- Significant business and scientific advances in the first half of 2024
- Further development of the MDG1015 lead program with IND submission on schedule for Q3 2024 and CTA submission for Q4 2024
- New additions to end-to-end platform technologies and IP portfolio
- Expansion of the partnership through new research partnership with WuXi Biologics leveraging Medigene’s world-class TCR generation capabilities in August 2024
- Cash runway until July 2025
- The Company will host a conference call today, August 14, 2024, at 3:30 p.m. CEST/9:30 a.m. EST
Planegg/Martinsried, August 14, 2024. Medigene AG (Medigene or the “Company”, FWB: MDG1, Prime Standard), an oncology platform company focused on the research and development of T cell receptor (TCR)-directed therapies to treat cancer, today published its financial results for the six months ended June 30, 2024 and provided a corporate update.
The 2024 half-year results report can be found on the website: https://medigene.com/investors-media/reports-presentations/
Selected financial results for the first half of 2024:
Sales revenue 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 release of the remaining contractual liability to Hongsheng Sciences HK Limited (EUR 1.5 million) following the termination of the partnership.
General and administrative costs decreased by 5% to EUR 4.1 million in the first half of 2024 (6M 2023: EUR 4.3 million including selling expenses), mainly due to lower personnel costs.
Research and development costs 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 as well as 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.
“We are pleased to have once again implemented all elements of our corporate strategy in the first half of 2024. We significantly further developed our end-to-end platform and added 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 in late 2024, subject to additional financing,” said Selwyn Ho, CEO of Medigene. “In addition, we successfully completed an oversubscribed capital increase with subscription rights, which resulted in gross proceeds of around EUR 5.9 million and enabled us to extend our liquidity reserves until July 2025. In addition, last week we announced our new strategic partnership with WuXi Biologics, which expands our opportunities to use Medigene’s TCRs in new modalities such as TCR-directed T cell engagers, creating additional value for both patients and our shareholders beyond TCR-T therapies.”
Financial forecast 2024:
Developments in the first half of 2024 were in line with the Management Board’s expectations.
On May 8, 2024, the company announced the successful completion of an oversubscribed capital increase with gross proceeds of approximately EUR 5.9 million. The company therefore adjusted its forecast and extended its cash runway until July 2025 (original forecast 2024: cash runway until April 2025).
Research and development costs have also been adjusted and are expected to increase from previous estimates of EUR 11.0 to 13.0 million to EUR 11.5 to 13.5 million in 2024. This is intended to support additional activities that will enable – subject to further funding – the recruitment of the first patients for the Phase 1 clinical trial of MDG1015 by the end of 2024.
The company maintained its forecast for expected sales in 2024, which will remain unchanged at between EUR 9.0 and 11.0 million.
These forecasts include potential future milestone payments from existing partnerships that are highly likely to occur (see Annual Report 2023). They do not include potential milestone payments from future/new partnerships or transactions, as the occurrence of such payments or their timing and amount are highly dependent on third parties and cannot be controlled or influenced by Medigene.
Highlights of program development:
MDG1015: MDG1015 is a first-in-class, third-generation T cell receptor (TCR-T)-based T cell therapy targeting NY-ESO-1/LAGE-1a (New York esophageal squamous cell carcinoma 1 / L Antigen Family Member-1a), protected and enhanced by the costimulation switch protein PD1-41BB and targeting HLA-A*02 (HLA, human leukocyte antigen). Preclinical data presented at the AACR and CHI conferences in 2024 demonstrated the clear potential of MDG1015 to improve clinical outcomes in solid tumors with the innovative approach of combining a 3S TCR (specific, sensitive and safe) with the Company’s PD1-41BB costimulation switch protein technology as well as an optimized drug formulation.
Following positive preliminary regulatory interactions in the EU and US, the Company remains on schedule to file the IND application in the third quarter and the CTA application in the fourth quarter of 2024. Subject to funding, the Company expects to initiate a first-in-human study for MDG1015 by the end of 2024.
MDG2011: MDG2011 is a potentially first-in-class third-generation TCR-T therapy targeting KRAS G12V (HLA-A*11) and is further protected and enhanced by the costimulatory switch protein PD1-41BB. Preclinical data on MDG2011 were presented at the International Neoantigen Summit and the CIMT Annual Meeting 2024.
MDG2021 MDG2021 is the second candidate within the KRAS library targeting KRAS G12D (HLA-A*11), for which the Company announced lead selection in June 2024.
MDG2012: Lead selection for the Company’s third announced KRAS-targeted program, MDG2012, KRAS G12V (HLA-A*03), is expected in 2025.
Highlights of corporate development:
In May 2024, Medigene successfully completed an oversubscribed rights offering, raising gross proceeds of approximately EUR 5.9 million.
Following the quarter, on August 8, 2024, the Company announced that it has entered into a three-year, multidisciplinary strategic partnership to jointly develop and research T cell receptor (TCR)-directed T cell engagers (TCR-TCEs) with WuXi Biologics to treat difficult-to-treat tumors. The collaboration combines the respective expertise of both companies with Medigene’s 3S TCR generation and characterization capabilities and WuXi Biologics’ unique anti-CD3 mAb, its industry-leading TCE platform and its proprietary bispecific antibody platform WuXiBody™. The companies intend to jointly research TCR-TCE constructs that will be owned by both collaborators, with options for Medigene to further advance their development.
Expansion of the patent portfolio:
By further developing its end-to-end platform, the Company was able to expand and strengthen its patent portfolio with new technologies and extend existing patents to additional jurisdictions, such as the filing of three patents with the European Patent Office to protect the Company’s innovative interferon-gamma (IFNγ) biosensor and its novel T cell receptor (TCR)-specific antigen-antibody combination technology UniTope & TraCR, the patent grants by the European and Japanese Patent Offices to protect Medigene’s inducible T cell receptor (iM-TCR) technology, and the patent grants by the European Patent Office to protect the Company’s TCR against NY-ESO-1 and LAGE 1a. As of June 30, 2024, the patent portfolio consisted of 97 granted patents and 124 pending patent applications (December 31, 2023: 28 patent families, 112 granted patents and 131 pending patent applications).
Conference call and webcast:
The company will hold a conference call today, August 14, at 3:30 p.m. CEST / 9:30 a.m. 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 August 8, 2024).
Full details of the conference call and webcast are as follows:
| Date | Wednesday, August 14, 2024 |
| Time | 3:30 p.m. CEST (9:30 a.m. EDT) |
| Conference call | Register for the conference call Here |
| Webcast | Join the live webcast Here |
Participants can pre-register and receive special dial-in details to easily and quickly access the call using the conference call registration link above.
Please dial in 10 minutes before the conference call begins to ensure a punctual start.
Following the conference call, an archived webcast will be available in the Investors and Media section of Medigene’s website: https://medigene.com/investors-media/reports-presentations/
— End of press release —
About Medigene AG
Medigene AG (FSE: MDG1) is an immuno-oncology platform company specializing in the development of T cell receptor (TCR)-directed therapies to effectively fight cancer. The company’s end-to-end platform generates optimal 3S (sensitive, specific and safe) T cell receptors with unique and distinctive properties that are used in numerous therapeutic modalities, such as T cell receptor-engineered T cell therapies (TCR-T), TCR-directed T cell engager therapies and TCR-natural killer cell therapies for both its own product pipeline and partnerships.
Medigene’s lead TCR-T program MDG1015 is a potentially first-in-class TCR-T therapy for the treatment of multiple solid tumor indications. The end-to-end platform technologies enable the armoring and enhancement of these T cells to overcome the immunosuppressive tumor microenvironment (TME) and ensure that the composition of the T cell drug maximizes safety, efficacy and durability of response. Medigene’s MDG1015 is on track for IND submission in Q3 2024 and CTA submission in Q4 2024. For more information, please visit www.medigene.com
This press release contains forward-looking statements that reflect the opinion of Medigene at the time of this publication. The actual results achieved by Medigene may differ materially from those contained in the forward-looking statements. Medigene is not obligated to update these forward-looking statements. Medigene® is a registered trademark of Medigene AG. This trademark may be owned or licensed in selected countries only.
Medigene AG
Pamela Keck
Phone: +49 89 2000 3333 01
E-mail: [email protected]
If you do not wish to receive any further information about Medigene, please let us know by email ([email protected]). We will then delete your address from our mailing list.
