Glepaglutide

Company announcement – No. 14 / 2026 Zealand Pharma Announces Financial Results for the First Three Months of 2026 A defining start to 2026, marked by pivotal progress for leading obesity assets, petrelintide and survodutide, and strong momentum in driving the next wave of metabolic health innovation. Announced decision to advance petrelintide into Phase 3 trials in H2 2026 following positive topline results from the Phase 2 ZUPREME-1 trial, demonstrating double-digit weight loss with a placebo-like tolerability, supporting its potential to redefine the weight management experience for people living with obesity or overweight. Announced Boehringer Ingelheim’s positive topline results from the SYNCHRONIZE TM -1 Phase 3 trial with survodutide, supporting its potential as a meaningful and differentiated treatment option for people living with obesity or overweight and metabolic dysfunction. Announced the establishment of a new research hub in Cambridge, Massachusetts, and entered into an agreement with DCAI to access a world-leading AI supercomputer, both key pillars to strengthen and accelerate drug discovery in line with Metabolic Frontier 2030 strategy. Announced initiation of a USD 200 million share buy-back program, reflecting financial flexibility and a strengthened financial outlook following positive developments for leading obesity programs. Copenhagen, Denmark, May 7, 2026 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company transforming the future of metabolic health, today announced the interim report for the three months ended March 31, 2026, and provided a corporate update. A defining quarter Adam Steensberg, President and Chief Executive Officer at Zealand Pharma said: “In this first part of 2026, we leveraged our agility, speed and proven scientific foundation to execute on our Metabolic Frontier 2030 strategy: A new research hub in Cambridge, AI partnerships, Phase 2 topline results with petrelintide followed by confirmation of Phase 3 advancement, and Phase 3 results with survodutide from Boehringer Ingelheim. These advancements not only build on our momentum, but significantly strengthen our long-term financial outlook, enabling a share buy-back program while cementing our commitment to invest heavily in our pipeline.” Key financial results for Q1 2026 DKK million Q1-26 Q1-25 Revenue 34 8 Net operating expenses, excl. OOI 1 -573 -393 Net operating expenses 1 -573 -415 Operating result -539 -407 Net financial items 145 70 DKK million Mar-31, 2026 Dec-31, 2025 Cash position 2 14,468 15,109 Notes: 1. Net operating expenses consist of R&D, S&M, and G&A and Other operating items (OOI). 2. Cash position includes cash, cash equivalents and marketable securities. Q1 2026 Highlights and Recent Developments Obesity Petrelintide, amylin analog. Reached a key milestone in the monotherapy program with the announcement of positive Phase 2 ZUPREME-1 topline results for petrelintide. Petrelintide demonstrated double-digit weight reduction and placebo-like tolerability, supporting its potential as a future foundational, first-choice therapy for chronic weight management. Petrelintide, amylin analog. In April 2026, Zealand Pharma and Roche announced that they will advance petrelintide monotherapy into Phase 3 trials for chronic weight management with planned initiation of the Phase 3 program in the second half of 2026. Survodutide, glucagon/GLP-1 receptor dual agonist. In April 2026, Zealand Pharma and Boehringer Ingelheim reported positive topline results from the 76-week SYNCHRONIZE TM -1 Phase 3 trial with survodutide in people with overweight or obesity without type 2 diabetes. Participants treated with survodutide achieved a significant weight loss of up to 16.6% and delivered meaningful metabolic improvements. Chronic inflammation ZP9830, Kv1.3 Ion Channel Blocker . Zealand Pharma reported positive topline results from the single ascending dose (SAD) part of the combined SAD/multiple ascending dose (MAD) Phase 1a clinical trial with ZP9830. Single doses of ZP9830 were well tolerated with no serious or severe adverse events or dose-limiting safety findings observed at any dose level. ZP9830 exhibited a pharmacokinetic pro line with predictions based on preclinical data, and exploratory pharmacodynamic biomarkers showed robust, dose-dependent activity consistent with Kv1.3 target engagement. Corporate Zealand Pharma announced the establishment of a new research hub in Cambridge, Massachusetts, enhancing the company’s research platform through AI-driven drug discovery, advanced automation, and next-generation molecule creation, accelerating the translation of scientific insights into innovative medicines. Zealand Pharma announced an agreement with the Danish Centre for AI Innovation (DCAI) to strengthen and accelerate drug discovery through access to Gefion, a world leading AI supercomputer. This positions the company to lead the next generation of metabolic health innovation while maintaining the rigorous scientific standards that underpin Zealand Pharma’s leadership in peptide therapeutics. On May 7, 2026, Zealand Pharma launched a share buy-back program of up to USD 200 million / DKK 1.3 billion. For more information on the share buy-back program, refer to Zealand Pharma Company Announcement No. 13/2026, May 7, 2026. Upcoming events next 12 months Obesity Petrelintide, amylin analog. Additional data from the Phase 2 ZUPREME-1 trial will be presented at the American Diabetes Association’s (ADA) 2026 Scientific Session in New Orleans, Louisiana. In the second half of 2026, Zealand Pharma and Roche expect to initiate registrational Phase 3 trials with petrelintide monotherapy. Petrelintide, amylin analog. In the second half of 2026, Zealand Pharma expects to report topline results from the Phase 2 ZUPREME-2 trial in people with overweight or obesity and type 2 diabetes. Petrelintide/enicepatide (CT-388), amylin+GLP-1/GIP fixed-dose combination. Zealand Pharma and Roche expect to initiate Phase 2 in the first half of 2026. Survodutide, glucagon/GLP-1 receptor dual agonist. Boehringer Ingelheim will present the full data from the SYNCHRONIZE TM -1 and SYNCHRONIZE TM -MASLD Phase 3 trials at the ADA 2026 Scientific Sessions in New Orleans, Louisiana. Survodutide, glucagon/GLP-1 receptor dual agonist. Results from the Phase 3 SYNCHRONIZE TM -2 and SYNCHRONIZE TM -CVOT trials are expected to be reported and presented at scientific meetings in 2026. Rare diseases Glepaglutide in SBS. Zealand Pharma expects potential regulatory approval in the EU in the first half of 2026. In parallel, the company is engaging in partnership discussions for future commercialization. Dasiglucagon in CHI. In the second half of 2026, Zealand Pharma expects to resubmit the New Drug Application (NDA) for three weeks of dosing to the U.S. FDA (Part 1 of the original NDA) and to submit the required and detailed analyses from existing continuous glucose monitoring datasets to support the use of dasiglucagon beyond three weeks (Part 2 of the original NDA). Chronic inflammation ZP9830, Kv1.3 Ion Channel Blocker. Zealand Pharma expects to report topline data from the MAD part of the Phase 1a clinical trial with ZP9830 in the second half of 2026 and expand the development program of ZP9830 with initiation of a Phase 1b/2a trial. Financial guidance for 2026 The financial guidance for net operating expenses for 2026, issued on February 19, 2026, is unchanged, and is expected to be between DKK 2.7-3.3 billion. Following the confirmation of Phase 3 progression for petrelintide monotherapy, planned for initiation in the second half of 2026, Zealand Pharma has recognized USD 700 million / DKK 4.5 billion as collaboration revenue in the second quarter of 2026. DKK million 2026 Guidance 3 2025 Actual Collaboration revenue 4.5 9.2 Net operating expenses, excl. OOI 1 2.7-3.3 2.1 Notes: 1. Financial guidance based on foreign exchange rates as of May 6, 2026. Conference call today at 2 PM CET / 8 AM ET Zealand Pharma’s management will host a conference call today at 2:00 PM CET / 8:00 AM ET to present results through the first three months of 2026 followed by a Q&A session. Participating in the call will be Chief Executive Officer, Adam Steensberg; Chief Financial Officer, Henriette Wennicke; and Chief Medical Officer, David Kendall. The conference call will be conducted in English. To receive telephone dial-in information and a unique personal access PIN, please register at .The live listen-only audio webcast of the call and accompanying slides presentation will be accessible at . 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 Pharma’s website at . Financial Calendar for 2026 Q2 2026 August 13, 2026 Q3 2026 November 12, 2026 About Zealand Pharma A/S Zealand Pharma A/S (Nasdaq: ZEAL) is a biotechnology company focused on advancing medicines for obesity and metabolic health. Combining more than 25 years of peptide R&D expertise with a proprietary data platform that leverages advanced data‑driven and AI/ML approaches, Zealand Pharma aims to lead a new era in obesity and metabolic health. To date, more than ten Zealand Pharma‑invented drug candidates have entered clinical development, of which two products have reached the market and three candidates are in late-stage development. The Company has collaborations with global pharmaceutical and biotechnology partners for research, development, and commercialization. Founded in 1998, Zealand Pharma is headquartered in Copenhagen, Denmark, with a U.S. presence in Boston, Massachusetts. Learn more at . Forward-looking Statements This company announcement 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 clinical trials and the reporting of data therefrom and the company’s significant events and potential catalysts in 2026 and financial guidance for 2026. 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 labelling; 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. 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 Eric Rojas (Investors) Vice President, Head of Investor Relations erojas@zealandpharma.com Adam Lange (Investors) Vice President, Investor Relations alange@zealandpharma.com Neshat Ahmadi (Investors) Manager, Investor Relations neahmadi@zealandpharma.com Rachel James-Owens (Media) Vice President, Corporate Communications & Media Relations Zealand Pharma Email: RJamesOwens@zealandpharma.com Andreas Hylleberg (Media) Director, External Communications Zealand Pharma Email: AHylleberg@zealandpharma.com Amber Fennell, Jessica Hodgson, Sean Leous (Media) ICR Healthcare Email: ZealandPharma@icrhealthcare.com +44 (0) 7739 658 783 Attachment Zealand Pharma Q1 2026 Interim Report

The FDA’s correspondence includes the decision not to approve Zealand Pharma’s GLP-2 drug glepaglutide for short bowel syndrome.\n The FDA’s ongoing effort to establish a culture of “radical transparency” saw the agency publish another haul of complete response letters (CRLs) yesterday.The latest batch of 89 rejection letters was uploaded Sept. 4 along with a pledge by the agency to begin publicly releasing this type of communication at the same time the documents are issued to sponsoring companies. As with the initial mailbag of more than 200 CRLs that the FDA made available back in July, a dive into yesterday’s letters sheds further light on the agency\'s often-opaque drug review process.Among the letters are some high-profile decisions for the likes of Ultragenyx’s gene therapy for Sanfilippo syndrome type A, Capricor Therapeutics’ Duchenne muscular dystrophy cell therapy and Replimune’s melanoma drug RP1. The contents of the letters often map onto information already in the public domain, but there are still some fresh insights to be gleaned about the FDA’s decision-making process.‘Numerous unreported adverse events’ The FDA’s correspondence certainly sheds more light on the agency’s decision at the end of last year not to approve Zealand Pharma’s GLP-2 drug glepaglutide in short bowel syndrome. That application—which could have set up glepaglutide as a possible challenger to Takeda’s Gattex—was based on results from a single placebo-controlled phase 3 study dubbed EASE-1.The trial hit its primary endpoint, with twice-weekly doses of glepaglutide reducing weekly parenteral support (PS) volume—a measure of tube feeding—by a statistically significant 5.13 liters at 24 weeks compared to baseline. However, once-weekly doses of glepaglutide failed to yield statistically significant reductions in PS.When Zealand announced that it had received the CRL in December 2024, the company didn’t divulge much detail, only confirming that the agency had “concluded that Zealand Pharma’s application did not meet the full requirements for substantial evidence to establish the efficacy and safety of the to-be-marketed dose of glepaglutide.”The full letter from the FDA, which was uploaded yesterday, gives a more detailed insight into the agency\'s rationale. While acknowledging the twice-weekly dosing endpoint win, the FDA pointed to “numerous uncertainties that limit the interpretability and/or persuasiveness of the results.”These included “observed inconsistencies” in PS as a result of adjustments outside of the trial’s protocol, according to the FDA. The inconsistencies “raise concerns that the observed changes in PS volume may have been impacted by factors other than the drug’s efficacy and may not accurately represent PS volume requirements of the subject,” the FDA said in the letter. The agency also noted that “incomplete or missing documentations of urinary output in the 48 hours prior to study visits” were observed in up to 12% of patients in the EASE-1 trial, as well as in 68% of patients in the follow-on EASE-2 study.Meanwhile, an FDA inspection of one of the study’s clinical investigator sites identified “several concerning observations,” including “numerous unreported adverse events” among six of the nine patients enrolled there. Two of these unreported events were considered “serious” and involved patients being hospitalized due to acute kidney injury or hypomagnesemia, respectively.The FDA’s recommendation was for Zealand to conduct a further trial, and the Danish biotech is on track to kick off that study later this year. In the meantime, the company is awaiting an approval decision for glepaglutide from European regulators.Psychedelic uncertainties When it came to the rejection of Lykos Therapeutics’ application for its MDMA candidate midomafetamine to treat post-traumatic stress disorder, the potential objections had been out in the open for a while. Even before the agency sent the CRL in August 2024, the FDA had voiced concerns in briefing documents about whether a clinical trial for an MDMA treatment could ever be properly blinded, given that the drug “produces profound alterations in mood, sensation, suggestibility and cognition.”The agency’s Psychopharmacologic Drugs Advisory Committee had also been unconvinced of approval, in what was the first instance of an FDA committee reviewing a psychedelic treatment.Summarizing the contents of the CRL at the time, Lykos said the letter had “included concerns that Lykos\' clinical data were insufficient to demonstrate durability along with questions about expectancy bias stemming primarily from participants with prior MDMA use.” Reading the full letter reveals that the FDA also echoed specific prior concerns it had raised about the need to record “positive” effects of the treatment as adverse events for the purposes of the study.“As you were specifically advised, regardless of whether a participant, therapist or physician may find a drug experience to be neutral, positive or favorable, events that are relevant to the abuse potential of a drug or potential for impairment should have been captured and reported,” the FDA wrote in its letter.“Because such events were not captured and reported, the studies failed to adequately characterize the safety of midomafetamine, its acute effects, the duration of impairment, or signals of abuse potential within these studies,” the agency added.The last we heard from Lykos, it hadn’t let this setback get it down. As of January, the biotech had met with the FDA to “chart a path forward for an independent third-party review of prior phase 3 clinical data and an additional phase 3 trial.”A matter of timing Regeneron got off lightly when the FDA rejected its application for the T-cell engager odronextamab to treat patients with follicular lymphoma or diffuse large B-cell lymphoma. Announcing the CRL in March 2024, the pharma was keen to stress that the agency had not identified “any approvability issues.”Regeneron’s original plan had been to enroll patients in various confirmatory phase 3 lymphoma trials that formed part of the wide-ranging Olympia program while it sought accelerated approval. Enrollment in the dose-finding portion of these trials had already begun when the company filed its application, but Regeneron explained at the time of the rejection that the FDA decided “the confirmatory portions of these trials should be underway and that the timelines to completion be agreed prior to resubmission” of the application.A close read of the FDA’s letter suggests the agency was certainly skeptical of Regeneron’s proposed time frames.“The current conduct and projected completion date of any of these Olympia trials in follicular lymphoma do not provide sufficient assurance of timely completion of the trial(s),” the letter reads.When it came to resubmitting the application, the FDA said Regeneron would be wise to “demonstrate sufficient progress in the conduct of the confirmatory portion of the confirmatory trial(s) to provide sufficient assurance of timely completion of the trial(s).\"The pharma returned to the FDA with an updated application in February, but this resulted in another rejection a few weeks ago. This time, Regeneron blamed the decision on problems uncovered during an FDA inspection of an Indiana plant now owned by Regeneron’s manufacturing partner Novo Nordisk.Regeneron can at least take some comfort from the fact that despite these U.S. setbacks, odronextamab secured the green light from European regulators back in August 2024.