On March 23, 2022 Medigene reported that results for fiscal year 2021 and outlook Martinsried/Munich, 23 March 2022. Medigene AG ( View Source) (Medigene, FSE: MDG1, Prime Standard), an immuno-oncology company focusing on the development of T-cell-based cancer therapies, today published its financial results and Annual Report for the 2021 fiscal year and its outlook for 2022 (Press release, MediGene, MAR 23, 2022, View Source [SID1234610751]). The full version of the Annual Report 2021 can be downloaded here: View Source/investors-media/reports-presentations/
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Business review and outlook
The Company has been repositioned with the aim of fully focusing its future development programs on T cell receptor-modified T cell immunotherapy (TCR-T immunotherapy) of solid cancer, based on scientific, clinical and commercial considerations. Medigene believes that this direction optimally leverages its unique technologies and opens the greatest commercial opportunities for the Company now and in the future. It remains Medigene’s mission to offer seriously ill cancer patients new, effective and well-tolerated therapies developed internally or through partnerships.
Validating, comprehensive TCR-T and technology partnership with BioNTech SE (BioNTech)
BioNTech recently acquired Medigene’s TCR-4 from the MDG10XX program and has an exclusive option to acquire additional existing TCRs in Medigene’s discovery pipeline. Medigene will develop a number of new TCRs under a development partnership agreement with BioNTech lasting initially for three years and has granted BioNTech licenses to its PD1-41BB switch receptor and precision pairing library. These are technologies that could make TCR-T therapies more efficient and safer.
Under the agreement, Medigene has received an upfront payment of EUR 26 million and will be reimbursed for research and development costs incurred during the period of the collaboration. Medigene will be eligible for development, regulatory and commercial milestone payments up to a triple-digit million Euro amount per program. In addition, the Company will be eligible for tiered deferred option payments on global net sales for products based on TCRs arising from the collaboration and royalties on products utilizing at least one of the licensed technologies.
MDG1011 – clinically validated TCR-T therapy in blood cancers
In June 2021, the last patient was enrolled in the third dose cohort of the Phase-I part of the Phase I/II trial of MDG1011 in blood cancer. Medigene reported on safety, tolerability and feasibility in December 2021. In February 2022, first efficacy and immune monitoring data were published. MDG1011 was successfully produced for 12 of the 13 heavily pretreated patients (92.3%) and proved to be safe and well tolerated. MDG1011 showed signs of both biological and clinical activity and one patient is currently still under observation, over nine months after treatment. In line with Medigene’s focus on solid cancers, the Company has decided that, contingent on the final results from the Phase I part, the Phase II part of the trial would only be conducted with or by a partner.
Unique tumor-specific antigens – the "dark matter" of our genome
Under the Company’s collaboration with the University of Montréal, Medigene gained access to 47 potential new tumor-specific antigens (TSAs) common to solid tumors of different origin, such as ovarian, breast, and lung cancer. Medigene’s high-throughput screening technology identified ten peptides that were immunogenic and able to induce specific T cell responses. To date, Medigene has isolated more than 20 TCRs of T cell clones that recognize these novel TSAs. Their further functional and safety characterization is ongoing.
Development partnerships
Medigene continues its successful collaborations with 2seventy bio, Inc. (formerly: bluebird bio, Inc.) and Cytovant Sciences HK Limited, a biopharmaceutical company founded by Roivant Sciences (Roivant/Cytovant) and initiates operations within a new partnership with BioNTech. To maximize the Company’s value, Medigene continues to evaluate new partnering opportunities related to its suite of technologies and portfolio of product candidates.
Prof. Dolores Schendel, Chief Executive Officer (CEO) and Chief Scientific Officer (CSO) at Medigene: "Our steadfast focus on TCR-T therapies against solid cancers, has led, most recently, to the comprehensive new partnership with BioNTech and the sound financial basis it provides for the Company.
This partnership validates Medigene’s investment in T-cell-based immunotherapy of cancer. This was clearly appreciated and valued by BioNTech in the lengthy due diligence process leading to the deal. We look forward to executing on this partnership.
Medigene is very well positioned to sustainably increase value through partnerships and our internal projects, discovering novel TCRs and developing and improving new technologies to make TCR-T therapies safer, more efficient and cost effective."
Change in the Executive Management Board
Axel Malkomes, Medigene’s Chief Financial and Business Development Officer, will leave the Company at the end of March 2022 by mutual consent at the expiry of his contract. Prof. Dolores Schendel will remain as CEO and CSO.
Dr. Gerd Zettlmeissl, Chairman of Medigene’s Supervisory Board: "Axel was a valued member of the Executive Management Board, making a significant contribution to the restructuring and improvement of Medigene’s financial outlook. We would like to thank Axel and wish him the best in his future endeavors.
We are very pleased that Dr. Birger Kohlert, Vice President Finance, Controlling, Procurement and IT at Medigene since January 2020, will act as CFO. Birger looks back on years of international experience in finance and was previously CFO at S + P Samson, Kissing, Germany, EvoBus Sweden and EvoBus Denmark. Prior to that, he had several positions in the finance department of the Daimler Group in Germany and the USA and in the audit department of KPMG in Germany. He holds a doctorate in the field of international accounting."
Financial development and guidance
In fiscal 2021, the financial forecast that was initially issued was adjusted to reflect the more favorable revenue and cost situation. Thereby, the expected range for total revenues was increased from previously EUR 7 – 9 million to EUR 10 – 11 million and the forecast for research and development expenses (R&D expenses) was reduced from EUR 14 – 20 million to EUR 11 – 12 million. The reason for this was, among other things, the efficiency measures of the previous year and active cost management, which were ultimately also reflected in the EBITDA loss, the range of which also shifted from EUR 10 – 17 million to EUR 7 – 9 million. The total revenues of EUR 10.5 million (2020: EUR 8.0 million) and EBITDA loss incurred in fiscal year 2021 of EUR -6.6 million (2020: EUR -22.2 million) were therefore within the specified forecast range, while R&D expenses of EUR 12.8 million (2020: EUR 22.3 million) were slightly higher.
The financial forecast for 2022 reflects the Company’s focus on and progress in the core business of immunotherapies and 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 2022, Medigene expects to achieve revenues of EUR 23 – 28 million, R&D expenses of EUR 11 – 15 million and a positive EBITDA in the amount of EUR 3 – 5 million.
Cash and cash equivalents amounted to EUR 22.4 million at the end of 2021 (31 December 2020: EUR 30.0 million). Including the upfront payment of EUR 26 million received under the new partnership with BioNTech signed in February 2022, Medigene is financed into Q4 2024 based on current planning.
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):