Asymptote ATMP Meeting 2019. 3. 27.¢  ATMP Meeting 9. Confidential. Not to be copied,...

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Transcript of Asymptote ATMP Meeting 2019. 3. 27.¢  ATMP Meeting 9. Confidential. Not to be copied,...

  • Confidential. Not to be copied, reproduced, or distributed without prior approval.

    CAUTION CONCERNING FORWARD-LOOKING STATEMENTS: This document contains "forward-looking statements" – that is, statements related to future events that by their nature address matters that are, to different degrees, uncertain. For details on the uncertainties that may cause our actual future results to be materially different than those expressed in our forward-looking statements, see http://www.ge.com/investor-relations/disclaimer-caution-concerning-forwardlooking- statements as well as our annual reports on Form 10-K and quarterly reports on Form 10-Q. We do not undertake to update our forward-looking statements. This document also includes certain forward-looking projected financial information that is based on current estimates and forecasts. Actual results could differ materially. to total risk-weighted assets.]

    NON-GAAP FINANCIAL MEASURES: In this document, we sometimes use information derived from consolidated financial data but not presented in our financial statements prepared in accordance with U.S. generally accepted accounting principles (GAAP). Certain of these data are considered “non-GAAP financial measures” under the U.S. Securities and Exchange Commission rules. These non-GAAP financial measures supplement our GAAP disclosures and should not be considered an alternative to the GAAP measure. The reasons we use these non-GAAP financial measures and the reconciliations to their most directly comparable GAAP financial measures are posted to the investor relations section of our website at www.ge.com. [We use non-GAAP financial measures including the following: • Operating earnings and EPS, which is earnings from continuing operations excluding non-service-related pension costs of our principal pension plans. • GE Industrial operating & Verticals earnings and EPS, which is operating earnings of our industrial businesses and the GE Capital businesses that we expect to retain. • GE Industrial & Verticals revenues, which is revenue of our industrial businesses and the GE Capital businesses that we expect to retain. • Industrial segment organic revenue, which is the sum of revenue from all of our industrial segments less the effects of acquisitions/dispositions and currency exchange. • Industrial segment organic operating profit, which is the sum of segment profit from all of our industrial segments less the effects of acquisitions/dispositions and currency exchange. • Industrial cash flows from operating activities (Industrial CFOA), which is GE’s cash flow from operating activities excluding dividends received from GE Capital. • Capital ending net investment (ENI), excluding liquidity, which is a measure we use to measure the size of our Capital segment. • GE Capital Tier 1 Common ratio estimate is a ratio of equity

    Asymptote Specialists in cryochain for advanced medicines

    5 October 2017

  • Confidential. Not to be copied, distributed, or reproduced without prior approval.

    About Asymptote

    5 October 2017ATMP Meeting 2

    • Small Cambridge company. • Founded by Dr John Morris in 1989. •Dedicated to the science of

    cryobiology.

    • Specialising in cryochain technology for advanced medicines.

    •Not too fond of liquid nitrogen.

  • Confidential. Not to be copied, distributed, or reproduced without prior approval.

    We’re building a complete solution Controlled-rate freezing, cryogenic shipping, automated thawing and end-to-end sample tracking

    3

    5 October 2017

    VIA Freeze range Liquid nitrogen-free controlled rate freezers

    VIA Thaw series Automated, dry conduction thawers

    VIA Shipper Specialist cryogenic shipper for advanced medicines [coming soon]

    my.Cryochain Centralized cryochain control

    We aim to be container agnostic and already support most cryovial and container types

    ATMP Meeting

  • Confidential. Not to be copied, distributed, or reproduced without prior approval.

    We’re best known for the VIA Freeze range Liquid nitrogen-free controlled rate freezers

    The VIA Freeze range maintain optimal cell viability, deliver consistent quality, clean room compatible and GMP compliant cryopreservation

    5 October 2017 4ATMP Meeting

  • Confidential. Not to be copied, distributed, or reproduced without prior approval.

    Some advantages of switching out LN2 Avoid the safety and contamination risks

    Asphyxiation Cold burns Explosion

    5

    Control plate - exposure to air, no liquid nitrogen exposure

    Plate exposed to liquid nitrogen - from a newly filled liquid nitrogen

    tank

    Microbial outgrowth following incubation at room temperature for a week

    5 October 2017ATMP Meeting

  • Confidential. Not to be copied, distributed, or reproduced without prior approval.

    VIA Freeze sample to sample consistency Conduction cooling removes heat evenly so every sample experiences exactly the same cooling rate

    Thermocouple read outs during VIA Freeze run

    Eight thermocouples randomly distributed across sample plate Infra-red sample images

    VIA Freeze: Conduction cooling à

    5 October 2017 6

    Consistent temperature between samples

    Liquid nitrogen CRFs: Convection cooling à Sample-to-sample variation

    ATMP Meeting

  • Confidential. Not to be copied, distributed, or reproduced without prior approval.

    Now we’re introducing the VIA Thaw series Automated, dry thawers for cryo-vials and cryo-bags

    The VIA Thaw series standardize cell therapy thawing with a simple, reproducible and traceable process

    The first thawers available in the series are the: • VIA Thaw CB1000 for thawing a

    range of cryo-bag sizes

    • VIA Thaw SC2 for thawing 2 mL screw cap cryo-vials

    5 October 2017ATMP Meeting 7

  • Confidential. Not to be copied, distributed, or reproduced without prior approval.

    Thawing challenges: What’s wrong with water baths?

    Multiple inconsistent elements in standard water bath thawing practice

    Cell Therapy Manufacturers told us water bath thawing had …

    • No standard procedure

    • No standard bath

    • Poor temperature control

    • Poor time control

    • Contamination risks

    • No record of the thaw

    The UK’s Cell and Gene Therapy Catapult identified…

    “a small benchtop thawing system which could …… meet GMP requirements, with a robust reporting architecture, would be fundamental to controlling and monitoring the final stages of release and use of cryopreserved therapies.” 1

    1. Developing benchtop thawing devices with a UK SME: https://ct.catapult.org.uk/case-study/developing-benchtop-thawing-devices-uk-sme. Last accessed March 2017.

    5 October 2017 8ATMP Meeting

  • Confidential. Not to be copied, distributed, or reproduced without prior approval.

    What if the thawed sample is left too long? In poorly controlled water bath thawing cell viability and function is damaged

    P. Mitchell et al. A new automated vial thawer controls the thawing of cryopreserved mesenchymal stem cells to achieve high cell viability and growth potential. Cytotherapy 19.5 (2017):S121-S122

    5 October 2017

    • Mishandling limits the viability and function and at worse destroys cells

    • Typically it is the least-well controlled part of the cryochain

    • Thawing in the clinical setting is likely to be carried out be non- specialist staff

    ATMP Meeting 9

  • Confidential. Not to be copied, distributed, or reproduced without prior approval.

    Capturing the data is critical

    10

    All our freezers and thawers integrate with my.Cryochain - a powerful research and process validation tool

    my.Cryochain makes it easy to standardise freezing and thawing protocols, and easy to audit that processes were properly followed.

    5 October 2017ATMP Meeting