PRESS RELEASE N 25 / 2018 of 11/08/2018
MOLOGEN AG: Implementation of financing measures and publication of study results
- Presentation of final data from IMPULSE study and update on time line for availability of top-line data from the IMPALA study
- Systematic implementation of financing measures
- Cash position of EUR12.4 million incl. completion of capital increase with gross proceeds of
- Agreement with the principal creditor on the waiver of terminations and adjustment of the terms of the convertible bonds 2016/2024 and 2017/2025
Berlin, 8 November 2018 - In the first nine months of the current financial year 2018, the biopharmaceutical company MOLOGEN AG (ISIN DE000A2LQ900 / WKN A2LQ90) made important progress in the further development of its lead compound lefitolimod and the related clinical studies as well as in its financing activities.
"In the last nine months we were able to implement several funding measures with total proceeds of around EUR20 million. Furthermore, in July we have restored our financing capacities by a reverse stock split followed by a capital increase with gross proceeds of EUR8.2 million in September. We also see important developments in our current clinical studies with our lead compound lefitolimod and are preparing new studies", said Dr Ignacio Faus, CEO of MOLOGEN AG.
Presentation of final data of the IMPULSE study and up-dated forecast for the availability of top-line data from the IMPALA study
The ongoing clinical studies with MOLOGEN's main product candidate, the immunotherapy lefitolimod, proceeded according to plan in the first nine months of the fiscal year 2018. The IMPULSE study in small cell lung cancer is particularly remarkable: MOLOGEN presented the final data at the ESMO Congress of the European Society for Medical Oncology in Munich in October. In particular, the data showed that maintenance therapy with lefitolimod in patients with extensive stage small-cell lung cancer (ES-SCLC) has a favorable safety profile, presented with the expected immunological responses and positive overall survival outcomes in two predefined patient groups. These data support continued investigation of lefitolimod as mono or combination therapy for extensive stage small-cell lung cancer (ES-SCLC). Regarding the pivotal study IMPALA in the indication metastatic colorectal cancer an updated prediction for the expected read out time-point has been conducted on the basis of more mature patient data collected up to October 2018. This forecast now predicts the availability of top-line data between summer and year-end 2019. The further development strategy in the indication HIV envisages the use of lefitolimod in the context of combination therapies. Currently, preparations are running for the planned TITAN study, which - financed by Gilead Sciences - is expected to start in 2018 or early 2019.
Capital increase with gross proceeds of above EUR8 million
After the successful 5:1 reverse share split in July and the corresponding adjustment of the share capital to EUR7,537,287, MOLOGEN implemented further financing measures: In September, MOLOGEN completed a capital increase from authorized capital. A total of around 1.7 million new shares were issued to national and international investors at a subscription price of EUR4.70 per share. This increased the Company's share capital to EUR9,271,632. The gross proceeds of EUR8.2 million from the capital increase will be largely used to finance the IMPALA study. The funds from the capital increases and framework agreements concluded in 2017 and 2018 including the payments already received from the cooperation with ONCOLOGIE would secure the financing presumably until mid-2019. MOLOGEN has received an initial payment of EUR3.0 million as part of the Chinese licensing agreement with ONCOLOGIE. In the third quarter of 2018, the first non-interest-bearing mandatory convertible bond without subscription rights for shareholders was issued to ONCOLOGIE with a total nominal amount of EUR2 million and a term of 5 years.
Agreement with the principal creditor on the waiver of terminations and adjustment of bond conditions
After the reporting period, at the beginning of October, MOLOGEN has entered into negotiations with major creditors of the convertible bonds against the background of the termination option provided for in the terms and conditions of the convertible bonds 2016/2024 and 2017/2025. The aim of the negotiations was to avoid an immediate maturity of both convertible bonds in the total amount of approximately EUR6.4 million and the resulting potential threat of insolvency of the Company. Following the agreement reached on 26 October, the principle bondholder waived its right to exercise the currently existing special termination right. This will avert the immediate maturity of both convertible bonds and the associated immediate repayment obligation of approximately EUR6.4 million. In return, the Company offered to amend the terms and conditions. The details of the agreement can be found in the quarterly statement of MOLOGEN. The Company will convene a Creditors' Meeting on 29 November 2018 for the convertible bond 2017/2025 in order to present the agreement reached with the principal creditor to all holders of the convertible bond for voting.
Lower R&D expenses and improved operating results
Compared to the previous year, research and development costs in the first nine months of 2018 decreased by around 20 percent to EUR8.4 million (previous year: EUR10.6 million). The main reason for this was the lower R&D expenditure due to the completion of two clinical studies. The operating result (EBIT) developed positively: Including the first license payments EBIT amounted to EUR-8.8 million (previous year: EUR-14.5 million). As of 30 September 2018, MOLOGEN AG had cash and cash equivalents of EUR4.2 million (December 31, 2017: EUR6.5 million), excluding the
1 October registered capital increase in the gross amount of EUR8.2 million.
Update of forecast for full-year 2018
Based on the progress planned for 2018, primarily in clinical development programs and commercialization, the Company expects a positive development in 2018. Overall, the Executive Board of MOLOGEN AG confirms the statements made in the 2017 Annual Report regarding the targets in the areas of research and development, cooperations and partnerships, earnings and liquidity development as well as personnel for the entire 2018 financial year, with the exception of subsequent additions. R&D expenses are expected to be below the previous year level due to limited activities with regard to the upscaling of the production. Operating result is expected to be above prior-year's level due to first revenues from the Chinese licensing agreement.
The complete interim statement of MOLOGEN AG for the first nine months of 2018 is available on the company's website at www.mologen.com
MOLOGEN AG is a biopharmaceutical Company and a pioneer in the field of immunotherapy on account of its unique active agents and technologies. Alongside a focus on immuno-oncology, MOLOGEN develops immunotherapies for the treatment of infectious diseases.
The focus of the development work is on the product family of DNA-based TLR9 agonists. This includes the lead compound lefitolimod and the next-generation molecule family EnanDIM(R).
The immunotherapeutic agent lefitolimod is the Company's lead compound and is currently being investigated in a pivotal trial. It is regarded as the best-in-class TLR9 agonist. Treatment with lefitolimod triggers a broad and strong activation of the immune system. On account of this mode of action, lefitolimod could potentially be used in various indications. Lefitolimod is currently being developed within the framework of a pivotal study for first line maintenance therapy for colorectal cancer. Key data of the phase II IMPULSE study in extensive-stage small cell lung cancer (ES-SCLC) and the data from the extension phase of the TEACH study in HIV have been published. In addition, lefitolimod is currently being investigated in a phase I combination study with the checkpoint inhibitor ipilimumab (Yervoy(R)) in various cancer indications. Along with various checkpoint inhibitors, lefitolimod, which is being investigated as part of a phase III clinical trial currently, is one of the few near-to-market product candidates in the field of immuno-oncology.
MOLOGEN's pipeline focus is on new innovative immunotherapies to treat diseases for which there is a great medical demand in particular.
MOLOGEN AG is a publicly listed Company, headquartered in Berlin. The shares (ISIN, DE000A2LQ900/SIN: A2L Q90) are listed in the Prime Standard of the German Stock Exchange.
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