The Company has closed on transactions with leading U.S. institutional specialist healthcare investors RA Capital Management, New Enterprise Associates (NEA) and Broadfin Capital. HealthCap, a leading European venture capital healthcare investor, also participated by increasing its existing investment in the company. The additional share issues were approved at an Extraordinary General Meeting on February 3.
"As we laid out our 2015 U.S. financing strategy and intention to build a global biopharmaceutical company initially focused on orphan endocrine diseases, we received strong interest and support from leading institutional investors in the U.S. as well as in Europe," said Matthew Pauls, President and CEO of Cortendo. "This financing strengthens our ability to drive enrollment in our global Phase 3 trial for COR-003 for endogenous Cushing's syndrome and work with potential partners to expand our orphan disease portfolio."
Cortendo previously closed on an $11 million investment led by HealthCap, announced in October 2014, and approved by the EGM on December 1, 2014.
As a result of the most recent private placement, the share capital of Cortendo will increase from SEK 106,708,863 to SEK 159,080,722 and the total number of shares in the company will amount to 159,080,722.
About Cortendo AB
Cortendo AB is a global biopharmaceutical company incorporated in Sweden and based in the United States. The Company's strategic focus is to be the global leader in commercializing innovative medicines for orphan endocrine disorders. Cortendo is leading the way in the field of cortisol inhibition through the investigational drug, COR-003 (levoketoconazole), currently being studied in the global Phase 3 SONICS trial for the treatment of Cushing's syndrome. COR-003 (levoketoconazole) has received orphan designation from both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). The Company's intent is to independently commercialize its Orphan/Endocrine assets in key global markets and partner non-strategic product opportunities, such as diabetes, at relevant development stages.
Risk and Uncertainty
The development of pharmaceuticals carries significant risk. Failure may occur at any stage during development and commercialization due to safety or clinical efficacy issues. Delays may occur due to requirements from regulatory authorities, difficulties in recruiting patients into clinical trials due to physician or patient preferences or competing products, not anticipated by the Company. There is no assurance that Cortendo will receive marketing and regulatory approvals necessary to commercialize or produce COR-003 (levoketoconazole) or other products. Regulatory approvals may be denied, delayed, limited or revoked.
The commercial success of COR-003 (levoketoconazole), if approved in a territory, cannot be predicted with certainty. In addition, Cortendo may face the risk of interrupted supply of COR-003 for clinical or commercial use from the subcontractors Cortendo has contracted.
Cortendo Forward-Looking Statements
This press release contains forward-looking statements concerning Cortendo that involve a number of risks and uncertainties. All statements other than statements of historical facts included in this press release, including, without limitation, statements regarding the Company's future financial position, strategy, anticipated investments, costs and results, plans, projects to enhance efficiency, outcomes of products development, future capital expenditures, liquidity requirements and objectives of management for future operations, may be deemed to be forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results, performance or achievements or industry results to be materially different from those contemplated, projected, forecasted, estimated or budgeted, whether expressed or implied, by these forward-looking statements. Given these risks and uncertainties, investors should not place any undue reliance on forward-looking statements as a prediction of actual results. None of these forward-looking statements constitutes a guarantee of the future occurrence of such facts and data or of actual results. These statements are based on data, assumptions and estimates that the Company believes are reasonable. The forward-looking statements contained in this document are made only as of the date hereof. The Company expressly disclaims any obligation or undertaking to release publicly any updates of any forward-looking statements contained in this press release to reflect any change in its actual results, assumptions, expectations or any change in events, factors, conditions or circumstances on which any forward-looking statement contained in this press release is based.