- Kiadis’ marketing authorization application for ATIR101 is currently under review. Kiadis plans to respond to day 180 outstanding issues by the end of May 2019. The Company aims to receive CHMP opinion in 2019, which, if positive, would enable a conditional marketing approval from the European Commission, followed by commercial launch of ATIR101 in a European country by the end of 2019.
- The global phase 3 trial for ATIR101, CR-AIR-009, is ongoing. The study, which will enroll approximately 250 patients, is comparing ATIR101 to the post-transplant cyclophosphamide (PTCy) or ‘Baltimore’ protocol.
- Additionally, over the past year the organization has been strengthened across all functions, with the addition of more than 60 staff, including key management team members.
- On April 17, 2019, Kiadis announced that it had entered a definitive agreement to acquire US-based CytoSen Therapeutics, Inc., subject to shareholder approval and customary closing conditions. The combination of Kiadis and CytoSen will create a leader in cell-based cancer immunotherapy, with complementary T-Cell and NK-cell platform
|(Amounts in EUR million, except per share data)||2018||2017||Change|
|Total revenue and other income||—||—||—|
|Total operating expenses||(25.2)||(16.1)||(9.1)|
|Research and development||(17.5)||(11.2)||(6.3)|
|General and administrative||(7.7)||(4.9)||(2.8)|
|Net financial result||(4.6)||(0.9)||(3.7)|
|Net operating cash flow||(24.2)||(15.9)||(8.3)|
|Cash position at end of year||60.3||29.9||30.4|
|Earnings per share before dilution (EUR)||(1.46)||(1.14)||(0.32)|
- Operating expenses increased to EUR 25.2 million in 2018 from EUR 16.1 million in 2017, an increase of EUR 9.1 million.
- Research and Development expenses increased to EUR 17.5 million in 2018 from EUR 11.2 million in 2017. Without the expenses for share-based compensation, Research and Development expenses increased to EUR 16.6 million in 2018 from EUR 10.9 million in 2017, an increase of EUR 5.7 million. This increase was primarily caused by a further expansion of the workforce in all areas of the organization, clinical expenses related to the CR-AIR-009 study, the move to a larger building which includes a commercial manufacturing facility, laboratories and office space.
- General and Administrative expenses increased to EUR 7.7 million in 2018 from EUR 4.9 million in 2017. Without the expenses for share-based compensation, General and Administrative expenses were EUR 3.0 million higher at EUR 7.0 million in 2018 compared to EUR 4.0 million in 2017. The increase was due to the expansion of the workforce, higher consultancy expenses related to market access preparations and financing rounds.
- As a result of the overall increase in total operating expenses, the Group’s operating loss increased from EUR 16.1 million in 2017 to EUR 25.2 million in 2018.
- Net finance expenses for 2018 increased to EUR 4.6 million from EUR 0.9 million in 2017. The increase of EUR 3.7 million is mainly due to interest on outstanding debt for the amount of EUR 1.6 million, interest on leases of our new Amsterdam office for the amount of EUR 0.5 million in 2018, unfavorable results of net foreign exchange and fair value adjustment of derivatives in 2018 versus 2017 for an amount of EUR 1.7 million and EUR 0.6 million respectively.
- As a result of the above items, the loss for the year increased by EUR 12.8 million to EUR 29.8 million in 2018 versus a loss of EUR 17.0 million in 2017.
- The Company significantly strengthened cash position in 2018 with private placements of 6.5 million ordinary shares raising EUR 54.6 million and a debt financing facility from Kreos Capital of up to EUR 20 million.
- The cash position increased by EUR 30.4 million to EUR 60.3 million at year-end 2018 compared to EUR 29.9 million at the end of 2017. This increase mainly results from the net proceeds of two share offerings for a total amount of EUR 50.6 million and net proceeds drawn on a new debt facility agreement (EUR 20 million total) of EUR 4.8 million and the cash proceeds from the exercise of warrants for the amount of EUR 2.9 million. In 2018, the net operating cash outflow amounted to EUR 24.2 million and further included the acquisition of PP&E, repayments of loans and lease liabilities for a total amount of EUR 4.0 million.
- The Company’s cash position as of March 31, 2019 was EUR 49.0 million.
- The Company’s equity position amounted to EUR 44.1 million at year-end 2018 versus EUR 15.9 million at the end of 2017, an increase of EUR 28.2 million. The main drivers of this increase are net proceeds of two share offerings of EUR 50.6 million in total, shares issued upon the exercise of warrants for EUR 5.0 million, partly offset by the loss for the year of EUR 29.8 million.
- The undiluted loss per share for 2018 increased to EUR 1.46 compared to EUR 1.14 in 2017.