Q4 2023 CureVac NV Earnings Call
[music].
Greetings and welcome to the cure that fourth quarter and full year 2023 financial results and business update conference call. At this time, all participants are in a listen only.
Operator: Greetings, and welcome to the Curevac fourth quarter and full year 2023 financial results and business update. At this time, all participants are on a, A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone.
A question and answer session will follow the formal presentation.
Anyone should require operator assistance during the conference. Please press star zero on your telephone keypad. Please note. This conference is being recorded.
Operator: Please note this conference is being recorded. I will now turn the conference over to your host, Sarah Fakih, and you may begin. Thank you.
Now I'll turn the conference over to your host Sarah.
Sarah: You may begin.
Sarah: Thank you.
Sarah Fakih: Good morning, good afternoon, and welcome to our conference call. My name is Sarah Fakih, and I'm the Vice President of Corporate Communications and Investor Relations at Genium. Please let me introduce today's speakers.
Sarah Fakih: Good afternoon, and welcome to our conference call. My name is Sarah Funky and I'm, the Vice President of corporate Communications and Investor Relations at Cusack.
Sarah Fakih: Let me introduce today's speakers.
Sarah Fakih: On the call with me from Curevac are Alexander Zehnder, Chief Executive Officer of Curevac, Myriam Mendila, our Chief Development Officer, and Pierre Kemula, Chief Financial Officer of Curevac. So, ahead of intellectual property, Marcus Dalton will be present for the Q&A. Please note that this call is being webcast live and will be archived in the events and presentation section under investor relations on our website.
Sarah Fakih: Nicole with me. Thank you that Oh defendant syndrome, Chief Executive officer of cubic DRAM.
Sarah Fakih: I'm Mindy Lowe, our Chief Development Officer.
Sarah Fakih: She knew long Chief financial officer at cubic.
Sarah Fakih: Ahead of intellectual properties more consultants will be present for the Q&A session.
Sarah Fakih: Please note that this policy would crystallize.
Sarah Fakih: First on the events and presentation section under Investor Relations.
Sarah Fakih: Right.
Sarah Fakih: Before we begin a few forward looking statements the discussions and responses to your questions on this call reflect management's view as of today Wednesday April 24th 2024.
Sarah Fakih: Before we begin, a few forward-looking statements. The discussions and responses to your questions on this call reflect management's view as of today, Wednesday, April 24th, 2021. We will be making statements and providing responses to your questions that state our intentions, beliefs, expectations, or predictions of the future. These constitute forward-looking statements for the purpose of the Safe Harbor Provision. These statements involve risks and uncertainties that could cause actual results to differ materially from those projected. The Company disclaims any intention or obligation to revise any forward-looking statement.
Sarah Fakih: We will be making statements and somebody responses to your question.
Sarah Fakih: Oh, what intentions beliefs expectations or predictions of the future.
Sarah Fakih: These constitute forward looking statements for the purpose of the Safe Harbor provisions.
Sarah Fakih: These statements involve risks and uncertainties that could cause actual results to differ materially from those projected.
Sarah Fakih: <unk> disclaims any intention or obligation to revise any forward looking statements.
Alexander Zehnder: For more information, please refer to our filings with the U.S. Securities and Exchange Commission. I will now turn the call over to Alexander. Thank you, Sarah.
Sarah Fakih: Information please refer to our filings with the U S Securities and Exchange Commission.
Sarah Fakih: I will now turn the call over to Alexander.
Alexander: Thank you Sarah ladies and gentlemen, good morning, good afternoon to everybody on the webcast.
Alexander Zehnder: Ladies and gentlemen, good morning, and good afternoon to everyone on the webcast. After recently celebrating my first year as CEO of Curevac, I'm thrilled to be speaking to you today as a leader of a company that is dramatically transforming itself. As societies are moving beyond the COVID-19 pandemic, we are embracing a new normal, where agility and innovation are more vital than ever. At Curevac, this means we are taking decisive steps in 2024 to trim unnecessary residual pandemic infrastructure and have started redesign initiatives to increase efficiency, reduce operating costs, and extend our cash runway. These initiatives began in March this year with a voluntary layoff program that aims to reduce 150 positions and is intended to align our workforce to our business scope and priorities.
Alexander: After recently celebrating my first year C O <unk> I'm thrilled to be speaking to you today as the leader of a company that is dramatically transforming itself.
Alexander: Our societies are moving beyond the COVID-19 pandemic, we are embracing a new normal for agility and innovation are more vital than ever.
Alexander: I'm sure that this means we have taken decisive steps in 2024.
Alexander: Unnecessary residual a debit get infrastructure and have started redesign initiatives to increase efficiency.
It is operating costs and extend our cash runway.
Alexander: Initiatives began in March of this year, but the voluntary leave program that aims to reduce the hunter. That's 50 positions and is intended to align our workforce to our business.
Alexander: Yes.
Alexander Zehnder: At the same time, based on the rapidly changing epidemiological environment following the end of the COVID-19 pandemic, together with our partner GSK, we have made the decision to wind down the pandemic preparedness agreement with the German government, signed in April 2020. Based on our solid cash position of €402.5 million at the end of 2023, and despite a negative cash impact in 2025 related to the wind-down of the pandemic preparedness agreement, our efficiency initiatives are expected to result in a net extension of our cash runway into the fourth quarter of 2025.
Alexander: At the same time based on their rapidly changing epidemiology logical environment. Following the end of the COVID-19 pandemic together with our partner GSK. We have made the decision to wind down, but that'd be prepared disagreement with the Chilean government signed in April 2022.
Alexander: Based on our solid cash position of four to 5 million euros at the end of 2023 despite a negative cash impact of 25 related to the wind job stepping that make per purchase agreement.
Alexander: Our efficiency initiatives are expected to result in the next extension of our cash runway into the fourth quarter of 2025.
Alexander Zehnder: While we continue to streamline the company and optimize costs, it is essential for us to preserve existing and create new value by maintaining a strong focus on advancing our research and development activities. Accordingly, we have made substantial progress in our clinical trials and have grown our pipeline of development programs in infectious disease and oncology. In infectious diseases, together with GSK, we have initiated a new phase one, two study of avian flu, which is considered a potential future pandemic threat.
Alexander: Well I think continue to streamline the company and optimized cost it is essential for us to preserve existing and create new value by maintaining a strong focus on advancing our research and development activities.
Alexander: Accordingly, we have made substantial progress in all clinical trials and a growing pipeline of development programs in infectious disease and oncology.
Alexander: In infectious diseases, together with GSK initiated a new phase one two study and avian flu, which is considered a potential future pandemic threat.
Alexander Zehnder: It is the latest program progressing to clinical trials under a broad infectious disease collaboration with GSK. Our ongoing programs in seasonal flu and COVID-19 have provided promising phase two interim data confirming that our technology platform generates strong antibody titers at well-tolerated dose levels. In Oncology, the dose escalation Part A of our Phase 1 study in patients with mastectomy glioblastoma has completed enrollment. Part A successfully progressed to a safety review, confirming no dose-limiting toxicity and providing a recommended dose of 100 micrograms for Part B of the study.
Alexander: It is still latest program progressing to clinical trials, there are broad infectious disease collaboration with GSK.
Alexander: Our ongoing programs in seasonal flu and COVID-19.
Alexander: By the promising phase two interim data confirming that our technology platform generates strong antibody titers at about tolerated dose dose levels.
Alexander: You know ecology dose escalation part a of our phase one study in patients with Resected Glioblastoma has completed enrollment, but a successfully progressed to a safety I mean, you I'm sure. It makes no dose limiting toxicity and providing a recommended dose of 100 microgram toward that part of it.
Alexander: The study.
Alexander: This important growth driver I'm, particularly thrilled about our collaboration with MD Anderson wants to watch leading cancer centers. We totally are joining forces 40 development of novel mrna cancer vaccines.
Alexander Zehnder: This important growth driver, I'm particularly thrilled about our collaboration with MD Anderson, one of the world's leading cancer centers with whom we are joining forces for the development of normal mRNA cancer vaccines. Further expanding such strategic collaborations will be a key focus for Taminda Ramanayake, a veteran in the biopharma industry who we are delighted to welcome as our new Chief Business Officer as of June 1st this year. Also supporting our oncology strategy is the mRNA printer, Curevac's end-to-end solution for the automated manufacturing of GMP-grade RNA vaccines and therapeutics.
Alexander: But they are expanding such strategic collaborations will be key focus for it to meet that Robin a young kid a veteran in the Biopharma industry, who we are delighted to welcome as our new Chief business Officer says as of June 1st to see it.
Alexander: Also supporting our oncology strategy, you see I'm already printer cubic's end to end solution for automated manufacturing them G. M. P. Great coordinate vaccines and therapeutics. The printer achieved next important regulatory milestones favorite shaping a framework license, providing even greater freedom and flex.
Alexander Zehnder: The printer achieved next important regulatory milestones by obtaining a framework license, providing even greater freedom and flexibility to manufacture different mRNA cancer vaccine candidates. Taking a step back and looking at 2023 on slide 5, I'm profoundly inspired by the progress that has been achieved by the entire Curevac team. Last year, we made critical advancements in our clinical trials, with notably positive Phase 1 data in COVID-19 and flu, that allowed us to transition into the current Phase 2 programs with potentially differentiated vaccine candidates in collaboration with you. We started the Phase I program in Glioblastoma, kicking off our strategy for the development of next-generation cancer vaccines based on our proprietary second-generation mRNA backbone.
Alexander: The ability to manufacture different mrna cancer vaccine candidates.
Alexander: Taking a step back and looking at 'twenty two 'twenty three on slide five I'm profoundly inspired by the progress that has been achieved by the entire care back cheap.
Alexander: Last year, we made critical advancements in our clinical trials, most notably the positive phase one data on COVID-19 and flu.
Now, there's two transitioning to the phase two programs with potentially a differentiated vaccine candidates in collaboration with GSK.
Alexander: Starting to phase one program in Glioblastoma kicking off our strategy for the development of next generation cancer vaccines based on our proprietary second generation of mrna backbone.
Alexander Zehnder: The successful capital raise in February 2023 was a vote of confidence from investors providing us with the resources to advance multiple programs and research activities. And last but not least, we strengthened our intellectual property position by adding new IP rights to ongoing patent litigation with Pfizer-BioNTech, demonstrating that we continue to be at the forefront of mRNA innovation. Building on our achievements in 2023, we are poised to continue in 2024 with a clear focus to make Curevac fit for the future. To this end, we have put strategic emphasis on an organizational redesign, which I will describe in more detail on the next slide.
Alexander: There's some capital raised in February 2023, that's a vote of confidence of investors, providing us with the resources to advance multiple programs and research activities.
Alexander: And last but not least we strengthened our intellectual property position by adding new Eid key right.
Alexander: Two ongoing patent litigation with pricing by demonstrating that we continue to be at the forefront of mrna innovation.
Alexander: Building on our achievements in 2020 Tweed, we are poised to continue in 2020 four.
Alexander: Clear focus to make sure a except for the future.
Alexander: Did this and be a good strategic emphasis on an organizational redesign, which I will describe in more detail on the next slide.
Alexander Zehnder: In our clinical trial programs, we continue to move forward with GSK following the promising Phase II interim data in COVID and flu this year, as well as the newly started Phase I-II study in avian flu. In Oncology, following the clearance of the Phase 1, Part A, glioblastoma safety data, we anticipate advancing to the dose confirmation, Part B, mid-2024. We expect to report a first data readout in the second half of 2024, most likely at scientific conferences such as ESMO or SARS.
Alexander: You know clinical trial programs, we continue to move forward with GSK. Following the promising phase two interim data coed flu this year as well as the newly started phase one two study and avian flu.
Alexander: You know call it cheap funding to clearance of the phase one part a you must have a safety data, we anticipate advancing to the dose confirmation part D. H 'twenty 'twenty four.
Alexander: We expect to report full data readout in the second half of 'twenty 'twenty four it's likely that scientific conferences, such as asthma or C. C.
Alexander Zehnder: Our efforts to build up our manufacturing facility, GMP4, are progressing, and we expect certification of the facility in the second half of 2024, contingent on regulatory approval. With these catalysts driving our efforts, we are confident in our ability to make meaningful strides in maturing the company and advancing our clinical trial programs in 2024. In slide 6, let me provide you with a more detailed overview of our corporate streamlining and redesign initiatives for 2024.
Alexander: Our efforts to build up our manufacturing facility G. M. Before are progressing and we expect certification of the facility in the second half of 'twenty 'twenty four contentions all regulatory approvals.
Alexander: With these catalysts driving our efforts we are confident in our ability to make meaningful strides in maturing the company and advancing our clinical trial programs in 2024.
Alexander: On slide six let me provide you later more detailed overview of our corporate streamline and redesign initiatives in 2024.
Alexander Zehnder: As already mentioned, the redesign aims to significantly increase efficiencies and performance while maintaining a strong focus on innovation and R&D activities. This encompasses a range of targeted actions to reduce unneeded pandemic area infrastructure, reduce operating costs, and become a leaner, more agile, and focused organization. The cornerstones of our efforts include our strategic reorganization, streamlining reporting lines, and digitizing the company.
Alexander: As already mentioned the redesign aims to significantly increase efficiencies and performance, while maintaining a strong focus on innovation and R&D activities.
Alexander: This encompasses a range of targeted actions to train I needed that make area infrastructure reduce operating costs and become a leaner more agile and focused organization.
Alexander: The cornerstones of our efforts include a strategic reorganization streamlining reporting lines and digitizing the company.
Alexander Zehnder: The focus is on an improved interface between our discovery, research, and clinical development areas by bringing them together under the leadership of Myriam as Chief Scientific Officer. A unified leadership will allow for an optimal alignment of strategic goals, improved prioritization, resource allocation, and seamless transition from innovation to innovation, from discovery to the clinic. Furthermore, we will double our company-wide digital and data strategy to enhance the use of data and AI throughout the company and enable accelerated business processes and pipeline innovation.
Alexander: Our focus is on that improved interface between our discovery research and clinical development areas by bringing them together under the leadership of Marriott as Chief Scientific Officer.
Alexander: Unified leadership will allow for optimal alignment on strategic goals improved prioritization and resource allocation and seamless transition from innovation.
Alexander: From discovery to the clinic.
Alexander: Furthermore, we lived doubled down on a company by digital and data strategy to enhance the use of data and AI throughout the company and the neighborhood accelerated basis processes that pipeline innovation.
Alexander Zehnder: In the areas where we are trimming pandemic structures, as mentioned earlier, the targeted resizing via a voluntary leaver program to reduce 150 positions is ongoing. The reduction in the workforce will be accompanied by an overall stronger financial discipline.
Alexander: The areas that we are training pedantic structures as mentioned earlier the targeted resizing. The voluntary leave program 250 positions is ongoing.
Alexander: The reduction of workforce would it be accompanied by an overall stronger financial discipline is includes a much leaner, but you did 24 to 23, which is driven by lower operating costs and lower expenses in raw materials as a commitment for first generation cobalt seats are mostly closed.
Alexander Zehnder: This includes a much leaner budget in 2024 compared to 2023, which is driven by lower operating costs and lower expenses on raw materials as our commitments for first-generation COVID vaccines are mostly closed. Also, our capex spend will be significantly lower with the completion of our GMP4 manufacturing. While these actions have already been initiated, we will continue to look for more opportunities to improve efficiencies throughout 2024. Pierre will go into more details in the financial update later in this call, and we will continue to inform you on the progress of these initiatives throughout the year.
Alexander: Also our capex spend will be significantly lower with the completion of our G M before manufacturing plant.
Alexander: While these actions have already been initiated we will continue to look for more opportunities to improve efficiencies throughout 2024.
Alexander: Let me go into more details in the financial update later in this call and we will continue to inform you on the progress of these initiatives throughout the year.
Alexander: In parallel with our organizational redesign we have made significant progress in achieving our goals through strategic collaborations such as the co development and licensing agreement. We recently entered we'd want us to where it's supposed to be down cancer institutions.
Alexander Zehnder: In parallel with our organizational redesign, we have made significant progress in achieving our goals through strategic collaboration, such as the co-development and licensing agreement we recently entered into with one of the world's most renowned cancer institutions, the University of Texas and the Anderson Cancer Center.
Alexander: City of Texas, MD Anderson Cancer Center.
Alexander Zehnder: The collaboration focuses on the joint development of differentiated, off-the-shelf, mRNA-based cancer vaccines in selected hematological and solid tumor indications with higher medical needs. It combines Curevac's unique end-to-end mRNA capabilities for cancer antigen discovery, mRNA design, and manufacturing with Andy Anderson's world-class expertise in cancer antigen discovery and validation, translational drug development, and clinical research This collaboration is more than just a synergy of skills.
Alexander: So collaborations focuses on the joint development of differentiated off the shelf mrna based cancer vaccines and selected Hematological and solid tumor indications with high unmet medical needs.
Alexander: It combines cubic's unique end to end mrna capabilities for cancer, It's Chad discovery mrna design and manufacturing, we'd MD Anderson's world class expertise in catch up just had to discovery and validation translational drug development and clinical research.
Alexander: This collaboration is more than just the synergy of skills. It's a shared commitment of cure back as the pioneer of mrna and N V I understand as far as the most trusted leaders in cancer care to go further and faster in making a profound impact on the lives of cancer patients.
Alexander Zehnder: It's a shared commitment of Curevac as the pioneer of mRNA and Andy Anderson as one of the most trusted leaders in cancer care to go further and faster in making a profound impact on the lives of cancer patients. Accordingly, both sites will contribute to the identification of novel cancer antigens based on whole genome sequencing, RNA sequencing, and cutting-edge bioinformatics. Preclinical validation of the highest quality cancer antigens is expected to be followed by Phase I-II studies with potential lead candidates conducted by MDM.
Alexander: Accordingly, both sides will contribute to that electrification of novel cancer antigens based on whole genome sequencing RNA sequencing and cutting edge bioinformatics.
Alexander: Jordan preclinical validation of the highest quality cancer antigens is expected to be followed by phase one two studies with potential lead candidates conducted by MD Anderson.
Alexander Zehnder: We are convinced that this collaboration will be instrumental in boosting our oncology strategy. It will be an engine for the development of new cancer vaccines, helping us to deliver novel treatment options faster and more efficiently. In this context, it's with great pleasure that I introduce Taminda Ramanayake as our new Chief Business Officer. Taminda will join our management team on June 1st at this pivotal moment in our corporate evolution.
Alexander: We are convinced that these collaborations will be instrumental in boosting our oncology strategy. It will be an engine for the development of new cancer vaccines, helping us to deliver novel treatment options faster and more efficiently.
Alexander: Yeah.
Alexander: In this context, it's with great pleasure that I introduce to Mr. Robert a young Kid is that new.
Robert: She says there's this officer to beat that will join our management team on June 1st at this pivotal moment in our corporate evolution.
Myriam Mendila: Tamina joins from AffinityT Therapeutics; he brings 15 plus years of international experience in business development and corporate strategy. He has a strong track record of successful clinical collaborations, M&A, licensing, and strategic financing across multiple therapeutic areas. He has previously had positions at Sanofi, BioMarin, Pharmaceuticals, and Amgen. This wealth of knowledge is complemented by a strong foundation in science with a focus on immunology and oncology. This broad expertise uniquely positions Taminda to build upon our current achievements and drive Curevac's COVID strategy forward. With that, let me hand over the call to Myriam for an update on our clinical development program. Thank you, Alex.
Robert: Did that joins from affinity T therapeutics. He breaks 15 plus years of international experience in business development and corporate strategy. He has a strong track record of successful clinical collaborations M&A as the same thing.
Robert: Saying that strategic financing across multiple therapeutic areas.
Robert: He has previously had physicians incentive fee Biomarin pharmaceuticals that Amgen is without the knowledge is complemented by a strong foundation in science, we'd focus on immunology and oncology. This broad expertise uniquely positions <unk> to build upon our current achievements and drive <unk> corporate strategy forward.
Robert: With this let me hand over the call to Mary Anne for an update on our clinical development programs.
Mary Anne: Thank you Alex.
Myriam Mendila: Moving on to slide 9, I would like to take a moment to outline our most recent development pipeline, which forms the core of our business strategy. Based on the versatility of our unique mRNA platform, we address indications in the three therapeutic areas of prophylactic vaccines, oncology, and molecular therapy. In this updated layout, you can see that across these areas, we have focused our program resources and have discontinued legacy programs that no longer align with our development goals and expectations for adding value.
Mary Anne: Moving onto slide nine I would like to take a moment to outline our most recent development pipeline, which pumps to call all business tried to cheat.
Mary Anne: Based on the rest of the tendency of our unique mrna platform, we address indications in the sweets arthritic areas of prophylactic vaccines oncology and more like a lost time accident.
Mary Anne: And this update didn't lay out you can see that across this area. We have focused our program with Tulsa and has this continued like I say programs.
Mary Anne: Along that line with all our development goals and expectations for adding value.
Myriam Mendila: In our most advanced area for phylactic vaccines, the phase two COVID-19 and seasonal two programs are ongoing, being developed jointly with GSB. Both phase 2 studies are fully enrolled, and recent interim analysis data confirm that our platform elicits strong antibody titers at well-tolerated dose levels. The newly initiated combined phase 1, 2 study in avian flu is being conducted in the U.S. and assesses a modified monovalent vaccine candidate and coded an influenza A H5 antigen in younger and older adults against the placebo control.
Mary Anne: Now our most advanced area prophylactic vaccine. The first two COVID-19 antigen that two programs are ongoing being developed jointly with GSK.
Mary Anne: Almost has taught us that is a funny in college and recent interim analysis data confirms that our platform and it's a strong antibody titers.
Mary Anne: On the right the total surplus.
Mary Anne: The newly initiated combined phase one two study and avian flu, it's being conducted in the U S and especially some modified monovalent vaccine candidate and coding in influenza a H five antigen and younger and older that's against a placebo control it.
Myriam Mendila: We continue to translate the progress in our prophylactic vaccines area into oncology. For example, our Phase I study in patients with resected glioblastoma is currently preparing to start Part B after having successfully completed the dose escalation phase A, as previously mentioned. In the third therapeutic area, molecular therapy, we are developing optimized mRNA therapeutics together with several collaboration partners, which are intended to enable the expression of therapeutic proteins to treat diseases in different areas with unmet medical needs.
Mary Anne: We continue to transfer to translate the progress in L. A prophylactic vaccines area into oncology.
Mary Anne: Phase one study in patients that's when it's excess Glioblastoma is currently preparing to start part b. After having successfully completed the dose escalation part a S frequently mentioned.
Mary Anne: And the therapeutic area molecular therapy.
Mary Anne: Developing optimized mrna therapeutics together with several collaboration partners, which are intended to enable the expression of therapeutic proteins to treat diseases in different areas with unmet medical needs.
Mary Anne: We remain committed to broadening and diversifying our pipeline being guided by our mission of advancing innovation in health solutions for pizza and patients.
Mary Anne: And now on slide 10, which offers more detail on our development programs and COVID-19, that's just not true.
Myriam Mendila: We remain committed to broadening and diversifying our pipeline, being guided by our mission to advance innovation and health solutions for people and patients. Now, look at slide 10, which offers more detail on our development programs for COVID-19 and seasonal flu. The phase 2 part of the combined phase 1 study for flu assesses a potentially differentiated multivalent candidate encoding antigens matched to all four WHO recommended flu strains. The candidate was selected from the Phase 1 part of the study, which tested a comprehensive series of multivariate modified seasonal flu candidates with up to eight constructs per candidate. The Phase II part of the study is fully enrolled with 480 younger adults aged 18 to 64 and 480 older adults aged 65 to 80. Both age groups were tested against age-matched licensed comparative examiners.
Mary Anne: The phase two part of the combined phase one study for flu.
Mary Anne: As a potentially differentiated multivalent can do that and coding antigen match to all four ws LS I couldn't industrial strength.
Mary Anne: The candidates are selected from the phase one part of the study, which tested a comprehensive series of Lucky. They then modified season, that's what kind of pet was up to eight construct a candidate.
Mary Anne: The phase two part of the study is fully enrolled with 480 younger adults, aged 18 to 64 and find out an 18, well without a doubt it's at 65 to 80.
Mary Anne: <unk> edge Cop's got tested against H, that's a licensed comparator vaccine.
Mary Anne: The vaccine candidate that showed an acceptable safety and Tolerability profile at least a majority of solicited adverse events reported as either mild or moderate.
Mary Anne: For influenza strains geometric mean titers generated by the vaccine candidate that numerically exceed it did you give a metric mean titers of the license comparator vaccine.
Mary Anne: Distantly across all tested dose levels and age groups.
Myriam Mendila: The vaccine candidate showed an acceptable safety and tolerability profile with the majority of solicited adverse events reported as either mild or moderate. For influenza A strains, geometric mean titers generated by the vaccine candidate numerically exceeded the geometric mean titers of the licensed comparator vaccine consistently across all tested dose levels and age groups. However, for influenza B strains, geometric mean titers were generally lower than those elicited by the licensed comparator
Mary Anne: For influenza B strain geometric mean titers generally know what themselves in this satisfies a licensed comparator vaccine.
Mary Anne: Based on the challenges and addressing these trends across vaccine technologies. This is in line with our expectations and the results from early studies.
Mary Anne: A best flu development programs.
GSK: Okay that was GSK.
GSK: Plan to assess target that optimization that took place that improve immune responses against these trends and an additional phase two setting.
GSK: We are confident on plant optimization, well improved performance against this historically challenging influenza strains.
Myriam Mendila: Based on the challenges in addressing B-strains across vaccine technologies, this is in line with our expectations and the results from early studies of other mRNA-based flu development programs. Together with GSK, we plan to assess targeted optimizations to further improve immune responses against B strains in an additional phase two study. We are confident that planned optimizations will improve performance against these historically challenging influenza strains. In the Phase 2 COVID-19 study, we assessed different booster vaccinations of two vaccine candidates. CV0601, a modified monovalent construct encoding the Omicron BA45 variant, and CV0701, a modified b-valent construct encoding the Omicron BA45 variant, as well as the original SARS-CoV-2 strain.
GSK: And then phase two COVID-19 study, we assessed different booster vaccination of two vaccine candidates.
GSK: 060, water and modified mono valent constructs encoding omi contour sulfites Ariane.
GSK: And so he was seven one and modified.
GSK: They like to construct in coding the omicron default five fabian as well ethanol richness that cause me to strain.
GSK: The study is fully enrolled with 427 participants aged 18, all all of that.
GSK: According to the applicable standard of care at the time, the sandy employ the license fee valent mrna comparator vaccine.
GSK: Interim data wasn't partisan early 'twenty 'twenty, four and confirmed a favorable tolerability profile combined with competitors in your responses at low doses.
GSK: All of the test at those levels for wealthy knows all she was in any of the mrna based COVID-19 vaccines license in the U S and U S.
GSK: As can be seen in the left also to block both vaccine candidate that shortened a lot or similar proportion of participants with project solicited adverse events compared to those who received the comparator vaccine.
Myriam Mendila: The study is fully enrolled with 427 participants aged 18 or older. According to the applicable standard of care at the time, the study employed a licensed B-valent mRNA comparator vaccine. Interim data was reported in early 2024 and confirmed a favorable tolerability profile combined with competitive immune responses at low doses. However, all tested dose levels were well below those used in any of the mRNA-based COVID-19 vaccines licensed in the U.S. and EU.
GSK: As illustrated on the right graph.
GSK: It was 601 shown in Orange was tested at the medium dose level and then instead of neutralizing antibody titers against the Omicron P. A full 5000 yards on day 29.
GSK: Which in America, they exceeded the type of center ratifies, the comparator vaccine by a factor of one four.
GSK: The low medium and high dose levels tested for Veeva, and then C. D 071.
GSK: Neutralizing antibody titers were opened seven one and one three times the tightest as a comparator vaccine.
Myriam Mendila: As can be seen in the left side of the two graphs, both vaccine candidates showed a lower or similar proportion of participants reporting solicited adverse events compared to those who received the comparative vaccine. As illustrated in the right graph, CV0601, shown in orange, was tested at a medium dose level and elicited neutralizing antibody titers against the Omicron BA45 variant on day 29, which numerically exceeded the titers generated by the comparator vaccine by a factor of 1.4. For the low, medium, and high-dose levels tested for B-valent CV0701, neutralizing antiviral titers were 0.7, 1, and 1.3 times the titers of the comparator vaccine.
GSK: The study is currently ongoing with an additional expansion cohort.
GSK: Taken together the promising interim data strongly underscores the strength of our proprietary technology platform.
Speaker Change: With this let me shift our focus back to our oncology area.
Speaker Change: I'm flagging that her let me briefly remind you of the strategy for oncology area, but she comes to the cornerstone of our future growth.
We have made significant strides in advancing our cancer vaccine programs based on our two pronged strategy, which encompasses both off the shelf and personalized cancer vaccines.
Speaker Change: Our off the shelf programs pockets of discovery of shared antigens with high prevalence in specific cancer types and the potential to enable more scalable and rapid cancer cats.
Speaker Change: And this part we have achieved key milestones over the past several months.
Speaker Change: We are delivering on Alexandria, Blastoma study by targeting non glioblastoma antigens to validate our second generation box back bone in the oncology setting.
Myriam Mendila: The study is currently ongoing with an additional expansion cohort. Taken together, the promising interim data strongly underscore the strength of our proprietary technology platform. With this, let me shift our focus back to our oncology area. On slide 11, let me briefly remind you of the strategy for our oncology area, which we consider a cornerstone of our future growth. We have made significant strides in advancing our cancer vaccine program based on our two-pronged strategy, which encompasses both off-the-shelf and personalized cancer vaccines.
Speaker Change: At the same time in collaboration with my Neo Therapeutics, we have identified novel shaft antigen based online is Atlanta, AI powered technology platform, which showed strong immunogenicity and undisclosed preclinical studies.
Speaker Change: The combination of antigen involving something on your collaboration with antigen that's come up with a proprietary platform.
Speaker Change: The selection of the next clinical candidate in oncology.
Speaker Change: Atlanta's candidate candidates to the clinic in 2025.
Myriam Mendila: Our off-the-shelf programs target the discovery of shared antigens with high prevalence in specific cancer types and the potential to enable more scalable and rapid cancer care. In this part, we have achieved key milestones over the past several months. We are delivering on our glioblastoma study by targeting known glioblastoma antigens to validate our second-generation backbone in the oncology setting. At the same time, in collaboration with Mineo Therapeutics, we have identified novel shared antigens based on Mineo's advanced AI power technology platform, which showed strong immunogenicity in undisclosed preclinical studies. The combination of antigens evolving from the MyNeo collaboration with antigens discovered with our proprietary platform enables selection of the next clinical candidate in oncology.
Speaker Change: Our collaboration with MD Anderson will also be an engine for the future development of new cancer vaccine candidates further strengthening our off the shelf clinical development program.
Speaker Change: In parallel we are also aiming to push the boundaries of first class cancer vaccines tailored to the unique genetic makeup of her patients you want.
Speaker Change: We have evolved our angiogenesis covered platform acquired with frame cancer Therapeutics, and specifically directed at the technology tell us the identification of novel classes of personalized cancer antigens.
Speaker Change: And flexible access to cancer candidates based on novel personalized antigen, but they critically enabled by the RNA printer, which was granted a framework license and the ongoing regulatory Matthew.
Speaker Change: As we continue to navigate the challenges and opportunities of the oncology landscape our achievements in both off the shelf and personalize cancer vaccines positioning us strongly for future growth and success in this important area.
Myriam Mendila: We plan to advance this candidate to the clinic in 2025. Our collaboration with MD Anderson will also be an engine for the future development of new cancer vaccine candidates, further strengthening our off-the-shelf clinical development program. In parallel, we are also aiming to push the boundaries of first-class cancer vaccines tailored to the unique genetic makeup of a patient's tumor. We have evolved our antigen discovery platform, acquired with Frame Cancer Therapeutics, and specifically directed the technology towards the identification of novel classes of personalized cancer antigens.
Speaker Change: Turning our attention now to the clinical front in oncology on slide 12.
Speaker Change: Let me give you a little bit more detail on our phase one study in patients with surgically resected M. G M T unless alleged glioblastoma.
Speaker Change: The slide you can see the setup of the open label Phase one study with a multi epitope cancer vaccine candidate.
Speaker Change: D M D.
Speaker Change: Jamie honestly, if just a singular unmodified mrna encoding eight epitopes derived from tumor associated antigens, which demonstrated immunogenicity in glioblastoma.
Jamie: Yeah exact nature of the epitopes, it's not disclosed.
Myriam Mendila: Fast and flexible access to cancer candidates based on novel personalized antigens will be critically enabled by the RNA printer, which was just granted a framework license in the ongoing regulatory review. As we continue to navigate the challenges and opportunities of the oncology landscape, our achievements in both off-the-shelf and first-line cancer vaccines position us strongly for future growth and success in this important area. Turning our attention now to the clinical front in oncology, on slide 12.
Jamie: The dose escalation part <unk> has successfully completed recruitment for 16 patients across four dose whether it's between 12 and 100 micrograms.
Jamie: And if you have the safety data for these dose levels by potato safety monitoring board abuse or be concerned no dose limiting toxicities.
Jamie: Accordingly, a decent begets a recommendation for a preferred dose of 100 micrograms wasn't subsequent to part b of the study.
Part B expected to start in the 'twenty 'twenty four will enroll up to 20 patients.
Jamie: We're looking forward to sharing first immunogenicity data from study in the second half of 'twenty 'twenty four at the scientific conference.
Myriam Mendila: Let me give you a little bit more detail on our Phase I study in patients with surgically resected MGMT-unmethylated glioblastoma. On this slide, you can see the setup of the Open Label Phase 1 study with a multi-epitope cancer vaccine candidate, CVGVM. CVGBM features a single, unmodified mRNA encoding eight epitopes derived from tumor-associated antigens with demonstrated immunogenicity in glioblastoma.
Jamie: To finalize the encouraging news flow in the context of oncologist strategy.
Jamie: We're in a printer our highly automated solution for T. M pay GMP grade manufacturing of cancer vaccines has the chiefs the next important regulatory milestone.
Myriam Mendila: The exact nature of the potips is not disclosed. The Dose Escalation Part A has successfully completed recruitment with 16 patients across four dose levels between 12 and 100 micrograms. A review of the safety data for these dose levels by the Data Safety Monitoring Board, or DSMB, confirmed no dose-limiting toxicities.
Jamie: You might remember that we reported the first manufacturing license, how the printer to spot oncology strategy in the third quarter of 2020 Street.
Jamie: And then ongoing regulatory revenue this license both expanded by so called framework license.
Jamie: It allows the flexible manufacturing of different mrna construct based on the established processes on the printer.
Myriam Mendila: Accordingly, the DSMB gave a recommendation for a preferred dose of 100 micrograms for the subsequent Part B of the study. Part B, expected to start in mid-2024, will enroll up to 20 patients. We are looking forward to sharing the first immunogenicity data from the study in the second half of 2024 at the scientific conference. To finalize the encouraging news flow in the context of our oncology strategy, the RNA printer, our highly automated solution for GMP-grade manufacturing of cancer vaccines, has achieved the next important regulatory milestone.
Jamie: In 'twenty to 'twenty four Oh I'll go into the first X Congress approach to also include the formulation module of the printer to a completely end to end capabilities of the system.
Jamie: With this let me hand back to Alexander.
Alexander: Thank you Mary Anne before we move on to the financial part of this call on Slide 14, I would like to briefly provide an update on our patent litigation against price of biotech in Germany at the U S.
Alexander: Starting with the recent development in the U S shown on the left hand side of the slide. Please recall that a total of 10 patents are currently at issue in this geography.
Alexander: November 2023, our partner acuity therapeutics moved to intervene silver or stay our U S litigation against Pfizer by Radzik Moshe.
Myriam Mendila: You might remember that we reported the first manufacturing license for the printer to support our oncology strategy in the third quarter of 2023. In an ongoing regulatory review, this license was expanded by a so-called framework license, which allows the flexible manufacturing of different mRNA constructs based on the established processes on the printer. In 2024, our goal is to further expand this approach to also include the formulation module of the printer to complete the end-to-end capabilities of the system. With this, let me hand it back to Alexander.
Motion is based on a co ownership and Coinventor ship claims related to one patent families covering four patents out of the 10 litigated in the U S. These.
Alexander: These four patents cover the specific design of COVID-19 vaccine using a lipid nanoparticle, which was used in the call me not to you, but first introduced to the clinic by cure back in 2019.
Alexander: Recently, a magistrate judge granted intervention and recommendation to stay litigation of all 10 patents before the district court to the acuity disclaimers resolved. So far no decision has been made and we are currently preparing objections to this recommendation and anticipate a decision we didn't do that.
Alexander Zehnder: Thank you, Myriam. Before we move on to the financial part of this call, on slide 14, I would like to briefly provide an update on our patent litigation against Pfizer-BioNTech in Germany and the U.S., starting with the recent development in the U.S., shown on the left-hand side of the slide. Please recall that a total of 10 patents are currently at issue in this geography. In November 2023, our partner Acuitas Therapeutics moved to intervene, sever, or stay our U.S. litigation against Pfizer-BioNTech.
Two months.
Germany shown on the right hand side of the slide on December 19, 2023, the German Federal Court patent court granted in the first instance, the 2022 requests by value and check to notify the German part of our technology patent don't you see enrichment.
Alexander: Given the broad scope of our robust patent portfolio. This initial decision does not diminish the strength of our value of our intellectual property position. As this is only the first instance decision proceedings are continuing in Germany with the remaining IP rights.
Alexander Zehnder: The motion is based on a co-ownership and co-inventorship claim related to one patent family covering four patents out of the 10 litigated in the U.S. These four patents cover the specific design of the COVID-19 vaccine using a lipid nanoparticle which was used in Corvinazzi but first introduced to the clinic by Curevac in 2008. Recently, a magistrate judge granted intervention and recommendation to stay litigation of all 10 patents before the district court until the acuitous claim is resolved.
Alexander: We are currently waiting to receive the judgment of the December decision.
Alexander: Which will enable us to find the appeal before the German federal court of Justice definitely firmly establish the merits of our case.
Alexander: Litigation is part of the business landscape, especially in industry is driven by high Stakes innovations such as ours and routinely take years to play out however, delays and setbacks, but not deter us from having our intellectual property rights acknowledged and fairly compensated.
Alexander Zehnder: So far, no decision has been made, and we are currently preparing objections to this recommendation and anticipate a decision within the next year. In Germany, shown on the right-hand side of the slide, on December 19, 2023, the German Federal Patent Court granted in the first instance the 2022 request by Valuantech to nullify the German part of our technology patent on GCM. Given the broad scope of our robust patent portfolio, this initial decision does not diminish the strength of our value of our intellectual property position, as this is only a first instance decision, and proceedings are continuing in Germany with the remaining IP rights.
Alexander: With this I would like to conclude the business update and her door to care for a review of the financial data.
Speaker Change: Thank you Alexander good morning, and good afternoon to everyone on the call.
Speaker Change: Before we go into financial statement details I would like to provide a little context.
Alexander: Context on our updated runway guidance and the main factors that are impacting a 'twenty 'twenty four and 2025 projections.
Alexander: I think sounds I already mentioned the joint Kozak Gsk's decision to wind down in 2022 pandemic preparedness agreement with the German government.
Alexander: Based on the 'twenty 'twenty four obligation from disagreement we expect the wind down to have a positive cash impact supporting a 'twenty 'twenty four runway.
Alexander: This was this relates to significant savings on raw materials stockpiling and reduction in running costs were just before mentioned manufacturing facility.
Alexander: On the other hand in 2025, we will no longer receive the son, but I see that the German government would have paid for maintaining a woman manufacturing base, resulting in a decrease 2025 revenues.
Alexander Zehnder: We are currently waiting to receive the written judgment of the December decision, which will enable us to file an appeal before the German Federal Court of Justice that will firmly establish the merits of our case. Patent litigation is part of the business landscape, especially in industries driven by high-stakes innovation such as ours, and routinely takes years to play out.
Alexander: We will offset this overall negative cash impacts two things first we have closed all remaining raw material commitments related to our first generation COVID-19 vaccine.
Alexander: Our organizational redesign, including virtual either program will enable reduced operating costs, allowing additional investments into selected developing programs.
Alexander Zehnder: However, delays and setbacks will not deter us from having our intellectual property rights acknowledged and fairly competent. With that, I would like to conclude the business update and hand over to Pierre for a review of the financial data. Thank you, Alexander.
Alexander: The reduction in cash out in 2024 compared to 22 in Q3 will be driven by lower operating expenses. There is this G&A functions.
Alexander: Because they'll just be full system is expected to be certified in the second half of this year subject of course to regulatory approval. The capex requirements in 'twenty 'twenty four will also be significantly reduced compared to 2023.
Pierre Kemula: Good morning and good afternoon to everyone on the call. Before we go into financial statement details, I would like to provide a little more context on our updated runway guidance and the main factors that are impacting our 2024 and 2025 projections. Alexander already mentioned the joint Curevac-GSK decision to wind down the 2022 pandemic preparedness agreement with the German government. Based on the 2024 obligation under this agreement, we expect the Rhine Dam to have a positive cash impact supporting a 2024 runway.
Alexander: Taken together.
Alexander: It allows us to extend our cash runway from mid 2025 into the fourth quarter of 2025, we will continue to look for more opportunities to increase efficiency in 'twenty 'twenty four and we'll keep you updated.
Alexander: Looking at our cash position slide 16, as already mentioned, we close 2023, with Florida and $2 5 million euros.
Cash used in operations was mainly allocated to R&D activities expenditures for our GMP production facility and purchases of R&D materials.
Alexander: I would underline in this presentation to significant one off effects that took place in 2022.
Alexander: Consequence of closing our first generation vaccine, especially in COVID-19.
Pierre Kemula: This relates to significant savings on raw materials stockpile and a reduction in running costs for a chip before manufacturing is finished. On the other hand, in 2025, we will no longer receive the standby fee that the German government would have paid for maintaining a warm manufacturing base, resulting in decreased revenue in 2025.
Alexander: First let's look at revenues.
Alexander: Revenues increased by $10 9 million euros to $22 6 million euros for fourth quarter and decreased by $13 6 billion euros to $53 8 million euros for the 12 months of 2023 compared to the same periods in 2022.
Alexander: The decrease year on year was primarily driven by lower revenues from our two GSK collaboration agreements.
Alexander: Revenues from both collaborations decreased year on year and amounted to a total of $47 1 billion euros in 2023 compared to $62 3 million euros in 2022.
Pierre Kemula: We will offset this overall negative cash impact with two things. First, we have closed all remaining raw material commitments related to our first-generation COVID-19 vaccine. And second, our organizational redesign, including a voluntary leaver program, will enable reduced operating costs, allowing additional investments into selective development. The reduction in cash-out in 2024 compared to 2033 will be driven by lower operating expenses in various SG&A functions.
Alexander: The decrease was driven by the agreement with both companies to focus on the larger indications.
Alexander: Revenues for the fourth quarter, it was higher compared to the prior year period as a significant portion of the milestone related to the nutrition initiation of phase II for the seasonal flu clinical trial was recognized.
Alexander: Operating loss was 88 million euros for the fourth quarter of 2023.
Alexander: I think it was $33 5 million euro decrease compared to the same quarter of 2020 two.
Alexander: For 12 months of 2023 operating loss increased by $24 7 billion euros to $274 2 million euros compared to the same period in 2022.
Pierre Kemula: With our GMP4 facility expected to be certified in the second half of this year, subject, of course, to regulatory approval, the CAPEX requirements in 2024 will also be significantly reduced compared to 2020. Taken together, this allows us to extend our cash runway from mid-2025 into the fourth quarter of 2020. We will continue to look for more opportunities to increase efficiency in 2024, and we'll keep you updated. Looking at our cash position on slide 16, as we have already mentioned, we close 2023 with 402.5 million euros. Cash use and operations were mainly allocated to R&D activities, expenditures for our GMP4 production facility, and purchases of R&D materials.
Alexander: It appears he was also was affected by several key drivers.
Alexander: First cost of sales decreased year over year, maybe as the impact of our first generation COVID-19 vaccine subsided.
Alexander: This resulted in lower write off of raw materials in 2023.
Alexander: As well as lower impact from costs related termination or seeing more activities.
Alexander: Second R&D expenses increased with higher investments in later stage infectious diseases and oncology development programs.
Alexander: That's where the strength of the workforce.
Alexander: In 2022, R&D expenses were positively impacted by a $38 5 million euro relate to a euro related to the reversal of a outstanding CRA provision as well as by one off mitigating for changing contract termination provision, resulting primarily in GSK, taking over from the company committed capacity.
Alexander: Third it's still in 2022.
Other income was positively impacted by a $32 5 million one off for reimbursement of prepayments and production because he said the CMO.
Alexander: And as a result of increased by $8 7 million euros to a profit of $1 5 million euros in the fourth quarter of 2023.
Pierre Kemula: I will underline in this presentation the significant one-off effects that took place in 2022 as a consequence of closing our first-generation vaccine efforts in COVID-19. But first, let us look at revenue. Revenues increased by €10.9 million to €22.6 million for the fourth quarter and increased by €13.6 million to €53.8 million for the twelfth month of 2023 compared to the same period in 2020. The decrease year-on-year was primarily driven by lower revenues from our two GSK collaboration agreements.
Alexander: Increased by $13 9 million euros to a profit of $14 2 million euros for the 12 months of 2023 compared to the same periods in 2022.
It was mainly driven by interest income on cash investments.
Alexander: These tax losses were $86 5 million euros for the fourth quarter and 260 million euros for the full year of 2023.
Alexander: With this overview I would like to hand back the call to Alexander for summarize today's key messages.
Alexander: Thank you Pierre.
Alexander: So building on our achievements in 2023, we have kicked off 2024 by delivering progress across several key areas and position ourselves for continued success throughout the year.
Pierre Kemula: Revenues from both collaborations decreased year-on-year and amounted to a total of €47.1 million in 2023 compared to €62.3 million in 2014. The decrease was driven by the agreement of both companies to focus on the larger industry. Revenues for the fourth quarter were higher compared to the prior year period, as a significant portion of the milestone related to the initiation of phase 2 for the seasonal flu clinical trial was recommended. Operating loss was 88 million euros for the fourth quarter of 2020, presenting a 33.5 million euro decrease compared to the same quarter of 2020. The 12-month operating loss in 2023 increased by 24.7 million euros to 274.2 million euros compared to the same period in 2018. The operating result was affected by several key drivers.
Alexander: Foremost we have launched.
Alexander: Brent says organizational redesign initiatives that trips the citral, a debit gateway infrastructure streamlines, our organization and applies increased financial discipline.
Alexander: These measures to significantly improve our operational efficiency and agility and contribute to a stronger financial performance in 2024.
Alexander: This expectation is reflected in the extension of our cash run way for mid 2025 into the fourth quarter of 2025.
Alexander: The clinic, our infectious disease vaccine development pipeline continues to make significant progress marked by most recently by a start of a new study in avian flu together with GSK.
Alexander: This is complemented by key data milestones into phase two studies for COVID-19, and seasonal flu confirming the competitiveness of our proprietary mrna technology platform.
Alexander: You don't call a G cornerstone of our strategy the establishment of our cancer vaccine collaborations with MD Anderson and the advancement of our phase one studies in patients with Glioblastoma, both reinforce our commitment to staying at the forefront of oncology innovation.
Pierre Kemula: First, cost of sales decreased year-on-year mainly as the impact of our first-generation COVID-19 vaccine subsided. This resulted in lower write-off of raw materials in 2023, as well as a lower impact on cost-related termination of CA modes. Second, R&D expenses increased with higher investment in later-stage infectious diseases and oncology development programs, as well as strengthening the workforce. In 2022, R&D expenses were positively impacted by €38.5 million related to the reversal of an outstanding CRO provision, as well as by a one-off net gain for a change in contract termination provision, resulting primarily in GSK taking over from the company-committed capacity at the C
Alexander: But does that make dramatically illustrated to utility of mrna technology and we believe that mrna. Most significant promise is still lies ahead of us and chew bag. It's Richard.
Alexander: Commission to bring got tremendous potential to life.
Speaker Change: And with this I would like to conclude our presentation and we'll now open the webcast for your questions.
Speaker Change: Thank you at this time, we will be conducting a question and answer session. If he would like to ask a question. Please press star one on your telephone keypad.
Pierre Kemula: 3rd, and still in 2020. Other income was positively impacted by a $32.5 million one-off offshore reimbursement of prepayments and production activities set up at sea. Financial results increased by €8.7 million to a profit of €1.5 million in the fourth quarter of 2023 and increased by €13.9 million to a profit of €14.2 million for the twelfth month of 2023, compared to the same periods in 2020. They were mainly driven by interest income and cash income. Pre-tax losses were €86.5 million for the fourth quarter and €260 million for the full year of 2021.
Speaker Change: A confirmation tone will indicate your line is in the question queue.
Speaker Change: Press Star two if you would like to remove your question from the queue.
Speaker Change: Participants using speaker equipment, it may be necessary to pick up your handset before pressing the heartbeat.
Speaker Change: Okay.
Speaker Change: One moment, please as we poll for questions.
Speaker Change: And our first question comes from the line of Evan Wang with Guggenheim.
Please proceed with your question.
Boran Wang: Okay, great. Thanks, guys. Thanks for taking the question back to one related to the infectious disease platform. Just wondering if you could provide any timelines or.
Boran Wang: Back to some of the next steps that we'll see for Covid seasonal flu and a potential combo.
Speaker Change: I guess, what the you know flu one question I did have was you know should we be thinking about a trivalent going forward.
Speaker Change: Or tried to you know.
Speaker Change: With a debit Rachel antigen, and then with GBM, but I can see the progress of inflection on the go forward dose anything you can share with respect to the park a immunogenicity that evaluated how does the response there compared to some of the response, we've seen from some competitors recently thanks.
Alexander Zehnder: With this overview, I would like to hand back the call to Alexander for the summary of today's key messages. Thank you, Pierre. Building on our achievements in 2023, we have kicked off 2024 by delivering progress across several key areas and positioned ourselves for continued success throughout the year. For most, we have launched a comprehensive organizational redesign initiative that trims residual pandemic-era infrastructure, streamlines our organization, and applies increased financial disincentives. We expect these measures to significantly improve our operational efficiency and agility and contribute to a stronger financial performance in 2024.
Speaker Change: Okay. Thank you very much maybe I can start and then let our medium to comment as well, but the first one on the I D platform you know as we mentioned, we just started a new trial.
Speaker Change: Just wanted to traveling avian flu. So that's an additional program as part of the G.
Speaker Change: GSK collaborations that is moving forward and I think might address.
Speaker Change: An important future need then for Covid and flu as we mentioned during the call. Both phase III studies are still ongoing for flu. We are about to start the additional study do you improve b strain response and for Covance. The additional part of the tissue studies that are going to optimize.
Alexander Zehnder: This expectation is reflected in the extension of our cash runway from mid-2025 into the fourth quarter of 2025. In the clinic, our infectious disease vaccine development pipeline continues to make significant progress, marked most recently by the start of a new study in avian flu together with GSK. This is complemented by key data milestones in the Phase 2 studies for COVID-19 and seasonal flu, confirming the competitiveness of our proprietary mRNA technology platform.
Speaker Change: Four different presentations after after vaccines and once we have all these data together from the relevant city you'd be able to complete our discussions with the regulatory authorities for the setup of the pivotal phase III studies.
Speaker Change: You know together with GSK, we are working on.
Speaker Change: Most value driving strategy for both our collaborations and that reflects the current needs for both indications.
Speaker Change: Question, two GBM and where the data is already available maybe like maybe a comment on this.
Speaker Change: Yeah, and and maybe before that that Evan I had another question on flu and that'd be goldman's a trivalent.
Alexander Zehnder: In oncology, a cornerstone of our strategy, the establishment of our cancer vaccine collaboration with Andy Anderson and the advancement of our Phase I study in patients with glioblastoma both reinforce our commitment to staying at the forefront of oncology innovation. The pandemic dramatically illustrated the utility of mRNA technology, and we believe that mRNA's most significant promises still lie ahead of us, and Curevac is resolute in its mission to bring that tremendous potential to life.
Speaker Change: Vaccine and yes, that's fatality rates, Oh recommendation and that would be the plan for phase III is that basically a and cold just fall Warner is trained in the future and we will always follow the things that would go with a recommendation that that's sort of the plan for phase III.
Speaker Change: And for TV and you know we are analyzing and doing what you didn't miss it or it happens that's close those N and M.
Speaker Change: As we touched on the presentation like Bosnia analyzing more data coming in between if we plan to present those data at upcoming oncology conferences in the second half of 'twenty 'twenty four or so at the moment, our target as ethanol and potentially at the to take my friends.
Operator: And with this, I would like to conclude our presentation and would now open the webcast to you. Thank you. If you would like to ask a question, please press star 1 on your telephone. A confirmation tone will indicate your line is in. You may press star 2 if you would like to remove your question.
Speaker Change: Later, this year and in the U S.
Speaker Change: And thank you.
Speaker Change: Our next question comes from the line of Ryan <unk> with citizens J M P.
Operator: For participants using speaker equipment, it may be necessary to pick up your handset before. One moment, please, as we poll for questions. And our first question comes from the line of Evan Wang with Guggenheim. Please proceed with your questions. Great. Thanks, guys. Thanks for taking the questions. I have two.
Ryan: With your question.
Ryan: Hey, Thanks for taking the question I guess Oh, she can answer this one but the seasonal flu phase III.
Ryan: Do you think you might be in a position to start that trial as early as later this year or is that.
Ryan: Most likely early next year and then the frame.
Ryan: While we can't say or you would've said was wondering when you might be in the clinic, let's say.
Alexander Zehnder: One related to the infectious disease platform. Just wondering if you could provide any timelines with respect to some of the next steps that we'll see for COVID, seasonal flu, and a potential combo. I guess with the, you know, flu, one question I did have was, you know, should we be thinking about a trivalent going forward or trivalent with the WHO antigens? And then with GBM, I'm glad to see the progress in selecting the go-forward dose. Anything you can share with respect to Part A on immunogenicity, was that evaluated? And how does the response there compare to some of the responses we've seen from some competitors recently? Thanks.
Ryan: Personalized approach and that's what scaling on that getting that into the clinic at this point. Thanks.
Ryan: Miriam So question on timing of flu phase III and the timing of a.
Ryan: Personalized cancer vaccines to the clinic.
Miriam: Yeah, so far through phase III right, we need to discuss also has those priorities in all corners of cost to bring it to returning as soon as possible.
Miriam: But right now, it's it's difficult and and and we are reluctant to commit to a eight basically stock. So maybe you can all once we have discuss with us how it doesn't have a clear plan for sure in the line or the sheets can't give an update on that as a piece of it we're working on it and communicated that Elliot This is complex.
Alexander Zehnder: Okay, thank you very much. Maybe I can start, and then, you know, I will let Myriam comment as well. Maybe first on the iID platform, you know, as we mentioned, we just started a new trial, phase 1-2 trial on avian flu, so that's an additional program as part of the GSK collaboration that is moving forward, and I think might address an important future need. And then for COVID and flu, as we mentioned during the call, both phase 2 studies are still ongoing. For flu, we are about to start an additional study to improve the B-strain response, and for COVID, the additional part of the phase 2 study is still ongoing to optimize for different presentations of the vaccine.
Miriam: And right now we are planning to go into the clinic 2026, plus.
Speaker Change: Okay, Great and then maybe just sorry, just one one more on the.
Speaker Change: And I think this is what he said, but the H five N. One program. That's another target selection by GSK. So it reduces their available August five one thanks.
Speaker Change: Yes, that's correct.
Speaker Change: Okay. Thank you.
Speaker Change: Thank you.
Speaker Change: Our next question comes from the line of Manny <unk>.
Manny: Who are with Leerink partners.
Manny: Please proceed with your question.
Hey, guys. Thank you for taking this call or question.
Manny: I wanted to pivot over to a financial one I'm looking at the guidance slide here Slide 15, which we're hopefully breaks up the bridge out to like 25.
Alexander Zehnder: Once we have all these data together from the relevant study, we will complete our discussions with the regulatory authorities for the establishment of the Pivotal Phase III study. And together with GSK, we are working on what is the most value-driving strategy for both our collaborations, which reflect the current needs for both indications. Your question to GBM and whether data is already available, maybe I'll let Myriam comment on that. Yeah, and maybe before that, Evan had another question about the flu and whether we go with the trivalent vaccine. And yes, that's the WHO recommendation.
Manny: Can you give us a little bit of granularity on the assumptions around the voluntary leave program that are baked into that and some of the economics of where we might see some of that severance expense versus some opex coming off his head count trends and how that will flow through the financial statements and what your operational assumptions are for degree.
Manny: And tempo of uptake.
Manny: Yeah.
Manny: I mean this is Jeff speaking thanks for your question I'm not sure I understood the last part but we.
Jeff: We basically you have on this slide you know I think the key elements of the key driving elements right. That's have an impact on on the runway. We havent disclose for instance, the P. P. A the revenue is as a consortium approach with GSK and the government. So it's difficult to comment on that what else would you understand from my.
Alexander Zehnder: And that would be the plan for phase three, that we would basically, and Co just for one B-strain in the future, and we will always follow the WHO recommendation, but that's sort of the plan for phase three. And for GBM, you know, we are analyzing immunogenicity data but haven't disclosed those. And as we said in the presentation, right, while we are analyzing and more data come in, we plan to present those data at upcoming oncology conferences in the second half of 2024. So at the moment, our target is ASIMO and potentially the SISI conference later this year in the U.S.
Jeff: Call is we have a an extension because we don't have to expense raw materials. So far this year, but we have less revenues from the P theater. So its a net net.
Jeff: Negative over the over the period right and this will be counterbalanced by of course, you know I'm a <unk>.
Jeff: Focused spend I guess on on R&D, and you know space savings that we have all the infrastructure, but also you know I would say on the G&A going forward importantly, I bet. He tried to underlying as well we had a little swings related to the end of the COVID-19 first Gen rights and so these are I.
Operator: Thank you. Our next question comes from the line of Roy Luchin with Citizens JMP. Please proceed with your question. Hey, thanks for taking the question. I guess, I'm not sure you can answer this one, but seasonal flu phase three, do you think you might be in a position to start that trial as early as later this year? Most likely early next year.
Jeff: I mean, it's mostly behind US now right. So I think this will help us and we talked about before where you'll see and you know documents would you be able to upload it to life, we have kind of finished our investing into.
Jeff: The building and the machines right. So this will never produce going forward. So I'm. You know this is the color I can I can provide it.
Jeff: All these pluses and minuses, you know and specifically with the effort that we've done you know in terms of the lighter budgets either budget more efficient debt and exotic was talking about we were able to extend the runway despite having a bit of a headwind you know over the two years in PPA.
Operator: And then the frame, you probably can't say, or you would have said, was wondering when you might be in the clinic with the personalized approach and just what's gating on that, getting that into the clinic at this point. Myriam, so question on timing of flu phase 3 and timing of personalized cancer vaccines to the clinic. Yeah, so for flu phase three, right, we need to discuss it with the health authorities. And our goal is, of course, to bring it to the clinic as soon as possible. But, right now, it's difficult, and we are reluctant to commit to a basically start.
Jeff: Okay pivoting over and a quick follow up two strategic and for clinical development question.
Jeff: When you think about the use of your technology in oncology, whether one wants to call. It a personalized cancer vaccine neo adjuvant therapy or whatever various competitors are calling their products now how.
Jeff: How do you think about indications collection and to what extent it uninformed by positioning an indication of the data from your competitors Madrone biotic, etc.
Operator: So maybe, you know, once we have discussed it with authorities and have a clear plan, we were for sure in the line of the cheesecake, give an update on this one for PCV. We're working on it and communicated that earlier. This is complicated.
And maybe I go to questions.
Speaker Change: Uh huh.
Speaker Change: Sorry, Alex asked me if you're okay. Yeah, I can take a I think it's a it's a great question and yes, we're doing all of that right, especially for oncology, where you could go into 50, plus two months and if you take that.
Operator: And right now, we are planning to go into the clinic in 2026 plus. Okay, great. And then maybe, sorry, just one more on the, I think this is what you said, but the H5N1 program is another target selection by GSK, so it reduces their available targets by one. That's correct.
Speaker Change: I'll stop.
Speaker Change: Stop divide them into molecular subtypes, it's even more than that.
Speaker Change: Strategic evaluation over the last quarter of last year really looking at all of the different possibilities are left to go and then applying different criteria with different waiting on how to rank those and then came up with basically a list of priorities considering commercial opportunity considering competitive landscape available data.
Operator: Thank you. Okay, thank you. Thank you. Our next question comes from the line of... Ruar from the Lingerie Department.
Operator: Please proceed with your questions. Yes, thank you for taking this call and asking this question. I wanted to pivot over to a financial one.
Speaker Change: And then and and and that basically was an underlying basis all became the underlying basis follow oncology strategy. So yeah.
Operator: I'm looking at the guidance slide here, slide 15, which would helpfully break out the bridge out to late 25. Can you give us a little bit of granularity on the assumptions around the voluntary leaver program that are baked into that and some of the economics? Where we might see some of that severance expense versus some OPEX coming off as headcount trims, just how that will flow through the financial statements, and what your operational assumptions are for degree and tempo. My name is Pierre speaking.
Strategically into specific indications, where we see the scientific a neat a scientific rationale the medical need a commercial opportunity.
Speaker Change: Maybe also an edge versus our competitors and and and and that's sort of like it's driving how be decided until we have until which indications for calling.
Speaker Change: Does that address your question.
Pierre Kemula: Thanks for your question. I'm not sure I answered the last part, but we basically have on the slide, you know, I think the key elements or the key driving elements, right, that have an impact on the runway. We haven't disclosed, for instance, the PPA or the revenues. It's a consortium approach with GSK and the government, so it's difficult to comment on that. What you understand from my call is we have an extension because we don't have to expense raw materials so far this year, but we have less revenues from the PPA.
Speaker Change: Yeah, it's a broadly I guess, the I guess, a more sort of narrow question would be.
Speaker Change: Where should we be looking for datasets from you guys, perhaps melanoma elsewhere that we could look at to provide a little bit of a comparison on efficacy versus your competitors sockets are getting value for it.
Speaker Change: To evaluate your opportunity to differentiate.
Speaker Change: Yeah.
Speaker Change: A satellite that we Havent published clinical data right.
Speaker Change: If that's your question. So that's why right now we'll stay that are not available.
Pierre Kemula: So it's a net, you know, small net negative over the period, right? And this will be counterbalanced by, of course, you know, a focus on R&D and, you know, savings that we have, you know, on the infrastructure, but also, you know, I would say on the G&A going forward. I mean, it's mostly behind us now, right?
Speaker Change: From basically from our cancer vaccine in the clinic, maybe I misunderstand your question Matt.
Matt: Yeah, I'm thinking about what the timing or how we should think about the timing when we could see a dataset that we could sort of an indication where we can sort of compare it with an existing competitor.
Pierre Kemula: So I think this will help us. And we talked about GMT-4, where you'll see in our documents which we all uploaded tonight, we have kind of finished investing in the building and the machines, right? So this will not reproduce going forward. So you know, this is the color I can provide.
Matt: That's.
Matt: Difficult to answer question, because our current trial is.
Matt: It's ongoing in Glioblastoma.
Matt: And to my knowledge there is no other mrna vaccine ongoing in the space right. So if you are specifically asking to compare our platform with other platforms.
Pierre Kemula: And all these pluses and minuses, you know, and specifically with the effort that we've done, you know, in terms of the lighter budget, the leader budget, more efficient that, you know, Alexander was talking about, we were able to extend the runway despite having a bit of a headwind, you know, over the two years in TTC. Okay, and pivoting over in a quick follow-up to strategic and sort When you think about the use of your technology in oncology, whether one wants to call it a personalized cancer vaccine, neoantigen therapy, or whatever various competitors are calling their products now,
Matt: Our next phase one trial is in planning, but I thought it might take some time until the data become available, whereas you could probably compare in across indications, but the one thing they all have to be cautious when you're comparing across trials. So I think we're doing that our tests, it's about looking at the other data and bandwidth.
Matt: Realize how difficult it is book on pet data and once Youre my indication based on different vaccine platform based on different SaaS patient selection criteria and so on and Ah why why we all want to hang on to those comparisons. They also have to be cautious that cross trial comparisons cross platform.
Pierre Kemula: How do you think about indication collection and to what extent is that informed by positioning indications and data from your competitors, Moderna, BioNTech, et cetera? And maybe I can take that question. Sorry, Alex, if you're okay. Yeah, I can take it.
Matt: Comparisons will have their limitations, so while I understand the nature wants like to do that that's also a I wanted to say a limited value. So I think you know when we published that J P. M data, we have to protect them as they are it's just a validation of our platform will it show a grinding in immunogenicity and whoever can compare across other vac.
Myriam Mendila: I think it's a great question, and yes, we're doing all of that, right? Especially for oncology, where you could go into 50 plus tumors, and if you subdivide them into molecular subtypes, there are even more. We did a strategic evaluation over the last quarter of last year, really looking at all of them, different possibilities where to go, and then applying different criteria with different weightings on how to rank those, and then came up with basically a list of priorities, considering commercial opportunity, considering the competitive landscape, available data, and that basically was an underlying basis or became the underlying basis for our oncology strategy.
Matt: Same technologies, but yeah.
Matt: You know that the those comparisons it doesn't have all the caveats and pitfalls.
Matt: Maybe just two.
Matt: I think.
Speaker Change: Yeah, maybe just to add to that I do believe here D.
Speaker Change: M D. Anderson collaborations will they'll be able to help us a lot.
Speaker Change: Because at the end.
Speaker Change: Shaded product, it's all about having the right antigens good backbone good delivery.
Speaker Change: Good translation of capabilities and I think this collaboration that we announced a few weeks back with MD Anderson will really help us there and.
Speaker Change: Create an engine for us too.
Speaker Change: Purdue is hopefully differentiated products that make a difference for patients and so.
Speaker Change: I think this is something that is going to increase our capabilities a lot.
Myriam Mendila: So we are going strategically into specific indications where we see the scientific need or the scientific rationale, the medical need, a commercial opportunity, and maybe also an edge versus the competitors, and that sort of thing is driving how we decide on which indications we're going to go. Does that address your question?
Speaker Change: No. It will still take some time, it's never been alluded until we see that the clinic, but at least we have a great day engine with this collaboration that should help us a lot to be faster and be more efficient as well and bring differentiated products to the market.
Speaker Change: Thank you.
Speaker Change: Our next question comes from the line of whom are rough at Evercore ISI. Please proceed with your question.
Myriam Mendila: Yeah, broadly, I guess a more sort of narrow question would be, where should we be looking for data sets from you guys, perhaps in Melanoma or perhaps elsewhere, that we could look at to provide a little bit of a comparison on efficacy versus your competitors, so that your stock can start getting some value for it, and you can sort of evaluate your opportunity to differentiate. Yeah, as I said, right? We haven't published any clinical data, right?
Evercore ISI: Hi, guys. Thanks for taking my question I have a three year. If I may 1st I know you talked about your wind down of the pandemic agreement with the German government, how does that change your anticipated timelines to market with your Covid vaccine I would've thought Germany would've allowed you more rapid path to market secondly for for your large.
Evercore ISI: And the most advanced trial with everything Youre running which is the COVID-19 vaccine I noticed the slides keep mentioning 601 in seven and one formulations, but not the Ada one which is a monovalent strain that you do have also as part of this trial could you give us more color on the anticipated timeline to read off of that and the specific stream that they don't want covers.
Myriam Mendila: And if that's your question, so that's why right now those data are not available from basically our cancer vaccine in the clinic. Maybe I misunderstand your question, but yeah, I'm thinking about the timing of when we should think about the timing when we could see a data set that gives us some indication where we can compare it with an existing competitor.
And then finally on acute as related delay on your on your on your litigation wasn't acute us only hoping to be a co owner on your formulation patents, meaning your C. G. In your polyol pants would've been unaffected anyways and I'm just trying to think about why all of those patents were also looped up as part of the broader state.
Myriam Mendila: Difficult to answer the question because our current trial is ongoing in glioblastoma, and to my knowledge, there is no other mRNA vaccine ongoing in this space. Right. So if you're specifically asking to compare our platform with other platforms,
Myriam Mendila: Our next phase one trial is in planning, right? So it will take some time until data will become available that you could probably compare across indications. But the one thing we all have to be cautious when we're comparing across trials, right? Because we're doing that ourselves as well when we're looking at the other data.
Speaker Change: Thank you very much.
Speaker Change: Thanks, a lot Omar so three questions one on the P. P. I N timelines co vaccine strain and then Mark I will let you comment on acute dosing and the recent updates here. So you've got the P. P. A PPA.
Speaker Change: It should not impact the timelines at all.
Myriam Mendila: But we realize how difficult it is to compare data from one tumor indication based on different vaccine platforms, based on different assays, patient selection criteria, and so on. While we all want to have and do those comparisons, we also have to be cautious that cross-trial comparisons, cross-platform comparisons will have their limitations. So while I understand the need you would like to do that, there's also, I want to say, limited value.
Mark: As you know following the pandemic emergency procedures that are in place to accelerate some of the the approvals that they are largely gone. So there's no impact at all related to PPA or discontinuing PPA in terms of in terms of timelines.
Mark: Germany.
Speaker Change: Do you want to comment on you must you must questions on strengths.
Speaker Change: Okay.
Speaker Change: Yes.
Germany: Yeah. So I'll take the old one is a mono valence trained for E. B, a four five variant and the 0701 S. A bofa land and Oh, eight a water wash the wild type.
Myriam Mendila: So I think, you know, when we publish the GBM data, we have to take them as they are. Is this a validation of the platform? Will it show great immunogenicity? And we can compare it with other vaccine technologies. Those comparisons, again, have all their caveats and pitfalls.
Speaker Change: A task coffee one trained so that that's why you know I'm not sure I understand your question. That's why basically there wouldn't be additional data coming maybe I misunderstood. The question, but our focus is definitely on the updated train them and and in all four quarters and again continuing to develop and motivate them to try.
Alexander Zehnder: Maybe just to add to that, I think. Yeah, maybe just to add to that, I do believe here the Anderson Collaboration will be able to help us a lot, because in the end, to have a differentiated product, it's all about having the right antigens, a good backbone, good delivery, good translation, and capabilities. And I think this collaboration that we announced a few weeks ago with Andy Anderson will really help us there and, you know, create an engine for us to... hopefully, produce differentiated products that make a difference.
Speaker Change: And Oh, and one of that and vaccine that is.
Speaker Change: Matching the most treatment cohort all corona strain.
Speaker Change: I guess, maybe just clarify it shouldn't.
Speaker Change: Eight of one or the 901 have been the X P. V 1.5, instead of being four or five at this point of development.
Alexander Zehnder: So I think this is something that is going to increase our capabilities a lot. Now, it will still take some time, as Myriam alluded, until we see it in the clinic, but at least we have a great engine with this collaboration that should help us a lot to be faster and be more efficient as well as bring differentiated products. Thank you. Our next question comes from the line of Umar Rafat, Evercore ISI.
Speaker Change: No at the time on the Mi startup this phase one and phase two program actually X P V. One five plus just basically on the rise.
Speaker Change: And and and yes, right. If we were to when we are planning for the next a clinical trial.
Speaker Change: Precisely.
Speaker Change: Or something different than.
Operator: Please proceed with your, Hi guys. Thanks for taking my question. I have three here, if I may.
Speaker Change: And then we would of course and code for whatever is the next train now X P. P. One five but it could be again until then until we thought the first week. The strain could have changed so we weren't always in cold again in the next wave. The most recent and an updated train that was recommended by the time it would be like Oh, Okay Fair pack.
Operator: First, I know you talked about your winding down of the pandemic agreement with the German government. How does that change your anticipated timelines to market with your COVID vaccine? I would have thought Germany would have allowed you a more rapid path to market.
But again at the time, we designed the study right and that the current strength in circulating strain wants to be a four five variant.
Operator: Secondly, for your largest and most advanced trial of everything you're running, which is a COVID vaccine, I noticed the slides keep mentioning 601 and 701 formulations, but not the 801, which is a monovalent strain that you do have also as part of this trial. Could you give us more color on the anticipated timeline, the readout of that, and the specific strain that the 801 covers? And then finally, on ACUTA's related delay in your litigation, wasn't ACUTA only hoping to be a co-owner of your formulation patents, meaning your CG and your poly-A patents would have been unaffected anyways? And I'm just trying to think about why all those patents were also looped up as part of the broader stay order.
Speaker Change: Yeah.
Speaker Change: Yeah.
Speaker Change: Okay.
Speaker Change: Markus do you want to come into the queue with us.
Yeah sure so.
Markus: Your question was right the.
Markus: Acuity is only off pool, the cyber wearing all the pool.
Markus: For formulation patents.
The court Didnt want but certainly not.
Markus: It may also be clear there is no decision yet to separate a little state there is a decision but a huge.
Markus: Just kind of intravenous the case, but the several studies a recommendation by the magistrate judge that has to be endorsed by the trial the trial judge.
Markus: And that will take some time, we have grounds to objects, which have to be in and then there'll be a response from the other side.
Operator: Thank you very much. Thanks a lot, Umar. So, three questions. One on the PPA and timelines, the COVID vaccine strain, and then, Marcus, I will let you comment on Q&As and recent updates here. So, Umar, on the PPA, PPA should not impact the timelines at all because, you know, following the pandemic emergency procedures that were in place to accelerate some of the approvals, they are largely gone. So, there's no impact at all related to PPA or stopping PPA in terms of timelines in Germany.
Markus: So it isn't the trial.
Still ongoing in the would pull the trial is ongoing at the moment.
Speaker Change: So you're right.
Speaker Change: Actually I didn't ask code no.
Nobody asked for the stay of the whole proceeding sits in sort of.
Speaker Change: A decision was a magistrate judge.
Speaker Change: To recommend that to the trial Judge and then Alexander said in his presentation, we expect that to be.
Speaker Change: So then the next.
Speaker Change: Two months or so.
Speaker Change: And in the interim.
Speaker Change: All the work is carrying on.
Speaker Change: Thank you very much.
Speaker Change: Thank you.
Speaker Change: Our next question comes from the line of Ellie Merle with UBS. Please proceed with your question.
Alexander Zehnder: Myriam, do you want to comment on Umar's questions about the strain? Yes. Thank you. Thank you. Yeah, so O6-O1 is a monovalent strain for the BA45 variant, and the O7-O1 is the B-valent, and O8-O1 was the wild type. SARS-CoV-1 strain.
Speaker Change: Hi, This is Sarah on for Alex. Thanks, So much for taking our questions I have two first on <unk>.
Sarah: Call me well how are you thinking about prioritizing the combo vaccine versus individual vaccine and then are you still planning to initiate clinical development in the second half and how should we be thinking about sort of economics here.
Myriam Mendila: So that's why, you know, I'm not sure I understood your question. That's why, basically, there wouldn't be any additional data coming. Maybe I misunderstood the question, but our focus is definitely on the updated strain. And our focus is, again, continuing to develop a monovalent vaccine that is matching the most recent COVID or coronavirus strain. I guess maybe to clarify, shouldn't the 801 or the 901 have been the XBV 1.5 instead of BA 4.5 at this point in development?
And then on your oncology program or the data second half what are you looking for and protect yard to serve kind of as a proof of concept for your platform in oncology.
Speaker Change: Okay. So two questions one on Hum on Covid and how we think about Oh boy I guess with the second one in terms of encore and what we're looking for in terms of to date that maybe I can start I.
Myriam Mendila: No, at the time when we started this phase 1 and phase 2 program, actually, XBB 1.5 was just basically on the rise. And yes, right, if we were to plan for the next clinical trial, whether it's phase three or something different, then we would, of course, encode for whatever is the next strain. Now XBB1-5, but it could be, you know, until then, until we start phase three, the strain could have changed. So we will always encode, again, in the next wave, the most recent and updated strain that was recommended by the WHO or VRBPAC.
I can start I could start with the first with the first one and then and then maybe you can comment to you can't comment on their own come on it. So you know with regards to Covid.
Speaker Change: Even though the pandemic has ended obviously, but it would be likely most likely stay with us and will require a seasonal booster vaccination, especially for the patients that have risks.
Speaker Change: And you know due to the continued need for these vaccines, we do believe that the Korean market is still expected to be a multi billion dollar market.
Speaker Change: However, there's definitely added convenience and potential perpetually immunization, and it's clear for us and I guess with GSK as well that there is real value for our combination vaccine that will be attractive.
Myriam Mendila: But again, at the time we designed this study, right, the current strains and circulating strains were the BA45 variant. Thank you. Do you want to come in?
Marcus Dalton: Yeah, sure. So, your question was right that, um... Curtis only asked for the severing of the four formulation patterns. Let me also be clear, there is no decision yet to sever or stay. There is a decision that prosecutors can intervene in the case, but the sever and stay is a recommendation by the magistrate judge that has to be endorsed by the trial judge.
Speaker Change: Population required both vaccines and MLR a technology honestly is perfect to address opportunities to its potency and flexibility and GSK is repeaters they've made the comment that combo vaccine in flu are a focus for them and good expectation of 3 billion plus peak sales.
Speaker Change: These vaccines so overall.
Marcus Dalton: And that will take some time. We have grounds to object, which have to be proven. And then there'll be a response from the other side. And so it isn't, the trial is still ongoing. And the work for the trial is ongoing at the moment. So, you're right, actually Acuity didn't ask for, nobody asked for the stay of the whole proceedings, a decision of the magistrate judge, to recommend that to the trial judge.
Speaker Change: We believe flu definitely set us a lot of potential but the combination is definitely something that we're looking at very closely at once we have the individual pieces from the two phase two data I think they will be able to provide more guidance in detail. It is moving.
Speaker Change: Moving forward.
Speaker Change: And then maybe the second question on oncology I guess it was kind of proof of concept state that we will look into them.
Speaker Change: Yeah. Thank you and thanks for the question. So in the part a of the GBM trial, we are because it's a phase one dose escalation trial. The primary endpoint of course that are.
Marcus Dalton: And as Alexander said in his presentation, we expect that to be resolved in the next. [inaudible] meanwhile. All the work is carrying on.
Speaker Change: First of all to look at safety and Tolerability and then we do have secondary endpoints and exploratory endpoints and regarding Immunogenicity and that part a we are looking at basically T cell activation by 80 spot ex vivo as well as a after in vitro stimulation.
Operator: Thank you very much. Thank you. Our next question comes from the line of Eli Merle with UBS. Please proceed with your question. Hi, this is Sarah. Thanks so much for taking our questions. I have two.
Operator: First, on COVID flu, how are you and GSA thinking about prioritizing the combo vaccine versus individual vaccines? And then are you still planning to initiate clinical development in the second half? And how should we be thinking about the sort of economics here?
Speaker Change: In the part B, we do and more ex Pongratz Immunogenicity testing program, where we of course continue to look at any sport, but also do more quantitative test and measurements and and and and more in depth analysis of our T cell repertoire in those patients and so that that's what you can expect that.
Alexander Zehnder: And then on your oncology program, for the data second half, what are you looking for in particular to serve kind of as proof of concept for your platform in oncology? So two questions, one on COVID and how we think about COMBO, I guess, and the second one in terms of ONCO and what we are looking for in terms of data. Maybe I can start with the first one, and then, Myriam, you can comment on the ONCO one.
Speaker Change: They find our internal sort of like hurt us we'd like to take but I hope you can understand that at the moment.
Speaker Change: I don't say comfortable just has those but clearly.
Speaker Change: We wanna be ambitious and in what we would like to teach will declare that the.
Alexander Zehnder: So, you know, with regard to COVID, even though the pandemic has ended, obviously, it will most likely stay with us and will require seasonal booster vaccinations, especially for patients at risk. And, you know, due to the continued need for these vaccines, we do believe that the COVID market is still expected to be a multi-billion dollar market. However, there's definitely added convenience and potential for better immunization, and it's clear for us, and I guess for GSK as well, that there is real value for a combination vaccine that will be attractive in populations requiring both vaccines. And MNRA technology obviously is perfect to address opportunities because of its potency and flexibility.
Speaker Change: Especially in units and the safety data from that trial confirmed basically that's up that some folks in oncology.
Speaker Change: We have to find out if that's your question.
Speaker Change: Okay, great. Thanks, guys.
Eliana Rachel Merle: Thank you. Our next question comes from the line of your Maccioni with Van Kampen.
Eliana Rachel Merle: Please proceed with your question.
Eliana Rachel Merle: Hello. Thank you very much for taking my question I'm kind of ones you don't want me on behalf of Tucson more than 4000.
Eliana Rachel Merle: So I have to say my phone disconnected, so I really hope I didn't Miss mouthwash.
Eliana Rachel Merle: So I wanted to ask you if you could elaborate more on the recently announced a M D Anderson collaboration.
Eliana Rachel Merle: So I was wondering how do you go about choosing programs an invitation.
Eliana Rachel Merle: Are you going to use the same strategy that's medium just discussed.
Alexander Zehnder: And GSK has repeatedly made the comment that the combo vaccine and flu are a focus for them, and with an expectation of 3 billion plus peak sales, you know, for these vaccines. So overall, we believe flu definitely still has a lot of potential, but the combination is definitely something that we're looking at very closely. And once we have the individual pieces from the two phase two data, I think we will be able to provide more guidance and detail on this moving forward. Maybe, Myriam, the second question in oncology was what kind of proof of concept data we would look for in TBM. Yeah, thank you.
Eliana Rachel Merle: Hello.
Yeah. So maybe I can take this one and so they are Alex that you want to start.
Speaker Change: But what I can add.
Okay. So far with MD Anderson of cost me discuss the selection of indications and followed the same approach where MTN doesn't have that priorities. We had our priorities and then we sort of like what is the in the end what we're where we had overlapping end. So we have a great already.
Speaker Change: On the indications that we will focus on our collaboration.
Speaker Change: And I don't recall, what I was trying to talk to the question.
Speaker Change: Oh that was it.
Speaker Change: Okay. Thank you.
Speaker Change: So with you.
Speaker Change: Thank you. Our next question comes from Charlie Yang with Bank of America. Please proceed with your question.
Myriam Mendila: And thanks, Sarah, for the question. So in Part A of the GBM trial, because it's a phase one dose escalation trial, the primary endpoints, of course, first of all, are to look at safety and tolerability. And then we do have secondary endpoints and exploratory endpoints regarding immunogenicity. And in Part A, we are looking at basically T cell activation by ELISPOT, ex vivo as well as after in vitro stimulation. In Part B, we do a more expanded immunogenicity testing program where we, of course, continue to look at ELISPOT but also do more quantitative T cell measurements and more in-depth analysis of the T cell repertoire in those patients. And so that's what you can expect.
Chen Yuan Yang: Great. Thanks for taking the questions I have it for you. Please the first one is could you just talk about the regulatory pathway for Glioblastoma trial.
Chen Yuan Yang: I guess, Mike you know.
Speaker Change: My impression maybe perhaps was.
Chen Yuan Yang: Was that you know this is going to be more of a proof of concept, but you'll you'll focus will be on the other indications with the other platforms.
Chen Yuan Yang: But you know, there's a passport and why would that time might kind of look like.
Chen Yuan Yang: I guess my second question is just thinking about you know all the different accounts.
Chen Yuan Yang: Stage programs that you have in the in the cancer cancer vaccine and thinking about the cash balance and the runway.
Chen Yuan Yang: Hum using them on my count prioritization.
Chen Yuan Yang: Among those programs as you know, which one is more important.
Myriam Mendila: And we have defined our internal sort of like hurdles we'd like to take, but I hope you can understand that at the moment. I don't feel comfortable to share those, but clearly, we want to be ambitious in what we would like to see to declare that the, especially neurogenicity data from that trial, confirm basically that the platform works in oncology. But we have defined it, if that's your question.
Chen Yuan Yang: As the others and why not just one because I'm on one set of countries a few.
Chen Yuan Yang: And lastly, you know just you know with hiring or kind of a new chief business officer.
Chen Yuan Yang: What kind of strategic deals that you are the company's thinking of how in incoming perhaps months or quarters.
Operator: Okay, great. Thanks, guys. Thank you. Our next question comes from the line of Chiara Monchironi with Van Lanshuis-Kempen.
Chen Yuan Yang: And how should we think about you know from the therapeutic how standpoint. Thank you.
Operator: Please proceed with your question. Hello. Thank you very much for taking my question. I'm Chiara Montironi on behalf of Suzanne Van Voorthuysen. So I have to say my phone is disconnected, so I really hope I didn't miss what I'm about to ask. So I wanted to ask you if you could elaborate a bit more on the recently announced MD Anderson collaboration. So I was wondering, how do you go about choosing programs and indications?
Chen Yuan Yang: Yeah.
Speaker Change: Okay. Thank you.
But for us.
Speaker Change: G B and related regulatory path.
Speaker Change: Yeah, maybe I can take the first two Alex and then you can address the third one so far G. P. M. As you rightly state that right for us as a proof of principle study, we already announced on their call. It's I'll just close out on their calls that that's as far as a trial, where we are using basically our platform.
Operator: Are you going to use the same strategy that Myriam just discussed five minutes ago? Yeah, so maybe I can take this one. And so, Alex, did you want to start? Go ahead, I can add.
Speaker Change: In oncology for the very first time and our intention is to show, it's safe and well tolerated and it's infusing and immune response against the encoded antigens.
Myriam Mendila: Okay, great. So with MD Anderson, of course, we discussed the selection of indications and followed the same approach, where MD Anderson had their priorities, we had our priorities, and then we sort of like, look, what is in the, where is it overlapping? And so we have already agreed on the indications on which we will focus our collaboration. And I don't recall if there was a second part to the question. Oh, that was it.
Speaker Change: We didn't have and don't have plans to then to take the that's a pox two proof of concept and then start a phase two or phase III program.
Speaker Change: And you never know right, but if we want to see.
Speaker Change: Which is unexpected I can know some strong compelling efficacy sickness, which will take time and there shouldn't be untried, because we are treating patients that have undergone surgery. So they don't have remaining chihuahua and and enhance assessing efficacy would always be based on an endpoint traveling parameters such as disease free survival or progression.
Operator: Okay, thank you. Thank you. Thank you. Our next question comes from Charlie Yang with Bank of America. Please proceed with your, Great. Thanks for taking the questions. I have a few, please.
Operator: First one is, can you just talk about the regulatory pathway for a glial blastoma trial? Um, I guess, you know, my impression maybe, perhaps, was that this was going to be more of a proof of concept, but your focus would be on the other indications with the other account platform. [inaudible] If this is a passport, then what would that timeline look like?
Speaker Change: And free survival, but in case with longer follow up we would see something compiling thank you ever revisit that decision right now, we're not considering to Texas and all the way through clinical development and into phase III, but again, just wondering what's the GBM data as a proof of principle of platform works in oncology.
Operator: And I guess my second question is just thinking about all the different kinds of early stage programs that you have in the cancer vaccine and thinking about the cash balance and the runway, how are you thinking about prioritizing among those programs as which one is more important versus the others and why not just focus on one instead of doing a few? And lastly, you know, just with the hiring of a new chief business officer. What kind of strategic deals is the company thinking of in the coming months or quarters? And how should we think about this from the therapeutic standpoint?
Speaker Change: And regarding the privatization of some different oncology programs.
Speaker Change: And and and the sort of like cash run way by having is of course, something that's what happened. Once he has the data right now and you know we have some GBM program. We are preparing for another phase one program with a clinical candidate and the collaboration with MD Anderson is just starting right and we need to see if we can find chat antigens.
Speaker Change: That will enable us to nominate a candidate and then again based on what I described before different pyrometer, we let's see what we can take to the clinic and otherwise prioritize based on the scientific evidence and the thickness Racine a in terms of what they would take it to the clinic.
Operator: Thank you. Okay, thank you, Charlie. GBM, Regulatory Pathways.
Myriam Mendila: Yeah, maybe I can take the first two, Alex, and then you can address the third one. So for GBM, as you rightly stated, for us, this is a proof of principle study. We already announced in earlier calls or disclosed in earlier calls that this is, for us, a trial where we are using basically our platform in oncology for the very first time, and our intention is to show it's safe and well tolerated, and it's inducing an immune response against the encoded antigens.
Speaker Change: Thank you Mary I mean, I think the last question was regarding the incoming new C. D O to mid <unk> and our strategic direction for business development or additional partnerships.
Speaker Change: Your focus area for us one being oncology.
Myriam Mendila: We didn't have and don't have plans to then take this as a POC, to proof of concept, and then start a phase two or phase three program, and you never know, right? But if we would see, which is unexpected, you know, some strong, compelling efficacy signals, which would take time in the CBM trial, because we're treating patients that have undergone surgery, so they don't have remaining tumors. Hence, assessing efficacy will always be based on an endpoint-driven parameter, such as disease-free survival or progression-free survival.
Speaker Change: For sure even though we have announced the collaboration with MD Anderson this wasn't that.
Speaker Change: Preclude us from additional partnerships for these assets if they make it too through face.
Speaker Change: Through phase two so oncology is definitely a big focus for us in looking for additional partnerships. We also still have opportunities on the infectious disease side for programs that are not partnered.
Speaker Change: With the weight with GSK are beyond the same molecular therapies, we have a few programs ongoing that we haven't fully disclosed but that could be interested for partnering and selected indications. So it's definitely something that we're looking at a very broad and very broadly and we are engaged with them in the coming on board.
Myriam Mendila: But in case, with longer follow-up, we see something compelling, then we will revisit that decision. Right now, we're not considering taking this all the way through clinical development and into phase 3, but again, just want to use the GBM data as a proof of principle that the platform works in oncology. Then regarding the prioritization of the different oncology programs and the sort of cash runway we're having, it's, of course, something that will happen once we have the data.
Speaker Change: Get you can further on this.
Speaker Change: Thank you.
Yes.
Speaker Change: Thank you and we have reached the end of the question and answer session. I will now turn the call back over to Sarah. Thank you Rick for closing remarks.
Sarah: Thank you with this we would like to conclude this conference call. Thank you very much for your participation and stay safe and please don't hesitate to contact US should you have any further questions. Thank you goodbye.
Myriam Mendila: Right now, you know, we have the GBM program, we are preparing for another phase one program with a clinical candidate, and the collaboration with MD Anderson is just starting, right? And we need to see if we can find shared antigens that will enable us to nominate a candidate. And then, again, based on what I described before, different parameters, we will see what we can take to the clinics and, otherwise, prioritize based on the scientific evidence and the signals we see in terms of what we take into the clinic.
Sarah: Thank you. This concludes today's conference you may disconnect. Your lines at this time. Thank you for your participation.
Sarah: Hum.
Sarah: Hum.
Sarah: Hum.
Sarah: Hum.
Sarah: Oh.
Sarah: [noise] [music].
Myriam Mendila: Thank you Myriam, and I think the last question was regarding the arrival of the new CBO, Taminda, and strategic direction for business development or additional partnerships. I think there are a few focus areas for us, one being oncology. For sure, even though we have announced the collaboration with MD Anderson, this will not preclude us from additional partnerships for these assets if they make it through phase two, through Phase II. So oncology is definitely a big focus for us when looking for additional partnerships.
Sarah: Uh huh.
Sarah: [music].
Sarah: Hum.
Sarah: [noise].
Sarah: Hum.
[noise].
Myriam Mendila: We also still have opportunities on the infectious disease side for programs that are not partnered with GSK, and beyond this, in molecular therapies, we have a few programs ongoing that we haven't fully disclosed, but that could be interested in partnering in selective indications.
Sarah: [noise] mhm.
Sarah: Hum.
Sarah: Hum.
Sarah: Hum.
Sarah: Mhm.
[music].
Alexander Zehnder: So it's definitely something that we're looking at very broadly, and we are engaged, and with Minda coming on board, we can engage even further on that. Thank you. Thank you, and we have reached the end of the question-and-answer session. I'll now turn the call back over to Sarah Fakih for closing. Thank you. With that, 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.
Sarah: Hum.
Sarah: Hum.
Sarah: Yes.
Sarah: [music].
Sarah: Hum.
Sarah: [music] Mhm mhm.
Sarah: Hum.
Sarah: Hum.
Sarah: [noise] Uh-huh.
Alexander Zehnder: Thank you, and goodbye. Thank you. This concludes today's conference, and you may disconnect your lines. Thank you for your participation. [inaudible] Sarah Fakih, Marcus Dalton, Curevac, Curevac, Curevac, Marcus Dalton, Curevac, Bye! [inaudible] BF-WATCH TV 2021, [inaudible]
Sarah: [music].
Sarah: [noise] mhm.
Sarah: Hum.
Sarah: [music].
Sarah: Mhm.
Sarah: [music].
Sarah: Hum.
Sarah: [music].