Medigene AG: Medigene provides results for fiscal year 2020 and outlook

Planegg/Martinsried (pta/25.03.2021/07:30) Medigene AG (Medigene, FSE: MDG1, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, today published its financial results and Annual Report for the 2020 fiscal year and its outlook for 2021. The full version of the Annual Report 2019 can be downloaded here: http://www.medigene.com/investors-media/reports-presentations/

Prof. Dolores Schendel, Chief Executive Officer and Chief Scientific Officer at Medigene: "We are working with the goal to further position ourselves as a key player in the development of novel immunotherapies and to provide patients and physicians with effective therapies as soon as possible. A key point in fiscal 2020 was that we completed the divestment and out-licensing of our non-immunotherapy projects and also realigned internally as part of a Group-wide refocusing so that we can now fully concentrate on immunotherapies in the solid tumor arena.

As part of the refocusing, the MDG1021 development program was discontinued in January 2021. Our expectations and the experience of others suggest that the timeframe for efficient development of MDG1021 would probably have been longer than previously anticipated. We believe that the challenges of recruiting patients to this program have been exacerbated under the prevailing pandemic conditions and that this situation would not likely have improved significantly in the coming months.

Important advances that contributed to our decision to henceforth focus on solid tumors included compelling preclinical data regarding our PD1-41BB switch receptor. We expect that this molecular tool will enable our TCR-T cells to penetrate the tumor mass and thus directly fight the cancer. In addition, the research collaboration with the University of Montréal is essential, as this collaboration gives us access to previously unknown potential cancer antigens which we are currently evaluating as targets for our future development candidates.

Based on patient numbers and the unmet medical need in the area of solid tumors, we believe that this will be the most significant commercial opportunity for Medigene's clearly differentiated technologies and our non-mutated, highly specific TCRs. I would like to take this opportunity to thank all of our employees and partners once again for their unwavering efforts to further develop Medigene's technologies in order to be able to offer innovative new immunotherapies to cancer patients as soon as possible, despite the ongoing pandemic situation. In particular, I would like to thank our departing Executive Board member for clinical and product development, Dr. Kai Pinkernell. We thank him for his five years of dedicated service to Medigene and we wish him all the best for his future endeavors."

Axel Sven Malkomes, Chief Financial Officer and Chief Business Officer at Medigene: "While continuing to progress the development of our key technologies, our refocused operations have also enabled our cash resources to be effectively deployed.

In 2020, we successfully completed the Phase I/II study with our DC vaccine in patients suffering from acute myeloid leukemia (AML) and have since published further data on this project at various conferences. As Medigene's focus is on the development of TCR-T therapies, further development of the DC vaccine will only be continued with partners. Recently, a new product was approved by the FDA as maintenance therapy for patients with AML in the U.S. and we expect similar approvals to be granted soon in other regions including China. These developments influence our further partnering efforts.

However, we continue to evaluate new partnering opportunities around our suite of TCR technologies and product candidates. As complements to our targeted proprietary developments, any new partnerships should enable Medigene to more aggressively build value for shareholders."

Business outlook
In 2021, Medigene will continue to push forward on the development of its immunotherapies. The corporate objectives will remain focused on the field of T cell-based immunotherapies to fight cancer but with a strategic shift towards solid cancers. Medigene Management is confident that, through years of intensive research, the Company has now established a sound basis, e.g. with the PD1-41BB switch receptor, for Medigene's TCR-T cells to overcome the adverse conditions surrounding solid cancers and to fight the cancerous tissue. This focus represents, in the Company's opinion, the most promising commercial business opportunity for Medigene's differentiated technologies.

- Medigene will continue to characterize new target antigens, among others, in the context of the partnership with UdeM, and TCR candidates for future studies and to collect preclinical data in preparation for further clinical TCR trials to be initiated. The Company's scientists will continue to present important results at upcoming scientific conferences.

- Patient enrollment for the Phase I portion of the Phase I/II trial of MDG1011 in AML and MDS is expected to be completed to enable topline data to be reported in 2021. Depending on the results of the Phase I portion, the Company would intend to partner the project prior to the start of the Phase II portion of the trial.

- Medigene plans to continue its successful collaborations with bluebird bio and Roivant/Cytovant and will continue to evaluate new partnering opportunities related to its portfolio of product candidates to maximize the Company's value.

Financial position and forecast
The financial forecast for 2021 reflects the Company's focus on and progress in the core business of immunotherapies. The forecast does not include potential future milestone payments from existing or future partnerships or transactions, as the timing and extent of such events depends to a large extent on external parties and therefore cannot be reliably predicted by Medigene.

In 2021, Medigene expects to achieve total revenues of Eur7 - 9 m, R&D expenses of Eur14 - 20 m and losses at the EBITDA-level in the amount of Eur10 - 17 m.

As part of the strategic focus, cost-saving measures were implemented in 2020 including a reduction in the cost of external services and the number of employees across all departments. These measures have since reduced the monthly cash burn. Cash and cash equivalents amounted to approximately Eur30 m at the end of 2020. Based on its current planning, the Company has sufficient financial resources to fund business operations into the third quarter of 2022.

Conference call
The Management Board will hold a conference call in English today at 3 pm CET (10 am ET). Please register beforehand and latest 2 hours prior to the event through this link in order to get your personal access information (phone number, passcode + individual PIN):
https://services.choruscall.de/DiamondPassRegistration/register?confirmationNumber=5155598&linkSecurityString=7da573fc4

Please don't distribute your dial-in details, your PIN is personalized. Please dial in at least 10 minutes before start time.

To find the Management presentation, please follow this link: https://www.medigene.com/investors-media/reports-presentations