MOLOGEN made further progress in its clinical studies. The focus of operative business continues to be on the three ongoing clinical studies investigating the lead product, namely the Immune Surveillance Reactivator lefitolimod (MGN1703). Patient recruitment for the colorectal cancer pivotal study continued further in the first quarter. The phase I study TEACH (indication HIV) was expanded following first promising results and the next part of the study will continue with more patients and a longer duration. The analysis stage of the IMPULSE study investigating small cell lung cancer is intended to begin in late 2016. A phase I combination study of lefitolimod with a checkpoint inhibitor is expected to start soon. In addition, the finalization of a currently ongoing pipeline review is scheduled for mid-2016. The results are expected to be presented to the shareholders at the 2016 year's annual general meeting, most likely in August 2016. The forecast for the current financial year remains unchanged. Successful continuation of clinical studies with lefitolimod (MGN1703) In the first three months of 2016, MOLOGEN concentrated on driving the clinical studies with the Immune Surveillance Reactivator (ISR) lefitolimod (MGN1703) forward. As part of the TEACH study in the indication HIV conducted in collaboration with Aarhus University, the first study results displayed significant activation of the immune system in HIV patients through treatment with lefitolimod (MGN1703). After the first phase of the study, which was conducted with a total of 15 patients and over a period of one month, an expansion study phase with a further 10 to 11 patients and a duration of six months is planned. The final results are expected in the first half of 2017. The analysis stage of the phase II IMPULSE study investigating small cell lung cancer will begin at the end of 2016. First results are expected to be available at the beginning of 2017 and will be presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2017. The IMPULSE study tests the effectiveness and safety of lefitolimod (MGN1703) in the treatment of patients with small cell lung cancer. The primary end point of the study is overall survival. New generation of immune-activating TLR9 agonists EnanDIM(R) belong to the same platform technology as lefitolimod, and represents a new generation of TLR9 agonists and successor substances from MOLOGEN's TLR9 technology with longer patent terms. Comprehensive immune activation together with a good level of tolerability is also expected from the Immune Surveillance Reactivator EnanDIM(R) family. The preclinical data presented at ASGCT 2016 in early May 2016 show that substances from the EnanDIM(R) family provoke a broad activation of immune cells, such as monocytes, natural killer cells (NK cells), and plasmacytoid dendritic cells (pDCs) in vitro. Furthermore, the data do not indicate any signs of toxicity following the administration of the higher possible dosage of the active EnanDIM(R) compound and confirms immunomodulatory effects in vivo. The mode of action of EnanDIM(R) should allow its application in a number of cancer indications, either as a monotherapy or in combination with other targeted therapies, checkpoint inhibitors, and other therapeutic approaches. In addition, different members of the EnanDIM(R) family will also be able to be used in the area of infectious diseases, including HIV, in future.

The company announced earnings results for the first quarter of 2016. For the quarter, the company's EBIT was EUR 4.5 million, as expected, below the reference period in the previous year of LBIT of EUR 3.2 million.

The company confirmed earnings guidance for the year 2016. For the year, the company assumes that the R&D expenses for 2016 will be higher than those for the 2015 financial year as a result of the advances in clinical research, and that the annual profit will be lower than in the previous year.