On March 27, 2024 Medigene AG (Medigene or the "Company", FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, reported financial results for the fiscal year ended December 31, 2023, and provided a corporate update (Press release, MediGene, MAR 27, 2024, View Source [SID1234641515]).

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Select FY 2023 financial results

Revenues amounted to EUR 6.0 million, a decrease of 81% (or EUR 25.2 million) compared to EUR 31.2 million in 2022. Higher revenues in 2022 were due to the comprehensive TCR-T and technology partnership with BioNTech concluded in February 2022, resulting in EUR 20.9 million in product revenues. In addition, revenues from the partnerships with 2seventy bio and Hongsheng Sciences were generated in 2022.

Selling expenses decreased from EUR 2.2 million in 2022 to EUR 20 thousand in 2023. This decrease is due to the above-mentioned partnership with BioNTech and the related costs incurred in the first half of 2022 as part of the preparation process leading up to the agreement.

General and administrative (G&A) expenses were EUR 9.3 million in 2023 compared to EUR 7.7 million in the year prior. This 21% increase was mainly due to higher personnel and consulting expenses as the Company supported its strategic efforts to advance all scientific and partnering activities.

Research and development (R&D) expenses decreased by 59% to EUR 11.5 million (2022: EUR 28.5 million) and reflect the work associated with the development of T cells for the treatment of solid tumors and pre-clinical development activities. The significant decrease in 2023 is mainly due to depreciation related to the full impairment of the drug candidate RhuDex, out-licensed to Dr. Falk Pharma GmbH for the amount of EUR 20.4 million in 2022. R&D expenses incurred in the collaborations with partner companies are reimbursed by the companies. The reimbursements are recognized as R&D payments in immunotherapies revenue.

Net loss for fiscal 2023 increased to EUR 16.2 million compared to EUR 8.3 million in 2022. The increase is due to the described partnership with BioNTech in February 2022 and the associated revenues.

Cash and cash equivalents amounted to EUR 8.7 million and time deposits for EUR 8 million, totaling EUR 16.7 million on Dec 31, 2023 (Dec 31, 2022: EUR 33.2 million), with a cash runway extended into April 2025 (previously Q1 2025).

"2023 was a highly productive year for Medigene. We have made significant progress in broadening our pipeline into TCR-T therapies targeting KRAS mutations, which represent one of the most frequent neoantigens in solid cancers. We significantly advanced our End-to-End (E2E) Platform, adding new technologies such as the CD40L-CD28 costimulatory switch protein, and with a focus on improving our drug product composition to enable better efficacy, safety and durability. This was reflected by an increase in the size and scope of our patent portfolio," said Selwyn Ho, Chief Executive Officer of Medigene. "Importantly, we advanced our lead program MDG1015 towards a first-in-human clinical trial, which is expected by the end of 2024 subject to financing. This first-in-human trial will target patients with gastric cancer, ovarian cancer, myxoid/round cell liposarcoma and synovial sarcoma as the initial clinical indications."

"In 2024, we will continue to advance our differentiated TCR-T therapies for the treatment of solid tumors. Using our core expertise and ability to generate optimal TCRs, we will also aim to apply these to new TCR-based modalities beyond TCR-T cell therapies, such as off-the shelf T cell engagers and allogeneic TCR-Natural Killer cells, where further value could be created for patients and our shareholders. We believe that these additional potential therapeutic options represent highly promising commercial opportunities for Medigene."

Financial Guidance 2024

The 2024 financial projections include potential future milestone payments from existing partnerships that are highly likely to materialize in the amount of USD 1 million and EUR 2 million, respectively. They do not include potential milestone payments from or future/new partnerships or new 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.

As such, the 2024 financial guidance reflects the Company’s focus and progress in its core immunotherapies business.

Based on the above assumptions, Medigene expects revenue in 2024 to be between EUR 9 and 11 million. The Company expects R&D costs to range from EUR 11 to 13 million. And as already mentioned, based on current planning, the Company is funded into April 2025.

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). Preclinical data presented in 2023 at the AACR (Free AACR Whitepaper) and ESMO (Free ESMO Whitepaper) conferences demonstrated the clear potential of MDG1015 to improve clinical outcomes in solid tumors.

Following recent positive EU and US preliminary regulatory interactions, the Company remains on track for an IND/CTA approval in the second half of 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. First pre-clinical data on MDG2011 was presented at the ESMO (Free ESMO Whitepaper) Congress 2023 and the SITC (Free SITC Whitepaper) Annual Meeting 2023. Lead selection for MDG2011 was announced in the third quarter 2023.

MDG2021 and MDG2012: MDG2021 is our second candidate within the KRAS library targeting KRAS G12D (HLA-A*11) with lead selection expected in the first half of 2024. 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

To support the development of our research projects, we have established a partnership network with both, well-known biotechs and renowned academic bodies.

In April 2023, Medigene entered into a joint collaboration with the US National Cancer Institute to assess the potential of Medigene’s proprietary TCRs for use in new cell constructs in the treatment of solid tumors.

The Company’s existing partnerships with BioNTech and 2seventy bio are progressing well.

In January 2023, Medigene received a USD 3 million milestone payment from its partner 2seventy bio triggered by 2seventy bio’s initiation of a strategic partnership with JW Therapeutics in December 2022.

Expansion of patent portfolio

The advancement of its E2E 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 costimulatory switch proteins for use in multiple cell types and their geographical coverage. As of Dec 31, 2023, Medigene’s IP portfolio consisted of 112 issued and 131 pending patents across 28 patent families.

Conference Call and Webcast

The Company will host a conference call and webcast today at 3 pm CET / 10 am ET. A Q&A session will follow the management’s formal presentation.

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

Date March 28, 2024
Time 3:00 p.m. CET (10 a.m. ET)
Conference ID: 20240088
Registration Conference Call: Registration Conference Call here
Webcast: Join the live webcast here
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 of the Medigene website: View Source