reports
- Sean Conroy
MOLOGEN - IMPALA readout ends monotherapy strategy
MOLOGEN has announced that its pivotal Phase III IMPALA trial testing lefitolimod as a maintenance therapy in patients with metastatic colorectal cancer (mCRC) has missed its primary endpoint of overall survival (OS). As a result, we have removed from our valuation lefitolimod’s prospects as a monotherapy in mCRC and small cell lung cancer (SCLC) (previously 72% of our valuation). MOLOGEN will focus on the development of lefitolimod and EnanDIM in combination with other therapies. Announced re...
- Daniel Wilkinson
MOLOGEN - IMPALA readout ends monotherapy strategy
MOLOGEN has announced that its pivotal Phase III IMPALA trial testing lefitolimod as a maintenance therapy in patients with metastatic colorectal cancer (mCRC) has missed its primary endpoint of overall survival (OS). As a result, we have removed from our valuation lefitolimod’s prospects as a monotherapy in mCRC and small cell lung cancer (SCLC) (previously 72% of our valuation). MOLOGEN will focus on the development of lefitolimod and EnanDIM in combination with other therapies. Recently ann...
- Daniel Wilkinson
Mologen - Retaining lefitolimod's value
Mologen has announced that it has terminated negotiations with Oncologie and will retain rights to lefitolimod. With the lefitolimod IMPALA Phase III readout now expected in H219, focus will likely shift to securing a partner for lefitolimod once data are available from this pivotal trial. We have updated our valuation to reflect the termination of Oncologie negotiations. We now forecast that lefitolimod will be out-licensed post the IMPALA trial and assume similar deal terms to those Oncologie ...
- Daniel Wilkinson
Mologen - Global lefitolimod partnership close to completion
Mologen announced that it has signed term sheets for a global partnership with Oncologie for its lead asset, lefitolimod. The deal is expected to complete in Q119, and in the near term Mologen expects to receive €23m from the agreement in a combination of R&D funding, cash payment and bond issues. Sensitivity remains around Oncologie who are an early stage biotech with $16m in seed funding. Mologen announced a capital raise in which it could receive gross proceeds of €18m. Focus remains on d...
MOLOGEN and ONCOLOGIE: Global assignment and co-development agreement ...
BERLIN--(BUSINESS WIRE)-- The biopharmaceutical company MOLOGEN AG yesterday signed, with the consent of the Supervisory Board, a term sheet outlining the framework for a global assignment of all intellectual property and other rights in MOLOGEN’s lead compound lefitolimod to ONCOLOGIE and an expansion of the existing global co-development agreement between MOLOGEN and ONCOLOGIE. The potential total deal value would be over €1 billion plus low double digit royalties on net sales, representing an attractive upside for MOLOGEN. MOLOGEN ...
Dr Ignacio Faus appointed as new CEO of MOLOGEN AG
BERLIN--(BUSINESS WIRE)-- The Supervisory Board of biopharmaceutical Company MOLOGEN AG appointed Dr Ignacio Faus as Member of the Executive Board and new Chief Executive Officer (CEO) of MOLOGEN AG with effect from August 1, 2018. Dr Faus has more than 25 years of experience in the life science industry, with invaluable experience in fundraising, organizational planning, strategic project evaluation, operational efficiency, Business Development & Licensing (BD & L), etc. In 2006 he was one of the founders of PALAU PHARMA, a ...
MOLOGEN AG: Reverse Stock Split Agreed at Annual General Meeting as Ba...
BERLIN--(BUSINESS WIRE)-- Shareholders have resolved the planned reverse stock split by a majority of 96.57% at the Annual General Meeting of MOLOGEN AG. The reverse stock split, which will be carried out at a ratio of 5:1, will serve to maintain MOLOGEN’s financing capability. Walter Miller, CFO at MOLOGEN: “We are pleased that our shareholders have ratified the planned reverse stock split by such a large majority. The share price development over the past weeks and months has unfortunately not reflected the Company's quite ...
- Daniel Wilkinson
Mologen - IMPALA the focus as funding gap remains
Mologen’s Phase III pivotal trial (IMPALA) in metastatic colorectal cancer (mCRC) is now the focus for investors as both the Phase II trial (IMPULSE) in small cell lung cancer (SCLC) and Phase I trial in HIV (TEACH) are now complete. The company recently announced the results of a statistical forecast that has predicted the primary analysis of the data will most likely occur in April 2020 (95% CI: +/- five months). Cash reach has been prolonged to the end of 2018 by recent financing arrangemen...
MOLOGEN: Data-Based Prediction for the Primary Analysis Date of The IM...
BERLIN--(BUSINESS WIRE)-- The biopharmaceutical company MOLOGEN AG has today published an initial data-based forecast for the expected date for the primary analysis of the pivotal IMPALA study. The study protocol of the IMPALA study foresees the conduct of the primary analysis when a prospectively defined amount of data on overall patient survival is available. Based on patient data collected up to April 2018 and using adequate statistical methodology, the time point for the primary analysis has now been predicted for April 2020. This...
MOLOGEN AG: Collaboration with licensing partner ONCOLOGIE gains momen...
BERLIN--(BUSINESS WIRE)-- The biopharmaceutical company MOLOGEN AG announced today that the collaboration with ONCOLOGIE, agreed on in February 2018, is making good progress. The collaboration includes a license agreement for the development, manufacturing and commercialization for MOLOGEN’s lead compound lefitolimod in East Asian markets and a global co-development leveraging novel biomarker know-how from ONCOLOGIE. In this context lefitolimod is initially planned to be developed in oncological indications with high unmet medical nee...
MOLOGEN Presented Strong EnanDIM® TME Data at AACR 2018
BERLIN--(BUSINESS WIRE)-- The biopharmaceutical company MOLOGEN AG presented data of its EnanDIM® molecules, a new generation of potent non chemically-modified TLR9 agonists, at the AACR Annual Meeting 2018 (American Association for Cancer Research) in Chicago, Illinois, U.S. (14 – 18 April 2018). In murine tumor models, monotherapy with EnanDIM® resulted in beneficial modulation of the tumor microenvironment (TME) translating into remarkable anti-tumor effects with highly increased survival rates. In two cancer models complete...
MOLOGEN: Final Analysis of IMPULSE Study Confirms Topline Data with Po...
BERLIN--(BUSINESS WIRE)-- The biopharmaceutical company MOLOGEN AG announced that the final evaluation of the randomized exploratory phase II IMPULSE study confirmed the findings presented in April 2017 and at the ESMO conference in September 2017. The study evaluated the efficacy and safety of lefitolimod in patients with extensive-stage small-cell lung cancer (ES-SCLC). Encouraging signals for beneficial effects on overall survival (OS) were observed in two predefined patient subgroups, although in the overall study population no re...
MOLOGEN Signs License Deal for China and Global Co-Development Agreeme...
BERLIN--(BUSINESS WIRE)-- The biopharmaceutical company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) announced today the signing of a license deal for the Chinese territory and a global co-development agreement between MOLOGEN and ONCOLOGIE Inc. for its lead compound lefitolimod. The signed agreement is conditional upon an initial payment of EUR 3 million received by MOLOGEN. ONCOLOGIE is an oncology-focused drug development company with headquarters in Boston and operations in Shanghai. The company is ...
- Daniel Wilkinson
Mologen - Licensing and funding milestones in Q3
Mologen has announced two new sources of funding that will likely extend its cash reach into mid-2018. The signing of a share subscription facility with Global Corporate Finance (GCF) commits GCF to purchase up to 3.4m Mologen shares (c 10% of share capital). At the current share price, this approximates to €10m in funds which, in addition to the expected completion of the iPharma deal (worth up to €100m) by year end (€3m initial payment), will boost Mologen’s cash position. Furthermore, Mologen...
- Daniel Wilkinson
- Lefitolimod trial readouts hint at future potential
In the last six months, mixed readouts in the Phase II SCLC trial (IMPULSE) and the Phase Ib/IIa HIV trial (TEACH) weighed on the stock. Full data packages presented in the next 12 months may yet highlight potential in these indications. Our valuation is adjusted to take into account both the current trial data and visibility of the long-term strategy in certain geographical regions. While long-term potential lies in the lefitolimod Phase III mCRC trial (IMPALA, readout expected in 2019), Mologe...
MOLOGEN’s presentations well received at ESMO 2017
BERLIN--(BUSINESS WIRE)-- The biopharmaceutical company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) presented two sets of data on its lead compound, the immunotherapeutic agent lefitolimod, at the European Society for Medical Oncology (ESMO 2017) in Madrid (8 – 12 September 2017). The coordinating investigator Prof. Dr. Michael Thomas, MD, Head of the Department Oncology/Internal Medicine at the Thorax Clinic at University of Heidelberg, Germany, gave an oral presentation on the top-line data from the ...
MOLOGEN AG and Chinese iPharma Ltd. signed binding term sheet for a co...
BERLIN--(BUSINESS WIRE)-- The biopharmaceutical company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) announced today the signing of a binding term sheet that defines the framework for the collaboration between MOLOGEN and iPharma, a China-based drug development company. The collaboration would be defined in a final agreement that will consist of two parts: First, a license agreement including sublicense rights under which MOLOGEN grants iPharma an exclusive license for the development, manufacturing and...
MOLOGEN AG: Results of the Extension Phase of the Exploratory Phase Ib...
BERLIN--(BUSINESS WIRE)-- The biopharmaceutical company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) announced the key results of the extension phase of the exploratory phase Ib/IIa TEACH trial to evaluate lefitolimod in HIV-positive (HIV: human immunodeficiency virus) patients on antiretroviral therapy (ART). The study, a cooperation with the Aarhus University Hospital in Denmark, was extended based on the positive results seen in the initial study phase as recently published1. Findings from the ...
- Susie Jana
- SCLC data - subgroup analysis hints at benefit
Top-line data from Mologen’s Phase II small cell lung cancer trial (IMPULSE) have been announced. Positive responses in two subgroups hint at a treatment-related benefit in certain subsets. However, the trial missed its primary endpoint of overall survival in the total study population. Additionally, in line with previous data, an agreeable safety profile was reported. We expect the data to further inform partnership discussions in the near term. The ‘Next Level’ strategy has now been implemente...
MOLOGEN AG: Recruitment goal achieved for the pivotal IMPALA study wit...
BERLIN--(BUSINESS WIRE)-- The biopharmaceutical company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) has achieved the recruitment goal with the inclusion of currently 540 patients for the pivotal IMPALA study in metastatic colorectal cancer “mCRC”. The aim of this study is to show that a switch maintenance therapy with the immunotherapeutic agent lefitolimod can lead to a prolongation of overall survival in patients with mCRC. With the finalization of recruitment, the company reached the next important ...
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