Release Date: August 14, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Medigene AG (MDGEF, Financial) successfully completed an oversubscribed capital raise, extending their cash runway into July 2025.
- The company has expanded its patent portfolio to 97 issued patents and 124 pending patent applications as of June 30, 2024.
- Medigene AG (MDGEF) reported a 45% increase in revenues for the first half of 2024 compared to the same period in 2023.
- The company has advanced its lead TCR-T program, MDG1015, and is on track for submitting an IND application to the FDA in Q3 2024.
- Medigene AG (MDGEF) has established a new strategic partnership with WuXi Biologics to co-develop TCR-guided T-cell engagers for the treatment of solid tumors.
Negative Points
- Access to public capital in the equity markets remains very challenging for biotech companies, including Medigene AG (MDGEF).
- Research and development expenses increased by 21% in the first half of 2024 compared to the same period in 2023.
- The net result for the first half of 2024 was a loss of EUR6.7 million, although this was an improvement from the previous year's loss of EUR7.0 million.
- The company terminated its partnership with Hongsheng Sciences, which included the return of the NY-ESO-1-targeted TCR asset.
- Medigene AG (MDGEF) has not disclosed specific terms of its new partnership with WuXi Biologics, leaving some uncertainty about the deal's financial impact.
Q & A Highlights
Q: Can you provide more specifics about your new partnership with WuXi Biologics, including what the partnership will look like over the next three years and any terms from the deal that you're able to disclose?
A: At this moment, we have not disclosed specifics of the deal other than to say it's a potential multi-target collaboration, looking at multiple TCRs combined with the CD3 WuXiBody construct. Over the next 15 to 16 months, we aim to ensure that the combined TCR-CD3 construct will be ready for its first lead selection. This partnership allows us to decide on further development into IND-enabling work and potentially into the clinic. There is also the opportunity for Medigene or WuXi to continue development if we see further opportunities to create incremental value.
Q: How different is the current management compared to previous ones, and could you elaborate on the cost-saving measures being undertaken recently?
A: The management team has changed significantly, with biotech specialists joining who have extensive experience in both biotech and big pharma. We now have specific expertise in corporate development, business development, corporate financing, commercialization, and early-stage clinical development, particularly in cell therapy. In terms of cost savings, we have prioritized programs, reduced or postponed others, and kept tight control over R&D and G&A costs. We have focused on projects of maximum value and managed to decrease G&A costs, predominantly through reductions in personnel costs.
Q: In what time frame do you expect the next milestone payment from BioNTech or WuXi?
A: We have guided for a $1 million milestone and a EUR2 million milestone this year, though we have not specified which partners these are linked to. We are working well with BioNTech on multiple targets beyond what has been publicly communicated, and we expect milestones based on the natural progression of delivering compelling data. We see a milestone this year and additional milestones in 2025.
Q: Can you provide an update on the progress of your lead TCR-T program, MDG1015?
A: MDG1015, a third-generation NY-ESO-1/LAGE-1a-targeted T-cell receptor combined with our PD1-41BB costimulatory switch protein, is near clinic and remains on track for submitting an IND application to the FDA in Q3 2024 and a CTA to the EMA in Q4 2024. We plan to enter the clinic by the end of 2024, subject to IND, CTA approval, and further financing.
Q: What are the financial highlights for the first half of 2024?
A: Revenues amounted to EUR4.5 million, a 45% increase compared to EUR3.1 million in the first half of 2023. R&D expenses increased by 21% to EUR6.3 million, while selling and general administrative expenses decreased by 5% to EUR4.1 million. The net result improved by EUR0.3 million to minus EUR6.7 million. EBITDA improved by 10% from minus EUR6.6 million to minus EUR6 million. Cash and cash equivalents amounted to EUR14.0 million, extending our cash runway into July 2025.
Q: What are the key strategic advancements made in the first half of 2024?
A: We expanded our end-to-end platform, added UniTope & TraCR combination technology for high-precision TCR tracking, and advanced our pipeline in TCR-T cell therapies. We also announced a new partnership with WuXi Biologics for TCR-TCEs and progressed our existing partnerships with BioNTech and Regeneron. Additionally, we successfully completed an oversubscribed capital raise, extending our cash runway into July 2025.
Q: What are the future plans for Medigene's TCR-T cell therapies?
A: We aim to provide clinical validation of MDG1015 and our emerging library of third-generation KRAS-targeted TCR-T cell therapies. We plan to initiate MDG1015 by the end of 2024, subject to additional financing, and expect an early data readout by the end of 2025. We will continue to expand our collaborative approach to R&D and seek new partnerships for our technology and assets.
Q: How is Medigene's partnership with BioNTech progressing?
A: Our collaboration with BioNTech to advance TCR immunotherapies against cancer has been extended beyond the initial three-year term. This extension enables ongoing and future work to potentially generate novel TCRs against multiple newly nominated antigen targets, further expanding BioNTech's warehouse of TCR candidates.
Q: What are the financial projections for the rest of 2024?
A: We maintain our guidance on expected revenues to be between EUR9 million and EUR11 million in 2024. R&D costs are expected to increase to EUR11.5 million to EUR13.5 million to support additional activities, enabling first patient enrollment for MDG1015's Phase 1 clinical trial by the end of 2024, subject to further financing.
Q: What are the key takeaways from Medigene's first half of 2024?
A: The first half of 2024 has been incredibly successful, with significant advancements in our scientific and corporate strategy. We have expanded our end-to-end platform, advanced our pipeline, and improved our financial position through a successful capital raise. We are excited about the second half of 2024 and the prospect of entering the clinic, providing treatment solutions for patients with solid tumors, and demonstrating the significant value of our approach.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
