Zealand Pharma Reports H1 2024 Financials

Zealand Pharma, a biotechnology company specializing in peptide-based medicines, has released its financial results for the first half of 2024. The company has made significant strides in its research and development pipeline, particularly in the area of obesity treatment, and has also completed a substantial capital raise to fund further advancements.

In the first half of 2024, Zealand Pharma reported positive outcomes in their obesity programs. Notably, a 16-week study of petrelintide, a long-acting amylin analog, showed promising results. Participants in the trial experienced an average weight reduction of up to 8.6% with weekly doses of petrelintide, compared to a 1.7% weight reduction in the placebo group. The treatment was well-tolerated, with no severe adverse events reported.

Additionally, the company shared updates on dapiglutide, a GLP-1/GLP-2 receptor dual agonist. In a recent study, low doses of dapiglutide resulted in a mean weight loss of up to 4.3% over 12 weeks. The treatment had a favorable safety profile, with fewer gastrointestinal issues compared to other incretin-based therapies. Zealand Pharma plans to continue exploring higher doses in ongoing trials, with more data anticipated later in the year.

Zealand Pharma also highlighted progress in their collaboration with Boehringer Ingelheim on survodutide, a glucagon/GLP-1 receptor dual agonist. A phase 2 trial in patients with MASH (metabolic dysfunction-associated steatohepatitis) revealed that up to 64.5% of patients with moderate to advanced fibrosis showed improvement after 48 weeks of treatment. These promising results have paved the way for a phase 3 trial.

The company bolstered its financial position through an upsized equity offering, raising DKK 7 billion (approximately USD 1 billion). This capital injection will support the progression of Zealand Pharma's proprietary obesity programs into phase 2b clinical trials and beyond. The funds will also be used for early-stage research and general corporate purposes.

Key financial figures for the first half of 2024 include revenue of DKK 49.2 million, up from DKK 24.0 million in the same period the previous year. However, net operating expenses increased to DKK 558.7 million, resulting in a net operating loss of DKK 523.5 million. The company's cash position significantly improved, reaching DKK 29,747.7 million by the end of June 2024.

Several important milestones are anticipated for the second half of 2024. In the realm of obesity treatment, detailed results from the petrelintide MAD trial will be presented at a scientific congress. Additionally, Zealand Pharma plans to initiate a phase 2b program for petrelintide in individuals with obesity or overweight conditions.

For dapiglutide, the company expects to report topline results from part 1 of the phase 1b dose titration trial, exploring doses up to 13 mg. There's also a new cohort in the same trial examining even higher doses up to 26 mg, with results expected in early 2025.

In the area of rare diseases, the US FDA has set a Prescription Drug User Fee Act (PDUFA) date of December 22, 2024, for glepaglutide in the treatment of short bowel syndrome (SBS). For dasiglucagon in congenital hyperinsulinism (CHI), an FDA decision is anticipated by October 8, 2024.

Zealand Pharma also aims to advance its chronic inflammation program by initiating the first human trial of ZP9830, a Kv1.3 ion channel blocker, in the latter half of 2024.

The company's strengthened financial position has prompted an update in guidance. Net operating expenses for 2024 are now expected to be between DKK 1.25 billion and DKK 1.35 billion.

Overall, Zealand Pharma's first half of 2024 showcases substantial progress across its R&D pipeline, backed by one of Europe's strongest capital raises, positioning the company for continued advancements in its innovative therapeutic programs.