Glepaglutide

Company announcement - No. 39 / 2024 Zealand Pharma Announces Financial Results for the First Half of 2024 Very strong progress across R&D pipeline followed by substantial capital raise enabling further investments to accelerate the development programs for wholly owned obesity assets. Extremely encouraging weight loss and tolerability data announced with long-acting amylin analog petrelintide from MAD Part 2 (16-week trial)Impressive data from Boehringer Ingelheim’s Phase 2 clinical trial with survodutide in MASH presented at the EASL congress in Milan, ItalySignificant strengthening of the balance sheet with completion of upsized equity offering raising gross proceeds of DKK 7 billion / USD 1 billion, which enables further investments to accelerate the development of our differentiated obesity assets resulting in a guidance update of net operating expenses to DKK 1.25 – 1.35 billion for 2024 Copenhagen, Denmark, August 15, 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 six months ended June 30, 2024, and provided a corporate update. Phenomenal first half of 2024 with impressive data in obesity followed by one of the strongest ever capital raises in EuropeAdam Steensberg, President and Chief Executive Officer at Zealand Pharma said:“I am very pleased with our progress in the first six months of 2024 that included impressive data across the obesity portfolio. In particular, the 16-week data with petrelintide reaffirmed our conviction in our amylin analog as an alternative to GLP-1RA-based therapies with potential to become the future backbone therapy for weight management. Looking into the second half of the year, we have an important data read-out for dapiglutide and potential approvals in the US for both our rare disease programs. Backed by a very solid financial position following the extraordinary capital raise in June, we are investing significantly in our differentiated obesity candidates to accelerate the development programs as we explore partnership opportunities.” Key financial results for H1 2024 DKK millionH1 2024H1 2023Revenue49.224.0Net operating expenses1-558.7-388.1Net operating result-523.5-364.0Net financial items-0.5-152.3 DKK millionJun-30, 2024Dec-31, 2023Cash position29,747.71,633.1 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. Revolving Credit Facility is not included. Highlights in the second quarter 2024Obesity Petrelintide, amylin analog: Reported positive topline data from the 16-week multiple ascending dose (MAD) trial, Part 2 of the Phase 1b trial. Topline results showed mean body weight reductions of up to 8.6% after 16 weeks with once-weekly dosing of petrelintide using a dose escalation scheme, versus 1.7% mean body weight reduction for the pooled placebo group. 79% of the 48 trial participants were male and median BMI was 29 kg/m2. Petrelintide was very well tolerated, with no serious or severe adverse events (AEs). All gastrointestinal (GI) AEs were mild, except for two moderate events (nausea and vomiting) reported in one participant who discontinued treatment. No other trial participants discontinued treatment due to AEs. No other events of vomiting occurred, and two events of diarrhea were reported, both of which were mild.Dapiglutide, GLP-1/GLP-2 receptor dual agonist: Reported topline data from the mechanistic investigator-led trial DREAM with low doses of dapiglutide. Topline results showed mean weight loss of up to 4.3% after 12 weeks with low doses of dapiglutide treatment. Dapiglutide was assessed to be well tolerated, with no treatment emergent adverse events (TEAEs) leading to treatment discontinuation and fewer GI TEAEs compared to what have been reported from other trials with incretin-based therapies, suggesting that doses of dapiglutide investigated were at the lower end of the therapeutic range in an obesity setting. Higher doses of dapiglutide are being investigated in the ongoing Phase 1b trial, with topline results from Part 1 of the trial exploring doses of dapiglutide up to 13 mg over 13 weeks of treatment expected in the second half of 2024. Additional data from DREAM on cardiovascular risk, systemic inflammatory markers, as well as data from gut biopsies, will be presented at a future scientific meeting. MASH Survodutide, glucagon/GLP-1 receptor dual agonist: Boehringer Ingelheim presented breakthrough results at the EASL congress from Phase 2 trial in MASH. The detailed results showed that up to 64.5% of adults with fibrosis stages F2 and F3 (moderate to advanced scarring) achieved a biopsy-proven improvement in fibrosis without worsening of metabolic dysfunction-associated steatohepatitis (MASH) after 48 weeks of survodutide treatment, versus 25.8% with placebo. Survodutide demonstrated safety data consistent with GLP-1RA-based molecules, with no new safety data concerns. Boehringer Ingelheim confirmed that survodutide will advance into Phase 3 for the potential treatment of MASH. Financial Solid financial position. Completed an upsized equity offering of 8.35 million new ordinary shares raising gross proceeds of USD 1 billion / DKK 7 billion representing one of the strongest ever capital raises in Europe. The net proceeds will support the advancement of Zealand’s proprietary obesity programs in Phase 2b clinical trials and beyond, including investments in associated CMC activities and additional clinical development activities in related indications. The net proceeds will also support continued early-stage research and fund general corporate purposes. Events after the reporting dateType 1 diabetes Zegalogue® (dasiglucagon injection for severe hypoglycemia) approval in the EU. The European Commission granted marketing authorization for dasiglucagon injection for the treatment of severe hypoglycemia in adults, adolescents and children aged six years or older with diabetes in Europe under the brand name Zegalogue®. Zegalogue® is licensed to Novo Nordisk who is responsible for commercialization worldwide. Corporate Appointed Eric Cox as Chief Commercial Officer. Eric will lead Zealand’s commercial strategy and assume responsibility for business development. Financial Terminated the Revolving Credit Facility provided by Danske Bank. The Revolving Credit Facility of DKK 350 million provided by Danske Bank was terminated in July 2024 following the equity offering in June 2024 that resulted in a cash position of DKK 9.7 billion as of June 30, 2024. Upcoming events in 2024Obesity Petrelintide, amylin analog. Detailed results from Part 2 of the MAD trial to be presented at a scientific congress in the coming months. In the second half of 2024, Zealand expects to initiate the Phase 2b program with petrelintide in people with overweight or obesity.Dapiglutide, a GLP-1/GLP-2 receptor dual agonist. In the second half of 2024, Zealand expects to report topline results from Part 1 of the Phase 1b dose titration trial, evaluating doses of dapiglutide treatment up to 13 mg and thus significantly higher doses compared to the prior 4-week MAD trial and the investigator-led trial DREAM. Based on the tolerability profile observed to date, a cohort (Part 2 of the Phase 1b trial) evaluating even higher doses up to 26 mg and with 28 weeks of treatment has been added, with topline results expected in the first half of 2025. The added cohort will have no impact on the expected timing for initiation of a Phase 2b trial in the first half of 2025.Survodutide in MASH. In the second half of 2024, Boehringer Ingelheim is expected to initiate the Phase 3 program with survodutide in MASH. The Phase 3 program with survodutide in obesity, SYNCHRONIZETM, was initiated in 2023. 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. US FDA has set a PDUFA date on October 8, 2024 for Part 1 of the NDA review related to dosing of up to three weeks. For Part 2 of the NDA review, which relates to use beyond three weeks, the US FDA requested additional analyses from existing continuous glucose monitoring (CGM) datasets, which Zealand expects to submit in the second half of 2024. CGM was included as a secondary outcome measure in the Phase 3 program. Zealand is engaging in partnership discussions for future commercialization of the product. In parallel, Zealand intends to make the product available to patients in the US contingent on an approval by the FDA in October 2024 for up to three weeks of dosing. Chronic inflammation ZP9830, Kv1.3 Ion Channel Blocker. Zealand expects to initiate the first-in-human clinical trial of ZP9830 in the second half of 2024. Financial guidance for 2024 Following the capital raise in June 2024, our significantly strengthened cash position provides a unique opportunity to accelerate the development programs of our differentiated obesity assets.Guidance updated compared to February 27, 2024 DKK million2024 Guidance(15 August)2024 Guidance(27 February)Revenue anticipated from existing and new license and partnership agreementsNo guidance due to uncertain size and timingNo guidance due to uncertain size and timingNet operating expenses31,250-1,3501,100-1,200 Notes:3. Financial guidance based on foreign exchange rates as of August 15, 2024. Conference call today at 2 PM CET / 8 AM ETZealand’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; 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 https://register.vevent.com/register/BI317d27d63df44f09bded2febfbe6b52a. The live listen-only audio webcast of the call and accompanying slide presentation will be accessible at https://edge.media-server.com/mmc/p/ya97oe47. 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/. Financial Calendar for 2024Q3 2024 November 7, 2024 About Zealand Pharma A/SZealand 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 StatementsThis 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 2023. 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:Adam LangeInvestor Relations OfficerZealand PharmaEmail: ALange@zealandpharma.com Anna Krassowska, PhDVice President, Investor Relations & Corporate CommunicationsZealand PharmaEmail: AKrassowska@zealandpharma.com Attachment Zealand Pharma H1 2024 Company Announcement_vFinal