freight to Miami. 1 nautical mile (NM) = 1.15 miles.

23 Sea Cages Non-Exclusive Alternatives AAS - RAS Wild Caught Lower Capital Cost Regions with suitable coastline Exposure to pathogens Escape of fish Predators, jellyfish, hazardous algal blooms Use of medications, chemicals Ecology of coastal waterways Biosecurity issues, vandalism Extreme weather events Exposed working conditions Operation (wellboats, etc.) Transportation Improved FCR/N2 retention Greater biosecurity, zero escapes Reduced/eliminated meds/chems Siting close to consumers Reduced transportation Zero impact on biodiversity Reduced environmental impact & carbon footprint Safe working conditions for employees Higher Capital cost Energy cost Management Marketing Distribution Capacity Stock Enhancement Ranching

24 Applications of Molecular Biology for Aquaculture Improve genetics Disease diagnosis, prevention and treatment Control of sex and fertility Improvement of growth, composition, and performance Traceability

25 It s really about food. NADA

Environmental Assessment for AquAdvantage Salmon

Environmental Assessment for AquAdvantage Salmon An Atlantic salmon (Salmo salar L.) bearing a single copy of the stably integrated α-form of the opafp-ghc2 gene construct at the α-locus in the EO-1α line