Latest news with #UtpalSingh
Yahoo
08-05-2025
- Business
- Yahoo
Zealand Pharma Announces Financial Results for the First Three Months of 2025
Notes: 1. Operating expenses consist of R&D, S&M, and G&A. 2. Excluding transaction costs of DKK 21.6 million related to the Roche partnership agreement. Operating expenses including transaction fees in Q1 2025 amount to DKK 415 million. 3. Cash position includes cash, cash equivalents and marketable securities. 4. Upfront payment of USD 1.4 billion from Roche is expected in the second quarter of 2025. Embarking on a new chapter with transformative partnership for petrelintide Adam Steensberg, President and Chief Executive Officer at Zealand Pharma said: 'Zealand Pharma has never been in a stronger position than we are today - financially, organizationally and in terms of our clinical development pipeline. The strong foundation enables us to unlock the full value potential of petrelintide in partnership with Roche and significantly accelerate investments in our early-stage research pipeline of next-generation peptide therapeutics targeting obesity and inflammation.' Copenhagen, Denmark, May 8, 2025 – 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 three months ended March 31, 2025, and provided a corporate update. Appointed Utpal Singh as Chief Scientific Officer in April 2025 to lead the next wave of differentiated and innovative medicines, building on Zealand Pharma's strong peptide heritage and its ambition to become a generational biotech company. Enrolled the last participant in the large, global Phase 2 ZUPREME-1 trial with petrelintide in people with overweight or obesity, three months after trial initiation. Entered historic and transformative partnership with Roche to co-develop and co-commercialize petrelintide as a future foundational therapy for weight management and rapidly expand into related indications, aiming to establish the leading amylin-based franchise. Story Continues Highlights in the first quarter of 2025 Obesity Petrelintide, amylin analog. Entered a collaboration and license agreement with Roche. The two companies will co-develop and co-commercialize petrelintide and potential combination products, including petrelintide/CT-388, aiming to establish the leading amylin-based franchise for weight management and related indications. The companies will share profits and losses on a 50/50 basis for petrelintide and petrelintide/CT-388 in the U.S. and Europe, and Zealand Pharma is eligible to receive royalties on net sales in the rest of the world. Total deal consideration amounts to USD 5.3 billion, including upfront cash payments of USD 1.65 billion and potential development milestone payments of USD 1.2 billion, primarily linked to initiation of Phase 3 trials with petrelintide monotherapy. Petrelintide, amylin analog. Completed enrollment in the large, global Phase 2 ZUPREME-1 trial with petrelintide in people with overweight or obesity, three months after trial initiation. Survodutide, glucagon/GLP-1 receptor dual agonist. Boehringer Ingelheim completed participant enrollment in the Phase 3 SYNCHRONIZETM-CVOT trial, marking full enrollment of all trials in the Phase 3 obesity program. Corporate Appointed Steven R. Smith, MD, as Senior Global Medical Advisor in Obesity. Steven will support Zealand Pharma's obesity research and clinical development programs. Events after the reporting date Obesity Petrelintide, amylin analog. In April 2025, Zealand Pharma initiated the Phase 2 ZUPREME-2 trial with petrelintide in people with overweight or obesity and type 2 diabetes, investigating the efficacy and safety of petrelintide over a treatment duration of 28 weeks. Corporate Appointed Utpal Singh as Chief Scientific Officer. Utpal joins the executive team to lead discovery research and translational sciences at Zealand Pharma. Utpal brings nearly 25 years of pharmaceutical industry experience spanning the full drug discovery and development lifecycle. Upcoming events next 12 months Obesity Petrelintide, amylin analog. In the first half of 2026, Zealand Pharma expects to report topline results from the Phase 2 ZUPREME-1 trial and complete the Phase 2 ZUPREME-2 trial with petrelintide. Petrelintide/CT-388, amylin+GLP-1/GIP fixed-dose combination . Zealand Pharma and Roche expect to initiate Phase 2 trials with petrelintide/CT-388 in the first half of 2026. Dapiglutide, GLP-1/GLP-2 receptor dual agonist. In the second quarter of 2025, Zealand Pharma expects to announce topline results from Part 2 of the Phase 1b trial evaluating higher doses of dapiglutide over 28 weeks of treatment, with subsequent initiation of a Phase 2 trial expected in the second half of 2025. Zealand Pharma will present the results from Part 1 of the Phase 1b trial at the American Diabetes Association's 85 th Scientific Sessions in Chicago, Illinois in June 2025. Survodutide, glucagon/GLP-1 receptor dual agonist. Topline data from SYNCHRONIZETM-1 and SYNCHRONIZETM-2, the Phase 3 trials with survodutide in participants with overweight or obesity without and with type 2 diabetes, respectively, are expected in the first half of 2026. Rare diseases Glepaglutide in SBS. In the second half of 2025, Zealand Pharma expects to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) and initiate a Phase 3 clinical trial of glepaglutide (EASE-5) that is anticipated to provide further confirmatory evidence for a regulatory submission in the U.S. and to support regulatory submissions outside the U.S. and the EU. In parallel, the company is engaging in partnership discussions for future commercialization. Dasiglucagon in CHI. Zealand Pharma is ready to resubmit the New Drug Application for dasiglucagon for up to three weeks of dosing and to submit the requested analyses from existing continuous glucose monitoring datasets to support use beyond three weeks. The regulatory submissions are, however, contingent on an inspection classification upgrade of a third-party manufacturing facility. In parallel, the company is engaging in partnership discussions for future commercialization. Chronic inflammation ZP9830, Kv1.3 Ion Channel Blocker. Zealand Pharma expects to complete the first-in-human clinical trial with ZP9830 in the fourth quarter of 2025 and report topline data in the first half of 2026. Corporate Zealand Pharma Capital Markets Day. Zealand Pharma will host a Capital Markets Day in London on December 11, 2025. Speakers will include Management as well as external experts and thought leaders in obesity. Financial guidance for 2025 Guidance unchanged from February 20, 2025, excluding transaction-related costs associated with the Roche collaboration, which are expected to be approximately DKK 200 million in 2025. DKK million 2025 Guidance5,6 2024 Actuals Revenue anticipated from existing and new license and partnership agreements No guidance 63 Net operating expenses 2,000-2,500 1,327 Notes: 5. Excluding transaction-related costs related to the Roche collaboration. 6. Financial guidance based on foreign exchange rates as of May 7, 2025. 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 first three months of 2025 followed by a Q&A session. Participating in the call will be Chief Executive Officer, Adam Steensberg; Chief Financial Officer, Henriette Wennicke; Chief Medical Officer, David Kendall; and Chief Commercial Officer, Eric Cox. 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 Pharma's website at Financial Calendar for 2025 Q2 2025 August 14, 2025 Q3 2025 November 13, 2025 Q4/FY 2025 February 19, 2026 About Zealand Pharma A/S Zealand Pharma A/S (Nasdaq: ZEAL) is a biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand Pharma 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 Pharma was founded in 1998 and is headquartered in Copenhagen, Denmark, with a presence in the U.S. For more information about Zealand Pharma's business and activities, please visit 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 2025 and Financial Guidance for 2025. 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 Adam Lange Vice President, Investor Relations Zealand Pharma Email: ALange@ Neshat Ahmadi Investor Relations Manager Zealand Pharma Email: NeAhmadi@ Anna Krassowska, PhD Vice President, Investor Relations & Corporate Communications Zealand Pharma Email: AKrassowska@ Attachment
Bloomberg
23-04-2025
- Business
- Bloomberg
Zealand Pharma Hires Lilly Executive as Biotech Ramps Up in Obesity
Zealand Pharma A/S hired a senior executive from Eli Lilly & Co. after an agreement with a major drugmaker helped bolster its ambitions in obesity. The Danish biotech named Utpal Singh as its chief scientific officer on Wednesday. Singh just relocated from the US after spending more than 18 years at Lilly, most recently as senior vice president of small molecule discovery.
Yahoo
23-04-2025
- Business
- Yahoo
Zealand Pharma appoints Utpal Singh as Chief Scientific Officer to drive next-generation peptide therapeutics discovery
Press release – No. 5 / 2025 Zealand Pharma appoints Utpal Singh as Chief Scientific Officer to drive next-generation peptide therapeutics discovery Utpal joins Zealand Pharma at a pivotal moment as it aims to become a leader in the management of obesity and related complications He will lead the discovery and clinical translation of peptide medicines, investing in new technologies including data and computational science Utpal to expand the global scientific team to drive Zealand Pharma's next wave of highly differentiated, innovative therapies, building on the Company's strong drug development heritage Copenhagen, Denmark, 23 April 2025 – Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announces the appointment of Utpal Singh as Chief Scientific Officer. Utpal will join the executive team to lead discovery research and translational sciences at Zealand Pharma. Utpal brings nearly 25 years of pharmaceutical industry experience spanning the full drug discovery and development lifecycle. Most recently, he served as Senior Vice President of Small Molecule Discovery at Eli Lilly and Company, where he led the transformation of the discovery engine by building new capabilities and strategic partnerships to advance a focused portfolio. His team contributed to the discovery of numerous clinical candidates across multiple therapeutic areas. 'We are committed to expanding our world-leading peptide discovery engine to support the next wave of innovation at Zealand – and Utpal's appointment further strengthens our foundation for growth,' said Adam Steensberg, Chief Executive Officer, Zealand Pharma. 'His leadership in design and discovery of life-changing medicines will be instrumental in our mission to develop enduring therapies for patients.' Utpal Singh, newly appointed Chief Scientific Officer at Zealand Pharma, added, 'The recent advances in data science and machine learning integrated with Zealand Pharma's exceptional peptide discovery and translational expertise can create a powerful engine for drug discovery. Our ambitions are backed by the deep expertise and financial capital needed to drive transformative ideas that address critical patient needs. It's a great time to invest in discovery research, and I'm eager to collaborate with this world-class team to develop medicines that could reshape the future of obesity and more.' Utpal began his pharmaceutical career in 2001 with Merck & Co following completion of a postdoctoral fellowship in organic chemistry at the Massachusetts Institute of Technology. He holds a PhD in chemical engineering from The Pennsylvania State University and a BS in chemical engineering from Purdue University. 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. Founded in 1998 and headquartered in Copenhagen, Denmark, Zealand has a team in the U.S. For more information about Zealand Pharma's business and activities, please visit Forward looking statements This press release 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. 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. 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 (Investors)Vice President, Investor RelationsZealand Pharmaalange@ Neshat Ahmadi (Investors)Investor Relations ManagerZealand Pharmaneahmadi@ Anna Krassowska, PhD (Investors and Media)Vice President, Investor Relations & Corporate CommunicationsZealand Pharmaakrassowska@ Amber Fennell, Jessica Hodgson, Sean Leous (Media)ICR HealthcareZealandPharma@ (0) 7739 658 783Sign in to access your portfolio
