CureVac N.V. (NASDAQ:CVAC) Q3 2023 Earnings Call Transcript
CureVac N.V. (NASDAQ:CVAC) Q3 2023 Earnings Call Transcript November 14, 2023
Operator: Greetings and welcome to the CureVac Financial Results for Third Quarter and First Nine Months of 2023 Business Update. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Sarah Fakih, Vice President Corporate Communications and Investor Relations. Thank you. Sarah, you may begin.
Sarah Fakih: Thank you. 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 CureVac. Please let me introduce today's speakers. 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. Our Head of Intellectual Property, Marcus Dalton will be present for the Q&A session. Please note that this call is being webcast live and will be archived on the Events & Presentations section under Investor Relations on our website. 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, Tuesday, November 14th, 2023.
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 provisions. These statements involve risks and uncertainties that could cause actual results to differ materially from those projected. CureVac disclaims any intention or obligation to revise any forward-looking statements. For more information, please refer to our filings with the US Securities and Exchange Commission. I will now turn the call over to Alexander.
Alexander Zehnder: Thank you, Sarah. Ladies and gentlemen, good morning, good afternoon to everyone on the webcast. As another year of strong performance draws to a close, we continue to successfully maintain our forward momentum in the clinical development programs in infectious diseases as well as in oncology, and we are delivering on our strategic priorities. Our lead programs in COVID-19 and seasonal flu jointly developed with GSK are now in Phase 2 and we are on track for delivering interim top line data in 2024. The Phase 2 COVID-19 study recently completed enrollment, and we expect interim data early next year. In the Phase 2 part of the combined Phase 1/2 study for seasonal flu, the first participant was dosed, and we expect interim Phase 3 data in the first half of 2024.
In oncology, our Phase 1 study in patients with resected glioblastoma is advancing and has recently progressed to the opening of the third dose level in the initial dose escalation part of the study, and we continue to expect data in the second half of 2024. Supported this Phase 1 study with promising data for a preclinical study that we presented at the beginning of this month at the 11th mRNA Health Conference, which CureVac hosted in Berlin and which is a global flagship mRNA R&D event. Also supporting our oncology strategy is the mRNA Printer, CureVac's end-to-end solution for integrated and automated manufacturing of GMP-grade vaccines and therapeutics. The Printer achieved an initial regulatory milestone by obtaining its first manufacturing license for an mRNA cancer vaccine candidate.
The regulatory review process is ongoing to provide greater freedom and flexibility to manufacture different mRNA cancer vaccine candidates. Considering our cash runway, our efforts in advancing our clinical development programs continue to be supported by prudent fiscal discipline. Our cash position of $464.1 million at the end of the third quarter provides a solid basis to continue to execute on our programs and priorities till mid-2025. As the pioneering company in mRNA technology, having maintained a traditional scientific leadership for more than two decades, CureVac continues to defend a broad and diversified intellectual property portfolio. Our litigation against Pfizer and BioNTech in Germany and the US has progressed with favorable developments in the German court and the provision of a trial date in the US on October 1st, 2024.
Please let me remind you that in an industry where innovation is a key driver of value that disputes are commonplace. In our currently pending cases, our interest is solely in having our intellectual property rights acknowledged and fairly compensated so that all parties can continue advancing new transformative mRNA-based medicines. On Slide 5, we showed a CureVac product development pipeline, which forms the core of our business strategy. The pipeline leverages our unique platform in three therapeutic areas of prophylactic vaccines, oncology, and molecular therapy. In our most advanced area, prophylactic vaccines, we have two programs in Phase 2, which are driven by our clinically validated technology platform and proprietary second-generation mRNA backbone.
Our Phase 2 COVID-19 and seasonal flu vaccine candidates are developed in collaboration with GSK. Two Phase 1 studies we started last year have successfully evolved into two current Phase 2 studies, which are testing updated candidates. We continue to translate the insight from our clinical infectious disease study into our oncology area as well. Our proof-of-concept Phase 1 trial in patients with resected glioblastoma is well on track, as previously mentioned. Combined with our highly differentiated capabilities in tumor antigen discovery, the study will be an important basis to further optimize our mRNA backbone to provide differentiated clinical cancer vaccines. 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 rare metabolic diseases.
And we are continuously investing in our development pipeline to advance innovation and healthcare solutions for people and patients. With this, let me hand over to Myriam for an update on our clinical development programs.
Myriam Mendila: Thank you, Alexander. I'm now on Slide 6 to give you an overview of our two most advanced clinical vaccine development programs in COVID-19 and seasonal flu, jointly being developed with GSK. As Alexander already mentioned, we recently reported solid progress in those programs with the completion of enrollment in the ongoing COVID-19 Phase 2 study and dosing of the first participant in the Phase 2 part of the combined Phase 1/2 study in seasonal flu. In the Phase 2 COVID-19 study shown on the left hand side of the slide, we assess the safety and immunogenicity of different single booster doses of two vaccine candidates based on our proprietary second-generation mRNA backbone. The first candidate, CV0601 is a modified monovalent construct encoding the Omicron BA.4-5 variant.
The second candidate, CV0701 is a modified bivalent contract encoding the Omnicom BA.4-5 variant as well as the original SARS-CoV-2 strain. According to the applicable and available standard-of-care when the first participant of the Phase 2 COVID-19 study was dosed in early August 2023, the study absorbs a licensed bivalent mRNA vaccine as a comparator. We expect interim Phase 3 data early next year, which will inform the design of a pivotal Phase 3 study planned to start in 2024. Following the September update of the COVID-19 standard of care in the US, the planned Phase 3 study is expected to feature an updated vaccine candidate and updated comparator has been according to the latest requirements. The Phase 1/2 study for seasonal flu is shown on the right hand side of the slide.
In this study, we are assessing the safety, reactogenicity and immunogenicity of flu vaccine candidate compared to a licensed comparator vaccine. The Phase 1 dose escalation part has already completed initial data analysis. It's just a comprehensive series of multivalent modified seasonal flu candidate with up to eight mRNA construct per candidate at different dose levels in 270 younger adults. Interim Phase 1 safety data showed no safety concerns across all [indiscernible]. The observed antibody responses to process the selection of a preferred vaccine candidate, which has now been advanced to the Phase 2 part of the study. The potentially differentiated multivalent candidates and antigens that address all four [indiscernible]. It will be tested in both healthy younger and older adults at different dose levels and will be compared to two different licensed seasonal flu comparator vaccines with intended use for the respective age group.
Interim data from this Phase 2 part are expected in the first half of 2024. Let us take a closer look at the study design of the two ongoing Phase 2 studies in COVID-19 and seasonal flu on Slide 7. While we don't disclose the expected dose levels for both studies, the COVID-19 Phase 2 study features a medium dose, framed by a higher and a lower dose for the bivalent candidate CV0701 and a medium dose level for the monovalent candidate CV0601. All dose levels, including the licensed bivalent mRNA comparator vaccine are fully recruited with a total of 427 participants aged 18 years and older. For seasonal flu, the selected multivalent candidate is being tested in two separate age groups, 480 younger adults aged 18 to 64 and 480 older adults aged 65 to 85.
Each age group features three different dose levels of the candidate as well as the age appropriate license comparator vaccine. With this, let me now shift gears and turn to our development progress in the oncology area. On Slide 8, I would like to provide a more detailed overview of the ongoing Phase 1 study we are currently conducting in patients with surgically resected MGMT-unmethylated glioblastoma. On the left hand side of the slide, you can see the schematic setup of the applied cancer vaccine candidate CVGBM with a focus on its coding region. The candidate is based on our advanced second-generation mRNA backbone and features a single unmodified mRNA stream. And in Code 8 epitope derived from tumor-associated antigen which demonstrate immunogenicity in glioblastoma.
The exact nature of the epitope is not being disclosed. However, you can see that CVGBM and Code 5 NHANHC+1 epitope and 3 NHC+2 epitope. NHC complexes of both classes are expressed on immune and other cells antigens, including tumor antigens to initiate CD8 and CD4 T cell responses against those antigens. CVGBM utilizes this concept to activate CD8 and CD4 T cells for optimal antitumor response. We clinically assess the vaccine design and the open-label Phase 1 study, which is described in more detail on the right hand side of the slide. The study evaluates the safety and vulnerability of CVGBM in two parts. The currently ongoing dose escalation Part A is expected to enroll up to 24 patients and a subsequent dose expansion Part B will include approximately 20 patients.
In the dose escalation part, four core dose levels between 12 and 100 micrograms are being tested. The first three dose levels have successfully been opened and recruitment is progressing well without dose limiting toxicities of drugs to-date. The trial is being conducted in Germany, Belgium, and the Netherlands. Our first data readout is expected in the second half of 2024. In this context, on Slide 9, I would like to highlight the results of a preclinical study that was we presented two weeks ago at the 11th International mRNA Health Conference hosted by CureVac at Berlin. We conducted this extensive study in mice to assess the potential of the multi-epitope mRNA design we applied for our clinical candidate CVGBM. The study assessed a multi-epitope mRNA design and encoding 10 separate cancer antigen epitope derived from the B16.F10 melanoma cell line, a well-known melanoma cancer model in mice.
Similar to glioblastoma, the B16.F10 melanoma grows very aggressively due to an immune suppressive tumor microenvironment. The result in tumors are purely hemogenic so-called co-tumors, which are cytokine deficient and exhibit only very little T cell infiltration. Accordingly, the tumor model is known to be resistant to checkpoint inhibitors and cannot be addressed with the PD-1 blocking antibody monotherapy. We are, therefore, all the more pleased that the immunogenic data obtained on day 21, illustrated on the left side of the slide demonstrates prominent induction of CD8 T cell responses against five and CD3 T cell responses against two of the encoded epitope. In B16.F10 tumor bearing mice, the successful induction of solid T cell responses against the superantigen led to a significantly expanded medium survival by approximately 50% for treated mice compared to mice vaccinated with the formulated controlled mRNA.
In the pre-clinical data such as the monotherapy regimen with our multi-epitope mRNA construct was aiming to efficiently recruit T cells to the challenging tumor microenvironment, thereby exhibiting tumor growth and extending end life survival. With this, let me hand back the call to Alexander.
Alexander Zehnder: Thank you, Myriam. To finalize our oncology update, the RNA Printer, our highly automated solution for GMP-grade manufacturing of cancer vaccines has achieved its first regulatory milestone. The Printer obtained its first manufacturing license for a defined mRNA construct to support our oncology strategy. The first license was granted for the manufacturing of the therapeutic mRNA by the DNA and mRNA modules of the Printer. Subject to ongoing regulatory review, we aim to license to be extended to a framework license, which will allow the flexible manufacturing of different mRNA construct based on the established processes. In 2024, our goal is to further expand this approach and also include the formulation module of the printer to complete the end-to-end capabilities of the system.
Let me now address on the next few slides, a topic that has gained attention in 2023, mainly our broad and diversified intellectual property portfolio. Over the next few slides, I would like to address the background of the ongoing legal action in Germany and the US by laying out the intellectual property rights in both jurisdictions, the innovations they referred to, the responsible courts as well as timelines and upcoming milestones. So, let's start by looking at Germany, where the process is generally more complex compared to the US. On the left side of Slide 11, you can see that there are a total of eight intellectual property rights and issue in Germany, which can be divided into three patents and five utility models. Utility models don't have an equivalent in the US, but are available in different countries, including Germany.
They represent a class of intellectual property rights, which unlike a patent is not subject to an examination and therefore, does not have an initial perception of validity. Correspondingly, the utility model is registered rather than granted. However, utility models are much faster to obtain than patents. They offer the same protection as patents, but their term is limited to 10 years. Point to damages if validities confirmed in associated proceedings will be awarded in the same way as for a patent. Patent protection normally evolves alongside a multi-year product development. In the case of COVID-19, we chose to file utility models as speed was critical to protect our innovations in the unprecedented dynamic mRNA field generated by the pandemic.
On the right hand side of the slide, the eight IP rights are sorted by patent family. The first two patent families cover foundational inventions to improve mRNA stability for medical use. This includes enrichment of the G/C content of the mRNA molecule and the implementation of a split Poly-A tail. The third patent family covers inventions that were specific to the development of prophylactic vaccines against SARS-CoV-2. Under German law, the courts that determine IP infringement are separate from the authorities that decide on IP validity. This means infringement and validity cases often proceed in parallel with damages assessed only when infringement and validity have been established. On Slide 12, you can see a schematic of this bifurcated German process.
The upper stream represents the infringement proceedings that will lead to a subsequent damages trial. For our IP dispute, infringement as well as potential damages related to all eight IP rights is initially decided by the regional court in Dusseldorf. The lower stream represents validity proceedings. Validity of our IP rights is heard by different authorities depending on the nature of the IP rights. This includes the European patent office or split poly-A tail patents, the German Federal Patent Court for the G/C Enrichment Patent, and the German Patent and Trademark Office for all five utility models. I would like to draw your attention to the fact that this two-stream setup applies to each of the eight IP rights issued in Germany. Each right is handled as a separate case for which infringement, validity, and potential damages will be decided separately.
So, this provides us with multiple opportunities in our German proceedings to have some aspect of our intellectual property rights acknowledged and fairly compensated. On Slide 13, you can see a timeline overview of the infringement as well as validity proceedings in terms of the past as well as upcoming milestones in 2023 and 2024. The part above the timeline references infringement milestones, the part below validity milestones. Looking at the validity proceedings on the bottom part of the slide, you can see that on April 6th, 2023, the German Federal Patent Court issued a positive preliminary opinion on the G/C Enrichment Patent supporting its validity. At the same time, the court set an oral hearing for December 19th, 2023, where we expect the ruling on the validity of the patent.
Looking at infringement, proceedings at the top part of the slide are public hearing on the first five IP rights took place on August 15th, 2023 before the original court in Dusseldorf. At this hearing, the court announced that on December 28th, 2023, a ruling on infringement of the G/C Enrichment Patent will be given. This means that the G/C Enrichment Patent will be the first IP right for which both validity and infringement are decided and that December 23 will be the first major milestones in our German litigation. For the remaining four rights under consideration from the August 15th hearing, infringement proceedings continued until September 28th, when the court in Dusseldorf postponed an infringement ruling on those remaining four rights until their validity challenges have been resolved by the respective authorities.
Now, let me explain why we consider this postponement a favorable outcome for CureVac. German infringement courts typically delay their proceedings to wait for a decision on validity only in cases where they consider that the challenged intellectual property right to be infringed. Therefore, it can be inferred that the regional court in Dusseldorf considers all four intellectual property rights infringed. The court noted that the questions of validity is still needed to be determined. Accordingly, it decided to postpone the infringement proceedings until the validity of these four IP rights has been assessed. This postponement does not reflect the preliminary assessment by the Dusseldorf Court of Validity. Validity can only be determined by authorities that are technically qualified and specialized in validity cases.
Moving on to the litigation in the US, again, on the left hand side of Slide 14, you can see that there is a total of 10 US patents currently at issue. These patents cluster into families, which mostly relate to the same innovations already discussed for the German litigation, namely the stabilization of mRNA via G/C Enrichment, the implementation of a split poly-A tail as well as the design of SARS-CoV-2 specific vaccines. An additional patent family added in the US relates to the innovation of filtration based MRNA purification methods, which forms a critical part of the overall mRNA manufacturing process. Looking at the litigation timelines and milestones in the US on Slide 15; the picture is more straightforward and a lot less complex compared to Germany.
For a start, all proceedings, including validity infringement and potential damages are public and heard by the same court. Also, all three proceedings will be decided in one trial, and this trial will cover all 10 patents. Therefore, there is no differentiation between proceedings featured in this timeline overview. As a brief reminder, the US litigation was initiated with a declarative judgment action filed by Pfizer and BioNTech in July 2022 and the federal district court of Massachusetts, seeking confirmation that COVID-19 does not infringe [indiscernible] patents. In May 2023, we successfully transferred the case to the US District Court for the Eastern District of Virginia, followed by our counterclaim alleging infringement of six additional patents which were further extended by another patent in July 2023 to result in the 10 overall patents being mitigated now.
The District Court for the Eastern District of Virginia is well known to have one of the fastest trial docs in the US. Accordingly, a trial that has already been set for October 1st, 2024. We remain confident in the strength of our IP portfolio and continue to make progress towards the recognition of our pioneering contributions to the development of COVID-19 mRNA vaccines. With this, I would like to conclude the business update and hand over to Pierre for a review of the financial data.
Pierre Kemula: Thank you, Alexander. Good morning and good afternoon to everyone on the call. Looking at our cash position on slide 16; as already mentioned, we closed the third quarter and the first nine months of 2023 with €464.1 million. Cash used in operation was mainly allocated to R&D activities, expenditures for our GMP IV production facility and purchases of R&D material. 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 assets in COVID-19. First, let us look at the revenues. Revenues increased by €5.3 million to €16.5 million in the third quarter and decreased by €24.5 million to €31.2 million in the first nine months of 2023 compared to the same period in 2022.
The decrease over the first nine months year-on-year was primarily driven by lower revenues from our two GSK collaboration agreements. Revenue from both collaboration decreased year-on-year and amounted to a total of €28.7 million, the first nine month of 2023 compared to €52.7 million in the same period in 2022. The decrease was driven by two elements. First, the agreement of both companies to focus on larger indications; and second, a higher 2022 comparator base due to the recognition of the milestone related to the start of the flu Phase 1 clinical trial in Panama. Operating loss was €54 million for the third quarter of 2023, representing a €1.6 million increase compared to the same quarter of 2022. The first nine months of 2023, operating loss increased by €58.3 million to €186.2 million compared to the same period in 2022.
Beyond the lower revenues, the operating result was affected by several key drivers. First, cost of sales decreased year-on-year, mainly as the impact of our first-generation COVID vaccine subsided. This resulted in lower write-off of raw materials in the first nine months of 2023 as well as lower impact on costs related to the termination of CMO activities. Second, R&D expenses increased with higher investment in later-stage infectious disease and oncology development programs as well as strengthening the workforce. The first nine months of 2022, R&D expenses were positively impacted in the amount of €36.8 million related to the reversal of an outstanding CRO provision as well as by a one-off net gain for a change in the contract termination provision, resulting primarily in GSK taking over from the company committed capacity at the CMO.
Third, and still in first nine months of 2022, other income was positively impacted by a one-off amounting to €32.5 million for reimbursement of prepayments and production activity setup at the CMO. Financial results increased by €0.6 million to a profit of €5.4 million in the third quarter of 2023, an increase by €5.2 million to a profit of €12.7 million for the first nine months of 2023 compared to the same period in 2022. They were mainly driven by interest income and cash investments. Pre-tax losses were €48.7 million for the third quarter and €173.5 million for the first nine months of 2023. With this, I would like to hand back the call to Alexander for the summary of today's key messages.
Alexander Zehnder: Thank you, Pierre. So let me summarize the key takeaways for today. We continue to deliver across our strategic priorities for 2023 by successfully advancing our clinical lead programs both in infectious diseases as well as oncology. Our Phase 2 studies in COVID-19 and seasonal flu, which are being conducted in collaboration with GSK as well as our Phase1I trial in glioblastoma are progressing well and according to plan. And we expect to maintain our strong momentum in 2024 with key clinical data readouts from all three studies as well as expected advancement to Phase 3 developments in infectious diseases. Together with the progress we have made in safeguarding our investment in innovation and our strong cash position of €464.1 million we will support the execution of our priorities to mid-2025.
This clinical progress underscores our strong commitment to introduce new health care solutions to the market. And with this, I would like to conclude our presentation, and we will now open the webcast for your questions.
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