MGN Mologen AG

Dr Ignacio Faus appointed as new CEO of MOLOGEN AG

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 biopharmaceutical company in the inflammation and autoimmune disease space. For several years he managed the investment – operational – divestment life cycle of the company, until its final sale. He has also held a number of advisory roles, consulting engagements, and Board of Directors positions in several pharmaceutical, biotechnology and private equity organizations.

In his role as CEO of MOLOGEN, he will be in charge of Business Development, Investor Relations & Corporate Communications, Partnering, Production, and Strategy. Dr Mariola Söhngen has resigned from her post as Chairwoman of the Executive Board on July 31, 2018 and will leave the Executive Board effective October 31, 2018. In the interim period from August 1, 2018 to October 31, 2018, Dr Söhngen will provide support as an Executive Board Member without a specific area of responsibility, cooperating with Dr Faus to ensure a smooth transition of the chairmanship. Dr Söhngen had informed the Supervisory Board that she will not extend her position as member of the Executive Board and CEO of MOLOGEN AG beyond her initial contract ending on October 31, 2018.

Oliver Krautscheid, Chairman of the Supervisory Board of MOLOGEN AG: “We are delighted that Dr Faus, an extremely competent and international biotech and pharma manager, will be the new CEO. He is an ideal choice for this position with ample experience in the management of biopharmaceutical companies. He also brings most valuable skills to MOLOGEN. We would like to extend our special thanks to Dr Söhngen for her outstanding commitment and the tremendous job she has done by successfully transforming MOLOGEN from a research and development company to one with a product and market-orientation. We believe MOLOGEN is now well positioned for the future. We wish her all the best.”

“I am delighted to join MOLOGEN and look forward to working with a strong team, in order to advance the Company´s portfolio of R&D projects, and to succeed in creating value for our shareholders. The Company is at the forefront of the exciting field of immuno- oncology, with lefitolimod and other programs with great potential to address unmet medical needs and improve patient lives,” comments Dr Ignacio Faus.

After the completion of his PhD in Biochemistry in 1988 (Indiana University Bloomington, US), he achieved a Master of Business Administration (MBA) in Finance, Innovation and Marketing from Kellogg School of Management, Northwestern University, US in 1993, and also the CEO Executive Education Program (PDG) at IESE Business School in Barcelona (2004).

MOLOGEN AG

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®.

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 small cell lung cancer have been announced in April 2017, and the final analysis in the first quarter 2018 confirmed the data. Furthermore, data from the extension phase of the TEACH study in HIV have also been published in 2017. In addition, lefitolimod is currently being investigated in a phase I combination study with the checkpoint inhibitor ipilimumab (Yervoy®) 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.

Note about risk for future predictions

Certain information in this report contains forward-looking statements or the corresponding statements with negation or versions deviating from this or comparable terminology. These are described as forward-looking statements. In addition, all of the information given here that refers to planned or future results of business areas, key financial figures, developments of the financial situation or other financial figures or statistical data, is to be understood as such forward-looking statements. The company points out to investors that they should not rely on these forward-looking statements as predictions about actual future events. The company is not obligated and refuses to accept any liability for the forward-looking statements and has no obligation to update such statements in order to accurately reflect the current situation.

EN
01/08/2018

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Reports on Mologen AG

Sean Conroy
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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
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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...

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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 ...

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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...

 PRESS RELEASE

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 ...

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