Company announcement - No. 20 / 2023
Zealand Pharma Announces Financial Results for the First Quarter of 2023
- Positive topline data from obesity portfolio
- On track for two regulatory submissions targeting rare diseases
- Strengthened balance sheet with
DKK 1.5 billion in April resulting in a runway to mid-2026
Delivered clinical results and strengthened balance sheet
“We are excited by the outlook for the year which we expect will be catalyst rich, including clinical data presentations at scientific conferences and initiation and reporting of new clinical studies across the obesity pipeline and regulatory submissions for our two rare disease programs.”
Key financial results for Q1 2023
DKK million | Q1 2023 | Q1 2022 |
Revenue | 13.6 | 11.0 |
Net operating expenses1 | -182.3 | -240.0 |
Net operating result | -168.7 | -229.0 |
Net financial items | -26.7 | -133.0 |
Cash, cash equivalents and marketable securities* | 1,002 | 1,123 |
Notes:
1. Net operating expenses consist of R&D, S&
*In
Highlights in the first quarter 2023
- Announced positive topline results from Phase 1a single ascending dose (SAD) trial of long-acting amylin analog ZP8396. Healthy participants with a mean BMI of 25.8 were treated with either subcutaneous ZP8396 or placebo (across 7 dose cohorts). Participants treated with ZP8396 had dose-dependent reductions in mean body weight of up to 4.2% from baseline. Placebo-treated participants had a mean body weight increase of 0.6%. The plasma half-life of ZP8396 was 230 hours, which supports once-weekly dose administration. ZP8396 was well tolerated in this study, with no serious or severe adverse events (AEs) and no withdrawals. Zealand will present the results from the SAD trial at the upcoming
American Diabetes Association (ADA) 83rd Scientific Sessions inJune 2023 .
Events after the reporting date
- Announced positive topline results from Phase 2 clinical trial with BI 456906, a glucagon receptor/glucagon-like peptide-1 receptor (GCGR/GLP-1R) dual agonist, in people living with obesity or overweight. BI 456906 achieved up to 14.9% weight loss from baseline after 46 weeks (including 20 weeks dosing escalation and 26 weeks fixed dose maintenance period). The analysis was based on the planned maintenance dose assigned at randomization regardless of whether the planned dose was reached during the first 20-week dose escalation phase. The safety and tolerability profile of BI 456906 was in line with other incretin-based pharmacotherapies. Full results, including an analysis using the actual maintenance dose administered regardless of assignment at randomization, indicating even greater weight loss, will be presented at the upcoming
ADA 83rd Scientific Sessions inJune 2023 .Boehringer Ingelheim is engaging in parallel with regulatory authorities to discuss plans for Phase 3 trials in people living with obesity or overweight. - Opened patient enrollment to DREAM, a Phase 2 investigator-led clinical trial of dapiglutide, a first-in-class GLP-1/GLP-2 receptor dual agonist in people with obesity. The DREAM trial aims to evaluate potential for weight loss following 12 weeks and gain key mechanistic insights into the effects of dapiglutide on inflammatory markers. Zealand expects the trial to complete in 2024.
- Completed the 6-month interim analysis of EASE-2, the long-term safety and efficacy extension trial of glepaglutide in patients with short bowel syndrome (SBS). Ninety-six participants continued into the EASE-2 from EASE-1. Participants continued their assigned treatment from EASE-1 with glepaglutide 10 mg once or twice weekly, while patients who received placebo in EASE-1 were re-randomized to treatment with either glepaglutide 10 mg once or twice weekly. At six months, clinical response to glepaglutide across the key efficacy endpoints was generally maintained or showed continued improvement. Data also demonstrated that additional patients on both doses weaned off parenteral support successfully. Glepaglutide appeared to be safe and well-tolerated in EASE-2, with a profile consistent with that observed in EASE-1. Both EASE-2 and EASE-3 long-term extension trials are ongoing. Zealand recently also completed the interim analysis of EASE-4, assessing the long-term effects of glepaglutide on intestinal fluid and energy uptake, and anticipates presenting these results at a future scientific conference.
- Strengthened balance sheet and extended runway to mid-2026. In April, Zealand received gross proceeds of
DKK 1.5 billion from a directed issue and private placement of 6,578,948 new shares. InMay 2023 , Zealand repaid theOberland Capital loan in full. With this final repayment, the loan agreement withOberland Capital is now terminated. The repayment is refinanced through a new Credit Facility provided by Danske Bank and expected near-term upcoming milestones from existing partners. For further information on the capital increase and repayment of Oberland loan refer to note 11 in the attached financial statement. Zealand’s projected financial runway remains until mid-2026.
Upcoming events
- Dasiglucagon in congenital hyperinsulinism (CHI). In the second quarter of 2023, Zealand expects to submit a new drug application (NDA) to the FDA for dasiglucagon treatment in the management of CHI.
- Glepaglutide in short bowel syndrome (SBS). In the second half of 2023, Zealand anticipates submitting an NDA to the FDA for glepaglutide administered via autoinjector for the treatment of SBS with intestinal failure.
- ZEGALOGUE® (dasiglucagon) for injection. Under the global license and development agreement with Novo Nordisk for Zegalogue®, Zealand is responsible for submitting a marketing authorization application (MAA) to the
European Medicines Agency (EMA), planned for the second quarter of 2023. - ZP8396, long-acting amylin analog. In the second half of the year, Zealand expects to report topline results from the ongoing 6-week multiple ascending dose (MAD) trial and initiate a 16-week dose titration trial.
- Dapiglutide, GLP-1/GLP-2 receptor dual agonist. Zealand expects to initiate a 13-week dose titration trial in people with obesity in the second half of 2023.
- ZP6590, GIP analog. Zealand expects to advance this program into first-in-human clinical trials in the second half of 2023.
Financial guidance for 2023
- Guidance unchanged from
March 2, 2023
DKK million | 2023 Guidance | 2022 Actual |
Revenue anticipated from existing and new license and partnership agreements | No guidance due to uncertain size and timing | 104 |
Net operating expenses1 | 800-900 | 941 |
Notes: 1. Net operating expenses consist of R&D, S& Financial guidance based on foreign exchange rates as of |
Conference call today at
Zealand’s management will host a conference call today at
+45 32 74 07 18 | |
+45 80 71 20 30 | |
+33 1 73 02 31 35 | |
+31 20 795 2681 | |
United Kingdom…………………. | +44 800 260 6470 |
United States……………………. | +1 646 968 2525 |
Conference ID: 7578501
A live listen-only audio webcast of the call, including an accompanying slide presentation, will be accessible at https://edge.media-server.com/mmc/p/tdxqkqw9. Participants are advised to register for the call or webcast approximately 10 minutes before the start. A recording of the event will be available following the call on the Investor section of Zealand’s website at https://www.zealandpharma.com/events/.
About
Zealand was founded in 1998 and is headquartered in
Forward-Looking Statements
This company announcement and interim report contains “forward-looking statements”, as that term is defined in the Private Securities Litigation Reform Act of 1995 in
Zegalogue® is a registered trademark of Novo Nordisk A/S.
Contacts:
Vice President, Investor Relations & Corporate Communications
Email: ank@zealandpharma.com
Attachment
Zealand Pharma - Q1 2023 Interim Report - 20230511
Source:
2023 GlobeNewswire, Inc., source