ArcticZymes Technologies — Investor Presentation 2023

Feb 2, 2023

Research & Development

Darren Ellis February 2023

ArcticZymes

Customers

Product Development

Product Placement

Innovation Cycle

Summary

ArcticZymes is well-named Cold-adaptation

The Arctic ecosystem is a vast genetic resource

Cold-active

Enzyme properties

Heat-sensitive

Salt tolerant

Unique

ArcticZymes operates B2B

Primary markets – Biomanufacturing and Molecular Tools (Dx)

Primary B2B markets – customer groups Product Family Alignment

technologies

Cell & Gene therapy (viral vectors); RNA therapeutics (mRNA vaccines); Recombinant protein production

R&D Team Organization 6 Functional Areas Programme Management ~5 FTE ~13 FTE ~4 FTE Discovery Development Post Launch Bioinformatics & Sequence Mapping Structure analysis & in-silico engineering Functional assays Core Competencies Rec. expression in E. Coli & P. pastoris Process development Formulation & stability testing. Assays & QC Technical Support Functional Assay Dev & Data Business Dev Customer relations 24 staff – 13 PhD's, international

How we develop products – ISO13485

Phases, Goals, Risks, Timelines

Combined B2B product development – pipeline Time-to-market

Product Placement – Molecular Dx

Case Study - Viral Dx qPCR workflow

Link individual enzymes into workflows → Investment Oslo Lab

Molecular Diagnostics

Building product value

Building product value through

• Complete MDx workflow with essential enzymes Reverse Transcriptase and Taq DNA Polymerase
• Customer-facing Application Data
• Link individual AZT products into complete workflow
• Significant value in formulations buffer chemistries, blockers, enhancers, protocols. Ease of use.
• Expand read-out technologies beyond qPCR
• 10 • Open to in-licensing/acquiring new technologies

Showing performance of Reverse Transcriptase RNA Virus isolated from serum

Product Placement - Biomanufacturing

Case Study – viral vector manufacturing (CGT)

Innovation Cycle

How VOC and Product Dev work together

Innovation Cycle

Case Study – Evolution of the salt-active nuclease (SAN) product family

Building out the product portfolio

Retrospective Q4 2022 – new products

❑ ArcticZymes Proteinase Glycerol Free (and Scale up ArcticZymes Proteinase) ✓

❑ AZScript (Reverse Transcriptase) ✓

❑ SAN HQ 2.0 ELISA ✓

• Very significant scale-up, lyophilization-friendly

• Critical enzyme for MDx, converts information from RNA to DNA ready for amplification technologies

• Essential companion product to SAN HQ 2.0 enzyme

Building out the product portfolio

Looking to the near future – new products 2023

*

• ❑ ArcticZymes Proteinase "bioprocessing grade"
• ❑ Taq Polymerase

• ❑ Salt Activated Nuclease - SAN "GMP grade"

• Building another pillar to our bioprocessing range

• Essential, the heart of molecular biology and MDx

• Premium SAN supported by DMF 'drug master file'

• * names of new products subject to change

• late product development – but some residual risk
• non-exhaustive listing

Building out the product portfolio

*

Looking further ahead – beyond 2023

❑ Expand Biomanufacturing capabilities

• o SAN product lifecycle management
• o Value through Quality Transitions & DMF
• o RNA therapeutics generic & novel
• o Two pillars nucleases and proteinases

❑ Expand Molecular Tools capabilities

• o Complete MDx workflow assembly
• o Push new RT and Taq ++
• o Hot Start / Formulations
• o Expand to NGS variants

Summary

Leverage Discovery Understand the Market VOC-Product Lifecycle

Novel unique products Fill in the workflow gaps Value through Quality

Drive Innovation Expand the Portfolio Support the Products

Applications Technical relationships Work with customers

Operations

Marit Sjo Lorentzen February 2023

Operations

Organisation

Facilities, Equipment and Capacity

Scalability and Future Growth

Logistics

Audits

Summary

Organisation

Personnel (15)

• Fermentation and Purification: 7.
• Filling and Shipments: 2
• Process Development: 2 3.
• Quality Control: 4.

Recruitment

Mainly University and University Hospital in Tromsø

Competence

• Highly competent personnel
• Continous internal competence building

QC department transfer to Quality Assurance during 2023

cGMP requirements.

Facilities

Fermentation, Purification and Process Development

Equipment and capacity

Fermentation and purification

Parallel lines

• Recombinant production in E. coli and P. pastoris.
• Yield: kUnits MUnits BUnits (depending on product).
• Fermentors.
• Internal and external (Contract Development Manufacturing Organisations).
• Purification systems.
• Equipment dedicated Nucleases and Proteinase.
• All downstream processes performed internally.
• Backup systems: Qualified equipment in R&D.

Capacity

• Currently at 70 %.
• Shared equipment with Process Development.
• Well equipped for the next 2 3 years.
• Possibility for growth internally.

Equipment and capacity QC and Filling

Quality Control

• Separated from fermentation and purification.
• Shared equipment with R&D.

Filling (always in Tromsø)

• Manual.
• Automated.

Scalability

Fermentation

• Up to 30 L in SIVA Innovation Centre (according to the Health Directorate).
• All products are scalable.
• rSAP and HL-SAN/SAN HQ/SAN HQ 2.0/M-SAN HQ at fermentation contractors (1 500 or 750 L).
• Paras Biopharmaceuticals for SAN HQ.
• Premises built for cGMP production.
• Aiming at cGMP certification in 2024.

Purification

All products are scalable (internally).

Future growth (fermentation)

External CDMO's

• Pros:
• No infrastructure or equipment investments.
• Cons:
• Risk of compromising products (agreements in place).
• Lack of complete control (cGMP requirements).

Build own facilities

• Pros:
• Complete control of premises, equipment and products.
• Cons:
• Lack of competence.
• Long timeframe.
• Costs \$\$\$

Buy ready to go facilities

• Pros:
• Complete control of premises, equipment and products.
• Competent personnel.
• Up and running in short time.
• Cons:

25

Costs \$\$\$?

Logistics

Standard order

• Standard products shipped from AZ's warehouses.
• Cryo Store in Joure, Netherlands, for EU and Asia.
• Percorso in Philadelphia, USA for US and Japan.
• Tromsø, primarily for Norway.

Customer reply

Within 48 hours.

Packing and shipments to warehouses

• Regularly to
• Netherlands, EU
• Philadelphia, US

Shipments to customers

Normally within one working day from external warehouses (Netherland and US).

Custom order

• Customised products and/or customised delivery methods.
• Normally from AZ's head quarter.
• Might require production of new dilution lots, quality controls and filling.

Audits

ISO 13485

• Recertification every 3 rd year (last in 2021).
• Surveillance (December 2022).
• No critical deviations.

Customer audits (mainly for Bioprocessing)

• Ten audits last two years
• ISO 13485 and relevant cGMP guidelines.
• Results
• No critical deviations.
• Continous cGMP competence.
• Continous improval of QMS.

Commercial

Dirk Hahneiser February 2023

Team

Sales Cycle

Areas for improvement in 2023

Sales by Geography 2022

Market Potential

Drug Master File (DMF)

Marketing & Sales Activities

Summary

Commercial Team

Business Development

Marketing & Customer Service

The Sales Process & Cycle

Continuously feeding the pipeline

• Working with numerous customers in various stages of the sales cycle
• Rigorous Sales Management Process
• DMF & Application Data help accelerate cycle

Key areas to improve in 2023

Commercial Excellence

• Execute price increase of 8.5% from January 1, 2023
• Execute Shipping & Handling fee structure from Oct. 1, 2022
• Utilizing analytics in Power BI
• Drive Opportunity Management leveraging CRM
• Accelerate sales cycle & improve conversion rate
• Use regulatory documentation (DMF) as competitive advantage
• Continue to build & invest into a high performing team

Demand Generation

• Laser sharp focus on generating new business with Key Accounts
• Aggressively take share in both, Biomanufacturing and Molecular Tools
• Update & leverage digital capabilities to create leads
• Attend selective trade shows to create awareness and leads
• Optimize product launch strategy and execution
• Capitalize on Asian opportunity
• Explore new, adjacent markets
• Hire additional resource for North America

Collaboration

• Closer collaboration between Market Development Managers and R&D community
• Market Development Managers key drivers in new product launch initiatives
• Product ideation and development with KOLs
• Oslo lab to improve and create content around workflows and applications

2022 Sales by Geography

Even split between North America and Europe, Asia needs more attention

Market Potential

Our partners who profit from our expertise

Biomanufacturing Focus on Cell & Gene Therapies

Market Size 2022 – 2030 13.85 - 75.6 Bil USD (CAGR 23.6% 2022-2030)

Bio-manufacturers

Manufacturers of viruses for gene therapy and vaccines, cell therapy, and bio-products.

Diagnostic Companies

Enzymes for driving assay technologies.

Molecular Tools Molecular Research & Diagnostics

Market Size 2022 – 2027 23.2 – 30.4 Bil USD (CAGR. 5.4% 2022-2027)

Marketing & Sales Investments & Activities

To support lead and demand generation

Digital Marketing

Transform web presence from informational to interactive and lead generation tool

Trade Shows

Participate at selected, most important trade shows to increase awareness and leads

Improved Analytics

Leverage Power BI and CRM tool to drive sales and pipeline/opportunity management

Sales Process & Management

Rigorous execution to drive all levers and close opportunities successfully

Drug Master File

What is it?

A drug master file (DMF) is a submission to the FDA that contains confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. It is used to provide information to the FDA about these aspects of a drug product without revealing trade secrets to the customer.

For which product do we submit?

SAN HQ

In short, the benefits of having a DMF are:

• Listen to voice of customer
• Improves AZT credibility and reputation
• Help customers streamline drug development and approval process
• Accelerate sales cycle
• Levels playing field against major competitors

Summary

Leverage Market Potential

• Grow with and take share in Molecular Tools & Biomanufacturing
• Tap into Asia (China)
• Explore new adjacent markets

Prioritize Demand Generation

• Winning with Key Accounts
• Get in early with highly innovative incubators
• Improve lead generation through digital capabilities

Accelerate Sales Cycle

• Continue to build opportunity pipeline
• Improve probability and speed of conversion
• Leverage DMF & Application Data to speed up cycle