Gubra: Another strong quarter in CRO and pipeline update

The company saw another strong quarter in the CRO business, driven by obesity service which is a major topic for the biotech and pharma industry. However, they also experienced strong growth in the kidney service due to development of a large model catalogue over the last couple of years.

In the D&P business advanced internal anti-obesity asset, Amylin GUBamy, continues according to plan. Gubra completed dosing of the key cohorts in June (cohorts 1-4) in the Phase 1 SAD-study. Based on a favourable safety profile, Gubra was able to dose the additional optional high-dose cohort five and six during the third quarter with customary follow-up visits completed at the beginning of October. The company expects to topline results of the study this month. In parallel, the company initiated the Multiple Ascending Dose study (MAD) in September.

Aside from Amylin, Gubra's urocortin-2 (UCN2) program for high quality weight loss is being prepared for further development. The compound holds great potential, pre-clinical co-administration studies showed that UCN2 completely prevents the lean mass loss observed in diet-induced obese rats treated with either GLP-1 or Amylin agonists while improving fat mass loss. The non-clinical toxicity program starts in the fourth quarter of 2024 and planning is ongoing for a clinical study potentially to be initiated in late 2025 or early 2026.

For partnered projects, Gubra, together with partner Boehringer Ingelheim (BI), in July announced the launch of a Phase 1 study of BI 3034701, a long-acting triple agonist peptide with a potential to become a next-generation and first-in-class obesity treatment. For another collaboration project with BI, NPY2R agonist, it was announced in October 2024 that BI will discontinue the development of this compound.

Guidance for 2024 upgraded:

Previous outlook 2024:

CRO segment:

Organic revenue growth 23-28%

Adjusted ebit-margin 29-32%

Updated outlook 2024:

CRO segment:

Organic revenue growth 26-28%

Adjusted ebit-margin 30-32%

In the D&P segment they keep their previous guidance:

Number of partnerships per 1-2

Total costs (adjusted) DKK 160-170m

Total costs excl. Amylin asset (adjusted) DKK 115-125m

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Disclaimer: HC Andersen Capital receives payment from Gubra for a Digital IR/Corporate Visibility subscription agreement. /Claus Thestrup 9:00 (updated 09:15) 07.11-2024.