Q4 2024 CureVac NV Earnings Call and Business Update
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Speaker Change: These statements involve risks and uncertainties that could cause actual results to differ materially from those projected.
Speaker Change: Do you like disclaims any intention or obligation to revise any forward looking statements.
For more information please refer to our filings with the U S Securities and Exchange Commission.
Speaker Change: Now turning to call them, which I found it.
Speaker Change: Ladies and gentlemen, good morning, good afternoon to everybody on the webcast.
Speaker Change: The fourth quarter of 2024 completed a transformation of the ear procure back which was marked by significant strategic shifts and positive financial milestones positioning the company for future growth in oncology and infectious diseases.
In July 2024, we took decisive action to streamline and rightsize the company laying a solid foundation for future success in 2025 and beyond.
Speaker Change: Our refocused the company on what we do best Technology innovation and R&D and that's.
Speaker Change: Made substantial progress in expanding and advancing our pipeline totally proprietary clinical development program.
Speaker Change: These programs have the potential to address critical unmet medical needs and capitalize on compelling market opportunities.
Speaker Change: Cala Chi we continued to make progress with our lead program in patients with refractory Glioblastoma.
Speaker Change: One study successfully completed enrollment of part B B.
Speaker Change: Speed up the enrollment underscored the urgent need for new treatment options and just aggressive form of brain cancer and we are encouraged with the rapid progress we are making.
Speaker Change: Our off the shelf positioning immunotherapy program in patients with squamous non small cell lung cancer achieved a significant regulatory milestone we see indeed clearance from the U S food and drug administration to proceed with phase one we anticipate treating the first patient in the second half 'twenty to 'twenty five.
Speaker Change: Additionally to infectious diseases, our new licensing agreement with GSK prophylactic vaccines continues to progress in November GSK initiated a combined phase one two study for seasonal.
Speaker Change: Kobe combination vaccine based on our proprietary second generation mrna backbone.
Speaker Change: Triggered a 10 million euro milestone.
Speaker Change: Have some payment was invoiced in the fourth quarter of 2024 and received in the first quarter was 2025.
Speaker Change: Additionally, in its full year at fourth quarter earnings support GSK confirmed that clinical program for Standalone seasonal influenza vaccine is being prepared for phase III.
Speaker Change: Transition to phase III would trigger another significant milestone payments.
Speaker Change: Further validating our technology.
Speaker Change: On the IP front as you may have seen recently the European patent office E. P. O upheld the validity of our sleep fully a J 0668 patent and amended falls. This outcome is particularly important as it validates our pioneering role do that'll be foundational.
Speaker Change: Technology.
Speaker Change: And finally, thanks to this steady progress across our portfolio and successful execution of our restructuring plan. We closed 2024 with a strong cash position of 482 million euros, reaffirming our expected financial runway into 'twenty or 'twenty eight.
Speaker Change: On slide five I would like to highlight the key accomplishments in 2024, which is that's true that's true.
Speaker Change: Inventory for increased performance and innovation.
Speaker Change: Our previously mentioned licensing agreement with GSK.
Speaker Change: In July 2024, and valued up to 1.45 billion euros, plus royalties walks a pivotal moment for Chebec district.
Speaker Change: This agreement provides us.
Speaker Change: If he can capital and leverage as gsk's expertise in infectious diseases for successful development and commercialization.
Speaker Change: Importantly, we then embarked on a strategic corporate restructuring to streamline the company, including a headcount reduction of approximately 30% which was completed in 2044.
Speaker Change: The restructuring has positioned us to achieve higher efficiency and agility in executing our pipeline priorities, allowing us to focus on developing potentially transformational mrna therapeutics in oncology and infectious diseases.
Speaker Change: Our oncology pipeline of phase one <unk> study demonstrated promising dose escalation data last year, confirming acceptable tolerability and antigen specific T cell responses in the majority of the patients. We also added a new program for squamous non small cell lung cancer.
Speaker Change: <unk> featuring a multi epitope immunotherapy.
Speaker Change: I didn't get.
Speaker Change: Derived from our collaboration with my view.
Speaker Change: In prophylactic vaccines, we initiated program against Euro pathogenic E coli bacteria or you pack.
Speaker Change: Urinary tract infections, which is what is the most common bacterial infections.
Speaker Change: Medical need supported by promising preclinical data.
Speaker Change: In the GSK licensed programs in infectious diseases.
Speaker Change: Austin, Houston Phase II headline data for season, and implants are well supported in September 2024.
Speaker Change: Some antibody titers against both influenza strains entered a toys the challenging influenza b strain.
Speaker Change: And as I mentioned, starting to phase III trial would trigger another significant milestone payment from GSK.
Speaker Change: On the management side, we welcome two new members to our leadership team to Mr. Robin <unk>, Chief business Officer, and excellent I'll call, Mike <unk> Chief Financial Officer.
Speaker Change: Both are seasoned industry experts and brings significant expertise and experience to share back.
Speaker Change: Building on our momentum in oncology infectious diseases and seen the leadership. He further anticipate chi cancellations in 'twenty two when there's five that would further expand our pipeline and reinforce our R&D priorities.
Speaker Change: Beginning with the quality they expect to share data from the fully recruited phase one part equally robust so much that the second half of 2025 and 10.
Speaker Change: Lending results you will take a decision to advance to phase two which is expected in the second half of 2025.
Speaker Change: Although the IMD clearance in the U S. The first patient in our program for squamous non small cell lung cancer is scheduled to be treated in the second half of this year.
Speaker Change: Clinical development of our new prophylactic vaccine program for you Peg is underway and we expect to file an NDA submission in the second half of this year for a phase one study to commence in the first half 'twenty 'twenty six.
Speaker Change: Also in the infectious disease area, we expect GSK trial programs with current candidates based on licensed <unk> technology.
Speaker Change: And lastly in 2025, we will continue to defend our broad.
Speaker Change: IP portfolio and anticipate further key decisions throughout the year in Europe and U S.
Speaker Change: Together these upcoming milestones position go back for another year of great momentum and with a sharpened focus.
Speaker Change: These pipeline, we probably made a leader in innovation within the hour and they take the system.
Speaker Change: In March 2025, the decision of the European patent office on E. P O to uphold the validity of four split probably eight to six eight.
Speaker Change: <unk> former represents an important step in our ongoing litigation with devices like sick.
Speaker Change: This decision supports a pioneering role that significant contributions to mrna vaccine technology, particularly in the space of COVID-19 vaccines.
Speaker Change: He said he called that in Europe, each I P. Right Sandy that's a separate case for beach validity infringement and potential damages would be decided separately.
Speaker Change: Just would be assessed only validity and infringement both have been established.
Speaker Change: On slide six you can see a schematic of this bifurcated process on the left side. The infringements proceedings are displayed for Ipd's Puget Central is decided by the regional court just the doors as well as potential damages related to all six IP rights issue on.
Speaker Change: On the right side validity proceedings, all displayed well listen these are a P rights sort by different authorities, depending on the nature of the IP right.
Speaker Change: But let me give the split on the API is sourced by D E. P O.
Speaker Change: Following the EPA was positive decision on their first splits probably a 668.
Speaker Change: Months adhering to rule on infringement is scheduled for July 1st 2025.
Speaker Change: You should have a little bit with the second split for the <unk> patent also be confirmed by E. P O N E.
Speaker Change: In which is scheduled for May 13 to 15 2025. It would also be included Detroit infringement hearing.
Speaker Change: So we remain confident of our position at the upcoming infringement case and believes that the validated patent is infringed and its amended form.
Speaker Change: That's the earliest pioneering them already technology, we are determined to have our contributions are recognized and compensated.
Marion: And with this let me now hand over to Marion for a review of our pipeline development activities.
Marion: Thank you unexciting time.
Marion: Moving on to slide seven I would like to provide an overview of our development pipeline, which prioritizes high value programs, they're all mrna technology can make a substantial difference in addressing diseases with significant unmet medical need.
Speaker Change: Alexander already mentioned, our oncology pipeline is left by I'll say, it's broadly Blastoma study the C V G B and and also shed its precision immunotherapy encoding eight segments from four known tumor associated antigens, which demonstrated development in this indication.
Speaker Change: The promising initial data be presented from the competed completed dose escalation part a of the study at a scientific conference in September and November last year demonstrated successful and that's enough cancer antigen specific T cell responses and 77% of 13 Evaluable patients.
Speaker Change: 84% of immune responses that generated didn't know awful, meaning T cell responses to successfully infused in patients with no pre existing T cell activity against encoded antigens prior to treatment with <unk>.
Speaker Change: It's the recommended 100 microgram dose for the expansion part of the study the majority of our sponsors are sustainable over a 99 day monitoring period.
Speaker Change: Treatment was generally well tolerated with no dose limiting toxicities to be taught it.
Speaker Change: The dose expansion part B of the study is ongoing and has already completed enrollment of 20 additional patients who are treated at the selected dose of 100 micrograms.
Speaker Change: Those data from this part are anticipated to be available in the second half of this year.
Speaker Change: Although new off the shelf multi epitope precision immunotherapy candidate for patients with squamous non small cell lung cancer and codes established antigens as well as novel antigens derived from our collaboration with <unk>.
Speaker Change: And just to go back more detail on this study later in this presentation.
Speaker Change: In infectious diseases.
Speaker Change: We call it that'd be directing our proprietary research and development efforts towards new non restaurant choice vacations as mentioned on our programs targeting respiratory indications that's fully licensed to GSK.
Speaker Change: You know all proprietary non risk territory infectious disease portfolio.
Speaker Change: The program for a prophylactic vaccine against Euro pathogenic E coli bacteria to prevent human touch infections as well on fixed.
Speaker Change: The kidney code candidate targets M. H, a highly conserved protein, which the city states adhesion of the bacteria to blood or tissue and biofilm formation, that's enabling innovation also status in the urinary tract.
Speaker Change: The candidates mrna design applies a unique technology, resulting in an in vivo says assembly of the protein nanoparticle with clustering of C. H antigen on its surface, which has shown superior immunogenicity in preclinical studies.
Speaker Change: In the respiratory infectious disease area licensed to GSK program, so seasonal influenza avian influenza and COVID-19 are currently in phase two development.
Speaker Change: The newly initiated combined phase one two study for our seasonal influenza COVID-19 combination vaccine is in phase one development.
Speaker Change: All the current candidate stuff the GSK twice our base until next proprietary second generation mrna backbone.
Speaker Change: We believe that there's great potential of our growing pipeline and look forward to reporting on its further development in the future.
Speaker Change: On slide eight we'll dive deeper into our oncology strategy.
Speaker Change: Over the last decade, there has been significant progress in treating solid tumors with immunotherapies either alone or in combination with chemotherapy. Okay. However, achieving significantly better patient outcomes remains elusive due to genetic defenses and she was their ability to develop resistance the complexity of it.
Speaker Change: The tumor microenvironment and the weakening of the patient's immune system over the course of various therapies.
Speaker Change: In this complex landscape.
Speaker Change: We see tremendous opportunity for our mrna therapeutics to revolutionize the immunotherapy for large patient populations with more precision.
Speaker Change: We are confident that our mrna therapeutics could be a game changer based on two factors.
Speaker Change: First our unique mrna technology, which uses our second generation of mrna backbone. This big bonus optimized for strong and broad immune responses and most importantly, it targets also cellular immune responses and it has been clinically validated in phase one and two studies in both infectious diseases and oncology.
Speaker Change: Cheap.
Speaker Change: Second Oh, private proprietary and highly differentiated whole genome based antigen discovery platform.
Speaker Change: This platform provides access to new classes of tumor antigens, enhancing the precision and effectiveness of our therapies.
Speaker Change: In our upcoming clinical development, we plan to combine our position immunotherapies with checkpoint inhibitors checkpoint inhibitors release, the brakes on the immune system, thereby boosting the ability of our mrna therapeutics to trigger powerful and precisely target the immune responses.
Speaker Change: Timing is critical and this approach intervening earlier when patients immune systems are healthier tumor burden is lower and resistance to therapy is less established offers the best chance for improved in Europe the outcomes.
Speaker Change: Accordingly, we aim to apply mrna therapeutics at early stages of cat and he actually went a peri operative setting.
Speaker Change: We believe by intervening early he has the potential to increase the chances of improved outcomes of patients whose tumors are surgically resected when their immune system is still strong and seamless easier to control it.
Speaker Change: So the next two slides, how we intend to make a difference with our precision immunotherapy approach.
Speaker Change: Typically how we expect to deliver strong and precise immune responses in combination with a checkpoint inhibitor in our new program for squamous non small cell lung cancer.
Speaker Change: Well, it's like there are more than 2 million patients diagnosed every year with lung cancer.
Speaker Change: In the United States only there are approximately 225000, new cases of lung cancer, each year, 87% of which are non small cell lung cancer or in the CLC. According to the American cancer Society squamous non small cell lung cancer represents approximately 20% to 30%.
Speaker Change: And as she has seen the cases, making it one of the most prevalent cancers worldwide.
Speaker Change: It's considered a more aggressive form of non small cell lung cancer with five year survival rates of patients with advanced disease, just around 20% and even if diagnosed in earlier stages and is treated with peri operative immunotherapy about 30% to 40% of patients relapsed within two years.
Speaker Change: Squamous non small cell lung cancer, thereby poses significant challenges and disease control and treatment contributing to the high unmet medical need in this indication.
Speaker Change: Importantly.
Speaker Change: Claims non small cell lung cancer has shown a particularly high prevalence of shared tumor antigens among patients providing a unique opportunity for developing targeted precision immunotherapies.
Speaker Change: We aim to leverage this opportunity was an mrna precision immunotherapy to improve outcomes for a larger patient population.
Speaker Change: I was elected investigation of positioning immunotherapy candidate is built on our advanced second generation mrna backbone.
Speaker Change: It features two different mrna construct and coding H two months associated antigens with high prevalence across squamous non small cell lung cancer patients.
Speaker Change: Four of these antigens unknown was established relevant it just started two months, providing a strong foundation for secrecy.
Speaker Change: The remaining four anti genz, we're just covered was in our collaboration with my knee or therapeutics and our uniquely derived from my newest attitude takes cutting edge AI powered technology platform.
Speaker Change: All four of these novel antigens that I just covered outside the XO and have not been previously tested in cancer immunotherapy trials.
Speaker Change: Oh, a patient population coverage calculations or candidates predict that approximately 95% of patients will express and present epitopes from at least one of the encoded antigens approximately 50% of patients after addicted to express them present epitopes from at least four off the encoded antigens.
Speaker Change: Well I was faithful and study this high patient coverage means that we can proceed without the need for specific patient selection beyond just claimants in non small cell lung cancer diagnosis.
Speaker Change: The general setup of the phase one dose finding open label study is illustrated on slide 10.
Speaker Change: In this study we will assess the safety and Tolerability of a candidate as first line maintenance treatment in combination with a checkpoint inhibitor of parallelism up in patients with advanced squamous non small cell lung cancer.
Speaker Change: In the dose escalation part eight hour candidates will be tested in doses ranging from 100 to 400 micrograms in combination with temporary there's enough maintenance therapy for up to 12 months or until disease progression or undue toxicity occur.
Speaker Change: In fact, eight we expect to include patients with metastatic stage false claim is non small cell lung cancer, who have received at least three cycles, sometimes isn't my either as monotherapy or in combination with chemotherapy.
Speaker Change: Following pat's, a an option of dose expansion pets eat will be conducted.
Speaker Change: The primary endpoint of the phase one study includes the incidents of dose limiting toxicities and treatment related treatment emergent adverse events and secondary endpoints include overall response rate progression free survival duration of response and disease control rate.
Speaker Change: A positive outcome from this study will enable us to evaluate this combination in earlier stages also diseases aligned with our go to apply mrna precision immunotherapy at early stages of cancer.
Speaker Change: Moving onto infectious diseases on slide 11, let me provide you with a brief overview of the details of the respiratory disease programs, which are fully licensed to GSK under our new licensing agreement from July last year.
Speaker Change: The most advanced program for seasonal influenza read out positive phase II headline data last year.
Speaker Change: As Alexander already mentioned Cheesecake confirmed earlier this year. That's a program. It's in preparation for our phase III study, which would be associated with a significant milestone payment for cubic.
Speaker Change: The program for a pre pandemic vaccine against avian influenza is currently in phase two of the combined phase two study initiated in April last year.
Speaker Change: As previously mentioned a new program for our seasonal influenza COVID-19 combination vaccine entered phase one in November last year.
Speaker Change: Lastly, phase two of the Standalone Standalone COVID-19 vaccine program was completed.
Speaker Change: Please note that this closeout study timelines and availability of clinical data is at the discretion of GSK.
Speaker Change: I Havent licensees programs to GSK.
Speaker Change: Leverage their expertise in vaccine development and commercialization to bring innovative vaccines based on our mrna technology to market.
Speaker Change: The new licensing agreement strongly validates the potential of our proprietary mrna platform I was a financial and strategic benefits from the agreement support our continuous innovation and development efforts.
Speaker Change: To further enhance mrna effectiveness in oncology and infectious diseases.
Speaker Change: We are advancing our proprietary mrna delivery technologies was improved proprietary lipid nano particles or in short LNP.
Speaker Change: As highlighted on slide 12, as specific requirements apply to develop efficacious precision immunotherapies and oncology and prophylactic vaccines and infectious diseases.
Speaker Change: And then pizza critical meetings has specific requirements underscoring the potential for N. P systems that are tailored to their respective therapeutic area.
Speaker Change: Prophylactic vaccines for infectious diseases treat healthy individuals necessitating activation of the.
Speaker Change: Immune system with minimal reactors in Mississippi and side effects.
Speaker Change: In contrast cancer immunotherapies treat seriously ill patients requiring robust activation of cellular signaling pathways to induce shrunk systemic immune responses.
Speaker Change: And allow greater tolerance for the extra Genesis cheap.
Speaker Change: Prophylactic vaccines, often target induction of height antibody titers and T cell responses only where relevant.
Speaker Change: Cancer Immunotherapies activation of tumor killing T cells is critical even if this is associated with increased reactors and as a team.
Speaker Change: Additionally, prophylactic vaccines need to be stable for longer periods, if a refrigerator a room temperature gives them. The season argues for physician cancer immunotherapy applications maximized. If he could see is key with stability being a secondary goes.
Speaker Change: He previously reported.
Speaker Change: Our proprietary and then Heath system for infectious diseases, featuring a heck free lipid composition that demonstrated strong sugars and cellular immune responses in preclinical models and highly localized bio distribution and immune compartments, showing no or very low expression in distant Oct.
Speaker Change: Such as the liver spleen and lung.
Speaker Change: Voting potential side effects and maximizing immunogenicity.
Speaker Change: Focusing on the additional need for stability and prophylactic vaccines, we have now advanced our infectious disease LNP system to achieve promising tells us that ability as well.
Speaker Change: On Slide 13, you can see data from our ongoing stability study was the bespoke infectious disease LNP system over a period of 12 months.
Speaker Change: And Lauren eight encoding Arabias intention was formulated within the new LNP system and start either as a freeze dry powder at room temperature.
Speaker Change: 25 degrees Celsius equivalent to 77 degrees Fahrenheit or under refrigeration at two to eight degrees Celsius, which equates to 36 to 46 degrees Fahrenheit.
Speaker Change: Formulated mrna was always the stored frozen liquid.
Speaker Change: At minus 80 degrees Celsius, or minus 100 degrees Fahrenheit as a control.
Speaker Change: The data on the left so that was the new LNP system mrna integrity remains stable with EMR and 18 in text and securely formulated for at least 12 months under all three storage conditions.
Speaker Change: As shown in the middle of the LNP size also remained stable over time and under different storage conditions.
Speaker Change: In vivo experiments in mice.
Speaker Change: Firms that throughout the test period, the vaccine start under the different conditions maintained their ability to ensure strong neutralizing antibodies.
Speaker Change: These findings provide a competitive advantage in addressable patients as our vaccines can be utilized globally without the need for complex coach data storage requirements.
Speaker Change: On Slide 14, let me now summarize our upcoming pipeline catalysts, which provides a strong development paths with the end of 2026 on.
Speaker Change: On the oncology front, starting with our most advanced phase one off the shelf program in Glioblastoma as already mentioned part B of the study is fully enrolled and first stage is expected in the second half of 2025.
Speaker Change: These data will provide the basis for potentially continuing to a phase III study, which could start in the second half of 2026.
Speaker Change: Following FDA clearance of the R&D submission the phase one study of our off the shelf program in squamous non small cell lung cancer is expected to start dosing patients in the second half of 2025.
Speaker Change: With our antigen discovery work continuing we intend to disclose additional also test programs and select new clinical candidate in different indications in 2026.
Speaker Change: Lastly, the first clinical phase one study with a personalized cancer vaccine candidate is expected to start in the second half of 2026.
Speaker Change: Is that just as Jesus for our proprietary you pay program, we expect to file an IND application in the second half of 2025 and to start a phase one clinical development in the first half of 2026.
Speaker Change: Additionally, this coffee work in other non respiratory diseases is ongoing and we anticipate expanding our pipeline in this area with additional programs in 2025 from from Beech clinical candidates could be selected in the second half of 2026.
Speaker Change: But there was teratoid programs licensed to GSK stated in Gsk's fourth quarter and full year earnings report in February this year. The seasonal influenza program is the preparation to progress to phase III.
Speaker Change: As a whole at this slide illustrates that we have before us as Trumpf Haas of pipeline catalysts in both oncology and infectious diseases.
Speaker Change: It was a substantial set of anticipated upcoming milestones we are in a strong position to make lasting impact on the huge self mrna medicines.
Speaker Change: I would now like to conclude support for your updates and hand over to Axa for a review of the financial data.
Speaker Change: Thank you Marianne.
Speaker Change: Okay.
Speaker Change: Progress we have made in streamlining our operations and focusing on strategic priorities on slide 15, I would like to provide context to key financial metrics in 'twenty 'twenty, four demonstrating all financial health and enabling us to reinvest in key areas of growth and innovation.
Speaker Change: We report a strong cash position of 481.7 million euros at the end of 'twenty 'twenty, four and reaffirm our expected cash runway into 2028.
Speaker Change: Our results are driven by the new licensing agreement with GSK, which positively impacted our cash position as well as revenues.
Speaker Change: The 400 million Euro upfront from the agreement was received as a nonrefundable payment for granting licenses to GSK and the exclusive rights to use cubic's intellectual property relating to applicable vaccine programs with no further R&D work obligation on our side.
Speaker Change: As such it was fully recognized as revenue in 2024.
Speaker Change: Given that under the terms of the new licensing agreement all publicly.
Speaker Change: Obligations for prior collaborations relating to R&D services had expired.
Speaker Change: Remaining contract liabilities amounting to 84 million euros.
Speaker Change: Were also recognized as revenue in 2024.
Speaker Change: Italy in 2020 for a development milestone of 10 million euros was reached under the new license agreement for the initiation of a phase one combo vaccine, which was also fully recognized as revenue.
Speaker Change: So I think the course for increased future financial stability a.
Speaker Change: Oh, a strategic redesign is key to enhancing our operational efficiency to further reduce costs.
Speaker Change: The 30% workforce reduction was completed by end of 'twenty 'twenty four was incurred costs, 17% below the allocated budget.
Speaker Change: 'twenty 'twenty five onwards, we anticipate a substantial decrease in operating expenses by over 30%, including a notable twenty-five knowing your reduction.
Speaker Change: And personnel costs.
Speaker Change: Licensing agreement with GSK and renewed focus on innovation and our R&D activities have also eliminated the need for commercial buildup.
Speaker Change: Large scale manufacturing activities.
Speaker Change: The streamlining of our in house manufacturing capacities to provide a new manufacturing footprint that are suited to our needs.
Speaker Change: It was accompanied by an impairment of our large scale production facility.
Speaker Change: Lastly, we have successfully terminated all remaining raw material commitments.
Speaker Change: And closed all contract manufacturing organization or CMO.
Speaker Change: Weighted arbitrations for all first generation COVID-19 vaccine, ensuring no further related payments for CBD and Cogs going forward.
Speaker Change: Taken together in 2024 extra ordinary payments related to the C b and carve out a strategic redesign and ongoing patent litigation amount to a total of 137 million euros.
Speaker Change: Moving on to our condensed financial statements on Slide 16, you can.
Speaker Change: You can see that our cash position of 481.7 million euros increased from $402 5 million euros at the end of 'twenty two 'twenty three based on the 400 million Euro upfront payment from GSK in August 2024.
Speaker Change: The increase is partially offset by our ongoing R&D activities.
Speaker Change: Well as a total of 137 million euros, one off payments related to all first generation COVID-19 vaccine as already discussed.
Speaker Change: Revenues decreased by $8 1 billion euros to $14 5 million euros for the fourth quarter and strongly increased by $481 4 million euros to $535 2 million euros for the 12 months of 'twenty 'twenty four.
Speaker Change: Compared to the same periods in 2023.
Speaker Change: As the year on year increase was primarily driven by the new licensing agreement with GSK, such increase must be considered to be a positive one time events.
Speaker Change: Operating loss was $43 8 million viewers for the fourth quarter of 2024 compared to an operating loss of 88 million euros for the same quarter of 2023.
Speaker Change: Well the full year 'twenty 'twenty four operating profit was $177 7 million euros compared to an operating loss of $274 2 million for the same period in 2023.
Speaker Change: The operating result was affected by several key drivers.
Speaker Change: First.
Speaker Change: Cost of sales decreased year on year, mainly due to the change in strategy associated with a new license agreement with GSK, resulting adapted R&D activities.
Speaker Change: The cost of <unk> manufacturing organization are no longer supporting revenue generating activities.
Speaker Change: And are those no longer classified as cost of sales. Additionally.
Speaker Change: Additionally, higher material costs appeared in the prior year, which were driven by write offs of raw materials. Originally purchased for the stockpiling of the terminated endemic preparedness agreement.
Speaker Change: Second R&D expenses increased due to the strategic change mentioned.
Speaker Change: That's a fine too you have X amount of faction of organization R&D rather than in cost of sales.
Speaker Change: With higher investments in oncology development programs as well as increased expenses related to the litigation to enforce intellectual property rights and higher personnel expenses related to the redesign of the organization.
Speaker Change: Third.
Speaker Change: General and administrative expenses expenses decreased compared to the prior year period, mainly driven by lower personnel expenses.
Speaker Change: Lastly, other operating expenses increased year on year due to the impairment of one production line within our G&P for production facility, which was initially planned and set up for commercial large scale production and cannot be scaled down to provide products for production in alignment with cubic's refocus on R&D.
Speaker Change: Financial results increased by $3 7 billion to $5 2 million euros in the fourth quarter of 2024.
Speaker Change: Increased by 1 billion euros to $13 2 million euros for the 12 months of 2024 completed compared to the same periods in 2023.
Speaker Change: Decrease was mainly driven by lower interest income on cash investments.
Speaker Change: For the fourth quarter pre tax loss was $38 6 million euros.
Speaker Change: For the full year pre tax profit was 199 million euros. This compares to pre tax losses in the same periods of 2023.
Speaker Change: With this I'd like to reinforce that key strategic decisions made to conserve resources throughout 2024 have had positive impact moving us into a position of strength as we work towards key milestones and continue to reshape what's possible in medicine.
Speaker Change: I'll now hand, the call back to Alexander for today's key messages.
Alexander: Excellent. Thank you all for your attention and fourth quarter of 2024 closed out a year of remarkable change procure back.
Speaker Change: The potential of mrna to transform medicines is enormous and our agility as an organization with the ability to pivot has enabled us to further build upon that potential and unlock new areas in which mrna technology can make a meaningful impact for patients.
Speaker Change: Financially, we close the fourth quarter of 2024 with a cash position of 482 million euros.
Speaker Change: Well I think obviously the solid expected financial runway into 2028.
Speaker Change: This gives us the stability needed to continue to drive innovation.
Speaker Change: We are making great progress in oncology rents are off the shelf and personalized precision immunotherapies.
Speaker Change: The current year results for our lead candidate in Glioblastoma. We are eager to show continued progress with an anticipated part b readout as well as advancements or off the shelf program in squamous.
Speaker Change: Okay.
Speaker Change: In infectious diseases, we are quickly moving forward with your pet vaccine and urinary tract infections eager to make it do medical breakthrough indication.
Speaker Change: Great.
Speaker Change: Yes.
Speaker Change: We continue in 2025 with a focus on high value opportunities for our wells finance position is supported by strong strategic partnerships and a broad IP portfolio.
Speaker Change: With that I conclude our presentation and open the floor for your questions.
Speaker Change: Thank you as he would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue.
Speaker Change: You May press star two if he would like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star one moment, while we poll for questions.
Alec Stranahan: Our first question is from Alec Stranahan with Bank of America. Please proceed.
Speaker Change: Oh, Hey, guys. Thanks for taking our questions and congrats on the progress to close 24 two.
Speaker Change: Two questions from Us maybe first Oh.
Alec Stranahan: Actually both are on the squamous program.
Speaker Change: The use of antigens outside of the X numbers, it's pretty unique to this program.
What would you say.
Speaker Change: But maybe the early signs you'd point folks to in the first in human clinical readout as evidenced that including these antigens is maybe having a preference for effects on activity and is it safe to say that the first patient dosed in the second half of this year would set you up to maybe a mid or second half 'twenty six readout.
Speaker Change: The phase one can see this on your catalyst slide in your prepared remarks. Thank you.
Speaker Change: Okay. So I didn't quite get the last part of success when I start with the first part.
Speaker Change: And so.
Speaker Change: And.
With our antigen discovery platform, especially for off the shelf antigens. They usually run them through an extensive set of validation assays, where we basically look and whether the antitrust is elected especially as another ones outside the Exxon whether they are expressed on the tumor whether they are not expressed on health.
Speaker Change: Tissues, because of human T cells and immune cells can recognize them.
Speaker Change: Where they basically they are presented or the a M. A C complexes and whether they basically lead to tumor cell, killing and B has a you know internally company defined algorithm.
Speaker Change: With very clearly set criteria to when we say an antigen passes the selection criteria or not and based on all of the preclinical experiments we have done with these novel antigens.
Speaker Change: We remain optimistic that we would see a basically strong immune responses to these quite novel and again also very foreign proteins to the.
Speaker Change: And in cancer patients and there is right now no clinical evidence right. Because he said this is the first time, we ever testing for these novel antigens in cancer patients, but there is also preclinical evidence from other groups in cancer animal models showing that win.
Speaker Change: You vaccinate animals as supposed to a colon cancer.
Speaker Change: Cancer models, when you vaccinate animals, who have a colorectal cancer.
Speaker Change: With a vaccine against these novel antigens that you see cancer regression. So that's preclinical evidence from other sites that are supporting us our own again experiments have suggested that these antigens immunogenic and that's why we are taking them into the clinic.
Speaker Change: Would you mind repeating the second part of the question I'm, sorry, I didn't quite understand it because you said something about the dosing of the first patient and and and and what that mean, Oh, what indication that would give.
Speaker Change: Yeah, no just more in terms of.
Speaker Change: Ada readout time, obviously pace of enrollment.
Speaker Change: Probably the biggest swing factor here, but I just didn't see a data catalyst on I think it was slide 14.
Speaker Change: 14 of your prepared Oh.
Speaker Change: We want to be a bit cautious here right because.
Speaker Change: It's a first in human study.
Speaker Change: And we have to do the dose escalation of close with it quite broad dose a dose limiting toxicity window and and that's why we sort of like half our internal projections, but right now not feel comfortable to share them. Because you never know we wanted to see like you said you wanted to see how recruitment goes in the first cohort and then maybe at the next update.
Speaker Change: We can give better projections when you will see the first data next year.
Speaker Change: And you can you know you probably cant know that he will do everything to speed up get a recruitment and you know on track or even faster and then of course analyze that data as quickly as possible.
Speaker Change: Got it thank you.
Manny: Our next question is from Manny.
Speaker Change: For her went Leerink. Please proceed.
Speaker Change: Hey, guys you have Ryan on for Marty. Thanks for taking our question just hoping you could provide a bit more detail on what you see as the regulatory path for the C. V. G. B M. F. At you know have you had conversation with regulators at this point on steps to approval and what that would look like and then I guess just to pivot off of that.
Speaker Change: Do you see the recent changes that the FDA influencing any prior conversations that you guys have had.
Speaker Change: Maybe I can start with the second one is that you can comment on the regulatory Pat on your question on whether we've seen any impact yet with the FDA.
Speaker Change: So far not for our program.
Speaker Change: The Iot cleared for a squamous program on time and without any major surprises.
Speaker Change: So no negative impact at that so far but you know we all understand it's quite a fluid situation with everything that's going on but so far at least in our own programs, we have not seen any negative impact.
Speaker Change: But if you want to comment on that.
Speaker Change: Two regulatory paths.
Greg: This is Greg maybe 1.2 I have to be also interact with S. T. A N O you can pay program and they're supposed to say, we don't see any impact to get responses quickly same quality unbiased absolutely no changes compared to the past four T. D. G. B N right is set and it's the data from.
Greg: Phase one expansion cohort showed meaningful clinical activity.
And then and we would go for phase two of course, we will do is as the next step I'm discussing again. This is all just under discussion a randomized phase two with an appropriate comparator arm and an appropriate endpoint and we haven't yet had any discussions with regulatory authorities and so far because we wanted to.
Greg: Await more data from phase one knowing that this is a high risk population.
Greg: And and any sort of like wanted to have more confidence that we will you know have indications as we go forward.
Greg: Great. Thank you.
Speaker Change: Our next question is from Roger song with Jefferies. Please proceed.
Roger Song: I'm thankful that they end up taking one question a couple of questions. Maybe the first one related to the D. B am given the part D data are going to be second half and then you will have you will make it go forward decisions. So just curious what is the criteria to make that decision and then on the squamous non small cell lung cancer. This.
Roger Song: You know the Monty complex antigen selection is very interesting just curious given you say, 95% of the patient they have a one plus the entergy and 50% have four plus just curious in your preclinical models do you see the difference when you have the model I only have one.
One person at four plus you see the difference on the activity anti tumor activity. The last part of the question is regarding your cash runway guidance into 2028.
Speaker Change: Can you give us some color around how much operation is included in this cash runway guidance given you have a couple ongoing pipeline and then you.
Speaker Change: Your pipeline coming in like the GBM squamous lung and in UTI and that you are that this passionate crew out of phase one phase two are in plan. Thank you.
Speaker Change: Okay. So three questions one on G. P M. I guess, where the bar is high we would assess no go no go decisions and what other squamous on the number of antigens and when do we see differences and then maybe one for actually the cash runway. Okay. Okay. That's that was a G. D. M question and so yes, we have.
Speaker Change: That's basically a high threshold for four G. P M and basically would you expect to see in our population. The median overall survival of 15 months or longer to say, it's a go or and also an overall response rate of about 20%. If we would see that in our population I'd put it give us.
Speaker Change: Confidence to say look this could look promising and and and potentially Barnes and investment into phase two.
Speaker Change: Regarding.
Speaker Change: Your question on coverage for those claims program, which is I think it's a really interesting question.
Speaker Change: But I have to tell you that the animal models do not allow us to actually investigate how clinic and clinical efficacy in those animals, what looked like if they have a response to anti Genesis of what antigens. The animal models actually Oh in our animal models. He can not vaccinate against the targets.
Speaker Change: He used to vaccinate human beings right, because we have to vaccinate for new REIT.
Speaker Change: And T J <unk> and that's by no animal model of what gives you the answer to this and the question. You asked is the sort of like million dollar question right. Do you do we need to have a broad immune response against multiple antigens to achieve maximum clinical efficacy or a deep and strong responses to skew antiques.
Speaker Change: Rents that are the right ones enough tool to give you a clinical efficacy and based on the data from us that's not our own we have seen some promising data we are basically in our immune responses against an average four antigens showed a difference and other trades that suggest that the two antigens are enough. So we don't really know the.
Speaker Change: Answer, but we would say based on all of our knowledge that some kind of diversity in terms of immune response would be good.
Speaker Change: And so hopefully again, we would see responses to pull more and more of those antigens that would then translate into clinical efficacy.
Speaker Change: So I cannot really give you an answer to the question because that's the 1 million dollar question that we have to address it Alex and then he can thrive in the future.
Speaker Change: Yeah. So in terms of the cash runway into 2028 so.
Speaker Change: So what I can tell you is that and we also want to be a little bit cautious here, but what I can tell you is is that the current for the current core pro ground, meaning you know our idea portfolio preparing.
Speaker Change: Sure.
Speaker Change: <unk> started 2026 as well as our oncology programs G. B M in squamous non small cell lung cancer.
Speaker Change: As well as all personalized cancer vaccine you know the clinical phases are included but always please remember that you know some of these clinical phases are also asked will the cash out.
Speaker Change: Everything of course is planned as.
Speaker Change: As the clinical pipeline is developed and planned for them, but you know not all phase one and phase twos are prior to the potential cash out.
Speaker Change: Got it that answers your question.
Speaker Change: Thank you.
Speaker Change: Our next question is from Ellie Merle with UBS. Please proceed.
Speaker Change: Hi, This is Jasmine I'm for Allie and thanks, so much for taking our question wanted to ask about your latest strategy on collaboration.
Speaker Change: Crossed oncology in the non respiratory infectious disease program, what's your latest thinking about where you would want to potentially partner with that keep developing yourself inks.
Speaker Change: Yeah. That's a good question I think in general what we tried to do this year is really focus cure back at work.
Speaker Change: Good at which is mostly technology innovation.
Speaker Change: Research and I would say early development.
Speaker Change: Of course, we had a few collaborations already in place is to work with GSK for the respiratory infectious disease program. We have a collaboration in place is probably the MD Anderson cancer Center on next generation shared off the shelf cancer vaccines.
Speaker Change: In general is actually just outside I feel we are in a position from a financial perspective, but also from a capability in manufacturing.
Speaker Change: Active to Rondi early clinical trials, you don't face one said, maybe depending on the indication also phase two but I think the goal, especially for the large T as such.
Speaker Change: Apology would be clearly two parts in the late stage development program with somebody that has real muscle and the few that really has.
Speaker Change: The beat to developing more broadly it doesn't eventually also commercialized worldwide.
Speaker Change: Great. Thank you.
Roy Buchanan: Our next question is from Roy Buchanan with citizens. Please proceed.
Roy Buchanan: Hey, Thanks for taking the questions I had a few on the European patent proceedings, I guess can you give a sense of the timeline.
Roy Buchanan: For the infringement hearing in possibly that I'm, assuming that's positive the damage.
Roy Buchanan: Proceedings for the 668 and seven and five five.
Roy Buchanan: That was just upheld as solid and then does does hydro biotech do I have a chance to appeal. The validity decision for 668, and then can you give a little bit of more detail on that subject to amendments.
Roy Buchanan: Comment in the slide 14, I think six sorry. Thanks.
Roy Buchanan: Sure.
Roy Buchanan: Highlights kind of the key.
Roy Buchanan: Overarching timelines I'm on slide six.
Roy Buchanan: After price the presentation right. So they're kind of a next milestones are as we have further European patent office here for a second <unk>.
Roy Buchanan: The 775 pad, which takes place on May 13 to 15, and then as it's a bifurcated process should that politically he confirmed to Sally goes back to the infringement of court in this case, it's the refrigerant caused a distant doors, where the hearing is scheduled for July 1st.
Roy Buchanan: And as I mentioned it includes the success aid at if the related difficult for them to solve the 775.
Roy Buchanan: Oh really.
Roy Buchanan: Absent that.
Roy Buchanan: Ah, Yes, there is an opportunity for the opposing partner.
Roy Buchanan: To appeal, but if infringement is confirmed that but maybe if he has to be conferred prior that whats. Nevertheless start at least the damages process in Europe, which helped me exactly that's the buy understandings could take up to a year or.
Roy Buchanan: To be hopefully.
Roy Buchanan: In the U S of course, it's different than the U S. You have one legal case, which can starting September eight this year did U S. One process that comverse.
Speaker Change: Lipton tea infringement as well as damages at the same time.
Speaker Change: Okay Great question.
Speaker Change: Yes.
Speaker Change: Yeah, just curious that are subject to amendment comment on that.
Yeah. So the amendment was mostly related to the name of the poly a tail I E. The number of adding a new class types are dead, where there's very clear does have a it's quite technical but I think we don't believe that dissipate weakened our infringement position I think that's the key point.
Speaker Change: Yeah.
Speaker Change: Okay, Great and then maybe just throw in one on the Genmab collaboration that was terminated can you just give us the crux of why that was terminated in what stage they got too. Thanks.
Speaker Change: Well I think it's the question was with Genmab collaboration. So I think it was dormant for quite some time. It didn't leave you didn't really leads to anything so also in our interest to really focus on the most promising program.
Speaker Change: I'd say, we terminated the program you've got mutual mutual agreement.
Speaker Change: Okay. Thank you.
Speaker Change: Our next question is from Jonathan Miller with Evercore ISI. Please proceed.
Jonathan Miller: Hi, guys. Thanks for taking my question and congrats on the recent progress maybe I'll start with one on the non small cell program. Obviously, you like others are trying to develop this primarily in early stage setting but of course the phase one is in a later stage patients in metastatic patients. So I'd just love to get a sense for.
Jonathan Miller: Or what you're hoping to see in that phase one data that would move you to early stage setting do you need to see Africa.
Jonathan Miller: Efficacy.
Jonathan Miller: The signs of early efficacy in metastatic setting beyond maybe immune engagement or or T cell induction for instance, do you need to see increases in O R or increases in PFS to drive even the early stage setting more or would safety and immune engagement be sufficient to make that decision and then and then secondly, maybe on.
Jonathan Miller: On the I P J, but I'll, let you read cancer cancer first please.
Jonathan Miller: Okay No. It's a great question so.
Jonathan Miller: As we said right, we do believe that the a position immunotherapies with working earlier kinds of things because the immune system is functioning and you have unless you're my button to control it and so with that basically all our criteria.
Jonathan Miller: And primary.
Jonathan Miller: Objectives.
Jonathan Miller: For the.
Jonathan Miller: Phase one trial in squamous non small cell lung cancer would be to see immune responses against the uncoated.
Jonathan Miller: And T. J, so that would be sort of like the primary hurdle is C. C. Then of course clinical activity that would be most encouraging but but we also are basically really want to test the treatment in earlier stages of cancer, because we have seen with other programs and.
Jonathan Miller: Sort of like similar platform that in advanced metastatic stages of cancer.
Jonathan Miller: Immunotherapies do not work well so immune responses all primary target to see if he sees truong and your responses against the encoded antigens and that would be encouraging and all of you want to see because we would then sort of like do an expansion cohort in earlier settings and from there and then look for political activities sickness in the earlier, Kansas sentence.
Jonathan Miller: Ted will then determine whether we go for phase two and beyond and in that setting.
Jonathan Miller: That's it.
Jonathan Miller: Yeah, absolutely absolutely I guess.
Jonathan Miller: One more then on that on the novel ex Exome antigens I'd be really curious to see more of that preclinical data more than antigen development data do you have plans in the near term to discuss that antigen selection process more.
Jonathan Miller: To to get deeper into the contribution of those X X novel antigens to immune engagement and efficacy.
Jonathan Miller: So we are discussing that we would like to discuss and disclose more b, we have to see when is what's possible.
Jonathan Miller: So it's exciting and I know everybody's interests right. There are some let's say internal checks we have to take before we can go public and share all the data around that.
Speaker Change: Okay. It makes sense on the IP front the poly a patent that was just held up in E. P O.
Speaker Change: This is this the same set of IP that was struck down in the U K Court last year I believe it was in the last year and if so can you discuss maybe some of the differences between those two cases and and whether we should be reading through from some prior art that they brought in.
Speaker Change: Two the potential for the patents in the U S corn.
Speaker Change: Maybe John is just quite a complex question that maybe we can do a follow up call of this but I mean, the U K situation is different the assessment is different I mean, and just the fact that.
Speaker Change: This drove an validity courts came to a different solution I think highlights some of these differently, but John very happy to set up a photo of a call with our IP team to go more into the details.
Speaker Change: Alright fair enough I look forward to that.
Speaker Change: Our next question is from Chi Arab an attorney.
Ken: Ken Please proceed.
Speaker Change: Hello team. Thanks, a lot for taking my questions the scatter.
Speaker Change: This is unusual for a thousand.
Speaker Change: Congratulation with the progress I was wondering on the Glioblastoma program, how should we think about the translation of Immunogenicity data to tumor responses and then I was curious to know them for the next indication for the shot at antigen vaccine.
Speaker Change: How do you usually go about selecting indication besides let's see having a comb on expression of the antigen on the SKU Morris.
Okay. So I'll start with the G. P. M. A question so I'd be upset at the Congresses that in that first.
Speaker Change: After a ulcer trial, a dose escalation part of the trial, where we were able to analyze 13 patients. We also saw in in in seven patients who entered the trial with a residual tumor mass we saw one partial response. Unfortunately, we couldn't unfortunately this person doesn't have enough material to the immune.
Speaker Change: And immuno assessments and that's why it's hard to correlate but normally coming to your question. If we if we see immune responses, we would like to of course see a translation into a pure gross control all clinical and overall response.
Speaker Change: But it's it's it's not happening in all cases, right because we know that sometimes immunotherapy just controllers that you will grow with and and Kent keeps it to more stable and but still by doing so can prolong overall survival. So why again it would be highly encouraging with any of our.
Speaker Change: Precision immunotherapy treatments, if we see more clinical responses the real benchmark tool to make a decision go no go is based on overall survival. Because if you don't have to have shrinkage you could still have two low gross control it and was that prolonged overall survival does.
Speaker Change: Does that answer your question.
Speaker Change: Yes, very clear thank you.
Speaker Change: Okay on television and then the.
Speaker Change: Selecting indications so you know in our N two tenders coffee approach be sort of like.
Speaker Change: Screen antigens, and then run them through our algorithms using like everybody else a lot, but how are your new it neat proprietary sort of like selection and ranking criteria and only for anti gender when they sort of like Pos.
Speaker Change: So you basically pick them and and and and consider them to be encoded on one of our candidates and what we usually do is in a in an oncology we have designed a year or so ago, a a strategic and therapeutic areas pretty cheap.
Speaker Change: We looked across different cancer types at a ton of cancer types had a certain criteria in terms of are these cancers responding to immunotherapy is there a high unmet medical need competitive landscape commercial case, and so on and sort of like prioritize the cancer cases, and then in those highly prioritized, Ohio ranked.
Speaker Change: Cancer indications, we drove and agenda is coffee and.
Speaker Change: Activities that then led to the identification of potential anti jam that we ran through our agribusiness and then came up as he Andy agenda and of course as you can imagine when you look at all cancer types lung cancer. It comes up as the number one priority of.
Speaker Change: Hydro responding to a unit therapy, that's been basically of some of our anti agenda caveats was initially focused on lung cancer, but also in others, but do you prioritize this program for the reasons I mentioned.
Speaker Change: So I think there's so much of a pleasure.
Speaker Change: Okay. Good yes, absolutely. Thank you.
Speaker Change: Our final question is from Mac Star with Goldman Sachs. Please proceed.
Speaker Change: Oh, Hi, this is Tom.
Speaker Change: On behalf of our Roger Soma. Thank you for taking my question. The first one is about R&D. How do you expect the cost to progress through 2025, given your clinical development plans and the second question is about the lung cancer trial.
Speaker Change: Do you plan to check how the response rates could change after patients receive the vaccine because I believe the first China is supposed to be pemble Timbral combined with Chemo. Then you are injured patients was a was a vaccine I'm just curious how the clinical trial design, yes for that.
Speaker Change: Art.
Speaker Change: Okay. So maybe I'll start with the second question because I have a question a clarifying question for you first one so in our phase one trial again, we select patients with metastatic disease, who are on temporary maintenance. These patients usually with lung cancer very few are going to have a complete response. So they will have some sort of like residual.
Speaker Change: You walk that is stable and up temporarily as a mono therapy and we are adding the vaccine.
Speaker Change: And again, what we would look at is immune responses and we will also monitor a lot of clinical efficacy. So if we do see a partial response of tumor shrinkage by adding the vaccine we would definitely measure that and also report that they look at progression free survival duration of response and other sort of like endpoint.
Speaker Change: Driven power Army does in that setting, but basically patients come in a stable and up hamburgers them up and we were adding the vaccine and from that moment on we will measure.
Speaker Change: I have regular tumor measurements to see the impact of adding the vaccine.
Speaker Change: Hey.
Speaker Change: And then for your first question R&D costs can you please repeat because.
Speaker Change: I wasn't sure.
Speaker Change: But you were I think the question was on R&D spend 25, moving forward to know if you want to comment if you want to comment in detail.
Speaker Change: I think there is you know as I said earlier there are two two things maybe to this equation.
Speaker Change: Said earlier to another.
Speaker Change: Elements that we included all core pipeline into also the early clinical faces into the cash one way of course very important to recognize is that as you know we came from a transformation in 'twenty 'twenty four.
Speaker Change: And we continue continuously we continue to you know try to.
Speaker Change: Have more efficiency more cost efficiency and reduce our overall expenses and.
Speaker Change: And that of course apply them and on the other side as you know we move this company being more of a biotech.
Speaker Change: Pipeline company, meaning that we focus very much on our you know.
Speaker Change: From a cost R&D cost perspective on our pipeline programs. So there of course, we tried to be as efficient and focused as possible.
Speaker Change: I don't know if that answers your question.
Speaker Change: At Oh, sorry, lifting another question I noticed that one of your charts show declining MRI integrity at a 25 degrees Celsius or could you talk about that.
Speaker Change: I think that's a slide 13.
Speaker Change: Yes, okay, so you're talking about a lot.
Speaker Change: The proprietary LNP wherein should use the data on slide 13 right.
Speaker Change: I showed already right I'm in A&P migratory.
Speaker Change:
Speaker Change: On the left side right, where basically and then the data then I guess your question is about the Blue line were freeze dried.
Speaker Change: Our integrity decreased to something around 50, 860% is that the question.
Speaker Change: Yeah.
Speaker Change: That's it.
Speaker Change: Specifications.
Speaker Change: This is still with the specifications, if you look at integrity, and and and and and whereas the specifications I was regulators and and so that's why this is encouraging because remember this is at room temperature.
Speaker Change: Mrna at room temperature and after a year at room temperature. It stood out in terms of integrity within the specifications agreed with regulators to date.
Speaker Change: Got it.
Speaker Change: Alright, thank you.
Speaker Change: Oh.
Speaker Change: We have reached the end of our question and answer session I would like to turn the conference back over to Sarah for closing remarks.
Sarah: Thank you with this we would like to conclude this conference call. Thank you very much for your participation stay safe and please don't hesitate to contact US should you have any further questions. Thank you and goodbye.
Sarah: Thank you. The conference has concluded you may now disconnect.
Sarah: Okay.
Sarah: Okay.
Sarah: Okay.
Sarah: Yeah.
Sarah: [music].
Sarah: Yeah.
Sarah: [music].
Sarah: Uh huh.
[music].
Sarah: Yeah.
Sarah: [music].