• Significant corporate and scientific progress in the first half of 2024
• Advancement of lead program MDG1015 with IND filing on track for 3Q 2024 and CTA filing for 4Q 2024
• New additions to End-to-End Platform technologies and IP portfolio
• Partnership expansion with new research partnership with WuXi Biologics leveraging Medigene’s best-in-class TCR generation capabilities in August 2024
• Cash runway into July 2025
• Company to host a conference call today, August 14, 2024, at 3.30 pm CEST/ 9.30 am EST

Planegg/Martinsried, August 14, 2024. Medigene AG (Medigene or the “Company”, FSE: MDG1, Prime Standard), an oncology platform company focused on the research and development of T cell receptor (TCR)-guided therapies for the treatment of cancer, today reported financial results for the six months ended June 30, 2024, and provided a corporate update.
The half-year 2024 earnings report can be found on the website: https://medigene.com/investors-media/reports-presentations/

Select Half-Year 2024 Financial Results:  

Revenues in the reporting period amounted to EUR 4.5 million, an increase of 46% compared to EUR 3.1 million in the first half of 2023. This increase compared to the first half of 2023 is due to the reversal of the remaining contractual liability to Hongsheng Sciences HK Limited (EUR 1.5 million) following the termination of the partnership.

General & administrative expenses decreased by 5% to EUR 4.1 million in the first half of 2024 (6M 2023: EUR 4.3 million including selling expenses), in particular due to lower personnel expenses.

Research and development expenses increased by 21% to EUR 6.3 million in the first half of 2024 (6M 2023: EUR 5.2 million). The reason for the increase is the focus on the development of TCR-T therapies (MDG1015, MDG2011 and MDG2021) for the treatment of solid tumors and preparatory activities for clinical trials (MDG1015).

The net result of the first half of 2024 improved by EUR 0.3 million to EUR -6.7 million compared to the first half of 2023 (6M 2023: EUR -7.0 million).

As of June 30, 2024, cash and cash equivalents amounted to EUR 14.0 million (December 31, 2023: EUR 16.7 million including time deposits). There were no open credit lines.

“In the first half of 2024, we are delighted to have again delivered on all the elements of our corporate strategy. We significantly advanced our End-to-End Platform, adding new technologies such as our innovative Interferon-gamma (IFNγ) Biosensor and our novel TCR-specific antigen-antibody combination technology, UniTope & TraCR. We advanced our lead program MDG1015 towards a first-in-human clinical trial, which is expected to start by the end of 2024 subject to additional financing,” said Selwyn Ho, Chief Executive Officer of Medigene.” We also successfully closed an oversubscribed capital raise with subscription rights resulting in gross proceeds of approximately EUR 5.9 million, which allowed us to extend our cash runway into July 2025. In addition, we announced our new strategic partnership with WuXi Biologics last week, expanding the ability to apply Medigene’s TCRs into new modalities, such as TCR-guided T cell engagers, to create additional value beyond TCR-T therapies for both, patients and our shareholders.”

Financial Guidance 2024:

Performance in the first half of 2024 was in line with the Executive Management Board's expectations.

On May 8, 2024, the Company reported that it had successfully completed an oversubscribed capital raise with gross proceeds of approximately EUR 5.9 million. The Company therefore amended its guidance and extended its cash runway into July 2025 (initial 2024 guidance: cash runway into April 2025).

Research and development costs were also amended and are expected to increase from prior estimates of EUR 11.0 to 13.0 million to EUR 11.5 to 13.5 million in 2024 to support additional activities enabling first patient enrollment for MDG1015 Phase 1 clinical trial by the end of 2024, subject to further financing.

The Company maintained its guidance on expected revenues to be between EUR 9.0 and 11.0 million (unchanged) in 2024.

These projections include potential future milestone payments from existing partnerships that are highly likely to materialize(see Annual Report 2023). They do not include potential milestone payments from or future/new partnerships or transactions as the occurrence of such payments or their timing and size largely depend on third parties and cannot be controlled or influenced by Medigene.

Program development highlights:

MDG1015: MDG1015 is a first-in-class, third generation T cell receptor engineered T cell (TCR-T) therapy targeting NY-ESO-1/LAGE-1a (New York esophageal squamous cell carcinoma 1 / L Antigen Family Member-1a), armored and enhanced by the costimulatory switch protein PD1-41BB and targeting HLA-A*02 (HLA, human leukocyte antigen). Pre-clinical data presented in 2024 at the AACR and CHI conferences demonstrated the clear potential of MDG1015 to improve clinical outcomes in solid tumors with the innovative approach of combining a 3S (specific, sensitive and safe) TCR with the Company’s PD1-41BB costimulatory switch protein technology as well as an optimized drug product composition.

Following positive EU and US preliminary regulatory interactions, the Company remains on track for IND-filing in Q3 and CTA-filing in Q4 2024. Subject to financing, the Company expects to initiate a first in-human trial for MDG1015 by the end of 2024.

MDG2011: MDG2011 is a potential best-in-class third generation TCR-T therapy targeting KRAS G12V (HLA-A*11), further armored and enhanced by the PD1-41BB costimulatory switch protein. Pre-clinical data on MDG2011 was presented at the International Neoantigen Summit and the CIMT Annual Meeting in 2024.

MDG2021 MDG2021 is the second candidate within the KRAS library targeting KRAS G12D (HLA-A*11) for which the Company announced the lead selection in June 2024.

MDG2012: The lead selection for the Company’s third announced KRAS-targeted program MDG2012, KRAS G12V (HLA-A*03), is expected in 2025.

Corporate development highlights:

In May 2024, Medigene successfully closed an oversubscribed capital raise with subscription rights resulting in gross proceeds of approximately EUR 5.9 million.

Subsequent to the quarter on August 8, 2024, the Company announced it has entered into a  three-year, multi-target strategic partnership to design and co-research T cell receptor (TCR)-guided T Cell Engagers (TCR-TCEs) for the treatment of difficult-to-treat tumors with WuXi Biologics. The collaboration combines the respective expertise of each company with Medigene’s 3S TCR generation and characterization capabilities and WuXi Biologics’ unique anti-CD3 mAb, its industry-leading TCE platform and proprietary bispecific antibody platform WuXiBody™. The companies aim to co-research TCR-TCE constructs, which will be owned by both cooperation partners with options to Medigene to further advance their development.

Expansion of patent portfolio:

The advancement of its End-to-End Platform allowed the Company to extend and strengthen its patent portfolio with new technologies as well as to expand existing patents into additional jurisdictions, such as the submission of three patents to the European Patent Office protecting the Company’s innovative Interferon-gamma (IFNγ) Biosensor and its novel T cell receptor (TCR)-specific antigen-antibody combination technology, UniTope & TraCR, the patent grant by the European Patent Office and Japan Patent Office protecting the inducible Medigene T cell receptor (iM-TCR) technology as well as the patent grant by the European Patent Office protecting the Company’s TCR targeting NY-ESO-1 and LAGE 1a. As of June 30, 2024, the patent portfolio consisted of 97 issued patents and 124 pending patent applications (December 31, 2023: 28 patent families, 112 issued patents and 131 pending patent applications).

Conference call and webcast:

The Company will host a conference call today, August 14, at 3:30 pm CEST / 9:30 am EDT. In addition to the financial results for the first six months of 2024, Medigene will provide a corporate update including its new partnership with WuXi Biologics (see press release on Aug 8, 2024).

Full details for the conference call and webcast are as follows:

Participants may pre-register and will receive dedicated dial-in details to easily and quickly access the call with the above registration link for the conference call.

Please dial in 10 minutes ahead of time to ensure a timely start of the conference call.

Following the call, an archived webcast will be accessible on the Investors & Media section on Medigene’s website: https://medigene.com/investors-media/reports-presentations/

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About Medigene AG

Medigene AG (FSE: MDG1) is an immuno-oncology platform company dedicated to developing T cell receptor (TCR)-guided therapies to effectively eliminate cancer. Its End-to-End Platform generates optimal 3S (sensitive, specific and safe) T cell receptors with unique and distinctive attributes that are utilized in multiple therapeutic modalities such as T cell receptor engineered T cell (TCR-T) therapies, TCR-guided T cell engager therapies and TCR-natural killer cell therapies for both its in-house product pipeline and partnering.

Medigene’s lead TCR-T program MDG1015 is a potential best-in-class, TCR-T therapy to treat multiple solid tumor indications. The End-to-End Platform technologies enable armoring and enhancing of these T cells to overcome the immunosuppressive tumor microenvironment (TME) and ensure the T cell drug product composition maximizes safety, efficacy and durability of response. Medigene’s MDG1015 is on track for IND filing in Q3 2024 and CTA filing in Q4 2024. For more information, please visit www.medigene.com

This press release contains forward-looking statements representing the opinion of Medigene as of the date of this release. The actual results achieved by Medigene may differ significantly from the forward-looking statements made herein. Medigene is not bound to update any of these forward-looking statements. Medigene^® is a registered trademark of Medigene AG. This trademark may be owned or licensed in select locations only.

Medigene AG

Pamela Keck
Phone: +49 89 2000 3333 01
E-mail: investor@medigene.com

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