Glepaglutide

Company announcement - No. 9 / 2024 Zealand Pharma Announces Financial Results for the Full Year 2023 Significant progress delivered across our obesity and rare disease assets while building a solid financial position Positive results achieved for petrelintide in 6-week Phase 1 trial and clinical advancement of dapiglutide and petrelintide towards obesity data readouts in 2024 Positive results announced in Boehringer Ingelheim Phase 2 clinical trials for survodutide in obesity and global Phase 3 clinical program in obesity initiated NDA submissions for dasiglucagon in congenital hyperinsulinism and glepaglutide in short bowel syndrome expected to support regulatory decisions for rare diseases in 2024 Private placement of shares to institutional investors, European Investment Bank loan facility, undrawn committed RCF and milestone payments from existing partners contribute to strengthened financial position Events after the reporting period Positive results announced in Boehringer Ingelheim Phase 2 clinical trial for survodutide in MASH and private placement of shares to institutional investors contribute to extended cash runway into 2027 Copenhagen, Denmark, February 27, 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 annual report for the year ended December 31, 2023, and provided a corporate update. Building momentum in 2024 “2023 was an extraordinary year for Zealand and I am proud of our team’s performance to progress our business,” said Adam Steensberg, President and Chief Executive Officer at Zealand Pharma. “With the promising results for our long-acting amylin analog, petrelintide, and the advancement of our dual GLP-1/GLP-2 receptor agonist, dapiglutide, in obesity, Zealand is well positioned to achieve significant milestones in 2024. We look forward to important clinical results for petrelintide and dapiglutide in obesity that we believe will support advancing both compounds into subsequent Phase 2b trials, and to progressing our rare disease product candidates through the regulatory phase to patients who need them.” Key financial results for FY 2023 DKK million FY 2023 FY 2022 Revenue 342.8 104.0 Net operating expenses1 -895.9 -941.1 Net operating result -572.2 -837.2 Net financial items -136.6 -134.9 Cash position2 1,633.1 1,177.8 Cash position including undrawn committed RCF3, EIB4 loan facility (Tranche A, B and C) and January 2024 private placement5 4,104.0 1,177.8 Notes: Net operating expenses consist of R&D, S&M, G&A and other operating items. Cash position includes cash, cash equivalents and marketable securities. RCF = Revolving Credit Facility of DKK 350 million provided by Danske Bank. EIB = European Investment Bank. The conditions for Tranche A (EUR 50 million) have been met. Pay-out expected in Q1 2024. Tranche B (EUR 20 million) and Tranche C (EUR 20 million) are subject to predefined milestones being met. In January 2024, Zealand received gross proceeds of DKK 1.45 billion in connection with a private placement of new shares. Maintaining a strong financial position. Revenue in 2023 of DKK 343 million was mainly driven by a EUR 30 million milestone payment from Boehringer Ingelheim associated with survodutide and USD 10 million from a milestone payment from Sanofi associated with lixisenatide. Cash position is DKK 4.1 billion including the undrawn committed RCF, the EIB loan facility (tranche A, B and C) and the January 2024 private placement of DKK 1.45 billion. Cash, cash equivalents and marketable securities as of December 31, 2023, was DKK 1.6 billion, including gross proceeds of DKK 1.5 billion from a directed issue and private placement in April 2023. Under the current assumptions Zealand projects its existing financial resources will be sufficient to fund operations into 2027. Financial guidance for 2024 The solid financial situation enables Zealand to expand its investments in the company’s wholly owned obesity assets and continue investing in progressing the rare disease product candidates through the regulatory phase while engaging in partnership discussions. DKK million 2024 Guidance 2023 Actual Revenue anticipated from existing and new license and partnership agreements No guidance due to uncertain size and timing 343 Net operating expenses5 1,100-1,200 896 Notes: 5. Financial guidance based on foreign exchange rates as of February 26, 2024. Recent R&D highlights and key events anticipated in 2024 Obesity – advancing the portfolio Petrelintide, a long-acting amylin analog. At Obesity Week in November 2023, Zealand presented results from Part 1 of the Phase 1b MAD trial (NCT05613387), in which low doses of up to 1.2 mg petrelintide administered once weekly for six weeks led to reductions in body weight of up to 5.3% in healthy lean and overweight participants (mean body weight of 82 kg and BMI of 25.4). Petrelintide was well tolerated in the trial with a mostly mild adverse event profile. In the first half of 2024, Zealand expects to report topline results from Part 2 of the MAD trial designed to evaluate higher doses of petrelintide administered for 16 weeks in participants with overweight or obesity (eligible BMI 27.0–39.9). In parallel, Zealand is planning a Phase 2b trial of petrelintide planned for initiation in the second half of 2024. Dapiglutide, a first-in-class GLP-1/GLP-2 receptor dual agonist: In the first half of 2024, Zealand anticipates topline results from the Phase 2a investigator-led DREAM trial (NCT05788601) designed to evaluate the potential for weight loss following 12 weeks of treatment with dapiglutide and gain key mechanistic insights into effects on inflammatory markers. In the second half of 2024, Zealand expects topline results from the Phase 1b 13-week dose titration trial (NCT06000891) designed to evaluate dapiglutide in otherwise healthy participants with overweight or obesity (eligible BMI 27.0–39.9). In this trial, higher maximum maintenance doses are planned than were used in the prior 4-week MAD trial and ongoing DREAM trial. Survodutide, a glucagon/GLP-1 receptor dual agonist. In February 2024, Boehringer Ingelheim and Zealand Pharma announced positive results from the Phase 2 trial of survodutide in metabolic dysfunction-associated steatohepatitis (MASH), previously known as nonalcoholic steatohepatitis (NASH). The topline results showed that up to 83.0% of adults treated with survodutide achieved a biopsy-proven improvement in MASH (stages F1, F2 and F3) after 48 weeks, versus 18.2% with placebo [response difference: 64.8% (CI 51.1% - 78.6%), p-value (p<0.0001)]. Boehringer expects to present these results at a scientific congress in the first half of 2024. In a Phase 2 trial in people living with overweight or obesity, survodutide achieved up to 18.7% mean weight loss from baseline after 46 weeks. The full data were presented at the 2023 American Diabetes Association’s (ADA) 83rd Scientific Sessions. Boehringer is currently evaluating survodutide in Phase 3 clinical trials, including SYNCHRONIZE™-1 and SYNCHRONIZE™-2, enrolling people living with overweight or obesity without and with type 2 diabetes, respectively, and SYNCHRONIZE™-CVOT, a long-term cardiovascular safety trial in people living with overweight or obesity with cardiovascular disease, chronic kidney disease or with risk factors for cardiovascular disease. Rare diseases – progressing towards patients Dasiglucagon in congenital hyperinsulinism (CHI). In the first half of 2024, Zealand expects to resubmit the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the prevention and treatment of hypoglycemia in pediatric patients seven days of age and older with CHI for up to three weeks of dosing. The resubmission is in response to a Complete Response Letter issued by the FDA in December 2023 related to deficiencies identified at a third-party manufacturing facility that are not specific to dasiglucagon. Also in the first half of 2024, to support use of dasiglucagon beyond three weeks, the company plans to submit additional analyses, requested by the FDA, from existing continuous glucose monitoring (CGM) datasets that were included as a secondary outcome measure in the Phase 3 program. Zealand plans to make dasiglucagon available to healthcare professionals and patients upon regulatory approval and expects to identify a partner for future commercialization. Glepaglutide in short bowel syndrome (SBS). In December 2023, Zealand submitted an NDA to the U.S. FDA for the treatment of adult patients with SBS dependent on parenteral support. The company expects to receive notification of a PDUFA date in the coming weeks following acceptance of the filing. Zealand anticipates identifying a partner for future commercialization of glepaglutide. Chronic inflammation – initiating first-in-human trials ZP10068, Complement Inhibitor. As part of the discovery and development collaboration with Alexion, Zealand has completed pre-clinical and CMC activities for the investigational long-acting complement inhibitor. Subsequent regulatory, clinical and development efforts will be led and conducted by Alexion. ZP9830, Kv1.3 Ion Channel Blocker. Zealand expects to initiate first-in-human clinical trials in 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 for the full year 2023 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. The live listen-only audio webcast of the call and accompanying slide presentation will be accessible at . To receive telephone dial-in information and a unique personal access PIN, please register 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’s website at . 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 . Forward-Looking Statements This company announcement and associated annual report contain “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 Key Events Anticipated 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, patient recruitment 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 at third party manufacturers; dependency on third parties, for instance contract research or development organizations; 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 the ongoing military conflict in Ukraine and the uncertainty surrounding upcoming elections in the US. 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 company announcement and are based on information available to Zealand Pharma as of the date of this 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. Contacts: Adam Lange Investor Relations Officer Zealand Pharma Email: ALange@zealandpharma.com Anna Krassowska, PhD Vice President, Investor Relations & Corporate Communications Zealand Pharma Email: AKrassowska@zealandpharma.com Attachments Zealand Pharma_Annual Report 2023 549300ITBB1ULBL4CZ12-2023-12-31-en

药渡数据-「全球新药批准月报」真实/可溯源/紧贴业内需求 012023年12月全球/中国新药批准情况及重磅药物解析 022024年1月可能获批的药物预测 03当月全球/中国范围内申报上市的新药、特殊资格认定及重磅药物解析Part 1全球/中国新药批准动态01全球/中国新药12月批准情况2023年12月全球新药批准共计26个，其中中国新药批准共计7个。全球/中国NDA批准详情（部分）全球/中国BLA批准详情全球/中国扩展适应症批准详情（部分）全球/中国新剂型批准详情全球/中国新复方批准详情02全球/中国新药12月批准领域概览本月全球批准新药中，肿瘤领域占比最大31%，涉及小细胞肺癌、胆道癌及胃癌等；其次是感染及血液和淋巴系统，适应症包括侵袭性念珠菌病，多发性骨髓瘤及巨细胞病毒感染等。本月中国批准新药中，肿瘤领域占比最大，达43%，适应症涉及小细胞肺癌及食管癌。03重磅药物解析伊普可泮（Iptacapan）Fabhalta是一种口服、首创（first-in-class）、有效和选择性的补体B因子(FB)小分子抑制剂，作用于免疫系统的补体旁路途径中的近端通路，可与补体替代通路的因子B结合，调节C3的裂解、下游效应物的产生和末端通路的扩增，可全面控制血管内外的红细胞（RBC）破坏（血管内和血管外溶血[IVH和EVH]）。阵发性睡眠性血红蛋白尿症（PNH）是一种罕见的血液系统疾病，临床表现特征包括血管内溶血(IVH)、血栓形成和骨髓衰竭。除PNH之外，Fabhalta目前也处于其他许多补体介导疾病的研究阶段，包括免疫球蛋白A肾病（IgAN）、C3肾小球疾病（C3G）、免疫复合物膜增殖性肾小球肾炎（IC-MPGN）和非典型溶血性尿毒症综合征（aHUS）。Part 22024年1月可能获批的药物预测2024年1月可能获批的药物预测（部分）Part 3全球/中国新药申报动态01全球/中国新药12月申报情况2023年12月全球新药NDA/BLA项目共计59个，其中中国NDA/BLA项目37个；特殊资格认定申报项目共计28个，其中中国申报项目6个。全球/中国NDA申报详情（部分）全球/中国BLA申报详情（部分）02全球/中国新药12月申报领域概览本月海外及中国NDA/BLA申报项目均主要集中血液和淋巴系统、肿瘤，及免疫系统等领域其中，肿瘤领域在海外和中国申报项目占比分别为19%及33%。03全球/中国新药特殊资格认定本月全球特殊资格认定申报项目共计28个（中国6个），主要集中肿瘤占比为53%免疫系统、血液接淋巴系统及眼部疾病等占比均为7%，细分适应症包括非细胞肺癌，胃癌等。全球/中国特殊资格认定（化学药）（部分）全球/中国特殊资格认定（生物药）（部分）04重磅药物解析GlepaglutideGlepaglutide是Zealand Pharma开发的一种长效GLP-2类似物，稳定状态下的有效半衰期约为88小时，通过自动注射器每周两次皮下给药。Zealand Pharma于2023年12月21日向FDA递交NDA，适应症为依赖肠外营养支持（PS）的短肠综合征（SBS）。短肠综合征（简称SBS）是由于小肠较短，功能较弱所引起的吸收异常，主要症状是腹泻，其可导致脱水，营养不良和体重减轻。胰高血糖素样肽2 (GLP-2) 是一种33个氨基酸的多肽，GLP-2及其关类似物可用于治疗短肠综合征、克隆氏症、骨质疏松症以及作为癌症化疗期间的辅助治疗。本次提交是基于关键性随机、双盲临床3期研究EASE-1(NCT03690206)的数据，研究入组了106名每周至少三天依赖肠外支持（PS）的SBS患者，评估每周一次和两次皮下注射Glepaglutide 10mg的安全性和有效性。结果显示：与安慰剂组对比，每周两次Glepaglutide给药在第24周显著降低患者每周PS所需总液体体积：Glepaglutide组 vs 安慰剂组：5.13公升/周 vs 2.85公升/周在无结肠连续性和有结肠连续性患者的解剖亚组分析中，第24周时的平均PS体积减少分别为-5.63L/周和-4.77L/周。咨询、合作请联系作者小D有话说为方便读者阅读及保存，我们将周报原文整理成了PDF版本，如需获取全文，可点击最上方蓝字，在药渡Daily公众号后台回复“12月批准月报”，即可下载。