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Corporate presentation

December 2023

An integrated orphan drug company, focusing on late-stage

development for commercialization

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Corporate presentation | Egetis Therapeutics | 2023-12-22

2

Agenda

  1. An integrated orphan drug company, focusing on late-stage development for commercialization
  2. Emcitate
    • Overview of MCT8-deficiency
    • Clinical experience with Emcitate
    • Regulatory pathway to submissions in EU and US
    • Commercial opportunity
  3. Aladote*
    • Paracetamol/Acetaminophen overdose and clinical experience with Aladote
    • Regulatory pathway to submissions in EU and US
    • Commercial opportunity
  4. The orphan drug segment
  5. Summary
  1. Appendix

Corporate presentation | Egetis Therapeutics | 2023-12-22

3

*In-house development of Aladote parked until Emcitate submissions have been completed

WE CARE

FOR THE RARE

1.

An integrated orphan drug company, focusing on late-stage

development for commercialization

An integrated orphan drug company, focusing on late-stage development for commercialization

1

Dedicated orphan drug company

Two late-stage assets: Emcitate and Aladote*

2

Emcitate MAA filed in October 2023

Pivotal trial for Emcitate NDA is ongoing

3

Highly attractive orphan drug segment

4

Plan to launch through small in-house commercial

organization in the EU and North America

5

Strong team with late-stage orphan clinical development,

registration and commercialization experience from:

Listed on NASDAQ Stockholm (EGTX)

HQ in Stockholm, Sweden

~30 FTEs

Corporate presentation | Egetis Therapeutics | 2023-12-22

5

*In-house development of Aladote parked until Emcitate submissions have been completed

Egetis has recently delivered transformative milestones

Jul 24

Oct 9

Oct 10

Nov 10

Nov 30

First patient

Submitted

Secured long-term

License agreement

EUR 10m draw

recruited in

application for

financing of SEK 462m,

with Fujimoto for

down of debt

ReTRIACt study,

regulatory approval

adding top-tier US

Emcitate in Japan

facility

which is pivotal

of Emcitate for

specialist investor as

for US NDA

MCT8 deficiency in

largest shareholder

EU (MAA)

SEK 172m equity

private placement (SEK 155m subscribed by Frazier Life Sciences)

  • SEK 290m debt financing (BlackRock; EUR 10m & EUR 15m tranches)

6

Submission of application

for regulatory approval in PRESS EU (MAA) for Emcitate for treatment of MCT8 deficiency

  • Marketing Authorisation Application (MAA) submitted and validated by the EMA in October
  • Application validated and found to be complete by the EMA on October 27, starting the clock for formal regulatory review
  • The median review time for MAAs in the EU is around 13-14 months
  • Orphan Drug Designation will provide 10 years of market exclusivity within the EU following approval of MAA

PRESS

7

Egetis secured long-term financing of SEK 462m and added top-tier US specialist investor as largest shareholder

Announcement published on October 10, 2023

Unique combined long-term financing, comprising SEK 172m private placement at a premium and SEK 290m debt financing

First in its class in a Swedish biotech setting, limiting dilution to existing shareholders and strengthening shareholder base

Private placement led by top-tier US healthcare specialist investor Frazier Life Sciences

    • Demand for the new shares significantly exceeding the size of the private placement
    • Frazier Life Sciences new largest strategic shareholder in EGTX and brings significant sector expertise
  • SEK 290m debt financing obtained from BlackRock (formerly Kreos)

Divided into two tranches, EUR 10m ("Tranche A") and EUR 15m ("Tranche B") which will become available provided that the Company reaches certain milestones, inter alia related to the phase III ReTRIACt study for Emcitate for Tranche B.

  • Egetis drew down Tranche A of the Debt Financing on November 30, 2023

8

Advancing rest of world with license agreement with Fujimoto for Emcitate in Japan

  • Highly suitable partner in Fujimoto

PRESS

    • Private company in Osaka, Japan, founded in 1933
    • Significant experience from successfully registering and launching medicines for Blood, Neurological and Orphan diseases in Japan
  • Egetis retains significant share of future revenues in Japan
    • Upfront, development & regulatory milestones of total JPY 600m (SEK 45m)
    • In addition, Fujimoto will finance the necessary development in Japan and be responsible for regulatory interactions
    • Egetis retains ~1/3 of future revenues

9

Building a sustainable orphan drug company

  • Successfully develop Emcitate for EU & US approvals in 2024/25 and Aladote post 2026
  • Commercialize Emcitate and Aladote through an inhouse organization in Europe/ North America and partnerships in RoW
  • Realize the full potential of our products via life-cycle management
  • Ensure fast and broad access to our products for the benefit of patients worldwide
  • Identify further assets that address the significant unmet medical need for patients with rare diseases
  • Provide an open culture that encourages Collaboration, Courage & Commitment
  • Egetis financial objective is to create increased value for shareholders in the long term

To bring unique therapies to patients with rare diseases that improve and extend life

To create value for patients, society and shareholders by developing and providing a portfolio of unique products for the treatment of rare diseases with substantial medical need

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Disclaimer

Egetis Therapeutics AB (publ) published this content on 27 December 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 27 December 2023 11:33:00 UTC.