Slides
Page 1
FY 2024 Presentation Zealand Pharma February 20, 2025 1
Page 2
Forward-looking Statements 2 This presentation 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 significant events and potential catalysts in 2025 and any financial guidance published by the company, as applicable. 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. 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 presentation and are based on information available to Zealand Pharma as of the date of this presentation. 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 intendedas advertising or medical advice.
Page 3
Agenda 3 Q&A Opening remarks R&D pipeline Financials Adam Steensberg Chief Executive Officer David Kendall Chief Medical Officer Henriette Wennicke Chief Financial Officer
Page 4
aSurvodutide is licensed to Boehringer Ingelheim from Zealand Pharma, with Boehringer solely responsible for development and commercialization globally (subject to Zealand's co-promotion rights in the Nordic countries). GLP-1=glucagon-like peptide-1; GLP-1RA=glucagon-like peptide-1 receptor agonist; GLP-2=glucagon-like peptide-2; GCG=glucagon; MASH=metabolic dysfunction-associated steatohepatitis. Petrelintide (amylin analog) Presented encouraging weight loss and tolerability data from Part 2 of the Phase 1b trial Potential best-in-class alternative to GLP-1RA-based therapies Dapiglutide (dual GLP-1/GLP-2 receptor agonist) Reported positive topline data from Part 1 of the Phase 1b trial Potential first-in-class therapy for obesity and inflammation-related comorbidities Significant progress across obesity pipeline in 2024 4 Survodutidea (dual GCG/GLP-1 receptor agonist) Breakthrough Therapy Designation for survodutide in MASH and initiation of two Phase 3 trials Potential best-in-class therapy for obesity and MASH
Page 5
aZUPREME-1 primary completion expected in H2 2025 and study completion expected in H1 2026, ClinicalTrials.gov (NCT06662539), accessed February 2025. bSurvodutide is licensed to Boehringer Ingelheim from Zealand Pharma, with Boehringer solely responsible for development and commercialization globally (subject to Zealand's co-promotion rights in the Nordic countries). cSYNCHRONIZETM-1 and 2 primary completion expected in H2 2025, ClinicalTrials.gov (NCT06066515; NCT06066528), accessed February 2025. T2D=type 2 diabetes; GLP-1R=glucagon-like peptide-1 receptor; GLP-2R=glucagon-like peptide-2 receptor; GLP-1RA=glucagon-like peptide-1 receptor agonist; GCGR=glucagon receptor; MASH=metabolic dysfunction-associated steatohepatitis; CHI=congenital hyperinsulinism; SBS=short bowel syndrome; SAD=single ascending dose; MAA=marketing authorization application; EMA=European Medicines Agency. 5 We have a strong focus in 2025 on advancing our differentiated obesity programs in Phase 2 and 3 Initiate Ph2b T2D obesity trial (ZUPREME-2) Petrelintide (amylin analog) Dapiglutide (GLP-1R/GLP-2R) Survodutideb (GCGR/GLP-1R) Complete Ph2b obesity triala (ZUPREME-1) Initiate Ph1b combination trial w. GLP-1RA Initiate Ph2b obesity trial Complete Ph3 obesity trialsc (SYNCHRONIZETM-1 and 2) Progress Ph3 MASH trials (LIVERAGE and LIVERAGE-Cirrhosis) Dasiglucagon (CHI) Initiate EASE-5 (Ph3 trial) Rare diseases Advance next-generation inflammation pipeline ZP9830 (Kv1.3 Ion Channel Blocker) Complete Ph1a trial ZP10068 (Complement C3 Inhibitor) Evaluate initiation of Ph1a trial Glepaglutide (SBS) Submit MAA to the EMA U.S. FDA approval Present detailed results from Ph1b trial Report topline data from 28-week Ph1b trial
Page 6
Sources: 1. World Obesity Atlas 2024; 2. Almandoz et al. (2024) Nutritional considerations with antiobesity medications, Obesity (Silver Spring), 32(9): 1613-1631; 3. American Medical Association 2024: https://www.ama- assn.org/topics/obesity. BMI=body mass index; CVD=cardiovascular disease. 6 The obesity pandemic represents one of the greatest healthcare challenges of our time The obesity pandemic has evolved in only 50 years 50% of adults globally are projected to have overweight or obesity by 20301 Today, more than 5 million deaths globally are ascribed to overweight and obesity every single year1 For 300,000 years, human beings maintained a relatively stable BMI… Early days in the evolution of this market… ~2% Eligible patients in the US receiving prescriptions for weight loss therapy2 >220 Complications and comorbidities associated with obesity Including CVD, liver disease, type 2 diabetes, kidney disease, neuro-inflammation and some cancers3 There is a significant unmet medical need for more and better treatment options
Page 7
Target product profile of petrelintide holds potential to address the needs of patients and physicians 7 GLP-1RA-based therapies are effective at reducing weight but are associated with GI tolerability issues1 Petrelintide is a long-acting amylin analog with the following target product profile: 15–20% mean weight loss and high-quality weight loss with potential for preservation of lean mass Reduced food intake via a non-incretin mechanism that increases satiety and restores leptin sensitivity Significantly improved GI tolerability with both lower frequency and severity of adverse events Today, two QW GLP-1RA-based therapies are approved,a,2,3 offering ~15–21% mean weight loss4,5 > aFor chronic weight management: Wegovy and Zepbound. Sources: 1. Wang et al. Front Endocrinol (Lausanne) 2023;14:1085799; 2. Wegovy (semaglutide) US PI. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215256s011lbl.pdf, accessed July 2024; 3. Zepbound (tirzepatide) US PI. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s003lbl.pdf, accessed July 2024; 4. Wilding et al. N Engl J Med 2021;384(11):989–1002; 5. Jastreboff et al. N Engl J Med 2022;387(3):205–216; 6. Blue Health Intelligence. Real-world trends in GLP-1 treatment persistence and prescribing for weight management. May 2024; 7. Gasoyan et al. Obesity (Silver Spring) 2024;32(3):486–493. GI=gastrointestinal; GLP-1RA=glucagon-like peptide-1 receptor agonist; QW=once-weekly. GLP-1RAs are commonly associated with GI side effects, including constipation, nausea, vomiting and diarrhea4,5 Up to 30% of patients with obesity discontinue GLP-1RA treatment within 1 month6 Month Month Up to 60–70% of patients discontinue GLP-1RA treatment within 12 months7Year
Page 8
aInvestigational compounds whose safety and efficacy have not been evaluated or approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority. bSurvodutide is licensed to Boehringer Ingelheim from Zealand Pharma, with Boehringer solely responsible for development and commercialization globally (subject to Zealand's co-promotion rights in the Nordic countries): EUR 315 million outstanding potential development, regulatory and commercial milestones + high single to low double digit % royalties on global sales. GCGR=glucagon receptor; GIP=gastric inhibitory polypeptide; GLP-1R=glucagon-like peptide-1 receptor; GLP-2=glucagon-like peptide-2; GLP-2R=glucagon-like peptide-2 receptor; MASH=metabolic dysfunction-associated steatohepatitis (formerly NASH, or nonalcoholic steatohepatitis); SC=subcutaneous. 8 Our R&D pipeline addresses unmet medical needs across several therapeutic areas Product candidatea Partnered Pre-clinical Phase 1 Phase 2 Phase 3 Registration , Petrelintide (amylin analog) Dapiglutide (GLP-1R/GLP-2R dual agonist) ZP6590 (GIP receptor agonist) Survodutide (GCGR/GLP-1R dual agonist)b Survodutide (GCGR/GLP-1R dual agonist)b Dasiglucagon: SC continuous infusion Glepaglutide (GLP-2 analog) ZP9830 (Kv1.3 ion channel blocker) ZP10068 (complement C3 inhibitor) Inflammation Rare diseases Obesity and related comorbidities Congenital hyperinsulinism Short bowel syndrome Undisclosed Obesity Undisclosed Obesity Obesity MASH Obesity
Page 9
9 Petrelintide has consistently shown best-in-class potential across early clinical trials to date SAD trial1 Placebo (N=6) 0.7 mg (N=6) 1.4 mg (N=6) 2.4 mg (N=6) 0.6% -2.6% -3.6% -4.2% % change in body weight from baseline at Day 7 • Well tolerated • No serious or severe TEAEs • No withdrawals MAD trial Part 1 (6-week study)2 Placebo (N=6) 0.6 mg (N=7) 1.2 mg (N=7) -0.4% -5.3% -5.1% % change in body weight from baseline at Week 6 • All drug-related TEAEs were mild • Three participants reported nausea • One participant reported vomiting • No withdrawals MAD trial Part 2 (16-week study)3 Placebo (N=12) 2.4 mg (N=12) 4.8 mg (N=11) 9.0 mg (N=10) -1.7% -4.8% -8.6% -8.3% % change in body weight from baseline at Week 16 • All GI AEs mild except for two moderate events reported by one participant (nausea, vomiting) • This participant was the only one discontinuing treatment due to AEs Sources: 1. Brændholt Olsen et al. Poster 92-LB. Presented at ADA 83rd Scientific Sessions, June 23–26, 2023, San Diego, CA; 2. Brændholt Olsen et al. Poster presented at ObesityWeek, October 14–17, 2023, Dallas, TX; 3. Data presented at ObesityWeek 2024 in San Antonio, Texas. GI=gastrointestinal; AE=adverse event; TEAE=treatment emergent adverse event; SAD=single ascending dose; MAD=multiple ascending dose; N=number of participants. Obesity Petrelintide
Page 10
Petrelintide dose group 5 Sources: 1. ClinicalTrials.gov (NCT06662539), accessed February 2025, ZUPREME-1 is intended to remain blinded until the safety follow up is complete at week 51; 2. Data on file. BMI=body mass index; HbA1c=glycated hemoglobin; MRI=magnetic resonance imaging; hsCRP=high-sensitivity C-reactive protein. 10 Continuing development of petrelintide as monotherapy through a comprehensive Phase 2b trial (ZUPREME-1) A randomized, double-blind, placebo-controlled, Phase 2b trial with petrelintide was initiated in Dec-20241,2 Randomization 51 Aim: to evaluate change in body weight with multiple doses of petrelintide versus placebo Screening 28 Time (weeks) Placebo Petrelintide dose group 4 Petrelintide dose group 3 42 Safety follow-up Petrelintide dose group 1 Petrelintide dose group 2 16 N=480 • Adults ≥18 years • HbA1c < 6.5% • BMI ≥30 kg/m2 OR ≥27 kg/m2 with one comorbidity R Dose escalation (every fourth week) Primary endpoint: • Percentage change in body weight from baseline to week 28 Secondary/exploratory endpoints (non-exhaustive): • Absolute change in body weight • Percentage change in body weight after 42 weeks • Categorical weight loss (≥5% and ≥10%) • Change in waist circumference • Percentage change in HbA1c after 42 weeks • Body composition (MRI) • Inflammation biomarkers • CV risk factors (e.g., hsCRP, triglycerides, cholesterol, blood pressure, pulse rate) Diet and exercise counseling during treatment period Obesity Petrelintide
Page 11
Petrelintide dose group 1 Petrelintide dose group 2 Source: 1. Data on file. T2D=type 2 diabetes; BMI=body mass index; QW=once-weekly; HbA1c=hemoglobin A1C (glycated hemoglobin); TEAE=treatment emergent adverse event. 11 Expanding the development program with Phase 2b trial in people with overweight/obesity and T2D (ZUPREME-2) A randomized, double-blind, placebo-controlled, Phase 2b trial with petrelintide to be initiated in H1 20251 Randomization Aim: Demonstrate superior weight loss for petrelintide vs. placebo in people with T2D and overweight or obesity Screening Time (weeks) Placebo 28 Safety follow-up Primary endpoint: • Percentage change in body weight from baseline to week 28 N=~200 • Adults ≥18 years • BMI ≥ 27 kg/m2 R Dose escalation (every fourth week) Secondary endpoints (non-exhaustive): • Categorical weight loss (≥5% and ≥10%) • HbA1c • Blood pressure • Fasting lipids • TEAEs • Hypoglycemia Petrelintide dose group 3 38 Diet and exercise counseling during treatment period Obesity Petrelintide 16
Page 12
Sources: 1. Zealand Pharma company announcement No. 44/2024, September 9, 2024; 2. ClinicalTrials.gov (NCT06000891), accessed December 2024. BMI=body mass index; GI=gastrointestinal; AE=adverse event; N=number of participants. 12 We expect to report topline results with dapiglutide from the 28-week Phase 1b trial in H1 2025… Phase 1b trial Part 1: Topline results1 Mean placebo-adjusted weight loss of up to 8.3% after 13 weeks • N=54, 85% male, median baseline BMI: 30 kg/m2 • No lifestyle modifications included in trial • Dapiglutide up to 13 mg assessed to be safe and well-tolerated • GI AEs consistent with profile of incretin-based therapies • Two treatment discontinuations due to GI AEs Phase 1b trial Part 2: Topline results in H1 20252 • Includes a higher dose cohort (up to 26 mg) with 28 weeks treatment • Monthly dose escalation • Topline results expected in H1 2025 Large, comprehensive Phase 2b trial to be initiated in H1 2025 Obesity Dapiglutide
Page 13
Source: 1. Data on file. BMI=body mass index; EOT=end of treatment 13 …and initiate a comprehensive Phase 2b trial with dapiglutide in people with overweight/obesity in H1 2025 DapiglutideObesity Dapiglutide Dapiglutide dose group 1 Dapiglutide dose group 2 A randomized, double-blind, placebo-controlled, Phase 2b trial with dapiglutide to be initiated in H1 20251 Randomization Aim: To evaluate change in body weight with multiple doses of dapiglutide versus placebo Screening Time (weeks) Placebo Safety follow-up Primary endpoint: • Percentage change in body weight from baseline to week 36 N=400+ • Adults ≥18 years • BMI ≥30 kg/m2 OR ≥27 kg/m2 with one comorbidity R Dose escalation (every fourth week) Secondary/explorative endpoints (non-exhaustive): • Categorical weight loss (≥5% and ≥10%) • Body composition • Inflammation biomarkers Dapiglutide dose group 3 Dapiglutide dose group 4 48 Dapiglutide dose group 5 36 ILLUSTRATIVE 20 55
Page 14
aSurvodutide is licensed to Boehringer Ingelheim from Zealand Pharma, with Boehringer solely responsible for development and commercialization globally (subject to Zealand's co-promotion rights in the Nordic countries). Sources: 1. Boehringer Ingelheim press release June 7, 2024. Data presented at the EASL Congress 2024 in Milan, Italy. 2. A s ensitivity analysis based on participants with paired biopsy results at baseline and end of treatment. 3. Boehringer Ingelheim press release October 8, 2024; 4. LIVERAGE: ClinicalTrials.gov (NCT06632444); 5. LIVERAGE-Cirrhosis: ClinicalTrials.gov (NCT06632457). MASH= metabolic dysfunction-associated steatohepatitis (formerly NASH=non-alcoholic steatohepatitis). 14 Survodutidea shows best-in-class potential in MASH Phase 2 trial and is now in large Phase 3 program 0 10 20 30 40 50 60 70 80 90 100 Proportion of participants (%) 56.1% Survodutide 2.4mg (N=41) 40.9% Survodutide 4.8mg (N=44) 64.5% Survodutide 6mg (N=31) 25.9% Placebo (N=54) Improvement in liver fibrosis with no worsening of MASH Paired biopsy results (F2/F3)2 P=0.0041 P=0.1191 P=0.0007 Actual treatment MASH Survodutide 48-week biopsy-driven Phase 2 trial in MASH1 Phase 3 program in MASH has been initiated3 LIVERAGE-Cirrhosis5 Efficacy and safety in patients with MASH and cirrhosis (F4) Primary endpoint: • Part 1: MASH resolution without worsening of liver fibrosis and improvement in fibrosis stage with no worsening of MASH • Part 2: Time to first occurrence of liver-related events or all-cause mortality LIVERAGE4 Efficacy and safety in patients with MASH and fibrosis (F2/F3) Granted Breakthrough Therapy Designation by the U.S. FDA Trial participants: 1,800 Trial duration: • Part 1: 52 weeks • Part 2: Up to 7 years Trial participants: 1,590 Trial duration: Up to 4.5 years Primary endpoint: Time to first occurrence of liver-related events or all- cause mortality
Page 15
aThe U.S. FDA issued a Complete Response Letter to Part 1 of the dasiglucagon NDA due to the timing of a third-party manufacturing facility reinspection. A prior inspection of the facility had identified deficiencies that did not involve dasiglucagon. These prior deficiencies had been resolved as of the reinspection. The third-party manufacturer has not yet received its Establishment Inspection Report. bThe U.S. FDA issued a Complete Response Letter for the glepaglutide New Drug Application for the treatment of short bowel syndrome with intestinal failure in December 2024. NDA=New drug application; CHI= congenital hyperinsulinism; FDA=Food and Drug Administration; MAA=marketing authorization application. 15 We remain committed to bring our rare disease programs to patients as soon as possible Rare diseases Glepaglutide: Short bowel syndrome Dasiglucagon: Congenital hyperinsulinism Timing of next steps contingent on third-party manufacturing facility receiving an inspection classification upgradea Prepared to resubmit Part 1 of the original NDA for up to three weeks of dasiglucagon treatment Submission of Part 2 of the original NDA for chronic treatment of CHI planned for after Part 1 Type-A meeting with the U.S. FDA expected Q1 2025b Anticipate proceeding with current plans to submit a MAA in 2025 to support EU approval Expect to initiate a Phase 3 trial in 2025 (EASE-5)
Page 16
Sources: 1. Chandy and Norton, Current Opinion in Chemical Biology 2017, 38:97–107; 2. ClinicalTrials.gov (NCT06682975), accessed February 2025. PK=pharmacokinetic; PD=pharmacodynamic; SAD=single ascending dose trial; SC=subcutaneous; IV=intravenous. Advancing early-stage pipeline through ongoing first- in-human clinical trial with Kv1.3 inhibitor ZP9830 16 Inflammation ZP9830 ZP9830 is a potent and selective Kv1.3 inhibitor Cohorts 1-3 (SC): Assess safety and PK Cohorts 4-9 (SC): Assess safety, PK, and PD Cohort 10 (IV): Assess safety and PK The first-in-human Phase 1 single ascending dose trial include 10 dose cohorts and is expected to enroll 92 healthy men. The trial will investigate: • Safety and tolerability profile with single ascending doses • PK profile to determine the appropriate dose level(s) • Effect of ZP9830 on the body’s immune system First-in-human SAD clinical trial2 ZP9830 holds potential to treat a broad range of cell-mediated autoimmune diseases Blocking Kv1.3 is believed to preserve the protective effects of the rest of the immune system, making it an attractive target Kv1.3 is highly expressed in effector memory T cells, which play a key role in autoimmunity and chronic inflammation1
Page 17
FY 2024 Profit & Loss DKK million FY 2024 FY 2023 Revenue 63 343 Gross profit 55 324 Research and development expenses -920 -685 Sales and marketing expenses -88 -31 General and administrative expenses -316 -185 Other operating Items -3 5 Net operating expenses -1,327 -896 Operating result -1,272 -572 Net financial items 189 -137 Result before tax -1,083 -709 Tax 5 5 Net result for the period -1,079 -704 Research and Development Sales and Marketing General and Administration Other Operating Items • Revenue of DKK 63 million is mainly driven by the license and development agreement with Novo Nordisk for Zegalogue®. • Total operating expenses of DKK 1,327 million are higher than last year, primarily driven by the increase in R&D expenses due to clinical advancement of the obesity pipeline, including preparations for large Phase 2b trials for the wholly-owned obesity assets. S&M expenses are mainly driven by pre-commercial activities for the rare disease assets, whereas the increase in G&A expenses reflects legal expenses related to our patent portfolio and strengthening of organizational capabilities. • Net financial items of DKK 189 million are mainly driven by interest income from the excess liquidity invested in marketable securities. P&L reflecting Zealand’s investments in its differentiated assets targeting obesity FY 2024 OPEX composition DKKm 920 (69%) 88 (7%) 316 (24%) 3 (0%) 17
Page 18
Strong cash position of DKK 9.0 billion enables significant investments in our obesity programs 18 aCash position includes cash, cash equivalents and marketable securities. EIB loan Tranches B and C (EUR 20 million each) are excluded from this chart. The two tranches are subject to pre-specified milestones being met. bOther cash adjustments include purchase of treasury shares to cover LTI programs. cThe EUR 50 million Tranche A of the EIB loan facility was disbursed in March 2024. EIB = European Investment Bank Secured cash of DKK 8.6 billion in 2024 through capital raises and the EIB loan facilitya DKK million 449 Cash position Dec-23a -931 Cash flow from operating activities -269 Other cash adjustmentsb Net proceeds from capital raise Jan-2024 373 Proceeds from EIB loan (Tranche A) Mar-2024c Net proceeds from capital raise Jun-2024 480 Cash position Dec-2024a 1,633 9,022 1,184 1,427 6,789 8,542 Cash and cash equivalents Marketable securities
Page 19
2025 financial guidance 19 DKK million 2025 Guidance 2024 Actuals Revenue anticipated from existing and new license and partnership agreements No guidance 63 Net operating expensesa 2,000 – 2,500 1,327 aNet operating expenses consist of R&D, S&M, G&A and other operating items. Financial guidance based on foreign exchange rates as of February 19, 2025. 2025 operating expenses anticipated to be in the range of DKK 2,000-2,500 million Anticipated increase in OPEX is mainly to support mid-stage obesity pipeline and further enhance research efforts • Development: Accelerate investments in obesity pipeline, which in 2025 will include three large Phase 2b trials. In addition to the clinical costs associated with conducting these trials, the guidance also includes CMC investments in activities mainly related to API and Drug Product, as well as preparations for Phase 3 • Research: Enhance investments in next-generation peptide research, including early-stage portfolio of novel peptides targeting obesity and inflammation
Page 20
Advancing for a sustainable future 20 Highlights and ambitions Calculated CO2 emissions and developed transition plan, with commitment to Science Based Targets initiative in 2025 Notable organizational growth while maintaining high employee engagement and low turnover Launched dedicated sustainability strategy, significantly increasing our efforts
Page 21
Potential partnership agreements across therapeutic areas aSurvodutide is licensed to Boehringer Ingelheim from Zealand Pharma, with Boehringer solely responsible for development and commercialization globally (subject to Zealand's co-promotion rights in the Nordic countries). Primary completion of SYNCHRONIZETM-1 and 2 is expected in H2 2025, ClinicalTrials.gov (NCT06066515; NCT06066528), accessed February 2025. T2D=Type 2 diabetes; SAD=single ascending dose; NDA=new drug application; FDA=Food and Drug Administration; GLP-1RA=glucagon-like peptide-1 receptor agonist; MAA=marketing authorization application. 21 Exciting news flow with many potential catalysts in 2025 NON-EXHAUSTIVE H2 2025 Dapiglutide Report topline results from Part 2 of Ph1b dose-titration trial (28wks) H1 2025 Glepaglutide (SBS) Initiate additional Ph3 trial (EASE-5) Dasiglucagon (CHI) Submit analyses supporting chronic use (Part 2) to US FDA Dasiglucagon (CHI) Resubmit Part 1 (acute use) of NDA to US FDA and potential approval Dapiglutide Present results from Ph1b dose-titration trial (13wks) Dapiglutide Initiate Ph2b trial (overweight/obesity) Petrelintide Complete enrollment in Ph2b trial (overweight/obesity without T2D) Petrelintide Initiate Ph2b trial (overweight/obesity with T2D) Obesity Rare diseases Legend: Inflammation ZP9830 (Kv1.3 Ion Channel Blocker) Complete Ph1 SAD trial Petrelintide Initiate Ph1b combination trial with GLP-1RA Survodutidea Complete Ph3 obesity trials (SYNCHRONIZETM-1 and 2) Glepaglutide (SBS) Submit MAA to the European Medicines Agency Dasiglucagon (CHI) Potential approval by US FDA of chronic use (Part 2) ZP10068 (Complement C3 Inhibitor) Evaluate potential initiation of Ph1 SAD trial
Page 22
Q&A 22 Adam Steensberg Chief Executive Officer David Kendall Chief Medical Officer Henriette Wennicke Chief Financial Officer Eric Cox Chief Commercial Officer