Oxurion : Business Update - H1 2020

Progressing Clinical Development of Next Generation Diabetic Macular Edema (DME) Therapies - Beyond anti-VEGF

Positive data from Phase 1 study evaluating THR-687, a pan-RGD integrin antagonist, for the treatment of DME

First Patient dosed in Phase 2 ('KALAHARI') study evaluating THR-149, a potent plasma kallikrein inhibitor, for the treatment of DME

Total Cash & Investments at €37.9 million as of June 30, 2020

Highlights

• Focused on developing a diabetic macular edema (DME) franchise based on novel therapeutics with the potential to improve vision for all DME patients

• DME franchise based on two innovative drug candidates, THR-149 and THR-687 with different and complementary, non-VEGF modes of action

• First patient dosed in Phase 2 ('KALAHARI') study evaluating multiple injections of THR-149, a potent plasma kallikrein inhibitor, for the treatment of DME in September

• Positive data from Phase 1 study evaluating THR-687, a pan-RGD integrin antagonist, for the treatment of DME was announced in January

• Preparations for Phase 2 study with THR-687 in DME are progressing as planned. Study expected to start by mid-2021

• In August, Oxurion appointed Grace Chang, M.D., Ph.D. as Chief Medical Officer to lead the company's clinical programs for THR-149 and THR-687

Financial

• At the end of June 2020, Oxurion had cash, cash equivalents & investments of €37.9 million. This compares to €52.9 million at the end of December 2019.

-----

Conference call scheduled on September 17 at 6.30 pm CET (details at the end of the release)

-----

Leuven, Belgium, September 17, 2020 - 17.45 PM CET - Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing next generation standard-of-care ophthalmic therapies, with a focus on diabetic macular edema (DME), today issues its business and financial update for the sixth-month period ending June 30, 2020.

Oxurion is focused on developing an industry leading DME franchise based on novel therapies designed to potentially provide improved visual outcomes for all DME patients.

The Company is progressing its pipeline of innovative clinical drug candidates for treating DME. DME is a significant global healthcare problem and the major cause of vision loss in diabetic patients worldwide.

Oxurion's clinical development pipeline consists of two novel products with different and complimentary, non-VEGF, modes of action:

• THR-149 is a potent plasma kallikrein inhibitor with the potential to become the treatment of choice for DME patients who respond sub-optimally to anti-VEGF therapy.

• THR-687 is a best in class small molecule pan-RGD integrin antagonist being developed to treat DME with the possibility to become the standard of care for all treatment-naïve DME patients.

Patrik De Haes, M.D., CEO of Oxurion, said:

'We have made significant progress in developing our DME franchise in the first half of 2020. Following the positive Phase 1 results for THR-149 in 2019, in January we announced positive and highly promising Phase 1 results with THR-687 showing that this novel pan-RGD integrin antagonist has the potential to deliver improved visual outcomes to a broad population of DME patients when compared to anti-VEGFs, the current standard of care.

We have recently started our Phase 2 study of THR-149 in patients with DME. This two-part study will first select the optimal dose of THR-149 and will then compare it with aflibercept in terms of improvements in best corrected visual acuity. This Phase 2 data is designed to support our plans to position THR-149 as the treatment of choice for the large number of DME patients who have a sub-optimal response to anti-VEGF therapy.

By successfully developing THR-149 and THR-687, two novel and complimentary drug candidates that could offer improved therapeutic options beyond anti-VGEFs, we believe we are positioned to build an industry leading DME franchise. We are confident that creating this franchise will deliver significant benefits to nearly all DME patients globally and will, in parallel, generate attractive returns for our shareholders.'

Click here to register for the webcast