Interim report Second quarter 2017 and subsequent events (Unaudited)

Transcription

1 SERODUS ASA Interim report Second quarter 2017 and subsequent events (Unaudited) August Q report

2 ABOUT SERODUS Serodus is a private biotech company with a focus on diabetic comorbidities and diabetes. The pipeline fundamentally shifts the current treatment paradigm by introducing novel anti-inflammatory compounds for the treatment of diabetic comorbidities and Type 2 Diabetes (T2D). The lead compound SER150 targets Nephropathy, a disease with large potential and with no specific cure available today. Treatment with antihypertensive drugs (ACE inhibitors) has demonstrated the slowing down of the loss of kidney function and thereby delaying time to dialysis. Approximately 33% of all patients with T2D develop kidney disease. SER150 is a new treatment that stops the inflammatory processes in the diabetic kidney and thereby further halt the progression of the kidney disease. Serodus has a pipeline of patented compounds. A new addition to its pipeline is SER190, an anti-inflammatory compound targeting Foot Ulcer one of the very severe diabetic comorbidities. In addition to the diabetic comorbidity and diabetes programs, the pipeline includes SER100 that has received an orphan drug designation for Pulmonary Arterial Hypertension (PAH) in the US. Previously, the company has performed studies in Isolated Systolic Hypertension (ISH) with SER100, but has encountered challenges in progressing this project, as an oral route of administration has been requested by potential partners suffering from ISH. Patients with PAH are often desperately ill and are used to injections both intravenously and intramuscularly. Comorbidities of Diabetes Retinopathy SER150 Nephropathy Stroke SER130 Heart Disease SER140 Neuropathy Peripheral Vascular Disease SER190 2

3 T2D is an inflammatory and metabolic disorder of epidemic proportions and leads to serious debilitating and fatal comorbidities, such as kidney disease, blindness, heart disease, foot ulcers leading to amputations (See figure) The company's business model is based on in-licensing of promising drug candidates from universities and biotech companies, maturing the candidates and ultimately establishing partnerships with international pharmaceutical companies. More information can be found at 30TUwww.serodus.comU30. Q Highlights Serodus requested a Pre-Investigational New Drug (pre-ind) meeting with the Food and Drug Administration (FDA), USA. The objective is to receive guidance for the development path for the lead compound SER150 in patient with Nephropathy. Serodus is proud to announce that the meeting has been granted and will be held ultimo September The aim of the meeting is to discuss the future development plan in the US for SER150. Similar meeting will be planned in Europe. Development of pipeline Serodus has a first in class pipeline within potential drugs for the treatment of diabetic comorbidities and diabetes that is of high interest due to the lack of curative treatments for any of these conditions. Furthermore, T2D is and increasing patient population and serious economic health burden. At the current stage the company is giving the highest priority to the lead compound SER150. SER150 for Nephropathy (DN) In early January 2017 Serodus announced the key results from the first SER150 clinical study in patients with Nephropathy. The study was primarily a phase 2a (safety and tolerability study) and the results were very positive with no safety issues or side effects in any of the patients treated with SER150. The encouraging efficacy results from the phase 2a study has lead Serodus to request a pre-ind meeting with the FDA in order to have FDA s guidance for the furure development of SER150. In order to be able to start the next clinical trial, new clinical material is currently being produced. This has a significant lead time and is critical in order to proceed. For the coming quarters preparing the pre-ind meeting with FDA and the detailed planning for the next clinical study will be the Serodus primarily focus. 3

4 Financing Serodus chose to delist the company from Norwegian stock exchange in order to gain both a strategic and financial flexibility provided by being private. This strategy seems to be right as it has been possible to positioned the company well towards new international investors. The interest for the company is increasing, and there is currently a significant interest from both potential partners and investors. Roadshows where Serodus pipeline with the focus on SER150 for Nephropathy are presented to international life science investors are ongoing. Interim financial statement Q Profit & Loss (All figures in thousand NOK) Q Q YTD 2017 YTD 2016 Operating income Revenue Operating expenses Cost of sales Personnel expenses Depreciation of assets Amortization of assets Other Operating Expenses Total Operating Expenses Operating result (3 322) (6 341) (9 588) (14 548) Financial income Other financial income (1) 156 (26) 131 Other Financial Expenses Net finance (22) (8) (52) (304) Profit/ (loss) before tax (3 344) (6 349) (9 640) (14 852) Tax - (9) - (103) Profit/ (loss) after tax (3 344) (6 340) (9 640) (14 749) 4

5 Balance Sheet (All figures in thousand NOK) ASSETS Assets Intangible assets Goodwill Sum intangible assets Current assets Other short term receivables Bank Sum Current assets Sum assets EQUITY AND DEBT Share capital Share premium reserve Other equity (4 927) (4 927) Capital not registered - - Retained earnings ( ) (96 450) Sum equity (2 227) Long term debt Convertible loan Deferred tax Sum long term debt Short term debt Accounts payable Other short term debt Sum short term debt Sum equity and debt A convertible loan of NOK 24.9 million was established in the second quarter of 2017 as a credit facility. At the end of the quarter NOK 9.9 million of the facility has been used, while the remaining facility will be drawndown once needed. The Board of Directors and CEO Serodus ASA 5