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Zealand Pharma A/S Form 6-K Current Event Report Filed 2019-01

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SECURITIES AND EXCHANGE COMMISSION FORM 6-K Current report of foreign issuer pursuant to Rules 13a-16 and 15d-16 Amendments Filing Date: 2019-01-04 | Period of Report: 2019-01-04 SEC Accession No. 0001104659-19-000829 (HTML Version on secdatabase.com) FILER Zealand Pharma A/S Mailing Address Business Address SMEDELAND 36 SMEDELAND 36 CIK:1674988| IRS No.: 000000000 | State of Incorp.:G7 | Fiscal Year End: 1231 2600 GLOSTRUP 2600 GLOSTRUP Type: 6-K | Act: 34 | File No.: 001-38178 | Film No.: 19510721 COPENHAGEN G7 00000 COPENHAGEN G7 00000 SIC: 2834 Pharmaceutical preparations 4588773600 Copyright © 2019 www.secdatabase.com. All Rights Reserved. Please Consider the Environment Before Printing This Document UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 January 4, 2019 Commission File Number: 001 - 38178 Zealand Pharma A/S (Exact Name of registrant as Specified in Its Charter) Smedland 36 2600 Glostrup (Copenhagen) Denmark (Address of principal executive offices) Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20-F x Form 40-F o Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): o Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): o Copyright © 2019 www.secdatabase.com. All Rights Reserved. Please Consider the Environment Before Printing This Document On January 4, 2019, Zealand Pharma A/S (the Company) issued a company announcement, announcing that the Company has completed an equity investment of USD 3.5 million in its strategic partner Beta Bionics, as part of the Series B financing of Beta Bionics and pursuant to the exercise of the Companys option to invest based on clinical development milestones. A copy of the company announcement is furnished as Exhibit 99.1 to this Report on Form 6-K (this Report). In addition, furnished as Exhibit 99.2 to this Report is the presentation expected to be used by the Company in connection with its attendance at the JP Morgan Healthcare Conference beginning on January 7, 2019 in San Francisco, California. The information in Exhibits 99.1 and 99.2 of this Report is being furnished and shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934 (the Exchange Act), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act. Exhibits Number Description 99.1 Company announcement dated January 4, 2019 99.2 Company Presentation for JP Morgan Healthcare Conference 2 Copyright © 2019 www.secdatabase.com. All Rights Reserved. Please Consider the Environment Before Printing This Document SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. Zealand Pharma A/S Date: January 4, 2019 By: /s/ Mats Blom Name: Mats Blom Title: Chief Financial Officer 3 Copyright © 2019 www.secdatabase.com. All Rights Reserved. Please Consider the Environment Before Printing This Document Exhibit 99.1 Press release No. 1 / 2019 Zealand Pharma completes equity investment in strategic partner Beta Bionics · Zealand Pharma invests USD 3.5 million in the final close of strategic partner Beta Bionics series B financing round · Beta Bionics is the developer of the iLet bionic pancreas an autonomous dual hormone artificial pancreas, using Zealands dasiglucagon for automated glucose regulation in type 1 diabetes · Dasiglucagon is a potential first-in-class glucagon analogue for use together with insulin in dual-hormone infusion therapy with potential to transform diabetes management Copenhagen, January 4, 2019 Zealand Pharma A/S (Zealand) (NASDAQ: ZEAL), a Copenhagen-based biotechnology company focused on the discovery and development of innovative peptide-based medicines, announced the completion of a USD 5 million strategic equity investment in Beta Bionics, a medical technology company developing the iLet bionic pancreas system. The iLet is a pocket-sized, dual-chamber, autonomous, glycemic control system that mimics a biological pancreas by calculating and dosing insulin and/or glucagon as needed based on data from the diabetic patients continuous glucose monitor. The iLet will utilize Zealands proprietary first-in-class stable glucagon analogue, dasiglucagon, in combination with insulin. This dual hormone therapy has the potential to significantly improve diabetes management for people who today are on insulin therapy. In 2017, Zealand made an initial USD 1.5 million equity investment in Beta Bionics with an option to invest a further USD 3.5 million pending the achievement of specific development milestones. Zealand has now exercised this option based on the significant regulatory and clinical progress seen throughout 2018. This strategic equity investment, as part of the Series B financing, further strengthens the collaboration between Zealand Pharma and Beta Bionics in moving forward with the Phase 3 program for iLet in 2019. Prior clinical studies have demonstrated that patients with type 1 diabetes using the autonomous dual hormone system spend significantly more time in the normal glucose range, had significantly fewer dangerous hypoglycemic events (low blood sugar), and reduced need for correcting the low blood glucose with excessive food intake (source: data on file). We are truly impressed with the clinical data generated so far with the iLet and excited by the progress in our collaboration with Beta Bionics. We look forward to starting the pivotal phase 3 development program in the second half of 2019, said Adam Steensberg, Chief Medical and Development Officer at Zealand. Zealands proprietary stable glucagon analogue, dasiglucagon, has great potential to dramatically improve Type 1 diabetes patient care and outcomes when used in cutting edge dual-hormone artificial pancreas pumps like the iLet. Zealand Pharma has demonstrated in multiple clinical trials that dasiglucagon is effective in preventing and correcting insulin-induced low plasma glucose events (hypoglycemia). With its unique stability profile in liquid formulations, dasiglucagon is strongly suited for use in dual-hormone artificial pancreas pump systems as already demonstrated with Beta Bionics iLet. 1 Copyright © 2019 www.secdatabase.com. All Rights Reserved. Please Consider the Environment Before Printing This Document Our enduring commitment at Beta Bionics is to bring the dual-hormone iLet to market to improve the lives of as many people with type 1 diabetes as possible, said Ed Damiano, President and Chief Executive Officer at Beta Bionics. We are very excited by the impressive results achieved with dasiglucagon in pre-clinical studies and clinical trials. We look forward to beginning our phase 3 pivotal trial program with the talented team at Zealand Pharma. For further information, please contact: Britt Meelby Jensen, President, and Chief Executive Officer Tel.: +45 51 67 61 28, e-mail: [email protected] Mats Blom, Executive Vice President and Chief Financial Officer Tel.: +45 31 53 79 73, e-mail: [email protected] About dasiglucagon (glucagon analog stable in liquid formulation) for use in other indications Dasiglucagon is a Zealand-invented glucagon analog with a unique stability profile in a ready-to-use aqueous solution. It is also in development for two additional indications: treatment of severe hypoglycemia, and treatment for children born with a genetic mutation that causes congenital hyperinsulinism (CHI). About Type 1 diabetes dual-hormone bionic pancreas People with type 1 diabetes suffer from insulin deficiency and inappropriate glucagon secretion. Both hormones are essential to ensure stable and healthy blood glucose levels. Consequently, patients must monitor and adjust their blood sugar levels to remain in proper glycemic control, as both high and low blood glucose may adversely impact their health, both in the short- and long-term. During outpatient and home-use randomized cross-over trials, the bionic pancreas dosing algorithms integrated into the iLet have shown significant reductions in blood glucose levels, and simultaneous reductions in hypoglycemia in adults, adolescents, and pre-adolescents with type 1 diabetes (New England Journal of Medicine. 2014, 371:313-25; Lancet Diabetes and Endocrinology. 2016, 4:233-43, Lancet. 2017, 389:369-80). About Zealand Pharma A/S Zealand Pharma A/S (Nasdaq Copenhagen and New York: ZEAL) (Zealand) is a biotechnology company focused on the discovery and development of innovative peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market. Zealands current pipeline of internal product candidates focus on specialty gastrointestinal and metabolic diseases. Zealands portfolio also includes two clinical license collaborations with Boehringer Ingelheim. Zealand is based in Copenhagen (Glostrup), Denmark. For further information about the Companys business and activities, please visit www.zealandpharma.com or follow Zealand Pharma on LinkedIn or Twitter @ZealandPharma. About Beta Bionics, Inc. Beta Bionics is a for-profit Massachusetts public benefit
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