Hellerup, Denmark, February 9, 2023, – UNION therapeutics A/S (“UNION”), a privately held, multi-asset, clinical stage, pharmaceutical development company focused on immunology and infectious disease, announces full-year results for the period January 1 to December 31, 2022.
2022 has been a year of great progress for UNION with several important achievements paving the way for a very exciting 2023, including positive topline results from the Phase 2b study with oral orismilast in psoriasis, advancement of our mid- to late-stage clinical programs with orismilast and niclosamide, presentations and publications of data at leading scientific conferences and in peer-reviewed journals as well as continued development of a purposeful company culture, The UNION Way, to support the growth of the organization.
Kim Kjøller, Chief Executive Officer of UNION therapeutics said:
“I am very proud of the progress made in 2022 with significant advancement of our pipeline leading up to positive topline results from our Phase 2b study with oral orismilast in psoriasis, confirming the best-in-class potential of orismilast. 2022 was also the year where the enrollment target was reached for the platform study with niclosamide nasal spray tested in immunocompromised patients, and finally, but not less importantly, we have worked closely with all colleagues to define our way of working, The UNION Way.”
Morten Boesen, Chief Financial Officer of UNION therapeutics adds:
"I am pleased to announce our full-year results for 2022. The investments in our clinical programs translated into very significant advancements across the pipeline, positioning us well for important data read-outs in 2023, but also demonstrating the capital efficiency of our development-focused business model. I am also very happy with the progress of our ESG-related initiatives, ranging from broad stakeholder engagement around disease awareness to closer collaboration with suppliers around the CO2 footprint across our value chain.”
Financial results for the full year 2022
- Revenue of DKK 34.4m (2021: DKK 118.9m)
- Research and development costs of DKK 186.4m (2021: DKK 155.3m)
- Operating result for the year of DKK –183.6m (2021: DKK –51.9m)
- Cash and cash equivalents at year-end of DKK 159.0m (2021: DKK 253.4m)
Highlights for orismilast
- Phase 2b study ADESOS initiated with oral orismilast in atopic dermatitis (AD), the most prevalent immunological skin disease.
- Treatment extension from the Danish Medicines Agency and Ethics Committee for Phase 2a investigator-initiated study OSIRIS with oral orismilast in hidradenitis suppurativa (HS).
- Data on orismilast was presented at leading scientific conferences and published in the Journal of European Academy of Dermatology and Venerology (JEADV).
- In early January 2023, UNION announced positive topline results from the Phase 2b study IASOS with oral orismilast for the treatment of moderate to severe psoriasis, a chronic, immunological skin disease.
- Moreover, in January 2023, UNION announced Fast Track Designation received from the U.S. Food and Drug Administration (FDA) for oral orismilast for the treatment of moderate to severe HS, a chronic debilitating systemic skin disease.
Highlights for niclosamide
- Conclusion of patient enrolment in Phase 2/3 platform study PROTECT-V investigating niclosamide nasal spray as a COVID-19 pre-exposure prophylactic agent in vulnerable kidney patients.
- Publication of large-scale analysis on COVID-19-associated mortality in dialysis and kidney transplant patients in the peer-reviewed journal Transplantation. The immunocompromised patients, for example kidney patients on dialysis and kidney transplant recipients, continue to be at high risk of severe outcomes when contracting COVID-19.
- In-vitro studies with niclosamide have demonstrated retained efficacy against sub-variants of Omicron, including BA.1 and BA.5 which have been the dominant strains of the SARS-CoV-2 during the majority of 2022.
Business highlights
- Continued strong investor support, including raising DKK 62.0m in new equity (DKK 275.0m across 2021/2022), conversion of DKK 45.0m of convertible debt to equity, term extension of DKK 79.5m of venture debt facility with the European Investment Bank and USD 4.0m in milestone payments from licensing agreements.
- Important progress of Environment, Social and Governance (ESG) initiatives, including supplier engagement in estimation of CO2 emissions, continued development of The UNION Way, and partnering with patient organizations and public stakeholders to raise disease awareness.
UNION’s Annual Report for 2022
This announcement is a summary of UNION’s Annual Report for 2022, published on February 9, 2023. A PDF version of the Annual Report will be available for download here: Annual Report 2022
Contacts
Morten Boesen, Chief Financial Officer, UNION therapeutics A/S
+45 2381 5487
Sarah Toft-Jørgensen, Director of Communications and IR, UNION therapeutics A/S
+45 5385 3044
About UNION therapeutics
UNION therapeutics is a privately held, mid- to late-stage, pharmaceutical development company advancing novel treatment options within immunology and infectious diseases, two large and fast-growing therapeutic areas. UNION is headquartered in Hellerup, Denmark, and led by an international team combining biotech entrepreneurs and seasoned pharma executives, with a track record of developing and launching more than fifteen marketed drugs. Read more at http://www.uniontherapeutics.com
