Medigene AG Q3 2024 Financial Results and Business Update

Planegg/Martinsried, October 24, 2024 - Medigene AG, an oncology platform company centered on the development of T cell receptor (TCR)-guided therapies for cancer treatment, has released its financial outcomes and provided a business update for the third quarter ending September 30, 2024. The complete report can be accessed on their website.

During the third quarter of 2024, Medigene maintained its strategic focus on advancing its T cell receptor engineered T cell (TCR-T) therapies and expanding its capabilities to apply their sensitive, specific, and potentially safer (3S) TCRs to new treatment modalities. The company announced a three-year strategic partnership with WuXi Biologics to co-research TCR-guided T Cell Engagers (TCR-TCEs) for solid tumors. This partnership aims to extend Medigene's pipeline, with the MDG3010 program set for joint development. These bispecific therapeutics will target cancer cells with high precision and reduced off-target effects, with the specific target to be disclosed later. Additionally, Medigene's lead program, MDG1015, has received FDA clearance for its investigational new drug (IND) application, with plans to submit a clinical trial application (CTA) to the European Medicines Agency (EMA) in Q4 2024. Subject to additional financing, the company aims to initiate and generate early data read-outs for the EPITOME-1015-I trial by the end of 2025.

Financially, Medigene's performance in Q3 2024 was consistent with the Executive Management Board's expectations. The company's revenues reached EUR 1.4 million, primarily generated from its partnership with BioNTech. Research and development expenses amounted to EUR 2.7 million, reflecting Medigene's ongoing commitment to advancing its therapeutic pipeline. As of September 30, 2024, Medigene held cash and cash equivalents totaling EUR 9.5 million.

During the quarter, Medigene executed a 2:1 share capital reduction and consolidation, as resolved by the AGM on June 24, 2024. This process reduced the number of shares from 29,475,188 to 14,737,594, with the new shares trading under WKN A40ESG (ISIN: DE000A40ESG2) since August 29, 2024. This restructuring did not affect the company's value or individual shareholders' ownership percentages, but aimed to raise the market value per share above the notional par value of one euro.

Following the quarter, Medigene announced the securing of a financing option through an equity commitment of up to EUR 15 million via a Standby Equity Purchase Agreement (SEPA) with a fund managed by Yorkville Advisors Global L.P. This facility enables Medigene to continue developing its programs, complementing potential financing sources from both capital markets and non-dilutive sources from current and future partners. This financing option provides significant flexibility in deploying the necessary capital.

Medigene also engaged in a three-year, multi-target strategic partnership with WuXi Biologics to design and co-research TCR-guided T Cell Engagers (TCEs) for solid tumors. The MDG3010 program will see the co-development of TCR-TCE constructs, with Medigene retaining the option to further their development. These constructs will combine Medigene's highly specific 3S TCRs with WuXi Biologics' anti-CD3 mAb, TCE platform, and proprietary bispecific antibody platform, WuXiBody™.

In terms of scientific and clinical development, Medigene's lead program MDG1015, targeting NY-ESO-1 / LAGE-1a with a 3S TCR and PD1-41BB costimulatory switch protein (CSP), received FDA clearance to initiate a phase 1 clinical trial (EPITOME1015-I) for several cancers, including advanced gastric cancer, ovarian cancer, and synovial sarcoma. The company is on track to submit a CTA to the EMA in Q4 2024.

During the quarter, Medigene presented at various scientific conferences, showcasing pre-clinical data for MDG2021 at the European Society for Medical Oncology (ESMO) Congress 2024. This program targets KRAS G12D mutation with HLA-A*11. Medigene also presented the latest expansion of its End-to-End Platform, UniTope & TraCR, at both the ESMO Congress 2024 and the American Society of Gene & Cell Therapy Annual Meeting.

Medigene continued to advance its intellectual property portfolio, which included 29 patent families with 104 issued patents and 124 pending applications as of September 30, 2024. New patents were granted for their TCR targeting NY-ESO-1 / LAGE 1a and JOVI technology, enhancing the company's portfolio and ensuring robust protection for its innovative therapies.