Delivering next-generation treatments for back of the eye disorders, with focus on diabetic eye disease

Oxurion NV Business Update – FY 2018

7 Mar 2019

Significant Progress with Novel Diabetic Eye Disease Portfolio

Positive Topline Results from Phase 1/2 evaluating THR-317 for treatment of DME

Multiple Clinical Readouts Expected towards the end of H2 2019

Total Cash & Investments at €85.1 million on 31 December 2018 

Highlights

Pipeline 

  • In April 2018, Oxurion reported positive Day90 (30 days after last injection) data from its Phase 1/2 clinical study evaluating THR-317 (anti-PlGF) for the treatment of DME: results showed safety and tolerability of THR-317 for intra-ocular use, and 30% of anti-VEGF treatment naïve patients showed >15 letter vision gain in BCVA (Best Corrected Visual Acuity)
  • In April 2018, the first patient was enrolled in a Phase 2 study evaluating the efficacy and safety of THR-317 in combination with ranibizumab (Lucentis®), for the treatment of DME
  • In May 2018, the first patient was enrolled in a Phase 1 open-label, multicenter, dose escalation study evaluating the safety of THR-149 for treatment of DME 
  • In July 2018, Oxurion reported positive Day150 data from its Phase 1/2 clinical study evaluating THR-317 for treatment of DME: the data confirmed the safety and tolerability of THR-317 for intra-ocular use, and that it could improve visual acuity for up to Day 90 after the last injection
  • In September 2018, the first patient was enrolled in Phase 1 clinical study evaluating THR-687, a novel pan-RGD integrin antagonist, for treatment of DME
  • In September 2018, the first patient was enrolled in Phase 2 clinical study evaluating THR-317 for treatment of Idiopathic Macular Telangiectasia Type 1 (MacTel 1)
  • The on-going clinical studies of all 4 drug candidates are expected to read out data towards the end of the second half of 2019
  • In November 2018, Oxurion signed a strategic research collaboration with Beta Therapeutics to develop new heparanase inhibitors for the treatment of retinal disorders such as dry age-related macular degeneration (AMD)

Corporate developments and Appointments

  • In September 2018, the Company rebranded as Oxurion NV. As a result, the Company’s stock ticker is OXUR.BR (EURONEXT Brussels)
  • In October 2018, Oxurion announced the appointment (co-opting) of Adrienne Graves to its Board of Directors, replacing Paul Howes

Financial

Oxurion generated Jetrea® sales of €5.2 million in 2018, compared to €4.6 million in 2017

Total revenue amounted to €5.3 million in 2018 compared to €9.1 million in 2017. The variance is due to a €3.2 million one-off positive settlement for cost of goods in 2017 and a reduction in Jetrea® royalty income of €1.2 million

At the end of December 2018, Oxurion had €85.1 million in cash and investments, compared to €115.7 million (including restricted cash) as of the end of December 2017

Leuven, Belgium, 7 March 2019 – Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing innovative treatments to preserve vision in patients with diabetic eye disease, today issues a business update and its financial update for the year ending December 31, 2018.

Oxurion is developing a highly competitive pipeline of disease modifying drug candidates for diabetic eye disease, particularly diabetic retinopathy (DR) and diabetic macular edema (DME), two key areas of unmet medical need. 

The Oxurion clinical development pipeline consists of distinct products with different modes of action, and includes:

THR-317 – PIGF (human placental growth factor) neutralizing monoclonal antibody, is in a Phase 2 study evaluating the efficacy and safety of intravitreal THR-317 when administered in combination with ranibizumab (Lucentis®), for the treatment of DME. Results from this Phase 2 study are expected towards the end of 2019.

In addition, THR-317 is being evaluated in a Phase 2 study for the treatment of Idiopathic Macular Telangiectasia Type 1 (MacTel 1). MacTel 1 is a rare disease that affects the macula and can lead to vision loss. First data from this study is expected towards the end of 2019.

THR-149 – is a potent plasma kallikrein inhibitor being developed for the treatment of DME. THR-149 is in a Phase 1 open-label, multicenter, dose escalation study. Results from this study are anticipated towards the end of 2019. 

THR-687 – is a small molecule pan-RGD integrin antagonist being developed to treat a broad range of patients with diabetic eye disease. THR-687 entered the clinic in September 2018. Results from this Phase 1 study are expected towards the end of 2019.

Patrik De Haes, MD, CEO of Oxurion nv, commented: “We are very pleased with the progress that we have made with our innovative clinical pipeline of novel drug candidates targeting diabetic eye disease. Diabetic eye disease is a growing global healthcare problem where there is a clear need for improved treatment options. 2019 is an important year for Oxurion as we expect to announce clinical data from 3 key on-going studies: a Phase 2 trial with THR-317, in combination with Lucentis® in patients with DME, as well as two Phase 1 studies evaluating THR-687 and THR-149 respectively. We are confident these data will demonstrate the potential of our candidates, provide the information we need to plan the next stages of their clinical development and deliver significant value to our shareholders.”

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