Hellerup, Denmark, February 7, 2024, – UNION therapeutics A/S (“UNION”), a privately held, clinical stage, pharmaceutical development company focused on immunology, announces full-year results for the period January 1 to December 31, 2023.
2023 has been a year of great progress for UNION with positive read-outs from two clinical studies with lead candidate orismilast, a next-generation, high potency PDE4B/D inhibitor, in psoriasis and hidradenitis suppurativa (HS). Results have been presented at leading scientific conferences and published in peer-reviewed journals. Additionally, patient enrollment was completed for the ADESOS Phase 2b study with orismilast in atopic dermatitis (AD).
2023 has also been the year where UNION expanded orismilast development beyond immuno-dermatology and into gastroenterology, an important step in the strategy of unlocking the full potential of orismilast across immunology. During the year, UNION has continued its ESG (Environmental, Social and Governance) efforts by refining the sustainability strategy and ESG focus areas while nourishing the company culture (The UNION Way).
Kim Kjøller, Co-Chief Executive Officer of UNION therapeutics said:
“We are proud of the exceptional progress made at UNION in 2023. Positive read-out of two clinical trials with orismilast in psoriasis and hidradenitis suppurativa, advancement of clinical programs in atopic dermatitis and ulcerative colitis, and a substantial pipeline-in-a-drug opportunity while pushing the boundaries of immune dermatology – and beyond. We are looking ahead to a very exciting 2024 with read-out of the Phase 2b study with orismilast in atopic dermatitis in the first half of 2024.”
Morten Boesen, Chief Financial Officer of UNION therapeutics adds:
“I am pleased to announce our full-year results for 2023 which are in line with expectations. The investments in our clinical programs translated into significant advancements across the pipeline, positioning us well for important data read-outs in 2024. We greatly appreciate the continued broad support from our shareholders allowing us to further advance and broaden our clinical pipeline with a hope to maximize impact of orismilast.”
Financial results for the full year 2023
- Research and development costs of DKK 140.3m (2022: 186.4m; 2021: DKK 155.3m)
- Operating result for the year of DKK –160.0m (2022: -183.6m; 2021: DKK –51.9m)
- Cash and cash equivalents at year-end of DKK 95.3m (2022: 159.0m; 2021: DKK 253.4m)
Highlights for orismilast
- Positive data read-out from the Phase 2b study IASOS with orismilast for the treatment of moderate to severe psoriasis, a chronic, immunological skin disease.
- Positive data read-out from the investigator-initiated Phase 2 study OSIRIS with orismilast for the treatment of moderate to severe hidradenitis suppurativa (HS), a chronic progressive inflammatory skin disease.
- Patient enrollment completed for the Phase 2b study ADESOS with orismilast in atopic dermatitis (AD), the most prevalent inflammatory skin disease.
- Initiation of investigator-initiated Phase 2 study UCORIS with orismilast in ulcerative colitis (UC), a chronic inflammatory bowel disease.
- Data on orismilast was presented at leading scientific conferences; American Academy of Dermatology (AAD) Annual Meeting and European Academy of Dermatology and Venerology (EADV).
- Data on orismilast has been published in peer-reviewed journals; Journal of American Academy of Dermatology and Journal of European Academy of Dermatology and Venerology (JEADV).
- A new publication on the clinical potential of the emerging class of PDE4B/D selective inhibitors like orismilast published in peer-reviewed Journal of Dermatology and Therapy.
- Moreover, UNION announced Fast Track Designation received from the U.S. Food and Drug Administration (FDA) for orismilast for the treatment of moderate to severe HS.
Business highlights
- Continued strong investor support, including raising DKK 103m in new equity (DKK 381m across 2021-2023).
- Decision to not progress niclosamide as the PROTECT-V study did not meet its primary endpoint.
- Further refinement of UNION’s sustainability strategy and ESG focus areas and continued nourishment of The UNION Way and development of a thriving, diverse and inclusive team.
UNION’s Annual Report for 2023
This announcement is a summary of UNION’s Annual Report for 2023, published on February 6, 2024. A PDF version of the Annual Report will be available for download here: Annual Report 2023
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, clinical stage, pharmaceutical development company focused on immunology. 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
