Zealand Pharma Reports Q1 2024 Financials

Zealand Pharma, a biotechnology company specializing in peptide-based medicines, has announced its first-quarter financial results for 2024. The company reported a strong start to the year, paving the way for significant data releases in the second quarter related to its obesity treatment portfolio.

Key Financial Metrics

For the first quarter of 2024, Zealand Pharma recorded revenues of DKK 15.1 million, a slight increase from DKK 13.6 million in the same period of 2023. Net operating expenses rose significantly to DKK 266.3 million compared to DKK 182.3 million in Q1 2023, leading to a net operating loss of DKK 255.8 million. The company’s cash position stood at DKK 3,234.8 million as of March 31, 2024, bolstered by a private placement of shares to institutional investors, which raised gross proceeds of DKK 1.45 billion in January 2024.

Obesity and MASH Developments

Zealand Pharma’s partner, Boehringer Ingelheim, announced positive results from a Phase 2 clinical trial evaluating survodutide, a glucagon/GLP-1 receptor dual agonist, for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). The trial showed that up to 83% of adults treated with survodutide experienced significant improvements in MASH over a 48-week period without worsening fibrosis, compared to 18.2% with placebo. These findings will be presented at the European Association for the Study of the Liver (EASL) congress in Milan on June 7, 2024.

Rare Disease Pipeline

Zealand Pharma is also making strides in rare disease treatments. The US FDA has set a Prescription Drug User Fee Act (PDUFA) date of December 22, 2024, for the potential approval of glepaglutide, a GLP-2 analog for treating short bowel syndrome (SBS). Additionally, the FDA has set a PDUFA date of October 8, 2024, for dasiglucagon in congenital hyperinsulinism (CHI) for up to three weeks of dosing.

Financial Outlook

Zealand Pharma has extended its cash runway into 2027, thanks to the private placement of shares and the disbursement of Tranche A of a EUR 90 million loan facility from the European Investment Bank (EIB). The company is well-positioned financially to continue investing in its R&D programs, including preparations for comprehensive Phase 2b trials of its obesity candidates.

Upcoming Key Events

The second quarter of 2024 is expected to be eventful for Zealand Pharma. The company anticipates reporting topline results from Part 2 of the multiple ascending dose (MAD) trial for petrelintide, an amylin analog, and from the investigator-led DREAM trial for dapiglutide, a GLP-1/GLP-2 receptor dual agonist. These trials aim to evaluate the potential for weight loss and gain mechanistic insights into the effects of these treatments.

Partnership and Commercialization Efforts

Zealand Pharma is actively engaging in discussions for the future commercialization of glepaglutide and dasiglucagon. Contingent on FDA approval, the company plans to make dasiglucagon available to patients in the US for up to three weeks of dosing by October 2024.

Chronic Inflammation Research

In the realm of chronic inflammation, Zealand Pharma plans to initiate a first-in-human clinical trial for ZP9830, a Kv1.3 ion channel blocker, in the second half of 2024. This trial represents a new avenue for the company's research and development efforts.

Conclusion

Zealand Pharma has started 2024 on a strong note, with significant clinical and financial milestones. The company is poised for further advancements in its obesity and rare disease pipelines, backed by a robust financial position. The second quarter of the year promises crucial data read-outs that could shape the future of Zealand Pharma’s portfolio.

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