22Z Zealand Pharma AS

Company announcement – No. 49 / 2024

Zealand Pharma Announces Financial Results for the First Nine Months of 2024

Continued strong progress across obesity pipeline with proprietary assets ready for Phase 2 backed by a solid financial position.  

• Presented extremely encouraging weight loss and tolerability data with long-acting amylin analog petrelintide from MAD Part 2 (16-week trial) at ObesityWeek 2024
• Announced positive topline results with GLP-1R/GLP-2R dual agonist dapiglutide from Part 1 of Phase 1b trial (13-week trial)
• Boehringer Ingelheim announced US FDA Breakthrough Therapy Designation and advancement to two large Phase 3 trials for survodutide in MASH

Copenhagen, Denmark, November 7, 2024 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced the interim report for the nine months ended September 30, 2024, and provided a corporate update.

Building momentum into 2025 following impressive data across obesity portfolio

Adam Steensberg, President and Chief Executive Officer at Zealand Pharma said:

“I am excited about the impressive data and continued clinical advancement across our portfolio of differentiated obesity candidates that recently included very encouraging topline data with dapiglutide, advancement by Boehringer Ingelheim of survodutide into an ambitious Phase 3 program in MASH, and of course the presentation of data with our potentially best-in-class amylin analog petrelintide. With petrelintide specifically, I believe we have a unique opportunity to develop an alternative to GLP-1RA-based therapies that could become the future foundational therapy for weight management. We look forward to initiating a large, comprehensive Phase 2b trial very soon and are now exploring collaboration opportunities with potential partners.”

Key financial results for Q3 2024 year-to-date

Notes:

1. Net operating expenses consist of R&D, S&M, G&A and other operating items.
2. Cash position includes cash, cash equivalents and marketable securities.

Highlights in the third quarter of 2024

Obesity

• Dapiglutide, GLP-1/GLP-2 receptor dual agonist: Reported positive topline data from Part 1 of the Phase 1b dose titration trial. Topline results showed placebo-adjusted reductions in body weight of up to a mean of 8.3% with dapiglutide after 13 weekly doses. 85% of the 54 trial participants were male and median BMI at baseline was 30 kg/m². Dapiglutide treatment with doses up to 13 mg was assessed to be safe and well-tolerated with gastrointestinal (GI) adverse events (AEs) consistent with the profile reported with other incretin-based therapies. Only two participants discontinued treatment due to GI AEs.

Corporate

• Appointed Eric Cox as Chief Commercial Officer. Eric will lead Zealand Pharma’s commercial strategy and assume responsibility for business development.

Events after the reporting date

Obesity

• Petrelintide, long-acting amylin analog: Presented detailed results at ObesityWeek 2024 from 16-week multiple ascending dose (MAD) trial, Part 2 of Phase 1b trial. Petrelintide demonstrated mean body weight reductions of 4.8%, 8.6% and 8.3% after 16 once-weekly doses of up to 2.4 mg, 4.8 mg and 9.0 mg, respectively, versus 1.7% for the pooled placebo group. Dose escalation within cohorts occurred every second week. Participants randomized to petrelintide received the three different maintenance doses of 2.4 mg, 4.8 mg and 9.0 mg for twelve, eight and six weeks, respectively. 79% of the 48 trial participants were male and mean BMI was 29.9 kg/m². Petrelintide was well tolerated, with no serious or severe adverse events. All gastrointestinal adverse events were mild, except for two moderate events (nausea and vomiting) reported in one participant who discontinued treatment. No other participants discontinued treatment due to AEs. No other events of vomiting occurred, and two events of diarrhea were reported, both of which were mild.

MASH

• Survodutide, glucagon/GLP-1 receptor dual agonist: Boehringer Ingelheim announced U.S. FDA Breakthrough Therapy Designation and initiation of two Phase 3 trials in MASH. LIVERAGE and LIVERAGE-Cirrhosis are global Phase 3 clinical trials investigating the efficacy and safety of survodutide in adults with metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis stages 2 or 3 and in those with compensated MASH cirrhosis (stage 4), respectively. Based on the groundbreaking results from the Phase 2 trial in MASH, survodutide has received U.S. FDA Breakthrough Therapy Designation for the treatment of adults with non-cirrhotic MASH and moderate or advanced fibrosis.

Rare diseases

• Dasiglucagon in congenital hyperinsulinism (CHI): The U.S. FDA issued a Complete Response Letter (CRL) for dasiglucagon in CHI for up to three weeks of dosing due to the timing of a third-party manufacturing facility reinspection. The reinspection of the facility was completed in August/September 2024 for which a new inspection classification is pending. A prior inspection of the facility had identified deficiencies that did not involve dasiglucagon. These prior deficiencies had been resolved as of this reinspection. The CRL did not state any concerns about the clinical data package or safety of dasiglucagon.

Upcoming events next 12 months

Obesity

• Petrelintide, amylin analog: advancing clinical development. Zealand Pharma expects to initiate a Phase 2b trial with petrelintide in people with overweight or obesity without type 2 diabetes in the fourth quarter of 2024, for which completion of enrollment is expected in the first half of 2025. Zealand also expects to initiate a Phase 2b trial in people with overweight or obesity and type 2 diabetes in the first half of 2025.

• Zealand also plans to initiate a Phase 1b combination trial with petrelintide and a GLP-1 receptor agonist in 2025.   

• Dapiglutide, a GLP-1/GLP-2 receptor dual agonist. In the first half of 2025, Zealand Pharma expects to announce topline results from a cohort (Part 2 of the Phase 1b trial) evaluating even higher doses up to 26 mg dapiglutide and with 28 weeks of treatment. The cohort was added based on dapiglutide’s tolerability profile observed to date and will have no impact on the timing for initiation of a Phase 2b trial in people with overweight or obesity also expected in the first half of 2025. Zealand also plans to present the results from the Phase 1b trial at a scientific congress in 2025.

Rare diseases

• Glepaglutide in SBS. US FDA has set a Prescription Drug User Fee Act (PDUFA) date on December 22, 2024. In parallel with the regulatory review process, Zealand is engaging in partnership discussions for future commercialization.

• Dasiglucagon in CHI. Contingent on an inspection classification upgrade of the third-party manufacturing facility, Zealand expects to resubmit Part 1 of the NDA for dasiglucagon in CHI for up to three weeks of dosing in the fourth quarter of 2024. For Part 2 of the NDA review, which relates to use beyond three weeks, Zealand expects to submit the additional analyses from existing continuous glucose monitoring (CGM) datasets requested by the U.S. FDA in the fourth quarter of 2024 as well. Zealand is continuing pre-commercial activities to prepare for a launch in the U.S. contingent on an approval by the FDA. In parallel, the company is engaging in partnership discussions for future commercialization of the product.

Chronic inflammation

• ZP9830, Kv1.3 Ion Channel Blocker. Zealand Pharma expects to initiate the first-in-human clinical trial of ZP9830 in the fourth quarter of 2024.

Financial guidance for 2024

• Guidance unchanged from August 15, 2024

Notes:

3. Financial guidance based on foreign exchange rates as of November 7, 2024.

Conference call today at 2 PM CET / 8 AM ET

Zealand’s management will host a conference call today at 2:00 PM CET / 8:00 AM ET to present results through the first six months of 2024 followed by a Q&A session. Participating in the call will be Chief Executive Officer, Adam Steensberg; Chief Financial Officer, Henriette Wennicke; Chief Medical Officer, David Kendall; and Chief Commercial Officer, Eric Cox. The conference call will be conducted in English.

To receive telephone dial-in information and a unique personal access PIN, please register at https://register.vevent.com/register/BI9feb9ca116c04d17abb506491ebf0b90. The live listen-only audio webcast of the call and accompanying slide presentation will be accessible at https://edge.media-server.com/mmc/p/4kd7ihsh/. 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/investors/events-presentations/.

Financial Calendar for 2025

About Zealand Pharma A/S

Zealand Pharma A/S (Nasdaq: ZEAL) (“Zealand”) is a biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. The company has development partnerships with a number of pharma companies as well as commercial partnerships for its marketed products.

Zealand was founded in 1998 and is headquartered in Copenhagen, Denmark, with a presence in the U.S. For more information about Zealand’s business and activities, please visit www.zealandpharma.com.

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 the United States, as amended, even though no longer listed in the United States this is used as a definition to provide Zealand Pharma’s expectations or forecasts of future events regarding the research, development and commercialization of pharmaceutical products, the timing of the company’s pre-clinical and clinical trials and the reporting of data therefrom and the company’s Upcoming Events and Financial Guidance for 2024. These forward-looking statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would” and other words and terms of similar meaning. You should not place undue reliance on these statements, or the scientific data presented. The reader is cautioned not to rely on these forward-looking statements. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions, which may cause actual results to differ materially from expectations set forth herein and may cause any or all of such forward-looking statements to be incorrect, and which include, but are not limited to, unexpected costs or delays in clinical trials and other development activities due to adverse safety events or otherwise; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; our ability to successfully market both new and existing products; changes in reimbursement rules and governmental laws and related interpretation thereof; government-mandated or market-driven price decreases for our products; introduction of competing products; production problems; unexpected growth in costs and expenses; our ability to effect the strategic reorganization of our businesses in the manner planned; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; regulatory authorities may require additional information or further studies, or may reject, fail to approve or may delay approval of our drug candidates or expansion of product labeling; failure to obtain regulatory approvals in other jurisdictions; exposure to product liability and other claims; interest rate and currency exchange rate fluctuations; unexpected contract breaches or terminations; inflationary pressures on the global economy; and political uncertainty, including due to the ongoing military conflict in Ukraine. If any or all of such forward-looking statements prove to be incorrect, our actual results could differ materially and adversely from those anticipated or implied by such statements. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. All such forward-looking statements speak only as of the date of this press release/company announcement and are based on information available to Zealand Pharma as of the date of this release/announcement. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice.

Zealand Pharma® is a registered trademark of Zealand Pharma A/S.

Contacts

Anna Krassowska, PhD
Vice President, Investor Relations & Corporate Communications
Zealand Pharma
Email: AKrassowska@zealandpharma.com

Adam Lange
Investor Relations Officer
Zealand Pharma
Email: ALange@zealandpharma.com

Neshat Ahmadi
Investor Relations Manager
Zealand Pharma
Email: NeAhmadi@zealandpharma.com

Attachment

• Zealand Pharma 2024 Q3 Interim Report

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