Q1 2024 Presentation
Zealand Pharma
May 16, 2024
Forward-looking statements
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 2024 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 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 intended as advertising or medical advice.
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Solid start to 2024 with strong progress across obesity pipeline and PDUFA dates for rare disease assets
Advancing differentiated obesity pipeline
Progressing rare disease assets to patients
Petrelintide
amylin analog
Dapiglutide
dual GLP-1/GLP-2
receptor agonist
Survodutide1
dual GCG/GLP-1 receptor agonist
- 16-weektrial completed; on track for topline data in late Q2 2024
- DREAM trial completed; on track for topline data in mid-Q2 2024
- Boehringer announced positive topline data from Phase 2 trial in
MASH
Dasiglucagon in congenital hyperinsulinism
- PDUFA date for Part 1 set by US FDA on October 8, 20242
Glepaglutide in
short bowel syndrome
- PDUFA date set by US FDA on December 22, 2024
Strengthening financial position
- Runway extended into 2027 through capital raise in January
Notes: 1. Survodutide 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. 2. Part 1 of the New Drug Application for dasiglucagon in congenital hyperinsulinism relates to dosing of up to three weeks.
MASH=metabolic dysfunction-associated steatohepatitis (formerly NASH=non-alcoholic steatohepatitis); PDUFA=Prescription Drug User Fee Act; FDA=Food and Drug Administration.
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We are well on track to deliver on the most important priorities for the year 2024
Petrelintide
(amylin analog)
Ph1b 16-week MAD clinical trial data
Ph2b trial initiation
Dapiglutide
(GLP-1R/GLP-2R)
Ph2a DREAM clinical trial data1
Ph1b 13-weekdose-titration clinical trial data
Survodutide2
(GCGR/GLP-1R)
Ph2 MASH clinical trial data
Ph3 obesity trial enrollment3
Deliver on rare disease and inflammation pipeline
Regulatory decisions for rare disease assets | First-in-human trial initiation with inflammation assets |
Dasiglucagon for CHI
Glepaglutide for SBS
ZP9830 (Kv1.3 Ion Channel Blocker)
ZP10068 (Complement C3 Inhibitor)
Notes: 1. DREAM is an investigator-led trial. 2. Survodutide 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). 3. SYNCHRONIZETM.
MAD=multiple ascending dose; MASH=metabolic dysfunction-associated steatohepatitis (formerly NASH=non-alcoholic steatohepatitis); CHI=congenital hyperinsulinism; SBS=short bowel syndrome.
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Our R&D pipeline addresses unmet medical needs across several therapeutic areas
Product candidatea | Partnered | Pre-clinical | Phase 1 | Phase 2 | Phase 3 | Registration |
Obesity
Rare | diseases |
Inflam- | mation |
T1DM |
,
Dapiglutide (GLP-1R/GLP-2R dual agonist)
Petrelintide (amylin analog)
ZP6590 (GIP receptor agonist)
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)
Dasiglucagon: bi-hormonal artificial pancreas systems
Dasiglucagon: mini-dose pen
Obesity
Obesity
Obesity
Obesity and MASH
Congenital hyperinsulinism
Short bowel syndrome
Undisclosed
Undisclosed
T1DM management
T1DM exercise-induced hypoglycemia
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-likepeptide-1 receptor; GLP-2=glucagon-likepeptide-2;GLP-2R=glucagon-likepeptide-2 receptor; MASH=metabolic dysfunction-associated steatohepatitis (formerly NASH, or nonalcoholic steatohepatitis); SC=subcutaneous; T1DM=type 1 diabetes mellitus.
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In late Q2 2024, we expect topline results with petrelintide from the Phase 1b 16-week trial
A potentially best-in-class amylin analog
Targeting GLP-1RA-like weight reduction; high
quality weight loss with preservation of lean mass
Unique, non-incretin mechanism that reduces food intake by increasing satiety and restoring leptin sensitivity
Potential for improved tolerability vs. GLP-1RAs
The 16-week trial is exploring significantly higher
doses using an up-titration scheme1
Trial design
- N=48, men and women aged 18-64 years (BMI 27.0-39.9 kg/m2)
- Duration = 16 weeks
- Dose strengths = significantly higher than in previous MAD Part 1 and SAD, thus much higher than 2.4 mg2
Topline data
- %-changein body weight from baseline to week 16
- Safety and tolerability profile
Phase 2b planned for initiation in H2 2024
Source: 1. ClinicalTrials.gov (NCT05613387).
GLP-1RA=glucagon-likepeptide-1 receptor agonist; MAD=multiple ascending dose; SAD=single ascending dose; TEAEs=treatment-emergent adverse events.
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In mid-Q2 2024, we expect topline results with dapiglutide from the investigator-led trial DREAM
A first-in-classGLP-1R/GLP-2R dual agonist
Safety and tolerability similar to other GLP- 1RA-based weight-lossmedications
Potential cardioprotective benefits from GLP-1agonism and additional anti-inflammatoryeffect from GLP-2agonism
Potential for regenerative effects to address organ damage associated with low-grade inflammation, e.g., MASH and Alzheimer's disease
DREAM evaluating effects on body weight,
gut permeability and inflammation1
Trial design
- N=54, men and women aged 18-75 years (BMI ≥30 kg/m2)
- Duration = 12 weeks
- Dose strengths = up to 6.0 mg (similar to 4-week MAD)2
Topline data
- %-changein body weight from baseline to week 12
- Safety and tolerability profile
Topline data from DREAM (low doses) in Q2 2024
Topline data from Phase 1b 13-week dose- titration trial (high doses) in H2 2024
Source: 1. ClinicalTrials.gov (NCT05788601). 2. Data presented by Agersnap at the 82nd ADA Scientific Sessions, June 3-7, 2022, New Orleans, LA.
MASH=metabolic dysfunction-associated steatohepatitis (formerly NASH=non-alcoholic steatohepatitis); GLP-1RA=glucagon-likepeptide-1 receptor agonist; GLP-2=glucagon-likepeptide-2; MAD=multiple ascending dose.
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Survodutide* glucagon/GLP-1 receptor dual agonist shows best-in-class potential in MASH Phase 2 trial
Phase 2 trial in people with overweight or obesity1 | Phase 2 biopsy-driven trial in people with MASH3 |
Mean relative change at Week 46 (%)
(%) | 0 | |||||||||||
weight | -2 | Placebo | -2.0% | |||||||||
-4 | (n=76) | |||||||||||
body | ||||||||||||
-6 | Survodutide | -6.8% | ||||||||||
in | ||||||||||||
-8 | 0.6 mg (n=88) | |||||||||||
CI) change | ||||||||||||
-10 | ||||||||||||
-12 | ||||||||||||
(95% | -14 | Survodutide | -13.6% | |||||||||
2.4 mg (n=92) | ||||||||||||
mean | -16 | Survodutide | -16.7% | |||||||||
-18 | 3.6 mg (n=71) | |||||||||||
Adjusted | Survodutide | |||||||||||
-18.7% | ||||||||||||
-20 | 4.8 mg (n=54) | |||||||||||
-22 | ||||||||||||
Dosing QW | ||||||||||||
0 | 2 | 4 | 6 | 8 101214161820 | 24 | 28 | 32 | 36 | 40 | 46 | ||
Baseline | Week |
SYNCHRONIZE Phase 3 clinical program in obesity ongoing2
Participants showing improvement in MASH without worsening of fibrosis (stages F1-F3):83.0% with survodutide vs. 18.2% with placebo (p<0.0001)
Statistically significant improvement in liver fibrosis with survodutide in secondary endpoint
Survodutide treatment did not show unexpected safety or tolerability issues, including at the higher dose of 6.0 mg
Full data to be presented at the EASL congress in Milan, Italy on June 7, 2024
Further development in MASH planned
*Survodutide 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). | |
Source: 1. Figure adapted from Le Roux et al. Oral presentation (51-OR) at ADA 83rd Scientific Sessions, June 23-26, 2023, San Diego, CA. Analysis based on dose reached at the end of treatment regardless of the dose assigned | |
at randomization. 2. ClinicalTrials.gov accessed February 2024; 3. Boehringer Ingelheim press release February 26, 2024. | 8 |
MASH=metabolic dysfunction-associated steatohepatitis (formerly NASH=non-alcoholic steatohepatitis); CI=confidence interval; QW=once-weekly; GCG=glucagon; GLP-1=glucagon-likepeptide-1. |
Dasiglucagon is being developed to address a high unmet medical need for the management of CHI
US FDA has accepted the resubmission1 of NDA
Part 1 with a PDUFA goal date of October 8, 2024
Two Phase 3 trials in neonates and children up to 12 years of age demonstrated clinical potential
PDUFA date for NDA Part 1 for up to three weeks of dosing set by US FDA for October 8, 2024
Submission of NDA Part 2 for use beyond three weeks2 of dosing expected in the second half of 2024
Investigational compound and device3 whose safety | |
Partnering discussions ongoing | and efficacy have not been evaluated or approved |
by the FDA or any other regulatory authority. |
Notes: 1. The US FDA issued a Complete Response Letter (CRL) in December 2023 due to inspection findings at a third-party manufacturing facility that were not specific to dasiglucagon. 2. To be supported by additional analyses from existing CGM datasets included as a secondary outcome measure in the Phase 3 program. 3. Zealand Pharma has entered a collaborative development and supply agreement with DEKA Research & Development Corporation and affiliates for infusion pump system.
CHI=congenital hyperinsulinism; NDA=new drug application; PDUFA=Prescription Drug User Fee Act; FDA=Food and Drug Administration; CGM=continuous glucose monitoring.
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Glepaglutide has best-in-class potential as a next- generation GLP-2 therapy for patients with SBS
US FDA has accepted the NDA submission with a
PDUFA goal date of December 22, 2024
Significantly reduced weekly PS volume at 24 weeks versus placebo in the EASE-1 trial in SBS1
Expected 10 mg twice-weekly subcutaneous dosing;
Ready-to-useauto-injector with needle protection
PDUFA date with US FDA on December 22, 2024
Glepaglutide is an investigational product whose safety and efficacy has not been evaluated or approved by the FDA or any other regulatory authority.
Partnering discussions ongoing
Notes: 1. Results presented by Palle B. Jeppesen at the ASPEN 2023 Nutrition Science & Practice Conference in April 2023.
SBS=short bowel syndrome; PS=parenteral support; PDUFA=Prescription Drug User Fee Act; FDA=Food and Drug Administration.
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Zealand Pharma A/S published this content on 16 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 16 May 2024 16:18:02 UTC.