On March 28, 2023 Medigene AG (Medigene, FSE: MDG1, Prime Standard), an early stage immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, reported financial results for the year ended December 31, 2022 and provided a corporate update (Press release, MediGene, MAR 28, 2023, View Source [SID1234629460]).

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Full Year 2022 Financial Results

Revenues amounted to EUR 31.3 million, up 200% compared to EUR 10.5 million in 2021.The increase in revenues compared to the previous year is mainly a result of the comprehensive TCR-T and technology partnership with BioNTech as well as a milestone payment received from 2seventy bio.

General and administrative (G&A) expenses were EUR 7.7 million in 2022 compared to EUR 6.2 million in the year prior. This 25% increase was mainly due to higher personnel expenses and consulting costs. In addition, some of the expenses for Executive Board compensation were reported under G&A expenses, whereas in previous years they were reported under R&D expenses.

Research and development (R&D) expenses increased from EUR 12.8 million in 2021, to EUR 28.5 million in fiscal 2022. The significant increase is mainly due to depreciation related to the full impairment of the drug candidate RhuDex, which was out-licensed to Dr. Falk Pharma GmbH, for the amount of EUR 20.4 million. This is attributable to the results of a clinical trial for primary biliary cirrhosis, where the efficacy of the drug candidate RhuDex could not be demonstrated. In the previous year, the impairment loss on RhuDex amounted to EUR 1.5 million.

Cash and cash equivalents amounted to EUR 22.2 million at the end of 2022, compared to EUR 22.4 million at the end of 2021. Based on current planning, Medigene is financed into the fourth quarter 2024.

"2022 was a transformational year for Medigene. We announced a strategic update, that involved the shift of our pipeline focus from liquid to solid tumors, expanding our in-house pipeline and accelerating the development of our lead candidates. We were thrilled to welcome BioNTech as our global strategic partner and received a milestone payment from one of our existing partners, 2seventy bio. In addition, we continued to expand our patent portfolio, which now consists of 57 issued and 94 pending patents across both our assets and technologies in our End-to-End Platform," said Selwyn Ho, Chief Executive Officer of Medigene.

"In 2023, we continue to progress our own MDG1015 program towards a first-in-human clinical trial and look forward to selecting our first lead candidate from the MDG10xx program in the second half of this year. We expect to extend our collaborative approach to R&D, maximizing our existing partnerships and evaluating new partnerships. We will continue to innovate and expand our End-to-End Platform to generate additional value from new development optimization and product enhancement technologies. Finally, despite our current strong cash position, we will explore opportunities to extend our cash runway into 2025 and beyond."

Recent Program Development Highlights and Anticipated 2023 Milestones

MDG1015: 3rd Generation TCR-T therapy for NY-ESO-1 combined with PD1-41BB Switch Receptor technology: MDG1015 is our lead internal solid tumor program. MDG1015 is being advanced towards a phase 1 clinical trial and is currently undergoing Investigational New Drug (IND) and Clinical Trial Application (CTA) enabling experiments, with the aim of having the IND / CTA approved in the 2nd half of 2024.

The first presentation of pre-clinical data for MDG1015 has been accepted for poster presentation at the upcoming American Academy of Clinical Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2023.

MDG10xx: Multiple TCR-T therapies for yet undisclosed targets combined with PD1-41BB Switch Receptor technology: MDG10xx is being developed against several, as yet undisclosed targets and involving multiple human leukocyte antigens (HLAs), again in combination with the PD1-41BB Switch Receptor technology. The Company expects to announce the first lead for this program in the second half of this year.

MDG1011: TCR-T therapy in blood cancers: The successful completion of the phase 1 MDG1011 trial provides clear clinical validation of our ability to generate and manufacture TCR-T therapies. Despite the positive data generated for MDG1011, the Company made the strategic decision to focus future research and development efforts towards solid tumors indications.

Recent Corporate Development Highlights

Milestone payment from 2seventy bio: In December 2022, a strategic partnership between 2seventy bio (Nasdaq: TSVT) and JW Therapeutics (HKEX: 2126) was announced that included plans for the advancement of the MAGE-A4 TCR licensed from Medigene into a phase 1 clinical trial in China. This triggered a USD 3 million milestone payment from 2seventy bio, which the Company received in January 2023. As a reminder, our partnership with 2seventy bio concluded in June 2022 in accordance with the contract. Upon achievement of contractually defined targets, Medigene remains eligible for milestone payments and royalties from 2seventy bio as per the existing agreement.

Strengthened leadership team with new appointments of James Cornicelli, Pamela Keck and Kirsty Crame: Mr. Cornicelli is the Head of Corporate Development and Strategy. As a highly seasoned executive with over 20 years in senior corporate development and strategic advisory roles, Mr. Cornicelli brings multiple areas of expertise that will help guide the company on critical decisions about partnering and accelerate the growth strategy.

Pamela Keck is the Head of Investor Relations and Corporate Communications. Ms. Keck brings more than 15 years of experience as investor relations and corporate communications professional, and will lead Medigene’s investor relations and corporate communication actvities.

Kirsty Crame, MD, was recently appointed as Medigene’s Head of Clinical Research & Development. Kirsty brings more than 10 years of experience in drug development and clinical operations, focusing primarily in immuno-oncology and in cell therapy development. Dr. Crame will lead the Company’s clinical operations and guide the development of the MDG1015 program towards IND/CTA submissions and approval