On August 3, 2022 Medigene AG (Medigene, FSE: MDG1, Prime Standard), an immuno-oncology company focusing on the development of T-cell-based cancer therapies, reported its Half-Year Report 2022 with an overview on its business performance and financial results (Press release, MediGene, AUG 3, 2022, View Source [SID1234617402]). The full version of the report can be downloaded here: View Source
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Business review Q2 2022 and outlook
MDG1011 – Clinically validated T cell receptor-modified T cell (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 patients and Medigene successfully reported on safety, tolerability and feasibility in December 2021. In February 2022, the first positive efficacy and immune monitoring data were published. The last trial visit of a patient whose myelodysplastic syndrome did not progress to secondary acute myeloid leukemia took place in June 2022, final data are currently being analyzed and will be published upon completion.
Development partnerships
At the end of June 2022, the research term for the partnership with 2seventy bio, Inc. was successfully concluded in accordance with the contract and Medigene remains eligible for potential milestone payments and royalties on future products based on Medigene’s technology. Roivant Sciences divested its holding in Cytovant Sciences in July 2022, which subsequently became Hongsheng Sciences HK Limited (Hongsheng Sciences). Due to financing constraints, Hongsheng Sciences has temporarily suspended its development activities within the Medigene partnership, but Medigene has meanwhile already started the extensive work under the new partnership with BioNTech SE (BioNTech) signed in February 2022.
Discovery of novel T cell receptors (TCRs) against undisclosed target molecules in solid tumors
Using Medigene’s proprietary TCR screening and discovery platform, the Company continuously evaluates novel target molecules in the solid tumor arena including tumor-specific molecules of the cancer-testis-antigen family, "dark matter" antigens stemming from non-coding regions of the DNA, and as yet undisclosed targets. If these targets fulfil Medigene’s target safety criteria during screening, candidates are selected for further TCR development, as part of the Company’s ongoing process to expand its pipeline.
Changes in the Executive Management Board
Dr. Selwyn Ho joined Medigene as Chief Executive Officer (CEO) on 25 July 2022. As a consequence, Prof. Dolores Schendel stepped down as CEO at the end of 24 July 2022 and now fully focuses on her responsibilities as Chief Scientific Officer (CSO) and Head of Research and Development at Medigene.
Prof. Dolores Schendel, CSO at Medigene: "The first half of 2022 was a period of significant transition at Medigene. Importantly, we completed two central projects that have involved intense efforts over the last few years. The Phase I part of our MDG1011 TCR-T trial in blood cancer was concluded with the end-of-trial visit of the last patient at 12 months. The experience we gained here regarding high fidelity manufacturing, drug product characterization, and implementation of immune monitoring strategies for patient assessment now enables straightforward transition to development activities for TCR-Ts in solid cancer.
Secondly, the TCR discovery phase of the 2seventy bio alliance concluded at the end of June, enabling Medigene to rapidly transition to our new multi-faceted alliance with BioNTech that extends beyond projects in TCR discovery to include innovation tools designed and developed at Medigene for next generation TCR-T immunotherapies.
We are also delighted to welcome Dr. Selwyn Ho as CEO of Medigene, which means I return to focusing full time on my role as CSO and Head of Research and Development. Selwyn has the ideal experience to take over and lead Medigene at this exciting time, enabling Medigene to optimally position itself for clinical development of TCR-T immunotherapies for solid cancer in the near future."
Dr. Selwyn Ho, CEO at Medigene: "Medigene is one of the pioneers in the TCR-T space, and the strength and potential of its validated and integrated discovery platform is what attracted me to join. From TCR screening and discovery of novel targets, with the ability to further enhance the activity of our selected TCR with product optimization tools, and finally to a validated manufacturing and clinical biomarker monitoring platform, Medigene has the capabilities to develop potentially highly differentiated TCR-based therapies for solid tumors with high unmet need.
We remain focused on our partnering activities as well as advancing our pipeline of wholly owned TCRs and optimization tools for solid tumors into the clinic as soon as possible. I look forward to be able to announce and discuss our updated plans in further detail by the end of this year."
Financial development and financial forecast
The Company’s revenues increased to €25.3 m in the first half of 2022 (6M 2020: €4.3 m) mainly resulting from the new partnership with BioNTech, research and development (R&D) expenses decreased by 42% to €3.7 m (6M 2021: €6.3 m) and the EBITDA improved to €15.4 m (6M 2021: €-4.5 m) due to the partnership with BioNTech.
Management confirms the financial forecast and still expects revenues of €23-28 m, R&D expenses of €11-15 m and EBITDA of €3-5 m in 2022, without the COVID-19 pandemic or Ukraine crisis having a material impact on these expectations. These estimates do not include potential future milestone payments from existing or future partnerships or transactions, as the occurrence of such events or their timing and scope depends to a large extent on external parties and therefore cannot be reliably forecast by Medigene.
As of 30 June 2022, cash and cash equivalents and time deposits amounted to €39.4 m (31 December 2021: €22.4 m). Based on its current planning, the Company has sufficient financial resources to fund business operations into the fourth quarter of 2024.
Investor and analyst conference call
Date: Wednesday, 3 August 2022, 3:00 pm CEST (9:00 am EDT)
Registration: View Source;linkSecurityString=9253bcaa2
Speakers*: Prof. Dr. Dolores Schendel, CSO and Head of Research and Development
Dr. Birger Kohlert, CFO
*Please note: Since both the report and the presentation mainly refer to the first six months of 2022, Prof. Dr. Dolores Schendel will lead the presentation.
Please register beforehand and latest 2 hours prior to the event through the registration link provided above to receive your personal access information (phone number, passcode, personal PIN). Please don’t distribute your dial-in details which will be personalized. Please dial in at least 10 minutes before start time.