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spk02: and is tailored to an accelerated, automated manufacturing process, which reduces time to treatment in patients and generates the optimal cell composition of our TCRT therapy to improve clinical efficacy, safety, and durability of the treatment. Taking a closer look at our end-to-end platform, this is the basis of our differentiated approach and combines multiple exclusive and proprietary technologies to create best-in-class differentiated TCRT therapies in specific development modules. The platform includes multiple safety-focused technologies here in green, efficacy-enhancing technologies in orange, and development optimization technologies designed to make the development process more efficient, higher quality, cheaper, and faster in gray. Examples of such technologies across each of our modules include TCR generation and optimization technologies, such as the allogeneic HLA or allo-HLA TCR priming, as well as precision pairing, and TCRT therapy armoring and enhancement technologies, such as our PD141BB and CD40 ligand CD28 co-stimulation switch protein, and our inducible medigene T-cell receptor to address challenges in developing effective, durable, and safe TCRT therapy. Our platform is dynamic and constantly being expanded with new intellectual property and technologies. And our partnerships with multiple companies, including Biontech and 270Bio, continue to validate the platform's value. Reflecting on our achievements in 2023, I would like to mention how proud I am of all my colleagues at MediGene and the execution and delivery of all our commitments. Over the past year, we have prioritized the programs that we believe will create the most value for patients and shareholders, with significant progress in further developing our end-to-end platform and advancing our product pipeline. In terms of platform innovation, we have significantly advanced our E2E platform. We've been able to improve clinical efficacy, safety, and durability of our drug product with our accelerated six-day automated GMP manufacturing. This includes the quick drug product generation with high proportion of CD8 positive cells. We also acquired the exclusive license for the CD40 ligand CD28 co-stimulatory switch protein, which expands our suite of product enhancement technologies within our platform and joins our existing PD141BB co-stimulatory switch protein as a technology that has the potential to further enhance the anti-tumor activity of our TCRT cells and improve their ability to overcome the immunosuppressive solid tumor microenvironment. Additionally, we added the next generation of the expert safety screening tool. Antigen selection and assessment of on- and off-target specificity is a major challenge in generation of TCRT therapies. To make such selections and reduce off-target toxicity, the identification of suitable epitopes is the first and most critical step for creation of our best-in-class TCRT therapies. The advances of our E2E platform allowed us to extend and strengthen our patent portfolio, with new technologies to expand existing patents into additional jurisdictions, such as our close-dimension switch proteins for use in multiple cell types, as well as their geographical expansion. As of December 31, 2023, Our IP portfolio consists of 112 issued and 131 pending patents. In 2023, we also made progress on expanding our platform into new TCR-based modalities, and more on that later in the presentation. In terms of our pipeline expansion advancements, for our lead program, NGC 1015, is our third-generation NYESO TCR combined with PD141BB. Here, we made substantial progress advancing this towards a first-in-human clinical trial. We have selected the CDMO, or Contract Development and Manufacturing Organization, AGC Therapeutics, and CRO, or Clinical Research Organization, and that we will work with as we look to bring our lead program into the clinic. Additionally, we have positive interactions with regulatory authorities in both the US and Europe. We remain on track for submitting an investigational new drug application to the FDA and a clinical trial application, or CTA, to the European Medicines Agency, EMA, for this program, with a plan to enter the clinic at the end of 2024, subject to financing. Importantly, we recently announced that we aim to recruit patients with synovial sarcoma, myxoid round cell liposarcoma, ovarian cancer, and gastric cancer as part of our first phase one clinical trial, thus targeting both rare tumors as well as those which are more commonly seen. In addition, we successfully broadened our pipeline into neoantigens, which are oncogenic driving mutations that alone are sufficient to initiate and maintain cancer, with KRS as one of the most frequent neoantigens in solid cancers. As part of our lead program, MDG2011, which is a KRAS G12V-specific T-cell receptor targeting HLA-A11. This is combined with our PD141BB co-stimulatory switch protein, and we generated three outstanding T-cell receptors, all of them exceeding the company's selection criteria for highly specific, sensitive, and safe TCRs. We were then able to select one of these TCRs as a lead to advance to the preclinical stage. Our follow-on KRAS programs, MDG2021, MDG2012, and MDG20XX, enables us to offer multiple TCR candidates and to potentially provide products for a much larger patient population with a variety of KRAS neoantigens and human leukocyte antigens in diverse solid cancers. This is our library approach. In partnering to support the development of our research projects, we have established a partnership network of both biotechs and renowned academic bodies. In 2023, we entered into a joint collaboration with the US National Cancer Institute to assess the potential of MediGene's proprietary T-cell receptors for use in new cell constructs in the treatment of solid tumors. Our existing partnerships with BioNTech and 270Bio are progressing well. with a number of undisclosed targets on the go with BioNTech currently. We received a milestone payment from 270Bio related to the MAGE A4 target licensed to them. We extended the licensing for our co-stimulatory switch proteins PD141BB and CD40 ligand CD28 for use in additional cell types and in chimeric antigen receptor T cells or CAR T therapies. broadening the application scope of our innovative technologies in immuno-oncology, as well as expanding our IP portfolio. Finally, on a corporate basis, we extended our cash runway through efficiencies in our cash spend and portfolio prioritization, and expanded our recess coverage from investment banks. We also continued to strengthen the executive leadership team to support the execution of our corporate strategy. Coming to our pipeline, MDG 1015 is our lead program. Following recent positive EU and US preliminary regulatory interactions, we remain on track for an IND CTA approval in the second half of 2024. Subject to financing, we expect to initiate a first in human trial for MDG 1015 by the end of 2024, targeting patients with multiple solid tumors, including gastric and ovarian cancer, and sinoblosarcopylamyxoid round cell liposarcoma. Our second TCRT therapy program is MDG2011, a best-in-class third-generation TCRT therapy targeting KRSG12B HLA-A11, again armored and enhanced by the PD141BB co-stimulatory protein. Encouraging first preclinical data on MDG2011, was presented at the ESMO Congress in 2023, as well as the CITSE Annual Meeting in 2023. Lead selection for MDG2011 was announced in the third quarter of last year. We will progress the remainder of our announced KOS program, namely MDG2021 and MDG2012 towards INDCT enabling work and lead selection, respectively, over the next 18 to 24 months. Consistent with our previously announced strategic pivot in November 2022, away from hematologic cancers to focus on solid tumors, the company has evaluated the possibility for partnering MDG 1011 with interested parties. A lack of interest from potential partners to drive the program forward indicates that the competitive landscape has changed. We have therefore decided to discontinue the active partnering of MDG 1011. As mentioned previously, our partnerships with BioNTech and 270Bio for the MAGE, A4, and PRAME TCRs we have licensed respectively continue to progress well and provide crucial scientific validation of MediGene's technology and assets. As these partner programs move into clinical development, they will further provide clinical proof of concept alongside MediGene's own programs. Coming on to partnerships and from our biopharma partnerships, with BioNTech, since the commencement of the agreement in February 2022, this has been making great progress with work progressing now on multiple potential targets. The 270Bio, as previously communicated, the research term for our partnership was concluded in accordance with the contract in 2022. Upon achievement of contractually defined targets, we remain eligible for milestone payments and royalties as per the existing agreement. To that end, in December 2022, 270Bio announced a strategic partnership with JW Therapeutics, which triggered a $3 million milestone payment from 270Bio. The payment was booked in 2022 and received in January of 2023. In November 2023, 270Bio announced the initiation of an investigator-initiated study in China of 270Bio's May J4 T-cell receptor program in solid tumors, and this was anticipated by the end of 2023. The trial is led by 270Bio's partner in China, JW Therapeutics, and MediGene expects to receive further milestone payments based on the successful conduct of this trial. Separately, 270Bio recently announced it will focus exclusively on the commercialization and development of abecma in partnership with Bristol Myosquib. And as a result, it will sell the research and development pipeline, clinical manufacturing, and platform technologies in oncology and autoimmune disease, which includes MediGene's MAI-J4 TCR, to Regeneron Pharmaceuticals to form the Regeneron Cell Medicines business. The transaction is expected to close in the first half of 2024, subject to certain closing conditions. As previously communicated, due to the prolonged funding and development pause by Hongsheng Sciences that included Medellin's NYESA-1 targeted TCR, the parties mutually agreed to terminate that partnership agreement as it relates to the NYESA-1 asset in the third quarter of 2023. Subsequent to the end of the reporting period, MediGene and Hongcheng Sciences have mutually agreed to terminate the remaining framework agreement of that partnership. Those assets previously under this agreement have been returned to MediGene for potential expansion into our pipeline. In April 2023, MediGene enters into a Cooperative Research and Development Agreement, or CRADA, with the United States National Cancer Institute headquartered in Bethesda, Maryland. to evaluate the use of MediGene's proprietary T-cell receptors in novel cell constructs. Through this collaboration, the company expects to expand the range of tools and technologies in its ETE platform and expects that this could lead to opportunities to use multiple immune cell types in addition to MediGene's current work with T-cell. The development of our research projects is also supported by our long-standing partnerships with academic institutions. notably the Helmholtz Munich and the Technical University in Munich. As innovation remains the lifeblood of both big farmers and biotechs, we remain very active in developing new partnership opportunities to maximize the value of our current and future assets and technologies and ultimately deliver novel and differentiated TCR-based therapies to patients and hope to provide further updates during the course of 2024. I will now go over the financial data for 2023. Our 2023 revenue consisted of income from service contracts with partner companies, pro rata revenue recognition from upfront payments received in the past, as well as milestone payments. Revenues amounted to 6 million euros, a decrease of 81% compared to 31.2 million euros in 2022. The decrease in 2023 is due to the comprehensive TCRT and technology partnership with BioNTech concluded in February 2022, as a result of which 20.9 million euros in product revenues were generated in 2022. In addition, revenues from the partnerships with 270Bio and Home Machine Scientists were also generated in 2022. The cost of sales in 2023 amounted to 1.6 million euros. a 14% decrease compared to approximately €2 million in 2022. The cost of sales included expenses incurred to generate the sales revenue, and this mainly relates to research and development activities for our partner companies. General and administrative, or G&A, expenses were €9.3 million in 2023 compared to €7.7 million in the prior year. This 21% increase is mainly due to higher personal expenses as we supported our strategic efforts to advance all our scientific and partnering activities. Research and development or R&D expenses decreased by 59% to 11.5 million euros compared to 28.5 million euros in 2022, despite the increased work associated with new preclinical development activities. The significant decrease in 2023 was mainly due to depreciation related to the full impairment of the drug candidate Rudex, which was outlicensed to Dr. Farmer in the amount of 20.4 million euros in 2022. R&D expenses incurred in the collaborations with partner companies were reimbursed by the companies. These reimbursements are recognized as R&D payments in the immunotherapies revenue. The company's EBITDA decreased by 28.2 million euros from 13.1 million in 2022 to negative 14.7 million euros due to the product sale in the previous year as part of the partnership with BioNTech. The net loss for fiscal 2023 increased to 16.2 million euros compared to 8.3 million euros in 2022. This increase is due to the described partnership with BioNTech in February 2022 and the associated revenues. Cash and cash equivalents amounted to 8.7 million euros, as well as time deposits in the amount of 8 million euros, totaling 16.7 million euros as of December 31st, 2023. In comparison, 33.2 million euros as of December 31st, 2022, with a cash runway extended into April 2025, previously first quarter of 2025. Based on these results, I'm pleased to report that we have met our financial guidance. As previously communicated, the group's revenue as well as R&D costs are the key performance indicators as MediGene's core activities are related to R&D. In addition, liquidity of the group and of MediGene AG is used as a key performance and management indicator. Liquidity is described as cash and cash equivalents and fixed-term deposits and is expressed as a cash reach in the planning period. This leads me now to our 2024 financial guidance. The 2024 financial projections include potential future milestone payments from existing partnerships that are highly likely to materialize in the amount of 1 million US dollars and 2 million euros respectively. They do not include potential milestone payments from our future or new partnerships or transactions as the occurrence of such payments or the 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 9 and 11 million euros. The company expects R&D costs ranging from 11 to 13 million euros. And as already mentioned, based on current planning, the company is funded into April of 2025. The basis of our non-financial outlook 2024 and beyond, which you might be familiar, involves the expansion of our focus into the potential for new TCR based treatment modalities. This leads us to our corporate vision. At the core of our expertise and capabilities, is our ability to generate optimal TCRs validated by our numerous partnerships. Underpinning this ability to generate potentially best-in-class TCRs is our decades of experience in immunology, T-cell biology, and cancer biology, which manifests in our proprietary end-to-end platform. As such, as we continue to generate these optimal TCRs, we aim to leverage these and apply these into new modalities beyond TCR T-cell therapies where additional value could be created for patients and our shareholders. Firstly, based on the significant interest in the role that TCR-derived, off-the-shelf therapies, we'd be aiming to apply our T-cell receptors in the form of antibody-based T-cell engagers, or TCEs, and allogeneic TCR natural killer cells, or TCR-NK cells, which both have a key advantage of being available to patients without long manufacturing time. We believe that by integrating optimal best-in-class TCRs within these new modalities, we could create highly differentiated therapies for patients. This is a short to medium term aim, and we look forward to being able to update you on progress in these new areas. In terms of our TCR T cell therapies, to be clear, we remain fully committed to TCR T cell therapies as part of the range of potential therapies for patients and focused in advancing our lead program MDG 1015 towards the clinic. As mentioned, MDG 1015 will be advanced towards first-in-human clinical trials with IND CTA approval expected in the second half of 2024. Subject to successful financing, we expect to be able to initiate a first-in-human trial for MDG 1015 by the end of 2024. We are also progressing our announced KRAS programs which will be supported with further scientific data and presented at upcoming scientific conferences in 2024. We will continue to extend our collaborative approach to R&D, maximizing our existing partnerships and evaluating new partnerships for our technology and assets. Whether through partnerships, licensing agreements or internal development, we will continue to innovate and expand our end-to-end platform to generate additional value from new technologies. Again, we have made significant progress here and hope to be able to announce updates to our proprietary technologies throughout 2024. Finally, with respect to our financial position, and as mentioned before, I'm pleased to confirm that we have extended our cash runway into April 25. We are confident that our current partnerships will continue to progress and that with our expanded approach to TCR-based therapies, that new partnerships will be forged with the potential to support continued investment in our research and development strategy. Despite this strong position, biotechnology is a capital-intensive industry, and we wish to be fully prepared to raise additional capital to extend our cash runway into 2026 and beyond. As such, we continue to manage expenses prudently while exploring financing opportunities. We aim to be ready to execute a capital raise allowing us to have sufficient capital to fully achieve our medium to long-term corporate objectives. So in summary, the fiscal year 2023 has been incredibly successful for MediGene. We remain fully on track in the first few months of 2024 on the successful execution and expansion of our strategy and the delivery against our vision to develop differentiated, best-in-class, TCRT, and more broadly speaking, TCR-based therapies for patients with solid tumors. Thank you, everyone. And this marks the end of today's prepared remarks. At this time, I'd like to open up the call for questions.
spk04: We will now begin the question and answer session. Anyone who wishes to ask a question may press star and one on the touchtone telephone. You will hear a tone to confirm that you have entered the queue. If you wish to remove yourself from the question queue, you may press star and two. Questioners on the phone are requested to use only handsets and eventually turn off the volume of the webcast. Anyone who has a question may press star and one at this time. The first question comes from Joseph Pantigis from HC Wainwright. Please go ahead.
spk00: Hi, this is Sarah on for Joe. Thanks for taking the question. We were just wondering regarding the MDG 1015 trial. I know it's not slated to start till the end of the year, but do you have any insights into, I guess, guidelines for any initial data readouts we could expect from that study? Would you be looking for like an interim readout that we could expect maybe early 25? Thank you.
spk01: Thanks for the question, Sarah. It's Selwyn here. Our base assumptions is, again, subject to financing and starting the trial as planned by the end of this year, that we would have an interim data readout towards the end of 2025. Okay. Thank you.
spk04: As a reminder, if you wish to register for a question, please press star followed by one. So far, we have no further questions. I would like to turn the conference back over to Pamela Keck for any closing remarks.
spk03: Thank you so much, operator. Thank you everyone for your time today. And I guess I'll send you all off into a happy Easter weekend. Thank you so much. Thank you.
spk04: Ladies and gentlemen, the conference is now over. Thank you for choosing Coral School and thank you for participating in the conference. You may now disconnect your lines. Goodbye.
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